{"dataset": "US medtech buying signals, complete archive", "schema_version": 1, "license": "https://creativecommons.org/licenses/by/4.0/", "canonical_base": "https://data.whimbrelresearch.com", "generated_at": "2026-09-27T15:42:15.973198+00:00", "next_update_utc": "2026-09-28T13:00:00+00:00", "update_cadence": "daily", "publisher": {"name": "Whimbrel Research", "url": "https://whimbrelresearch.com", "contact": "mailto:nate@whimbrelresearch.com"}, "total_events": 16595, "window_note": "The complete archive, not a window. 'date' is the event's own date; 'observed' is when it entered the archive, which was seeded from registry history, so early events share an observed date. 'id' is stable across editions.", "events": [{"id": "nsf:2604948", "company": "UltraMend Inc", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-10-01", "observed": "2026-08-19", "amount_usd": 305000, "summary": "NSF SBIR award: SBIR Phase I: 3D Micropillar Scaffolds for Self-Powered Bioelectric Stimulation ($305,000)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2604948", "people": [{"name": "John Phillips", "role": "Principal Investigator"}]}, {"id": "nsf:2604906", "company": "Medenovate LLC", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-10-01", "observed": "2026-08-19", "amount_usd": 305000, "summary": "NSF SBIR award: SBIR Phase I: Prosthetic implantable lens with integrated intraocular pressure sensor ($305,000)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2604906", "people": [{"name": "Jae Kim", "role": "Principal Investigator"}]}, {"id": "nsf:2528353", "company": "Modular Matter, Inc.", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-10-01", "observed": "2026-08-19", "amount_usd": 305000, "summary": "NSF SBIR award: SBIR Phase I: Universally-Adjustable Modular Prosthesis Socket ($305,000)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2528353", "people": [{"name": "Jeffrey L Gair", "role": "Principal Investigator"}]}, {"id": "nsf:2537968", "company": "Senphonix, Inc", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-10-01", "observed": "2026-08-19", "amount_usd": 304950, "summary": "NSF STTR award: STTR Phase I: A New Class of Injection Molded Biosymbiotic Devices for Long-Term, Multimodal Physiological Monitoring ($304,950)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2537968", "people": [{"name": "John L Grant", "role": "Principal Investigator"}]}, {"id": "nsf:2604339", "company": "Myxtek Bio, LLC", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-10-01", "observed": "2026-08-20", "amount_usd": 305000, "summary": "NSF STTR award: STTR Phase I: A Scalable Bruchs Membrane Platform to Find Better Treatments and a Cure for Age Related Macular Degeneration ($305,000)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2604339", "people": [{"name": "Christian Iverson", "role": "Principal Investigator"}]}, {"id": "nsf:2611964", "company": "Nuukbio Inc", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-10-01", "observed": "2026-08-22", "amount_usd": 305000, "summary": "NSF STTR award: STTR Phase I: Revealing Dangers in Heart Cells Using Multiple Molecular Sensors ($305,000)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2611964", "people": [{"name": "CHANGHO CHUN", "role": "Principal Investigator"}]}, {"id": "nsf:2537739", "company": "Yadonai LLC", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-10-01", "observed": "2026-09-15", "amount_usd": 304990, "summary": "NSF SBIR award: SBIR Phase I: Ultra-low volume approach to injections using a novel jet injection system ($304,990)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2537739", "people": [{"name": "Israel Ojo", "role": "Principal Investigator"}]}, {"id": "usasp:15B10626P00000383", "company": "Sterilelink, Inc", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-10-01", "observed": "2026-09-15", "amount_usd": null, "summary": "Federal medical R&D contract from Federal Prison System / Bureau of Prisons: STERILELINK: STERILIZER PREVENTIVE MAINTENANCE DOS: OCTOBER 1, 2026 THRU SEPTEMBER 30, 2027 QUOTE #: 15145, BILLED QUARTERLY", "source_url": "https://www.usaspending.gov/award/CONT_AWD_15B10626P00000383_1540_-NONE-_-NONE-"}, {"id": "usasp:75N91026F00028", "company": "Leidos Biomedical Research Inc", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-30", "observed": "2026-09-15", "amount_usd": 1912753, "summary": "Federal medical R&D contract from National Institutes of Health: 126797 CAMPUS REPLACE BSCS ($1,912,753)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_75N91026F00028_7529_75N91019D00024_7529"}, {"id": "usasp:75F40126C00093", "company": "University Of Massachusetts Lowell", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-30", "observed": "2026-09-20", "amount_usd": 456721, "summary": "Federal medical R&D contract from Food and Drug Administration: TO PROVIDE RESEARCH AND DEVELOPMENT SERVICES TO DESIGN, DEVELOP, VALIDATE, AND DELIVER AN AI-ASSISTED DIGITAL TWIN PLATFORM FOR PHARMACEUTIC ($456,721)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_75F40126C00093_7524_-NONE-_-NONE-"}, {"id": "usasp:75F40126C00059", "company": "University Of Connecticut", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-30", "observed": "2026-09-23", "amount_usd": 511219, "summary": "Federal medical R&D contract from Food and Drug Administration: TO ADVANCE THE DEVELOPMENT, EVALUATION, AND PREDICTIVE MODELING OF LEVONORGESTREL INTRAUTERINE SYSTEMS (LNG-IUSS) BY INTEGRATING ACCELERATED ($511,219)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_75F40126C00059_7524_-NONE-_-NONE-"}, {"id": "usasp:75F40126P00282", "company": "Harvard Pilgrim Health Care, Inc.", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-29", "observed": "2026-09-15", "amount_usd": 80000, "summary": "Federal medical R&D contract from Food and Drug Administration: SENTINEL 2.0 DATA RETENTION ($80,000)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_75F40126P00282_7524_-NONE-_-NONE-"}, {"id": "trialreg:NCT07840235", "company": "Pregnolia AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-24", "observed": "2026-09-24", "amount_usd": null, "summary": "New device trial registered: Cervical Stiffness in Women With Threatened Preterm Labor: a Czech Cohort Study", "source_url": "https://clinicaltrials.gov/study/NCT07840235"}, {"id": "trialreg:NCT07837921", "company": "Novlead Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-24", "observed": "2026-09-24", "amount_usd": null, "summary": "New device trial registered: Post Market Clinical Follow-up to Assess the Portable Nitric Oxide Generation and Delivery System (INOwill N200) for the Treatment of Neonatal Hypoxic Respiratory Failure Complicated by Pulmonary Hypertension", "source_url": "https://clinicaltrials.gov/study/NCT07837921", "people": [{"name": "Daniele DE LUCA, Professor", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07838077", "company": "Olympus Corporation of the Americas", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-24", "observed": "2026-09-24", "amount_usd": null, "summary": "New device trial registered: Modified SOLTIVE Study", "source_url": "https://clinicaltrials.gov/study/NCT07838077"}, {"id": "trialreg:NCT07840157", "company": "Mynerva Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-24", "observed": "2026-09-24", "amount_usd": null, "summary": "New device trial registered: A Mixed-Methods Exploratory Pilot Study of the Investigational MYNERVA Leia Sensory Prosthesis in U.S. Adults With Peripheral Neuropathy", "source_url": "https://clinicaltrials.gov/study/NCT07840157"}, {"id": "trialreg:NCT07839923", "company": "Siloam Vision", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-24", "observed": "2026-09-24", "amount_usd": null, "summary": "New device trial registered: Prospective Evaluation of iCam-OCT", "source_url": "https://clinicaltrials.gov/study/NCT07839923", "people": [{"name": "John P Campbell, MD", "role": "Study Chair"}]}, {"id": "trialreg:NCT07839091", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-24", "observed": "2026-09-24", "amount_usd": null, "summary": "New device trial registered: Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia", "source_url": "https://clinicaltrials.gov/study/NCT07839091", "people": [{"name": "Andrew Tan", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07839793", "company": "Navamedic AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-24", "observed": "2026-09-24", "amount_usd": null, "summary": "New device trial registered: A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients", "source_url": "https://clinicaltrials.gov/study/NCT07839793"}, {"id": "trialreg:NCT07836998", "company": "Haleon", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-23", "observed": "2026-09-23", "amount_usd": null, "summary": "New device trial registered: A Study to Assess the Efficacy of an Experimental Mouthwash Used With a Marketed Whitening Toothpaste on Stain Build-up", "source_url": "https://clinicaltrials.gov/study/NCT07836998"}, {"id": "trialreg:NCT07836855", "company": "Aquea Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-23", "observed": "2026-09-23", "amount_usd": null, "summary": "New device trial registered: A Fellow Eye Comparative Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent and the Alcon Hydrus Glaucoma Microstent", "source_url": "https://clinicaltrials.gov/study/NCT07836855"}, {"id": "trialreg:NCT07835542", "company": "Neptune Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-23", "observed": "2026-09-23", "amount_usd": null, "summary": "New device trial registered: Triton 1.5 Robotic System for Diagnostic Colonoscopy in the Middle East", "source_url": "https://clinicaltrials.gov/study/NCT07835542"}, {"id": "trialreg:NCT07834593", "company": "Laboratoires Gilbert", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-22", "observed": "2026-09-22", "amount_usd": null, "summary": "New device trial registered: Performance, Safety and Participant Satisfaction Regarding A-CERUMEN\u00ae Medical Devices Used for the Removal of Earwax.", "source_url": "https://clinicaltrials.gov/study/NCT07834593", "people": [{"name": "Marc Henocq, Dr", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07835178", "company": "BrosMed Medical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-22", "observed": "2026-09-22", "amount_usd": null, "summary": "New device trial registered: Post-Marketing Clinical Study of High-Pressure Cutting Balloon", "source_url": "https://clinicaltrials.gov/study/NCT07835178"}, {"id": "trialreg:NCT07834372", "company": "HeartFlow, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-22", "observed": "2026-09-22", "amount_usd": null, "summary": "New device trial registered: REWRITE-CAD Protocol: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease", "source_url": "https://clinicaltrials.gov/study/NCT07834372"}, {"id": "trialreg:NCT07835009", "company": "DyAnsys, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-22", "observed": "2026-09-22", "amount_usd": null, "summary": "New device trial registered: Burnout Among Cardiac Anaesthesiology and Cardiac Surgery Residents", "source_url": "https://clinicaltrials.gov/study/NCT07835009", "people": [{"name": "Bhavya G, Dr", "role": "Principal Investigator"}]}, {"id": "usasp:36C24E26P0034", "company": "University Of Missouri System", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-22", "observed": "2026-09-23", "amount_usd": 32053, "summary": "Federal medical R&D contract from Department of Veterans Affairs: TESTING OF ELECTROSPUN POLYLACTIC-CO-GLYCOLIC ACID FIBERS ($32,053)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_36C24E26P0034_3600_-NONE-_-NONE-"}, {"id": "usasp:36C24126N0927", "company": "The General Hospital Corporation", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-21", "observed": "2026-09-20", "amount_usd": 97219, "summary": "Federal medical R&D contract from Department of Veterans Affairs: BRAIN GATE: ALS HAND STUDIES ($97,219)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_36C24126N0927_3600_36C24123D0050_3600"}, {"id": "trialreg:NCT07829419", "company": "CooperVision International Limited (CVIL)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-21", "observed": "2026-09-21", "amount_usd": null, "summary": "New device trial registered: Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers", "source_url": "https://clinicaltrials.gov/study/NCT07829419"}, {"id": "trialreg:NCT07830797", "company": "Medprin Regenerative Medical Technologies Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-21", "observed": "2026-09-21", "amount_usd": null, "summary": "New device trial registered: Absorbable Hemostatic Fluid Gelatin Trial", "source_url": "https://clinicaltrials.gov/study/NCT07830797"}, {"id": "trialreg:NCT07830550", "company": "American Laboratory Products Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-21", "observed": "2026-09-21", "amount_usd": null, "summary": "New device trial registered: Blood Donation Study for ALPCO Syphilis-T and Syphilis-NT Assay Development", "source_url": "https://clinicaltrials.gov/study/NCT07830550"}, {"id": "trialreg:NCT07831447", "company": "Hypersound Medical Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-21", "observed": "2026-09-21", "amount_usd": null, "summary": "New device trial registered: Hypersound Treatment for Chronic Neuropathic and Radicular Pain", "source_url": "https://clinicaltrials.gov/study/NCT07831447"}, {"id": "nih:5R42NS125895-04", "company": "Navinetics Neuromodulation, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-18", "observed": "2026-09-21", "amount_usd": 1076596, "summary": "NIH award 5R42NS125895-04: An Integrated Neurochemical/Electrophysiological Recording and Neuromodulation System for Basic and Clinical Research ($1,076,596)", "source_url": "https://reporter.nih.gov/project-details/11179569", "people": [{"name": "Kevin Elliott Bennet", "role": "Principal Investigator"}, {"name": "Kendall Lee", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "trialreg:NCT07828184", "company": "CEN Biotech", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-18", "observed": "2026-09-18", "amount_usd": null, "summary": "New device trial registered: URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis", "source_url": "https://clinicaltrials.gov/study/NCT07828184", "people": [{"name": "Carole Perrin, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07827105", "company": "AccurKardia, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-18", "observed": "2026-09-18", "amount_usd": null, "summary": "New device trial registered: ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting", "source_url": "https://clinicaltrials.gov/study/NCT07827105"}, {"id": "nih:1R43AT013908-01", "company": "Pediatric Psychology Partners, Pc D/b/a Streamind Health", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 657113, "summary": "NIH award 1R43AT013908-01: A Digital Therapy Platform to Improve Access to Cognitive Behavioral Treatment for Youth with Chronic Headaches ($657,113)", "source_url": "https://reporter.nih.gov/project-details/11405195", "people": [{"name": "Samantha Barry", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44TR005335-02A1", "company": "Capienda Biotech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1401698, "summary": "NIH award 2R44TR005335-02A1: High-throughput kinetic system for small-molecule drug discovery ($1,401,698)", "source_url": "https://reporter.nih.gov/project-details/11254697", "people": [{"name": "Mark Aguirre Bernard", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43NS149895-01", "company": "Vibiller, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 324115, "summary": "NIH award 1R43NS149895-01: A Novel Platform to Measure Motor and Reward Biomarkers in Music-Based Stroke Therapy ($324,115)", "source_url": "https://reporter.nih.gov/project-details/11408082", "people": [{"name": "Dana Michelle Bevilacqua", "role": "Principal Investigator"}, {"name": "Pablo Ripolles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EY037603-02", "company": "Universal Adherence, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 927707, "summary": "NIH award 5R44EY037603-02: The iD2: A Smart Eye Drop Cap Monitor for Eye Drop Adherence ($927,707)", "source_url": "https://reporter.nih.gov/project-details/11365143", "people": [{"name": "Brian Edward Breiling", "role": "Principal Investigator"}, {"name": "Robert Kinast", "role": "Principal Investigator"}, {"name": "Steven L Mansberger", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA306750-02", "company": "Cereus Diagnostics Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 714448, "summary": "NIH award 5R44CA306750-02: Lung Cancer FAST (Fragment Analysis, SNP, and Translocations) Testing ($714,448)", "source_url": "https://reporter.nih.gov/project-details/11401239", "people": [{"name": "Justin T Brown", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG099489-01", "company": "Carevirtue Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 499998, "summary": "NIH award 1R44AG099489-01: Reducing ADRD Caregiver Burden With a Novel AI Voice Agent and Automated Workflow Solution for Adult Day Service (ADS) Providers. ($499,998)", "source_url": "https://reporter.nih.gov/project-details/11314148", "people": [{"name": "Richard E Chunga", "role": "Principal Investigator"}, {"name": "Nicole E Werner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG099413-01A1", "company": "Daily Burn, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 499996, "summary": "NIH award 1R43AG099413-01A1: Daily Burn Active Together: A personalized, dyadic exercise and health program for people living with dementia and their family care partners ($499,996)", "source_url": "https://reporter.nih.gov/project-details/11407045", "people": [{"name": "Nathaniel Cohen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA314892-01", "company": "Tempo Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1423186, "summary": "NIH award 1R44CA314892-01: MOSAIC II: A Randomized Clinical Study of the MAP Wound Matrix to Reduce Time to Graft-Readiness after Non-Melanoma Skin Cancer Resection ($1,423,186)", "source_url": "https://reporter.nih.gov/project-details/11406980", "people": [{"name": "Stephanie Deshayes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41HD118857-01", "company": "Ifit Prosthetics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 306870, "summary": "NIH award 1R41HD118857-01: ADVANCED CLOSURE SYSTEM FOR ADJUSTABLE , SUBISCHIAL TRANSFEMORAL SOCKETS ($306,870)", "source_url": "https://reporter.nih.gov/project-details/11183394", "people": [{"name": "TIMOTHY R DILLINGHAM", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HG014106-01A1", "company": "Imyoo Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 794486, "summary": "NIH award 1R44HG014106-01A1: Cell Locker kit: A whole blood fixative chemistry kit for preserving single cell gene expression at room temperature to enable geographical reach of patient-centric at-home immune monitoring ($794,486)", "source_url": "https://reporter.nih.gov/project-details/11315880", "people": [{"name": "Tatyana Dobreva", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR087914-01", "company": "Mechano Therapeutics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 314133, "summary": "NIH award 1R43AR087914-01: A mechano-sensitive drug delivery approach for a non-opioid therapeutic to control acute postoperative joint pain ($314,133)", "source_url": "https://reporter.nih.gov/project-details/11409518", "people": [{"name": "George R. Dodge", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41LM015320-01", "company": "Centaur Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 312528, "summary": "NIH award 1R41LM015320-01: Scalable Free-Text Annotation with Validation: Building Explainable Vision-Language Models in Dermatology ($312,528)", "source_url": "https://reporter.nih.gov/project-details/11407563", "people": [{"name": "Erik Duhaime", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42CA275587-03", "company": "Gradient Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1150000, "summary": "NIH award 5R42CA275587-03: Commercialization of Algorithmic Non-thermal Ablation Technology for the Treatment of Inoperable Tumors ($1,150,000)", "source_url": "https://reporter.nih.gov/project-details/11411434", "people": [{"name": "Jordan Fong", "role": "Principal Investigator"}, {"name": "Michael Benjamin Sano", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA298389-02", "company": "Vigilant Laboratories LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1019384, "summary": "NIH award 5R44CA298389-02: Development of an effective, low-cost, point-of-care early detection test for oral cancer in low resource settings ($1,019,384)", "source_url": "https://reporter.nih.gov/project-details/11401361", "people": [{"name": "Joseph A Califano", "role": "Principal Investigator"}, {"name": "Xi Steven Chen", "role": "Principal Investigator"}, {"name": "Elizabeth J Franzmann", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44NS124469-02", "company": "Bmseed, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 700518, "summary": "NIH award 2R44NS124469-02: The first adaptable 3D-formfitting microelectrode array for organoid-based models of neurological and neurodegenerative diseases ($700,518)", "source_url": "https://reporter.nih.gov/project-details/11311188", "people": [{"name": "Oliver Graudejus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG099200-01", "company": "Kneevoice, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 398432, "summary": "NIH award 1R43AG099200-01: A non-invasive auscultation device for early detection of articular cartilage damage ($398,432)", "source_url": "https://reporter.nih.gov/project-details/11308404", "people": [{"name": "Gustavo De Greiff", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA315543-01", "company": "Smart Breast Corporation D/b/a Smart Breast Corp", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 945687, "summary": "NIH award 1R44CA315543-01: Commercial-Ready Molecular Breast Imaging (MBI) for Biopsy Guidance ($945,687)", "source_url": "https://reporter.nih.gov/project-details/11410559", "people": [{"name": "James W Hugg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA314758-01", "company": "Cellsbin, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1045925, "summary": "NIH award 1R44CA314758-01: Detection and Isolation of Circulating Myeloma Cells: Toward a Minimally-Invasive CLIA-Certified Diagnostic for Multiple Myeloma ($1,045,925)", "source_url": "https://reporter.nih.gov/project-details/11409627", "people": [{"name": "Ali Kabiri", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG099700-01", "company": "Aventusoft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 500000, "summary": "NIH award 1R43AG099700-01: A Smart Remote Monitoring System for Cardiometabolic Management in Patients with Alzheimer's and Related Dementia ($500,000)", "source_url": "https://reporter.nih.gov/project-details/11319458", "people": [{"name": "Kaustubh Kale", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA291369-02", "company": "Exai Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 718994, "summary": "NIH award 5R44CA291369-02: Orphan Non-coding RNA-based Test for Detecting Minimal Residual Disease in Resectable Non-small Cell Lung Cancer ($718,994)", "source_url": "https://reporter.nih.gov/project-details/11192382", "people": [{"name": "Jeremy Ku", "role": "Principal Investigator"}, {"name": "Sandip Pravin Patel", "role": "Principal Investigator"}, {"name": "Lee S Schwartzberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41CA302359-01A1", "company": "Photodynamic Solutions Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 315333, "summary": "NIH award 1R41CA302359-01A1: Low-cost technology for image-guided photodynamic treatment of oral lesions in resource-limited settings ($315,333)", "source_url": "https://reporter.nih.gov/project-details/11409103", "people": [{"name": "Hui Liu", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA275508-03", "company": "Sonalasense Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 497384, "summary": "NIH award 5R44CA275508-03: Sonodynamic therapy using MRI-guided focused ultrasound in combination with 5-aminolevulinic acid to treat recurrent glioblastoma multiforme ($497,384)", "source_url": "https://reporter.nih.gov/project-details/11408427", "people": [{"name": "Stuart Marcus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R42CA314789-01", "company": "Cansera, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 290828, "summary": "NIH award 1R42CA314789-01: CellLogic: Deep Learning Identification and Characterization of Rare Events in Fluorescent Whole Slide Imaging ($290,828)", "source_url": "https://reporter.nih.gov/project-details/11409312", "people": [{"name": "Jeremy Mason", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL172473-03", "company": "Cerulean Scientific Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1072347, "summary": "NIH award 5R44HL172473-03: Slippery, Omniphobic Coating to Prevent Thrombosis and Biofilm Formation on Peripheral Vascular Grafts ($1,072,347)", "source_url": "https://reporter.nih.gov/project-details/11364195", "people": [{"name": "Todd McFarland", "role": "Principal Investigator"}, {"name": "Daniel Durant Myers", "role": "Principal Investigator"}, {"name": "Andrea Tara Obi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44NS155776-04", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1040504, "summary": "NIH award 2R44NS155776-04: Vibration-integrated Lancing System to Reduce Stress, Pain Response, Heel Damage and Developmental Harm from Recurring Heel Sticks in Neonates ($1,040,504)", "source_url": "https://reporter.nih.gov/project-details/11252698", "people": [{"name": "Olga M Ocon-Grove", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44CA314878-01", "company": "Civatech Oncology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1205017, "summary": "NIH award 1R44CA314878-01: CivaDerm Non-Melanoma Skin Cancer Radiation Therapy Device ($1,205,017)", "source_url": "https://reporter.nih.gov/project-details/11408990", "people": [{"name": "Kristy Perez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44MD018245-02", "company": "Saavsus, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 706921, "summary": "NIH award 2R44MD018245-02: Development, feasibility, and acceptability of Aim to Play, a user-friendly digital application for teacher skills training and physical education activities for K-2 elementary students ($706,921)", "source_url": "https://reporter.nih.gov/project-details/11180889", "people": [{"name": "Deborah Johnson-Shelton", "role": "Principal Investigator"}, {"name": "Jeanette Ricci", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG099631-01", "company": "Springbok, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1019030, "summary": "NIH award 1R44AG099631-01: Automated MRI-Based Musculoskeletal and Body Composition Assessment for Healthy Aging ($1,019,030)", "source_url": "https://reporter.nih.gov/project-details/11323830", "people": [{"name": "Silvia Salinas Blemker", "role": "Principal Investigator"}, {"name": "Lara Isabella Riem", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA314780-01", "company": "Insight Surgical Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 982300, "summary": "NIH award 1R44CA314780-01: Advanced Surgical Guidance with Image Updating ($982,300)", "source_url": "https://reporter.nih.gov/project-details/11410095", "people": [{"name": "DAVID W ROBERTS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG100684-01", "company": "Sharper Sense, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 308481, "summary": "NIH award 1R43AG100684-01: Brain-based hearing enhancement: a wearable, noninvasive patch to enhance speech communication and expand treatment access for the hearing impaired ($308,481)", "source_url": "https://reporter.nih.gov/project-details/11349511", "people": [{"name": "Charles Rodenkirch", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HL164191-02A1", "company": "Vasowatch LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1249147, "summary": "NIH award 2R44HL164191-02A1: VIBRANT: Postpartum Hemorrhage Risk Prediction using Maternal Heart Rate ($1,249,147)", "source_url": "https://reporter.nih.gov/project-details/11316152", "people": [{"name": "Christine Rohan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44AG084431-02", "company": "Constantiam Biosciences Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1252240, "summary": "NIH award 2R44AG084431-02: Leveraging high-throughput functional data for assessment of Alzheimer's risk ($1,252,240)", "source_url": "https://reporter.nih.gov/project-details/11406172", "people": [{"name": "Nicholas P Schafer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA309961-01", "company": "Imagenomix Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 157826, "summary": "NIH award 1R43CA309961-01: Analytical Variables and Clinical Utility of AKT1 Mutation Prediction in Breast Cancer Using Deep Learning on Histopathology Images ($157,826)", "source_url": "https://reporter.nih.gov/project-details/11312149", "people": [{"name": "Mikhail Teverovskiy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DK127882-04", "company": "Aplos Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1030000, "summary": "NIH award 2R44DK127882-04: Pivotal Clinical Study to Validate Early Outcomes of a Novel Implantable Device for Surgical Treatment of Gastroesophageal Reflux Disease ($1,030,000)", "source_url": "https://reporter.nih.gov/project-details/11409770", "people": [{"name": "Claude NMN Tihon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R41AG097345-01", "company": "Thought Forward Design, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 392702, "summary": "NIH award 1R41AG097345-01: Skywalker: Innovations in design to improve adoption and use of mobility aids by older adults ($392,702)", "source_url": "https://reporter.nih.gov/project-details/11255726", "people": [{"name": "Meryl Unger", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG080861-03", "company": "Biosensics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 1000082, "summary": "NIH award 2R44AG080861-03: Phase IIB: A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration Syndromes ($1,000,082)", "source_url": "https://reporter.nih.gov/project-details/11408363", "people": [{"name": "ADAM L. BOXER", "role": "Principal Investigator"}, {"name": "Irene Litvan", "role": "Principal Investigator"}, {"name": "Julio Cesar Rojas-Martinez", "role": "Principal Investigator"}, {"name": "Ashkan Vaziri", "role": "Principal Investigator"}, {"name": "Anne-Marie Wills", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA232879-06", "company": "Doseoptics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 998974, "summary": "NIH award 5R44CA232879-06: DoseRT\u2122 : A Non-Contact Optical Patient and Beam Dosimetry System for Continuous in vivo Radiotherapy Verification ($998,974)", "source_url": "https://reporter.nih.gov/project-details/11337506", "people": [{"name": "William Ware", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R43HG014430-01A1", "company": "Foli Bio Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-21", "amount_usd": 399875, "summary": "NIH award 1R43HG014430-01A1: Development of fecal exfoliome sequencing as a multi-omics approach for gut health management ($399,875)", "source_url": "https://reporter.nih.gov/project-details/11314303", "people": [{"name": "Yiming Huang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG102361-01", "company": "Nextstep Robotics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-22", "amount_usd": 306884, "summary": "NIH award 1R41AG102361-01: A Modular Overground Balance Walkway for Task-Specific Perturbation-based Fall Prevention Assessment and Training ($306,884)", "source_url": "https://reporter.nih.gov/project-details/11407994", "people": [{"name": "Kelly Westlake", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA310250-01", "company": "Cellfe Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-22", "amount_usd": 1052108, "summary": "NIH award 1R44CA310250-01: High throughput, high efficiency, rapid mechanical transfection for CAR T-cell therapeutics ($1,052,108)", "source_url": "https://reporter.nih.gov/project-details/11314137", "people": [{"name": "Todd Sulchek", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG097312-01A1", "company": "Numentus Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-23", "amount_usd": 304788, "summary": "NIH award 1R43AG097312-01A1: Highly Multiplexed Extracellular Vesicle Analysis for Alzheimer's Disease ($304,788)", "source_url": "https://reporter.nih.gov/project-details/11409249", "people": [{"name": "GREGORY W FARIS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG091950-01A1", "company": "Carevirtue Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-17", "observed": "2026-09-24", "amount_usd": 498170, "summary": "NIH award 1R41AG091950-01A1: KNOW Dementia: An Evidence-based Intervention with Artificial Intelligence to Support the Unique Mealtime Management Needs of AD/ADRD Care Partners ($498,170)", "source_url": "https://reporter.nih.gov/project-details/11315776", "people": [{"name": "Wen Liu", "role": "Principal Investigator"}, {"name": "Nicole E Werner", "role": "Principal Investigator"}, {"name": "Matthew Zuraw", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07825337", "company": "Eric Rosenberg", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-17", "observed": "2026-09-17", "amount_usd": null, "summary": "New device trial registered: Pilot Study: Feasibility and Usability of a Head-Mounted Spatial Computing Device for Intraoperative Visualization During Intraocular Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07825337"}, {"id": "trialreg:NCT07825363", "company": "NIRSense Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-17", "observed": "2026-09-17", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock", "source_url": "https://clinicaltrials.gov/study/NCT07825363", "people": [{"name": "David A. Baran, MD", "role": "Principal Investigator"}, {"name": "Thibault Roumengous, PhD", "role": "Study Director"}]}, {"id": "trialreg:NCT07825558", "company": "Signal Relief", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-17", "observed": "2026-09-17", "amount_usd": null, "summary": "New device trial registered: A Study of the Jovi Patch, Powered by Signal Relief, for the Improvement of General Menstrual Discomfort", "source_url": "https://clinicaltrials.gov/study/NCT07825558"}, {"id": "trialreg:NCT07826637", "company": "Hemorai Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-17", "observed": "2026-09-17", "amount_usd": null, "summary": "New device trial registered: Study of the Hemorai Vysio Wearable Device for Monitoring Changes Related to Blood Loss in Patients During and After Surgery.", "source_url": "https://clinicaltrials.gov/study/NCT07826637", "people": [{"name": "Elliot Servais, MD, FACS", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07826429", "company": "Fisher and Paykel Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-17", "observed": "2026-09-17", "amount_usd": null, "summary": "New device trial registered: Evaluation of the F&P Licorice Mask, US, 2026", "source_url": "https://clinicaltrials.gov/study/NCT07826429"}, {"id": "trialreg:NCT07824583", "company": "Varian, a Siemens Healthineers Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-17", "observed": "2026-09-17", "amount_usd": null, "summary": "New device trial registered: A Study Evaluating a New Radiation Treatment Workflow (NGDS)", "source_url": "https://clinicaltrials.gov/study/NCT07824583"}, {"id": "nih:4R44CA310319-02", "company": "Persistence Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-16", "observed": "2026-09-21", "amount_usd": 818764, "summary": "NIH award 4R44CA310319-02: The SynthNode Paradigm: Reimagining CAR T Cell Therapy for Improved Patient Outcomes ($818,764)", "source_url": "https://reporter.nih.gov/project-details/11457453", "people": [{"name": "Pritha Agarwalla", "role": "Principal Investigator"}, {"name": "Jan Van Deursen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41EB038879-01", "company": "Better Bleeding Control LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-16", "observed": "2026-09-21", "amount_usd": 320217, "summary": "NIH award 1R41EB038879-01: Advanced Biofeedback Mechanisms for Realistic Hemorrhage Control Training ($320,217)", "source_url": "https://reporter.nih.gov/project-details/11314013", "people": [{"name": "Brittany Bankhead", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HD115460-02", "company": "Finnegan The Dragon, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-16", "observed": "2026-09-21", "amount_usd": 1586983, "summary": "NIH award 2R44HD115460-02: Development of preschool speech-to-print curricula with online gaming technology for early language development. ($1,586,983)", "source_url": "https://reporter.nih.gov/project-details/11405682", "people": [{"name": "Emily John Cadiz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41GM170768-01", "company": "Noma AI Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-16", "observed": "2026-09-21", "amount_usd": 315149, "summary": "NIH award 1R41GM170768-01: A real-time decision support software tool for enhancing ED triage and disposition decisions ($315,149)", "source_url": "https://reporter.nih.gov/project-details/11316047", "people": [{"name": "Francis X. Guyette", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG102262-01", "company": "Senescope, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-16", "observed": "2026-09-21", "amount_usd": 396631, "summary": "NIH award 1R43AG102262-01: A novel AI platform to detect cellular senescence and measure biological age using biofluids ($396,631)", "source_url": "https://reporter.nih.gov/project-details/11409915", "people": [{"name": "Indra Heckenbach", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R41CA306611-02", "company": "Navigation Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-16", "observed": "2026-09-21", "amount_usd": 181271, "summary": "NIH award 5R41CA306611-02: Targeted Localization and Optimized Surgical Resection for Lung Cancer ($181,271)", "source_url": "https://reporter.nih.gov/project-details/11417942", "people": [{"name": "Jayender Jagadeesan", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44EB038173-01A1", "company": "Opticara LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-16", "observed": "2026-09-21", "amount_usd": 1022499, "summary": "NIH award 1R44EB038173-01A1: Perfusion assessment of parathyroid glands intra-operatively using a hand heldlaser speckle contrast imaging ($1,022,499)", "source_url": "https://reporter.nih.gov/project-details/11410401", "people": [{"name": "Kevin Kjoller", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL164325-04", "company": "Ivos Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-16", "observed": "2026-09-21", "amount_usd": 144919, "summary": "NIH award 5R44HL164325-04: IVOS Medical: Intubation, Optimized. ($144,919)", "source_url": "https://reporter.nih.gov/project-details/11389221", "people": [{"name": "Gabriel Punsalan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43GM165210-01", "company": "Proteovista, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-16", "observed": "2026-09-21", "amount_usd": 286118, "summary": "NIH award 1R43GM165210-01: Development of the High-Density SNAP-Dimer Microarray for Functional Analysis of Dimeric Protein Complexes ($286,118)", "source_url": "https://reporter.nih.gov/project-details/11409383", "people": [{"name": "Mary Szatkowski Ozers", "role": "Principal Investigator"}, {"name": "Christopher L Warren", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HD115478-03A1", "company": "Bsolutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-16", "observed": "2026-09-22", "amount_usd": 556507, "summary": "NIH award 2R44HD115478-03A1: Cribsy: A platform for home-based automated developmental risk screening ($556,507)", "source_url": "https://reporter.nih.gov/project-details/11407124", "people": [{"name": "BHARATH MODAYUR", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07823088", "company": "MedVasc AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-16", "observed": "2026-09-16", "amount_usd": null, "summary": "New device trial registered: Open Label Safety Investigation of Solutio\u2122 Tumescent Catheter", "source_url": "https://clinicaltrials.gov/study/NCT07823088", "people": [{"name": "Michael Akesson, MD", "role": "Study Director"}]}, {"id": "trialreg:NCT07821697", "company": "Adraxe Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-16", "observed": "2026-09-16", "amount_usd": null, "summary": "New device trial registered: Translational Recording and Characterization of Epilepsy Signals Using Subgaleal EEG During Standard-of-care SEEG Monitoring", "source_url": "https://clinicaltrials.gov/study/NCT07821697"}, {"id": "trialreg:NCT07822581", "company": "SB Technology, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-16", "observed": "2026-09-16", "amount_usd": null, "summary": "New device trial registered: \"Discovery2\" Study of Using MCG at Emergency Departments", "source_url": "https://clinicaltrials.gov/study/NCT07822581", "people": [{"name": "Kit Yee Au-Yeung, PhD", "role": "Study Director"}]}, {"id": "trialreg:NCT07823465", "company": "NeuroPace", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-16", "observed": "2026-09-16", "amount_usd": null, "summary": "New device trial registered: RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study", "source_url": "https://clinicaltrials.gov/study/NCT07823465", "people": [{"name": "Ashish Deshpande, MD", "role": "Principal Investigator"}]}, {"id": "usasp:36C24126N0923", "company": "Tasso Inc.", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-16", "observed": "2026-09-22", "amount_usd": 671160, "summary": "Federal medical R&D contract from Department of Veterans Affairs: SELF-COLLECTION BLOOD SAMPLE KIT DISTRIBUTION/TRACKING ($671,160)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_36C24126N0923_3600_36C24123D0012_3600"}, {"id": "trialreg:NCT07820397", "company": "Apyx Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-15", "observed": "2026-09-15", "amount_usd": null, "summary": "New device trial registered: Within-Subject Comparison of Adipose Tissue Viability Following Liposuction", "source_url": "https://clinicaltrials.gov/study/NCT07820397", "people": [{"name": "Paul Vanek, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07819773", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-15", "observed": "2026-09-15", "amount_usd": null, "summary": "New device trial registered: Device for Treating Generalized Anxiety", "source_url": "https://clinicaltrials.gov/study/NCT07819773"}, {"id": "trialreg:NCT07820631", "company": "Circle Safe, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-15", "observed": "2026-09-15", "amount_usd": null, "summary": "New device trial registered: First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation", "source_url": "https://clinicaltrials.gov/study/NCT07820631", "people": [{"name": "St\u00e9phane COMBES, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07820930", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-15", "observed": "2026-09-15", "amount_usd": null, "summary": "New device trial registered: A Global Randomized Trial Evaluating the FARAFLEX\u2122 Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07820930"}, {"id": "usasp:36C24E26P0039", "company": "The Cleveland Clinic Foundation", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-15", "observed": "2026-09-15", "amount_usd": 99840, "summary": "Federal medical R&D contract from Department of Veterans Affairs: EYE MOVEMENT OPHTHALMOLOGY RESEARCH SUPPORT ($99,840)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_36C24E26P0039_3600_-NONE-_-NONE-"}, {"id": "usasp:36C26026P0712", "company": "University Of Washington", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-15", "observed": "2026-09-15", "amount_usd": 38954, "summary": "Federal medical R&D contract from Department of Veterans Affairs: FIT TESTING COST-EFFECTIVENESS RESEARCH - BASE + 1 OPTION YEAR. ($38,954)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_36C26026P0712_3600_-NONE-_-NONE-"}, {"id": "usasp:75F40126F80135", "company": "The Mitre Corporation", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-15", "observed": "2026-09-15", "amount_usd": 519949, "summary": "Federal medical R&D contract from Food and Drug Administration: CMS FFRDC TASK ORDER - CYBERSECURITY RISK ASSESSMENT OF EMERGING AND LEGACY MEDICAL DEVICES ($519,949)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_75F40126F80135_7524_75FCMC23D0004_7530"}, {"id": "usasp:36C24E26P0037", "company": "Oregon Health & Science University", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-15", "observed": "2026-09-17", "amount_usd": 174999, "summary": "Federal medical R&D contract from Department of Veterans Affairs: MACHINE LEARNING ANALYTICS FOR TOTAL BRAIN DIAGNOSTICS ($174,999)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_36C24E26P0037_3600_-NONE-_-NONE-"}, {"id": "usasp:36C24E26P0045", "company": "Case Western Reserve University", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-15", "observed": "2026-09-17", "amount_usd": 30000, "summary": "Federal medical R&D contract from Department of Veterans Affairs: PROTOTYPE AND FABRICATION RESEARCH SERVICES ($30,000)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_36C24E26P0045_3600_-NONE-_-NONE-"}, {"id": "usasp:36C26126P1095", "company": "The Leland Stanford Junior University", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-15", "observed": "2026-09-19", "amount_usd": 39171, "summary": "Federal medical R&D contract from Department of Veterans Affairs: MASS SPECTROMETRY SERVICES EO 14398 ($39,171)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_36C26126P1095_3600_-NONE-_-NONE-"}, {"id": "nih:5R44HL172541-03", "company": "Rithim Biologics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-21", "amount_usd": 768857, "summary": "NIH award 5R44HL172541-03: Novel Gene Therapy, Techniques, and Devices to Prevent Ventricular Tachycardia ($768,857)", "source_url": "https://reporter.nih.gov/project-details/11411411", "people": [{"name": "Ronald Lee Anderson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44DK145303-01A1", "company": "Equa Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-21", "amount_usd": 325417, "summary": "NIH award 1R44DK145303-01A1: Live Coaching Support Integration in Digital Mindfulness Training ($325,417)", "source_url": "https://reporter.nih.gov/project-details/11405169", "people": [{"name": "John David Creswell", "role": "Principal Investigator"}, {"name": "Mathew Polowitz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R42NS134505-03", "company": "Neurinsight, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-21", "amount_usd": 822591, "summary": "NIH award 5R42NS134505-03: Towards intra-operative guidance in brain tumor surgery using real-time resting-state functional MRI ($822,591)", "source_url": "https://reporter.nih.gov/project-details/11418910", "people": [{"name": "Dieter W Dennig", "role": "Principal Investigator"}, {"name": "Stefan Posse", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44EY038558-01", "company": "Family Eye Care Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-21", "amount_usd": 981739, "summary": "NIH award 1R44EY038558-01: A Multi-Center Study of the Custom 3-D Printed Magnetic Levator Prosthesis for Severe Blepharoptosis ($981,739)", "source_url": "https://reporter.nih.gov/project-details/11313718", "people": [{"name": "Kevin Edward Houston", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA257624-02", "company": "Microstructure Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-21", "amount_usd": 1137424, "summary": "NIH award 2R44CA257624-02: Non-invasive neurosurgical planning with Random Matrix Theory MRI ($1,137,424)", "source_url": "https://reporter.nih.gov/project-details/11407450", "people": [{"name": "Grigoriy Lemberskiy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA302049-01A1", "company": "Mango, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-21", "amount_usd": 306817, "summary": "NIH award 1R43CA302049-01A1: Developing a rapid sterility solution to deliver Time to Detection for autologous CAR-T Cell Therapies ($306,817)", "source_url": "https://reporter.nih.gov/project-details/11308426", "people": [{"name": "Jonathan Pham", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB038809-01", "company": "Auscultech Dx, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-21", "amount_usd": 314364, "summary": "NIH award 1R43EB038809-01: Development of a Compact Wireless Interface for Augmented Reality Ultrasound Guidance ($314,364)", "source_url": "https://reporter.nih.gov/project-details/11312489", "people": [{"name": "Raj Shekhar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS110114-04", "company": "Endomimetics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-21", "amount_usd": 665292, "summary": "NIH award 5R44NS110114-04: Enhanced endothelialization of nanomatrix coated flow diverter for intracranial aneurysms ($665,292)", "source_url": "https://reporter.nih.gov/project-details/11418933", "people": [{"name": "Jennifer Sherwood", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44DK145328-01A1", "company": "Origin Endoscopy Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-21", "amount_usd": 1212289, "summary": "NIH award 1R44DK145328-01A1: Development of EpiMAX, a first-in-class injectable hemostatic agent for long-acting hemostasis of gastrointestinal bleeding ($1,212,289)", "source_url": "https://reporter.nih.gov/project-details/11407431", "people": [{"name": "Jeremy SHANE Starkweather", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41DE035779-01A1", "company": "Preserver Tech LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-21", "amount_usd": 306872, "summary": "NIH award 1R41DE035779-01A1: A Cost-Effective Alternative Product for Gingival Regeneration ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11407730", "people": [{"name": "Lobat Tayebi", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44GM165269-01", "company": "Membrane Sciences, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-21", "amount_usd": 306645, "summary": "NIH award 1R44GM165269-01: Development of a Kit for Profiling Unbound Free Fatty Acids ($306,645)", "source_url": "https://reporter.nih.gov/project-details/11410500", "people": [{"name": "Andy Huber", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41DE035767-01", "company": "Intellident Systems Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-14", "observed": "2026-09-24", "amount_usd": 304974, "summary": "NIH award 1R41DE035767-01: Communication Optimization via Artificial Intelligence for Dentistry (CoAID): Validating a Three-Stage Digital Health Platform to Enhance Dental Care Communication ($304,974)", "source_url": "https://reporter.nih.gov/project-details/11314089", "people": [{"name": "Niam Yaraghi", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07817394", "company": "Dermal Laboratories Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-14", "observed": "2026-09-14", "amount_usd": null, "summary": "New device trial registered: Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Psoriasis", "source_url": "https://clinicaltrials.gov/study/NCT07817394"}, {"id": "trialreg:NCT07819305", "company": "Johnson & Johnson Vision Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-14", "observed": "2026-09-14", "amount_usd": null, "summary": "New device trial registered: Evaluation of Approved Contact Lenses (CR-6657)", "source_url": "https://clinicaltrials.gov/study/NCT07819305", "people": [{"name": "Johnson & Johnson Vision Care, Inc. Clinical Trial", "role": "Study Director"}]}, {"id": "trialreg:NCT07819370", "company": "Colgate Palmolive", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-14", "observed": "2026-09-14", "amount_usd": null, "summary": "New device trial registered: Enamel Lesion Detection With New DX Tool", "source_url": "https://clinicaltrials.gov/study/NCT07819370"}, {"id": "usasp:36C24626P1069", "company": "Duke University", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-14", "observed": "2026-09-17", "amount_usd": 18095, "summary": "Federal medical R&D contract from Department of Veterans Affairs: MRI RESEARCH SERVICES ($18,095)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_36C24626P1069_3600_-NONE-_-NONE-"}, {"id": "fda:K262526", "company": "Tianjin Huahong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-13", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262526: Safety lancet (XL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262526", "people": [{"name": "Ningning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262526%22"}, {"id": "fda:K261287", "company": "Ascom Ums Srl Unipersonale", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-12", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261287: Digistat Care", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261287", "people": [{"name": "Tomaso Muzzu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261287%22"}, {"id": "fda:K260133", "company": "Odin Medical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-12", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260133: CADDIE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260133", "people": [{"name": "Luke Sampson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260133%22"}, {"id": "nih:5R44CA310518-02", "company": "Embiosys Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-11", "observed": "2026-09-14", "amount_usd": 870482, "summary": "NIH award 5R44CA310518-02: CuRrEnT: Capecitabine in RCB2/3 with a wearable induced Electric field device in Triple Negative Breast Cancer ($870,482)", "source_url": "https://reporter.nih.gov/project-details/11418087", "people": [{"name": "Christopher Barron", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42HL166051-03", "company": "Coram Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-11", "observed": "2026-09-14", "amount_usd": 1043326, "summary": "NIH award 5R42HL166051-03: Non Magnetic MRI Conditional External Defibrillator with Reduced Skeletal Muscle Contraction ($1,043,326)", "source_url": "https://reporter.nih.gov/project-details/11399943", "people": [{"name": "HENRY R HALPERIN", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA281547-03", "company": "Vizlitics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-11", "observed": "2026-09-14", "amount_usd": 1145004, "summary": "NIH award 5R44CA281547-03: VIPCare: Virtual Predictive Care workflow with EHR integrated surveillance for optimalfollow-up care management for Cancer Patients ($1,145,004)", "source_url": "https://reporter.nih.gov/project-details/11411074", "people": [{"name": "Tarun Kumar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL178318-02", "company": "Vesteck, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-11", "observed": "2026-09-14", "amount_usd": 624389, "summary": "NIH award 5R44HL178318-02: Endovascular Suturing Device for Augmentation of Endograft Fixation During Endovascular Repair of Abdominal Aortic Aneurysm to Reduce Reinterventions Due to Endograft Migration or Type 1a Endoleak ($624,389)", "source_url": "https://reporter.nih.gov/project-details/11414951", "people": [{"name": "Kent Stalker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R42NS147759-01", "company": "Objective Biotechnology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-11", "observed": "2026-09-14", "amount_usd": 479794, "summary": "NIH award 1R42NS147759-01: Bionic Imaging Platform (BIP) for high performance functional imaging in freely navigating rodents ($479,794)", "source_url": "https://reporter.nih.gov/project-details/11316597", "people": [{"name": "Aaron Michael Kerlin", "role": "Principal Investigator"}, {"name": "Suhasa B Kodandaramaiah", "role": "Principal Investigator"}, {"name": "Daniel A Surinach", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R42CA314592-01", "company": "Bioptics Imaging LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-11", "observed": "2026-09-14", "amount_usd": 294571, "summary": "NIH award 1R42CA314592-01: Real-Time, Dye-Free, Time-Resolved Optical Imaging of Mastectomy Flap Viability ($294,571)", "source_url": "https://reporter.nih.gov/project-details/11407401", "people": [{"name": "Guoqiang Yu", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44EY039162-01", "company": "Vivid Vision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-11", "observed": "2026-09-21", "amount_usd": 1047810, "summary": "NIH award 1R44EY039162-01: Use of a virtual reality headset to test the untestable patients with glaucoma ($1,047,810)", "source_url": "https://reporter.nih.gov/project-details/11406843", "people": [{"name": "BENJAMIN T BACKUS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL182394-01A1", "company": "Upstream Access, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-11", "observed": "2026-09-21", "amount_usd": 320893, "summary": "NIH award 1R43HL182394-01A1: Development of combined U-turn catheter and self-anchoring sheath system for turning direction of established percutaneous vascular access ($320,893)", "source_url": "https://reporter.nih.gov/project-details/11403143", "people": [{"name": "Jeffrey Carpenter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL184579-01A1", "company": "Lucier Pharmaceuticals Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-11", "observed": "2026-09-21", "amount_usd": 606311, "summary": "NIH award 1R41HL184579-01A1: Diagnostic and Therapeutic Potential of LU-1001 for Coronary Microvascular Dysfunction ($606,311)", "source_url": "https://reporter.nih.gov/project-details/11409376", "people": [{"name": "JONATHAN BOVA", "role": "Principal Investigator"}, {"name": "Guangrong Lu", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07816029", "company": "Append Medical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-11", "observed": "2026-09-11", "amount_usd": null, "summary": "New device trial registered: Append Prague Study", "source_url": "https://clinicaltrials.gov/study/NCT07816029"}, {"id": "trialreg:NCT07815314", "company": "Rhaeos, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-11", "observed": "2026-09-11", "amount_usd": null, "summary": "New device trial registered: A Prospective Study Comparing CSF Shunt Flow Between \"Virtual Off\" and \"Flow Permissive\" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow Sensor", "source_url": "https://clinicaltrials.gov/study/NCT07815314"}, {"id": "trialreg:NCT07816185", "company": "Pulmovant, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-11", "observed": "2026-09-11", "amount_usd": null, "summary": "New device trial registered: A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier)", "source_url": "https://clinicaltrials.gov/study/NCT07816185", "people": [{"name": "Ubaldo Martin", "role": "Study Director"}]}, {"id": "fda:K254185", "company": "Jeisys Medical Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254185: Potenza Prime", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254185", "people": [{"name": "HeeKyung Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254185%22"}, {"id": "fda:K262874", "company": "CraniUS, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262874: CraniUS Plate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262874", "people": [{"name": "Sachin Thanawala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262874%22"}, {"id": "fda:K260410", "company": "Zhejiang Chuangxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260410: Single Use Ureteral Access Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260410", "people": [{"name": "Haishao Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260410%22"}, {"id": "fda:K260063", "company": "The General Hospital Corporation, d/b/a Massachusetts", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260063: GSPE Spacer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260063", "people": [{"name": "Orhun Muratoglu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260063%22"}, {"id": "fda:K262025", "company": "INNO Holdings Inc. DBA Innovasis", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262025: Innovasis AxTiHA\u00ae Stand-Alone ALIF System;Innovasis TxTiHA\u00ae IBF System;Innovasis HAtetracell\u00ae-C Titanium Cervical IBF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262025", "people": [{"name": "Michael Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262025%22"}, {"id": "fda:K262397", "company": "Eizo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262397: CuratOR EX2742", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262397", "people": [{"name": "Hiroaki Hashimoto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262397%22"}, {"id": "fda:K262151", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262151: SpaceOAR Flex\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262151", "people": [{"name": "Shirin Mate", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262151%22"}, {"id": "fda:K262763", "company": "Beta Bionics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262763: iLet Dosing Decision Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262763", "people": [{"name": "Liz Cooper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262763%22"}, {"id": "fda:K261305", "company": "Microstructure Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261305: MICSI-PET", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261305", "people": [{"name": "Gregory Lemberskiy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261305%22"}, {"id": "fda:K260115", "company": "41Medical AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260115: DRIM-Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260115", "people": [{"name": "Alfred Niederberger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260115%22"}, {"id": "fda:K254051", "company": "SmartWise Sweden AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254051: Extroducer Infusion Catheter System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254051", "people": [{"name": "Kamran Kaviani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254051%22"}, {"id": "fda:K261019", "company": "Heidelberg Engineering GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261019: ANTERION", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261019", "people": [{"name": "Arianna Schoess Vargas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261019%22"}, {"id": "fda:K260001", "company": "Beta Bionics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260001: Mint ACE Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260001", "people": [{"name": "Douglas Ferguson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260001%22"}, {"id": "fda:K254123", "company": "Ecomed Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254123: Ecomed Disposable Administration Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254123", "people": [{"name": "David Yurek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254123%22"}, {"id": "fda:K261338", "company": "Smith & Nephew Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261338: RENASYS DYNAFLOW Kit (66807741)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261338", "people": [{"name": "Eve Lester", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261338%22"}, {"id": "fda:K262861", "company": "Xtreem Pulse, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262861: PureLift Pro Max", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262861", "people": [{"name": "Jackie Schmainda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262861%22"}, {"id": "fda:K254119", "company": "Shenzhen Xinyan Medical Technology Co.,ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254119: Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254119", "people": [{"name": "Zhang Haibo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254119%22"}, {"id": "fda:K254177", "company": "Guizhou Zirui Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254177: Disposable Sterile Skull Drill (LZ)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254177", "people": [{"name": "Chang Feng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254177%22"}, {"id": "fda:K261255", "company": "Kowa Company, Ltd. Chofu Factory", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261255: KOWA FM-600", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261255", "people": [{"name": "Kazunori Matsumura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261255%22"}, {"id": "fda:K254174", "company": "Guizhou Zirui Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254174: Surgical Power System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254174", "people": [{"name": "Chang Feng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254174%22"}, {"id": "fda:K253063", "company": "Vitaltec Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K253063: Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253063", "people": [{"name": "Joseph Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253063%22"}, {"id": "fda:K261807", "company": "Bio Compression Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261807: Sequential Circulator (SC-4004-DL, SC-4008-DL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261807", "people": [{"name": "Marc Somelofski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261807%22"}, {"id": "fda:K261580", "company": "Zbeats, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261580: ZBPro Diagnostic (Version 2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261580", "people": [{"name": "Bin Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261580%22"}, {"id": "fda:K254041", "company": "Magic Science Supply, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254041: SkinSmart Antimicrobial HydroGel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254041", "people": [{"name": "Eoin Croke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254041%22"}, {"id": "fda:K261837", "company": "Baebies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261837: FINDER Flu A&B/SARS-CoV-2 Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261837", "people": [{"name": "Vijay Srinivasan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261837%22"}, {"id": "fda:K262007", "company": "PRIMED Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262007: PRIMED AAMI Level 3 Open Back Gowns", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262007", "people": [{"name": "Mitra Fard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262007%22"}, {"id": "fda:K262230", "company": "Bone Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262230: Mg OSTEOREVIVE\u0099;Mg OSTEOCRETE\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262230", "people": [{"name": "Drew Diaz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262230%22"}, {"id": "fda:K262050", "company": "Spident Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262050: Vioseal X", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262050", "people": [{"name": "Eunok Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262050%22"}, {"id": "fda:K254072", "company": "Curvebeam AI / Curvebeam, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-11", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254072: BoneVue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254072", "people": [{"name": "Ryan Conlon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254072%22"}, {"id": "nih:5R44EY031202-06", "company": "Ihealthscreen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-10", "observed": "2026-09-14", "amount_usd": 698032, "summary": "NIH award 5R44EY031202-06: A Model for Predicting 2-Year Risk of Incident Late Age-related Macular Degeneration ($698,032)", "source_url": "https://reporter.nih.gov/project-details/11399767", "people": [{"name": "Alauddin Bhuiyan", "role": "Principal Investigator"}, {"name": "Roland THEODORE SMITH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R44EY036316-02", "company": "Xr Navigation Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-10", "observed": "2026-09-14", "amount_usd": 1010897, "summary": "NIH award 5R44EY036316-02: Developing and Evaluating Visual, Auditory, and Tactile and Text Digital Thematic Map Viewer to Provide Blind and Low Vision Individuals Full Access to Thematic Maps for the First Time ($1,010,897)", "source_url": "https://reporter.nih.gov/project-details/11420791", "people": [{"name": "Brandon Biggs", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41DE036130-01", "company": "Craniosure LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-10", "observed": "2026-09-14", "amount_usd": 302853, "summary": "NIH award 1R41DE036130-01: Development and Validation of a Novel AI-Augmented Mobile Platform for Early Head Shape Screening in Infants. ($302,853)", "source_url": "https://reporter.nih.gov/project-details/11405683", "people": [{"name": "Daniel Youngwhan Cho", "role": "Principal Investigator"}, {"name": "Maja Waldron", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EB038123-02", "company": "Capesym, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-10", "observed": "2026-09-14", "amount_usd": 872556, "summary": "NIH award 5R44EB038123-02: High-Resolution Direct-Conversion X-ray Detectors for Low-Dose Imaging ($872,556)", "source_url": "https://reporter.nih.gov/project-details/11395276", "people": [{"name": "Amlan Datta", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA298354-01A1", "company": "Onvagus, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-10", "observed": "2026-09-14", "amount_usd": 398525, "summary": "NIH award 1R44CA298354-01A1: Neuromodulation of the Gut-Brain Axis to Treat Cancer-Associated Cachexia ($398,525)", "source_url": "https://reporter.nih.gov/project-details/11313729", "people": [{"name": "Aliesha Danielle Garrett", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK143768-01A1", "company": "Analytical Diagnostic Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-10", "observed": "2026-09-14", "amount_usd": 312453, "summary": "NIH award 1R43DK143768-01A1: A Point of Care-Device for the Determination of Blood Tyrosine (TYR) the \"TYR Now\" ($312,453)", "source_url": "https://reporter.nih.gov/project-details/11398329", "people": [{"name": "Robert Harper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HD114377-02A1", "company": "Momease Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-10", "observed": "2026-09-14", "amount_usd": 1035970, "summary": "NIH award 2R44HD114377-02A1: Novel warming and massaging bra for improved breast milk expression ($1,035,970)", "source_url": "https://reporter.nih.gov/project-details/11186473", "people": [{"name": "Ashley Mooneyham", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DK139877-03", "company": "Xylyx Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-10", "observed": "2026-09-14", "amount_usd": 956566, "summary": "NIH award 5R44DK139877-03: Liver fibrosis cell-based assay platform: integrating patient-derived fibrotic liver ECM with primary stellate cells, Kupffer cells, and hepatocytes to accelerate anti-fibrotic drug development ($956,566)", "source_url": "https://reporter.nih.gov/project-details/11413845", "people": [{"name": "John David O'Neill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41CA314549-01", "company": "Gapscore Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-10", "observed": "2026-09-14", "amount_usd": 406500, "summary": "NIH award 1R41CA314549-01: GapScore: A Functional Biomarker for Predicting Therapy Response in BRCA-Deficient Tumors ($406,500)", "source_url": "https://reporter.nih.gov/project-details/11406991", "people": [{"name": "Jenna Whalen", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44EY030385-04", "company": "Newhaptics Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-10", "observed": "2026-09-21", "amount_usd": 1045938, "summary": "NIH award 2R44EY030385-04: Microfluidic technology for a full-page braille and graphical tactile display ($1,045,938)", "source_url": "https://reporter.nih.gov/project-details/11409085", "people": [{"name": "Alexander Russomanno", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R41HD122577-01", "company": "Myomech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-10", "observed": "2026-09-21", "amount_usd": 399632, "summary": "NIH award 1R41HD122577-01: Novel Wearable Electrode Array Stimulation Technology for Post-Stroke Drop-Foot Assistance ($399,632)", "source_url": "https://reporter.nih.gov/project-details/11407287", "people": [{"name": "Nitin Sharma", "role": "Principal Investigator"}, {"name": "Xiangming Xue", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07811934", "company": "Shanghai Shineyo Medical Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-10", "observed": "2026-09-10", "amount_usd": null, "summary": "New device trial registered: Single-Use Spherical Pulsed Ablation Catheter for Paroxysmal Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07811934"}, {"id": "trialreg:NCT07812818", "company": "Stereotaxis", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-10", "observed": "2026-09-10", "amount_usd": null, "summary": "New device trial registered: MAGiC - Congenital Heart DIsease", "source_url": "https://clinicaltrials.gov/study/NCT07812818", "people": [{"name": "Nathan McConkey, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07814118", "company": "Truway Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-10", "observed": "2026-09-10", "amount_usd": null, "summary": "New device trial registered: Multimodal Physiologic State Intelligence Study", "source_url": "https://clinicaltrials.gov/study/NCT07814118", "people": [{"name": "Gavin C Solomon, M.D.", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07812896", "company": "Udisense DBA Nanit", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-10", "observed": "2026-09-10", "amount_usd": null, "summary": "New device trial registered: Smart Baby Monitor Effects on Infant Sleep and Parent Well-being", "source_url": "https://clinicaltrials.gov/study/NCT07812896"}, {"id": "trialreg:NCT07813546", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-10", "observed": "2026-09-10", "amount_usd": null, "summary": "New device trial registered: Comparion of Effects of Two Different Power Toothbrushes on Plaque and Gum Health", "source_url": "https://clinicaltrials.gov/study/NCT07813546"}, {"id": "trialreg:NCT07812324", "company": "Medacta USA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-10", "observed": "2026-09-16", "amount_usd": null, "summary": "New device trial registered: A Trial to Assess the Safety and Effectiveness of an Anatomic Total Shoulder System", "source_url": "https://clinicaltrials.gov/study/NCT07812324"}, {"id": "fda:K262079", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262079: 4K Camera Head OLYMPUS CH-S700-08-LB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262079", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262079%22"}, {"id": "fda:K253856", "company": "Koh Young Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K253856: Geniant Cranial (Navigated Neurosurgical Positioning Robot)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253856", "people": [{"name": "Sooji Shin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253856%22"}, {"id": "fda:K262293", "company": "Suzhou Microport Orthorecon Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262293: EVOLUTION MPX\u0099 Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262293", "people": [{"name": "Hongxing Qiu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262293%22"}, {"id": "fda:K261696", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261696: ACUNAV Luxera 4D ICE Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261696", "people": [{"name": "Bongsoo Cho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261696%22"}, {"id": "fda:K260879", "company": "Invia, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260879: 4DM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260879", "people": [{"name": "Edward Ficaro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260879%22"}, {"id": "fda:K254074", "company": "Procerus Enterprises", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254074: TruPress", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254074", "people": [{"name": "Jordan Cox", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254074%22"}, {"id": "fda:K262202", "company": "GC America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262202: Cerasmart Forte", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262202", "people": [{"name": "Futoshi Fusejima", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262202%22"}, {"id": "fda:K261409", "company": "Bioteke Corporation (Wuxi) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261409: BioTeke\u00ae Multi-Drug Urine Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261409", "people": [{"name": "Zhitu Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261409%22"}, {"id": "fda:K261562", "company": "Sanhe LEFIS Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261562: Diode Laser Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261562", "people": [{"name": "Dandan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261562%22"}, {"id": "fda:K261929", "company": "OMRON Healthcare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261929: Upper Arm Blood pressure monitor (BP7155D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261929", "people": [{"name": "Bhoomika Joyappa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261929%22"}, {"id": "fda:K254111", "company": "B.Braun Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254111: Irrigation/Urology Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254111", "people": [{"name": "Rachel Pappas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254111%22"}, {"id": "fda:K261795", "company": "Omniscient Neurotechnology Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261795: Quicktome Software Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261795", "people": [{"name": "Arie Henkin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261795%22"}, {"id": "fda:K254246", "company": "Zhejiang Longterm Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254246: LT Antibacterial Foam with Silver Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254246", "people": [{"name": "Claudia Zsang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254246%22"}, {"id": "fda:K254009", "company": "Lakong Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254009: Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254009", "people": [{"name": "Zhongliang Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254009%22"}, {"id": "fda:K262426", "company": "Wuhan Pioon Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262426: Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262426", "people": [{"name": "Feng Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262426%22"}, {"id": "fda:K260110", "company": "Danumed Medizintechnik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-10", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260110: danumed Extension Set for Gastrostomy Button", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260110", "people": [{"name": "Helena Bastian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260110%22"}, {"id": "nih:1R41EB039615-01", "company": "Vigilant Labels Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-09", "observed": "2026-09-14", "amount_usd": 349828, "summary": "NIH award 1R41EB039615-01: Al-powered camera system for medication error detection in real-time at the point of care. ($349,828)", "source_url": "https://reporter.nih.gov/project-details/11409549", "people": [{"name": "Peter Baek", "role": "Principal Investigator"}, {"name": "Kelly Michaelsen", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL184797-01A1", "company": "Pure Somni Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-09", "observed": "2026-09-14", "amount_usd": 309881, "summary": "NIH award 1R43HL184797-01A1: Somni: A Randomized Trial of an Integrated Digital Platform for Treating Insomnia and Insufficient Sleep Duration ($309,881)", "source_url": "https://reporter.nih.gov/project-details/11405325", "people": [{"name": "Matt Berg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR086099-01A1", "company": "Entangl3d, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-09", "observed": "2026-09-14", "amount_usd": 314138, "summary": "NIH award 1R43AR086099-01A1: Stiff and Tough Bioadhesive Patch to Limit Recurrent Disc Prolapse ($314,138)", "source_url": "https://reporter.nih.gov/project-details/11316734", "people": [{"name": "Matthew David Davidson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL184078-01", "company": "General Biophysics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-09", "observed": "2026-09-14", "amount_usd": 479185, "summary": "NIH award 1R43HL184078-01: Xenon Gas Preservation of Refrigerated Platelets ($479,185)", "source_url": "https://reporter.nih.gov/project-details/11284335", "people": [{"name": "Ilya Ilin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI188680-03", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-09", "observed": "2026-09-14", "amount_usd": 1000000, "summary": "NIH award 5R44AI188680-03: A Rapid, Point-of-Care Diagnostic to Identify Viable Sexually Transmitted Infections, Reduce Overtreatment, and Prevent Emerging Antibiotic Resistance ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11415832", "people": [{"name": "Rainer Ng", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42HL149495-03", "company": "Corami Biotech Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-09", "observed": "2026-09-14", "amount_usd": 1164977, "summary": "NIH award 5R42HL149495-03: Minimally Invasive Local Delivery of Cardiac Gene Therapy ($1,164,977)", "source_url": "https://reporter.nih.gov/project-details/11395638", "people": [{"name": "Rebecca Diane Levit", "role": "Principal Investigator"}, {"name": "Esra Roan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42MH136878-03", "company": "Mainsquare Co", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-09", "observed": "2026-09-14", "amount_usd": 1044386, "summary": "NIH award 5R42MH136878-03: Engagement and clinical impact of the Teleo virtual therapy platform in clinical settings ($1,044,386)", "source_url": "https://reporter.nih.gov/project-details/11421489", "people": [{"name": "DAVID S HONG", "role": "Principal Investigator"}, {"name": "Eric Roland Kuhn", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41DE035030-01A1", "company": "Oralbiolife Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-09", "observed": "2026-09-14", "amount_usd": 318017, "summary": "NIH award 1R41DE035030-01A1: Bone and soft tissue responses to a hydrogel with piezoelectric potential in conservative non-surgical peri-implantitis treatment ($318,017)", "source_url": "https://reporter.nih.gov/project-details/11312068", "people": [{"name": "Ronaldo Santana", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL184761-01", "company": "Limax Biosciences Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-09", "observed": "2026-09-15", "amount_usd": 1047908, "summary": "NIH award 1R44HL184761-01: Advanced Hemostatic Adhesive Hydrogel System for Postpartum Hemorrhage Control ($1,047,908)", "source_url": "https://reporter.nih.gov/project-details/11315884", "people": [{"name": "Benjamin Ross Freedman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07810231", "company": "Research Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-09", "observed": "2026-09-09", "amount_usd": null, "summary": "New device trial registered: Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture", "source_url": "https://clinicaltrials.gov/study/NCT07810231", "people": [{"name": "juan velez, MD, plastic surgery", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07810725", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-09", "observed": "2026-09-09", "amount_usd": null, "summary": "New device trial registered: Effect of a Myopia Control Lens on the Astigmatism in Children", "source_url": "https://clinicaltrials.gov/study/NCT07810725", "people": [{"name": "Si Ying Lim", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07810803", "company": "Research Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-09", "observed": "2026-09-09", "amount_usd": null, "summary": "New device trial registered: Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants", "source_url": "https://clinicaltrials.gov/study/NCT07810803", "people": [{"name": "juan velez, MD, plastic surgery", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07810335", "company": "FlowMod, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-09", "observed": "2026-09-09", "amount_usd": null, "summary": "New device trial registered: Evaluation of FlowMod System While Intermittently Partially Occluding Vena Cava Blood Flow in Subjects With ADHF", "source_url": "https://clinicaltrials.gov/study/NCT07810335"}, {"id": "trialreg:NCT07810205", "company": "Research Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-09", "observed": "2026-09-09", "amount_usd": null, "summary": "New device trial registered: Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture", "source_url": "https://clinicaltrials.gov/study/NCT07810205", "people": [{"name": "juan velez, MD, plastic surgery", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07810192", "company": "Research Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-09", "observed": "2026-09-09", "amount_usd": null, "summary": "New device trial registered: Randomized Assessor-Masked Trial of Moderate Graduated Compression Stockings for Popliteal Vein Dilation During Long-Haul Economy-Class Air Travel After Aesthetic Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07810192", "people": [{"name": "Hugo Aguilar", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07809516", "company": "Hillcrest", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-09", "observed": "2026-09-09", "amount_usd": null, "summary": "New device trial registered: Pedal Pump Clinical Trial on Edema V2", "source_url": "https://clinicaltrials.gov/study/NCT07809516"}, {"id": "trialreg:NCT07810257", "company": "Research Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-09", "observed": "2026-09-09", "amount_usd": null, "summary": "New device trial registered: Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure", "source_url": "https://clinicaltrials.gov/study/NCT07810257", "people": [{"name": "juan velez, MD, plastic surgery", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07808931", "company": "Research Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-09", "observed": "2026-09-09", "amount_usd": null, "summary": "New device trial registered: Prospective Stratified Randomized Four-Group Study of Cabin Class and Graduated Compression Stockings on Popliteal Vein Dilation After Long-Haul Air Travel After Aesthetic Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07808931", "people": [{"name": "Hugo Aguilar", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07809308", "company": "Laboratorios Ozoaqua", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-09", "observed": "2026-09-09", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation of an Ozonated Oil for the Regeneration and Healing of Surgical Wounds in Patients Undergoing Breast Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07809308"}, {"id": "usasp:140D0426C0135", "company": "Electronic Biosciences, Inc.", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-09", "observed": "2026-09-15", "amount_usd": 2999975, "summary": "Federal medical R&D contract from Departmental Offices: UNIFIED NANOPORE PLATFORM FOR SIMULTANEOUS DNA, RNA, AND PROTEIN SEQUENCING ($2,999,975)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_140D0426C0135_1406_-NONE-_-NONE-"}, {"id": "usasp:140D0426C0101", "company": "Oceanit Laboratories Inc", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-09", "observed": "2026-09-15", "amount_usd": 3499999, "summary": "Federal medical R&D contract from Departmental Offices: LYMPHOLAB PRODISCOVER KIT ($3,499,999)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_140D0426C0101_1406_-NONE-_-NONE-"}, {"id": "fda:K261793", "company": "Maxter Healthcare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-09", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261793: Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261793", "people": [{"name": "Sajeev Joseph", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261793%22"}, {"id": "fda:K252486", "company": "Gleamer", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-09", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K252486: ChestView US (1.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252486", "people": [{"name": "Antoine Tournier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252486%22"}, {"id": "fda:K262488", "company": "Guangzhou Red Pine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-09", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262488: Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262488", "people": [{"name": "Weihua Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262488%22"}, {"id": "fda:K262542", "company": "Top Glove Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-09", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262542: Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262542", "people": [{"name": "Noor Akilah Saidin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262542%22"}, {"id": "fda:K260652", "company": "Covalon Technologies, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-09", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260652: ColActive Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260652", "people": [{"name": "Christina Mitchell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260652%22"}, {"id": "fda:K260997", "company": "Endoclot Plus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-09", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260997: SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260997", "people": [{"name": "Huihui Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260997%22"}, {"id": "fda:K261470", "company": "E.A.M Benelux B.V", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-09", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261470: PurGuard360(QF10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261470", "people": [{"name": "Ilan Aberman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261470%22"}, {"id": "fda:K251417", "company": "Argus Cognitive, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-09", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K251417: ReVISION 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251417", "people": [{"name": "Zoltan Toser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251417%22"}, {"id": "nih:1R43HL184725-01", "company": "Bauhealth, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 306807, "summary": "NIH award 1R43HL184725-01: EPIPHANY (machinE PredIction of Prolonged mecHAnical ventilatioN and tracheostomY) ($306,807)", "source_url": "https://reporter.nih.gov/project-details/11315591", "people": [{"name": "ANEEL ADVANI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44AG094520-02S1", "company": "Posit Science Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 498809, "summary": "NIH award 3R44AG094520-02S1: Improving Neurological Health with Acetylcholine via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment (INHANCE-MCI) ($498,809)", "source_url": "https://reporter.nih.gov/project-details/11626504", "people": [{"name": "Mouna Attarha", "role": "Principal Investigator"}, {"name": "Etienne de Villers-Sidani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DE035396-01A1", "company": "Dentosity, LLC D/b/a Vertex Discoveries", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 290566, "summary": "NIH award 1R43DE035396-01A1: Design and assembly of a trial-ready UVC LED device to kill endodontic microorganisms ($290,566)", "source_url": "https://reporter.nih.gov/project-details/11399201", "people": [{"name": "Kim Alan Brogden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DK123910-04A1", "company": "Coaptech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 1097977, "summary": "NIH award 2R44DK123910-04A1: Optimization of the clinically-successful Pediatric PUMA-G ultrasound gastrostomy device for safety, efficiency, human factors, and market-readiness. ($1,097,977)", "source_url": "https://reporter.nih.gov/project-details/11409150", "people": [{"name": "Howard Carolan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R42NR020458-02", "company": "Family Room LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 1373038, "summary": "NIH award 2R42NR020458-02: Operationalizing Family Caregiver Engagement in the Intensive Care Unit with FamilyRoom.Health ($1,373,038)", "source_url": "https://reporter.nih.gov/project-details/11313259", "people": [{"name": "Breanna D Hetland", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R43GM161135-02", "company": "Molecular Intelligence LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 87668, "summary": "NIH award 5R43GM161135-02: Modeling Receptor-ligand interactions for Drug Discoveryfrom Cryo-EM data using AI ($87,668)", "source_url": "https://reporter.nih.gov/project-details/11382186", "people": [{"name": "Dongwook Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG102286-01", "company": "Vivid Bioinnovations, Pbc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 506495, "summary": "NIH award 1R44AG102286-01: AstroTarget\u2122 Astro-Enrichment Kit: A Microfluidic-Free Platform for High-Throughput Rare-Astrocyte Isolation and Multi-Omic Profiling from Frozen Alzheimer\u2019s Brain ($506,495)", "source_url": "https://reporter.nih.gov/project-details/11410332", "people": [{"name": "Robin Prince", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA302210-02", "company": "Imagine Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 1462590, "summary": "NIH award 5R44CA302210-02: Transforming Mammography With STARLIGHT, Imagine Scientific's Monochromatic X-Ray Imaging System ($1,462,590)", "source_url": "https://reporter.nih.gov/project-details/11400515", "people": [{"name": "Eric Silver", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41GM165229-01", "company": "Ez Diagnostics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 312740, "summary": "NIH award 1R41GM165229-01: Low-Cost Software-based Solution for Commercial Application of PDS ($312,740)", "source_url": "https://reporter.nih.gov/project-details/11409344", "people": [{"name": "Karen Tsay", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AI197509-01", "company": "Inbios International, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 314363, "summary": "NIH award 1R41AI197509-01: Development of a sensitive Point-of-Care immunoassay for tick- borne spotted fever group rickettsioses ($314,363)", "source_url": "https://reporter.nih.gov/project-details/11313004", "people": [{"name": "Aarthy C Vallur", "role": "Principal Investigator"}, {"name": "DAVID H WALKER", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R42CA291243-02", "company": "Olmeda Biosciences LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 1028948, "summary": "NIH award 2R42CA291243-02: CLIA-LDT Development and Clinical Validation of anAqueous Humor-Based Multiplex Assay for Uveal Melanoma Metastatic Risk Prediction ($1,028,948)", "source_url": "https://reporter.nih.gov/project-details/11312222", "people": [{"name": "Liya Xu", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA314574-01", "company": "Leadoptik Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-14", "amount_usd": 1477882, "summary": "NIH award 1R44CA314574-01: Optical Precision Targeting for Informed Cancer biopsy (OPTIC) ($1,477,882)", "source_url": "https://reporter.nih.gov/project-details/11405793", "people": [{"name": "Jiang You", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA302214-01A1", "company": "Arphion, Ltd", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-15", "amount_usd": 309391, "summary": "NIH award 1R41CA302214-01A1: Use of neural networks and deep learning to construct a miRNA classifier to differentiate with high accuracy and noninvasively oral squamous cell carcinoma from benign leukoplakia ($309,391)", "source_url": "https://reporter.nih.gov/project-details/11314925", "people": [{"name": "Guy Richard Adami", "role": "Principal Investigator"}, {"name": "Antonia Kolokythas", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA309870-01", "company": "Silbiotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-08", "observed": "2026-09-15", "amount_usd": 364168, "summary": "NIH award 1R43CA309870-01: Tumor Marker Assay Technology for Tailoring Prophylactic Therapy and Prevention of Breast Cancer ($364,168)", "source_url": "https://reporter.nih.gov/project-details/11307855", "people": [{"name": "Indira none Poola", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07807423", "company": "Volta Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-08", "observed": "2026-09-08", "amount_usd": null, "summary": "New device trial registered: Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation.", "source_url": "https://clinicaltrials.gov/study/NCT07807423", "people": [{"name": "Cl\u00e9ment BARS, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07806240", "company": "Zhejiang Raytone Bioscience Co.,Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-08", "observed": "2026-09-08", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy Study of Absorbable Tacrolimus Lacrimal Canalicular Plug for Dry Eye", "source_url": "https://clinicaltrials.gov/study/NCT07806240", "people": [{"name": "Ying Jie, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07806409", "company": "Braile Biomedica Ind. Com. e Repr. Ltda.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-08", "observed": "2026-09-08", "amount_usd": null, "summary": "New device trial registered: Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis", "source_url": "https://clinicaltrials.gov/study/NCT07806409"}, {"id": "trialreg:NCT07807397", "company": "Colgate Palmolive", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-08", "observed": "2026-09-08", "amount_usd": null, "summary": "New device trial registered: Oral Hygiene Assistance Training Program", "source_url": "https://clinicaltrials.gov/study/NCT07807397"}, {"id": "trialreg:NCT07807891", "company": "Lyv Life Inc. (dba: Cora)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-08", "observed": "2026-09-08", "amount_usd": null, "summary": "New device trial registered: Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon", "source_url": "https://clinicaltrials.gov/study/NCT07807891"}, {"id": "fda:K260227", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260227: EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260227", "people": [{"name": "Hanbyul Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260227%22"}, {"id": "fda:K254294", "company": "Zhejiang Geyi Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K254294: Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254294", "people": [{"name": "Cathy Tan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254294%22"}, {"id": "fda:K261823", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261823: da Vinci Surgical System, Model IS5000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261823", "people": [{"name": "Changxin Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261823%22"}, {"id": "fda:K260062", "company": "DreaMed Diabetes, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260062: MODI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260062", "people": [{"name": "Adi Berkovitch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260062%22"}, {"id": "fda:K262173", "company": "Shoulder Innovations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262173: N22 Offset Humeral Head", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262173", "people": [{"name": "Mark Hanes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262173%22"}, {"id": "fda:K261715", "company": "Emboline, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261715: Emboliner Embolic Protection System (EPC-03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261715", "people": [{"name": "Will Michul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261715%22"}, {"id": "fda:K261462", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261462: LANDMARK Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261462", "people": [{"name": "Jessica Roach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261462%22"}, {"id": "fda:K261987", "company": "Osstell AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261987: Reusable SmartPeg", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261987", "people": [{"name": "Stellan Sundstroem", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261987%22"}, {"id": "fda:K260053", "company": "Beijing OrionStar Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260053: Power Wheelchair (OS-R-M01I)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260053", "people": [{"name": "Shengnan Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260053%22"}, {"id": "fda:K262341", "company": "B-One Ortho, Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K262341: b-ONE\u00ae Mobio\u0099 Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262341", "people": [{"name": "Allison Gecik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262341%22"}, {"id": "fda:K261956", "company": "ANI Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K261956: Dental Barriers and Sleeves (AB0006)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261956", "people": [{"name": "Seongcheol Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261956%22"}, {"id": "fda:K260229", "company": "Yongkang Hengyi Vehicle Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260229: Electric wheelchair (HC819N, HC830N, HC831N)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260229", "people": [{"name": "Kathyrn Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260229%22"}, {"id": "fda:K253988", "company": "Nobel Biocare AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K253988: LiteSet Trays", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253988", "people": [{"name": "Bernice Jim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253988%22"}, {"id": "fda:K260312", "company": "Gmp Medicare Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-08", "observed": "2026-09-22", "amount_usd": null, "summary": "FDA 510(k) K260312: Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260312", "people": [{"name": "Ummi Salmah Othman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260312%22"}, {"id": "nih:1R43HD121261-01", "company": "Ciconia Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-14", "amount_usd": 306841, "summary": "NIH award 1R43HD121261-01: Bridging Healthcare Disparities: Real-Time AI Assessment for Preterm Labor Risk ($306,841)", "source_url": "https://reporter.nih.gov/project-details/11313683", "people": [{"name": "Roni Cantor Balan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG099493-01A1", "company": "Biosight LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-14", "amount_usd": 238300, "summary": "NIH award 1R41AG099493-01A1: Neurofluid Biomarkers for Clinical Trials of Neurodegeneration ($238,300)", "source_url": "https://reporter.nih.gov/project-details/11406734", "people": [{"name": "Manus Joseph Donahue", "role": "Principal Investigator"}, {"name": "Paula Trujillo Diaz", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM166946-01", "company": "Omaroon Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-14", "amount_usd": 306872, "summary": "NIH award 1R43GM166946-01: Miniaturization and Human-Centered Design of an AI-Enabled At-Home PKU Monitoring System for Children ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11410435", "people": [{"name": "Louay Fakhro", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG076067-04A1", "company": "Life Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-14", "amount_usd": 963977, "summary": "NIH award 2R44AG076067-04A1: Optimization of an at-home continuous multi-domain monitoring and assessment system to improve Alzheimer's and related disorders clinicaltrials ($963,977)", "source_url": "https://reporter.nih.gov/project-details/11314283", "people": [{"name": "Lawrence J Frye", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44NS143486-02", "company": "Cnd Life Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-14", "amount_usd": 1012800, "summary": "NIH award 5R44NS143486-02: Analysis of Cutaneous Phosphorylated alpha-Synuclein to Identify Patients at Risk of Progressing from Essential Tremor to Parkinson's Disease ($1,012,800)", "source_url": "https://reporter.nih.gov/project-details/11401181", "people": [{"name": "CHRISTOPHER H GIBBONS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA302219-02", "company": "Biotex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-14", "amount_usd": 936698, "summary": "NIH award 5R44CA302219-02: Novel wearable rotating magnetic field therapy device targeting treatment of brain cancers ($936,698)", "source_url": "https://reporter.nih.gov/project-details/11417972", "people": [{"name": "Ashok Gowda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44NS132718-03", "company": "Perception Dynamics Institute", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-14", "amount_usd": 1005434, "summary": "NIH award 2R44NS132718-03: Retraining neural pathways improves cognitive skills after a mild traumatic brain injury ($1,005,434)", "source_url": "https://reporter.nih.gov/project-details/11406497", "people": [{"name": "Teri A Lawton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HG014887-01", "company": "Cantata Bio LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-14", "amount_usd": 406703, "summary": "NIH award 1R43HG014887-01: Pangenome-based Inference of Phased, Inherited Genome from Patient-Derived Sequencing Data ($406,703)", "source_url": "https://reporter.nih.gov/project-details/11294135", "people": [{"name": "John Zachary Sanborn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA310335-01", "company": "Oncopatch, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-14", "amount_usd": 305893, "summary": "NIH award 1R41CA310335-01: Activated GaP-32 for the Treatment of Non-Melanoma Skin Cancer ($305,893)", "source_url": "https://reporter.nih.gov/project-details/11314378", "people": [{"name": "Fred Sarazin", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42CA314557-01", "company": "Olmeda Biosciences LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-14", "amount_usd": 398880, "summary": "NIH award 1R42CA314557-01: Deep Whole Genome Sequencing of Aqueous Humor cfDNA for Diagnosis of Intraocular Malignancies ($398,880)", "source_url": "https://reporter.nih.gov/project-details/11406648", "people": [{"name": "Liya Xu", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB038849-01", "company": "Spinhance, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-21", "amount_usd": 306358, "summary": "NIH award 1R43EB038849-01: Quality assurance imaging phantom for clinical pulmonary gas exchange xenon MRI ($306,358)", "source_url": "https://reporter.nih.gov/project-details/11316661", "people": [{"name": "Nicholas Drachman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44AR086730-02", "company": "Reselute", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-07", "observed": "2026-09-21", "amount_usd": 1335869, "summary": "NIH award 4R44AR086730-02: Local and Sustained Release of Antibiotics in the Surgical Treatment of Diabetic Charcot Foot ($1,335,869)", "source_url": "https://reporter.nih.gov/project-details/11525360", "people": [{"name": "Fioleda Prifti Kesseli", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "usasp:75N93026F00002", "company": "Advanced Bioscience Laboratories, Inc.", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-07", "observed": "2026-09-15", "amount_usd": 1010033, "summary": "Federal medical R&D contract from National Institutes of Health: DIAGNOSTIC DEVELOPMENT SERVICES ($1,010,033)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_75N93026F00002_7529_75N93023D00015_7529"}, {"id": "fda:K261131", "company": "Shenzhen Osto Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-06", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261131: Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261131", "people": [{"name": "Yang Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261131%22"}, {"id": "fda:K260396", "company": "Fidelity BioPharma Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-06", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260396: KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260396", "people": [{"name": "Song Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260396%22"}, {"id": "fda:K254135", "company": "Nouvag Ag", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-05", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K254135: LipoSurg ARTIST", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254135", "people": [{"name": "Christof K\u00fcnz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254135%22"}, {"id": "fda:K261684", "company": "Cryosurgery, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-05", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261684: FreezeSpray TA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261684", "people": [{"name": "Ronald McDow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261684%22"}, {"id": "nih:1R44HL187056-01", "company": "Stealth Labs Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 306864, "summary": "NIH award 1R44HL187056-01: REST- Respiratory Ear System for CPAP Therapy adherence ($306,864)", "source_url": "https://reporter.nih.gov/project-details/11408674", "people": [{"name": "Yadid Ayzenberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R42EY034411-02A1", "company": "Xr Navigation Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 977598, "summary": "NIH award 2R42EY034411-02A1: Audiom: Developing an Indoor Non-Visual Mapping System ($977,598)", "source_url": "https://reporter.nih.gov/project-details/11314950", "people": [{"name": "Brandon Biggs", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA288032-03", "company": "Lagrange Scientific, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 582245, "summary": "NIH award 5R44CA288032-03: A PROGNOSTIC ASSAY FOR METASTATIC CLEAR CELL RENAL CELL CARCINOMA ($582,245)", "source_url": "https://reporter.nih.gov/project-details/11412572", "people": [{"name": "RICHARD Thomas COUGHLIN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44HL164222-04", "company": "Linshom Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 1133058, "summary": "NIH award 2R44HL164222-04: Development and Multi-Site Clinical Evaluation of the Linshom CPRM System - A Wearable, AI Enabled, Wireless Alarm Activated Detection System for Early Intervention of Emerging Respiratory Decline ($1,133,058)", "source_url": "https://reporter.nih.gov/project-details/11292738", "people": [{"name": "Ronen Feldman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44DE032549-02A1", "company": "Cellectgen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 935551, "summary": "NIH award 2R44DE032549-02A1: DEVELOPMENT OF A SALIVARY ASSAY FOR MEASURING PERIODONTAL DISEASE ACTIVITY ($935,551)", "source_url": "https://reporter.nih.gov/project-details/11309805", "people": [{"name": "Robert Gellibolian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44MH133521-03", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 745337, "summary": "NIH award 2R44MH133521-03: A parallelized imaging platform for accurate and efficient long-term assessment of brain organoid development ($745,337)", "source_url": "https://reporter.nih.gov/project-details/11315676", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DE035900-01", "company": "Innotech Precision Medicine, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 365004, "summary": "NIH award 1R43DE035900-01: Integrated Multiomics Diagnostics at the Point of Care for Healthy Living ($365,004)", "source_url": "https://reporter.nih.gov/project-details/11350268", "people": [{"name": "ROYA KHOSRAVI-FAR", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS139730-02", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 884357, "summary": "NIH award 5R44NS139730-02: A Novel Method of Non-Invasive Brain Stimulation to Enhance Motor Function in Chronic Stroke Patients ($884,357)", "source_url": "https://reporter.nih.gov/project-details/11397366", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL180181-02", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 1008567, "summary": "NIH award 5R44HL180181-02: Peptide-based ELISA for laboratory diagnosis of sarcoidosis ($1,008,567)", "source_url": "https://reporter.nih.gov/project-details/11417199", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43GM165162-01", "company": "Nanores LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 368915, "summary": "NIH award 1R43GM165162-01: A Comprehensive Computation Platform for Single Molecule Localization Microscopy: From Molecular Localization, Visualization to Quantitative Data Analysis ($368,915)", "source_url": "https://reporter.nih.gov/project-details/11407441", "people": [{"name": "Yilun Li", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA314595-01", "company": "Ecogenome LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 399105, "summary": "NIH award 1R43CA314595-01: Developing a DACH1 specific detection assay that predicts therapy response in advanced prostate cancer. ($399,105)", "source_url": "https://reporter.nih.gov/project-details/11407343", "people": [{"name": "Zhiping Li", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL184661-01", "company": "Energybiocode LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 306799, "summary": "NIH award 1R43HL184661-01: Optimizing ModiFlow Geometry for Enhanced Efficiency of Aerosol Drug Delivery ($306,799)", "source_url": "https://reporter.nih.gov/project-details/11311550", "people": [{"name": "Arevik Mosoian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DE035769-01", "company": "Illumifydx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 396280, "summary": "NIH award 1R44DE035769-01: Advancing Actionability in Oncology: Enhanced Detection of Head and Neck Cancer Recurrence ($396,280)", "source_url": "https://reporter.nih.gov/project-details/11315161", "people": [{"name": "Maria Navas-Moreno", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL186878-01", "company": "Amygo Solutions LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 329469, "summary": "NIH award 1R43HL186878-01: Development of a blood-based diagnostic test for ATTR amyloidosis ($329,469)", "source_url": "https://reporter.nih.gov/project-details/11407018", "people": [{"name": "Rose Pedretti", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH144704-03", "company": "Quant, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 651949, "summary": "NIH award 5R44MH144704-03: Ultra-high sensitivity, high spatial resolution single photon emission tomography using mechanical flux manipulation ($651,949)", "source_url": "https://reporter.nih.gov/project-details/11421510", "people": [{"name": "Larry Pierce", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DE035053-01A1", "company": "Leden LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 306084, "summary": "NIH award 1R43DE035053-01A1: Smart Dental Implant(TM): Advanced Self-Powered Phototherapuetic Dental Implant ($306,084)", "source_url": "https://reporter.nih.gov/project-details/11255589", "people": [{"name": "Sophia Selvarajan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42MH142197-02", "company": "Virtuallybetter Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-07", "amount_usd": 742395, "summary": "NIH award 4R42MH142197-02: Improving adherence and outcomes in evidence-based treatment for OCD: Type I Effectiveness-Implementation RCT and Scaled Development of OC-Go, a crowdsourced interactive patient-provider tool ($742,395)", "source_url": "https://reporter.nih.gov/project-details/11536937", "people": [{"name": "Joseph McGuire", "role": "Principal Investigator"}, {"name": "John C. Piacentini", "role": "Principal Investigator"}, {"name": "Peter Tuerk", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL178006-02", "company": "New Health Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-16", "amount_usd": 984232, "summary": "NIH award 5R44HL178006-02: Efficacy of Hypoxic Red Blood Cells Processed with the Hemanext ONE\u00ae System in Patients with Sickle Cell Anemia ($984,232)", "source_url": "https://reporter.nih.gov/project-details/11415142", "people": [{"name": "Biree Andemariam", "role": "Principal Investigator"}, {"name": "Laurel Omert", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43OH012978-01", "company": "Medical Tactile, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-04", "observed": "2026-09-16", "amount_usd": 300748, "summary": "NIH award 1R43OH012978-01: Development of a hardened Industrial TactileGlove for assessing worker injury and performance in Factory Environments ($300,748)", "source_url": "https://reporter.nih.gov/project-details/11254706", "people": [{"name": "Jae S. Son", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07805655", "company": "Jeisys Medical Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-04", "observed": "2026-09-04", "amount_usd": null, "summary": "New device trial registered: Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris", "source_url": "https://clinicaltrials.gov/study/NCT07805655"}, {"id": "trialreg:NCT07805512", "company": "Galderma R&D", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-04", "observed": "2026-09-04", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Effectiveness and Safety of Restylane Shaype in the Improvement of Jawline Definition", "source_url": "https://clinicaltrials.gov/study/NCT07805512", "people": [{"name": "Galderma S.A.", "role": "Study Director"}]}, {"id": "trialreg:NCT07805213", "company": "KardioVis S.r.l.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-04", "observed": "2026-09-04", "amount_usd": null, "summary": "New device trial registered: KV-PREDICT Diagnostic Device in Patients With Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07805213", "people": [{"name": "Giuseppe Boriani, MD, PhD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07804277", "company": "Tomey Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-04", "observed": "2026-09-04", "amount_usd": null, "summary": "New device trial registered: Comparative Study of the Tomey FT-1000, and Goldmann Applanation Tonometer (GAT)", "source_url": "https://clinicaltrials.gov/study/NCT07804277"}, {"id": "trialreg:NCT07805798", "company": "Integra LifeSciences Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-04", "observed": "2026-09-04", "amount_usd": null, "summary": "New device trial registered: Urinary Bladder Matrix (UBM) Registry", "source_url": "https://clinicaltrials.gov/study/NCT07805798"}, {"id": "trialreg:NCT07805759", "company": "i+Med S.Coop.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-04", "observed": "2026-09-04", "amount_usd": null, "summary": "New device trial registered: Daydrop\u00ae Triple Action for Allergic Eye Symptoms", "source_url": "https://clinicaltrials.gov/study/NCT07805759"}, {"id": "trialreg:NCT07805148", "company": "Flaus, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-04", "observed": "2026-09-04", "amount_usd": null, "summary": "New device trial registered: Clinical Assessment of the Safety and Efficacy of Flaus Electric Flosser on Plaque and Gingivitis Compared to a Manual Toothbrush", "source_url": "https://clinicaltrials.gov/study/NCT07805148"}, {"id": "trialreg:NCT07803679", "company": "Amgen", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-04", "observed": "2026-09-10", "amount_usd": null, "summary": "New device trial registered: A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma", "source_url": "https://clinicaltrials.gov/study/NCT07803679", "people": [{"name": "MD", "role": "Study Director"}]}, {"id": "fda:K262292", "company": "Alimetry , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262292: Gastric Alimetry", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262292", "people": [{"name": "Yaara Yarmut", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262292%22"}, {"id": "fda:K262060", "company": "Radiopharmaceutical Imaging & Dosimetry, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262060: 3D-RD-S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262060", "people": [{"name": "Nadine Bonds", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262060%22"}, {"id": "fda:K261935", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261935: Surgical and Prosthetic Trays", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261935", "people": [{"name": "Rebecca Sporer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261935%22"}, {"id": "fda:K260756", "company": "Sentinel Medical Technologies,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260756: TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260756", "people": [{"name": "Jackelyn Rodriguez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260756%22"}, {"id": "fda:K253836", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K253836: FCT iStream Phase 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253836", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253836%22"}, {"id": "fda:K262277", "company": "Piraeus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262277: 70 NeuGlide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262277", "people": [{"name": "Sarah Kabanuk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262277%22"}, {"id": "fda:K254264", "company": "Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K254264: Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254264", "people": [{"name": "Xiaoxi Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254264%22"}, {"id": "fda:K262235", "company": "Medtronic Xomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262235: ApexCut \u0099 Blade with Automated EM Tracking (187BL4012EM);ApexCut \u0099 Blade with Automated EM Tracking (187BL4040EM);ApexCut \u0099 Blade with Automated EM Tracking (187BL4060EM);ApexCut \u0099 Blade with Automated EM Tracking (187BL2975EM);ApexCut \u0099 Blade with Automated EM Tracking (187BL3590EM);ApexCut \u0099 Blade with Automated EM Tracking (187BL4000LEM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262235", "people": [{"name": "Penny Goodman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262235%22"}, {"id": "fda:K253909", "company": "NuSmile, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K253909: NeoPEX\u0099 Pre-Mixed Obturation Paste", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253909", "people": [{"name": "Priscilla Lara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253909%22"}, {"id": "fda:K261057", "company": "Bioretec, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261057: ActivaScrew\u0099 Cannulated COM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261057", "people": [{"name": "Mari Ruotsalainen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261057%22"}, {"id": "fda:K253529", "company": "Peerbridge Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K253529: Peerbridge COR MDx (Cor MDx)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253529", "people": [{"name": "Mr. Chris Darland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253529%22"}, {"id": "fda:K262130", "company": "Depuy Orthopaedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262130: ATTUNE Revision Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262130", "people": [{"name": "Christina Kaucic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262130%22"}, {"id": "fda:K254262", "company": "Ortho Clinical Diagnostics Inc. (QuidelOrtho)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K254262: Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254262", "people": [{"name": "Marisa Pugliese", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254262%22"}, {"id": "fda:K260331", "company": "Siemens Healthcare Diagnostics Products, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260331: IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260331", "people": [{"name": "Julie Warren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260331%22"}, {"id": "fda:K260525", "company": "MRI2CT, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260525: NextMR Spine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260525", "people": [{"name": "Aveim Amossi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260525%22"}, {"id": "fda:K262828", "company": "S.m.a.i.o", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262828: KHEIRON\u00ae Spinal Fixation System, including patient specific K-ROD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262828", "people": [{"name": "Jean-Charles Roussouly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262828%22"}, {"id": "fda:K260035", "company": "UAB Telemedicina", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260035: Digital Indeflator INFLANTE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260035", "people": [{"name": "Evaldas Kalvaitis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260035%22"}, {"id": "nih:5R44CA297977-02", "company": "5 Point App", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-03", "observed": "2026-09-07", "amount_usd": 1029679, "summary": "NIH award 5R44CA297977-02: Decentralized Clinical Trial of Effectiveness of EnergyPoints App to Guide Acupressure Use for Fatigue and Sleep Disturbances in Cancer Survivors ($1,029,679)", "source_url": "https://reporter.nih.gov/project-details/11332724", "people": [{"name": "SUSAN L BECK", "role": "Principal Investigator"}, {"name": "MELANIE Ariane GOLD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41NS143513-01A1", "company": "Aneuvas Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-03", "observed": "2026-09-07", "amount_usd": 435979, "summary": "NIH award 1R41NS143513-01A1: Development of a novel biocompatible polymer coating for aneurysm treatment devices ($435,979)", "source_url": "https://reporter.nih.gov/project-details/11316546", "people": [{"name": "Timothy Andrew Becker", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH122028-05", "company": "Champaign Imaging, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-03", "observed": "2026-09-07", "amount_usd": 1580718, "summary": "NIH award 5R44MH122028-05: Next Generation Pediatric Neuroimaging (NGPN) Development ($1,580,718)", "source_url": "https://reporter.nih.gov/project-details/11387527", "people": [{"name": "Curtis Andrew Corum", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44MH134709-03", "company": "Equa Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-03", "observed": "2026-09-07", "amount_usd": 907396, "summary": "NIH award 5R44MH134709-03: Mindfulness Meditation and Respiration Biosignal Feedback ($907,396)", "source_url": "https://reporter.nih.gov/project-details/11411494", "people": [{"name": "John David Creswell", "role": "Principal Investigator"}, {"name": "Mathew Polowitz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HD122546-01", "company": "Cfd Research Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-03", "observed": "2026-09-07", "amount_usd": 399978, "summary": "NIH award 1R43HD122546-01: FertiliChip: An Innovative Fallopian Tube-on-Chip Model for Women's Reproductive Health Research ($399,978)", "source_url": "https://reporter.nih.gov/project-details/11406698", "people": [{"name": "Abigail G Edwards", "role": "Principal Investigator"}, {"name": "Ashley Gilbert Helser", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44GM163446-01", "company": "Cambridge Medical Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-03", "observed": "2026-09-07", "amount_usd": 1010698, "summary": "NIH award 1R44GM163446-01: Lactate Measurement Using a Novel Non-invasive Device ($1,010,698)", "source_url": "https://reporter.nih.gov/project-details/11313626", "people": [{"name": "Emil Jachmann", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AR086679-01A1", "company": "Tissuerate Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-03", "observed": "2026-09-07", "amount_usd": 1262374, "summary": "NIH award 1R44AR086679-01A1: A novel bioactive bone graft to promote accelerated bone regeneration ($1,262,374)", "source_url": "https://reporter.nih.gov/project-details/11405145", "people": [{"name": "Sungwoo Kim", "role": "Principal Investigator"}, {"name": "YUNZHI YANG", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44DA058431-02", "company": "Wavi Company", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-03", "observed": "2026-09-07", "amount_usd": 1208000, "summary": "NIH award 4R44DA058431-02: Development of an AI-empowered device that utilizes multimodal data-visualization to aid in the diagnosis, and treatment, of OUD ($1,208,000)", "source_url": "https://reporter.nih.gov/project-details/11363282", "people": [{"name": "DAVID OAKLEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R41MH139347-02", "company": "Walnot, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-03", "observed": "2026-09-07", "amount_usd": 439764, "summary": "NIH award 5R41MH139347-02: A precision functional neuroimaging platform to enable collection of highly-sampled data at home ($439,764)", "source_url": "https://reporter.nih.gov/project-details/11405496", "people": [{"name": "Audrey Kynsella Bowden", "role": "Principal Investigator"}, {"name": "Ali Rahimpour Jounghani", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA306680-01A1", "company": "Orlucent, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-03", "observed": "2026-09-07", "amount_usd": 1556529, "summary": "NIH award 1R44CA306680-01A1: Development of Manufacturing Controls for ORL1: A Fluorescent Imaging Agent for In Vivo Molecular Imaging of Melanomas ($1,556,529)", "source_url": "https://reporter.nih.gov/project-details/11410547", "people": [{"name": "Catherine Shachaf", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41EY038621-01", "company": "Synvivo, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-03", "observed": "2026-09-21", "amount_usd": 290400, "summary": "NIH award 1R41EY038621-01: Development of the First Standardized, Commercial Retinal Barrier-on-Chip Using Donor-Matched Human Primary Retinal Pigment Epithelial and Choroidal Endothelial Cells for AMD Therapeutic Testing ($290,400)", "source_url": "https://reporter.nih.gov/project-details/11314934", "people": [{"name": "Gwendolyn D Fewell", "role": "Principal Investigator"}, {"name": "Gregory Hobart Grossman", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07802327", "company": "MicroTech Medical\uff08Hangzhou\uff09Co.,Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-03", "observed": "2026-09-03", "amount_usd": null, "summary": "New device trial registered: PMCF Study of GX-01S CGM in Adults With Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07802327", "people": [{"name": "Julia Mader, Professor, M.D.", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07802431", "company": "Jeisys Medical Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-03", "observed": "2026-09-03", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of Linear Z for Body Contouring", "source_url": "https://clinicaltrials.gov/study/NCT07802431"}, {"id": "trialreg:NCT07801105", "company": "Kevin Doody", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-03", "observed": "2026-09-03", "amount_usd": null, "summary": "New device trial registered: Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer", "source_url": "https://clinicaltrials.gov/study/NCT07801105", "people": [{"name": "Kevin Doody, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07802886", "company": "Haleon", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-03", "observed": "2026-09-03", "amount_usd": null, "summary": "New device trial registered: A Clinical Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity", "source_url": "https://clinicaltrials.gov/study/NCT07802886"}, {"id": "fda:K254000", "company": "Happy Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K254000: Happy Health Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254000", "people": [{"name": "Dustin Freckleton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254000%22"}, {"id": "fda:K261622", "company": "Philips Consumer Lifestyle B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261622: Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261622", "people": [{"name": "Jeff Chau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261622%22"}, {"id": "fda:K261800", "company": "Endovascular Engineering", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261800: Helo Max Thrombectomy System (HEL2090)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261800", "people": [{"name": "Ishita Raje", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261800%22"}, {"id": "fda:K261647", "company": "Pace Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261647: Tempo Plating System; Ultra Compression Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261647", "people": [{"name": "Bill Rhoda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261647%22"}, {"id": "fda:K261281", "company": "Filmecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261281: CROSSLEAD Standard 035 and CROSSLEAD Stiff 035", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261281", "people": [{"name": "Hayato Tsuboi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261281%22"}, {"id": "fda:K253673", "company": "Marani Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K253673: M\u0095care System (MW-20)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253673", "people": [{"name": "Mindy A. Ditch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253673%22"}, {"id": "fda:DEN250044", "company": "Powerful Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) DEN250044: STEMI AI ECG Model", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250044", "people": [{"name": "Arezou Azar", "role": "510(k) submission contact"}]}, {"id": "fda:K254035", "company": "MicroVention, Inc., d/b/a Terumo Neuro", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K254035: Mayumi\u0099 Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254035", "people": [{"name": "Remya Krishnan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254035%22"}, {"id": "fda:K262769", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262769: Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262769", "people": [{"name": "Alyssa McDermott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262769%22"}, {"id": "fda:K262460", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262460: Rezum System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262460", "people": [{"name": "Yuki Yamashita", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262460%22"}, {"id": "fda:K251794", "company": "Bryan Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K251794: Tenax\u00ae Laser Resistant Endotracheal Tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251794", "people": [{"name": "David Rattigan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251794%22"}, {"id": "fda:K262243", "company": "Kettenbach GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262243: Profisil Free", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262243", "people": [{"name": "Marleen Steger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262243%22"}, {"id": "fda:K260503", "company": "Neptune Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260503: Triton 1 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260503", "people": [{"name": "Alex Tilson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260503%22"}, {"id": "fda:K262315", "company": "Monteris Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262315: NeuroBlate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262315", "people": [{"name": "Amber Daly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262315%22"}, {"id": "fda:K253989", "company": "Maxigen Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K253989: HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253989", "people": [{"name": "Cheng-Han Chou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253989%22"}, {"id": "denovo:DEN250044", "company": "Powerful Medical, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-09-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250044 granted: STEMI AI ECG Model", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250044"}, {"id": "nih:5R41AI188742-02", "company": "Luna Bioscience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 300435, "summary": "NIH award 5R41AI188742-02: Antibody Detection for Diagnosis of Acute Leptospirosis ($300,435)", "source_url": "https://reporter.nih.gov/project-details/11423693", "people": [{"name": "Carla Ellen Devillers", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44HD105575-04", "company": "Claria Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 107203, "summary": "NIH award 5R44HD105575-04: A Safe, Fast, and Cost-Effective System for Tissue Removal in Laparoscopic Hysterectomy and Other Minimally Invasive Surgery ($107,203)", "source_url": "https://reporter.nih.gov/project-details/11416770", "people": [{"name": "Daniel Francis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44DA059519-03", "company": "Dynamicare Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 451415, "summary": "NIH award 5R44DA059519-03: Decentralized clinical trial of contingency management digital therapeutic to treat stimulant use disorder ($451,415)", "source_url": "https://reporter.nih.gov/project-details/11385450", "people": [{"name": "David R Gastfriend", "role": "Principal Investigator"}, {"name": "Carla J Rash", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HD114325-03", "company": "Analytical Diagnostic Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 1095992, "summary": "NIH award 5R44HD114325-03: A point of care-device for the determination of creatinine phosphokinase (CPK), the CPK Now ($1,095,992)", "source_url": "https://reporter.nih.gov/project-details/11419681", "people": [{"name": "Robert Harper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44AI172551-04", "company": "Aldatu Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 996962, "summary": "NIH award 2R44AI172551-04: PANDAA for universal, pan-lineage molecular detection of filoviruses to enable rapid epidemic response. ($996,962)", "source_url": "https://reporter.nih.gov/project-details/11316507", "people": [{"name": "Iain James MacLeod", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44HD118822-02", "company": "Optimal Mobility Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 754292, "summary": "NIH award 5R44HD118822-02: Kids Standing Up: Promoting Independent Mobility in Children with Neuromuscular Conditions with a Standing Wheelchair ($754,292)", "source_url": "https://reporter.nih.gov/project-details/11412951", "people": [{"name": "Patricia J McCracken", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42HD115517-03", "company": "Takeoff41, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 903784, "summary": "NIH award 5R42HD115517-03: An AI-driven total parenteral nutrition platform for cost-effective and scientifically personalized nutrition for premature newborns ($903,784)", "source_url": "https://reporter.nih.gov/project-details/11412694", "people": [{"name": "Nima Aghaeepour", "role": "Principal Investigator"}, {"name": "Thanaphong Phongpreecha", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43GM165166-01", "company": "Third Floor Materials, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 298111, "summary": "NIH award 1R43GM165166-01: High-throughput snapshot hyperspectral imager for multiplexed fluorescence microscopy ($298,111)", "source_url": "https://reporter.nih.gov/project-details/11407063", "people": [{"name": "Edward Sachet", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS143568-02", "company": "Cooltech LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 998747, "summary": "NIH award 5R44NS143568-02: Development of Mi-Helper: A Thermodynamic Neuromodulation Device for Migraine Relief ($998,747)", "source_url": "https://reporter.nih.gov/project-details/11418001", "people": [{"name": "Steven Edward Schaefer", "role": "Principal Investigator"}, {"name": "Stewart Tepper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA261360-03", "company": "Kubanda Cryotherapy, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 700023, "summary": "NIH award 5R44CA261360-03: Low Cost Carbon Dioxide-Based Cryoablation for Breast Cancer Treatment in Low Resource Settings ($700,023)", "source_url": "https://reporter.nih.gov/project-details/11405001", "people": [{"name": "Bailey Surtees", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41AR087264-01A1", "company": "Biosensics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 314362, "summary": "NIH award 1R41AR087264-01A1: Digital Assessment of Motor Skills in Infants and young boys with Duchenne Muscular Dystrophy using Wearable Sensors ($314,362)", "source_url": "https://reporter.nih.gov/project-details/11407133", "people": [{"name": "Mathula Thangarajh", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD115509-03", "company": "Contraline, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 829377, "summary": "NIH award 5R44HD115509-03: Development of ADAM Air: A Non-Hormonal Vas Occlusive Contraceptive Device ($829,377)", "source_url": "https://reporter.nih.gov/project-details/11412605", "people": [{"name": "Yelena Tropsha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL187080-01", "company": "Lynntech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 319607, "summary": "NIH award 1R43HL187080-01: BREATHWISE - An AI-Driven Early Warning System for COPD Exacerbations ($319,607)", "source_url": "https://reporter.nih.gov/project-details/11409774", "people": [{"name": "Arinzechukwu Uchenna Ufondu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41EY039188-01", "company": "Fasda Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 292058, "summary": "NIH award 1R41EY039188-01: Practical device for automated monitoring of neovascularization in diabetic retinopathy ($292,058)", "source_url": "https://reporter.nih.gov/project-details/11409917", "people": [{"name": "Nestor Uribe-Patarroyo", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42HL163783-04", "company": "Arcascope, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 598418, "summary": "NIH award 5R42HL163783-04: Real-world translation of a dynamic and personalized intervention for shift workers ($598,418)", "source_url": "https://reporter.nih.gov/project-details/11393360", "people": [{"name": "Olivia Walch", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43EY038518-01", "company": "Perzeption Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-02", "observed": "2026-09-07", "amount_usd": 305406, "summary": "NIH award 1R43EY038518-01: Efficient Achromatic and Chromatic Photostress Recovery Assessment for Age-related Macular Degeneration ($305,406)", "source_url": "https://reporter.nih.gov/project-details/11310564", "people": [{"name": "THADDEUS ORION WILMERDING", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07799857", "company": "SoLa Pelvic Therapy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-02", "observed": "2026-09-02", "amount_usd": null, "summary": "New device trial registered: A Prospective Registry of Vaginal Photobiomodulation for Chronic Pelvic Pain.", "source_url": "https://clinicaltrials.gov/study/NCT07799857"}, {"id": "trialreg:NCT07799194", "company": "Energenx Medical LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-02", "observed": "2026-09-02", "amount_usd": null, "summary": "New device trial registered: A Clinical Study To Evaluate The Performances of A Pulsed Electric Field Ablation Through Percutaneous Approach for Patients With Early-Stage Lung Cancer or Lung Oligometastatic Tumor.", "source_url": "https://clinicaltrials.gov/study/NCT07799194"}, {"id": "trialreg:NCT07800962", "company": "Truway Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-02", "observed": "2026-09-02", "amount_usd": null, "summary": "New device trial registered: Federated Learning for Point-of-Care Cardiac Ultrasound", "source_url": "https://clinicaltrials.gov/study/NCT07800962", "people": [{"name": "Gavin Solomon, MD", "role": "Principal Investigator"}]}, {"id": "fda:K262809", "company": "ArthroTAK, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262809: ArthroTAK Tendon Anchor Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262809", "people": [{"name": "Don Running", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262809%22"}, {"id": "fda:K254026", "company": "Flexicare Medical Limited.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K254026: 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254026", "people": [{"name": "Rebecca Funston", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254026%22"}, {"id": "fda:K253065", "company": "Aevumed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K253065: Aevumed SUPERCYNCH\u0099 Button System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253065", "people": [{"name": "Saif Khalil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253065%22"}, {"id": "fda:K254198", "company": "Trexo Robotics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K254198: Trexo Theo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254198", "people": [{"name": "Linda Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254198%22"}, {"id": "fda:K254090", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K254090: I-View\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254090", "people": [{"name": "Manuela Restrepo Parra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254090%22"}, {"id": "fda:K253948", "company": "United Orthopedic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K253948: Momentum Acetabular Cup System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253948", "people": [{"name": "Lois Ho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253948%22"}, {"id": "fda:K261589", "company": "Zhengzhou PZ Laser Slim Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261589: 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261589", "people": [{"name": "Yueming Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261589%22"}, {"id": "fda:K262364", "company": "Ellian Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262364: Ellian Enigma RF Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262364", "people": [{"name": "Julie Summerville", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262364%22"}, {"id": "fda:K261313", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261313: Vivid Explorer/Vivid Advanced/Vivid Focus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261313", "people": [{"name": "Yuan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261313%22"}, {"id": "fda:K261749", "company": "Cardinalhealth", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261749: Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261749", "people": [{"name": "Vani Bala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261749%22"}, {"id": "fda:K260432", "company": "Venocare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260432: Ruby Intravascular Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260432", "people": [{"name": "Ivenette Guzman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260432%22"}, {"id": "fda:K262153", "company": "Modular Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262153: Pivot Insulin Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262153", "people": [{"name": "Paul DiPerna", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262153%22"}, {"id": "fda:K261311", "company": "Anika Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261311: HYALOMATRIX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261311", "people": [{"name": "Wei Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261311%22"}, {"id": "fda:K262420", "company": "Serpex Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262420: Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262420", "people": [{"name": "Neil Zimmerman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262420%22"}, {"id": "nih:5R44EY036772-02", "company": "Intelon Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 668604, "summary": "NIH award 5R44EY036772-02: Next-generation Brillouin ocular scanner ($668,604)", "source_url": "https://reporter.nih.gov/project-details/11414904", "people": [{"name": "Claire Shelley Barnes", "role": "Principal Investigator"}, {"name": "Giuliano Scarcelli", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL180057-01A1", "company": "Fascia Sleep Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 417686, "summary": "NIH award 1R43HL180057-01A1: A wearable device for at-home sleep studies that merges comfort with clinical-grade insights ($417,686)", "source_url": "https://reporter.nih.gov/project-details/11314914", "people": [{"name": "Guillermo Bernal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43CA306431-02", "company": "Myolex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 136944, "summary": "NIH award 5R43CA306431-02: Electrical impedance myography (EIM) to detect and track cancer cachexia ($136,944)", "source_url": "https://reporter.nih.gov/project-details/11402064", "people": [{"name": "David P. Dickinson", "role": "Principal Investigator"}, {"name": "Ishan Roy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH136880-02", "company": "Ampa Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 770028, "summary": "NIH award 5R44MH136880-02: Validation of next-generation TMS system optimizing for widely scalable, personalized treatment of depression ($770,028)", "source_url": "https://reporter.nih.gov/project-details/11415481", "people": [{"name": "Jonathan Alexander Stewart Downar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HG014985-01", "company": "Cytoterra Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 296543, "summary": "NIH award 1R43HG014985-01: Reliable detection of Robertsonian translocations via Genomic Proximity Mapping ($296,543)", "source_url": "https://reporter.nih.gov/project-details/11315985", "people": [{"name": "Stephen Matthew Eacker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44GM165165-01", "company": "Everest Biolabs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 1153043, "summary": "NIH award 1R44GM165165-01: High-yield, High-purity Extracellular Vesicle Isolation Columns for High-throughput Plate-based Biomarker Discovery and Diagnosis ($1,153,043)", "source_url": "https://reporter.nih.gov/project-details/11407090", "people": [{"name": "Tal Gilboa", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44EB038843-01A1", "company": "Virtuoso Surgical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 1094485, "summary": "NIH award 1R44EB038843-01A1: A Robot to Enable Broad Deployment of the Least Invasive Uterine Fibroid Surgical Intervention ($1,094,485)", "source_url": "https://reporter.nih.gov/project-details/11409530", "people": [{"name": "Richard Joseph Hendrick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41DK146772-01", "company": "Data4systemschange, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 349640, "summary": "NIH award 1R41DK146772-01: Nutri-DeepDish: Enhancing AI-Powered Dietary Assessment for Accurate, Real-World Food Intake Measurement ($349,640)", "source_url": "https://reporter.nih.gov/project-details/11315970", "people": [{"name": "CHRISTINA D ECONOMOS", "role": "Principal Investigator"}, {"name": "Erin Hennessy", "role": "Principal Investigator"}, {"name": "Karen Panetta", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL186091-01", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 305365, "summary": "NIH award 1R43HL186091-01: Cooled RF Bronchoscopic Lung Volume Reduction ($305,365)", "source_url": "https://reporter.nih.gov/project-details/11349295", "people": [{"name": "Howard Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA302204-01A1", "company": "Pathware Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 1057841, "summary": "NIH award 1R44CA302204-01A1: Leveraging Coded Ptychography to Deliver AI-powered Rapid Analysis of Unstained Lung Biopsy Samples at the Point of Care ($1,057,841)", "source_url": "https://reporter.nih.gov/project-details/11310522", "people": [{"name": "David Goldberger", "role": "Principal Investigator"}, {"name": "Torsten Lyon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44LM014847-02", "company": "Clairyon, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 1143788, "summary": "NIH award 4R44LM014847-02: Automating Quality to Accelerate Transformational Improvements in Care (AQUATIC) ($1,143,788)", "source_url": "https://reporter.nih.gov/project-details/11453739", "people": [{"name": "Michael T. McCurdy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44MD021394-01", "company": "Accuhealth Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 311977, "summary": "NIH award 1R44MD021394-01: Health360x.ai: Accelerating Access to Medical Breakthroughs at the Point of Care ($311,977)", "source_url": "https://reporter.nih.gov/project-details/11350219", "people": [{"name": "Chamberlain Obialo", "role": "Principal Investigator"}, {"name": "Elizabeth O. Ofili", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK148331-01", "company": "Pupil Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 1015056, "summary": "NIH award 1R44DK148331-01: Development of an early detection test for Type 1 Diabetes via NGS-based analysis of \u03b2 cells-specific methylation patterns in cfDNA ($1,015,056)", "source_url": "https://reporter.nih.gov/project-details/11409949", "people": [{"name": "Alessandro Pinto", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL184803-01", "company": "Giner, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 591499, "summary": "NIH award 1R43HL184803-01: Asthma Management by Monitoring Nitric Oxide (NO) Levels in Exhaled Breath ($591,499)", "source_url": "https://reporter.nih.gov/project-details/11315861", "people": [{"name": "Muhit Rana", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD021412-01", "company": "Datanomy Group LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 306801, "summary": "NIH award 1R43MD021412-01: Project VELA: A Cloud-Based, Model-Agnostic Federated Query Tool to Enable Scalable, Inclusive Multi-Site Research Across Health Systems ($306,801)", "source_url": "https://reporter.nih.gov/project-details/11350099", "people": [{"name": "Leslie Hinyard", "role": "Principal Investigator"}, {"name": "Thomas Sessa", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL180095-01A1", "company": "Corfigo, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 447736, "summary": "NIH award 1R43HL180095-01A1: Corfigo HeartPad Cryoablation System ($447,736)", "source_url": "https://reporter.nih.gov/project-details/11314121", "people": [{"name": "Deron Siddons", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA310451-01A1", "company": "Eleuthra Photonics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 399268, "summary": "NIH award 1R43CA310451-01A1: Multi-Scale Nonlinear Optics Label-Free Microscopy for Rapid Prostate Cancer Research and Diagnosis ($399,268)", "source_url": "https://reporter.nih.gov/project-details/11407608", "people": [{"name": "Kayvan Forouhesh Tehrani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41EB039551-01", "company": "Et-trac LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 307596, "summary": "NIH award 1R41EB039551-01: A cost-effective near-infrared imaging device for continuous and noninvasive assessment of endotracheal tube position in children ($307,596)", "source_url": "https://reporter.nih.gov/project-details/11407048", "people": [{"name": "Bing Yu", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL178315-02", "company": "Invia, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-07", "amount_usd": 1109351, "summary": "NIH award 5R44HL178315-02: Development of Deep Learning Tools for Widely-Available, Inexpensive Diagnosis of Coronary Microvascular and Vasomotor Dysfunction ($1,109,351)", "source_url": "https://reporter.nih.gov/project-details/11417161", "people": [{"name": "Jonathan Bryan Moody", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43GM165163-01", "company": "Np Photonics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-08", "amount_usd": 306873, "summary": "NIH award 1R43GM165163-01: Low-cost robust compact 900 nm femtosecond laser source for two-photon microscopy ($306,873)", "source_url": "https://reporter.nih.gov/project-details/11407296", "people": [{"name": "Weerasinghe Kushan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R42MD015978-02A1", "company": "Inhealth USA, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-08", "amount_usd": 1160093, "summary": "NIH award 2R42MD015978-02A1: Virtually Supporting Schools: Hispanic Adolescent Resilience and Mental health Opportunities in the Nation's Youth-US (HARMONY-US) Phase 2 ($1,160,093)", "source_url": "https://reporter.nih.gov/project-details/11410574", "people": [{"name": "Laverne Morrow Carter", "role": "Principal Investigator"}, {"name": "Alan Meca", "role": "Principal Investigator"}, {"name": "SETH J. SCHWARTZ", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44GM165220-01", "company": "Partillion Bioscience Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-10", "amount_usd": 979071, "summary": "NIH award 1R44GM165220-01: Nanovial Kits for Large-Scale Cell-Cell Interaction Sequencing ($979,071)", "source_url": "https://reporter.nih.gov/project-details/11410488", "people": [{"name": "Joseph de Rutte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH143422-01", "company": "Innovation Research And Training, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-09-01", "observed": "2026-09-12", "amount_usd": 314362, "summary": "NIH award 1R43MH143422-01: Building Assets Together: A toolkit for youth mentors ($314,362)", "source_url": "https://reporter.nih.gov/project-details/11313524", "people": [{"name": "Rebecca Lynn Stelter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nsf:2605023", "company": "Atrility Medical LLC", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-09-01", "observed": "2026-08-25", "amount_usd": 312500, "summary": "NSF SBIR award: SBIR Phase II: Development of Automated Post Operative Rhythm Identification Through Computerized Evaluation of Atrial Signals ($312,500)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2605023", "people": [{"name": "Matthew Knoespel", "role": "Principal Investigator"}]}, {"id": "nsf:2600002", "company": "Medicarbone, Inc.", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-09-01", "observed": "2026-08-25", "amount_usd": 100000, "summary": "NSF SBIR award: SBIR Phase II: Design and Development of Minimally-Invasive Orthopedic Fracture Fixation ($100,000)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2600002", "people": [{"name": "Krishna Kolan", "role": "Principal Investigator"}]}, {"id": "nsf:2604976", "company": "Informuta, Inc.", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-09-01", "observed": "2026-08-25", "amount_usd": 312500, "summary": "NSF SBIR award: SBIR Phase II: Leveraging Sequencing to Identify and Predict Multidrug Resistance ($312,500)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2604976", "people": [{"name": "Kalen Hall", "role": "Principal Investigator"}]}, {"id": "nsf:2605011", "company": "Adavance Nanolytics Inc", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-09-01", "observed": "2026-08-25", "amount_usd": 312500, "summary": "NSF STTR award: STTR Phase II: A Plasmonic Nanopore Sensor Device to Quantify DNA Loading Efficiency of Single Adeno-associated Virus (AAV) Particles ($312,500)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2605011", "people": [{"name": "Scott Renkes", "role": "Principal Investigator"}]}, {"id": "nsf:2537899", "company": "Radiation Detection Solutions LLC", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-09-01", "observed": "2026-08-27", "amount_usd": 305000, "summary": "NSF STTR award: STTR Phase I: Conformal sensor for radiation monitoring using organic semiconductors and conductors ($305,000)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2537899", "people": [{"name": "Michael Bardash", "role": "Principal Investigator"}]}, {"id": "nsf:2605191", "company": "Perceptra Technologies, Inc.", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-09-01", "observed": "2026-08-28", "amount_usd": 250000, "summary": "NSF SBIR award: SBIR Phase II: High-Performance Integrated Photonic Raman Analyzers ($250,000)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2605191", "people": [{"name": "Amir H Atabaki", "role": "Principal Investigator"}]}, {"id": "nsf:2605002", "company": "Meteora3d, Incorporated", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-09-01", "observed": "2026-08-28", "amount_usd": 100000, "summary": "NSF SBIR award: SBIR Phase II: Rapid Lift-Based Peel Separation Masked Inverted Stereolithography 3D Printing for Trauma and Emergency Procedural Planning ($100,000)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2605002", "people": [{"name": "Prashanth Ravi", "role": "Principal Investigator"}]}, {"id": "nsf:2550084", "company": "3fates-xray, Inc.", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-09-01", "observed": "2026-08-28", "amount_usd": 312049, "summary": "NSF SBIR award: SBIR Phase II: Deep-learning Driven Single-shot X-ray Phase-contrast Computed Tomography for Security Screening ($312,049)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2550084", "people": [{"name": "Yao-Te Cheng", "role": "Principal Investigator"}]}, {"id": "nsf:2527821", "company": "Ecate LLC", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-09-01", "observed": "2026-08-30", "amount_usd": 308414, "summary": "NSF SBIR award: SBIR Phase II: A Novel Implantable System for Neurogenic Control ($308,414)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2527821", "people": [{"name": "Alessandro Maggi", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07798427", "company": "Truway Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-01", "observed": "2026-09-01", "amount_usd": null, "summary": "New device trial registered: TruVascular Access - Ultrasound-Guided Vascular Access Study", "source_url": "https://clinicaltrials.gov/study/NCT07798427", "people": [{"name": "Gavin C Solomon, M.D.", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07797348", "company": "Zenflow, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-01", "observed": "2026-09-01", "amount_usd": null, "summary": "New device trial registered: Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH.", "source_url": "https://clinicaltrials.gov/study/NCT07797348"}, {"id": "trialreg:NCT07796230", "company": "Optos, PLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-01", "observed": "2026-09-01", "amount_usd": null, "summary": "New device trial registered: Modified P200TE Data Collection", "source_url": "https://clinicaltrials.gov/study/NCT07796230"}, {"id": "trialreg:NCT07796659", "company": "Polares Medical SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-01", "observed": "2026-09-01", "amount_usd": null, "summary": "New device trial registered: EXPLORE MRace (GE): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant", "source_url": "https://clinicaltrials.gov/study/NCT07796659"}, {"id": "trialreg:NCT07798128", "company": "Becton, Dickinson and Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-01", "observed": "2026-09-01", "amount_usd": null, "summary": "New device trial registered: An Observational, Multinational, In Hospital Evaluation of Catheter Utilization Rates in Female Patients Using Indwelling Urinary Catheters and the PureWick\u2122 Flex Female External Catheter Across Europe and the Middle East", "source_url": "https://clinicaltrials.gov/study/NCT07798128"}, {"id": "trialreg:NCT07796165", "company": "Europa Life Sciences Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-09-01", "observed": "2026-09-01", "amount_usd": null, "summary": "New device trial registered: SNIP follow-on Case Series Using v3 Device", "source_url": "https://clinicaltrials.gov/study/NCT07796165", "people": [{"name": "Aung Soe, MBChB MSc FRCPCH AFHEA", "role": "Principal Investigator"}]}, {"id": "nsf:2538823", "company": "M3d, Inc.", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-09-01", "observed": "2026-09-03", "amount_usd": 312500, "summary": "NSF SBIR award: SBIR Phase II: Gamma Camera Design and Studies for Intraoperative Imaging ($312,500)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2538823", "people": [{"name": "Jerimy Polf", "role": "Principal Investigator"}]}, {"id": "nsf:2537926", "company": "Total Analysis L.l.c.", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-09-01", "observed": "2026-09-13", "amount_usd": 287421, "summary": "NSF SBIR award: SBIR Phase II: Combating Pathogens with Onsite Universal Detection ($287,421)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2537926", "people": [{"name": "Darrell D Marshall PhD", "role": "Principal Investigator"}]}, {"id": "fda:K253961", "company": "Just Medical Devices (Tianjin) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K253961: SK Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253961", "people": [{"name": "Wendy Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253961%22"}, {"id": "fda:K260613", "company": "Sequitur Health Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260613: AMI\u0099 Plasma Cartridge, AMI\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260613", "people": [{"name": "Marylaura Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260613%22"}, {"id": "fda:K260656", "company": "GE Healthcare Finland Oy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260656: Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260656", "people": [{"name": "Anssi Ruokonen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260656%22"}, {"id": "fda:K260758", "company": "Siemens Shenzhen Magnetic Resonance , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260758: MAGNETOM Free.Max; MAGNETOM Free.Star", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260758", "people": [{"name": "Li Hai Ting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260758%22"}, {"id": "fda:K262451", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262451: Arthrex DynaNite Staples", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262451", "people": [{"name": "Konrad Wolfmeyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262451%22"}, {"id": "fda:K262783", "company": "Eizo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262783: RadiForce MX247W", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262783", "people": [{"name": "Hiroaki Hashimoto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262783%22"}, {"id": "fda:K261811", "company": "PRIMED Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261811: PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261811", "people": [{"name": "Mitra Fard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261811%22"}, {"id": "fda:K260884", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260884: UNIDRIVE Select System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260884", "people": [{"name": "Alita McElroy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260884%22"}, {"id": "fda:K262774", "company": "Guangdong Horigen Mother & Baby Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262774: Wearable breast pump (Model: XN/MD-2249BS, ZFHF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262774", "people": [{"name": "Changxin Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262774%22"}, {"id": "fda:K262269", "company": "Beijing Mega Beauty Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-09-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262269: CO2 Laser System (MBT- CO2 Laser)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262269", "people": [{"name": "Alex Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262269%22"}, {"id": "usasp:75N98026F00001", "company": "Mriglobal", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-09-01", "observed": "2026-09-15", "amount_usd": 369210, "summary": "Federal medical R&D contract from National Institutes of Health: THIS TASK ORDER IS TO PROVIDE REGULATORY SUPPORT FOR VAGINITIS PCR ASSAY. ($369,210)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_75N98026F00001_7529_75N93023D00017_7529"}, {"id": "nih:5R44GM161237-02", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-31", "observed": "2026-09-07", "amount_usd": 1047458, "summary": "NIH award 5R44GM161237-02: PhysioSim: Innovative Physiology Simulation Education Kits for Pre-College Students and Teachers ($1,047,458)", "source_url": "https://reporter.nih.gov/project-details/11381216", "people": [{"name": "Adam Becker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL178050-02", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-31", "observed": "2026-09-07", "amount_usd": 1034896, "summary": "NIH award 5R44HL178050-02: ENT-based Approach to Cervical Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea ($1,034,896)", "source_url": "https://reporter.nih.gov/project-details/11414970", "people": [{"name": "Mark Gelfand", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM146557-03", "company": "Cytorum, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-31", "observed": "2026-09-07", "amount_usd": 843224, "summary": "NIH award 5R44GM146557-03: Xbeads: A Platform for Flow Cytometry Sample QC and Harmonization ($843,224)", "source_url": "https://reporter.nih.gov/project-details/11384461", "people": [{"name": "Peter Krutzik", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL184690-01A1", "company": "Inflo Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-31", "observed": "2026-09-07", "amount_usd": 595332, "summary": "NIH award 1R43HL184690-01A1: Advancing Pediatric ECMO Through A Biocompatible System Design ($595,332)", "source_url": "https://reporter.nih.gov/project-details/11402519", "people": [{"name": "zahra mahdieh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR087245-01A1", "company": "Thinks Works, Pbc D/b/a Thinksworks", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-31", "observed": "2026-09-07", "amount_usd": 306346, "summary": "NIH award 1R43AR087245-01A1: The RESILIENT Brace: a flexible, adjustable, connected bracing system for Adolescent Idiopathic Scoliosis ($306,346)", "source_url": "https://reporter.nih.gov/project-details/11402856", "people": [{"name": "Ryan C Murdock", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK146368-01A1", "company": "Sfc Fluidics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-31", "observed": "2026-09-07", "amount_usd": 250000, "summary": "NIH award 1R43DK146368-01A1: Development of a Phenolics Depletion Chip (PDC) for Use in Insulin Delivery Patch Pumps ($250,000)", "source_url": "https://reporter.nih.gov/project-details/11401313", "people": [{"name": "Forrest Payne", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD102241-05", "company": "Collamedix Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-31", "observed": "2026-09-07", "amount_usd": 933974, "summary": "NIH award 5R44HD102241-05: Collagen-based tissue guidance biofabric for treatment of stress urinary incontinence in women ($933,974)", "source_url": "https://reporter.nih.gov/project-details/11367360", "people": [{"name": "Subba Shankar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44GM161156-02", "company": "Newomics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-31", "observed": "2026-09-07", "amount_usd": 1000000, "summary": "NIH award 5R44GM161156-02: Multispray Technology for Studying Biomolecular Interactions ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11392251", "people": [{"name": "DAOJING WANG", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44ES033890-03", "company": "Giner, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-31", "observed": "2026-09-07", "amount_usd": 1003898, "summary": "NIH award 5R44ES033890-03: Low-Cost Amperometric Ozone Monitor for Communities Affected by Wildfires ($1,003,898)", "source_url": "https://reporter.nih.gov/project-details/11417234", "people": [{"name": "Andrew Weber", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL178322-01A1", "company": "Medluidics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-31", "observed": "2026-09-13", "amount_usd": 227639, "summary": "NIH award 1R43HL178322-01A1: A cardiopulmonary unit-on-a-chip to investigate the pathophysiology and develop targeted treatments for right ventricular hypertrophy caused by pulmonary arterial hypertension ($227,639)", "source_url": "https://reporter.nih.gov/project-details/11410451", "people": [{"name": "Fakhrul Ahsan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07795606", "company": "Bayer", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-31", "observed": "2026-08-31", "amount_usd": null, "summary": "New device trial registered: An Observational Study to Learn How Mirena and Other Progestogen Treatments Are Used for Endometrial Protection in Women 40+ With a Uterus in the United States Receiving Estrogen Therapy, and Their Respective Health Outcomes", "source_url": "https://clinicaltrials.gov/study/NCT07795606"}, {"id": "trialreg:NCT07793981", "company": "Linshom Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-31", "observed": "2026-08-31", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of an Alarm Activated Detection System to Enable Early Intervention of Emerging Respiratory Decline With the Linshom Medical Continuous Predictive Respiratory Sensor (CPRS)", "source_url": "https://clinicaltrials.gov/study/NCT07793981", "people": [{"name": "Richard D Urman, MD, MBA", "role": "Principal Investigator"}, {"name": "Alberto Uribe, MD", "role": "Study Director"}]}, {"id": "trialreg:NCT07794891", "company": "AbbVie", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-31", "observed": "2026-08-31", "amount_usd": null, "summary": "New device trial registered: Study to Assess Participant Satisfaction After Jawline and Neck Treatment", "source_url": "https://clinicaltrials.gov/study/NCT07794891", "people": [{"name": "ABBVIE INC.", "role": "Study Director"}]}, {"id": "trialreg:NCT07795359", "company": "Berlin Heals GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-31", "observed": "2026-08-31", "amount_usd": null, "summary": "New device trial registered: A Study Evaluating an Implantable Cardiac Microcurrent Device in Patients With Chronic Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07795359"}, {"id": "trialreg:NCT07794215", "company": "Field Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-31", "observed": "2026-08-31", "amount_usd": null, "summary": "New device trial registered: This Study Will Evaluate if the Field Force Pulsed Field Ablation System is Safe and Effective for Treating Sustained Monomorphic Ventricular Tachycardia, a Potentially Serious Fast Heart Rhythm of the Heart. The Treatment Uses Short Pulses of Energy to Target and Destroy the Heart Tissue Causing VT", "source_url": "https://clinicaltrials.gov/study/NCT07794215", "people": [{"name": "Vivek Reddy, MD", "role": "Principal Investigator"}]}, {"id": "fda:K262788", "company": "Aura Wellness, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262788: Nova HD+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262788", "people": [{"name": "Scott Blomberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262788%22"}, {"id": "fda:K260488", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260488: MULTIX Impact; MULTIX Impact C", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260488", "people": [{"name": "AnnTina Walker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260488%22"}, {"id": "fda:K260767", "company": "Kam Yuen Plastic Products , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260767: Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260767", "people": [{"name": "Shihe Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260767%22"}, {"id": "fda:K261403", "company": "Global Life Sciences Solutions USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261403: Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261403", "people": [{"name": "Brian Goetz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261403%22"}, {"id": "fda:K262747", "company": "Abbott Diagnostics Scarborough, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262747: ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262747", "people": [{"name": "Stephanie Rose", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262747%22"}, {"id": "fda:K260387", "company": "Hironic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K260387: SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260387", "people": [{"name": "Byoungkook Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260387%22"}, {"id": "fda:K262658", "company": "Honsun (Nantong) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K262658: Automatic Digital Blood Pressure monitor (LD-526)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262658", "people": [{"name": "Jian Shen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262658%22"}, {"id": "fda:K261695", "company": "Guilin Kevin Peter Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261695: Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261695", "people": [{"name": "Qian Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261695%22"}, {"id": "fda:K254217", "company": "Evolym, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K254217: Aerloom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254217", "people": [{"name": "Alex Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254217%22"}, {"id": "fda:K261718", "company": "Radformation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA 510(k) K261718: EZFluence (RADEZ V2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261718", "people": [{"name": "Jennifer Wampler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261718%22"}, {"id": "nih:4R44GM161221-02", "company": "Calis Books Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-08-31", "amount_usd": 1211165, "summary": "NIH award 4R44GM161221-02: Introducing Young Children to Biomedical Science with a Screenless Interactive Device (infinibook) ($1,211,165)", "source_url": "https://reporter.nih.gov/project-details/11380373", "people": [{"name": "Carinne Meyrignac", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL184460-01", "company": "Syncardia Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 606498, "summary": "NIH award 1R43HL184460-01: A wearable, mechanically actuated total artificial heart (Emperor) enabling destination therapy for severe biventricular heart failure patients ($606,498)", "source_url": "https://reporter.nih.gov/project-details/11312498", "people": [{"name": "Duffy Elmer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42NS150010-01A1", "company": "Neurorobotic Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 500000, "summary": "NIH award 1R42NS150010-01A1: Development and assessment of a powered prosthetic digit system with novel wrist-based control and integrated sensory feedback ($500,000)", "source_url": "https://reporter.nih.gov/project-details/11408725", "people": [{"name": "Jacob Anthony George", "role": "Principal Investigator"}, {"name": "Marta M Iversen", "role": "Principal Investigator"}, {"name": "Levin Sliker", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL172564-03", "company": "Informai, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 992164, "summary": "NIH award 5R44HL172564-03: Artificial Intelligence Tool to Optimize Organ Transplantation Outcomes (Transplant-AI) ($992,164)", "source_url": "https://reporter.nih.gov/project-details/11419808", "people": [{"name": "Jim Havelka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43MD021361-01", "company": "Biotarget Dx LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 295924, "summary": "NIH award 1R43MD021361-01: Dual-Platform Plasma Assay for Early Lung Cancer Detection in African Americans ($295,924)", "source_url": "https://reporter.nih.gov/project-details/11329410", "people": [{"name": "Feng Jiang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM146498-03", "company": "Cascade Metrix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 897537, "summary": "NIH award 5R44GM146498-03: Automated Multiplex Analyzer for Sepsis and Beyond ($897,537)", "source_url": "https://reporter.nih.gov/project-details/11406343", "people": [{"name": "Kislaya Kunjan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41HL180137-01A1", "company": "Fastline LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 306383, "summary": "NIH award 1R41HL180137-01A1: FastLine: Simplified, one-handed placement of central venous catheters ($306,383)", "source_url": "https://reporter.nih.gov/project-details/11314759", "people": [{"name": "Graham Lieberman", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR086680-01A1", "company": "Mds II LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 299996, "summary": "NIH award 1R43AR086680-01A1: The Rotational Femoral Nail: Late Stage Translation from Lab to Marketplace ($299,996)", "source_url": "https://reporter.nih.gov/project-details/11405287", "people": [{"name": "Omer Mei Dan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL176399-02", "company": "Aveera Medical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 1011669, "summary": "NIH award 5R44HL176399-02: Preventing major amputations and preserving functional limbs in no option critical limb-threating ischemia patients ($1,011,669)", "source_url": "https://reporter.nih.gov/project-details/11397749", "people": [{"name": "Brian DeRubertis", "role": "Principal Investigator"}, {"name": "Elizabeth Anne Genovese", "role": "Principal Investigator"}, {"name": "Joseph Rodgers Steele", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA298522-02", "company": "Ef Therapeutics Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 1060745, "summary": "NIH award 5R44CA298522-02: IntellipulseTM Platform Technology for Effective Delivery of Therapeutic Agents ($1,060,745)", "source_url": "https://reporter.nih.gov/project-details/11404812", "people": [{"name": "GARY STRANGE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL182519-01A1", "company": "Jb Healthtech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 529283, "summary": "NIH award 1R43HL182519-01A1: Enhanced Diagnosis and Clinical Management of Preeclampsia with a Highly Accurate Dual-Mode Wearable Blood Pressure Monitor. ($529,283)", "source_url": "https://reporter.nih.gov/project-details/11410131", "people": [{"name": "Sharon X. Wang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL182448-01A1", "company": "Anova Biomedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 345938, "summary": "NIH award 1R41HL182448-01A1: Compliant and degradable peripheral vascular grafts ($345,938)", "source_url": "https://reporter.nih.gov/project-details/11406427", "people": [{"name": "Yadong Wang", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH111463-05", "company": "Meadowlark Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 1038134, "summary": "NIH award 5R44MH111463-05: Improving Speed and Cost of Entry for Holographic Optogenetics ($1,038,134)", "source_url": "https://reporter.nih.gov/project-details/11401020", "people": [{"name": "CHRISTOPHER LUK HOY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44AA033865-01A1", "company": "Innovation Research And Training, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-07", "amount_usd": 999430, "summary": "NIH award 1R44AA033865-01A1: Parent resource to improve communication for adolescent substance use prevention ($999,430)", "source_url": "https://reporter.nih.gov/project-details/11406474", "people": [{"name": "Tracy Marie Scull", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R43DK143762-02", "company": "Exhalix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-09", "amount_usd": 116757, "summary": "NIH award 5R43DK143762-02: A Hydrogen Sulfide Delivery Technology for Organ Preservation Therapy ($116,757)", "source_url": "https://reporter.nih.gov/project-details/11412612", "people": [{"name": "Reza Shekarriz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44AI197758-01", "company": "Hesperos, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-10", "amount_usd": 1000000, "summary": "NIH award 1R44AI197758-01: Expanded implementation of a human-based Malaria-on-a-Chip phenotypic disease model for the evaluation of therapeutic efficacy and off-target toxicity ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11316388", "people": [{"name": "James J Hickman", "role": "Principal Investigator"}, {"name": "Aakash Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R42HL174259-03", "company": "Third Coast Dynamics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-28", "observed": "2026-09-21", "amount_usd": 751837, "summary": "NIH award 5R42HL174259-03: Anatomic Imaging Derived 4D Hemodynamics using Deep Learning ($751,837)", "source_url": "https://reporter.nih.gov/project-details/11403868", "people": [{"name": "Bradley David Allen", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07792317", "company": "Vivalyx GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-28", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation", "source_url": "https://clinicaltrials.gov/study/NCT07792317"}, {"id": "trialreg:NCT07793058", "company": "Keystone OrthotropiX", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-28", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: A 6-month Study on the Feasibility, Safety, and Tolerability of a Silicone Myofunctional Infant Pacifier", "source_url": "https://clinicaltrials.gov/study/NCT07793058", "people": [{"name": "Nafys Samandari, DDS", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07792772", "company": "HUINNO Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-28", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Arrhythmia Detection With MEMO Patch Plus in Patients With Acute Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07792772"}, {"id": "fda:K262722", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262722: Primal K-Wire (P99-193-1410)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262722", "people": [{"name": "Daniel Nelson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262722%22"}, {"id": "fda:K260047", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260047: cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260047", "people": [{"name": "Jinali Bhavsar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260047%22"}, {"id": "fda:K262013", "company": "Reflow Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262013: Kiba CTO Crossing Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262013", "people": [{"name": "Angela Lamprey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262013%22"}, {"id": "fda:K260343", "company": "GE Healthcare Finland Oy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260343: Carescape Canvas 1000; Carescape Canvas Smart Display", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260343", "people": [{"name": "P\u00e4ivi Roiha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260343%22"}, {"id": "fda:K260045", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260045: cobas\u00ae Cdiff Nucleic acid test for use on the cobas\u00ae Liat\u00ae System (07454945190); cobas\u00ae Cdiff Positive and Negative Control Kit for use on the cobas\u00ae Liat\u00ae System (07454970190)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260045", "people": [{"name": "Jinali Bhavsar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260045%22"}, {"id": "fda:K262735", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262735: LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262735", "people": [{"name": "Shreya Chenni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262735%22"}, {"id": "fda:K261830", "company": "Ortler Global Tibbi Gerecler Anonim Sirketi", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261830: FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261830", "people": [{"name": "TAHA CIBIR", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261830%22"}, {"id": "fda:K260617", "company": "Rapid Medical Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260617: Tigertriever 13 Ultra Revascularization Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260617", "people": [{"name": "Ina Gutman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260617%22"}, {"id": "fda:K253630", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253630: Mpact 3D Metal Foam", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253630", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253630%22"}, {"id": "fda:K254261", "company": "Cell Store (beijing) Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K254261: Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254261", "people": [{"name": "Kang Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254261%22"}, {"id": "fda:K261582", "company": "Zhengzhou PZ Laser Slim Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261582: Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261582", "people": [{"name": "Junmei Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261582%22"}, {"id": "fda:K260517", "company": "Zhejiang Curaway Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260517: Automatic Core Biopsy Instrument", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260517", "people": [{"name": "Yin Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260517%22"}, {"id": "fda:K261176", "company": "Imperative Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261176: Zoom 4S Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261176", "people": [{"name": "Peter Taylor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261176%22"}, {"id": "fda:K253954", "company": "X-Nav Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253954: X-Guide Surgical Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253954", "people": [{"name": "Kimberly Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253954%22"}, {"id": "fda:K260203", "company": "Beijing Fule Science & Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260203: Fule Vertebroplasty Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260203", "people": [{"name": "Xiaoliang Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260203%22"}, {"id": "fda:K261378", "company": "AZmed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-28", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261378: Rayvolve AZchest", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261378", "people": [{"name": "Victor DE POLLI", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261378%22"}, {"id": "nih:5R44AG094520-02", "company": "Posit Science Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-27", "observed": "2026-08-31", "amount_usd": 506971, "summary": "NIH award 5R44AG094520-02: Improving Neurological Health with Acetylcholine via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment (INHANCE-MCI) ($506,971)", "source_url": "https://reporter.nih.gov/project-details/11418530", "people": [{"name": "Mouna Attarha", "role": "Principal Investigator"}, {"name": "Etienne de Villers-Sidani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42HD116627-03", "company": "Klein Buendel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-27", "observed": "2026-09-07", "amount_usd": 678944, "summary": "NIH award 5R42HD116627-03: Hybrid Delivery to Increase Access and Sustainability: Evaluating ezParent Implementation ($678,944)", "source_url": "https://reporter.nih.gov/project-details/11415781", "people": [{"name": "Susan M Breitenstein", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA254543-03", "company": "Glyciome, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-27", "observed": "2026-09-07", "amount_usd": 1244380, "summary": "NIH award 5R44CA254543-03: Cervical Cancer Prevention Prebiotic Device ($1,244,380)", "source_url": "https://reporter.nih.gov/project-details/11419171", "people": [{"name": "Joanna Elizabeth Ellington", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44CA314776-01", "company": "Pulmera, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-27", "observed": "2026-09-07", "amount_usd": 1131690, "summary": "NIH award 1R44CA314776-01: Advanced 3D Imaging to Aid in Peripheral Lung Nodule Diagnosis ($1,131,690)", "source_url": "https://reporter.nih.gov/project-details/11410412", "people": [{"name": "Bryan Hartley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R42AR087918-01", "company": "Vecgen, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-27", "observed": "2026-09-07", "amount_usd": 333689, "summary": "NIH award 1R42AR087918-01: Pre-Market Approval (PMA) Enabling Validation of a Diagnostic to Predict Immune Responses to AAV-based Therapies for GNE Myopathy and Broad Ranging Indications ($333,689)", "source_url": "https://reporter.nih.gov/project-details/11407962", "people": [{"name": "John Klich", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AG091101-02", "company": "Vivid Bioinnovations, Pbc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-27", "observed": "2026-09-07", "amount_usd": 1012648, "summary": "NIH award 4R44AG091101-02: FIND-seq: A Novel Cell Sorting Technology to Enable Investigation of Rare Cells in Primary Human Tissues ($1,012,648)", "source_url": "https://reporter.nih.gov/project-details/11541993", "people": [{"name": "Robin Prince", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK143922-01A1", "company": "Angiograft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-27", "observed": "2026-09-07", "amount_usd": 314081, "summary": "NIH award 1R43DK143922-01A1: Acellular Bio-engineered Vascular Grafts ($314,081)", "source_url": "https://reporter.nih.gov/project-details/11310469", "people": [{"name": "Daniel Swartz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM165235-01", "company": "Photothermal Spectroscopy Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": 306802, "summary": "NIH award 1R43GM165235-01: High-Speed, High-Content, Label-Free Live-Cell Chemical Imaging in Multiwell Plates Using Photothermal Stimulated Raman Scattering (PT-SRS) Microscopy ($306,802)", "source_url": "https://reporter.nih.gov/project-details/11407011", "people": [{"name": "Kevin Kjoller", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07791381", "company": "Staar Surgical Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-27", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Study of an Implantable Collamer Lens (ICL)", "source_url": "https://clinicaltrials.gov/study/NCT07791381", "people": [{"name": "Gabriel Quesada Larez, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07790965", "company": "Staar Surgical Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-27", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Study of a Phakic Implantable Collamer Lens (ICL)", "source_url": "https://clinicaltrials.gov/study/NCT07790965", "people": [{"name": "Gabriel Quesada Larez, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07789730", "company": "Inception Fertility Research Institute, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-27", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Aspire In Vitro Maturation Study", "source_url": "https://clinicaltrials.gov/study/NCT07789730"}, {"id": "trialreg:NCT07789925", "company": "Medtronic Cardiac Ablation Solutions", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-27", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Sphere-9 PAF China Study", "source_url": "https://clinicaltrials.gov/study/NCT07789925", "people": [{"name": "Liqun Wu, PHD, MD", "role": "Principal Investigator"}]}, {"id": "fda:K253859", "company": "VIOL Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253859: Scarlet Pro (Scarlet Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253859", "people": [{"name": "Hyein Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253859%22"}, {"id": "fda:K260401", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260401: EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260401", "people": [{"name": "Toshio Nakamura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260401%22"}, {"id": "fda:K262104", "company": "Ram.Shaw Pte., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262104: Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262104", "people": [{"name": "Emma Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262104%22"}, {"id": "fda:K262677", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262677: Iconix Knotless T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262677", "people": [{"name": "Brice Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262677%22"}, {"id": "fda:K262744", "company": "Stereotaxis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262744: GenesisX RMN", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262744", "people": [{"name": "Angela McKnight", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262744%22"}, {"id": "fda:K261802", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261802: Glidewell\u0099 Denture Base Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261802", "people": [{"name": "Jiahe Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261802%22"}, {"id": "fda:K261821", "company": "Zhengzhou PZ Laser Slim Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261821: 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261821", "people": [{"name": "Xiaopei Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261821%22"}, {"id": "fda:K260870", "company": "Gebauer Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260870: Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260870", "people": [{"name": "Amy Paukovits", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260870%22"}, {"id": "fda:K260824", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260824: Gastrointestinal Videoscope Olympus GIF-2T1500", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260824", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260824%22"}, {"id": "fda:K262268", "company": "Fisher and Paykel Healthcare Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262268: Optiflow Oxygen Kit (AA484J)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262268", "people": [{"name": "Amelia Rosario", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262268%22"}, {"id": "fda:K261360", "company": "Resmed Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261360: EasyCare Tx 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261360", "people": [{"name": "Lawrence Kwan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261360%22"}, {"id": "fda:K260751", "company": "Piraeus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260751: 35 Helix Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260751", "people": [{"name": "Jared Hutar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260751%22"}, {"id": "fda:K260481", "company": "Samsung Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260481: GC85A", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260481", "people": [{"name": "Jaesang NOH", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260481%22"}, {"id": "fda:K262654", "company": "Zhejiang Qiangnao Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262654: Dexus Prosthetic System (MSL2, MSR2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262654", "people": [{"name": "Guifang Dai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262654%22"}, {"id": "fda:K260545", "company": "Ascensia Diabetes Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260545: CONTOUR\u00ae PLUS BLUE Blood Glucose Monitoring System; CONTOUR\u00ae NEXT GEN Blood Glucose Monitoring System; CONTOUR\u00ae NEXT ONE Blood Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260545", "people": [{"name": "Shahrir Alam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260545%22"}, {"id": "fda:K260856", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260856: Disposable Distal Attachment D-201-13404", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260856", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260856%22"}, {"id": "fda:K260711", "company": "Berkeley Advanced Biomaterials", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-27", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260711: Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260711", "people": [{"name": "Bradley Glover", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260711%22"}, {"id": "trialreg:NCT07788989", "company": "Biosense Webster, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-27", "observed": "2026-09-15", "amount_usd": null, "summary": "New device trial registered: A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE\u2122 PFA Catheter", "source_url": "https://clinicaltrials.gov/study/NCT07788989", "people": [{"name": "Biosense Webster, Inc. Clinical Trial", "role": "Study Director"}]}, {"id": "nih:3R44AG094520-01S1", "company": "Posit Science Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-26", "observed": "2026-08-31", "amount_usd": 505282, "summary": "NIH award 3R44AG094520-01S1: Improving Neurological Health with Acetylcholine via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment (INHANCE-MCI) ($505,282)", "source_url": "https://reporter.nih.gov/project-details/11465368", "people": [{"name": "Mouna Attarha", "role": "Principal Investigator"}, {"name": "Etienne de Villers-Sidani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44EB036883-02", "company": "Glimpse Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-26", "observed": "2026-08-31", "amount_usd": 610664, "summary": "NIH award 5R44EB036883-02: Deep learning image classification model for pediatric ear disease ($610,664)", "source_url": "https://reporter.nih.gov/project-details/11384480", "people": [{"name": "Courtney Hill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA310364-02", "company": "Raiz Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-26", "observed": "2026-09-07", "amount_usd": 520000, "summary": "NIH award 5R44CA310364-02: Scaling Lymphoma Diagnosis: A Cost-Effective Gene Expression Assay for Broad Implementation ($520,000)", "source_url": "https://reporter.nih.gov/project-details/11417251", "people": [{"name": "Edward Briercheck", "role": "Principal Investigator"}, {"name": "Timothy Guyon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NS097113-08", "company": "Biocircuit Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-26", "observed": "2026-09-07", "amount_usd": 777562, "summary": "NIH award 5R44NS097113-08: Line extension and expanded preclinical evidence for Nerve Tape, a sutureless nerve repair coaptation device ($777,562)", "source_url": "https://reporter.nih.gov/project-details/11401935", "people": [{"name": "Ryan S Clement", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 8, "new_award": false}, {"id": "nih:1R41MH140642-01A1", "company": "North Shore Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-26", "observed": "2026-09-07", "amount_usd": 450020, "summary": "NIH award 1R41MH140642-01A1: NST-SPARK: Developing an Augmented Reality (AR) Digital Health Intervention for Negative Symptoms in Schizophrenia ($450,020)", "source_url": "https://reporter.nih.gov/project-details/11315398", "people": [{"name": "William Francis Cronin", "role": "Principal Investigator"}, {"name": "Moein Foroughi", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EB033715-03", "company": "Akna Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-26", "observed": "2026-09-07", "amount_usd": 1318850, "summary": "NIH award 5R44EB033715-03: Assay development for the assessment of pregnancy risks in early pregnancy ($1,318,850)", "source_url": "https://reporter.nih.gov/project-details/11418895", "people": [{"name": "David Randall Armant", "role": "Principal Investigator"}, {"name": "Sascha Drewlo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44EB034611-02", "company": "Elements Endoscopy Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-26", "observed": "2026-09-07", "amount_usd": 1435234, "summary": "NIH award 2R44EB034611-02: Development of a modular, drive-by-wire, haptic controlled, reusable colonoscope system ($1,435,234)", "source_url": "https://reporter.nih.gov/project-details/11406863", "people": [{"name": "Dwight Meglan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41ES038042-01", "company": "Kuhler Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-26", "observed": "2026-09-07", "amount_usd": 283808, "summary": "NIH award 1R41ES038042-01: Active Thermoregulation with Palm Cooling for Efficient Human-Climate Adaptation ($283,808)", "source_url": "https://reporter.nih.gov/project-details/11254439", "people": [{"name": "Braeden Ostepchuk", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI184104-03", "company": "Salus Discovery, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-26", "observed": "2026-09-07", "amount_usd": 999991, "summary": "NIH award 5R44AI184104-03: Flow Direct: Next Generation Urine LFA for TB Diagnosis in Point-of-Care Settings ($999,991)", "source_url": "https://reporter.nih.gov/project-details/11418834", "people": [{"name": "Jay Wyatt Warrick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44DK142547-01A1", "company": "Sarxion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": 1545942, "summary": "NIH award 1R44DK142547-01A1: Development of Thrombospondin 2 deficient hydrogels to accelerate healing ($1,545,942)", "source_url": "https://reporter.nih.gov/project-details/11405973", "people": [{"name": "THEMIS R KYRIAKIDES", "role": "Principal Investigator"}, {"name": "Martin Spang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07788040", "company": "Truway Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-26", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study", "source_url": "https://clinicaltrials.gov/study/NCT07788040", "people": [{"name": "Gavin C Solomon, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07788521", "company": "Johnson & Johnson Vision Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-26", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Comparison of ACUVUE\u00ae OASYS MAX 1-Day Multifocal and DAILIES\u00ae AquaComfort Plus\u00ae Multifocal", "source_url": "https://clinicaltrials.gov/study/NCT07788521", "people": [{"name": "Johnson & Johnson Vision Care, Inc. Clinical Trial", "role": "Study Director"}]}, {"id": "fda:K262581", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262581: GraftGun Universal Graft Delivery System (GDS\u00ae)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262581", "people": [{"name": "Gui Pires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262581%22"}, {"id": "fda:K260407", "company": "Principle & Will Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260407: Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260407", "people": [{"name": "I Chun Chuang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260407%22"}, {"id": "fda:K253877", "company": "Bioventus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253877: StimTrial Neuromodulation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253877", "people": [{"name": "Sageev George", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253877%22"}, {"id": "fda:K261142", "company": "Oticon Medical AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261142: Ponto 5 Mini; Ponto 5 Superpower", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261142", "people": [{"name": "Anders Johansson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261142%22"}, {"id": "fda:K260733", "company": "Manteia Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260733: MRIA Radiation Therapy Information System (MRIA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260733", "people": [{"name": "Chao Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260733%22"}, {"id": "fda:K262595", "company": "Wenzel Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262595: VariLift-C Cervical Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262595", "people": [{"name": "Erik Emstad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262595%22"}, {"id": "fda:K253715", "company": "Maquet Critical Care AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253715: Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253715", "people": [{"name": "Jerker \u00c5berg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253715%22"}, {"id": "fda:K261394", "company": "JOYTECH Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261394: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261394", "people": [{"name": "Yingting Lan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261394%22"}, {"id": "fda:K254103", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K254103: HOPKINS Telescopes for Arthroscopy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254103", "people": [{"name": "Jordan Lydia Verla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254103%22"}, {"id": "fda:K261153", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261153: LithoVue Elite Digital Flexible Ureteroscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261153", "people": [{"name": "Avinash Purohit", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261153%22"}, {"id": "fda:K260972", "company": "Sony Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260972: OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260972", "people": [{"name": "Hideaki Kawano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260972%22"}, {"id": "fda:K260811", "company": "Heartvue.ai, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-26", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260811: Heartvue.Proton", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260811", "people": [{"name": "Jeffrey Dendy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260811%22"}, {"id": "usasp:36C24126P0571", "company": "10x Genomics, Inc.", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-08-26", "observed": "2026-09-15", "amount_usd": 42541, "summary": "Federal medical R&D contract from Department of Veterans Affairs: XENIUM ANALYZER RECERTIFICATION AND SERVICE PLAN ($42,541)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_36C24126P0571_3600_-NONE-_-NONE-"}, {"id": "nih:5R44HL152835-06", "company": "Vantis Vascular Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-08-31", "amount_usd": 997212, "summary": "NIH award 5R44HL152835-06: Catheter for Complex Percutaneous Coronary Intervention ($997,212)", "source_url": "https://reporter.nih.gov/project-details/11261185", "people": [{"name": "Tim Alexander Fischell", "role": "Principal Investigator"}, {"name": "Michael Mirizzi", "role": "Principal Investigator"}, {"name": "Frank S Saltiel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R44DK146647-01", "company": "Integrated Medical Sensors", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-08-31", "amount_usd": 922875, "summary": "NIH award 1R44DK146647-01: A Miniaturized and Flexible Continuous Glucose Monitoring Platform using Scalable Semiconductor Manufacturing ($922,875)", "source_url": "https://reporter.nih.gov/project-details/11316861", "people": [{"name": "Muhammad Mujeeb-U-Rahman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS120394-04", "company": "Soterya, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-09-07", "amount_usd": 395940, "summary": "NIH award 5R44NS120394-04: A Device to Prevent Sudden Unexpected Death in Epilepsy (SUDEP) ($395,940)", "source_url": "https://reporter.nih.gov/project-details/11391160", "people": [{"name": "Pranav Bansal", "role": "Principal Investigator"}, {"name": "Jong Woo Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43DK146593-01A1", "company": "Silicon Kidney, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-09-07", "amount_usd": 354500, "summary": "NIH award 1R43DK146593-01A1: An intracorporeal hemodialysis system (iHemo) enabling home hemodialysis ($354,500)", "source_url": "https://reporter.nih.gov/project-details/11408209", "people": [{"name": "Charles Blaha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41MH140605-01A1", "company": "Frd Accel, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-09-07", "amount_usd": 456447, "summary": "NIH award 1R41MH140605-01A1: Transforming Trauma Care: Innovative Solutions for Enhancing Behavioral Health Outcomes ($456,447)", "source_url": "https://reporter.nih.gov/project-details/11311704", "people": [{"name": "Tatiana Margarita Davidson", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41EB039603-01", "company": "Nusonex LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-09-07", "amount_usd": 323645, "summary": "NIH award 1R41EB039603-01: Image-guided FUS Rhizotomy Using Dual-mode Ultrasound Array Systems ($323,645)", "source_url": "https://reporter.nih.gov/project-details/11409925", "people": [{"name": "Emad S. Ebbini", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA314728-01", "company": "Aim Medical Robotics Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-09-07", "amount_usd": 1008660, "summary": "NIH award 1R44CA314728-01: Intraoperative MRI-Guided Neurosurgery Robot for Enhancing Ablative Treatment of Brain Cancer ($1,008,660)", "source_url": "https://reporter.nih.gov/project-details/11407571", "people": [{"name": "GREGORY S FISCHER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44MD013767-04A1", "company": "Great Lakes Neurotechnologies", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-09-07", "amount_usd": 949447, "summary": "NIH award 2R44MD013767-04A1: DiSCERN: Advanced PD Therapy Candidacy and Evaluation System ($949,447)", "source_url": "https://reporter.nih.gov/project-details/11405932", "people": [{"name": "Dustin A. Heldman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43EB037507-01A1", "company": "Medulate LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-09-07", "amount_usd": 339866, "summary": "NIH award 1R43EB037507-01A1: Optimizing Central Venous Catheterization Training with Affordable Platform Technology ($339,866)", "source_url": "https://reporter.nih.gov/project-details/11314645", "people": [{"name": "Inki Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA314618-01", "company": "Mcc Health, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-09-07", "amount_usd": 201112, "summary": "NIH award 1R41CA314618-01: Improving patient outcomes through a digital health delivered intervention to monitor and manage symptoms after chimeric antigen receptor T-cell therapy ($201,112)", "source_url": "https://reporter.nih.gov/project-details/11405310", "people": [{"name": "Anna Barata", "role": "Principal Investigator"}, {"name": "Daniella Landau", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA295318-02", "company": "Panome Bio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-09-07", "amount_usd": 1164167, "summary": "NIH award 5R44CA295318-02: Biomarker discovery in colon cancer through next-generation metabolomics ($1,164,167)", "source_url": "https://reporter.nih.gov/project-details/11404018", "people": [{"name": "Ethan Stancliffe", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44OD032088-03", "company": "Paratechs Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-09-07", "amount_usd": 535088, "summary": "NIH award 5R44OD032088-03: A novel rat sperm cryopreservation and artificial insemination system ($535,088)", "source_url": "https://reporter.nih.gov/project-details/11397362", "people": [{"name": "Barbara Jean Stone", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44OD024970-04", "company": "Spoc Proteomics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-25", "observed": "2026-09-07", "amount_usd": 815054, "summary": "NIH award 5R44OD024970-04: Tools and Methods for Producing High Quality Functional Protein Microarrays for Biomarker Discovery ($815,054)", "source_url": "https://reporter.nih.gov/project-details/11416485", "people": [{"name": "Bharath Takulapalli", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "trialreg:NCT07785401", "company": "Implai Sp z o.o", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-25", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Efficacy of Platelet-Rich Plasma Added to Hyaluronic Acid in Knee Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07785401", "people": [{"name": "Urszula Zdanowicz, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07785050", "company": "Respiree Pte Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-25", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Accuracy of Respiree Pulse Oximeters With Profound Hypoxia", "source_url": "https://clinicaltrials.gov/study/NCT07785050"}, {"id": "trialreg:NCT07783698", "company": "Cook Research Incorporated", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-25", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Cook iMRI Needles NSR Clinical Study", "source_url": "https://clinicaltrials.gov/study/NCT07783698", "people": [{"name": "Vikas Gulani, MD,PhD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07785310", "company": "ResMed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-25", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: PAP-NAP Device Clinical Study", "source_url": "https://clinicaltrials.gov/study/NCT07785310", "people": [{"name": "Xueling Zhu", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07784907", "company": "Implai Sp z o.o", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-25", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Efficacy of Platelet-Rich Plasma Combined With Hyaluronic Acid in Knee Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07784907", "people": [{"name": "Jaromir Jarecki, DSc", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07784088", "company": "BCIFlex Medical Technology Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-25", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia", "source_url": "https://clinicaltrials.gov/study/NCT07784088"}, {"id": "trialreg:NCT07786207", "company": "Smith & Nephew, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-25", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Knee Cartilage Repair Registry", "source_url": "https://clinicaltrials.gov/study/NCT07786207", "people": [{"name": "Nick DePhillipo, PhD, MBA, ATC", "role": "Study Chair"}]}, {"id": "trialreg:NCT07785960", "company": "SuperPatch Limited LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-25", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Recovery and Early Sleep Tracking Using the SuperPatch REM Patch", "source_url": "https://clinicaltrials.gov/study/NCT07785960"}, {"id": "trialreg:NCT07786025", "company": "Distal Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-25", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: DisTal Arterio-Venous Fistula Feasibility", "source_url": "https://clinicaltrials.gov/study/NCT07786025"}, {"id": "trialreg:NCT07784673", "company": "SurGenTec LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-25", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: OsteoFlo HydroFiber Ambispective Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT07784673"}, {"id": "fda:K261514", "company": "Guilin Kevin Peter Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-25", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261514: Calcium Hydroxide Temporary Filling Material (KP-Cal)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261514", "people": [{"name": "Libin Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261514%22"}, {"id": "fda:K261595", "company": "Ceevra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-25", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261595: Ceevra Reveal 4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261595", "people": [{"name": "Ken Koster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261595%22"}, {"id": "fda:K252184", "company": "Sol-Millennium Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-25", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K252184: SOL-M Luer Lock Syringe with Exchangeable Needle Tray", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252184", "people": [{"name": "Mike Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252184%22"}, {"id": "fda:DEN250049", "company": "Abbott Diabetes Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-25", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) DEN250049: Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250049", "people": [{"name": "Katherine Doll Kanne", "role": "510(k) submission contact"}]}, {"id": "fda:K252535", "company": "Taiwan Surgical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-25", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K252535: Inno-Switch\u0099 Laparoscopic Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252535", "people": [{"name": "Ken Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252535%22"}, {"id": "fda:K261747", "company": "Beacon Biosignals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-25", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261747: Report Studio", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261747", "people": [{"name": "Tahir Rizvi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261747%22"}, {"id": "fda:K261719", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-25", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261719: Promisemed X-Safety Pen Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261719", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261719%22"}, {"id": "fda:K262631", "company": "SteriLance Medical (Suzhou), Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-25", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262631: Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262631", "people": [{"name": "Susan Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262631%22"}, {"id": "fda:K254304", "company": "Achaemenid, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-25", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K254304: iNOS intraoral biosensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254304", "people": [{"name": "Reza Radmand", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254304%22"}, {"id": "fda:K253879", "company": "Samyang Holdings Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-25", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253879: MONOFIX PDO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253879", "people": [{"name": "Kim Ahram", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253879%22"}, {"id": "denovo:DEN250049", "company": "Abbott Diabetes Care", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-08-25", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250049 granted: Libre Duo 10 Day Continuous Dual Glucose", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250049"}, {"id": "nih:1R44DK146594-01", "company": "Cobio Diagnostics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-08-31", "amount_usd": 306867, "summary": "NIH award 1R44DK146594-01: Fast-Track Phage-amplified MALDI-TOF MS for rapid phenotypic UTI diagnosis and antimicrobial susceptibility testing ($306,867)", "source_url": "https://reporter.nih.gov/project-details/11315023", "people": [{"name": "Christopher R Cox", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DC023164-01A1", "company": "Augmental Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-08-31", "amount_usd": 329475, "summary": "NIH award 1R43DC023164-01A1: Development of a novel intra-oral wearable device with an inaudible speech computer interface for users with cervical spinal cord injuries ($329,475)", "source_url": "https://reporter.nih.gov/project-details/11403178", "people": [{"name": "Suraj Gowda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI186917-01A1", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-08-31", "amount_usd": 303250, "summary": "NIH award 1R43AI186917-01A1: Rapid Diagnostic Immunoassay for Strongyloidiasis ($303,250)", "source_url": "https://reporter.nih.gov/project-details/11256317", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK148210-01", "company": "Silq Technologies Corp", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-08-31", "amount_usd": 320965, "summary": "NIH award 1R43DK148210-01: A novel, silicone zwitterion-treated ureteral stent to reduce device-related complications and failure ($320,965)", "source_url": "https://reporter.nih.gov/project-details/11406834", "people": [{"name": "Brian McVerry", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH144721-03", "company": "Cytocybernetics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-08-31", "amount_usd": 1013217, "summary": "NIH award 5R44MH144721-03: Real Time NEURON Simulation for Experimental Applications ($1,013,217)", "source_url": "https://reporter.nih.gov/project-details/11404831", "people": [{"name": "Mark W Nowak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DK143844-01A1", "company": "Kscube, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-08-31", "amount_usd": 315335, "summary": "NIH award 1R43DK143844-01A1: Real-Time, Non-Invasive Urine Oxygen Monitoring System for Acute Kidney Injury (AKI) Prevention ($315,335)", "source_url": "https://reporter.nih.gov/project-details/11313673", "people": [{"name": "Spencer Shumway", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK143772-01A1", "company": "Connecting Health Innovations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-09-07", "amount_usd": 306870, "summary": "NIH award 1R44DK143772-01A1: Developing and testing the DII\u00ae recipe calculator app based on the inflammatory potential of food ingredients. ($306,870)", "source_url": "https://reporter.nih.gov/project-details/11310483", "people": [{"name": "Julia Faith Houston", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL186984-01", "company": "Sigt, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-09-07", "amount_usd": 848381, "summary": "NIH award 1R44HL186984-01: Intraoperative Cardiac Pulsed Field Ablation and Lesion Assessment System ($848,381)", "source_url": "https://reporter.nih.gov/project-details/11409042", "people": [{"name": "Parag Karmarkar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43TR006333-01", "company": "Octozi Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-09-07", "amount_usd": 306013, "summary": "NIH award 1R43TR006333-01: AI-Powered Medical Review Assistant: Automated Clinical Consistency Checking for Enhanced Safety Monitoring in Clinical Trials ($306,013)", "source_url": "https://reporter.nih.gov/project-details/11407643", "people": [{"name": "Matthew Purri", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44OD042685-01A1", "company": "Biometric Positioning Systems LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-09-07", "amount_usd": 1004323, "summary": "NIH award 1R44OD042685-01A1: A Portable Device for Safe and Accurate Access to the Circulatory System of Small Laboratory Animals ($1,004,323)", "source_url": "https://reporter.nih.gov/project-details/11313899", "people": [{"name": "Harrison Kim", "role": "Principal Investigator"}, {"name": "Sean Simmons", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA306595-01A1", "company": "Rheotek Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-09-07", "amount_usd": 1045569, "summary": "NIH award 1R44CA306595-01A1: An Ultra-Precise Needle Delivery System for Cutaneous Cancer Treatment ($1,045,569)", "source_url": "https://reporter.nih.gov/project-details/11405218", "people": [{"name": "Daniel Mazzaferro", "role": "Principal Investigator"}, {"name": "Laura Taylor", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL182792-01A1", "company": "Bridgesource Medical Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-24", "observed": "2026-09-16", "amount_usd": 320727, "summary": "NIH award 1R43HL182792-01A1: A Right Heart Catheter for Pressure-Volume Loop Risk Stratification for Percutaneous Valve Repair in Tricuspid Regurgitation ($320,727)", "source_url": "https://reporter.nih.gov/project-details/11407066", "people": [{"name": "John E Porterfield", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07781397", "company": "SuperPatch Limited LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Prevention and Reduction of Falls: Testing and Evaluating Cutting Edge Haptic Technology", "source_url": "https://clinicaltrials.gov/study/NCT07781397"}, {"id": "trialreg:NCT07783165", "company": "Dermal Laboratories Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Ichthyosis", "source_url": "https://clinicaltrials.gov/study/NCT07783165"}, {"id": "trialreg:NCT07782814", "company": "Zedsen Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: An Investigation Into Dielectric Testing for the Evaluation and Characterisation of Breast Tissue Using a Novel Time-Domain Bioimpedance Tool", "source_url": "https://clinicaltrials.gov/study/NCT07782814", "people": [{"name": "Marc Goldfinger, PhD", "role": "Study Director"}, {"name": "Adrian Lim, MD FRCP FRCR", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07781384", "company": "SuperPatch Limited LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Observing Performance of Haptic Vibrotactile Trigger Technology by Measuring Changes in Resting Metabolic Rate: Assessment and Analysis", "source_url": "https://clinicaltrials.gov/study/NCT07781384"}, {"id": "trialreg:NCT07783087", "company": "Flen Health", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: A Study Comparing an Investigational Wound Gel With Standard Treatment for Mild to Moderate Diabetic Foot Ulcers", "source_url": "https://clinicaltrials.gov/study/NCT07783087"}, {"id": "trialreg:NCT07782762", "company": "Nowwell AS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)", "source_url": "https://clinicaltrials.gov/study/NCT07782762", "people": [{"name": "Frank Holden Mose, MD, PhD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07780851", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Wearing Behavior and Eye Length Changes in Children With Myopia Wearing Myopia Control Spectacle Lenses", "source_url": "https://clinicaltrials.gov/study/NCT07780851", "people": [{"name": "Danny Sim", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07781852", "company": "Lumina Pharmaceuticals Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Distribution of 64Cu/68Ga Labeled CM500 in Healthy Volunteers and Patients With Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07781852"}, {"id": "trialreg:NCT07782008", "company": "Molnlycke Health Care AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Performance and Safety of Mepilex\u00ae Up in Leg and Foot Ulcers and Skin Tears", "source_url": "https://clinicaltrials.gov/study/NCT07782008"}, {"id": "trialreg:NCT07781124", "company": "Vantive Health LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Clinical Effectiveness and Resource Use in End-Stage Renal Disease Patients: Remote Patient Monitoring Across Dialysis Modalities", "source_url": "https://clinicaltrials.gov/study/NCT07781124"}, {"id": "trialreg:NCT07780786", "company": "NinaMED Pty Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Non-invasive Saphenous Nerve Stimulation Therapy for Overactive Bladder", "source_url": "https://clinicaltrials.gov/study/NCT07780786"}, {"id": "trialreg:NCT07782619", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-24", "observed": "2026-08-28", "amount_usd": null, "summary": "New device trial registered: Agreement of Two OCT Biometers: A Pilot Study", "source_url": "https://clinicaltrials.gov/study/NCT07782619", "people": [{"name": "Clinical Trial Lead, Surgical", "role": "Study Director"}]}, {"id": "fda:K260106", "company": "Flower Orthopedics Corporation DBA Conventus Flower Orthoped", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-24", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260106: OsteoCoil\u0099 GT Active Compression System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260106", "people": [{"name": "Andrew Wolf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260106%22"}, {"id": "fda:K260604", "company": "Abmrc, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-24", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260604: BiWaze Clear System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260604", "people": [{"name": "Priyanka Paul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260604%22"}, {"id": "fda:K260246", "company": "Bolt Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-24", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260246: SEISMIQ\u0099 Intravascular Lithotripsy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260246", "people": [{"name": "Stephanie Onstot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260246%22"}, {"id": "fda:K253515", "company": "Biomet Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-24", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253515: Zimmer Biomet OSS\u0099 Orthopedic Salvage System OsseoTi\u00ae Sleeves and Augments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253515", "people": [{"name": "Ainsley Carne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253515%22"}, {"id": "fda:K261381", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-24", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261381: TiLink-L\u0099 SI Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261381", "people": [{"name": "Juan Zuluaga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261381%22"}, {"id": "fda:K254027", "company": "Sonoscape Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-24", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K254027: Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254027", "people": [{"name": "Toki Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254027%22"}, {"id": "fda:K254286", "company": "DentalMaster(Xiamen)Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-24", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K254286: Guided Bone Regeneration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254286", "people": [{"name": "Junfeng Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254286%22"}, {"id": "fda:K260691", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-23", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260691: BTL-699", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260691", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260691%22"}, {"id": "fda:K253910", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-22", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253910: Stitch - Suture Wires and Tapes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253910", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253910%22"}, {"id": "nih:5R44HL178137-02", "company": "Pranions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-08-24", "amount_usd": 1343024, "summary": "NIH award 5R44HL178137-02: High-flow portable oxygen concentrator for long-term oxygen therapy ($1,343,024)", "source_url": "https://reporter.nih.gov/project-details/11371179", "people": [{"name": "Benjamin Robert Dickerhoff", "role": "Principal Investigator"}, {"name": "Syed Mubeen", "role": "Principal Investigator"}, {"name": "MADHAVAN L RAGHAVAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH142142-02", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-08-24", "amount_usd": 1409572, "summary": "NIH award 5R44MH142142-02: Efficacy of kTMP, a novel non-invasive brain stimulation method, for the treatment of anhedonia patients. ($1,409,572)", "source_url": "https://reporter.nih.gov/project-details/11395657", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44GM161182-02", "company": "Owic Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-05", "amount_usd": 1228929, "summary": "NIH award 4R44GM161182-02: High throughput electrosynthesis for enhanced drug discovery via light-powered smart microelectronics ($1,228,929)", "source_url": "https://reporter.nih.gov/project-details/11381154", "people": [{"name": "Alejandro J Cortese", "role": "Principal Investigator"}, {"name": "Song Lin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44HL186085-01", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-07", "amount_usd": 1020633, "summary": "NIH award 1R44HL186085-01: Improving the Training of CPR and AED Interventions to Real World Characteristics ($1,020,633)", "source_url": "https://reporter.nih.gov/project-details/11350004", "people": [{"name": "Adam Becker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD121294-01", "company": "Inherent Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-07", "amount_usd": 1167156, "summary": "NIH award 1R44HD121294-01: Epigenetic Diagnostic for Severe Spermatogenic Failure and Associated Malignancy Risks ($1,167,156)", "source_url": "https://reporter.nih.gov/project-details/11314862", "people": [{"name": "Kristin R Brogaard", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL167405-03", "company": "Blue Marble Rehab, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-07", "amount_usd": 1002703, "summary": "NIH award 5R44HL167405-03: BREATHE-BRinging Exercise, Asthma Assessments, TeacHing to Everyone ($1,002,703)", "source_url": "https://reporter.nih.gov/project-details/11417239", "people": [{"name": "Sheryl Flynn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH132156-03", "company": "Outcome Referrals Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-07", "amount_usd": 916056, "summary": "NIH award 5R44MH132156-03: Consumer-Therapist-Connector: Increasing Access to Quality Behavioral Healthcare ($916,056)", "source_url": "https://reporter.nih.gov/project-details/11423655", "people": [{"name": "David R. Kraus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43MH143427-01", "company": "Dream Face Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-07", "amount_usd": 314362, "summary": "NIH award 1R43MH143427-01: Developing Robot-Administered Cognitive Behavioral Therapy for Older Adults with Depression ($314,362)", "source_url": "https://reporter.nih.gov/project-details/11315693", "people": [{"name": "Mohammad Mahoor", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB038821-01A1", "company": "Actinia Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-07", "amount_usd": 329058, "summary": "NIH award 1R43EB038821-01A1: High-resolution energy-integrating computed tomography scanners using direct-conversion detectors made from cesium lead bromide ($329,058)", "source_url": "https://reporter.nih.gov/project-details/11408235", "people": [{"name": "Biju Jacob", "role": "Principal Investigator"}, {"name": "Indra Raj Pandey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL180159-01A1", "company": "Prenosis, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-07", "amount_usd": 1218102, "summary": "NIH award 1R44HL180159-01A1: Derivation and Validation of the Heart Failure CardioScore: an AI Diagnostic for HeartFailure using Novel Biomarkers and Clinical Data ($1,218,102)", "source_url": "https://reporter.nih.gov/project-details/11315860", "people": [{"name": "Bobby Reddy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL184598-01", "company": "Icardio.ai", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-07", "amount_usd": 290142, "summary": "NIH award 1R43HL184598-01: Artificial Intelligence Enabled Diagnostic Support for Echocardiography ($290,142)", "source_url": "https://reporter.nih.gov/project-details/11313586", "people": [{"name": "Roman Sandler", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL184633-01", "company": "Ram Medical Innovations, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-07", "amount_usd": 344740, "summary": "NIH award 1R43HL184633-01: Stabilizing Coronary Sheath for Complex PCIs ($344,740)", "source_url": "https://reporter.nih.gov/project-details/11314155", "people": [{"name": "Mubin I Syed", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43TR006311-01", "company": "Irb Assist, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-07", "amount_usd": 314141, "summary": "NIH award 1R43TR006311-01: IRB-Assist: AI-powered decision support platform that enhances the speed, consistency, and accuracy of Institutional Review Board reviews ($314,141)", "source_url": "https://reporter.nih.gov/project-details/11399650", "people": [{"name": "Madison Yanken", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41EB039570-01", "company": "Tissuelock LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-07", "amount_usd": 314362, "summary": "NIH award 1R41EB039570-01: Antioxidative Mesh Adhesive to Prevent Seroma ($314,362)", "source_url": "https://reporter.nih.gov/project-details/11405687", "people": [{"name": "Xiaowei Li", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL184685-01A1", "company": "Matregenix", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": 314211, "summary": "NIH award 1R41HL184685-01A1: Sustained 9-cis Retinoic Acid-Eluting Nanofiber Scaffolds for Enhanced Lymphatic Regeneration and Lymphedema Treatment ($314,211)", "source_url": "https://reporter.nih.gov/project-details/11410245", "people": [{"name": "Sherif Soliman", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH143566-01", "company": "Oregon Res Behavioral Intervention Strat", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": 314362, "summary": "NIH award 1R43MH143566-01: Addressing Rising Mental Health Concerns in Youth: Development of an Digital Evidence-Based App for Providers and Teens ($314,362)", "source_url": "https://reporter.nih.gov/project-details/11316679", "people": [{"name": "B Grace M BULLOCK", "role": "Principal Investigator"}, {"name": "David Randolph Smith", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL184836-01A1", "company": "Precisionbio AI, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-10", "amount_usd": 374472, "summary": "NIH award 1R43HL184836-01A1: Machine Learning-Driven Precision Dosing System for Improved Anticoagulation Therapy ($374,472)", "source_url": "https://reporter.nih.gov/project-details/11409810", "people": [{"name": "Michael Kurdahi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA314866-01", "company": "Senticell LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-21", "observed": "2026-09-11", "amount_usd": 399995, "summary": "NIH award 1R41CA314866-01: RBC-Based Liquid Biopsy for Early Detection of Tumor DNA in Resectable NSCLC ($399,995)", "source_url": "https://reporter.nih.gov/project-details/11409441", "people": [{"name": "Nilam S. Mangalmurti", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07779564", "company": "Flaus, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of Flaus Electric Flosser on Plaque and Gingivitis Compared to a Manual Toothbrush", "source_url": "https://clinicaltrials.gov/study/NCT07779564"}, {"id": "trialreg:NCT07777991", "company": "Adraxe Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "New device trial registered: Stimulation Evaluation for Neuromodulation Sensory Effects", "source_url": "https://clinicaltrials.gov/study/NCT07777991", "people": [{"name": "Rosana Esteller, PhD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07779239", "company": "Oneness Biotech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "New device trial registered: PREPUP: A Randomized Trial of Bonvadis\u00ae Versus Collagenase Ointment in Diabetic Foot Ulcers", "source_url": "https://clinicaltrials.gov/study/NCT07779239"}, {"id": "fda:DEN250026", "company": "Matap Ii, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) DEN250026: Avulux", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250026", "people": [{"name": "Charles Posternack", "role": "510(k) submission contact"}]}, {"id": "fda:K261710", "company": "Apyx Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261710: AYON\u0099 Power Liposuction Cannulas and AYON\u0099 Power Liposuction Cannula Adaptors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261710", "people": [{"name": "Nikita Gajbhiye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261710%22"}, {"id": "fda:K261354", "company": "Foshan Sowell Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261354: Electric wheelchair (D03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261354", "people": [{"name": "Qiaoer Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261354%22"}, {"id": "fda:K253692", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253692: AVVIGO\u0099+ Multi-Modality Guidance System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253692", "people": [{"name": "Kevin Catalano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253692%22"}, {"id": "fda:K253817", "company": "Immunodiagnostics Systems Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253817: IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253817", "people": [{"name": "Mohammed Adil Shaik Hussain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253817%22"}, {"id": "fda:K260584", "company": "Mriguidance B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260584: BoneMRI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260584", "people": [{"name": "Marijn van Stralen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260584%22"}, {"id": "fda:K262089", "company": "Hangzhou Tappa Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262089: Disposable Warming Blanket", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262089", "people": [{"name": "Dan Cao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262089%22"}, {"id": "fda:K253728", "company": "Microport Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253728: EVOLUTION\u00ae AM BIOFOAM\u00ae Tibial System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253728", "people": [{"name": "Jonas Susaraba", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253728%22"}, {"id": "fda:K261466", "company": "Zeus Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261466: Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261466", "people": [{"name": "Daniel Zweitzig", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261466%22"}, {"id": "fda:K260643", "company": "Cimilre Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260643: Cimilre Dual Max", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260643", "people": [{"name": "Misun Na", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260643%22"}, {"id": "fda:K262005", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262005: Affera Integrated Mapping System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262005", "people": [{"name": "Matthew Lobeck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262005%22"}, {"id": "fda:K261015", "company": "Gi View, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261015: Solo Scope Colonoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261015", "people": [{"name": "Oded Nissan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261015%22"}, {"id": "fda:DEN250067", "company": "Brixton Biosciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) DEN250067: ReneuRx\u0099 (Neural Ice)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250067", "people": [{"name": "Olivier Kagan", "role": "510(k) submission contact"}]}, {"id": "fda:K262074", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262074: Any-Zircos", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262074", "people": [{"name": "Ku Da Hyeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262074%22"}, {"id": "fda:K262127", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262127: DS Core CBCT Anatomy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262127", "people": [{"name": "Deepthi Paknikar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262127%22"}, {"id": "fda:K261882", "company": "Osseus Fusions Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261882: Pisces-SC Standalone Cervical Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261882", "people": [{"name": "Jonathan Rosen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261882%22"}, {"id": "fda:K253726", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253726: uAngio AVIVA CX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253726", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253726%22"}, {"id": "fda:K253699", "company": "Tempus AI, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253699: Tempus ECG-PH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253699", "people": [{"name": "Bethany Barrett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253699%22"}, {"id": "fda:K262538", "company": "Inari Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-21", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262538: Artix\u0099 MT;Artix\u0099 Thin-Walled Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262538", "people": [{"name": "Tosan Eweka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262538%22"}, {"id": "usasp:75A50126F61010", "company": "Battelle Memorial Institute", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-08-21", "observed": "2026-09-15", "amount_usd": 6768004, "summary": "Federal medical R&D contract from Office of Assistant Secretary for Preparedness and Response: RTOR BIO-AMT-2311: ADVANCED DEVELOPMENT AND VALIDATION OF ASSAYS TO ASSESS FILOVIRUS INFECTION IN NONHUMAN PRIMATES ($6,768,004)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_75A50126F61010_7505_75A50122D00017_7505"}, {"id": "denovo:DEN250067", "company": "Brixton Biosciences", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-08-21", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250067 granted: ReneuRx\u2122 (Neural Ice)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250067"}, {"id": "denovo:DEN250026", "company": "Matap Ii, LLC", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-08-21", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250026 granted: Avulux", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250026"}, {"id": "nih:5R44DE033312-03", "company": "Innotech Precision Medicine, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-20", "observed": "2026-08-24", "amount_usd": 1069047, "summary": "NIH award 5R44DE033312-03: Point of Care Detection of HPV and P16 in Saliva ($1,069,047)", "source_url": "https://reporter.nih.gov/project-details/11389274", "people": [{"name": "ROYA KHOSRAVI-FAR", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DE033307-03", "company": "Light Research, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-20", "observed": "2026-08-24", "amount_usd": 477217, "summary": "NIH award 5R44DE033307-03: Multimodal intraoral camera ($477,217)", "source_url": "https://reporter.nih.gov/project-details/11395662", "people": [{"name": "PETRA E WILDER-SMITH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44GM161309-02", "company": "Vivid Bioinnovations, Pbc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-20", "observed": "2026-08-30", "amount_usd": 1027505, "summary": "NIH award 4R44GM161309-02: A Universal Platform for Ultrahigh-Throughput Biocatalyst Evolution With micro-Mass Spectrometry ($1,027,505)", "source_url": "https://reporter.nih.gov/project-details/11417110", "people": [{"name": "Robin Prince", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41CA310202-01", "company": "Blue Physics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-20", "observed": "2026-09-07", "amount_usd": 405632, "summary": "NIH award 1R41CA310202-01: Active Real-Time Dosimetric Monitoring for FLASH Radiation Therapy in Cancer Treatment ($405,632)", "source_url": "https://reporter.nih.gov/project-details/11313733", "people": [{"name": "Marcos Andres Feijoo", "role": "Principal Investigator"}, {"name": "Siyong Kim", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA298055-03", "company": "Data Driven Bioscience Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-20", "observed": "2026-09-07", "amount_usd": 1022841, "summary": "NIH award 5R44CA298055-03: Validation of Duoseq as a Genomic Swiss Army Knife for the Diagnosis of Lymphomas ($1,022,841)", "source_url": "https://reporter.nih.gov/project-details/11412715", "people": [{"name": "Sandeep Dave", "role": "Principal Investigator"}, {"name": "Lanie Elizabeth Happ", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R41OD039877-02", "company": "Objective Biotechnology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-20", "observed": "2026-09-07", "amount_usd": 386174, "summary": "NIH award 5R41OD039877-02: High performance miniaturized microscopes for through skull cortex-wide imaging in freely behaving mice ($386,174)", "source_url": "https://reporter.nih.gov/project-details/11405060", "people": [{"name": "Suhasa B Kodandaramaiah", "role": "Principal Investigator"}, {"name": "Daniel A Surinach", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07777562", "company": "MED-EL Elektromedizinische Ger\u00e4te GesmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-20", "observed": "2026-08-20", "amount_usd": null, "summary": "New device trial registered: Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.", "source_url": "https://clinicaltrials.gov/study/NCT07777562"}, {"id": "trialreg:NCT07775469", "company": "CareTaker Medical LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-20", "observed": "2026-08-20", "amount_usd": null, "summary": "New device trial registered: Comparison Study for Hemodynamic Parameters Generated by Vitalstream Relative to Appropriate Gold Standard References in Different Clinical Settings, (OR, EP Lab Etc.).", "source_url": "https://clinicaltrials.gov/study/NCT07775469"}, {"id": "trialreg:NCT07775976", "company": "Peerbridge Health, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-20", "observed": "2026-08-20", "amount_usd": null, "summary": "New device trial registered: Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR\u00ae Wearable ECG to Inform Outcomes-Oriented Care Pathways", "source_url": "https://clinicaltrials.gov/study/NCT07775976", "people": [{"name": "Sandeep Gulati, PhD", "role": "Principal Investigator"}]}, {"id": "fda:K253807", "company": "Convergence Medical Sciences , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-20", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253807: Valence InVent Xtend\u0099 (CVG-4101-VXA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253807", "people": [{"name": "Marvin Cervantes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253807%22"}, {"id": "fda:K260817", "company": "Virtual Incision", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-20", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260817: MIRA Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260817", "people": [{"name": "Florence Beck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260817%22"}, {"id": "fda:K261298", "company": "Guangdong Youmeng Electrical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-20", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261298: Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261298", "people": [{"name": "Zhongjun Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261298%22"}, {"id": "fda:DEN250043", "company": "Cm Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-20", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) DEN250043: Qoramatic Automated Stool Management", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250043", "people": [{"name": "Nishith Chasmawala", "role": "510(k) submission contact"}]}, {"id": "fda:K260579", "company": "Draeger Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-20", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260579: Infinity\u00ae Acute Care System (IACS) \u0096 VG8.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260579", "people": [{"name": "Deborah Herrington", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260579%22"}, {"id": "fda:K262113", "company": "Hardy Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-20", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262113: HardyDisk AST Tebipenem 10\u00b5g (TBP10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262113", "people": [{"name": "Lauren Hamilton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262113%22"}, {"id": "fda:K261049", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-20", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261049: SCALA\u00ae TL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261049", "people": [{"name": "Estelle Godeau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261049%22"}, {"id": "fda:K262515", "company": "Kneu Health Digital , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-20", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262515: Kneu Platform (V2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262515", "people": [{"name": "Alessia Nannetti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262515%22"}, {"id": "fda:K262506", "company": "Remex Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-20", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262506: Remex Spine Surgery Navigation - Universal Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262506", "people": [{"name": "Jessie Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262506%22"}, {"id": "fda:K260242", "company": "Medibyt , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-20", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260242: CPETWise Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260242", "people": [{"name": "Or Inbar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260242%22"}, {"id": "pma:P250018", "company": "Implantica CE Reflux , Ltd.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-08-20", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA PMA approval P250018: RefluxStop\u00ae Device and RefluxStop\u00ae Deployment Tool", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250018", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250018%22"}, {"id": "denovo:DEN250043", "company": "Cm Technologies, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-08-20", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250043 granted: Qoramatic Automated Stool Management", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250043"}, {"id": "nih:1R43MD021449-01", "company": "Amissa, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-19", "observed": "2026-08-24", "amount_usd": 504222, "summary": "NIH award 1R43MD021449-01: HERMOSA: Understanding the Perimenopausal Health Experience of Latina Women Using Digital Biomarkers from Apple Watch. ($504,222)", "source_url": "https://reporter.nih.gov/project-details/11349550", "people": [{"name": "Jon Andrew Corkey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AT013712-01", "company": "Cryo Ergonomics Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-19", "observed": "2026-08-24", "amount_usd": 312823, "summary": "NIH award 1R43AT013712-01: Wearable long duration postoperative topical cryotherapy for enhanced pain management ($312,823)", "source_url": "https://reporter.nih.gov/project-details/11313074", "people": [{"name": "Roger Diebold", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH140129-03", "company": "In Vivo Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-19", "observed": "2026-08-24", "amount_usd": 907050, "summary": "NIH award 5R44MH140129-03: A modular bioluminescence imaging platform using a novel multi-aperture method ($907,050)", "source_url": "https://reporter.nih.gov/project-details/11384484", "people": [{"name": "Alexander D. Klose", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44NR021881-02", "company": "Eysz, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-19", "observed": "2026-08-24", "amount_usd": 1591774, "summary": "NIH award 4R44NR021881-02: Detecting Absence Seizures Using Hyperventilation In a Home Environment ($1,591,774)", "source_url": "https://reporter.nih.gov/project-details/11584327", "people": [{"name": "Rachel Kuperman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44ES038062-02", "company": "Attagene, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-19", "observed": "2026-08-28", "amount_usd": 1095747, "summary": "NIH award 5R44ES038062-02: A Two-Tier Effect-Based Water Bioactivity Surveillance System. ($1,095,747)", "source_url": "https://reporter.nih.gov/project-details/11387869", "people": [{"name": "Sergei S Makarov", "role": "Principal Investigator"}, {"name": "NICHOLAS H. OBERLIES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AI195215-01", "company": "Vivid Bioinnovations, Pbc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-19", "observed": "2026-08-30", "amount_usd": 307074, "summary": "NIH award 1R44AI195215-01: HIVE-seq: A Novel Omics Technology to Profile Thousands of Single HIV-Positive Cells ($307,074)", "source_url": "https://reporter.nih.gov/project-details/11256632", "people": [{"name": "Robin Prince", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44EY038605-01", "company": "Nanoscope Instruments, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-19", "observed": "2026-09-07", "amount_usd": 1019678, "summary": "NIH award 1R44EY038605-01: Development of Multi-Luminance Shape Discrimination Test for Assessment of Functional Vision ($1,019,678)", "source_url": "https://reporter.nih.gov/project-details/11316377", "people": [{"name": "Sang hoon Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AI197850-01", "company": "Vivid Bioinnovations, Pbc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-19", "observed": "2026-09-07", "amount_usd": 299991, "summary": "NIH award 1R44AI197850-01: Spatially Resolved Single-Cell DNA Sequencing: A General Spatial Genomics Platform with Application to HIV Reservoir Mapping ($299,991)", "source_url": "https://reporter.nih.gov/project-details/11316768", "people": [{"name": "Robin Prince", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44EY032847-02A1", "company": "Vasoptic Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-19", "observed": "2026-09-07", "amount_usd": 999883, "summary": "NIH award 2R44EY032847-02A1: Imaging of episcleral venous blood flow for assessment of micro-invasive glaucoma surgery ($999,883)", "source_url": "https://reporter.nih.gov/project-details/11407312", "people": [{"name": "Abhishek Rege", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R43AI188960-02", "company": "L2 Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-19", "observed": "2026-09-07", "amount_usd": 274710, "summary": "NIH award 5R43AI188960-02: A Point of Care Test for Babesia microti ($274,710)", "source_url": "https://reporter.nih.gov/project-details/11419590", "people": [{"name": "Alan Gordon Sutherland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44DK145399-01A1", "company": "Updoc AI", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-19", "observed": "2026-09-07", "amount_usd": 1467300, "summary": "NIH award 1R44DK145399-01A1: Titration Response and Enhancement by AI Tools for T2DM (TREAT-T2DM) ($1,467,300)", "source_url": "https://reporter.nih.gov/project-details/11407615", "people": [{"name": "Sharif Vakili", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07774091", "company": "Bonebridge AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-19", "observed": "2026-08-20", "amount_usd": null, "summary": "New device trial registered: Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System", "source_url": "https://clinicaltrials.gov/study/NCT07774091", "people": [{"name": "Stephen J Warner, MD, PhD, Associate Professor", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07774169", "company": "Perin Health Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-19", "observed": "2026-08-20", "amount_usd": null, "summary": "New device trial registered: Noninvasive Blood Pressure Validation Study", "source_url": "https://clinicaltrials.gov/study/NCT07774169"}, {"id": "fda:K261686", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261686: Elecsys Phospho-Tau (217P) Plasma", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261686", "people": [{"name": "Todd Davis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261686%22"}, {"id": "fda:K262622", "company": "Hyperfine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262622: Swoop\u00ae Portable MR Imaging\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262622", "people": [{"name": "Jon Wojculewicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262622%22"}, {"id": "fda:K253240", "company": "C2N Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253240: PrecivityAD2 Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253240", "people": [{"name": "Ilana Fogelman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253240%22"}, {"id": "fda:K261413", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261413: EXTRON 3;EXTRON 6", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261413", "people": [{"name": "Youngeun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261413%22"}, {"id": "fda:K262537", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262537: Versalock Sterile Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262537", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262537%22"}, {"id": "fda:K260463", "company": "Zeros Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260463: ZEROS Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260463", "people": [{"name": "UK-HYON JOO", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260463%22"}, {"id": "fda:K261964", "company": "Elesta S.P.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261964: ECHOLASER X4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261964", "people": [{"name": "Alessia Blundo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261964%22"}, {"id": "fda:DEN250046", "company": "Vitestro", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) DEN250046: Aletta\u00ae Autonomous Robotic Phlebotomy Device (ARPD\u0099) (Gen1 US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250046", "people": [{"name": "Luuk Giesen", "role": "510(k) submission contact"}]}, {"id": "fda:K253431", "company": "Shokz Health Global Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K253431: Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253431", "people": [{"name": "Guihong Dai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253431%22"}, {"id": "fda:K262070", "company": "Hebei Zollvan Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262070: Diode Laser Therapy Systems (DL612A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262070", "people": [{"name": "Zhichao Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262070%22"}, {"id": "fda:K254213", "company": "Pascall Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K254213: Pascall Sensor Unit (PSU1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254213", "people": [{"name": "Tuan Le Mau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254213%22"}, {"id": "fda:K261083", "company": "CooperSurgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261083: Wallace\u00ae Aspiration Pump (WAPV1); Wallace\u00ae Pump Filter Connector (WFC); Wallace\u00ae Vacuum Connection Kit (WVCK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261083", "people": [{"name": "Ewa Paterson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261083%22"}, {"id": "fda:K260799", "company": "Nipro Technical Solutions, Incoporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260799: Nipro Dry Acid Concentrate Mixer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260799", "people": [{"name": "Jessica Oswald-McLeod", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260799%22"}, {"id": "fda:K260209", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-19", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260209: ENDOFLATOR+; Smart Smoke Evacuation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260209", "people": [{"name": "Emily Rhiel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260209%22"}, {"id": "usasp:75D30126P21238", "company": "Beacon Scientific Inc", "kind": "federal_contract", "kind_label": "Federal medical R&D contract", "date": "2026-08-19", "observed": "2026-09-15", "amount_usd": 234000, "summary": "Federal medical R&D contract from Centers for Disease Control and Prevention: INTEGRASE INHIBITOR LAT FLOW DEVICES - EO 14398 ($234,000)", "source_url": "https://www.usaspending.gov/award/CONT_AWD_75D30126P21238_7523_-NONE-_-NONE-"}, {"id": "denovo:DEN250046", "company": "Vitestro", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-08-19", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250046 granted: Aletta\u00ae Autonomous Robotic Phlebotomy De", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250046"}, {"id": "nih:1R43AI197687-01", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-08-24", "amount_usd": 313110, "summary": "NIH award 1R43AI197687-01: Automated Skill Assessment of Sterile Procedures ($313,110)", "source_url": "https://reporter.nih.gov/project-details/11315934", "people": [{"name": "Adam Becker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R41MH141906-02", "company": "Spike Neuro LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-08-24", "amount_usd": 173801, "summary": "NIH award 5R41MH141906-02: The development of a flexible carbon fiber penetrating nerve cuff and cortical array for neural recording, stimulation, and neurochemical detection ($173,801)", "source_url": "https://reporter.nih.gov/project-details/11330548", "people": [{"name": "Aidan Boyer", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA314644-01", "company": "Intus Biosciences LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-08-24", "amount_usd": 404338, "summary": "NIH award 1R44CA314644-01: Non-Invasive, Bacterial-Based Early-Onset Colorectal Screen ($404,338)", "source_url": "https://reporter.nih.gov/project-details/11407987", "people": [{"name": "Mark David Driscoll", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41EY039129-01", "company": "Aeon Imaging, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-08-24", "amount_usd": 311748, "summary": "NIH award 1R41EY039129-01: Lowering the cost of improved measurements of VA in real-world older patients ($311,748)", "source_url": "https://reporter.nih.gov/project-details/11396861", "people": [{"name": "ANN E ELSNER", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB039538-01", "company": "Emai, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-08-24", "amount_usd": 306872, "summary": "NIH award 1R43EB039538-01: Practical Microwave Breast Imaging Device ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11405724", "people": [{"name": "Wenyi Shao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG090130-02", "company": "Translucence Biosystems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-08-24", "amount_usd": 1307377, "summary": "NIH award 5R44AG090130-02: Brain-Wide Quantification of Blood-Brain Barrier Penetrating Antibody Therapeutics ($1,307,377)", "source_url": "https://reporter.nih.gov/project-details/11418994", "people": [{"name": "Damian G. Wheeler", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44MD018950-02", "company": "Million Marker Wellness Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-08-25", "amount_usd": 1483146, "summary": "NIH award 2R44MD018950-02: A person-centered digital intervention program to reduce exposures to endocrine disrupting chemicals in an under-resourced population ($1,483,146)", "source_url": "https://reporter.nih.gov/project-details/11409093", "people": [{"name": "Jenna Hua", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44MH138151-03", "company": "Psychogenics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-08-26", "amount_usd": 924001, "summary": "NIH award 4R44MH138151-03: EEG Signature Analysis for Drug Repurposing for Rare Diseases ($924,001)", "source_url": "https://reporter.nih.gov/project-details/11536936", "people": [{"name": "Emer Leahy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AI186802-01A1", "company": "Peak Diagnostic Partners LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-09-03", "amount_usd": 1000000, "summary": "NIH award 1R44AI186802-01A1: Multidimensional analysis of biologic treatment failure in uncontrolled asthma ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11185076", "people": [{"name": "Tasha E. Fingerlin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL187059-01", "company": "Autonomous Healthcare, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-09-07", "amount_usd": 305999, "summary": "NIH award 1R43HL187059-01: A Feasibility Study for a Clinical Decision Support System to Assist with Vasopressor Titration ($305,999)", "source_url": "https://reporter.nih.gov/project-details/11406875", "people": [{"name": "Behnood Gholami", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL184750-01", "company": "Pulsentry, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-09-07", "amount_usd": 309198, "summary": "NIH award 1R43HL184750-01: Early, Rapid, Non-invasive, & Automated Detection of Cardiac Tamponade ($309,198)", "source_url": "https://reporter.nih.gov/project-details/11316708", "people": [{"name": "GREGORY R MASON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44TR006374-01A1", "company": "Repro-t Company", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-09-07", "amount_usd": 1215061, "summary": "NIH award 1R44TR006374-01A1: A high throughput platform for intracellular delivery of impermeable drug molecules and molecular probes to enable a new generation of screening assays ($1,215,061)", "source_url": "https://reporter.nih.gov/project-details/11409819", "people": [{"name": "Armon R Sharei", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41EB038861-01", "company": "Creosalus, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-09-07", "amount_usd": 314359, "summary": "NIH award 1R41EB038861-01: Point of Care Differential Scanning Calorimetry ($314,359)", "source_url": "https://reporter.nih.gov/project-details/11316332", "people": [{"name": "Nichola C. Garbett", "role": "Principal Investigator"}, {"name": "Thomas J Roussel", "role": "Principal Investigator"}, {"name": "Michael Wilson", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42HG013908-03", "company": "Nest Genomics", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-18", "observed": "2026-09-08", "amount_usd": 790626, "summary": "NIH award 5R42HG013908-03: Closing the GAPS: Guideline Adherence, Prevention and Surveillance in Hereditary Cancer ($790,626)", "source_url": "https://reporter.nih.gov/project-details/11415655", "people": [{"name": "Moran Snir", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07771231", "company": "EchoNous Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Kosmos PLAX EF Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT07771231"}, {"id": "trialreg:NCT07769489", "company": "Novo Nordisk A/S", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study to Assess Tolerability of Injecting Larger Volumes (2-5 mL) Subcutaneously at Different Rates: Participant Experience and Acceptance", "source_url": "https://clinicaltrials.gov/study/NCT07769489", "people": [{"name": "Clinical Transparency dept. 2834", "role": "Study Director"}]}, {"id": "trialreg:NCT07770867", "company": "Neudive Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of NDTx-03 in Children and Adolescents With ASD or SCD", "source_url": "https://clinicaltrials.gov/study/NCT07770867", "people": [{"name": "Yoo Sook Joung, MD., PhD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07771270", "company": "EchoNous Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Kosmos Guidance Performance Evaluation Data Annotation", "source_url": "https://clinicaltrials.gov/study/NCT07771270"}, {"id": "trialreg:NCT07769593", "company": "EverEx Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MORA Cure for Knee Osteoarthritis With Anterior Knee Pain", "source_url": "https://clinicaltrials.gov/study/NCT07769593"}, {"id": "trialreg:NCT07770789", "company": "Forest Hills Lab", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial to Study the Efficacy and Safety of Rejeunesse Shape With Lidocaine (HA Filler) in Treating Healthy Subjects", "source_url": "https://clinicaltrials.gov/study/NCT07770789"}, {"id": "fda:K262479", "company": "Sight Sciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-18", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262479: TearCare System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262479", "people": [{"name": "Rachel Franco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262479%22"}, {"id": "fda:K260794", "company": "Kossan International Sdn Bhd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-18", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260794: NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260794", "people": [{"name": "Cho Sow Fong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260794%22"}, {"id": "fda:K254256", "company": "Huizhou Foryou Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-18", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K254256: LUOFUCON\u00ae Wound Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254256", "people": [{"name": "Ni Zhan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254256%22"}, {"id": "fda:K262729", "company": "Theramicro", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-18", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262729: TeKBrace Solo Soft Tissue Reinforcement Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262729", "people": [{"name": "Christine Scifert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262729%22"}, {"id": "fda:K260984", "company": "Axora Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-18", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260984: HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260984", "people": [{"name": "Kimberly Marquez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260984%22"}, {"id": "fda:K261641", "company": "AI Planning Logic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-18", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261641: Lower Limb AI (LLAI)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261641", "people": [{"name": "Philippe Ballaire", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261641%22"}, {"id": "fda:K254071", "company": "Wallaby Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-18", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K254071: p17 XR Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254071", "people": [{"name": "Rachel McDaid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254071%22"}, {"id": "fda:K260266", "company": "Grace Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-18", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260266: Tympendi\u0099 (810)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260266", "people": [{"name": "Thomas Fearnley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260266%22"}, {"id": "fda:K262135", "company": "Tianjin Huahong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-18", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262135: Lancing device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262135", "people": [{"name": "Ningning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262135%22"}, {"id": "fda:K262489", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-18", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K262489: BluEX Cervical Expandable Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262489", "people": [{"name": "Kihyang Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262489%22"}, {"id": "nih:5R44AG061985-08", "company": "Zetroz Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-17", "observed": "2026-08-24", "amount_usd": 2154078, "summary": "NIH award 5R44AG061985-08: Daily & Localized NSAID Sonophoresis for Symptomatic Treatment of Knee Osteoarthritis ($2,154,078)", "source_url": "https://reporter.nih.gov/project-details/11390466", "people": [{"name": "George Kenneth Lewis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 8, "new_award": false}, {"id": "nih:1R41TR006349-01", "company": "Cfd Research Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-17", "observed": "2026-08-24", "amount_usd": 349752, "summary": "NIH award 1R41TR006349-01: High-throughput Organoid Platform for Electrophysiology Studies (HOPES) ($349,752)", "source_url": "https://reporter.nih.gov/project-details/11408054", "people": [{"name": "Kevin Roehm", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG080849-03", "company": "Carevirtue Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-17", "observed": "2026-09-07", "amount_usd": 1001990, "summary": "NIH award 5R44AG080849-03: A Novel, Personalized Innovation to Reduce Health Disparities for Rural ADRD Care Partners: CareVirtue Resource Connection. ($1,001,990)", "source_url": "https://reporter.nih.gov/project-details/11402215", "people": [{"name": "Christian Elliott", "role": "Principal Investigator"}, {"name": "Nicole E Werner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44DA063251-01A1", "company": "Altrumed LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-17", "observed": "2026-09-07", "amount_usd": 403307, "summary": "NIH award 1R44DA063251-01A1: Responding to the Opioid Crisis with DOVE: A Standalone Opioid Overdose Detection and Alert Device ($403,307)", "source_url": "https://reporter.nih.gov/project-details/11286565", "people": [{"name": "Anush Lingamoorthy", "role": "Principal Investigator"}, {"name": "Olumuyiwa Oni", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI197772-01", "company": "Abterra Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-17", "observed": "2026-09-14", "amount_usd": 306555, "summary": "NIH award 1R43AI197772-01: A platform for serum antibody repertoire analysis for autoimmune disease diagnosis ($306,555)", "source_url": "https://reporter.nih.gov/project-details/11316086", "people": [{"name": "Stefano Romoli Bonissone", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07768553", "company": "Medprin Regenerative Medical Technologies Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Trial of Absorbable Medical Adhesive for Prevention of CSF Leak", "source_url": "https://clinicaltrials.gov/study/NCT07768553"}, {"id": "trialreg:NCT07768735", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: UNITY DX Cornea Study", "source_url": "https://clinicaltrials.gov/study/NCT07768735", "people": [{"name": "Clinical Trial Lead, Surgical", "role": "Study Director"}]}, {"id": "trialreg:NCT07768475", "company": "Nvision Laser Eye Centers", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Study Comparing Visual Outcomes and Patient Satisfaction Following Implantation of the Clareon PanOptix Versus Tecnis Odyssey IOL in Patients Undergoing Cataract Surgery.", "source_url": "https://clinicaltrials.gov/study/NCT07768475"}, {"id": "trialreg:NCT07768787", "company": "Aml", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of Vaginal Self-Sampling With the Abbott Multi-Collect Swab for HPV Screening in Women Aged 30 to 64 Years", "source_url": "https://clinicaltrials.gov/study/NCT07768787"}, {"id": "trialreg:NCT07768631", "company": "Endogenex, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07768631", "people": [{"name": "Daniel DeMarco, M.D.", "role": "Study Chair"}]}, {"id": "fda:K261500", "company": "S.m.a.i.o", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-17", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K261500: KBA3D (v2.4.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261500", "people": [{"name": "Jean-Charles Roussouly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261500%22"}, {"id": "fda:K260137", "company": "KLS-Martin L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-17", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260137: KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260137", "people": [{"name": "Melissa Bachorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260137%22"}, {"id": "fda:K254250", "company": "Xingaoyi Medical Equipment Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-17", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K254250: MagicScan-1.5, GreenMR Serenity 1.5T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254250", "people": [{"name": "ZhengYing ZUO", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254250%22"}, {"id": "fda:K260224", "company": "ImpediMed Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-17", "observed": "2026-09-08", "amount_usd": null, "summary": "FDA 510(k) K260224: MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260224", "people": [{"name": "Richard Hines", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260224%22"}, {"id": "fda:K260563", "company": "FIND Surgical Sciences Inc. D/B/A FIND Neuro", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-16", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260563: CN-Suite\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260563", "people": [{"name": "Noam Peled", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260563%22"}, {"id": "nih:1R43CK000713-01A1", "company": "Microsensor Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-15", "observed": "2026-09-07", "amount_usd": 306872, "summary": "NIH award 1R43CK000713-01A1: A High-throughput Automated Platform for Rapid Isolation and Testing of Salmonella ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11184528", "people": [{"name": "Peng Paul Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44OH012575-02", "company": "Intelligent Optical Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-15", "observed": "2026-09-08", "amount_usd": 520010, "summary": "NIH award 2R44OH012575-02: Low SWaP Phosgene Clip Detector ($520,010)", "source_url": "https://reporter.nih.gov/project-details/11253861", "people": [{"name": "Lihua Zhang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44OH012425-02A1", "company": "Hava, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-15", "observed": "2026-09-11", "amount_usd": 455409, "summary": "NIH award 2R44OH012425-02A1: Rapid Production of Metal Organic Framework - Fabrics for Air Filtration ($455,409)", "source_url": "https://reporter.nih.gov/project-details/11185123", "people": [{"name": "Nick Cienski", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nsf:2537987", "company": "Simplybreathe L.l.c.", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-08-15", "observed": "2026-08-19", "amount_usd": 304857, "summary": "NSF STTR award: STTR Phase I: Steroid eluting biodegradable implant ($304,857)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2537987", "people": [{"name": "Cecil Lewis", "role": "Principal Investigator"}]}, {"id": "nsf:2537833", "company": "Levosens, Inc.", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-08-15", "observed": "2026-08-19", "amount_usd": 305000, "summary": "NSF STTR award: STTR Phase I: Integrating Machine Learning and Multimodal eCH Sensing for Real-Time Biomarker Detection ($305,000)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2537833", "people": [{"name": "David Probst", "role": "Principal Investigator"}]}, {"id": "nsf:2538085", "company": "Trellis Robotics Inc", "kind": "nsf_award", "kind_label": "NSF award", "date": "2026-08-15", "observed": "2026-08-22", "amount_usd": 304985, "summary": "NSF STTR award: STTR Phase I: Fast non-destructive inspection of confined-space industrial assets with a novel vine robot ($304,985)", "source_url": "https://www.nsf.gov/awardsearch/showAward?AWD_ID=2538085", "people": [{"name": "Elvymond Yao", "role": "Principal Investigator"}]}, {"id": "nih:1R44EY039171-01", "company": "Edge Eye Labs Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-14", "observed": "2026-08-17", "amount_usd": 1123233, "summary": "NIH award 1R44EY039171-01: AmblyoGo\" a 'Smart' Easy-to-use Occlusion Dose Monitor (ODM) for Amblyopia in Children ($1,123,233)", "source_url": "https://reporter.nih.gov/project-details/11410213", "people": [{"name": "Omondi Luthuli Nyongo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44HL169137-02A1", "company": "Urban Design 4 Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-14", "observed": "2026-08-18", "amount_usd": 1253332, "summary": "NIH award 2R44HL169137-02A1: STREET SOLUTIONS: BLUEPRINTS AND FOOTPRINTS FOR CREATORS AND USERS OF URBAN ENVIRONMENTS ($1,253,332)", "source_url": "https://reporter.nih.gov/project-details/11316081", "people": [{"name": "James Chapman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG085913-03", "company": "Friendi.fi Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-14", "observed": "2026-08-18", "amount_usd": 852676, "summary": "NIH award 5R44AG085913-03: Implementing and Scaling the STEADI Fall Prevention Algorithm Using a Conversational Relational Agent for Community-Dwelling Older Adults with and without Mild Cognitive Impairment (MCI). ($852,676)", "source_url": "https://reporter.nih.gov/project-details/11418945", "people": [{"name": "Chantal M Kerssens", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44CA310443-01", "company": "Informed Medical Decisions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-14", "observed": "2026-08-18", "amount_usd": 1216515, "summary": "NIH award 1R44CA310443-01: INHERET: Commercialization and EHR Integration of an Innovative Personalized Medicine Tool to Advance Cancer Screening and Management ($1,216,515)", "source_url": "https://reporter.nih.gov/project-details/11315138", "people": [{"name": "Rebecca Sutphen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG078063-03", "company": "Tf Health Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-14", "observed": "2026-08-18", "amount_usd": 817562, "summary": "NIH award 5R44AG078063-03: Smart driving technology for non-invasive detection of age-related cognitive decline ($817,562)", "source_url": "https://reporter.nih.gov/project-details/11418920", "people": [{"name": "Erica Silvia Forzani", "role": "Principal Investigator"}, {"name": "Francis Tsow", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG097243-02", "company": "Revbio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-14", "observed": "2026-08-19", "amount_usd": 205450, "summary": "NIH award 5R44AG097243-02: Improved Treatment Options for Vertebral Compression Fractures in Elderly Patients Using Minimally Invasive, Image-Guided Delivery of a Regenerative Bone Adhesive ($205,450)", "source_url": "https://reporter.nih.gov/project-details/11420547", "people": [{"name": "Brittany McDonough", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44GM156169-02", "company": "Mitegen, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-14", "observed": "2026-08-21", "amount_usd": 999741, "summary": "NIH award 2R44GM156169-02: Improving cryopreservation outcomes of small biological samples through ultra-fast convective cooling and warming ($999,741)", "source_url": "https://reporter.nih.gov/project-details/11409780", "people": [{"name": "Benjamin Arthur Apker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44TR003071-04", "company": "Insightfil", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-14", "observed": "2026-09-07", "amount_usd": 598106, "summary": "NIH award 5R44TR003071-04: Personalized multi-medication packaging with integrated real-time instrumentation to improve adherence ($598,106)", "source_url": "https://reporter.nih.gov/project-details/11383131", "people": [{"name": "Edward Acworth", "role": "Principal Investigator"}, {"name": "Kimberly Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R41AI195068-02", "company": "Orlance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-14", "observed": "2026-09-07", "amount_usd": 298837, "summary": "NIH award 5R41AI195068-02: Therapeutic nucleic acid vaccine for chronic hepatitis B in HIV/HBV co-infected individuals ($298,837)", "source_url": "https://reporter.nih.gov/project-details/11415128", "people": [{"name": "Kenneth C Bagley", "role": "Principal Investigator"}, {"name": "Deborah H. Fuller", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R41DA064798-01", "company": "Ibis LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-14", "observed": "2026-09-07", "amount_usd": 387369, "summary": "NIH award 1R41DA064798-01: ElevateAR: A Scalable Digital Therapeuticthat Uses Augmented Reality to Enhance Access, Engagement, and Effectiveness of Vaping CessationAmong the Pediatric Population ($387,369)", "source_url": "https://reporter.nih.gov/project-details/11292687", "people": [{"name": "Mikael Rubin", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43AG090142-02", "company": "Seeinme Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-14", "observed": "2026-09-07", "amount_usd": 173498, "summary": "NIH award 5R43AG090142-02: SeeInMe: Digital Profiles Facilitating Person-centered Coordinated Care for People with Dementia ($173,498)", "source_url": "https://reporter.nih.gov/project-details/11419587", "people": [{"name": "Risa Stein", "role": "Principal Investigator"}, {"name": "Kristine N. Williams", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07764614", "company": "Stryker Trauma and Extremities", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Tornier Perform\u2122 Reversed Monopost Study", "source_url": "https://clinicaltrials.gov/study/NCT07764614", "people": [{"name": "Rebecca Gibson", "role": "Study Director"}]}, {"id": "trialreg:NCT07766044", "company": "Suturion AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy Closure", "source_url": "https://clinicaltrials.gov/study/NCT07766044"}, {"id": "trialreg:NCT07764874", "company": "InSightec", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.", "source_url": "https://clinicaltrials.gov/study/NCT07764874", "people": [{"name": "Joohi Jimenez-shahed, MD", "role": "Principal Investigator"}]}, {"id": "fda:K253562", "company": "Schiller AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253562: medilogFD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253562", "people": [{"name": "Stefan Bigler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253562%22"}, {"id": "fda:K261228", "company": "Brain Ultimate, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261228: QuickVision Ultimate rTMS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261228", "people": [{"name": "Frank Ge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261228%22"}, {"id": "fda:K261890", "company": "Boehringer Laboratories, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261890: 52Fr ViSiGi LUX\u0099; 52Fr ViSiGi 3D\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261890", "people": [{"name": "Evan Langdale", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261890%22"}, {"id": "fda:K253747", "company": "Jiangsu Enjosim Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253747: Disposable Pen Injector (KXYC-03C02, KXYC-03A03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253747", "people": [{"name": "Hao Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253747%22"}, {"id": "fda:K260559", "company": "IMDS Operation B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260559: NHanceIT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260559", "people": [{"name": "Edwin Schulting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260559%22"}, {"id": "fda:K262452", "company": "Radformation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262452: AutoContour (RADAC V6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262452", "people": [{"name": "Jennifer Wampler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262452%22"}, {"id": "fda:K260171", "company": "BMC Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260171: Portable Oxygen Concentrator (PO1 5B, PO1 6B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260171", "people": [{"name": "Nicole Niu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260171%22"}, {"id": "fda:K260438", "company": "Infinium Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260438: Vital Signs Monitor (CLEO2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260438", "people": [{"name": "Aydin Bilgutay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260438%22"}, {"id": "fda:K261646", "company": "Beijing Kreate Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261646: Redermax\u00ae Antibacterial Wound Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261646", "people": [{"name": "Gary Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261646%22"}, {"id": "fda:K261428", "company": "Medtronic Ireland", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261428: NC Euphora Rapid Exchange Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261428", "people": [{"name": "Michelle Greaney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261428%22"}, {"id": "fda:K260898", "company": "Screenpoint Medical B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260898: Transpara (2.1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260898", "people": [{"name": "Robin Barwegen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260898%22"}, {"id": "fda:K262552", "company": "Scivita Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262552: Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262552", "people": [{"name": "Wu Ruqin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262552%22"}, {"id": "fda:K262419", "company": "Cerenovus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262419: MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262419", "people": [{"name": "Ryan Rivera", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262419%22"}, {"id": "fda:K262424", "company": "Arbor Endovascular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262424: Willow 12 Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262424", "people": [{"name": "Kathy Tansey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262424%22"}, {"id": "fda:K262571", "company": "Bard Peripheral Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262571: EnCor EnCompass\u0099 Breast Biopsy and Tissue Removal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262571", "people": [{"name": "Jakob Wells", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262571%22"}, {"id": "fda:K260374", "company": "Empatica S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260374: Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260374", "people": [{"name": "Alberto Poli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260374%22"}, {"id": "fda:K262449", "company": "Advahealth Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262449: AdvaView", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262449", "people": [{"name": "Imad Nijim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262449%22"}, {"id": "fda:K262639", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-14", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262639: BAGUERA\u00ae C Cervical Disc Surgical Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262639", "people": [{"name": "Estelle Godeau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262639%22"}, {"id": "hde:H200002", "company": "OncoSil Medical USA, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2026-08-14", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H200002: OncoSil\u2122", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "nih:2R44AA030231-05", "company": "Actiox LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-13", "observed": "2026-08-17", "amount_usd": 1099865, "summary": "NIH award 2R44AA030231-05: Discreet Wearable device for Continuous Real-time Monitoring of Alcohol ($1,099,865)", "source_url": "https://reporter.nih.gov/project-details/11410513", "people": [{"name": "Farshad Tehrani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44MH134669-03", "company": "Pinnacle Technology, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": 984425, "summary": "NIH award 5R44MH134669-03: Functionalized Multi-Modal Tetrode Arrays for Real-Time, Site-Specific Neurochemical Monitoring ($984,425)", "source_url": "https://reporter.nih.gov/project-details/11365890", "people": [{"name": "DAVID A JOHNSON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44ES035665-01A1", "company": "Photothermal Spectroscopy Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": 1022908, "summary": "NIH award 1R44ES035665-01A1: High-Speed Automated Analysis of Sub-20 \u00b5m Microplastics by Photothermal Infrared Spectroscopy ($1,022,908)", "source_url": "https://reporter.nih.gov/project-details/11312399", "people": [{"name": "Kevin Kjoller", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AG091857-02", "company": "Plans4care Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": 1190509, "summary": "NIH award 4R44AG091857-02: Activites4Care: A Digital Platform to Enhance Caregiver Well-being by Providing Customized Activities that Improve Quality of Life for People Living with Dementia ($1,190,509)", "source_url": "https://reporter.nih.gov/project-details/11530760", "people": [{"name": "Laura N. Gitlin", "role": "Principal Investigator"}, {"name": "Sokha Koeuth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH129065-04", "company": "Doxy.me, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": 704454, "summary": "NIH award 5R44MH129065-04: Doxy.me VR: A scalable virtual reality app to facilitate evidence-based immersive telemental health ($704,454)", "source_url": "https://reporter.nih.gov/project-details/11375504", "people": [{"name": "Brian E. Bunnell", "role": "Principal Investigator"}, {"name": "Triton Ong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44DA059017-03", "company": "Biomedical Development Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-13", "observed": "2026-09-07", "amount_usd": 1721119, "summary": "NIH award 5R44DA059017-03: Real World Adoption of an OUD Digital Health Therapeutic ($1,721,119)", "source_url": "https://reporter.nih.gov/project-details/11417309", "people": [{"name": "Gregg Siegel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07762053", "company": "EyeCBetter Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation of Eye C Better's Photobionic Intraocular Pressure Biomonitor Tonometer", "source_url": "https://clinicaltrials.gov/study/NCT07762053", "people": [{"name": "Joel Solano, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07763769", "company": "Medhub Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)", "source_url": "https://clinicaltrials.gov/study/NCT07763769", "people": [{"name": "Hector M. Garcia-Garcia, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07764055", "company": "Medprin Regenerative Medical Technologies Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Trial of Absorbable Regenerated Oxidized Cellulose for Surgical Hemostasis)", "source_url": "https://clinicaltrials.gov/study/NCT07764055"}, {"id": "trialreg:NCT07764146", "company": "Voyager Therapeutics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease", "source_url": "https://clinicaltrials.gov/study/NCT07764146"}, {"id": "trialreg:NCT07763990", "company": "Hallura Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER", "source_url": "https://clinicaltrials.gov/study/NCT07763990"}, {"id": "trialreg:NCT07762365", "company": "General Neuro Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia", "source_url": "https://clinicaltrials.gov/study/NCT07762365", "people": [{"name": "Alec Sheffield, PhD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07762209", "company": "Hifas da Terra S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With HPV", "source_url": "https://clinicaltrials.gov/study/NCT07762209"}, {"id": "trialreg:NCT07762118", "company": "General Neuro Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Brain Stimulation Paired With Structured Language Learning in Adults", "source_url": "https://clinicaltrials.gov/study/NCT07762118", "people": [{"name": "Alec Sheffield, PhD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07763873", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study Examining Acceptability of Auditory Implant Fitting Software Technologies", "source_url": "https://clinicaltrials.gov/study/NCT07763873"}, {"id": "fda:K253795", "company": "Menicon Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253795: MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253795", "people": [{"name": "Kana Nagasaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253795%22"}, {"id": "fda:K253790", "company": "Beijing Winkonlaser Technology Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253790: High Intensity Focused Electromagnetic Stimulation Device (FE60)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253790", "people": [{"name": "Sindy Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253790%22"}, {"id": "fda:K253808", "company": "GE Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253808: AIR Recon DL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253808", "people": [{"name": "Andrew Turner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253808%22"}, {"id": "fda:K261626", "company": "Guangzhou Heygears IMC., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261626: UltraPrint Flexible Denture UV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261626", "people": [{"name": "Mingyang Qu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261626%22"}, {"id": "fda:K260211", "company": "Hill-Rom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260211: Dashboard (P007000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260211", "people": [{"name": "Igor Bendersky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260211%22"}, {"id": "fda:K260413", "company": "Levo Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260413: Levo Gen 2 Tinnitus Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260413", "people": [{"name": "Matt Lopez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260413%22"}, {"id": "fda:K253425", "company": "Joytech Healthcare Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253425: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253425", "people": [{"name": "Yuanyuan Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253425%22"}, {"id": "fda:K260907", "company": "Covidien LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260907: BIS\u0099 Advance pEEG Module", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260907", "people": [{"name": "Monica Gupta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260907%22"}, {"id": "fda:K261139", "company": "Freyja Healthcare, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261139: VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261139", "people": [{"name": "Eric Frattura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261139%22"}, {"id": "fda:K254201", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K254201: Any-Cem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254201", "people": [{"name": "Ku Da Hyeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254201%22"}, {"id": "fda:K261061", "company": "Wellvii, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261061: BP Go (BPP-855)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261061", "people": [{"name": "Mark Khachaturian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261061%22"}, {"id": "fda:K262398", "company": "CERENOVUS, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262398: CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262398", "people": [{"name": "Mia Dudicova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262398%22"}, {"id": "fda:K261499", "company": "Aw Technologies Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261499: TrachFlush", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261499", "people": [{"name": "Jorgen Hansen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261499%22"}, {"id": "fda:K260277", "company": "Mikron Makina San. ve Tic. Ltd. Sti.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-13", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260277: MIKRON TRAUMA BONE PLATE& SCREW SYSTEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260277", "people": [{"name": "Mustafa Ekiz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260277%22"}, {"id": "nih:5R44HD090793-06", "company": "Advanced Tactile Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-12", "observed": "2026-08-18", "amount_usd": 868804, "summary": "NIH award 5R44HD090793-06: Cervix monitor for risk assessment of spontaneous preterm delivery ($868,804)", "source_url": "https://reporter.nih.gov/project-details/11413722", "people": [{"name": "Vladimir Egorov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:2R44GM154526-02", "company": "3D Molecular Designs", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-12", "observed": "2026-08-18", "amount_usd": 1004963, "summary": "NIH award 2R44GM154526-02: Harnessing Machine Learning & Object Detection for Automated Evaluation of Student-folded Protein Models ($1,004,963)", "source_url": "https://reporter.nih.gov/project-details/11183303", "people": [{"name": "Mark Andrew Hoelzer", "role": "Principal Investigator"}, {"name": "Heather Noelle Ryan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DC023165-01A1", "company": "Su-kam Intelligent Education Systems, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-12", "observed": "2026-08-18", "amount_usd": 314363, "summary": "NIH award 1R43DC023165-01A1: Visual Play: An Interactive Play Idea and AAC Grid Generator to Assist in Behavioral Interventions for Minimally Verbal Autistic Children ($314,363)", "source_url": "https://reporter.nih.gov/project-details/11406559", "people": [{"name": "Julius Tsu-Li Su", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI197708-01", "company": "Nephropathology Associates", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-12", "observed": "2026-08-19", "amount_usd": 266613, "summary": "NIH award 1R43AI197708-01: Precision Diagnostics in T-cell Mediated Rejection: Predicting Treatment Resistance at Time of Diagnosis ($266,613)", "source_url": "https://reporter.nih.gov/project-details/11315213", "people": [{"name": "Christopher P Larsen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43MH142283-02", "company": "Habitaware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-12", "observed": "2026-09-07", "amount_usd": 422072, "summary": "NIH award 5R43MH142283-02: Developing an Integrated Wearable and Patch System to Address Skin Picking Disorder ($422,072)", "source_url": "https://reporter.nih.gov/project-details/11400423", "people": [{"name": "Christopher A. Flessner", "role": "Principal Investigator"}, {"name": "Sameer Kumar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R42MH132191-04", "company": "Northwest Prevention Science Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-12", "observed": "2026-09-07", "amount_usd": 870724, "summary": "NIH award 5R42MH132191-04: A Digital Health Technology to Prevent Family Violence and Improve Child Mental Health ($870,724)", "source_url": "https://reporter.nih.gov/project-details/11415654", "people": [{"name": "ANNE Marie MAURICIO", "role": "Principal Investigator"}, {"name": "Lisa Ann Reiter", "role": "Principal Investigator"}, {"name": "ELIZABETH A STORMSHAK", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44MH126788-04", "company": "Oregon Res Behavioral Intervention Strat", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-12", "observed": "2026-09-07", "amount_usd": 633205, "summary": "NIH award 5R44MH126788-04: Walk with Me (WWM) for Perinatal Grief ($633,205)", "source_url": "https://reporter.nih.gov/project-details/11379151", "people": [{"name": "Camille C Cioffi", "role": "Principal Investigator"}, {"name": "David Randolph Smith", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "trialreg:NCT07760363", "company": "David McVay", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pedal Pump Clinical Trial on Edema V1", "source_url": "https://clinicaltrials.gov/study/NCT07760363", "people": [{"name": "David McVay, DO", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07759817", "company": "FA Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear\u00ae) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment Areas", "source_url": "https://clinicaltrials.gov/study/NCT07759817", "people": [{"name": "Paul M Friedman, MD", "role": "Principal Investigator"}]}, {"id": "fda:K262792", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262792: Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262792", "people": [{"name": "Christine Stahley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262792%22"}, {"id": "fda:K260086", "company": "BeamWorks, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260086: CadAI-B Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260086", "people": [{"name": "Nayeon Oh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260086%22"}, {"id": "fda:K262344", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262344: Large Compression Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262344", "people": [{"name": "Annika Lind", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262344%22"}, {"id": "fda:K262391", "company": "Alembic, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262391: APRO 35 Swift Catheter and Alembic Aspiration Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262391", "people": [{"name": "Stina Almaleh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262391%22"}, {"id": "fda:K261170", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261170: BA-004CC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261170", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261170%22"}, {"id": "fda:K260944", "company": "Manamed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260944: ManaCold Compression System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260944", "people": [{"name": "Trevor Theriot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260944%22"}, {"id": "fda:K261916", "company": "Cortechs Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261916: NeuroQuant PET", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261916", "people": [{"name": "Stephen Kosnosky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261916%22"}, {"id": "fda:K262392", "company": "Alembic, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262392: APRO 35 Swift Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262392", "people": [{"name": "Stina Almaleh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262392%22"}, {"id": "fda:K262406", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262406: EluPro Antibiotic-Eluting BioEnvelope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262406", "people": [{"name": "Cary Percy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262406%22"}, {"id": "fda:K251641", "company": "Nihon Kohden Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K251641: GF-310R Multigas Unit (GF-310R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251641", "people": [{"name": "Charlemagne Chua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251641%22"}, {"id": "fda:K253417", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253417: Masimo Root Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253417", "people": [{"name": "Sindura Penubarthi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253417%22"}, {"id": "fda:K253846", "company": "Hangzhou Ruidi Biotechnology , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253846: Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253846", "people": [{"name": "Siran Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253846%22"}, {"id": "fda:K262399", "company": "Perfuze, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-12", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262399: Millipede System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262399", "people": [{"name": "Jeanine O'Donnell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262399%22"}, {"id": "nih:5R44AI183961-03", "company": "Ossium Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-08-17", "amount_usd": 579970, "summary": "NIH award 5R44AI183961-03: Developing a bank of purified myeloid progenitor cells as a bridging therapy for transient pancytopenia resulting from radiation injury ($579,970)", "source_url": "https://reporter.nih.gov/project-details/11404025", "people": [{"name": "Brian H. Johnstone", "role": "Principal Investigator"}, {"name": "Subhrajit Saha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43MD021438-01", "company": "Flourish Collective Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": 306798, "summary": "NIH award 1R43MD021438-01: AI-Driven Risk Prediction and Action Platform to Reduce Maternal Health Risks Among Expecting Mothers Enrolled in Medicaid ($306,798)", "source_url": "https://reporter.nih.gov/project-details/11349846", "people": [{"name": "Elisabeth Howard", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK127631-05", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": 1099700, "summary": "NIH award 5R44DK127631-05: Kidney Support in Pediatric Patients using an Ultrafiltration Device ($1,099,700)", "source_url": "https://reporter.nih.gov/project-details/11408830", "people": [{"name": "Robert J Knuesel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R43HL186922-01", "company": "Resuscitation Innovations LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": 396098, "summary": "NIH award 1R43HL186922-01: A Dual-Setting Airway Device for Optimized Hemodynamics in Cardiac Arrest and Post-Resuscitation States ($396,098)", "source_url": "https://reporter.nih.gov/project-details/11406531", "people": [{"name": "Keith Lurie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42HD104305-04", "company": "Nuborn Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": 1008475, "summary": "NIH award 5R42HD104305-04: A Novel Non-Invasive Method of Dysphagia Detection in Preterm Infants: Bottle Finalization & Validation ($1,008,475)", "source_url": "https://reporter.nih.gov/project-details/11392556", "people": [{"name": "Katlyn Elizabeth McGrattan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R41MD021420-01", "company": "Collective Good Dx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": 349322, "summary": "NIH award 1R41MD021420-01: Enhancing Peer Diagnostic Support for Rural Clinicians via Collective Intelligence and Adaptive Machine Learning ($349,322)", "source_url": "https://reporter.nih.gov/project-details/11350053", "people": [{"name": "Drew Ghirvan Narayan", "role": "Principal Investigator"}, {"name": "Sean Y Sylvia", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD021402-01", "company": "Hairdays, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": 306872, "summary": "NIH award 1R43MD021402-01: Hybrid telehealth platform to facilitate dermatologist referrals through AI-assisted image screening and collaboration between hair professionals and dermatologists. ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11350152", "people": [{"name": "Tiffany St. Bernard", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44NS147449-01", "company": "Posit Science Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": 1048180, "summary": "NIH award 1R44NS147449-01: RECLAIM A Novel Telehealth Treatment for Acquired Brain Injury ($1,048,180)", "source_url": "https://reporter.nih.gov/project-details/11315643", "people": [{"name": "Thomas VanVleet", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD021459-01", "company": "Sequestbio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-08-19", "amount_usd": 290612, "summary": "NIH award 1R43MD021459-01: \"Quantum-Enhanced Prediction of Metastasis and Residual Disease in Breast-Cancer Patients from Low- Resourced Populations ($290,612)", "source_url": "https://reporter.nih.gov/project-details/11349330", "people": [{"name": "Arvin Honari", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44MD021095-02A1", "company": "Objective Ed, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-08-19", "amount_usd": 1031318, "summary": "NIH award 2R44MD021095-02A1: PREP - Prepare for college success by improving EF, SA and SI skills for students with a disability. ($1,031,318)", "source_url": "https://reporter.nih.gov/project-details/11379651", "people": [{"name": "marty schultz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R43NS145909-02", "company": "Neurovascular Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-09-07", "amount_usd": 266097, "summary": "NIH award 5R43NS145909-02: Testing a Blood-Based Assay for Detection and Risk Assessment of Intracranial Aneurysms in Familial Cases ($266,097)", "source_url": "https://reporter.nih.gov/project-details/11417233", "people": [{"name": "Kerry Poppenberg", "role": "Principal Investigator"}, {"name": "Vincent Matthew Tutino", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44TR004975-03", "company": "Syntr Health Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-11", "observed": "2026-09-07", "amount_usd": 1000251, "summary": "NIH award 5R44TR004975-03: Device Automation of an FDA-cleared CD-Microfluidic Platform for Rapid Tissue Microsizing ($1,000,251)", "source_url": "https://reporter.nih.gov/project-details/11421478", "people": [{"name": "Ahmed Nabil Zobi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07757776", "company": "Polares Medical SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (DE)", "source_url": "https://clinicaltrials.gov/study/NCT07757776"}, {"id": "trialreg:NCT07758907", "company": "Intelligent Bio Solutions Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Interference and Stability Evaluation of the Intelligent Fingerprinting Drug Screening System", "source_url": "https://clinicaltrials.gov/study/NCT07758907"}, {"id": "trialreg:NCT07757490", "company": "Sonablate", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Sonablate HIFU International Registry for PC & BPH Patients", "source_url": "https://clinicaltrials.gov/study/NCT07757490", "people": [{"name": "Clint D. Bahler, MD, MS", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07758777", "company": "Intelligent Bio Solutions Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Usability Evaluation of the Intelligent Fingerprinting Drug Screening System", "source_url": "https://clinicaltrials.gov/study/NCT07758777", "people": [{"name": "Elan Cohen, PhD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07757698", "company": "Polares Medical SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (AU)", "source_url": "https://clinicaltrials.gov/study/NCT07757698"}, {"id": "trialreg:NCT07758881", "company": "Eight Medical International BV", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Safety and Performance of the Eight Medical Hyperthermia System IV 1.0 for HIVEC in NMIBC.", "source_url": "https://clinicaltrials.gov/study/NCT07758881"}, {"id": "trialreg:NCT07759076", "company": "Raylution AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical Study", "source_url": "https://clinicaltrials.gov/study/NCT07759076"}, {"id": "trialreg:NCT07757607", "company": "Polares Medical SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (FR)", "source_url": "https://clinicaltrials.gov/study/NCT07757607"}, {"id": "trialreg:NCT07757009", "company": "Hamad Medical Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Perioperative Forced-Air Warming During Elective Cesarean Delivery Under Spinal Anesthesia", "source_url": "https://clinicaltrials.gov/study/NCT07757009", "people": [{"name": "Dr Eynas Omer Ibrahim Abdalla, Arab Board", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07757451", "company": "Shenzhen Core Medical Technology CO.,LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Multicenter,Single-arm Study of DuoCor 2 Ventricular Assist System for the Treatment of Advanced Biventricular Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07757451", "people": [{"name": "Nianguo Dong", "role": "Principal Investigator"}]}, {"id": "fda:K262472", "company": "Dexcom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-11", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262472: Stelo Glucose Biosensor System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262472", "people": [{"name": "Ginny Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262472%22"}, {"id": "fda:K261398", "company": "Distalmotion SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-11", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261398: Dexter L6 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261398", "people": [{"name": "Coline Lahaye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261398%22"}, {"id": "fda:K253985", "company": "Siemens Healthcare Diagnostic Products GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-11", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253985: INNOVANCE\u00ae D-Dimer 2.0 (SMN 10873803)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253985", "people": [{"name": "Petra Maria Dissmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253985%22"}, {"id": "fda:K253665", "company": "Urgo Medical North America, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-11", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253665: Vashe Plus Antimicrobial Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253665", "people": [{"name": "Steven Dowdley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253665%22"}, {"id": "fda:K261115", "company": "PolyConversions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-11", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261115: VR\u00ae Personal Protective Level 4 Gown (VR Gowns)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261115", "people": [{"name": "William Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261115%22"}, {"id": "fda:K261841", "company": "Beijing Nubway S&T Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-11", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261841: Q Switched Nd:YAG Laser machine (QLQW-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261841", "people": [{"name": "Xiting Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261841%22"}, {"id": "nih:2R44EY034066-02", "company": "X-biomedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-10", "observed": "2026-08-17", "amount_usd": 889154, "summary": "NIH award 2R44EY034066-02: Development of a tele-mentoring system integrated into an ultra-portable surgical microscope to treat cataract in underserved populations ($889,154)", "source_url": "https://reporter.nih.gov/project-details/11408785", "people": [{"name": "Matthew Rudolph Maltese", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL184714-01", "company": "Biocircuit Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-10", "observed": "2026-08-17", "amount_usd": 379187, "summary": "NIH award 1R43HL184714-01: Lymph Tape: A Device for Simplified Lymphovenous Anastomosis ($379,187)", "source_url": "https://reporter.nih.gov/project-details/11315949", "people": [{"name": "Isaac Perry Clements", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL184709-01A1", "company": "Corvion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": 1499984, "summary": "NIH award 1R44HL184709-01A1: Development of a Novel Pediatric LVAD for Home Discharge of Children Awaiting Heart Transplant ($1,499,984)", "source_url": "https://reporter.nih.gov/project-details/11407580", "people": [{"name": "Greg Aber", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD021487-01", "company": "Salimetrics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": 213640, "summary": "NIH award 1R43MD021487-01: An At Home Dried Saliva Spot (DSS) Test to Determine Insulin Resistance: A Scalable Tool for Early Detection in Underserved Communities ($213,640)", "source_url": "https://reporter.nih.gov/project-details/11348660", "people": [{"name": "STEVEN W GRANGER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL182431-01A1", "company": "Romix Biosciences Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": 1343973, "summary": "NIH award 1R44HL182431-01A1: Development of a Cell-Free RNA Diagnostic Test for Kawasaki disease ($1,343,973)", "source_url": "https://reporter.nih.gov/project-details/11405945", "people": [{"name": "Conor Loy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL180100-01A1", "company": "Daris LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": 343067, "summary": "NIH award 1R41HL180100-01A1: Automated Perfusion System for Ex-Vivo Organ Preservation ($343,067)", "source_url": "https://reporter.nih.gov/project-details/11403089", "people": [{"name": "daniel edward mazur", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL182396-01", "company": "Acouflow Therapeutics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": 497857, "summary": "NIH award 1R41HL182396-01: Toward Establishing the Feasibility and Commercial Readiness of VortexPAP for Improving OSA Treatment ($497,857)", "source_url": "https://reporter.nih.gov/project-details/11253024", "people": [{"name": "Liran Oren", "role": "Principal Investigator"}, {"name": "Ann Romaker", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM164214-01", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-10", "observed": "2026-09-07", "amount_usd": 311847, "summary": "NIH award 1R43GM164214-01: Fluorescence-based Lyobead Assay for Rapid Phage Detection in Bioreactor Systems ($311,847)", "source_url": "https://reporter.nih.gov/project-details/11313706", "people": [{"name": "Grace Cai", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44GM165281-01", "company": "Nirrin Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-10", "observed": "2026-09-07", "amount_usd": 1156172, "summary": "NIH award 1R44GM165281-01: Integration of High-Precision Tunable Laser Spectroscopy (HPTLS) into Liquid Chromatography for Quantitative Bioformulation Analysis ($1,156,172)", "source_url": "https://reporter.nih.gov/project-details/11409439", "people": [{"name": "Bryan Hassell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44DA057785-02", "company": "Oregon Res Behavioral Intervention Strat", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-10", "observed": "2026-09-08", "amount_usd": 796801, "summary": "NIH award 2R44DA057785-02: VisitBoost: A Home Visiting Enhancement to Reduce Harm for Families Affected by Substance Misuse ($796,801)", "source_url": "https://reporter.nih.gov/project-details/11410204", "people": [{"name": "Camille C Cioffi", "role": "Principal Investigator"}, {"name": "David Randolph Smith", "role": "Principal Investigator"}, {"name": "Mishka Terplan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07754201", "company": "VividWhite Pty Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: VividFlo System Validation Study", "source_url": "https://clinicaltrials.gov/study/NCT07754201", "people": [{"name": "Michael Coote", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07754344", "company": "Medprin Regenerative Medical Technologies Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Dural Medical Adhesive for Watertight Sealing in Dural Repair", "source_url": "https://clinicaltrials.gov/study/NCT07754344"}, {"id": "trialreg:NCT07755267", "company": "Intelligent Bio Solutions Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cutoff Assessment for Codeine in Fingerprint Sweat Relative to Oral Fluid, Following Controlled, Oral Administration of Codeine Phosphate Tablets to 40 Healthy Adults", "source_url": "https://clinicaltrials.gov/study/NCT07755267"}, {"id": "trialreg:NCT07756489", "company": "Tissium", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SECURE Post-Market Study", "source_url": "https://clinicaltrials.gov/study/NCT07756489"}, {"id": "trialreg:NCT07755579", "company": "Regenera Activa Worldwide S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effect of Autologous Ear Cartilage Micrografting in Knee Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07755579", "people": [{"name": "Zsombor Lacza, Dr", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07754240", "company": "Lifetech Scientific (Shenzhen) Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Investigational Study of Ankura\u2122 II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm", "source_url": "https://clinicaltrials.gov/study/NCT07754240"}, {"id": "trialreg:NCT07754526", "company": "Omeza, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: OCM\u2122 Treatment With Routine Care in Venous Leg Ulcers Compared to Routine Care Treatment Alone.", "source_url": "https://clinicaltrials.gov/study/NCT07754526", "people": [{"name": "Alisha Oropallo, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07754318", "company": "Medtronic Cardiovascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Aneurysm Treatment Using the Heli-FX\u2122 EndoAnchor\u2122 System China Study(ATHENA)", "source_url": "https://clinicaltrials.gov/study/NCT07754318"}, {"id": "fda:K254143", "company": "EM-TECH Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K254143: EM-TECH Passive Ultrasound Probe Strap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254143", "people": [{"name": "Enayatullah Motahedy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254143%22"}, {"id": "fda:K253528", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253528: Atellica IM CA 19-9 II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253528", "people": [{"name": "Kelly Maher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253528%22"}, {"id": "fda:K260176", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260176: Mobility Scooter (W3483, W3483A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260176", "people": [{"name": "Yolanda Ge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260176%22"}, {"id": "fda:K261602", "company": "Shenzhen Goodwind Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261602: Eye Recovery Pro (PH-e03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261602", "people": [{"name": "Ziming Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261602%22"}, {"id": "fda:K261705", "company": "Shenzhen Jianchao Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261705: Hair Removal Device (R3C16-G Pro, R3C16-V Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261705", "people": [{"name": "Renne Qin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261705%22"}, {"id": "fda:K254069", "company": "Hangzhou AGS MedTech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K254069: Hemoclip (511 series, 543 series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254069", "people": [{"name": "Xufan Chi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254069%22"}, {"id": "fda:K253794", "company": "Lucida Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253794: Prostate Core", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253794", "people": [{"name": "Toby Davis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253794%22"}, {"id": "fda:K254036", "company": "Datex Ohmeda, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K254036: Novii+ Wireless Patch System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254036", "people": [{"name": "Shiwani Zalpuri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254036%22"}, {"id": "fda:K253468", "company": "Nova Eye, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K253468: Nova Eye iTrack\u0099 250A Canaloplasty Microcatheter (iTrack\u0099 250A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253468", "people": [{"name": "Don Watton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253468%22"}, {"id": "fda:K262427", "company": "Hh Global Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K262427: Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262427", "people": [{"name": "Grace Hammond", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262427%22"}, {"id": "fda:K260094", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260094: Mobility Scooter (W3465, W3902 (S50 Carbon))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260094", "people": [{"name": "Yolanda Ge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260094%22"}, {"id": "fda:K261576", "company": "Corin, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K261576: Icona Hip Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261576", "people": [{"name": "Aaron Brunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261576%22"}, {"id": "fda:K260165", "company": "Spectrum Vascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA 510(k) K260165: Unimpregnated Central Venous Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260165", "people": [{"name": "Sharon Klugewicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260165%22"}, {"id": "pma:P250042", "company": "Spineart USA, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-08-10", "observed": "2026-08-26", "amount_usd": null, "summary": "FDA PMA approval P250042: BAGUERA\u00aeC Cervical Disc Prosthesis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250042", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250042%22"}, {"id": "nih:4R44MH136867-02", "company": "Ceretype Neuromedicine Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-07", "observed": "2026-08-13", "amount_usd": 606409, "summary": "NIH award 4R44MH136867-02: Design and Development of an Advanced Functional MRI Software as Medical Device (SaMD) for Clinical Trials and Therapeutic Applications in Neuropsychiatry ($606,409)", "source_url": "https://reporter.nih.gov/project-details/11536933", "people": [{"name": "EMILY STERN", "role": "Principal Investigator"}, {"name": "Roni A Setton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44MH140727-01", "company": "Deliberate Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": 1415720, "summary": "NIH award 1R44MH140727-01: AI-Clinical Outcome Assessment (AI-COA) for Depression: an Innovative Drug Development Tool ($1,415,720)", "source_url": "https://reporter.nih.gov/project-details/11186928", "people": [{"name": "Marc Aafjes", "role": "Principal Investigator"}, {"name": "JEFFREY F COHN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD021396-01", "company": "Renalis Health Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": 327593, "summary": "NIH award 1R43MD021396-01: Culturally Adapted Digital Behavioral Therapy for Overactive Bladder in Black Women: An Innovative AI-Assisted Approach ($327,593)", "source_url": "https://reporter.nih.gov/project-details/11350201", "people": [{"name": "Anna Baccellieri", "role": "Principal Investigator"}, {"name": "Oluwateniola Brown", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41MD021474-01", "company": "Asterion AI Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": 314363, "summary": "NIH award 1R41MD021474-01: Accelerating Time-to-Treatment in Rural Areas with a Pre-Hospital EEG Stroke Classification System ($314,363)", "source_url": "https://reporter.nih.gov/project-details/11349184", "people": [{"name": "Ezekiel Fink", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DA066336-01", "company": "Labsys, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": 302225, "summary": "NIH award 1R44DA066336-01: A Wearable Continuous Polydrug Monitor (CPM) for Personalized SUD Treatment ($302,225)", "source_url": "https://reporter.nih.gov/project-details/11406706", "people": [{"name": "Yue Huang", "role": "Principal Investigator"}, {"name": "Zhe Wang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD021464-01", "company": "Opio Connect, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": 356648, "summary": "NIH award 1R43MD021464-01: Linguistic and Cultural Adaptation of Remote Medication Dispensing System (Hub+Spoke) for OUD Treatment Among Limited English Proficient (LEP) Populations ($356,648)", "source_url": "https://reporter.nih.gov/project-details/11349313", "people": [{"name": "Amber Norbeck", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM162022-01A1", "company": "Neuralytix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": 353059, "summary": "NIH award 1R43GM162022-01A1: Mechanomyography-based system for quantitative nerve assessment during standard pain management procedures ($353,059)", "source_url": "https://reporter.nih.gov/project-details/11403158", "people": [{"name": "Chris Wybo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH143510-01", "company": "Ividence Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-07", "observed": "2026-08-19", "amount_usd": 315276, "summary": "NIH award 1R43MH143510-01: Repurposing Glucagon-Like Peptide-1 Receptor Agonists for Mental Health Outcomes via Federated Causal Inference ($315,276)", "source_url": "https://reporter.nih.gov/project-details/11315139", "people": [{"name": "Hao Ding", "role": "Principal Investigator"}, {"name": "Yu-Lun Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HG013284-03", "company": "Realseq Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-07", "observed": "2026-08-28", "amount_usd": 1020220, "summary": "NIH award 5R44HG013284-03: Preparation of sequencing libraries for multi-analyte analysis of RNAs ($1,020,220)", "source_url": "https://reporter.nih.gov/project-details/11399711", "people": [{"name": "Sergei A Kazakov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44CA310740-01", "company": "Vivid Bioinnovations, Pbc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-07", "observed": "2026-08-30", "amount_usd": 306872, "summary": "NIH award 1R44CA310740-01: Ultrahigh-Throughput Cell Interaction Screening to Advance CAR-T Therapeutic Development ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11314450", "people": [{"name": "Robin Prince", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL182545-02", "company": "Xylyx Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-07", "observed": "2026-09-03", "amount_usd": 1483340, "summary": "NIH award 5R44HL182545-02: Translational development and clinical evaluation of a bioengineered human lung graft for clinical transplantation ($1,483,340)", "source_url": "https://reporter.nih.gov/project-details/11408825", "people": [{"name": "Matthew Dominic Bacchetta", "role": "Principal Investigator"}, {"name": "John David O'Neill", "role": "Principal Investigator"}, {"name": "Ciara M Shaver", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07753005", "company": "Aesculap AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: HISTOACRYL\u00ae Used for Embolization of Thoracoabdominal Artery Bleeding", "source_url": "https://clinicaltrials.gov/study/NCT07753005", "people": [{"name": "Miyuki Sone, Dr.", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07751172", "company": "CooperVision International Limited (CVIL)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter", "source_url": "https://clinicaltrials.gov/study/NCT07751172"}, {"id": "trialreg:NCT07751965", "company": "Ceric S\u00e0rl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR", "source_url": "https://clinicaltrials.gov/study/NCT07751965", "people": [{"name": "Ignacio Amat Santos", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07751484", "company": "Intalight, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Intalight Reference Database Protocol for VG200D", "source_url": "https://clinicaltrials.gov/study/NCT07751484"}, {"id": "trialreg:NCT07751562", "company": "SleepRes Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: KPAP vs AirSense 11 With EPR", "source_url": "https://clinicaltrials.gov/study/NCT07751562"}, {"id": "fda:K253505", "company": "Roen Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253505: Zamenix\u0099 P", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253505", "people": [{"name": "Dayoung Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253505%22"}, {"id": "fda:K253702", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253702: Intuitive Endoluminal Gastrointestinal System (IG1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253702", "people": [{"name": "Einav Yemini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253702%22"}, {"id": "fda:K251544", "company": "Lakong Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K251544: Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251544", "people": [{"name": "Zhongliang Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251544%22"}, {"id": "fda:K261905", "company": "Bumlicious, LLC (DBA \u0093Bumlicious\u0094)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261905: BUM Oil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261905", "people": [{"name": "Louie Goryoka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261905%22"}, {"id": "fda:K252571", "company": "Mediaire GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K252571: mdprostate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252571", "people": [{"name": "Wegener Alexander", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252571%22"}, {"id": "fda:K261437", "company": "The Surgical Company International B.V., doing business as TSC Life", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261437: Mistral-Air\u00ae Warming System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261437", "people": [{"name": "Gianpaolo Soares", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261437%22"}, {"id": "fda:K254205", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K254205: Zenition 30", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254205", "people": [{"name": "Gyanendra Mani Tripathi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254205%22"}, {"id": "fda:K253453", "company": "Aptitude Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253453: Metrix COVID Test; Metrix COVID Test Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253453", "people": [{"name": "Tyler Chozinski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253453%22"}, {"id": "fda:K261362", "company": "Cepheid", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261362: Xpert Hemorrhagic Fever", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261362", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261362%22"}, {"id": "fda:K253554", "company": "Leica Biosystems Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253554: Aperio GT 450 DX; Aperio GT 180 DX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253554", "people": [{"name": "April Komplin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253554%22"}, {"id": "fda:K261028", "company": "Yadu Medical (Henan) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261028: Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261028", "people": [{"name": "Peilong Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261028%22"}, {"id": "fda:K253561", "company": "Leica Biosystems Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253561: Aperio iQC DX Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253561", "people": [{"name": "Tamatha Melton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253561%22"}, {"id": "fda:K260933", "company": "Hangzhou Qiantang Longyue Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260933: Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260933", "people": [{"name": "Chen Meijun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260933%22"}, {"id": "fda:K261601", "company": "Shenzhen Chuangtong Yigou Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261601: LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261601", "people": [{"name": "Kingway Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261601%22"}, {"id": "fda:K261937", "company": "The Belport Company Inc., DBA Gingi-Pak", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261937: PacTemp Automix NE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261937", "people": [{"name": "Nikki Huynh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261937%22"}, {"id": "fda:K262357", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262357: Arthrex Bioabsorbable PushLock Suture Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262357", "people": [{"name": "Alex Underberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262357%22"}, {"id": "fda:K261668", "company": "GE Medical Systems Ultrasound and Primary care Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261668: Venue Go", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261668", "people": [{"name": "Karin Shimoni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261668%22"}, {"id": "fda:K261563", "company": "Maxx Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261563: Freedom Total Knee System (E-Poly Tibial Liners)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261563", "people": [{"name": "Asawari Hare", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261563%22"}, {"id": "fda:K260567", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260567: EW10-EC02 Endoscopy Support Program", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260567", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260567%22"}, {"id": "nih:5R44CA228920-06", "company": "Leuko Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-06", "observed": "2026-08-13", "amount_usd": 991877, "summary": "NIH award 5R44CA228920-06: Reducing the incidence of febrile neutropenia in cancer patients treated with chemotherapy with PointCheck: a portable non-invasive neutropenia analyzer ($991,877)", "source_url": "https://reporter.nih.gov/project-details/11364218", "people": [{"name": "Carlos Castro-Gonzalez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R44CA275673-04", "company": "Pro-change Behavior Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": 676175, "summary": "NIH award 5R44CA275673-04: PreCharge: An Innovative Digital Program to Increase Coping, Resilience, and Health Care Engagement Among Cancer Previvors ($676,175)", "source_url": "https://reporter.nih.gov/project-details/11380960", "people": [{"name": "Kerry Evers", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44NS135867-02", "company": "Artificial Axon Labs Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": 1478216, "summary": "NIH award 2R44NS135867-02: In vitro myelination assay modeling the environment of MS lesions for predictive discovery of remyelinating therapies ($1,478,216)", "source_url": "https://reporter.nih.gov/project-details/11409835", "people": [{"name": "Anna Jagielska", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL186093-01", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": 293759, "summary": "NIH award 1R43HL186093-01: Percutaneous Stellate Ganglion Stimulation in Septic Shock to Improve Hemodynamics and Vasopressor Requirements During Transport ($293,759)", "source_url": "https://reporter.nih.gov/project-details/11349290", "people": [{"name": "Howard Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK146600-01A1", "company": "Daecos LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": 304910, "summary": "NIH award 1R43DK146600-01A1: Personalized Assessment and Care of Kidney Support in Critically Ill Patients(PACKS-ICU) ($304,910)", "source_url": "https://reporter.nih.gov/project-details/11409014", "people": [{"name": "Ravindra L. Mehta", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AI157322-04A1", "company": "Helixbind, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": 1000000, "summary": "NIH award 2R44AI157322-04A1: Direct-from-specimen characterization of bloodstream infections ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11251853", "people": [{"name": "Alon Singer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43HL184399-01A1", "company": "Talk Story Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": 550000, "summary": "NIH award 1R43HL184399-01A1: Beat-to-Beat: AI-Powered, Locally Relevant Engagement to Promote Rural Cardiovascular Health ($550,000)", "source_url": "https://reporter.nih.gov/project-details/11405675", "people": [{"name": "Tetine L. Sentell", "role": "Principal Investigator"}, {"name": "Wesley Sumida", "role": "Principal Investigator"}, {"name": "Deborah Ann Taira", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07749820", "company": "BrosMed Medical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial of Thrombectomy Systems", "source_url": "https://clinicaltrials.gov/study/NCT07749820"}, {"id": "trialreg:NCT07749170", "company": "Penumbra Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions", "source_url": "https://clinicaltrials.gov/study/NCT07749170", "people": [{"name": "Alejandro Spiotta, MD", "role": "Principal Investigator"}, {"name": "Nitin Goyal, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07749963", "company": "CardiacSense Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Collection Study Using CS (CardiacSense) BP (Blood Pressure) Watch and Pillow Systems", "source_url": "https://clinicaltrials.gov/study/NCT07749963"}, {"id": "fda:K253999", "company": "Nobel Biocare AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253999: Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253999", "people": [{"name": "Bernice Jim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253999%22"}, {"id": "fda:K261059", "company": "Overjet, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261059: Overjet Multi-Image Caries and Charting Assist", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261059", "people": [{"name": "Gayatri Sekaran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261059%22"}, {"id": "fda:K261121", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261121: Megalodon Dynamic Compression System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261121", "people": [{"name": "Brittanie Dogue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261121%22"}, {"id": "fda:K260223", "company": "Scientia Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260223: Aristotle Mini Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260223", "people": [{"name": "Jamila Abou-Bakr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260223%22"}, {"id": "fda:K251508", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K251508: Telemetry Monitor (iT30, iT50)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251508", "people": [{"name": "Tracy Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251508%22"}, {"id": "fda:K261571", "company": "Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261571: Manual Wheelchair (H008, PCK7)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261571", "people": [{"name": "Fang (Fawn) Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261571%22"}, {"id": "fda:K253469", "company": "Mozarc Medical Us, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253469: Ritus\u0099 Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus\u0099 Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus\u0099 Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus\u0099 Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus\u0099 Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus\u0099 Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253469", "people": [{"name": "Sara Miller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253469%22"}, {"id": "fda:K261898", "company": "Howmedica Osteonics Corp. dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261898: Triathlon\u00ae Knee System; Triathlon\u00ae Hinge Knee System; Scorpio\u00ae Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261898", "people": [{"name": "Elizabeth Jodon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261898%22"}, {"id": "fda:K254194", "company": "QIAGEN GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K254194: QIAstat-Dx BCID GPF Plus AMR Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254194", "people": [{"name": "Kristen Kanack", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254194%22"}, {"id": "nih:5R44DK135225-03", "company": "Livivos Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-05", "observed": "2026-08-13", "amount_usd": 785714, "summary": "NIH award 5R44DK135225-03: Accurate Point of Care Liver Disease Diagnostics, Phase II ($785,714)", "source_url": "https://reporter.nih.gov/project-details/11417428", "people": [{"name": "PABLO J PRADO", "role": "Principal Investigator"}, {"name": "CLAUDE B SIRLIN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL174221-03", "company": "Pgxl Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": 957571, "summary": "NIH award 5R44HL174221-03: UroMarker Test Panel for Obstructive Sleep Apnea ($957,571)", "source_url": "https://reporter.nih.gov/project-details/11393085", "people": [{"name": "Christopher Thomas Burns", "role": "Principal Investigator"}, {"name": "Roland Valdes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44DA061387-02", "company": "Sano Healthcare Consultants, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-05", "observed": "2026-08-19", "amount_usd": 1055180, "summary": "NIH award 2R44DA061387-02: Secure Remote Dispensing of Liquid Methadone with Home Monitoring: Environmental Interactive Devices Support Sustainable Economic and Expansive Clinical Treatment of Opioid Use Disorder Treatment ($1,055,180)", "source_url": "https://reporter.nih.gov/project-details/11405774", "people": [{"name": "Edwin Kendrick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R43AI189008-02", "company": "Mucommune, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-05", "observed": "2026-08-19", "amount_usd": 309210, "summary": "NIH award 5R43AI189008-02: Engineering a physiologically-tuned reservoir intravaginal ring releasing lactic acid for the treatment and prevention of bacterial vaginosis ($309,210)", "source_url": "https://reporter.nih.gov/project-details/11398077", "people": [{"name": "Keiichiro Kushiro", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:2R44AI170237-02A1", "company": "Oak Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-05", "observed": "2026-08-21", "amount_usd": 899010, "summary": "NIH award 2R44AI170237-02A1: Novel antiretroviral therapy delivery platform for infants and young children: oral dispensable strips (ODS) ($899,010)", "source_url": "https://reporter.nih.gov/project-details/11181757", "people": [{"name": "EDWARD G MALISKI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK146426-01", "company": "Analytical Diagnostic Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-05", "observed": "2026-09-03", "amount_usd": 311172, "summary": "NIH award 1R43DK146426-01: A Point of Care Device for Patients with Oxalurias, the Oxalate Now ($311,172)", "source_url": "https://reporter.nih.gov/project-details/11310574", "people": [{"name": "Robert Harper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "pma:P220015", "company": "Tianjin MasterVision Technology Co., Ltd.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA PMA approval P220015: DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220015", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P220015%22"}, {"id": "trialreg:NCT07746843", "company": "BioRegen Biomedical (Changzhou) Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Efficacy and Safety Study of 2107 Injection in Subjects With Mild to Moderate Knee Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07746843"}, {"id": "trialreg:NCT07746531", "company": "Distalmotion SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Robotic Minimally Invasive Benign Hysterectomy Post-market Clinical Study With the DEXTER Robotic System", "source_url": "https://clinicaltrials.gov/study/NCT07746531"}, {"id": "trialreg:NCT07747233", "company": "Toku Eyes Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Precision Study of CLAiR AI Software", "source_url": "https://clinicaltrials.gov/study/NCT07747233", "people": [{"name": "Michael Mcconnell, MD", "role": "Study Director"}]}, {"id": "trialreg:NCT07748572", "company": "Phenox GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France", "source_url": "https://clinicaltrials.gov/study/NCT07748572", "people": [{"name": "Laurent Pierot, Prof.", "role": "Principal Investigator"}, {"name": "Laurent Spelle, Prof.", "role": "Principal Investigator"}]}, {"id": "fda:K252853", "company": "Xiamen Inno Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K252853: CAD - Lower GI (EC07-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252853", "people": [{"name": "Jianqing Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252853%22"}, {"id": "fda:K260845", "company": "Tianjin Huahong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260845: Huahong Sharps Container (HHR-I, HHR-II)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260845", "people": [{"name": "Ningning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260845%22"}, {"id": "fda:K260919", "company": "Class Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260919: Transurethral Catheter Safety Valve (TUCSV) (80050)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260919", "people": [{"name": "Danny Forde", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260919%22"}, {"id": "fda:K261456", "company": "Dental Manufacturing S.p.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261456: Ruthinium Disc", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261456", "people": [{"name": "Barbara Piazza", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261456%22"}, {"id": "fda:K254211", "company": "Vesalio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K254211: pVasc Net Mechanical Thrombectomy Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254211", "people": [{"name": "Sharon Shachar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254211%22"}, {"id": "fda:K261932", "company": "Elekta Solutions AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261932: Leksell\u00ae Vantage Stereotactic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261932", "people": [{"name": "Jesper Bruske", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261932%22"}, {"id": "fda:K260120", "company": "HCS Innovation, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260120: NaturaJel\u0099 Oral Wound Care Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260120", "people": [{"name": "Ronnie Hanes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260120%22"}, {"id": "fda:K260737", "company": "Convatec", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260737: Cure Aqua\u0099 Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua\u0099 Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua\u0099 Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260737", "people": [{"name": "Kim Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260737%22"}, {"id": "fda:K262056", "company": "Teleflex Medical Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262056: Rusch Latex Gold Foley Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262056", "people": [{"name": "Yuvaanesswary Nallappan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262056%22"}, {"id": "fda:K253858", "company": "T.A.G. Medical Products Corporation, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253858: GFS - Sterile Screws and Top Hat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253858", "people": [{"name": "Shlomi Dines", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253858%22"}, {"id": "fda:K261380", "company": "Proscia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261380: Concentriq AP-Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261380", "people": [{"name": "Ian Cadieux", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261380%22"}, {"id": "trialreg:NCT07747883", "company": "IVX Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-05", "observed": "2026-08-20", "amount_usd": null, "summary": "New device trial registered: IV-X Medical First-in-Human Peripheral Intravascular Lithotripsy Study for PAD", "source_url": "https://clinicaltrials.gov/study/NCT07747883"}, {"id": "nih:5R44AI181154-03", "company": "Nanopathdx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": 919857, "summary": "NIH award 5R44AI181154-03: Multiplexed Assay for Point-of-Care UTI Diagnosis (ID/AMR) ($919,857)", "source_url": "https://reporter.nih.gov/project-details/11290730", "people": [{"name": "Alison Burklund", "role": "Principal Investigator"}, {"name": "Amogha Tadimety", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL184377-01", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": 351388, "summary": "NIH award 1R43HL184377-01: Acute Decompensation Avoidance in Heart Failure Patients ($351,388)", "source_url": "https://reporter.nih.gov/project-details/11309272", "people": [{"name": "Brian R Clark", "role": "Principal Investigator"}, {"name": "B EUGENE PARKER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44MH138162-02", "company": "Adaptive Testing Technologies", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": 1018713, "summary": "NIH award 4R44MH138162-02: Modifying and validating the K-CAT mental health scales for children and adolescents on the autism spectrum ($1,018,713)", "source_url": "https://reporter.nih.gov/project-details/11194639", "people": [{"name": "Paige Elizabeth Cervantes", "role": "Principal Investigator"}, {"name": "Yehuda Cohen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44GM150354-02A1", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": 1049845, "summary": "NIH award 2R44GM150354-02A1: Metabolic Cytometry for In-line Process Analysis ($1,049,845)", "source_url": "https://reporter.nih.gov/project-details/11313907", "people": [{"name": "NICUSOR IFTIMIA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA285081-03", "company": "Am Operating LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": 1096097, "summary": "NIH award 5R44CA285081-03: Development of a novel visualization, labeling, and tracking engine for human anatomy. ($1,096,097)", "source_url": "https://reporter.nih.gov/project-details/11380977", "people": [{"name": "Matthew Alexander Molenda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL187101-01", "company": "Minnesota Healthsolutions Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": 329537, "summary": "NIH award 1R43HL187101-01: Novel Balloon Angioplasty Inflation Device ($329,537)", "source_url": "https://reporter.nih.gov/project-details/11408243", "people": [{"name": "Nick Rydberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NR019556-03", "company": "Ocuvera LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": 808534, "summary": "NIH award 5R44NR019556-03: Refinement of a Digital Monitoring System to Reduce Risk of Hospital Acquired Pressure Injuries ($808,534)", "source_url": "https://reporter.nih.gov/project-details/11416650", "people": [{"name": "Lucas Sabalka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL186097-01", "company": "Environment And Health Group, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": 314321, "summary": "NIH award 1R43HL186097-01: HeartSense.AI: A Generative AI-Driven Mobile Health Solution to Improve Hypertension Control Among Lower Income Adults ($314,321)", "source_url": "https://reporter.nih.gov/project-details/11350027", "people": [{"name": "Ellen Seely", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI155075-05", "company": "Jan Biotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-04", "observed": "2026-08-19", "amount_usd": 998781, "summary": "NIH award 5R44AI155075-05: Sequence-based RNA Fluorescence Assay to Measure Latent HIV Reservoirs ($998,781)", "source_url": "https://reporter.nih.gov/project-details/11398110", "people": [{"name": "Janet L Huie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44GM163514-01", "company": "Vivid Bioinnovations, Pbc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-04", "observed": "2026-08-19", "amount_usd": 300001, "summary": "NIH award 1R44GM163514-01: Integrated High-Throughput Microfluidic-Mass Spectrometry for Enhanced Biomedical Data Generation and AI Model Training ($300,001)", "source_url": "https://reporter.nih.gov/project-details/11316567", "people": [{"name": "Robin Prince", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07745998", "company": "Indigo Diabetes NV", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The BRIGHT Study (Device Name: HALO System)", "source_url": "https://clinicaltrials.gov/study/NCT07745998", "people": [{"name": "Christophe De Block, Prof. dr.", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07746011", "company": "Life Harmony Energies, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Trial to Evaluate the Effects of EMF Protection Devices on Sleep and Energy Levels", "source_url": "https://clinicaltrials.gov/study/NCT07746011"}, {"id": "trialreg:NCT07744945", "company": "C. R. Bard", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Male and Female External Catheters for Urine Output Monitoring in the ICU", "source_url": "https://clinicaltrials.gov/study/NCT07744945"}, {"id": "trialreg:NCT07745647", "company": "Voll Medical Technologies Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Voll Non-Degradable Shoulder Spacer FIH Study", "source_url": "https://clinicaltrials.gov/study/NCT07745647"}, {"id": "trialreg:NCT07745621", "company": "Vivifi Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia", "source_url": "https://clinicaltrials.gov/study/NCT07745621", "people": [{"name": "Daniel Root, MD", "role": "Study Chair"}]}, {"id": "trialreg:NCT07744711", "company": "Circadian OS, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real-World Use of an iPad-Based Light Therapy App, With Optional Biomarker Collection", "source_url": "https://clinicaltrials.gov/study/NCT07744711", "people": [{"name": "Sofia Axelrod, PhD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07745244", "company": "SiBionics, Co, Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Accuracy and Safety of a Continuous Glucose Monitoring System", "source_url": "https://clinicaltrials.gov/study/NCT07745244"}, {"id": "trialreg:NCT07743528", "company": "Shenzhen Tonglu Technology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Multicenter, Two-cohorts, Single Arm Study Evaluating Safety, Effectiveness and Performance of Angimis Atherectomy System for the Treatment of Non-crossable and/or Non-dilatablE Lesions in CorONary Arteries Disease (NEON Study).", "source_url": "https://clinicaltrials.gov/study/NCT07743528"}, {"id": "trialreg:NCT07744425", "company": "Cision Vision, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Shortwave Infrared Surgical Imaging Device Study", "source_url": "https://clinicaltrials.gov/study/NCT07744425", "people": [{"name": "Lisa M. Knowlton, MD, MPH", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07744568", "company": "Ethicon Endo-Surgery", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study Comparing ETHICON\u2122 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures", "source_url": "https://clinicaltrials.gov/study/NCT07744568", "people": [{"name": "Gianluca Casali, MD", "role": "Study Director"}]}, {"id": "trialreg:NCT07744659", "company": "Beijing Pins Medical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Spinal Cord Stimulation for Poststroke Spasticity", "source_url": "https://clinicaltrials.gov/study/NCT07744659"}, {"id": "trialreg:NCT07745712", "company": "ABLE Human Motion S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting", "source_url": "https://clinicaltrials.gov/study/NCT07745712"}, {"id": "fda:K253760", "company": "Sight Sciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253760: OMNI Ultra Surgical System (1-110)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253760", "people": [{"name": "Rachel Franco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253760%22"}, {"id": "fda:K261496", "company": "Duplex International Trading Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261496: LED Light Therapy Masks (PE748, PE749, PE756)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261496", "people": [{"name": "JunYi Xing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261496%22"}, {"id": "fda:K261851", "company": "Shenzhen Qianyu Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261851: LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261851", "people": [{"name": "Li Guoyang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261851%22"}, {"id": "fda:K260572", "company": "Medimetrix, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260572: Marrow Marxman", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260572", "people": [{"name": "Brian Austin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260572%22"}, {"id": "fda:K261523", "company": "Jupiter Endovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261523: Vertex\u0099 Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261523", "people": [{"name": "Nicole Barber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261523%22"}, {"id": "fda:K254043", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K254043: TRIVANCE\u0099 Hip Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254043", "people": [{"name": "Amber Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254043%22"}, {"id": "fda:K253902", "company": "3diemme Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253902: RealGUIDE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253902", "people": [{"name": "Alesandro Avis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253902%22"}, {"id": "fda:K262311", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-04", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262311: Alturion Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262311", "people": [{"name": "Irma Sandoval-Watt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262311%22"}, {"id": "nih:4R44DA060643-02", "company": "Resilient Lifescience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-03", "observed": "2026-08-13", "amount_usd": 1018701, "summary": "NIH award 4R44DA060643-02: Developing a wearable medical device to detect opioid overdose ($1,018,701)", "source_url": "https://reporter.nih.gov/project-details/11579934", "people": [{"name": "Bradford A Holden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44HL162218-04", "company": "Starlight Cardiovascular, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-03", "observed": "2026-08-17", "amount_usd": 1166665, "summary": "NIH award 2R44HL162218-04: DEVELOPMENT OF A PULMONARY FLOW RESTRICTOR FOR HYPOPLASTIC LEFT HEART SYNDROME ($1,166,665)", "source_url": "https://reporter.nih.gov/project-details/11292148", "people": [{"name": "Beverly Tang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43CA314667-01", "company": "Medara, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": 399860, "summary": "NIH award 1R43CA314667-01: A Longitudinal Multimodal Risk Prediction Platform for Personalized Breast Cancer Screening ($399,860)", "source_url": "https://reporter.nih.gov/project-details/11406030", "people": [{"name": "Kendra Batchelder", "role": "Principal Investigator"}, {"name": "Mert Rory Sabuncu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HL152912-04", "company": "Cognita Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": 1160874, "summary": "NIH award 2R44HL152912-04: SonoHeal: Smart Resonating Closed-loop Airway Clearance Technology ($1,160,874)", "source_url": "https://reporter.nih.gov/project-details/11292805", "people": [{"name": "Rajoshi Biswas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43MH139167-01A1", "company": "37degrees, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": 456902, "summary": "NIH award 1R43MH139167-01A1: InVitreON: A compact and integrated platform for long-term neuronal culture incubation, recording and closed-loop stimulation ($456,902)", "source_url": "https://reporter.nih.gov/project-details/11311780", "people": [{"name": "Tilak Jain", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH143378-01", "company": "Habitaware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": 417403, "summary": "NIH award 1R43MH143378-01: TrichTok: Developing a scalable, video-based mobile intervention with peer support for adolescents and emerging adults with trichotillomania ($417,403)", "source_url": "https://reporter.nih.gov/project-details/11312515", "people": [{"name": "Sameer Kumar", "role": "Principal Investigator"}, {"name": "Hilary Weingarden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44GM161195-01A1", "company": "Monod Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": 377260, "summary": "NIH award 1R44GM161195-01A1: Design of rapid and quantitative biosensors with computational protein design ($377,260)", "source_url": "https://reporter.nih.gov/project-details/11410560", "people": [{"name": "Alfredo QUIJANO RUBIO", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM149003-03", "company": "Sansimeon, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": 1129755, "summary": "NIH award 5R44GM149003-03: A Uniquely Scalable Platform for Sequencing Tens of Millions of Single Cells from Complex Clinical Samples with a Streamlined Workflow ($1,129,755)", "source_url": "https://reporter.nih.gov/project-details/11389440", "people": [{"name": "Philipp Stefan Spuhler", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07742345", "company": "BrosMed Medical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study of Coronary Extension Catheter", "source_url": "https://clinicaltrials.gov/study/NCT07742345"}, {"id": "trialreg:NCT07742839", "company": "Edwards Lifesciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CLAARITY is a Prospective, Observational, Single-arm, Multi-center, Post-market US Study Designed to Evaluate the Safety and Performance of the ECLIPTIS Left Atrial Appendage Exclusion System for Exclusion of the Left Atrial Appendage (LAA) During Concomitant Open-heart Cardiac Surgery.", "source_url": "https://clinicaltrials.gov/study/NCT07742839", "people": [{"name": "Chris Malaisrie, MD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07742878", "company": "Rebiscan, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Early Prospective Study of the Traq\u2122 Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury", "source_url": "https://clinicaltrials.gov/study/NCT07742878", "people": [{"name": "Heidi Bell, OD", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07741656", "company": "Andromeda Surgical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)", "source_url": "https://clinicaltrials.gov/study/NCT07741656"}, {"id": "trialreg:NCT07742241", "company": "Instituto de Investigacion Biotecnologica, Farmaceutica y Medicamentos Huerfanos, S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy Study of a Repairing Cream in Atopic Dermatitis", "source_url": "https://clinicaltrials.gov/study/NCT07742241"}, {"id": "trialreg:NCT07742592", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Retrospective Real-World Data Collection of the Conformable GORE\u00ae TAG\u00ae Thoracic Endoprosthesis When Used in Frozen Elephant Trunk Procedures for Treatment of Aortic Aneurysms and Dissections", "source_url": "https://clinicaltrials.gov/study/NCT07742592"}, {"id": "fda:K262115", "company": "ACIST Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262115: VueJect\u00ae Ultrasound Enhancing Agent Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262115", "people": [{"name": "Linda Busklein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262115%22"}, {"id": "fda:K261856", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261856: Halcyon, Ethos Radiotherapy System (5.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261856", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261856%22"}, {"id": "fda:K262047", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262047: Grappler Suture Anchor System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262047", "people": [{"name": "Brittanie Dogue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262047%22"}, {"id": "fda:K260381", "company": "Wandercraft SAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260381: Eve", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260381", "people": [{"name": "Maria Ida Iacono", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260381%22"}, {"id": "fda:K261503", "company": "3-D Matrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261503: PuraStat GI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261503", "people": [{"name": "Alan MISKEWICZ", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261503%22"}, {"id": "fda:K261504", "company": "3-D Matrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261504: PuraStat-RM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261504", "people": [{"name": "Alan Miskewicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261504%22"}, {"id": "fda:K261408", "company": "Elevation Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261408: SABER-XA System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261408", "people": [{"name": "John Kirwan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261408%22"}, {"id": "fda:K260236", "company": "Gemss Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260236: XLITE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260236", "people": [{"name": "Jeongbin Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260236%22"}, {"id": "nih:1R43HD121341-01", "company": "Results Group", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-08-01", "observed": "2026-08-06", "amount_usd": 305904, "summary": "NIH award 1R43HD121341-01: FlyBand-Peds: Evaluating Biomechanics of Integrated Exoskeleton Footwear for Pediatric Charcot-Marie-Tooth Disease ($305,904)", "source_url": "https://reporter.nih.gov/project-details/11315400", "people": [{"name": "Mark C Roser", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH142191-01", "company": "Openbci, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-31", "observed": "2026-08-06", "amount_usd": 732736, "summary": "NIH award 1R44MH142191-01: Affordable, FDA-Cleared Bioamplifier: Removing Barriers to Scalable EEG and Multimodal Physiological Monitoring ($732,736)", "source_url": "https://reporter.nih.gov/project-details/11254689", "people": [{"name": "Musa Mahmood", "role": "Principal Investigator"}, {"name": "Conor D Russomanno", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL184694-01", "company": "Perfusion Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-31", "observed": "2026-08-06", "amount_usd": 217013, "summary": "NIH award 1R41HL184694-01: A Bearingless, Fail-safe, High Performance Pump for \"Failing Fontan\" Patients ($217,013)", "source_url": "https://reporter.nih.gov/project-details/11314240", "people": [{"name": "Eric Loren Severson", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AI195231-01", "company": "Jan Biotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": 300000, "summary": "NIH award 1R44AI195231-01: Clinical Assay to Accurately Profile and Monitor the HIV-1 Reservoir in Chronic-treated Individuals to Guide Treatment Decisions ($300,000)", "source_url": "https://reporter.nih.gov/project-details/11255801", "people": [{"name": "Janet L Huie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH143449-01", "company": "Panluminate Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": 454646, "summary": "NIH award 1R43MH143449-01: Development of pan-ExM for whole-brain, molecularly annotated connectomics ($454,646)", "source_url": "https://reporter.nih.gov/project-details/11316438", "people": [{"name": "Ons M'Saad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM150296-02A1", "company": "Alchemie Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": 961652, "summary": "NIH award 2R44GM150296-02A1: Multisensory learning to support accessible interactive tools for math ($961,652)", "source_url": "https://reporter.nih.gov/project-details/11312087", "people": [{"name": "Julia Winter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07739342", "company": "Abbott Diabetes Care", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Occurrence of DKA in People With Type I Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07739342", "people": [{"name": "Shridhara Alva, PhD", "role": "Study Director"}]}, {"id": "trialreg:NCT07738237", "company": "Rehear Audiology Company LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss", "source_url": "https://clinicaltrials.gov/study/NCT07738237", "people": [{"name": "Bettina Turnbull, Doctor of Audiology", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07739147", "company": "Kimberly Meathrel", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparing Standard Platelet-Rich Plasma and Light-Enhanced Platelet-Rich Plasma for Treating Hair Loss in Androgenetic Alopecia: A Randomized Controlled Trial", "source_url": "https://clinicaltrials.gov/study/NCT07739147", "people": [{"name": "Kimberly Meathrel", "role": "Study Director"}]}, {"id": "trialreg:NCT07739667", "company": "Evondos Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Blood Pressure Measurement Using Vitacam", "source_url": "https://clinicaltrials.gov/study/NCT07739667", "people": [{"name": "Antti Vehkaoja", "role": "Principal Investigator"}]}, {"id": "fda:K261331", "company": "Esaote, S.p.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261331: I-Genius (100019400)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261331", "people": [{"name": "Vanessa Ronconi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261331%22"}, {"id": "fda:K253800", "company": "Rayence Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253800: 0909FCE, 0909FCE-HS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253800", "people": [{"name": "Sung Woo Jung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253800%22"}, {"id": "fda:K261912", "company": "DnB Innovations, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261912: Sn\u00d8reNegat\u00d8r", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261912", "people": [{"name": "Colette Cozean", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261912%22"}, {"id": "fda:K261810", "company": "Foundation Surgical Group", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261810: Vertiwedge\u00ae Intraosseous System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261810", "people": [{"name": "Asher Breverman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261810%22"}, {"id": "fda:K253835", "company": "Hermes Medical Solutions AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253835: Affinity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253835", "people": [{"name": "Hanne Grinaker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253835%22"}, {"id": "fda:K261451", "company": "ZSFab, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261451: ZSAlign Cervical Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261451", "people": [{"name": "David Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261451%22"}, {"id": "fda:K254042", "company": "Itamar Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K254042: WatchPAT SW", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254042", "people": [{"name": "Dafna Raiman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254042%22"}, {"id": "fda:K261809", "company": "Foundation Surgical Group", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261809: Interwedge\u00ae Standalone Lateral", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261809", "people": [{"name": "Asher Breverman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261809%22"}, {"id": "fda:K261494", "company": "Shanghai Hulu Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261494: Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261494", "people": [{"name": "Junfeng Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261494%22"}, {"id": "fda:K261183", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261183: EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261183", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261183%22"}, {"id": "fda:K260852", "company": "Siemens Healthineers AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260852: MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260852", "people": [{"name": "Friederike Hertle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260852%22"}, {"id": "fda:K260607", "company": "Radiaction , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260607: Shield System (Siemens 30x40)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260607", "people": [{"name": "Shlomit Cymbalista", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260607%22"}, {"id": "fda:K252812", "company": "Suzhou Haowei Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K252812: UniPearls\u00ae Embolic Microspheres", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252812", "people": [{"name": "Jinyan Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252812%22"}, {"id": "fda:K261824", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261824: da Vinci Surgical System, Model IS5000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261824", "people": [{"name": "Medha Sateesh Bharadwaj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261824%22"}, {"id": "fda:K253655", "company": "W&H Dentalwerk B\u00fcrmoos GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253655: Angled Screwdriver MED (M-SD090)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253655", "people": [{"name": "Gerhard Weidler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253655%22"}, {"id": "fda:K261335", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261335: VitalFlow Set with Balance\u0099 Biosurface", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261335", "people": [{"name": "Vinoda Palanisamy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261335%22"}, {"id": "fda:K262251", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262251: ACTIFY\u0099 Total Knee System, ACTIFY\u0099 3D Total Knee System (ACTIFY MC Tibial Insert)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262251", "people": [{"name": "Katherine Warren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262251%22"}, {"id": "fda:K261482", "company": "Led Intellectual Properties, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261482: LightStim for Wrinkles (1984); LightStim for Acne (2038)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261482", "people": [{"name": "Brian Purcell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261482%22"}, {"id": "fda:K260936", "company": "Neurocareai, Inc. (Dba Savelife.Ai)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260936: RadioViewAI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260936", "people": [{"name": "Junaid Siddiq Kalia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260936%22"}, {"id": "fda:K261854", "company": "Augmedics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261854: xvision Spine system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261854", "people": [{"name": "Tami Harel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261854%22"}, {"id": "fda:K262681", "company": "3bfab Teknoloji A.s.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262681: NanoCeram Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262681", "people": [{"name": "\u00d6mer Arslan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262681%22"}, {"id": "fda:K261187", "company": "Samsung Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261187: Hearing Aid Feature", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261187", "people": [{"name": "Hon Pak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261187%22"}, {"id": "fda:K253555", "company": "Tactile Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253555: Flexitouch\u00ae Plus Advanced Pneumatic Compression System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253555", "people": [{"name": "Sunday Hoy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253555%22"}, {"id": "fda:K262253", "company": "Orthalign, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262253: Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262253", "people": [{"name": "Michaela Lindemann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262253%22"}, {"id": "nih:5R44AI157650-05", "company": "Aldatu Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-30", "observed": "2026-08-06", "amount_usd": 960045, "summary": "NIH award 5R44AI157650-05: PANDAA for universal, pan-lineage molecular detection of Crimean-Congo Hemorrhagic Fever virus. ($960,045)", "source_url": "https://reporter.nih.gov/project-details/11393717", "people": [{"name": "Iain James MacLeod", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:2R44NS125709-03", "company": "Altec, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-30", "observed": "2026-08-06", "amount_usd": 970548, "summary": "NIH award 2R44NS125709-03: NeuroVision\u2122: A Smartphone Application for Neurology and Telemedicine ($970,548)", "source_url": "https://reporter.nih.gov/project-details/11315174", "people": [{"name": "Bhawna Shiwani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44AI177051-02A1", "company": "Acatechol, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": 1000000, "summary": "NIH award 2R44AI177051-02A1: High-performance antibiofilm central venous catheters for prevention of central line associated bloodstream infections ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11175089", "people": [{"name": "Kollbe Ahn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R42DC021128-02A1", "company": "Haystack Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": 1276115, "summary": "NIH award 2R42DC021128-02A1: Intracochlear access via ultrasharp-microneedles ($1,276,115)", "source_url": "https://reporter.nih.gov/project-details/11408989", "people": [{"name": "Aykut Aksit", "role": "Principal Investigator"}, {"name": "Anil K Lalwani", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43EY038530-01", "company": "Illumination Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": 319330, "summary": "NIH award 1R43EY038530-01: Continuous Transpalpebral Pupillometer for Early Detection of Brain Swelling and Visual Loss in the ICU and Operating Room Through Closed Eyelids ($319,330)", "source_url": "https://reporter.nih.gov/project-details/11311090", "people": [{"name": "Melissa Li", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK148299-01", "company": "Panluminate Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": 354958, "summary": "NIH award 1R44DK148299-01: AI-Enabled Expansion Microscopy Platform for Renal Pathology ($354,958)", "source_url": "https://reporter.nih.gov/project-details/11409973", "people": [{"name": "Ons M'Saad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43ES037583-01A1", "company": "Gsi Environmental Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-30", "observed": "2026-08-29", "amount_usd": 180843, "summary": "NIH award 1R43ES037583-01A1: Advanced PFAS Removal From Impacted Water Streams Using Colloidal Gas Aphrons ($180,843)", "source_url": "https://reporter.nih.gov/project-details/11313144", "people": [{"name": "Charles Newell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "pma:P250036", "company": "Personal Genome Diagnostics, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-07-30", "observed": "2026-08-13", "amount_usd": null, "summary": "FDA PMA approval P250036: PGDx elio tissue complete CDx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250036", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250036%22"}, {"id": "trialreg:NCT07737184", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Vacuum Compression Therapy for Chronic Lower Limb Ulcers", "source_url": "https://clinicaltrials.gov/study/NCT07737184", "people": [{"name": "Lenka Krupov\u00e1, Mgr., Ph.D.", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07735403", "company": "Turtle Shell Technologies Pvt. Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Dozee Validation for Contactless Heart Rate and Respiration Monitoring in Clinical Settings", "source_url": "https://clinicaltrials.gov/study/NCT07735403", "people": [{"name": "Lindsay Darthard, LVN LNFA", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07736066", "company": "HUINNO Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation After Heart Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07736066"}, {"id": "fda:K254038", "company": "Click Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K254038: Motivista (CT-155)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254038", "people": [{"name": "Austin Speier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254038%22"}, {"id": "fda:K261389", "company": "Salter Labs", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261389: PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261389", "people": [{"name": "Robert Yamashita", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261389%22"}, {"id": "fda:K262330", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262330: dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262330", "people": [{"name": "Ketaki Bendre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262330%22"}, {"id": "fda:K260566", "company": "VertigoDx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260566: SMARTVERTIGO\u0099 Vestibular Assessment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260566", "people": [{"name": "Trevor Meyerowitz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260566%22"}, {"id": "fda:K251959", "company": "T&R BIOFAB CO., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K251959: TnR Cranial Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251959", "people": [{"name": "Chaewon Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251959%22"}, {"id": "fda:K261448", "company": "Misonix, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261448: neXus Ultrasonic Surgical Aspirator System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261448", "people": [{"name": "Shreyash Jalgaonkar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261448%22"}, {"id": "fda:K261410", "company": "Suite 201, National Innovation Centre", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261410: Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261410", "people": [{"name": "David Thomson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261410%22"}, {"id": "fda:K262369", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262369: AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262369", "people": [{"name": "Katie Farraro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262369%22"}, {"id": "fda:K262239", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262239: Obsidian\u00ae Press Over Zirconia", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262239", "people": [{"name": "So Hyun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262239%22"}, {"id": "fda:K260980", "company": "Curemetrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260980: cmAngio\u00ae V2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260980", "people": [{"name": "Kevin Harris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260980%22"}, {"id": "fda:K252042", "company": "Swift Sync, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K252042: Sync AV II Temporary Pacing Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252042", "people": [{"name": "Christian Marin y Kall", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252042%22"}, {"id": "fda:K260161", "company": "UC-CARE , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260161: SmartGuide Disposable Guides and Grids", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260161", "people": [{"name": "Hadas Sheynise", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260161%22"}, {"id": "fda:K261835", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261835: LOGIQ Focus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261835", "people": [{"name": "Lee Bush", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261835%22"}, {"id": "fda:K260620", "company": "Spirair, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260620: SeptAlign (SPLN001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260620", "people": [{"name": "Tracey Henry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260620%22"}, {"id": "fda:K261288", "company": "Imgfax Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261288: Handheld Ultrasound Scanner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261288", "people": [{"name": "Chen Salon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261288%22"}, {"id": "fda:K260624", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260624: Arthrex Radial Head Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260624", "people": [{"name": "Rebecca Homan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260624%22"}, {"id": "nih:5R44HD111106-03", "company": "Venova Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-29", "observed": "2026-08-06", "amount_usd": 1100754, "summary": "NIH award 5R44HD111106-03: Development of a novel, non-hormonal female contraceptive device to submit IDE ($1,100,754)", "source_url": "https://reporter.nih.gov/project-details/11376556", "people": [{"name": "Emily Man", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44CA314945-01", "company": "Levee Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-29", "observed": "2026-08-06", "amount_usd": 912125, "summary": "NIH award 1R44CA314945-01: Novel Scaffold for Mitigating Post-Prostatectomy Urinary Incontinence ($912,125)", "source_url": "https://reporter.nih.gov/project-details/11409594", "people": [{"name": "Bruce Choi", "role": "Principal Investigator"}, {"name": "Ahmed Ghazi", "role": "Principal Investigator"}, {"name": "Adam Irving", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44MH140651-02", "company": "Miresource, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-29", "observed": "2026-08-06", "amount_usd": 1116579, "summary": "NIH award 4R44MH140651-02: Improving longitudinal mental health monitoring to generate personalized guides and timely referrals ($1,116,579)", "source_url": "https://reporter.nih.gov/project-details/11536932", "people": [{"name": "Gabriela Asturias", "role": "Principal Investigator"}, {"name": "Arno Klein", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NS137845-03", "company": "Neurologic Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": 524517, "summary": "NIH award 5R44NS137845-03: EpiScalp: An EEG Analytics Solution to Improve Diagnosis of Epilepsy ($524,517)", "source_url": "https://reporter.nih.gov/project-details/11393704", "people": [{"name": "Andrew Gotshalk", "role": "Principal Investigator"}, {"name": "Babitha Haridas", "role": "Principal Investigator"}, {"name": "Jennifer L. Hopp", "role": "Principal Investigator"}, {"name": "Michael R Sperling", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07734220", "company": "Medline Industries", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Two Heel Protection Devices to Assess Off-loading Via Pressure Mapping.", "source_url": "https://clinicaltrials.gov/study/NCT07734220", "people": [{"name": "Gregory J Gomez, RN BSN MPH", "role": "Principal Investigator"}]}, {"id": "trialreg:NCT07733960", "company": "Medtronic Cardiac Rhythm and Heart Failure", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer", "source_url": "https://clinicaltrials.gov/study/NCT07733960"}, {"id": "trialreg:NCT07734025", "company": "Onecrea Medical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve", "source_url": "https://clinicaltrials.gov/study/NCT07734025"}, {"id": "fda:K261766", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261766: CPS Locator 3D Plus Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261766", "people": [{"name": "Lauren Marold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261766%22"}, {"id": "fda:K261210", "company": "Cleerly, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261210: Cleerly Plaque", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261210", "people": [{"name": "Felicia Hosey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261210%22"}, {"id": "fda:K261829", "company": "CMT Health PTE., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261829: Profoject\u0099 Dual-Safety Pen Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261829", "people": [{"name": "Monica Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261829%22"}, {"id": "fda:K261770", "company": "Skeletal Dynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261770: Suture Button Repair System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261770", "people": [{"name": "Alexandra Rodriguez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261770%22"}, {"id": "fda:K262240", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262240: SSPC NXT Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262240", "people": [{"name": "Lauren Marold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262240%22"}, {"id": "fda:K251908", "company": "Emanate Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K251908: Emanate Tray", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251908", "people": [{"name": "Jarret Fass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251908%22"}, {"id": "fda:K260588", "company": "Cleerly, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260588: Cleerly LABS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260588", "people": [{"name": "Felicia Hosey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260588%22"}, {"id": "fda:K261205", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261205: SPINEART Navigation Instrument System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261205", "people": [{"name": "Estelle Godeau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261205%22"}, {"id": "fda:K253526", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253526: NAMIC Dilator and Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253526", "people": [{"name": "Payal Solanki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253526%22"}, {"id": "fda:K262200", "company": "Sonomotion, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262200: Stone Clear (BWSC-LP9-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262200", "people": [{"name": "Emily Hergenreter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262200%22"}, {"id": "fda:K261058", "company": "CraniUS, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261058: CraniUS Plate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261058", "people": [{"name": "Natalie Wisniewski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261058%22"}, {"id": "nih:5R44DK141388-03", "company": "Vortex Medical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-28", "observed": "2026-08-06", "amount_usd": 1146235, "summary": "NIH award 5R44DK141388-03: Developing a novel vesico-amniotic shunt to treat fetal lower urinary tract obstruction ($1,146,235)", "source_url": "https://reporter.nih.gov/project-details/11382222", "people": [{"name": "Eric Johnson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44OD037625-02", "company": "Objective Biotechnology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": 1200472, "summary": "NIH award 2R44OD037625-02: A computer-vision guided automated microinjection system with increased robustness, throughput, and generalizability to diverse species ($1,200,472)", "source_url": "https://reporter.nih.gov/project-details/11409842", "people": [{"name": "Andrew D Alegria", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44ES034301-02A1", "company": "Attogene", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": 421018, "summary": "NIH award 2R44ES034301-02A1: Development of a portable, rapid, easy-to-use, quantitative dihydroanatoxin-a detection system ($421,018)", "source_url": "https://reporter.nih.gov/project-details/11399643", "people": [{"name": "LANCE P FORD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG081111-03", "company": "Outlier Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": 1152435, "summary": "NIH award 5R44AG081111-03: NeuroSync: a data-driven, music-based augmented reality neurorehabilitation platform of games & puzzles to stimulate neuroplasticity and prolong functional independence in Alzheimer's Disease patients ($1,152,435)", "source_url": "https://reporter.nih.gov/project-details/11371373", "people": [{"name": "Peter Gray", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43ES038453-01", "company": "Uv01 Technologies, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": 306548, "summary": "NIH award 1R43ES038453-01: Leveraging AI/ML for Environmental Health Risk Assessment in Homes ($306,548)", "source_url": "https://reporter.nih.gov/project-details/11316738", "people": [{"name": "Neil Edward Klepeis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44NS135645-02", "company": "Patchclamp Medtech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": 1524947, "summary": "NIH award 2R44NS135645-02: Novel device for the repair and sealing of dural perforations in minimally invasive surgery ($1,524,947)", "source_url": "https://reporter.nih.gov/project-details/11313359", "people": [{"name": "Marc Robert Mayberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AI197429-01", "company": "Impact Proteomics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": 320863, "summary": "NIH award 1R43AI197429-01: Transforming Autoimmune Diagnostic and Disease Monitoring with a Scalable IP-to-MS Platform for Autoantigen Profiling ($320,863)", "source_url": "https://reporter.nih.gov/project-details/11313355", "people": [{"name": "Robyn Therese Domsic", "role": "Principal Investigator"}, {"name": "JONATHAN S MINDEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42AG062130-06", "company": "Aromha, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": 1243304, "summary": "NIH award 5R42AG062130-06: Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD ($1,243,304)", "source_url": "https://reporter.nih.gov/project-details/11422352", "award_phase": "STTR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:4R44MH136888-03", "company": "Oui Therapeutics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": 966804, "summary": "NIH award 4R44MH136888-03: Development and Evaluation of a Novel Digital Therapeutic for Adults with Post-Traumatic Stress Disorder ($966,804)", "source_url": "https://reporter.nih.gov/project-details/11536935", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AI179391-03", "company": "Oak Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-28", "observed": "2026-08-21", "amount_usd": 814340, "summary": "NIH award 5R44AI179391-03: Oral Dissolvable Strips (ODS) as new pediatric and adult delivery mode of therapy for latent tuberculosis ($814,340)", "source_url": "https://reporter.nih.gov/project-details/11393763", "people": [{"name": "EDWARD G MALISKI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG097298-02", "company": "Homecare Hub US Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-28", "observed": "2026-08-21", "amount_usd": 1169847, "summary": "NIH award 5R44AG097298-02: Scaling a network of small community-based care homes as a high-value alternative to institutional care ($1,169,847)", "source_url": "https://reporter.nih.gov/project-details/11417296", "people": [{"name": "Vipan Nikore", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07730099", "company": "ReEmerge, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cognitive Network Restoration Therapy for Moderate to Severe Traumatic Brain Injury: A Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07730099"}, {"id": "trialreg:NCT07730359", "company": "Mintech Bio Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07730359"}, {"id": "fda:DEN250042", "company": "Caristo Diagnostics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) DEN250042: CaRi-Heart", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250042", "people": [{"name": "Frank Cheng", "role": "510(k) submission contact"}]}, {"id": "fda:K253450", "company": "NeuroLogica Corp., a Samsung Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253450: BodyTom Elite (NL4000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253450", "people": [{"name": "Ninad Gujar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253450%22"}, {"id": "fda:K261412", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261412: V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261412", "people": [{"name": "Dayoung Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261412%22"}, {"id": "fda:K253651", "company": "Bluewind Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K253651: Revi System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253651", "people": [{"name": "Angel Estrada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253651%22"}, {"id": "fda:K261427", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261427: uMI Panvivo (uMI Panvivo M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261427", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261427%22"}, {"id": "fda:K261399", "company": "Nipro Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261399: ELISIO\u0099-HX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261399", "people": [{"name": "Jessica Oswald-McLeod", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261399%22"}, {"id": "fda:K260326", "company": "Datex-Ohmeda, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260326: Giraffe\u0099 OmniBed\u0099 Carestation (CS1); Giraffe\u0099 Incubator Carestation (CS1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260326", "people": [{"name": "Isabel McGann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260326%22"}, {"id": "fda:K261430", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261430: TruLift Expandable System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261430", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261430%22"}, {"id": "fda:K261511", "company": "Newclip Technics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261511: Xpert Ankle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261511", "people": [{"name": "Ga\u00eblle Gourbi\u00e8re", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261511%22"}, {"id": "fda:K260303", "company": "See-Mode Technologies Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260303: See-Mode Augmented Reporting Tool, Breast (SMART-B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260303", "people": [{"name": "Sadaf Monajemi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260303%22"}, {"id": "fda:K260558", "company": "Hartalega NGC Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260558: Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260558", "people": [{"name": "Kuan Mun Leong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260558%22"}, {"id": "denovo:DEN250042", "company": "Caristo Diagnostics , Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-07-28", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250042 granted: CaRi-Heart", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250042"}, {"id": "nih:5R44MH142259-02", "company": "Neuralthread Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": 1168551, "summary": "NIH award 5R44MH142259-02: TulleKit: Integrated Deep Brain Neural Recording System for Non-Human Primate Models ($1,168,551)", "source_url": "https://reporter.nih.gov/project-details/11418067", "people": [{"name": "Joseph Novello", "role": "Principal Investigator"}, {"name": "Jan Zimmermann", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DE030019-04", "company": "Oregon Res Behavioral Intervention Strat", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-27", "observed": "2026-08-20", "amount_usd": 352691, "summary": "NIH award 5R44DE030019-04: Multi-Media Professional Development for Parenting Educators to Deliver Oral Hygiene Education for Parents of Young Children ($352,691)", "source_url": "https://reporter.nih.gov/project-details/11386440", "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "trialreg:NCT07727057", "company": "Biosense Webster, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of Dual Energy THERMOCOOL SMARTTOUCH\u2122 SF Catheter With the TRUPULSE\u2122 Generator for Treatment of Ventricular Arrhythmias", "source_url": "https://clinicaltrials.gov/study/NCT07727057"}, {"id": "trialreg:NCT07729228", "company": "Heartstream US LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pulse Detection in Cardiac Arrest Patients Using a Doppler Ultrasound Patch on the Carotid Artery", "source_url": "https://clinicaltrials.gov/study/NCT07729228"}, {"id": "trialreg:NCT07726927", "company": "Shenzhen Bihe Medical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of the Patent Foramen Ovale Suture System for the Closure of Patent Foramen Ovale", "source_url": "https://clinicaltrials.gov/study/NCT07726927"}, {"id": "trialreg:NCT07729579", "company": "Sun Pharmaceutical Industries Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Open-Label Pharmacokinetic Study for Patients With Actinic Keratosis on the Upper Extremities or the Face", "source_url": "https://clinicaltrials.gov/study/NCT07729579"}, {"id": "trialreg:NCT07728552", "company": "HUINNO Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: 7-Day MEMO Patch Monitoring for Arrhythmia Detection in Patients With Palpitations", "source_url": "https://clinicaltrials.gov/study/NCT07728552"}, {"id": "fda:K260529", "company": "Xiamen High Top Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260529: Air Compression Massager (HY-1165)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260529", "people": [{"name": "Haiou Liang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260529%22"}, {"id": "fda:K261105", "company": "Inquis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261105: Powered Aventus Thrombectomy System\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261105", "people": [{"name": "Zachary Woodson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261105%22"}, {"id": "fda:K261211", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261211: Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261211", "people": [{"name": "Colin Jacob", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261211%22"}, {"id": "fda:K261310", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261310: FlexTract Deflectable-Rotational Dilator Sheath Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261310", "people": [{"name": "Kirk McIntosh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261310%22"}, {"id": "fda:K262201", "company": "Shockwave Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262201: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262201", "people": [{"name": "Eric Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262201%22"}, {"id": "fda:K250419", "company": "Plus EV Holdings, Inc. D/B/A Intimate Rose", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K250419: Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250419", "people": [{"name": "Aaron Wilt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250419%22"}, {"id": "fda:K262474", "company": "Accurate Access, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K262474: ND Needle Guidance System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262474", "people": [{"name": "Nabil Dib", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262474%22"}, {"id": "fda:K260835", "company": "Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K260835: ARCHIMEDES Biodegradable Stent (Medium)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260835", "people": [{"name": "Eric Mangiardi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260835%22"}, {"id": "fda:K261759", "company": "Medtronic Ireland", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-27", "observed": "2026-08-18", "amount_usd": null, "summary": "FDA 510(k) K261759: Euphora Rapid Exchange (RX) Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261759", "people": [{"name": "Sarah Grant", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261759%22"}, {"id": "fda:K261367", "company": "Corsano Health B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261367: Corsano CardioWatch 287-2 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261367", "people": [{"name": "Peter STAS", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261367%22"}, {"id": "fda:K253576", "company": "Analytics For Life, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253576: CorVista System\u00ae with PCWP Add-On", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253576", "people": [{"name": "Stephen Davies", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253576%22"}, {"id": "fda:K253206", "company": "Meticuly Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253206: METICULY Patient-specific CMF solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253206", "people": [{"name": "Lohwongwatana Peeranoot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253206%22"}, {"id": "fda:K260382", "company": "Auris Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260382: MONARCH\u0099 Platform (MON-000008)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260382", "people": [{"name": "James P Garvey II", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260382%22"}, {"id": "nih:1R43AI192167-01", "company": "Datanova Scientific LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-24", "observed": "2026-08-18", "amount_usd": 306969, "summary": "NIH award 1R43AI192167-01: Technology-Driven Root cause Analysis and Clinical Enhancement for Clostridioides difficile Infection (TRACE-CDI), a Digital Thread to trace Hospital-acquired Infections ($306,969)", "source_url": "https://reporter.nih.gov/project-details/11186538", "people": [{"name": "David L Chin", "role": "Principal Investigator"}, {"name": "Sameer Joshi", "role": "Principal Investigator"}, {"name": "Eric A Wright", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI197963-01", "company": "Transdermal Specialties Global, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-24", "observed": "2026-08-18", "amount_usd": 320863, "summary": "NIH award 1R43AI197963-01: Provide a Set-It-And-Forget-it Copaxone Patch for Hourly Dosing of Medication to Combat Multiple Sclerosis. ($320,863)", "source_url": "https://reporter.nih.gov/project-details/11310939", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM151897-02A1", "company": "Glyphic Biotechnologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-24", "observed": "2026-08-21", "amount_usd": 1599463, "summary": "NIH award 2R44GM151897-02A1: Single-molecule protein sequencing: resolving individual amino acids via commercially accessible nanopores ($1,599,463)", "source_url": "https://reporter.nih.gov/project-details/11406864", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K261849", "company": "Luma Vision Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261849: VERAFEYE Imaging Catheter (VF-VIC-002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261849", "people": [{"name": "Marta Walker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261849%22"}, {"id": "fda:K253277", "company": "Ge Medical Systems Information Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253277: Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253277", "people": [{"name": "Yanli Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253277%22"}, {"id": "fda:K260362", "company": "MANTIZ Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260362: QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260362", "people": [{"name": "Jay Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260362%22"}, {"id": "fda:K260948", "company": "Wavepulse (Xiamen) Healthcare Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260948: Air Compression Massager (EP30B001 I)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260948", "people": [{"name": "Jie Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260948%22"}, {"id": "fda:K261024", "company": "THINK Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261024: TMINI Miniature Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261024", "people": [{"name": "Denise Duchene", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261024%22"}, {"id": "fda:K253452", "company": "Rivanna Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253452: Accuro 3S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253452", "people": [{"name": "F. William Mauldin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253452%22"}, {"id": "fda:K254180", "company": "LIMIS Development B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254180: PerfusiX-Imaging", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254180", "people": [{"name": "Kelsey van Abbema", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254180%22"}, {"id": "fda:K261349", "company": "Airs Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261349: SwiftMR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261349", "people": [{"name": "Markus Cho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261349%22"}, {"id": "fda:K252370", "company": "Free Wheelchair Mission", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252370: GEN 4 JOY Wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252370", "people": [{"name": "Keith Herr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252370%22"}, {"id": "fda:K261312", "company": "Eyekon Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261312: Temporary Keratoprosthesis (QuickSet TKP\u0099)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261312", "people": [{"name": "Mark Robinson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261312%22"}, {"id": "fda:K261027", "company": "Hycor Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261027: NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261027", "people": [{"name": "Aashrey Kaul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261027%22"}, {"id": "fda:K262294", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262294: dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262294", "people": [{"name": "K Jeevan Kumar Reddy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262294%22"}, {"id": "fda:K253703", "company": "Deka R&D Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253703: RemunityPRO+ Pump for Remodulin\u00ae (treprostinil) Injection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253703", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253703%22"}, {"id": "fda:K260598", "company": "iSMART Developments, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260598: 5 Wavelength LED Facemask (TN2508)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260598", "people": [{"name": "Susan D'Arcy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260598%22"}, {"id": "fda:K261781", "company": "Thermo Fisher Scientific (Oxoid Ltd.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261781: Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 \u00b5g) FPZ60", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261781", "people": [{"name": "Sonali Karnik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261781%22"}, {"id": "fda:K253943", "company": "Zavation Medical Products, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253943: Tiger 2 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253943", "people": [{"name": "Frankie Cummins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253943%22"}, {"id": "fda:K261364", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261364: Atellica CH Acetaminophen 2 (ACTM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261364", "people": [{"name": "Kelly Maher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261364%22"}, {"id": "fda:K260192", "company": "ROPCA ApS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260192: DIANA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260192", "people": [{"name": "Trine Straarup Winther", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260192%22"}, {"id": "fda:K261488", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261488: OBSIDIO Conformable Embolic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261488", "people": [{"name": "Liz Johnston", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261488%22"}, {"id": "fda:K262152", "company": "VISION MEDICAL Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262152: VS-370CF, VS-370CT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262152", "people": [{"name": "Ham Ui-Seong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262152%22"}, {"id": "fda:K253541", "company": "Medical Impact", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253541: EZ-Close\u0099 (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253541", "people": [{"name": "Hanna Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253541%22"}, {"id": "fda:K262383", "company": "Nucletron B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262383: LumenCare Azure", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262383", "people": [{"name": "Loes Vloet-Emonts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262383%22"}, {"id": "fda:K262121", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262121: Ion-L Navigated Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262121", "people": [{"name": "Richard Sharp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262121%22"}, {"id": "fda:K260259", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260259: DiscreetDuo\u0099 Flow Wearable Breast Pump (Model S3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260259", "people": [{"name": "Dale Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260259%22"}, {"id": "fda:K262165", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262165: FARADRIVE\u0099 Steerable Sheath (M004PF21M402)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262165", "people": [{"name": "Mariafernanda Marroquin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262165%22"}, {"id": "fda:K262462", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262462: TheraSphere 360\u0099 Y-90 Management Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262462", "people": [{"name": "Amy McKinney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262462%22"}, {"id": "fda:K261274", "company": "Cook Ireland, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261274: EchoTip Ultra\u00ae Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore\u00ae Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261274", "people": [{"name": "Caoimhe Murphy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261274%22"}, {"id": "fda:K261221", "company": "Olympus Surgical Technologies America", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261221: SOLTIVE\u0099 Laser System (SOLTIVE\u0099 Pro SuperPulsed Laser, SOLTIVE\u0099 Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261221", "people": [{"name": "Dolan Mills", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261221%22"}, {"id": "fda:K262290", "company": "Osteoremedies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262290: REMEDY POLY+PLUS SNAP FIT Acetabular Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262290", "people": [{"name": "Eric Stookey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262290%22"}, {"id": "fda:K261014", "company": "Rivanna Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261014: Accuro\u00ae 3S Needle Guide Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261014", "people": [{"name": "F. William Mauldin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261014%22"}, {"id": "fda:K261267", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261267: Careflux H60;Careflux H70;Careflux V500", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261267", "people": [{"name": "Timothy Groves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261267%22"}, {"id": "pma:P250029", "company": "Freenome, LLC", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-07-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250029: SimpleScreen\u0099 CRC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250029", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250029%22"}, {"id": "trialreg:NCT07725237", "company": "GE Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SPECT/CT Prospective Double-Scanning Study", "source_url": "https://clinicaltrials.gov/study/NCT07725237"}, {"id": "trialreg:NCT07725419", "company": "Algiamed Technologies USA, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain", "source_url": "https://clinicaltrials.gov/study/NCT07725419"}, {"id": "trialreg:NCT07725445", "company": "HUINNO Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of an AI-Based Lightweight ECG Telemetry Monitoring System", "source_url": "https://clinicaltrials.gov/study/NCT07725445"}, {"id": "trialreg:NCT07725640", "company": "Batea Oncology", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Assessment of a Medical Device for Tumour Cell Retention and Radiotherapy Sensitization in Patients With Suspected High-grade Glioma", "source_url": "https://clinicaltrials.gov/study/NCT07725640"}, {"id": "nih:1R43MH142174-01", "company": "Biosignal Solutions LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": 453695, "summary": "NIH award 1R43MH142174-01: BrainGain: a neurofeedback platform to improve memory from home in individuals with schizophrenia ($453,695)", "source_url": "https://reporter.nih.gov/project-details/11253666", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43ES038796-01", "company": "Nanohmics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-23", "observed": "2026-08-18", "amount_usd": 313365, "summary": "NIH award 1R43ES038796-01: Handheld Fluorescent Lysosomal Yeast (FLY) Biosensor for Toxic Metal Ions and Organic Pollutants in Water ($313,365)", "source_url": "https://reporter.nih.gov/project-details/11406416", "people": [{"name": "John Bruno", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42HL174371-03", "company": "Pip Care, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-23", "observed": "2026-08-18", "amount_usd": 1026003, "summary": "NIH award 5R42HL174371-03: Novel Digital Health Platform with Virtual Health Coach for Improving Perioperative Patient Outcomes and Care Coordination ($1,026,003)", "source_url": "https://reporter.nih.gov/project-details/11393855", "people": [{"name": "Jennifer Holder-Murray", "role": "Principal Investigator"}, {"name": "Kathy Kaluhiokalani", "role": "Principal Investigator"}, {"name": "Aman Mahajan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44DC023860-01", "company": "Micro-leads, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-23", "observed": "2026-08-18", "amount_usd": 1486972, "summary": "NIH award 1R44DC023860-01: Closed-Loop Stimulation to Restore Voice and Swallowing by Reanimating Paralyzed Vocal Folds ($1,486,972)", "source_url": "https://reporter.nih.gov/project-details/11409928", "people": [{"name": "Bryan L McLaughlin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM163512-01", "company": "Monod Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-23", "observed": "2026-08-19", "amount_usd": 330955, "summary": "NIH award 1R43GM163512-01: Computational Protein Design of Robust and Scalable Recombinant HRP and Poly-HRP Reagents ($330,955)", "source_url": "https://reporter.nih.gov/project-details/11316873", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K261272", "company": "Esonic Technology (Wuhan) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261272: ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261272", "people": [{"name": "Souquet Jacques", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261272%22"}, {"id": "fda:K261644", "company": "Xvivo Perfusion AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261644: Perfadex Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261644", "people": [{"name": "Petra Rosen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261644%22"}, {"id": "fda:K261694", "company": "Eko Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261694: CORE 300 Digital Stethoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261694", "people": [{"name": "Min Cao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261694%22"}, {"id": "fda:K253044", "company": "Resvent Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253044: RXiBreeze PAP System (RXiBreeze 20C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253044", "people": [{"name": "Harry Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253044%22"}, {"id": "fda:K251576", "company": "Total Flow Medical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251576: Total Flow Medical Femoral Arterial (TFA) cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251576", "people": [{"name": "Hillary Pierce", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251576%22"}, {"id": "fda:K253932", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253932: FACEGYM Pro Device (HD-109)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253932", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253932%22"}, {"id": "fda:K261136", "company": "Guangzhou Daxin Health Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261136: Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261136", "people": [{"name": "Yanjuan(Jane) Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261136%22"}, {"id": "fda:K253041", "company": "Fims Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253041: 3d Cage Cervical", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253041", "people": [{"name": "Lee Jiyeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253041%22"}, {"id": "fda:K254096", "company": "Velmeni, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254096: VELMENI for DENTISTS (V4D) 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254096", "people": [{"name": "Mini Suri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254096%22"}, {"id": "fda:K261734", "company": "Total Joint Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261734: Klassic Infection Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261734", "people": [{"name": "Georgia Murray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261734%22"}, {"id": "fda:K261082", "company": "Microlife Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261082: Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261082", "people": [{"name": "Jimmy Deng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261082%22"}, {"id": "fda:K261081", "company": "Beijing Konted Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261081: Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261081", "people": [{"name": "Deyi Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261081%22"}, {"id": "fda:K261748", "company": "Hefei Meyer Optoelectronic Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261748: Dental Cone-beam Computed Tomography (mDX-15P Series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261748", "people": [{"name": "Zixuan Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261748%22"}, {"id": "fda:K262116", "company": "Trividia Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262116: TRUE METRIX Self Monitoring Blood Glucose System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262116", "people": [{"name": "Jacqueline Davis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262116%22"}, {"id": "fda:K262143", "company": "Candelis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262143: ImageGrid StreamVue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262143", "people": [{"name": "Josh Baker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262143%22"}, {"id": "fda:K261853", "company": "Liofilchem, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261853: Gepotidacin GEP 10 \u00b5g", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261853", "people": [{"name": "Emily Hodgkins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261853%22"}, {"id": "trialreg:NCT07722832", "company": "KLAVA Innovation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Efficacy of QUITOXIL\u00ae in Smoking Cessation", "source_url": "https://clinicaltrials.gov/study/NCT07722832"}, {"id": "trialreg:NCT07722741", "company": "Geneos Therapeutics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Personalized Neoantigen Vaccine Plus IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC", "source_url": "https://clinicaltrials.gov/study/NCT07722741"}, {"id": "trialreg:NCT07722039", "company": "HUINNO Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours", "source_url": "https://clinicaltrials.gov/study/NCT07722039"}, {"id": "trialreg:NCT07722026", "company": "HUINNO Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: This Exploratory Medical Device Study Evaluated the Arrhythmia Diagnostic Yield of MEMO Patch V2, a Wearable Patch-type Electrocardiographic Monitor, in Adults With Suspected Arrhythmia Who Presented With Symptoms Such as Palpitations or Dizziness, or Who Had Cryptogenic Ischemic Stroke or Transient", "source_url": "https://clinicaltrials.gov/study/NCT07722026"}, {"id": "trialreg:NCT07722715", "company": "Freiburger Medizintechnik GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis", "source_url": "https://clinicaltrials.gov/study/NCT07722715"}, {"id": "trialreg:NCT07723664", "company": "Sofwave Medical LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation", "source_url": "https://clinicaltrials.gov/study/NCT07723664"}, {"id": "trialreg:NCT07721493", "company": "Providence Medical Technology, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety and Effectiveness of the CORUS\u2122 Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease", "source_url": "https://clinicaltrials.gov/study/NCT07721493"}, {"id": "nih:2R44HL145941-04", "company": "Aventusoft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": 1166667, "summary": "NIH award 2R44HL145941-04: Non-invasive cloud connected device for hemodynamic-guided therapy to improve outcomes for heart failure patients ($1,166,667)", "source_url": "https://reporter.nih.gov/project-details/11292754", "people": [{"name": "Kaustubh Kale", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44HL183952-05", "company": "Pediastent LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": 1472094, "summary": "NIH award 2R44HL183952-05: CardiaZn Stent: First-in-Baby Clinical Study ($1,472,094)", "source_url": "https://reporter.nih.gov/project-details/11292522", "people": [{"name": "Timothy Moran", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44HL184658-01", "company": "Aquilo Sports, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": 1111191, "summary": "NIH award 1R44HL184658-01: DEVELOPMENT & TESTING OF A NOVEL THERAPEUTIC DEVICE FOR IMPROVING MOBILITY IN PATIENTS WITH LOWER-EXTREMITY PERIPHERAL ARTERY DISEASE ($1,111,191)", "source_url": "https://reporter.nih.gov/project-details/11313575", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL184876-01", "company": "Nightingale Labs Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": 1368368, "summary": "NIH award 1R44HL184876-01: Commercialization of Non-contact Cardiopulmonary Monitoring for Heart Failure ($1,368,368)", "source_url": "https://reporter.nih.gov/project-details/11323850", "people": [{"name": "Raymond C Chan", "role": "Principal Investigator"}, {"name": "Kevin R King", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41AI197272-01", "company": "Pulmonescence Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": 312276, "summary": "NIH award 1R41AI197272-01: Non-Invasive Rapid Test for Pediatric Tuberculosis ($312,276)", "source_url": "https://reporter.nih.gov/project-details/11311250", "people": [{"name": "Jeffrey D. Cirillo", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44NS132690-03S1", "company": "Ipaces, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": 50000, "summary": "NIH award 3R44NS132690-03S1: Neuro-exergaming for the Prevention and Remediation of Decline due to Parkinson's Disease: Clinical Trial of the Interactive Physical and Cognitive Exercise System (iPACES v3) ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11428520", "people": [{"name": "PAUL J ARCIERO", "role": "Principal Investigator"}, {"name": "Cay Anderson-Hanley", "role": "Principal Investigator"}, {"name": "John P. Arciero", "role": "Principal Investigator"}, {"name": "Sean Clark", "role": "Principal Investigator"}, {"name": "Robert Willson Gillen", "role": "Principal Investigator"}, {"name": "David Arthur Merrill", "role": "Principal Investigator"}, {"name": "Eric Steven Molho", "role": "Principal Investigator"}, {"name": "STELLA E PANOS", "role": "Principal Investigator"}, {"name": "Melita Petrossian", "role": "Principal Investigator"}, {"name": "Emilie Saulnier", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41AI197809-01", "company": "Capture Bioscience Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": 306810, "summary": "NIH award 1R41AI197809-01: High-Throughput Detection of Autoimmune Antibodies with Beads by Time-Of-Flight (B-TOF) ($306,810)", "source_url": "https://reporter.nih.gov/project-details/11316657", "people": [{"name": "David Robert McIlwain", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA302212-02", "company": "Onc.ai, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": 313742, "summary": "NIH award 5R44CA302212-02: Deep Learning Serial Radiomics for Improved Cancer Therapy Response Assessment. ($313,742)", "source_url": "https://reporter.nih.gov/project-details/11384900", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL184590-01", "company": "Nytricx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": 314337, "summary": "NIH award 1R43HL184590-01: Engineering Nitric Oxide Releasing Intravascular Catheters with Solid Slippery Surfaces to Combat Infection and Thrombosis ($314,337)", "source_url": "https://reporter.nih.gov/project-details/11313954", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DC023888-01A1", "company": "Cognixion Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": 1258551, "summary": "NIH award 1R44DC023888-01A1: BCI and Hybrid BCI Wearable Agency Device for ALS. ($1,258,551)", "source_url": "https://reporter.nih.gov/project-details/11407240", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM157779-02", "company": "Brightspec, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-22", "observed": "2026-08-19", "amount_usd": 819002, "summary": "NIH award 5R44GM157779-02: MR^3: Development of a Molecular Rotational Resonance Ratiometer ($819,002)", "source_url": "https://reporter.nih.gov/project-details/11378480", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K254296", "company": "Sounduct", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254296: Ossiclear (Ossiclear System)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254296", "people": [{"name": "Camille Bonnassieux", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254296%22"}, {"id": "fda:K260964", "company": "Hamamatsu Photonics K.K.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260964: NanoZoomer S540MD Slide Scanner System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260964", "people": [{"name": "Shinichi Fujisaka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260964%22"}, {"id": "fda:K262086", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262086: PreludeSYNC\u0099 Radial Compression Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262086", "people": [{"name": "Frank Sauz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262086%22"}, {"id": "fda:K262075", "company": "Relja Innovations, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262075: Lapidus Screw Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262075", "people": [{"name": "Robby Amiot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262075%22"}, {"id": "fda:K261179", "company": "Gimmi GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261179: AlphaTriPart - Monopolar MIC Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261179", "people": [{"name": "Anita Rudischhauser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261179%22"}, {"id": "fda:K253840", "company": "Stroke DX", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253840: STEDI Scan Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253840", "people": [{"name": "Richard Lilly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253840%22"}, {"id": "fda:K262211", "company": "Tianjin Huahong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262211: Lancet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262211", "people": [{"name": "Ningning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262211%22"}, {"id": "fda:K261113", "company": "Ecential Robotics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261113: Op.n\u0099 Spine Navigation and Robotic Guidance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261113", "people": [{"name": "Elodie Bouillet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261113%22"}, {"id": "fda:K260804", "company": "Momentis Surgical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260804: Anovo Surgical System (6Ne)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260804", "people": [{"name": "Maya Leib Shlomo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260804%22"}, {"id": "fda:K262094", "company": "Evolution Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262094: E3D\u0099-C Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262094", "people": [{"name": "Francia Sanchez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262094%22"}, {"id": "fda:K260721", "company": "Tornier, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260721: Tornier Perform Advanced Glenoid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260721", "people": [{"name": "Stefanie Tarara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260721%22"}, {"id": "trialreg:NCT07720219", "company": "Cryosa, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (OASIS)", "source_url": "https://clinicaltrials.gov/study/NCT07720219"}, {"id": "trialreg:NCT07720882", "company": "NeuroXess Technology (shanghai) Co.,Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study of a Fully Implanted, Wireless and Functional BCI for Upper-Limb Functional Replacement in Tetraplegia Due to Spinal Cord Injury: Efficacy and Safety", "source_url": "https://clinicaltrials.gov/study/NCT07720882"}, {"id": "trialreg:NCT07719608", "company": "Salvia BioElectronics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine", "source_url": "https://clinicaltrials.gov/study/NCT07719608"}, {"id": "trialreg:NCT07718516", "company": "Stan Kachnowski", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospital Discharge", "source_url": "https://clinicaltrials.gov/study/NCT07718516"}, {"id": "trialreg:NCT07719244", "company": "xDot Medical, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: xDot Access Management System Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT07719244"}, {"id": "trialreg:NCT07720557", "company": "Shanghai MicroPort EP MedTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PulseMagic\u2122 TrueForce\u2122 PAF NMPA Study", "source_url": "https://clinicaltrials.gov/study/NCT07720557"}, {"id": "nih:1R44CA310213-01", "company": "Envisagenics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-21", "observed": "2026-08-18", "amount_usd": 889653, "summary": "NIH award 1R44CA310213-01: SpliceDisco: A Machine Learning Tool for the Identification of Alternative Splicing Events Directly Regulated by Pathological Splicing Factors in Cancer ($889,653)", "source_url": "https://reporter.nih.gov/project-details/11313545", "people": [{"name": "MARTIN AKERMAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R42TR005299-03", "company": "Cellchorus Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-21", "observed": "2026-08-18", "amount_usd": 1021147, "summary": "NIH award 5R42TR005299-03: LF-TIMING: Large-scale label-free profiling of cell-cell interactions ($1,021,147)", "source_url": "https://reporter.nih.gov/project-details/11381696", "people": [{"name": "Rebecca L Berdeaux", "role": "Principal Investigator"}, {"name": "BADRINATH ROYSAM", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG078020-03", "company": "Wicked Sheets, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-21", "observed": "2026-08-18", "amount_usd": 1042829, "summary": "NIH award 5R44AG078020-03: Wicked Smart Pad: Washable Sensorized Bedding for the Prevention and Detection of Moisture Events ($1,042,829)", "source_url": "https://reporter.nih.gov/project-details/11419592", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K260591", "company": "Hycor Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260591: NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260591", "people": [{"name": "Hiromi Kubota", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260591%22"}, {"id": "fda:DEN250068", "company": "Auris Health, Inc., part of Johnson & Johnson MedTech", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250068: OTTAVA\u0099 Robotic Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250068", "people": [{"name": "Anna (Inna) Libman", "role": "510(k) submission contact"}]}, {"id": "fda:K260500", "company": "ResolutionMD, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260500: ResolutionMD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260500", "people": [{"name": "Sharon Cholowsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260500%22"}, {"id": "fda:K262014", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262014: PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262014", "people": [{"name": "Sahrudin Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262014%22"}, {"id": "fda:K261738", "company": "Rhein Laser Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261738: Medical Thulium Fiber Laser Systems (UroFiber 150Q)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261738", "people": [{"name": "Na Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261738%22"}, {"id": "fda:K261775", "company": "Xuzhou Kernel Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261775: Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261775", "people": [{"name": "Shanfeng Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261775%22"}, {"id": "fda:K253814", "company": "Beijing Honghugaoxiang Science and Technology Development CO", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253814: Raney Clips Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253814", "people": [{"name": "Zichen Jia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253814%22"}, {"id": "fda:K253770", "company": "GE Medical Systems SCS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253770: CardIQ Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253770", "people": [{"name": "Haddad Mireille", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253770%22"}, {"id": "fda:K261728", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261728: One-Fil LC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261728", "people": [{"name": "Ku Da Hyeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261728%22"}, {"id": "fda:K261406", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261406: Versalock Proximal Tibial Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261406", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261406%22"}, {"id": "trialreg:NCT07717866", "company": "Axial Therapeutic Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Trifecta Research Study", "source_url": "https://clinicaltrials.gov/study/NCT07717866"}, {"id": "trialreg:NCT07716020", "company": "Xeltis", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: XPAD European Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07716020"}, {"id": "denovo:DEN250068", "company": "Auris Health, Inc., part of Johnson & Jo", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-07-21", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250068 granted: OTTAVA\u2122 Robotic Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250068"}, {"id": "nih:5R44DA058470-03", "company": "Autonomous Healthcare, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-20", "observed": "2026-08-06", "amount_usd": 886573, "summary": "NIH award 5R44DA058470-03: Noncontact Monitoring for the Detection of Opioid-Induced Respiratory Depression ($886,573)", "source_url": "https://reporter.nih.gov/project-details/11369119", "people": [{"name": "Behnood Gholami", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43ES036911-01A1", "company": "Million Marker Wellness Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": 306871, "summary": "NIH award 1R43ES036911-01A1: Endocrine Disruptors and Men's Reproductive Health: A randomized behavioral intervention to increase environmental health literacy and reduce exposures among men with low semen quality ($306,871)", "source_url": "https://reporter.nih.gov/project-details/11313694", "people": [{"name": "Jenna Hua", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42GM157918-02", "company": "Biosensing Instrument, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": 807496, "summary": "NIH award 4R42GM157918-02: Spotting-free Nano-Oscillator Array for Quantification of Virion Displayed Membrane Protein Binding Kinetics ($807,496)", "source_url": "https://reporter.nih.gov/project-details/11321001", "people": [{"name": "Nguyen Ly", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44TR006356-01", "company": "Empowerx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": 245264, "summary": "NIH award 1R44TR006356-01: Preparing Pharmacists for Public Health Services (PrePPS) ($245,264)", "source_url": "https://reporter.nih.gov/project-details/11409950", "people": [{"name": "Jenny Leigh Newlon", "role": "Principal Investigator"}, {"name": "Sally Rafie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH129132-04", "company": "Tissuevision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": 1438419, "summary": "NIH award 5R44MH129132-04: The Development of Tabletop Brain-Mapping Platform ($1,438,419)", "source_url": "https://reporter.nih.gov/project-details/11337434", "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R42GM148086-04", "company": "Continuum Educational Technologies, Pbc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-20", "observed": "2026-08-21", "amount_usd": 887778, "summary": "NIH award 2R42GM148086-04: Scaling the Continuum Platform to Support Commercialization and Federal Grant Training Across Central IDeA State Region Institutions ($887,778)", "source_url": "https://reporter.nih.gov/project-details/11410228", "people": [{"name": "Adam Courtney", "role": "Principal Investigator"}, {"name": "ELIZABETH A FRIIS", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K261535", "company": "Hi-D Imaging AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261535: Hi-D Imaging 4TAVR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261535", "people": [{"name": "Utku Gulan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261535%22"}, {"id": "fda:K261011", "company": "Samsung Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261011: Sleep Apnea Feature (v2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261011", "people": [{"name": "Hon Pak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261011%22"}, {"id": "fda:K254285", "company": "Hartalega NGC Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254285: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs \u0096 Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs \u0096 Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs \u0096 Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs \u0096 Dark Violet Blue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254285", "people": [{"name": "Kuan Mun Leong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254285%22"}, {"id": "fda:K260516", "company": "MacroLux Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260516: BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260516", "people": [{"name": "Ye Linbin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260516%22"}, {"id": "fda:K261632", "company": "Responsive Arthroscopy, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261632: Thunderbolt System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261632", "people": [{"name": "Gretchen Hinchley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261632%22"}, {"id": "fda:K261573", "company": "Aktormed GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261573: ENDOSCOPE HOLDER (182214)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261573", "people": [{"name": "Hanna Kafurke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261573%22"}, {"id": "fda:K254231", "company": "Taiwan Surgical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254231: Inno-Hook\u0099 Disposable Clip Appliers (Ligating Clips) and Inno-Hook\u0099 Ligating Clips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254231", "people": [{"name": "Ken Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254231%22"}, {"id": "trialreg:NCT07714876", "company": "Kardium Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety and Effectiveness of the Globe\u00ae Pulsed Field System for Treating Patients With Symptomatic Paroxysmal Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07714876"}, {"id": "trialreg:NCT07712861", "company": "Ventaris Surgical Incorporated", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis", "source_url": "https://clinicaltrials.gov/study/NCT07712861"}, {"id": "trialreg:NCT07715266", "company": "Noxelis", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: POST CATARACT SURGERY DRY EYE DISEASE", "source_url": "https://clinicaltrials.gov/study/NCT07715266"}, {"id": "trialreg:NCT07714889", "company": "Toivoa Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Development of an Accessible Cognitive Behavioral Therapy Digital Therapeutic for Individuals With Long COVID", "source_url": "https://clinicaltrials.gov/study/NCT07714889"}, {"id": "trialreg:NCT07713576", "company": "Huawei Device Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024.", "source_url": "https://clinicaltrials.gov/study/NCT07713576"}, {"id": "trialreg:NCT07714694", "company": "Hollister Incorporated", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Consumer Evaluation of an Investigational Intermittent Catheter", "source_url": "https://clinicaltrials.gov/study/NCT07714694"}, {"id": "trialreg:NCT07715240", "company": "Olympus Corporation of the Americas", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The HANAROSTENT\u00ae Multi-Hole\u2122 Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole\u2122 Stent for the Palliative Treatment of Malignant Biliary Obstruction.", "source_url": "https://clinicaltrials.gov/study/NCT07715240"}, {"id": "trialreg:NCT07714330", "company": "SleepDev, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effectiveness of Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea", "source_url": "https://clinicaltrials.gov/study/NCT07714330"}, {"id": "nih:5R41HL178190-02", "company": "Cutcath LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": 200604, "summary": "NIH award 5R41HL178190-02: Aortic dissection flap division by novel electrosurgical catheter facilitates aortic endograft landing zones ($200,604)", "source_url": "https://reporter.nih.gov/project-details/11371187", "people": [{"name": "Ramon Berguer", "role": "Principal Investigator"}, {"name": "Jonathan Lee Eliason", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA298064-02", "company": "Rarecyte, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": 658336, "summary": "NIH award 5R44CA298064-02: Adaptive imaging for pioneering multiplexed spatial profiling of tumors and tissues for cancer research and diagnosis ($658,336)", "source_url": "https://reporter.nih.gov/project-details/11332255", "people": [{"name": "Tad George", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41EY038588-01", "company": "Carolina Instruments, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": 313927, "summary": "NIH award 1R41EY038588-01: Pupil-Light: A novel method to capture high speed pupil dynamics and saccades in humans ($313,927)", "source_url": "https://reporter.nih.gov/project-details/11315059", "people": [{"name": "Ellora Mctaggart", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH142264-02", "company": "Spikegadgets, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-17", "observed": "2026-08-21", "amount_usd": 860666, "summary": "NIH award 5R44MH142264-02: A Commercial Platform for High-Volume Behavior and Electrophysiology Research ($860,666)", "source_url": "https://reporter.nih.gov/project-details/11384909", "people": [{"name": "Loren M Frank", "role": "Principal Investigator"}, {"name": "Mattias Peter Karlsson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM159469-02", "company": "Alida Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-17", "observed": "2026-08-21", "amount_usd": 1146785, "summary": "NIH award 5R44GM159469-02: Pseudouridine detection with single-base resolution in a multiplexed epitranscriptomics assay ($1,146,785)", "source_url": "https://reporter.nih.gov/project-details/11392969", "people": [{"name": "Zachary Miles", "role": "Principal Investigator"}, {"name": "Gudrun Stengel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K251952", "company": "Virasoft Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251952: Virasight", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251952", "people": [{"name": "Ted Regan Baird", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251952%22"}, {"id": "fda:K260694", "company": "Carl Zeiss Meditec, AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260694: ZEISS CLINIC 360", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260694", "people": [{"name": "Todd Milholland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260694%22"}, {"id": "fda:DEN250040", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250040: SportSuite Vision Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250040", "people": [{"name": "Lucas Dan", "role": "510(k) submission contact"}]}, {"id": "fda:K261675", "company": "Shenzhen Chuanghong Zhilian Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261675: CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261675", "people": [{"name": "Ya Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261675%22"}, {"id": "fda:K261475", "company": "Biofire Defense, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261475: BIOFIRE\u00ae FILMARRAY\u00ae Tropical Fever Panel Control Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261475", "people": [{"name": "David Rabiger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261475%22"}, {"id": "fda:K261658", "company": "Wellspect AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261658: LoFric Origo Pro Coud\u00e9", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261658", "people": [{"name": "Emad Ramzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261658%22"}, {"id": "fda:K261046", "company": "Hunan Qinghao Puzhong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261046: Dental Zirconia Blank & Coloring Liquid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261046", "people": [{"name": "Zhiquan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261046%22"}, {"id": "fda:K261984", "company": "Assure Tech., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261984: AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261984", "people": [{"name": "Allen Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261984%22"}, {"id": "fda:K253694", "company": "Natural Cycles Nordic AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253694: Natural Cycles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253694", "people": [{"name": "Megan Callanan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253694%22"}, {"id": "fda:K261614", "company": "Lg Electronics.Inc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261614: LED LCD Monitor (OEV-271H)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261614", "people": [{"name": "Wonhi Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261614%22"}, {"id": "fda:K254006", "company": "Rapid Medical Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254006: Drivewire 35 Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254006", "people": [{"name": "Ina Gutman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254006%22"}, {"id": "fda:K262061", "company": "Stryker Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262061: Tritanium\u00ae C Anterior Cervical Cage; Tritanium\u00ae PL Cage; Tritanium\u00ae TL Curved Posterior Lumbar Cage; Aero\u00ae -C Cervical Cage System; AVS\u00ae Anchor-C Cervical Cage System; AVS\u00ae TL PEEK Spacer; AVS\u00ae PL PEEK Spacers; AVS\u00ae Navigator PEEK Spacer; AVS\u00ae AS PEEK Spacer; Monterey\u0099 AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI\u0099 Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262061", "people": [{"name": "Kristina Daoud", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262061%22"}, {"id": "fda:K253011", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253011: Catalyft PL Expandable Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253011", "people": [{"name": "Michelle Obenauer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253011%22"}, {"id": "fda:K253963", "company": "Cubresa, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253963: Cubresa BrainPET", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253963", "people": [{"name": "Lisa Bako", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253963%22"}, {"id": "fda:K261693", "company": "Beijing Nubway S&T Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261693: Diode laser hair removal machine (QDTM-04)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261693", "people": [{"name": "Xiting Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261693%22"}, {"id": "trialreg:NCT07711145", "company": "SEEUS95 Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Reusable, Transparent, and Reconfigurable N95-equivalent Respirator Masks: Design, Fabrication, and Trials for Enhanced Adoption", "source_url": "https://clinicaltrials.gov/study/NCT07711145"}, {"id": "trialreg:NCT07710443", "company": "Helios Aesthetics Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of Mosaic for the Treatment of Midface Volume Deficit", "source_url": "https://clinicaltrials.gov/study/NCT07710443"}, {"id": "trialreg:NCT07712614", "company": "Cosmos Rx, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Comparison of Cosmos Rx Medication Adherence Platform vs. Pharmacy Fill Adherence Measures", "source_url": "https://clinicaltrials.gov/study/NCT07712614"}, {"id": "trialreg:NCT07711249", "company": "Sonova AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Benefit of Hearing Aid Tinnitus Feature on Tinnitus-Related Annoyance in Tinnitus Patients in Belgium", "source_url": "https://clinicaltrials.gov/study/NCT07711249"}, {"id": "trialreg:NCT07709754", "company": "Spiro Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PULmonary Stimulation for Asthma Relief", "source_url": "https://clinicaltrials.gov/study/NCT07709754"}, {"id": "trialreg:NCT07711847", "company": "HeroSupport SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy", "source_url": "https://clinicaltrials.gov/study/NCT07711847"}, {"id": "trialreg:NCT07711678", "company": "Beijing Pins Medical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea", "source_url": "https://clinicaltrials.gov/study/NCT07711678"}, {"id": "trialreg:NCT07711067", "company": "ElmediX", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study Comparing Whole-Body Heat Treatment Plus Systemic Therapy to Systemic Therapy Alone, for Advanced Pancreatic Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07711067"}, {"id": "denovo:DEN250040", "company": "Stryker Endoscopy", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-07-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250040 granted: SportSuite Vision Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250040"}, {"id": "nih:3R44HL151147-05S1", "company": "DNA Medicine Institute", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-16", "observed": "2026-08-06", "amount_usd": 50000, "summary": "NIH award 3R44HL151147-05S1: TABA Supplement for Hemophilia Point-of-Care Device ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11405365", "people": [{"name": "Eugene Yan-ho Chan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44LM015020-01", "company": "Mountain Biometrics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-16", "observed": "2026-08-21", "amount_usd": 306721, "summary": "NIH award 1R44LM015020-01: Unlocking Medical AI: A Scalable, Privacy-Preserving Annotation Platform for Clinical and Physiological Data ($306,721)", "source_url": "https://reporter.nih.gov/project-details/11255371", "people": [{"name": "Matthias Christenson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI186929-01A1", "company": "Partillion Bioscience Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-16", "observed": "2026-08-21", "amount_usd": 306865, "summary": "NIH award 1R43AI186929-01A1: Multiplexed analysis of antibody secreting cells for enhanced function first antibody discovery ($306,865)", "source_url": "https://reporter.nih.gov/project-details/11185485", "people": [{"name": "Joseph de Rutte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG065130-04", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-16", "observed": "2026-08-21", "amount_usd": 968011, "summary": "NIH award 5R44AG065130-04: An Automated System for Caregivers and Staff to Locate Items Misplaced by Personswith Dementia in a Care Facility ($968,011)", "source_url": "https://reporter.nih.gov/project-details/11419660", "people": [{"name": "Paul Gibson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K261706", "company": "Karl Storz Se & Co. Kg", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261706: Endomat Select (UP220)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261706", "people": [{"name": "Emily Rhiel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261706%22"}, {"id": "fda:K260021", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260021: cobas\u00ae BV/CV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260021", "people": [{"name": "Nicole Gasser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260021%22"}, {"id": "fda:K261309", "company": "Bethesda Medical Devices, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261309: Palisades\u0099 Buttress Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261309", "people": [{"name": "Amanda Shade", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261309%22"}, {"id": "fda:K261271", "company": "Pioneer Surgical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261271: Cable-Ready\u00ae Cable Grip System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261271", "people": [{"name": "Sravyalahari Sripada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261271%22"}, {"id": "fda:K261674", "company": "Beijing Nubway S&T Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261674: Skin Air Cooling System (QALF-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261674", "people": [{"name": "Xiting Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261674%22"}, {"id": "fda:K260002", "company": "Scientia Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260002: Socrates Aspiration System (Socrates 70 Aspiration Catheter)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260002", "people": [{"name": "Thomas Lippert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260002%22"}, {"id": "fda:K262032", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262032: TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262032", "people": [{"name": "Sneha Potlapally", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262032%22"}, {"id": "trialreg:NCT07708675", "company": "MMI (Medical Microinstruments, Inc.)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - EU", "source_url": "https://clinicaltrials.gov/study/NCT07708675"}, {"id": "nih:5R44GM145205-03", "company": "Bioinvision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-15", "observed": "2026-08-21", "amount_usd": 1257239, "summary": "NIH award 5R44GM145205-03: TissueReM: Whole-Organism, Real-time Decision-enabled 3D Tissue Imaging and Recovery for Molecular Analysis ($1,257,239)", "source_url": "https://reporter.nih.gov/project-details/11381828", "people": [{"name": "SUSANN M BRADY-KALNAY", "role": "Principal Investigator"}, {"name": "Madhusudhana Gargesha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K261353", "company": "Kyocera Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261353: Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261353", "people": [{"name": "Scott Rucker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261353%22"}, {"id": "fda:K261407", "company": "Dongguan Miqiang Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261407: XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261407", "people": [{"name": "Charles (Chengyu) Shen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261407%22"}, {"id": "fda:K262030", "company": "Inquis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262030: Aventus Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262030", "people": [{"name": "Zachary Woodson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262030%22"}, {"id": "fda:K260338", "company": "ThinkSono GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260338: ThinkSono Guidance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260338", "people": [{"name": "Fouad Al-Noor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260338%22"}, {"id": "fda:K260050", "company": "Huneo, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260050: WRAP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260050", "people": [{"name": "Philip Ryder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260050%22"}, {"id": "fda:K260739", "company": "CMT Health PTE., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260739: Profoject\u0099 Pen Needles (Model A; Model B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260739", "people": [{"name": "Monica Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260739%22"}, {"id": "fda:K260851", "company": "Better Diagnostics AI Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260851: Better Diagnostics Dental Assist (BDDA) Version 1.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260851", "people": [{"name": "Rajeev Nohria", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260851%22"}, {"id": "fda:K260206", "company": "UPlanner B.V. - Presurgeo", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260206: SkeletonPlanner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260206", "people": [{"name": "Frans van Belle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260206%22"}, {"id": "fda:K262006", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262006: EnSite\u0099 X EP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262006", "people": [{"name": "Alexandra Agre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262006%22"}, {"id": "fda:K252822", "company": "Atlas Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252822: Atlas Spine HiRISE\u0099 Expandable Cervical-p Corpectomy Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252822", "people": [{"name": "Thomas Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252822%22"}, {"id": "fda:K253606", "company": "Hamamatsu Photonics K.K.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253606: NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253606", "people": [{"name": "Shinichi Fujisaka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253606%22"}, {"id": "pma:P250025", "company": "Traferox Technologies, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-07-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250025: TorEx Lung Perfusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250025", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250025%22"}, {"id": "trialreg:NCT07704424", "company": "Shenzhen Core Medical Technology CO.,LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07704424"}, {"id": "trialreg:NCT07705594", "company": "Jenscare Scientific", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation", "source_url": "https://clinicaltrials.gov/study/NCT07705594"}, {"id": "trialreg:NCT07706491", "company": "Resilia Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of Two Versions of the Uresta Pessary Handle for Women With Stress Urinary Incontinence", "source_url": "https://clinicaltrials.gov/study/NCT07706491"}, {"id": "trialreg:NCT07706361", "company": "LifeWave, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Two-Part Study of the Effects of the X39 Patch on Circulating GHK and GHK-Cu Levels in Healthy Adults", "source_url": "https://clinicaltrials.gov/study/NCT07706361"}, {"id": "trialreg:NCT07704931", "company": "TriCity Research Center", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pilot Study to Evaluate Changes in Intra-Epidermal Nerve Fiber Density (IENFD) in Patients With Small-Fiber Neuropathy", "source_url": "https://clinicaltrials.gov/study/NCT07704931"}, {"id": "trialreg:NCT07705425", "company": "EchoPixel, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EPX-HTG for Structural Heart Procedures", "source_url": "https://clinicaltrials.gov/study/NCT07705425"}, {"id": "nih:5R44CA302033-02", "company": "Rivanna Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-14", "observed": "2026-08-06", "amount_usd": 1104515, "summary": "NIH award 5R44CA302033-02: Reduced Traumatic Lumbar Puncture Rates in Pediatric Oncology Patients Through Development of an AI-Assisted, Ultrasound-Based Interventional Guidance Platform ($1,104,515)", "source_url": "https://reporter.nih.gov/project-details/11370213", "people": [{"name": "Frank William Mauldin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA285197-03", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-14", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44CA285197-03: A parallelized computational microscope platform for high-throughput live imaging of patient-derived organoids ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11350904", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R41NR022239-02", "company": "The Glimpse Group, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-14", "observed": "2026-08-21", "amount_usd": 167944, "summary": "NIH award 5R41NR022239-02: Life at 100.4: An Immersive Social Virtual Reality Education Tool for Adolescent and Young Adult Cancer Patients and Caregivers ($167,944)", "source_url": "https://reporter.nih.gov/project-details/11461692", "people": [{"name": "Asher Marks", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:2R44MH136563-03", "company": "Pacific Optica, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-14", "observed": "2026-08-21", "amount_usd": 723250, "summary": "NIH award 2R44MH136563-03: Advanced optics to unlock large field-of-view multiphoton imaging for neuroscienceand beyond ($723,250)", "source_url": "https://reporter.nih.gov/project-details/11314181", "people": [{"name": "Ryan Patrick McGreal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K253667", "company": "Sp Medical A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253667: Accoat Guide Wire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253667", "people": [{"name": "Philip Davenport", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253667%22"}, {"id": "fda:K261020", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261020: Symmetrix\u0099 L Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261020", "people": [{"name": "Kelly McDonnell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261020%22"}, {"id": "fda:K261633", "company": "Affirm Medical Technologies II, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261633: VisuBreath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261633", "people": [{"name": "Brian Cain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261633%22"}, {"id": "fda:K261232", "company": "Jochu Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261232: IERO Mobility Scooter (IERO-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261232", "people": [{"name": "JIMMY(CHIHMING) WEI", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261232%22"}, {"id": "fda:K261284", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261284: Invictus\u00ae Small Stature Spinal Fixation System; Invictus\u00ae 2.0 Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261284", "people": [{"name": "Andrew Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261284%22"}, {"id": "fda:K261249", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261249: Universal Seal (5-12 mm)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261249", "people": [{"name": "Stephanie Rincones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261249%22"}, {"id": "fda:K260578", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260578: Ambu\u00ae NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu\u00ae NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu\u00ae NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260578", "people": [{"name": "Lenka Vaculciakova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260578%22"}, {"id": "fda:K253662", "company": "Luwi, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253662: LIXI (LXOSFM1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253662", "people": [{"name": "Lisa Kinsella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253662%22"}, {"id": "trialreg:NCT07703241", "company": "Roelmi Hpc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vaginitis (ROVUL25).", "source_url": "https://clinicaltrials.gov/study/NCT07703241"}, {"id": "trialreg:NCT07700433", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of the BTL-043 and BTL-899 Devices in Alleviating Back Pain", "source_url": "https://clinicaltrials.gov/study/NCT07700433"}, {"id": "trialreg:NCT07700927", "company": "Solenic Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection", "source_url": "https://clinicaltrials.gov/study/NCT07700927"}, {"id": "trialreg:NCT07701863", "company": "Biovico Sp. z o.o.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: F-GYN for Vaginal Dryness and Vulvovaginal Atrophy", "source_url": "https://clinicaltrials.gov/study/NCT07701863"}, {"id": "trialreg:NCT07700342", "company": "Cellmedis", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease (The QUIET Trial)", "source_url": "https://clinicaltrials.gov/study/NCT07700342"}, {"id": "trialreg:NCT07700810", "company": "Shenzhen Core Medical Technology CO.,LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Corheart 6 LVAS Clinical Investigation", "source_url": "https://clinicaltrials.gov/study/NCT07700810"}, {"id": "fda:K254044", "company": "Meta Platform Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254044: Hearing assist", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254044", "people": [{"name": "Lucas Fernandez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254044%22"}, {"id": "fda:K261199", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261199: Wearable Breast Pump (Model S32A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261199", "people": [{"name": "Dale WANG", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261199%22"}, {"id": "fda:K253504", "company": "Classys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253504: Volnewmer\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253504", "people": [{"name": "Gene Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253504%22"}, {"id": "fda:K260208", "company": "embecta Medical II, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260208: Ultra-Fine\u0099 SAFETY Insulin Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260208", "people": [{"name": "Ewelina Rog", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260208%22"}, {"id": "fda:K260199", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260199: SLIM Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260199", "people": [{"name": "Catherine Chiou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260199%22"}, {"id": "fda:K261085", "company": "iSchemaview", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261085: Rapid Vessel Occlusion (Rapid VO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261085", "people": [{"name": "James Rosa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261085%22"}, {"id": "fda:K261640", "company": "Merit Medical Ireland , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261640: Merit MAK Nitinol/Gold-Tungsten Guide Wire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261640", "people": [{"name": "Siobhan King", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261640%22"}, {"id": "trialreg:NCT07697105", "company": "Hope Care, S.A", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effectiveness of the Telemonitoring Program for Patients With Chronic Obstructive Pulmonary Disease (COPD)", "source_url": "https://clinicaltrials.gov/study/NCT07697105"}, {"id": "trialreg:NCT07698951", "company": "Recross Cardio, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS Study", "source_url": "https://clinicaltrials.gov/study/NCT07698951"}, {"id": "trialreg:NCT07700147", "company": "Nu Eyne Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of an Electric Stimulator for Medical Use by Personal (LRTPM1) for Visual Function in Early to Intermediate Dry Age-Related Macular Degeneration", "source_url": "https://clinicaltrials.gov/study/NCT07700147"}, {"id": "trialreg:NCT07698353", "company": "Aquea Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Feasibility Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent", "source_url": "https://clinicaltrials.gov/study/NCT07698353"}, {"id": "trialreg:NCT07698119", "company": "Arctx Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Trial of the Arctx Cool Catheter in Acute Pancreatitis", "source_url": "https://clinicaltrials.gov/study/NCT07698119"}, {"id": "trialreg:NCT07697950", "company": "GE Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NIBP Accuracy Study for Adult Subject Populations", "source_url": "https://clinicaltrials.gov/study/NCT07697950"}, {"id": "trialreg:NCT07698639", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Anti-Gravity Treadmill and Electromagnetic Stimulation in Stroke Rehabilitation", "source_url": "https://clinicaltrials.gov/study/NCT07698639"}, {"id": "trialreg:NCT07697638", "company": "Shanghai MicroPort Rhythm MedTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Coronary Laser Atherectomy System for Treatment of Coronary Artery Stenosis (SHINE)", "source_url": "https://clinicaltrials.gov/study/NCT07697638"}, {"id": "nih:5R44HL172444-03", "company": "Lasarrus Clinic And Research Center, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": 887583, "summary": "NIH award 5R44HL172444-03: Bilateral Acoustic Sensing and Automated Breathing Segmentation for Remote Monitoring of Patients with COPD: A Longitudinal Study ($887,583)", "source_url": "https://reporter.nih.gov/project-details/11402697", "people": [{"name": "Lloyd E Emokpae", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG087868-03", "company": "Senaptec Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": 602882, "summary": "NIH award 5R44AG087868-03: Development of an In-Home Sensory Training Therapy to Mitigate Falls Risk Among the Elderly ($602,882)", "source_url": "https://reporter.nih.gov/project-details/11400486", "people": [{"name": "Elizabeth Ann Fleming", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG063683-07", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": 745322, "summary": "NIH award 5R44AG063683-07: A Mobile Informatics Solution to Assist Caregivers with Care Coordination and Social Engagement ($745,322)", "source_url": "https://reporter.nih.gov/project-details/11378550", "people": [{"name": "GARY D HAVEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "nih:5R44AG060779-05", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": 1508825, "summary": "NIH award 5R44AG060779-05: Non-Contact Point of Care Device for Sleep Studies ($1,508,825)", "source_url": "https://reporter.nih.gov/project-details/11419906", "people": [{"name": "John Paul Condon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44AG063679-04", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": 962408, "summary": "NIH award 5R44AG063679-04: A Gait and Path Tortuosity System for Monitoring Cognitive Decline in Individuals at Risk for Alzheimer's Disease and/or Alzheimer's Disease Related Dementias (AD/ADRD) ($962,408)", "source_url": "https://reporter.nih.gov/project-details/11393757", "people": [{"name": "John Paul Condon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AG084351-03", "company": "Revel Pharmaceuticals Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-10", "observed": "2026-08-21", "amount_usd": 923550, "summary": "NIH award 5R44AG084351-03: Development of enzymatic tools for rapid measurement of Advanced Glycation and Lipoxidation End Product-protein adducts ($923,550)", "source_url": "https://reporter.nih.gov/project-details/11393659", "people": [{"name": "Aaron Cravens", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG063589-04", "company": "Tymora Analytical Operations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-10", "observed": "2026-08-21", "amount_usd": 747422, "summary": "NIH award 5R44AG063589-04: Validation and clinicaldevelopment of plasma EV protein biomarkers for minimally-invasive detection of Alzheimersdisease ($747,422)", "source_url": "https://reporter.nih.gov/project-details/11385378", "people": [{"name": "Anton Iliuk", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AG074812-03", "company": "Toi Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-10", "observed": "2026-08-21", "amount_usd": 1089746, "summary": "NIH award 5R44AG074812-03: Use of a Novel Toilet Seat to Passively Collect Digital Biomarkers in Assisted Living Settings ($1,089,746)", "source_url": "https://reporter.nih.gov/project-details/11393803", "people": [{"name": "Vikram Kashyap", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43ES038814-01", "company": "Uv01 Technologies, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-10", "observed": "2026-08-21", "amount_usd": 306487, "summary": "NIH award 1R43ES038814-01: Interactive and Personalized Exposure Simulation: Empowering Households to Reduce Indoor Air Quality Health Risks ($306,487)", "source_url": "https://reporter.nih.gov/project-details/11410377", "people": [{"name": "Neil Edward Klepeis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG084365-04", "company": "Plans4care Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-10", "observed": "2026-08-21", "amount_usd": 634627, "summary": "NIH award 5R44AG084365-04: Plans4Care: Personalized Dementia Care On-Demand ($634,627)", "source_url": "https://reporter.nih.gov/project-details/11390447", "people": [{"name": "Eric Jutkowitz", "role": "Principal Investigator"}, {"name": "Sokha Koeuth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AG090247-03", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-10", "observed": "2026-08-21", "amount_usd": 1069722, "summary": "NIH award 5R44AG090247-03: Developing an Elderly Patient-Specific, Accurate, Intuitive and Highly Interpretable System for Unconsciousness Management in General Anesthesia Using PASCALL FDA-Cleared Intraoperative EEG Monitor ($1,069,722)", "source_url": "https://reporter.nih.gov/project-details/11419855", "people": [{"name": "EMERY N BROWN", "role": "Principal Investigator"}, {"name": "Tuan Le Mau", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K261624", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261624: Omnifit\u00ae 20\u00b0 Series I Insert;Omnifit\u00ae Crossfire\u00ae 10\u00b0 Series II Insert; Constrained Acetabular Insert; Trident\u00ae Crossfire\u00ae 0\u00b0 Polyethylene Insert; Trident \u00ae Crossfire \u00ae 10\u00b0 Polyethylene Insert;System 12 Crossfire\u00ae 10\u00b0 Insert; Trident\u00ae 0\u00b0 Constrained Acetabular Insert; Trident\u00ae Constrained Acetabular Liner;Trident\u00ae All Poly Constrained Acetabular Insert; Crossfire\u00ae Eccentric Insert 10\u00b0; Artisan\u00ae Bone Plug;UHR\u00ae Universal Head Bipolar Component", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261624", "people": [{"name": "Elizabeth Jodon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261624%22"}, {"id": "fda:K253670", "company": "Philips Medical Systems B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253670: SmartCT (R3.0 (L10))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253670", "people": [{"name": "Jeroen de Schrijver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253670%22"}, {"id": "fda:K253514", "company": "C.R. Bard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253514: Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253514", "people": [{"name": "Caitlin Bowles", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253514%22"}, {"id": "fda:K261212", "company": "ACON Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261212: Flowflex Plus RSV + Flu A/B + COVID Rapid Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261212", "people": [{"name": "Catherine Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261212%22"}, {"id": "fda:K261031", "company": "Signus Medinzintechnik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261031: POSEIDON ST", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261031", "people": [{"name": "Iris Wegener", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261031%22"}, {"id": "fda:K261041", "company": "MedSource Labs, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261041: ClearSafe Closed System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261041", "people": [{"name": "Emilie Andrews", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261041%22"}, {"id": "fda:K261306", "company": "Varian Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261306: AI Contouring (VA10A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261306", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261306%22"}, {"id": "fda:K261949", "company": "New York Embroidery Studio", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261949: NYES Tuff Cuff L3 Disposable Gowns", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261949", "people": [{"name": "Michelle Feinberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261949%22"}, {"id": "fda:K261978", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261978: WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261978", "people": [{"name": "Katherine Swanson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261978%22"}, {"id": "fda:K260880", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260880: SedLine Sedation Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260880", "people": [{"name": "Monish Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260880%22"}, {"id": "fda:K261149", "company": "Zhejiang Lumbre Electric Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261149: Electric Wheelchair (DY611A-2, DY612A-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261149", "people": [{"name": "Yubiao Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261149%22"}, {"id": "fda:K260902", "company": "Cochlear Americas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260902: Cochlear\u0099 Osia\u00ae 3(I) Sound Processor;Cochlear\u0099 Osia\u00ae 3 Sound Processor;Cochlear\u0099 Osia\u00ae 3 Charger;Cochlear\u0099 Osia\u00ae 3 Aqua+;Cochlear\u0099 Osia\u00ae Fitting Software 3;Cochlear\u0099 Osia\u00ae Smart App;Cochlear\u0099 Osia\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260902", "people": [{"name": "Whitney Alexander", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260902%22"}, {"id": "fda:K253480", "company": "Capenergy Medical S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253480: Capenergy C Equipments RF C200 and C400 Drakarian", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253480", "people": [{"name": "Pilar Sanchez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253480%22"}, {"id": "fda:K254037", "company": "Free Flow Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254037: LungFlow Airway Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254037", "people": [{"name": "Mark Mathis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254037%22"}, {"id": "fda:K262120", "company": "Avara Software", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262120: Avara Viewer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262120", "people": [{"name": "Richard Bailey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262120%22"}, {"id": "fda:K254295", "company": "Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254295: Sofia Lyme FIA; Sofia 2 Campylobacter FIA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254295", "people": [{"name": "Xiaoxi Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254295%22"}, {"id": "trialreg:NCT07695558", "company": "GI Windows, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post Market Study of the Flexagon Only System and Flexagon Plus OTOLoc for Creation of Side-to-Side Duodeno-Ileal Diversion & Flexagon Plus OTOLoc Self Forming Magnet (SFM) System for Creation of Side-to-Side Jejunum-Jejunum and Ileal-Ileal Anastomoses", "source_url": "https://clinicaltrials.gov/study/NCT07695558"}, {"id": "trialreg:NCT07696507", "company": "Axon srl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain", "source_url": "https://clinicaltrials.gov/study/NCT07696507"}, {"id": "trialreg:NCT07695688", "company": "Imbed Biosciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety Study of Microlyte DualGuard", "source_url": "https://clinicaltrials.gov/study/NCT07695688"}, {"id": "trialreg:NCT07696182", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR", "source_url": "https://clinicaltrials.gov/study/NCT07696182"}, {"id": "trialreg:NCT07696975", "company": "V-Wave Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF", "source_url": "https://clinicaltrials.gov/study/NCT07696975"}, {"id": "nih:2R44DC022208-02", "company": "Zwicoat Materials Innovations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": 907712, "summary": "NIH award 2R44DC022208-02: Reducing Inflammation and Improving Electrical Performance of Cochlear Implants Through Zwitterionic Surface Modification ($907,712)", "source_url": "https://reporter.nih.gov/project-details/11315977", "people": [{"name": "Kameron Rex Hansen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HD105529-05", "company": "Autoivf, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": 998971, "summary": "NIH award 5R44HD105529-05: OvaReady: An automated microfluidic oocyte retrieval and denudation device ($998,971)", "source_url": "https://reporter.nih.gov/project-details/11372993", "people": [{"name": "Ismail Emre Ozkumur", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44HG013294-03", "company": "Survey Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-09", "observed": "2026-08-21", "amount_usd": 876466, "summary": "NIH award 5R44HG013294-03: Pioneering assays for spatially-resolved single-cell multiomics ($876,466)", "source_url": "https://reporter.nih.gov/project-details/11303371", "people": [{"name": "George Christopher Hartoularos", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K261569", "company": "Lifesignals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261569: UbiqVue\u0099 2AYe Cardiac System (UX2253)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261569", "people": [{"name": "Saravanan Balasubramanian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261569%22"}, {"id": "fda:K260539", "company": "MedSource Labs, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260539: MedSource QuickSafe\u0099 Safety IV Catheter; MedSource PurSafe\u0099 Safety IV Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260539", "people": [{"name": "Emilie Andrews", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260539%22"}, {"id": "fda:K260723", "company": "Procept Biorobotics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260723: HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260723", "people": [{"name": "Ankur Kaushal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260723%22"}, {"id": "fda:K253899", "company": "Provect.AI", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253899: 3D-Anywhere", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253899", "people": [{"name": "Dorian Averbuch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253899%22"}, {"id": "fda:K261177", "company": "Pinkslip, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261177: PINKSLIP Water-Based Personal Lubricant and Moisturizer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261177", "people": [{"name": "Louie Goryoka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261177%22"}, {"id": "fda:K261962", "company": "Medtronic MiniMed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261962: SmartGuard Technology; Predictive Low Glucose Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261962", "people": [{"name": "Rushabh Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261962%22"}, {"id": "fda:K261968", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261968: Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261968", "people": [{"name": "Xianjun Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261968%22"}, {"id": "fda:K252978", "company": "Synergen Technology Labs, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252978: ScioCardio ECG Analysis Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252978", "people": [{"name": "Sunil Konda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252978%22"}, {"id": "fda:K261166", "company": "DiaDent Group International", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261166: DIA-CEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261166", "people": [{"name": "Seung-Geun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261166%22"}, {"id": "fda:K261988", "company": "Teleflex Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261988: Monodek\u0099 (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261988", "people": [{"name": "Laura Medlin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261988%22"}, {"id": "fda:K261471", "company": "Zeta Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261471: Zeta TMS Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261471", "people": [{"name": "Hieu Le Mau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261471%22"}, {"id": "fda:K260157", "company": "LifeLens Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260157: LifeLens Physiological Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260157", "people": [{"name": "Matthew Walenciak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260157%22"}, {"id": "fda:K253901", "company": "Perfuze, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253901: Millipede88 Access Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253901", "people": [{"name": "Jeanine O'Donnell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253901%22"}, {"id": "pma:P250016", "company": "Merz North America, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-07-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250016: Belotero\u00ae Intense (+) Lidocaine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250016", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250016%22"}, {"id": "trialreg:NCT07691814", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Powered Toothbrush Versus Manual Toothbrush on Plaque and Gingivitis After a Six-Week Period of Home Use", "source_url": "https://clinicaltrials.gov/study/NCT07691814"}, {"id": "trialreg:NCT07691931", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TBE Zone 0/1 PMS in Japan", "source_url": "https://clinicaltrials.gov/study/NCT07691931"}, {"id": "nih:1R44DK148334-01", "company": "Sojourn Medtech LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-08", "observed": "2026-08-21", "amount_usd": 905234, "summary": "NIH award 1R44DK148334-01: Development and Validation of a Simulator-based Fundamental Skills Curriculum for Hemodialysis Cannulation Skills Training ($905,234)", "source_url": "https://reporter.nih.gov/project-details/11409703", "people": [{"name": "Lydia Petersen", "role": "Principal Investigator"}, {"name": "PRABIR ROY-CHAUDHURY", "role": "Principal Investigator"}, {"name": "Ravikiran Singapogu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K262300", "company": "Formlabs Ohio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262300: Denture Base Resin V2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262300", "people": [{"name": "Paige Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262300%22"}, {"id": "fda:K254130", "company": "C.A. Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254130: C.A. Medical Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254130", "people": [{"name": "Harold Childs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254130%22"}, {"id": "fda:K261396", "company": "Ningbo Resshidi Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261396: Electric Wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261396", "people": [{"name": "Dongchao Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261396%22"}, {"id": "fda:K260160", "company": "bioMerieux, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260160: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260160", "people": [{"name": "Joshua Lay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260160%22"}, {"id": "fda:K260750", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260750: Virtual Cone (1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260750", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260750%22"}, {"id": "fda:K260278", "company": "Stihler Electronic GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260278: ThermAffyx(TM) Patient Safety System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260278", "people": [{"name": "Gary Brennan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260278%22"}, {"id": "fda:K253751", "company": "Neurocareai, Inc. (Dba Savelife.Ai)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253751: CXRDetectAI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253751", "people": [{"name": "Junaid Siddiq Kalia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253751%22"}, {"id": "fda:K261191", "company": "Newclip Technics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261191: Alians Elbow S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261191", "people": [{"name": "Ga\u00eblle Gourbi\u00e8re", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261191%22"}, {"id": "fda:K260917", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260917: cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260917", "people": [{"name": "Ginger Emrich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260917%22"}, {"id": "fda:K260700", "company": "BlueDop Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260700: BlueDop Vascular Expert", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260700", "people": [{"name": "Ciaran McCourt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260700%22"}, {"id": "trialreg:NCT07690995", "company": "MED-EL Elektromedizinische Ger\u00e4te GesmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating a New Software (OTOGUIDE) to Help Monitor Electrode Insertion During Cochlear Implant Surgery.", "source_url": "https://clinicaltrials.gov/study/NCT07690995"}, {"id": "trialreg:NCT07689812", "company": "Natera, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.", "source_url": "https://clinicaltrials.gov/study/NCT07689812"}, {"id": "trialreg:NCT07690059", "company": "Sensory Cloud, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Investigate the Efficacy and Safety of SC0032, a Magnesium Salt Oral Spray, in Adults With Refractory or Unexplained Chronic Cough", "source_url": "https://clinicaltrials.gov/study/NCT07690059"}, {"id": "nih:1R41AI197550-01", "company": "Shabri LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-07", "observed": "2026-08-06", "amount_usd": 306864, "summary": "NIH award 1R41AI197550-01: Antimicrobial prosthetic liner for preventing residual limb infection ($306,864)", "source_url": "https://reporter.nih.gov/project-details/11313379", "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44EY039153-01", "company": "Biolight Engineering, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-07", "observed": "2026-08-06", "amount_usd": 906443, "summary": "NIH award 1R44EY039153-01: A Low-Cost, Ultra-Widefield, Nonmydriatic Retinal Imager for Pediatric Eye Care and ROP Screening ($906,443)", "source_url": "https://reporter.nih.gov/project-details/11405867", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA281709-03", "company": "Voxel Healthcare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-07", "observed": "2026-08-06", "amount_usd": 665400, "summary": "NIH award 5R44CA281709-03: Long term radiation treatment planning in brain tumors in the pediatric population ($665,400)", "source_url": "https://reporter.nih.gov/project-details/11364918", "people": [{"name": "Niharika R Gajawelli", "role": "Principal Investigator"}, {"name": "Natasha Lepore", "role": "Principal Investigator"}, {"name": "Justin Low", "role": "Principal Investigator"}, {"name": "Benjamin Paul Ziemer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44DK136396-03", "company": "X-therma Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-07", "observed": "2026-08-21", "amount_usd": 1100001, "summary": "NIH award 2R44DK136396-03: Phase IIB - Greatly Extended Subzero Ischemic Storage of Renal Allografts Using Novel Bio-inspired Next Generation Cryoprotectants ($1,100,001)", "source_url": "https://reporter.nih.gov/project-details/11405551", "people": [{"name": "Mark A Kline", "role": "Principal Investigator"}, {"name": "Byoung Chol Oh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HG013591-03", "company": "Lase Innovation Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-07", "observed": "2026-08-21", "amount_usd": 900298, "summary": "NIH award 5R44HG013591-03: DNA-optical barcoding technology for spatiotemporal single-cell analysis ($900,298)", "source_url": "https://reporter.nih.gov/project-details/11293464", "people": [{"name": "Sheldon J.J. Kwok", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K261164", "company": "Yongkang Ruihe Metal Product Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261164: Electric wheelchair (XW-LY007 )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261164", "people": [{"name": "Honey Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261164%22"}, {"id": "fda:K261812", "company": "HOYA Lamphun , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261812: HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261812", "people": [{"name": "Timothy Ting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261812%22"}, {"id": "fda:K253942", "company": "Mirion Technologies (Capintec), Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253942: Pulmonex II Xenon System (132-503)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253942", "people": [{"name": "Mary Anne Yusko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253942%22"}, {"id": "fda:K262045", "company": "Coloplast A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262045: Luja Soft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262045", "people": [{"name": "Troy Thome", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262045%22"}, {"id": "fda:K261163", "company": "Yongkang Ruihe Metal Product Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261163: Mobility Scooter (R200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261163", "people": [{"name": "Honey Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261163%22"}, {"id": "fda:K260973", "company": "Beijing Infervision Healthcare Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260973: InferOperate Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260973", "people": [{"name": "Matt Deng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260973%22"}, {"id": "trialreg:NCT07687472", "company": "Kaneka Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous Malformation", "source_url": "https://clinicaltrials.gov/study/NCT07687472"}, {"id": "trialreg:NCT07687485", "company": "Laplace Interventional, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System", "source_url": "https://clinicaltrials.gov/study/NCT07687485"}, {"id": "trialreg:NCT07686328", "company": "LUMA Vision Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Multicenter Feasibility Study With the VERAFEYE Imaging and Guidance System as Anatomical Navigation System", "source_url": "https://clinicaltrials.gov/study/NCT07686328"}, {"id": "trialreg:NCT07686289", "company": "Kubota Vision Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Controlled Evaluation of Optical Defocus Parameters on Transient Changes in Axial Length Using Kubota Glass", "source_url": "https://clinicaltrials.gov/study/NCT07686289"}, {"id": "nih:5R44HL151147-05", "company": "DNA Medicine Institute", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-06", "observed": "2026-08-06", "amount_usd": 1000000, "summary": "NIH award 5R44HL151147-05: Hemophilia Point-of-Care Monitoring Device and App ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11367348", "people": [{"name": "Eugene Yan-ho Chan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44NS139748-02", "company": "Savanna Biotherapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-06", "observed": "2026-08-21", "amount_usd": 1489811, "summary": "NIH award 5R44NS139748-02: Engineered microglia for the treatment of Adult-onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP) ($1,489,811)", "source_url": "https://reporter.nih.gov/project-details/11384453", "people": [{"name": "Sunil Gandhi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41DC023812-01", "company": "Young Tech Solutions LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-06", "observed": "2026-08-21", "amount_usd": 313354, "summary": "NIH award 1R41DC023812-01: Developing a Learning Platform to Support Minimally Verbal Individuals with Autism ($313,354)", "source_url": "https://reporter.nih.gov/project-details/11407400", "people": [{"name": "Sheikh Iqbal Ahamed", "role": "Principal Investigator"}, {"name": "HYUNKYOUNG OH", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K261009", "company": "Waldemar Link GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261009: MobileLink Acetabular Cup System \u0096 40mm ID Inserts (various)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261009", "people": [{"name": "Stefanie Fuchs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261009%22"}, {"id": "fda:K253317", "company": "GC America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253317: Cytrans\u0099 Elashield", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253317", "people": [{"name": "Futoshi Fusejima", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253317%22"}, {"id": "fda:DEN250037", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250037: TESSA Spatial Surgery System; INTELLIO Tablet (72205455)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250037", "people": [{"name": "Pooja Dalvi", "role": "510(k) submission contact"}]}, {"id": "fda:K261529", "company": "Hartman Medical Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261529: Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261529", "people": [{"name": "Pooja Kannam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261529%22"}, {"id": "fda:K260122", "company": "SteriLance Medical (Suzhou), Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260122: Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260122", "people": [{"name": "Susan Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260122%22"}, {"id": "fda:K261909", "company": "PCCA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261909: Plum Vagiceuticals\u0099 Vaginal Moisturizing Suppositories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261909", "people": [{"name": "Daniel Banov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261909%22"}, {"id": "fda:K261465", "company": "Indigo Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261465: INDIRA CLOUD VIEWER", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261465", "people": [{"name": "Andres Felipe Sanabria Diaz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261465%22"}, {"id": "trialreg:NCT07684807", "company": "Corsano Health B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Synchronised ECG and PPG Data Collection for AI-based QT/QTc Reconstruction (ILECS-ECGPPG)", "source_url": "https://clinicaltrials.gov/study/NCT07684807"}, {"id": "trialreg:NCT07684573", "company": "Hanson Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Scar Gel Product Family Clinical Investigation", "source_url": "https://clinicaltrials.gov/study/NCT07684573"}, {"id": "trialreg:NCT07685821", "company": "Sofwave Medical LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: In Vivo Study to Evaluate Tissue Remodeling Via Fibroblast Stimulation Following a Single SofWave Treatment", "source_url": "https://clinicaltrials.gov/study/NCT07685821"}, {"id": "trialreg:NCT07685106", "company": "CardioStory INC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.", "source_url": "https://clinicaltrials.gov/study/NCT07685106"}, {"id": "trialreg:NCT07685834", "company": "Sofwave Medical LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Facial and Neck Skin Laxity With SofWave Treatment in Adults Initiating Tirzepatide for Weight Loss", "source_url": "https://clinicaltrials.gov/study/NCT07685834"}, {"id": "trialreg:NCT07685522", "company": "Vicora, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Vibrato Aspiration System - Simple, Intuitive Approach to Clot Removal in Acute Pulmonary Embolism - a Safety & Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07685522"}, {"id": "trialreg:NCT07684313", "company": "Edwards Lifesciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)", "source_url": "https://clinicaltrials.gov/study/NCT07684313"}, {"id": "trialreg:NCT07684664", "company": "Allurion Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Allurion Gastric Balloon PAS", "source_url": "https://clinicaltrials.gov/study/NCT07684664"}, {"id": "trialreg:NCT07683481", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparing Myopia Control Spectacle Lenses for Visual Comfort, Adaptation, and Satisfaction in Myopic Children", "source_url": "https://clinicaltrials.gov/study/NCT07683481"}, {"id": "trialreg:NCT07682909", "company": "Aesculap AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study", "source_url": "https://clinicaltrials.gov/study/NCT07682909"}, {"id": "trialreg:NCT07684794", "company": "Motif Neurotech, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium - Maintenance", "source_url": "https://clinicaltrials.gov/study/NCT07684794"}, {"id": "trialreg:NCT07683910", "company": "Advantage Silver Dental Arrest, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Sequential PVP-I and FV", "source_url": "https://clinicaltrials.gov/study/NCT07683910"}, {"id": "trialreg:NCT07684885", "company": "GE Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NIBP Study for Neonate and Pediatric Subject Populations", "source_url": "https://clinicaltrials.gov/study/NCT07684885"}, {"id": "trialreg:NCT07685847", "company": "S&R Farmaceutici S.p.A.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of the Efficacy and Safety of a Medical Device in the Form of Rectal Suppositories (Prospidol\u00ae) for the Treatment of Symptoms Associated With Chronic Prostatitis/Chronic Pelvic Pain Syndrome.", "source_url": "https://clinicaltrials.gov/study/NCT07685847"}, {"id": "denovo:DEN250037", "company": "Smith & Nephew, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-07-06", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250037 granted: TESSA Spatial Surgery System; INTELLIO T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250037"}, {"id": "nih:1R43AA032752-01", "company": "Bd Holding, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-03", "observed": "2026-08-21", "amount_usd": 310235, "summary": "NIH award 1R43AA032752-01: Does the Alcohol T Score (ATS) Predict Mortality in the PLCO Population? ($310,235)", "source_url": "https://reporter.nih.gov/project-details/11251163", "people": [{"name": "Robert A Philibert", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K253704", "company": "iHealthscreen, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253704: iPredict-DR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253704", "people": [{"name": "Alauddin Bhuiyan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253704%22"}, {"id": "fda:K260527", "company": "Avinent Implant System S.L.U.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260527: FACE4D Aligner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260527", "people": [{"name": "Anna Cortina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260527%22"}, {"id": "fda:K260528", "company": "Oncosoft. Inc.,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260528: OncoStudio", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260528", "people": [{"name": "Boram Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260528%22"}, {"id": "fda:K252463", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252463: SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252463", "people": [{"name": "Tracy Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252463%22"}, {"id": "fda:K261867", "company": "Cepheid\u00ae", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261867: Xpert Carba-R", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261867", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261867%22"}, {"id": "fda:K261847", "company": "Align Technology , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261847: iTero Lumina\u0099 Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261847", "people": [{"name": "Aviva Touati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261847%22"}, {"id": "fda:K261825", "company": "Abbott", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261825: Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261825", "people": [{"name": "Maddie Cook", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261825%22"}, {"id": "fda:K261880", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261880: FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261880", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261880%22"}, {"id": "fda:K261587", "company": "BPEndo, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261587: Insufflation Retention Device (IRD) (11173-325-101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261587", "people": [{"name": "Robert Hollbrook", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261587%22"}, {"id": "fda:K260755", "company": "Optrascan, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260755: OptraSCAN System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260755", "people": [{"name": "Abhi Gholap", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260755%22"}, {"id": "fda:K261897", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261897: HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261897", "people": [{"name": "Anureet Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261897%22"}, {"id": "fda:K252243", "company": "Suzhou Precigenome, Ltd. Co;", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252243: Fastplex\u0099 BCR-ABL (p210) %IS digital PCR Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252243", "people": [{"name": "Yaqi Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252243%22"}, {"id": "fda:K253463", "company": "Implicity, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253463: ILR ECG Analyzer (IM007)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253463", "people": [{"name": "Caroline Florequin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253463%22"}, {"id": "fda:K260596", "company": "Ventris Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260596: Collagen Wound Powder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260596", "people": [{"name": "John Brunelle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260596%22"}, {"id": "fda:K261129", "company": "Spident Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261129: OrthoFit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261129", "people": [{"name": "Choi Eunok", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261129%22"}, {"id": "fda:DEN250034", "company": "Claria Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250034: Claria System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250034", "people": [{"name": "Brian Fisher", "role": "510(k) submission contact"}]}, {"id": "fda:K253884", "company": "Koios Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253884: Koios DS (3.8)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253884", "people": [{"name": "Michael Bocchinfuso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253884%22"}, {"id": "trialreg:NCT07681154", "company": "Flow Medical Solutions, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism", "source_url": "https://clinicaltrials.gov/study/NCT07681154"}, {"id": "trialreg:NCT07681102", "company": "Magnetic Tides", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Amplitude Modulation Frequency Comparison in Kilohertz Transcranial Magnetic Perturbation (kTMP) for Chronic Stroke", "source_url": "https://clinicaltrials.gov/study/NCT07681102"}, {"id": "trialreg:NCT07680543", "company": "ProVerum Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ProVIDE Studies Post Exit Analysis", "source_url": "https://clinicaltrials.gov/study/NCT07680543"}, {"id": "trialreg:NCT07681375", "company": "DexCom, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom G6 Sensor", "source_url": "https://clinicaltrials.gov/study/NCT07681375"}, {"id": "trialreg:NCT07680673", "company": "Encellin", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ENCRT-103-hPI: Evaluation of an Immune-protected ENCRT-103-hPI Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.", "source_url": "https://clinicaltrials.gov/study/NCT07680673"}, {"id": "trialreg:NCT07681024", "company": "DexCom, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Global Long-term Outcomes and Real-World Evaluation of Dexcom Continuous Glucose Monitoring System (Dexcom GLOW)", "source_url": "https://clinicaltrials.gov/study/NCT07681024"}, {"id": "trialreg:NCT07680244", "company": "Carl Zeiss Meditec-Dublin CoCe", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: (CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000", "source_url": "https://clinicaltrials.gov/study/NCT07680244"}, {"id": "denovo:DEN250034", "company": "Claria Medical, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-07-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250034 granted: Claria System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250034"}, {"id": "nih:9R44MH144943-03", "company": "Modendo Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": 1499367, "summary": "NIH award 9R44MH144943-03: SBIR Phase II: Multi-probe minimally invasive endomicroscope ($1,499,367)", "source_url": "https://reporter.nih.gov/project-details/11255466", "people": [{"name": "Antonio Miguel Caravaca Aguirre", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AI191918-01A1", "company": "Alpacure LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-01", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43AI191918-01A1: A single-domain antibody-based lateral flow assay for Tuberculosis ($300,000)", "source_url": "https://reporter.nih.gov/project-details/11314220", "people": [{"name": "Timothy Andrew Bates", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44MD021154-02", "company": "Malama Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-01", "observed": "2026-08-21", "amount_usd": 1136976, "summary": "NIH award 4R44MD021154-02: A Specialized Risk-Stratification Platform and Tailored Diabetes Prevention Program for Post-Partum to Reduce Progression to Type 2 Diabetes ($1,136,976)", "source_url": "https://reporter.nih.gov/project-details/11424350", "people": [{"name": "Mika Eddy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42GM145129-03", "company": "Odmr Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-01", "observed": "2026-08-21", "amount_usd": 984215, "summary": "NIH award 5R42GM145129-03: Diamond NMR spectrometer for microfluidic metabolite profiling ($984,215)", "source_url": "https://reporter.nih.gov/project-details/11367530", "people": [{"name": "Victor Marcel Acosta", "role": "Principal Investigator"}, {"name": "Andrejs Jarmola", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R43MH139287-02", "company": "3 I", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-01", "observed": "2026-08-21", "amount_usd": 385727, "summary": "NIH award 5R43MH139287-02: High bandwidth all-optical electrophysiology ($385,727)", "source_url": "https://reporter.nih.gov/project-details/11252005", "people": [{"name": "Karl Kilborn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R42AA033287-01", "company": "Behavior Change Hub Limited Liability Company", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-07-01", "observed": "2026-08-21", "amount_usd": 303008, "summary": "NIH award 1R42AA033287-01: Scaling up AUD Information Resources for Provider Education: The Behavioral Health Counseling Competencies AUD Training Suite ($303,008)", "source_url": "https://reporter.nih.gov/project-details/11404111", "people": [{"name": "Molly Magill", "role": "Principal Investigator"}, {"name": "Nadine Rachel Mastroleo", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K261147", "company": "JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261147: Neodent Implant System - NeoConvert Fit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261147", "people": [{"name": "Mariana Hartmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261147%22"}, {"id": "fda:K261889", "company": "Stryker Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261889: Trevo Trak 21 Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261889", "people": [{"name": "Jesse Nelson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261889%22"}, {"id": "fda:K261485", "company": "Ivoclar Vivadent, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261485: Tetric plus Fill;Tetric plus Flow", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261485", "people": [{"name": "Anderjeet Gulati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261485%22"}, {"id": "fda:K261474", "company": "Dentca, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261474: DENTCA Tru Flexible", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261474", "people": [{"name": "Jason Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261474%22"}, {"id": "fda:K253802", "company": "S.m.a.i.o", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253802: KHEIRON\u00ae Spinal Fixation System, including patient specific K-ROD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253802", "people": [{"name": "Jean-Charles Roussouly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253802%22"}, {"id": "fda:K254056", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254056: THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254056", "people": [{"name": "Norikiyo Shibata", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254056%22"}, {"id": "fda:K260556", "company": "Restor3D", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260556: Veritas Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260556", "people": [{"name": "Knox Pittman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260556%22"}, {"id": "fda:K261473", "company": "Termosalud S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261473: Chromix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261473", "people": [{"name": "Cristina Cifuentes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261473%22"}, {"id": "fda:K253420", "company": "SeaSpine Orthopedics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253420: Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253420", "people": [{"name": "Kendal Moulton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253420%22"}, {"id": "fda:K252483", "company": "Chirana T.Injecta,A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252483: Enteral Syringe (20ml, 60ml)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252483", "people": [{"name": "Rastislav Broska", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252483%22"}, {"id": "fda:K253527", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253527: Tri-Staple\u0099 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple\u0099 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253527", "people": [{"name": "Frank Maistrovich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253527%22"}, {"id": "fda:K261021", "company": "Winter Innovations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261021: EasyWhip Family", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261021", "people": [{"name": "Lia Winter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261021%22"}, {"id": "fda:K261852", "company": "Ortoma AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261852: OTS Hip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261852", "people": [{"name": "Fredrik Str\u00f6mberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261852%22"}, {"id": "fda:K253434", "company": "Biomet, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253434: OSSTM Orthopedic Salvage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253434", "people": [{"name": "Yoriko Kobayashi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253434%22"}, {"id": "fda:K262228", "company": "Ultradent Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262228: Transcend Bulk Fill Flowable Composite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262228", "people": [{"name": "Ruth Gardner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262228%22"}, {"id": "fda:K261054", "company": "Stryker Leibinger GmbH & Co KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-07-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261054: RibPlate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261054", "people": [{"name": "Amelia Kesti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261054%22"}, {"id": "trialreg:NCT07679074", "company": "Samphire Group, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life", "source_url": "https://clinicaltrials.gov/study/NCT07679074"}, {"id": "trialreg:NCT07679568", "company": "Fresenius Medical Care Deutschland GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation", "source_url": "https://clinicaltrials.gov/study/NCT07679568"}, {"id": "trialreg:NCT07679035", "company": "Rhaeos, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor", "source_url": "https://clinicaltrials.gov/study/NCT07679035"}, {"id": "trialreg:NCT07679646", "company": "Air Liquide Healthcare Spain", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)", "source_url": "https://clinicaltrials.gov/study/NCT07679646"}, {"id": "trialreg:NCT07679750", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: rTMS Device for Improvement of Obsessive and Compulsive Behaviors", "source_url": "https://clinicaltrials.gov/study/NCT07679750"}, {"id": "trialreg:NCT07679347", "company": "SAVA Technologies Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Performance Evaluation of the SAVA Continuous Glucose Monitor for Effective Glucose Detection", "source_url": "https://clinicaltrials.gov/study/NCT07679347"}, {"id": "trialreg:NCT07677696", "company": "Shandong Branden Med.Device Co.,Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Midline Catheters in Clinical Practice", "source_url": "https://clinicaltrials.gov/study/NCT07677696"}, {"id": "trialreg:NCT07677657", "company": "SpectralMD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Deepview HHF Training and Validation Study", "source_url": "https://clinicaltrials.gov/study/NCT07677657"}, {"id": "trialreg:NCT07678034", "company": "TIPMED Medical Device Manufacturing Ltd. Co.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of T\u0131pmed\u2122 Shoulder Prosthesis System", "source_url": "https://clinicaltrials.gov/study/NCT07678034"}, {"id": "nih:4R44LM014736-02", "company": "Guided Clinical Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-30", "observed": "2026-08-06", "amount_usd": 1085406, "summary": "NIH award 4R44LM014736-02: GuidedOR: A Real-Time Medication Safety Software Platform for the Operating Room ($1,085,406)", "source_url": "https://reporter.nih.gov/project-details/11453697", "people": [{"name": "Karen C Nanji", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI124871-07", "company": "Scanogen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-30", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI124871-07: Bloodstream infection detection directly on whole blood ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11352556", "people": [{"name": "Alfredo Andres Celedon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "nih:1R43DE035410-01", "company": "Petcoil, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-30", "observed": "2026-08-21", "amount_usd": 409779, "summary": "NIH award 1R43DE035410-01: Real-Time Motion Correction Method for a Portable, High-Resolution TOF PET Scanner for Imaging the Brain, Head, and Neck ($409,779)", "source_url": "https://reporter.nih.gov/project-details/11253404", "people": [{"name": "Chenming Chang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K261119", "company": "Imricor Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261119: NorthStar Mapping System (MAP01 or MAP01-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261119", "people": [{"name": "Oksana Alswager", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261119%22"}, {"id": "fda:K261068", "company": "Serpex Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261068: Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261068", "people": [{"name": "Neil Zimmerman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261068%22"}, {"id": "fda:K262195", "company": "Zima International Inc., dba Dandy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K262195: Dandy Ceramic Stain and Glaze", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262195", "people": [{"name": "Nolan Shenai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K262195%22"}, {"id": "fda:K261101", "company": "Ceribell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261101: Ceribell Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261101", "people": [{"name": "Raymond Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261101%22"}, {"id": "fda:K260576", "company": "MeVis Medical Solutions AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260576: MeVis AVM Contour", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260576", "people": [{"name": "Anne Schmidt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260576%22"}, {"id": "fda:K261808", "company": "Microvention Inc. d/b/a Terumo Neuro", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261808: ISAAC Neurovascular Navigation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261808", "people": [{"name": "Miranda Beach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261808%22"}, {"id": "fda:K253767", "company": "Universal Brain", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253767: UB ERP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253767", "people": [{"name": "Kazutaka Okuda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253767%22"}, {"id": "trialreg:NCT07677137", "company": "Man and Science, SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A First-in-human Study to Assess the Initial Safety, Tolerability, and Effectiveness of the ONSS Bilateral Occipital Nerve Field Stimulation System for the Prophylactic Treatment of Chronic Cluster Headache in Difficult-to-treat Subjects.", "source_url": "https://clinicaltrials.gov/study/NCT07677137"}, {"id": "trialreg:NCT07675161", "company": "Medtronic MiniMed, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MiniMed Fit Payload Wear Pediatric Study", "source_url": "https://clinicaltrials.gov/study/NCT07675161"}, {"id": "trialreg:NCT07676643", "company": "Elixir MD Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ELIXIR MDTM Satisfaction Clinical Trial", "source_url": "https://clinicaltrials.gov/study/NCT07676643"}, {"id": "trialreg:NCT07675408", "company": "Fortis Medical Devices Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of cueStim for Reduction of Freezing of Gait in Parkinson's Disease", "source_url": "https://clinicaltrials.gov/study/NCT07675408"}, {"id": "trialreg:NCT07676110", "company": "soundBrilliance LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Impact of Enhanced Music & Natural Visuals on Emotional Health", "source_url": "https://clinicaltrials.gov/study/NCT07676110"}, {"id": "trialreg:NCT07675109", "company": "Noctrix Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Optimizing Extended-Duration (XD-) TOMAC Therapy for Restless Legs Syndrome (RLS)", "source_url": "https://clinicaltrials.gov/study/NCT07675109"}, {"id": "fda:K261052", "company": "Guangdong Newdermo Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261052: LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261052", "people": [{"name": "Junyi Xing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261052%22"}, {"id": "fda:K253969", "company": "Adas3D Medical S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253969: ADAS 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253969", "people": [{"name": "Antoni Riu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253969%22"}, {"id": "fda:K254149", "company": "Sterilmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254149: Reprocessed AcuNav CRYSTAL\u0099 Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL\u0099 Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL\u0099 Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL\u0099 Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254149", "people": [{"name": "Rachel Poltilove", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254149%22"}, {"id": "fda:K260667", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260667: Alturion Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260667", "people": [{"name": "Irma Sandoval-Watt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260667%22"}, {"id": "fda:K261415", "company": "Guilin Kevin Peter Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261415: Injectable Root Canal Sealer (KP-Root SP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261415", "people": [{"name": "Qian Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261415%22"}, {"id": "fda:K261481", "company": "Stryker GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261481: Pangea Femur Reconstruction System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261481", "people": [{"name": "Megan DenBleyker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261481%22"}, {"id": "fda:K261461", "company": "Insulet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261461: Omnipod 6 algorithm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261461", "people": [{"name": "Lavanya Ramnath", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261461%22"}, {"id": "fda:K251492", "company": "New Deantronics Taiwan , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251492: Irrigation Tubing Bipolar Cord Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251492", "people": [{"name": "Hung-Kuei Tsai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251492%22"}, {"id": "fda:K253628", "company": "Agada Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253628: Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253628", "people": [{"name": "Duane Linenkugel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253628%22"}, {"id": "fda:K253484", "company": "Cynosure Lutronic Technology Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253484: LUTRONIC GENIUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253484", "people": [{"name": "Nicole Getman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253484%22"}, {"id": "fda:K260918", "company": "Amann Girrbach AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260918: Zolid Lunaris", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260918", "people": [{"name": "Lisa Fassing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260918%22"}, {"id": "trialreg:NCT07674173", "company": "Shanghai MicroPort Endovascular MedTech\uff08Group\uff09Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-market European & Asian Registry to Evaluate the Minos\u2122 Stent-Graft and Delivery System in Abdominal Aortic Aneurysm Treatment", "source_url": "https://clinicaltrials.gov/study/NCT07674173"}, {"id": "trialreg:NCT07672977", "company": "Bitbrain", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Home-Based Closed-Loop Auditory Stimulation to Enhance Slow-Wave Activity in MCI Due to Alzheimer's Disease: A Proof-of-Concept Study", "source_url": "https://clinicaltrials.gov/study/NCT07672977"}, {"id": "fda:K253390", "company": "Honeynaps Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253390: SOMNUM (SOMNUM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253390", "people": [{"name": "Young Jun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253390%22"}, {"id": "fda:K253301", "company": "Time IS Brain, S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253301: BraiN20\u00ae (BraiN20)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253301", "people": [{"name": "Montserrat Guti\u00e9rrez de Dios", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253301%22"}, {"id": "fda:K261122", "company": "Imagine Milling Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261122: MIST IC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261122", "people": [{"name": "Felix Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261122%22"}, {"id": "nih:5R44DA058474-03", "company": "Opiaid, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": 1132593, "summary": "NIH award 5R44DA058474-03: Development of the OpiAID strength band platform ($1,132,593)", "source_url": "https://reporter.nih.gov/project-details/11300218", "people": [{"name": "Trace Brookins", "role": "Principal Investigator"}, {"name": "David Alderson MacQueen", "role": "Principal Investigator"}, {"name": "WENDY DONLIN WASHINGTON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DC023170-01A1", "company": "Auspex Medix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-26", "observed": "2026-08-21", "amount_usd": 305923, "summary": "NIH award 1R43DC023170-01A1: Developing an AI-Powered Speech Annotation and Transcription Enhancer Tool ($305,923)", "source_url": "https://reporter.nih.gov/project-details/11407819", "people": [{"name": "Wei Bo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH136864-02", "company": "Groupware Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-26", "observed": "2026-08-21", "amount_usd": 750996, "summary": "NIH award 5R44MH136864-02: A unified eligibility application and determination system to increase Ryan White linkage to care and retention in care by reducing structural barriers and facilitating client engagement ($750,996)", "source_url": "https://reporter.nih.gov/project-details/11321251", "people": [{"name": "Bob Harrison Hedgcock", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K253921", "company": "Silony Medical GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253921: VERTICALE\u00ae Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253921", "people": [{"name": "David Weckler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253921%22"}, {"id": "fda:K260018", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260018: Arthrex FiberButton", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260018", "people": [{"name": "Rebecca Homan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260018%22"}, {"id": "fda:K250070", "company": "Shenzhen Changkun Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250070: Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250070", "people": [{"name": "Qingpeng Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250070%22"}, {"id": "fda:K260412", "company": "Shenzhen Dongdixin Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260412: TENS 7000 Rechargeable 4 Channel (TENS 7000H)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260412", "people": [{"name": "Siping Yuan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260412%22"}, {"id": "fda:K253316", "company": "Phast Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253316: PhAST instrument and PhAST Blood Culture Gram-negative Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253316", "people": [{"name": "Roman Stocker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253316%22"}, {"id": "fda:K260714", "company": "Therapixel", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260714: MammoScreen\u00ae (5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260714", "people": [{"name": "Shalyna Long Bansropun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260714%22"}, {"id": "fda:K254232", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254232: ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254232", "people": [{"name": "Corinne Yestrepsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254232%22"}, {"id": "fda:K261455", "company": "Spectrum Vascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261455: Arterial Pressure Monitoring Set/Tray", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261455", "people": [{"name": "Sharon Klugewicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261455%22"}, {"id": "fda:K261745", "company": "ElectroWire Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261745: LightningWire Transseptal Puncture System (TPS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261745", "people": [{"name": "Robert (Bobby) Leonardi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261745%22"}, {"id": "fda:K261253", "company": "Ziree Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261253: Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261253", "people": [{"name": "Aijie Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261253%22"}, {"id": "fda:K253306", "company": "Biotracker, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253306: BioTracker 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253306", "people": [{"name": "Breno Moreira", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253306%22"}, {"id": "fda:K260061", "company": "BioHorizons Implant Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260061: BioHorizons CEREC Compatible Ti-Bases", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260061", "people": [{"name": "Amanda Hatley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260061%22"}, {"id": "fda:K261039", "company": "Abbott Point of Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261039: i-STAT Crea cartridge with the i-STAT 1 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261039", "people": [{"name": "Brian Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261039%22"}, {"id": "fda:K261351", "company": "Bonebridge AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261351: SALGINA 2.5mm Distal Radius System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261351", "people": [{"name": "Salome Bruetsch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261351%22"}, {"id": "fda:K261442", "company": "Cadwell Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261442: Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261442", "people": [{"name": "Jason Ford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261442%22"}, {"id": "pma:P250055", "company": "Artivion, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-06-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250055: AMDS Hybrid Prosthesis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250055", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250055%22"}, {"id": "trialreg:NCT07671027", "company": "Piezo Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PIEZO-101 First-in-Human Safety and Proof-of-Concept Study", "source_url": "https://clinicaltrials.gov/study/NCT07671027"}, {"id": "trialreg:NCT07671820", "company": "Lifecord Otd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Anchord Mitral Chordal Repair System - FIH", "source_url": "https://clinicaltrials.gov/study/NCT07671820"}, {"id": "breakthrough:K253316", "company": "Phast Corp.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-06-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K253316: PHAST INSTRUMENT AND PHAST BLOOD CULTURE GRAM-NEGATIVE PANEL", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R42AG059475-05", "company": "Advanced Smart Systems/evaluation Techno", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": 1629186, "summary": "NIH award 5R42AG059475-05: Mitigating Injurious Falls in Older Adults Through Non-Injurious Fall and Gait Analysis From Floor Vibrations ($1,629,186)", "source_url": "https://reporter.nih.gov/project-details/11420561", "people": [{"name": "Stacy Lynne Fritz", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R42AG084399-03", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-25", "observed": "2026-08-21", "amount_usd": 999317, "summary": "NIH award 5R42AG084399-03: Developing a novel system combining cognitive assessment with PASCALL FDA-cleared intraoperative anesthesia EEG brain monitor to prevent postoperative neurocognitive disorders in aging patients ($999,317)", "source_url": "https://reporter.nih.gov/project-details/11400076", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R43AG094486-02", "company": "Advanced Brain Monitoring, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-25", "observed": "2026-08-21", "amount_usd": 365227, "summary": "NIH award 5R43AG094486-02: Characterizing neurocognitive deficits in post-acute sequelae of COVID-19 ($365,227)", "source_url": "https://reporter.nih.gov/project-details/11417238", "people": [{"name": "Jennifer Graves", "role": "Principal Investigator"}, {"name": "Amir Hossein Meghdadi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "fda:K253274", "company": "Intelligent Dots, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253274: BedDot (G1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253274", "people": [{"name": "WenZhan Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253274%22"}, {"id": "fda:K261458", "company": "DePuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261458: ATTUNE Total Knee System; ATTUNE Cementless Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261458", "people": [{"name": "Paige Myers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261458%22"}, {"id": "fda:K253367", "company": "Phadia AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253367: EliA CTD 13 Screen", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253367", "people": [{"name": "Darleen Welford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253367%22"}, {"id": "fda:K260480", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260480: VELYS\u0099 Robotic-Assisted Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260480", "people": [{"name": "Camille Chua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260480%22"}, {"id": "fda:K253216", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253216: IntraOp Alignment System; CONTOUR3D Bending System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253216", "people": [{"name": "Unnati Bhuptani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253216%22"}, {"id": "fda:K260231", "company": "Apryse Software Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260231: MiPACS V5 (1.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260231", "people": [{"name": "Hilal Chami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260231%22"}, {"id": "fda:K253394", "company": "ETHICON, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253394: Coated VICRYL\u0099 (Polyglactin 910) Plus Antibacterial Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253394", "people": [{"name": "Ryan Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253394%22"}, {"id": "fda:K252584", "company": "Weyo Surgical Technology , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252584: Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252584", "people": [{"name": "Jianfeng Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252584%22"}, {"id": "fda:K253330", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253330: A5 Anesthesia System (A5); A7 Anesthesia System (A7)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253330", "people": [{"name": "Li Lei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253330%22"}, {"id": "fda:K253384", "company": "Seers Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253384: mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253384", "people": [{"name": "Stan Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253384%22"}, {"id": "fda:K261025", "company": "Shenzhen Qinyi Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261025: Wearable breast pump (QY-101, QY-102, QY-108)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261025", "people": [{"name": "Chen Gu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261025%22"}, {"id": "fda:K260809", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260809: Arthrex Sterile VAL and VAL KreuLock\u0099 Compression Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260809", "people": [{"name": "Konrad Wolfmeyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260809%22"}, {"id": "fda:K260790", "company": "ASESSO HEALTH, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260790: G-Series Grind Guard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260790", "people": [{"name": "Abhijit Limaye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260790%22"}, {"id": "fda:K260709", "company": "Longeviti Neuro Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260709: ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260709", "people": [{"name": "Brooke Lindsey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260709%22"}, {"id": "fda:K253386", "company": "Vistar Medical Supplies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253386: DVT Garment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253386", "people": [{"name": "Chainy Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253386%22"}, {"id": "fda:K251188", "company": "Uniqa Dental, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251188: UNIQA\u00ae Dental Implants System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251188", "people": [{"name": "Dima Goberman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251188%22"}, {"id": "fda:K260992", "company": "Neuralytix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260992: iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260992", "people": [{"name": "Brian Dean", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260992%22"}, {"id": "fda:K254108", "company": "GN Hearing A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254108: Jabra Enhance Select Self-fit (Jabra Enhance Select 550)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254108", "people": [{"name": "Lars Hagander", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254108%22"}, {"id": "fda:K261242", "company": "Pendracare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261242: SimplGuide", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261242", "people": [{"name": "Erendira Rodriguez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261242%22"}, {"id": "fda:K253786", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253786: syngo.CT Coronary Cockpit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253786", "people": [{"name": "Kenny M Bello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253786%22"}, {"id": "trialreg:NCT07668089", "company": "HeartEye", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Application of a New Handheld ECG Device", "source_url": "https://clinicaltrials.gov/study/NCT07668089"}, {"id": "trialreg:NCT07668687", "company": "Shanghai MicroPort Endovascular MedTech\uff08Group\uff09Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: European Multi-Centre Post-Market Registry on Thoracic Endovascular Arch Repair Using Castor\u2122 and Cratos\u2122", "source_url": "https://clinicaltrials.gov/study/NCT07668687"}, {"id": "trialreg:NCT07668102", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Visual Performance of Highly Aspherical Lenslet Spectacles in Children (Ancillary to WS10246)", "source_url": "https://clinicaltrials.gov/study/NCT07668102"}, {"id": "trialreg:NCT07667777", "company": "Asklepios proresearch", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effect of a Cervical Pessary on the Rate of Bleeding in Placenta Praevia", "source_url": "https://clinicaltrials.gov/study/NCT07667777"}, {"id": "trialreg:NCT07669727", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.", "source_url": "https://clinicaltrials.gov/study/NCT07669727"}, {"id": "trialreg:NCT07668258", "company": "Exosystems", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial to Evaluate the Efficacy of Neuromuscular Electrical Stimulation Therapy in Patients With Sarcopenia", "source_url": "https://clinicaltrials.gov/study/NCT07668258"}, {"id": "fda:K261866", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261866: Concerto Versa\u0099 Detachable Coil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261866", "people": [{"name": "Rishu Rathee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261866%22"}, {"id": "fda:K260937", "company": "Shanghai Waylong Intelligent Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260937: Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260937", "people": [{"name": "Jin Chunxiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260937%22"}, {"id": "fda:K253263", "company": "Convatec Limited, Gdc Building", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253263: ConvaVAC\u0099 Negative Pressure Wound Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253263", "people": [{"name": "Michelle Campbell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253263%22"}, {"id": "fda:K260394", "company": "Hangzhou Jimushi Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260394: Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260394", "people": [{"name": "Fenlong Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260394%22"}, {"id": "fda:K261772", "company": "Stryker Neurovscular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261772: Target Xtra Detachable Coil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261772", "people": [{"name": "Zach Borla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261772%22"}, {"id": "fda:K260998", "company": "Ceribell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260998: Ceribell Neurology Review Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260998", "people": [{"name": "Raymond Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260998%22"}, {"id": "fda:K252117", "company": "Sw Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252117: Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252117", "people": [{"name": "Michael Van Sunder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252117%22"}, {"id": "fda:K251929", "company": "Silverceuticals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251929: SilverCeuticals\u00ae Antimicrobial Wound Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251929", "people": [{"name": "Cameron Moeller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251929%22"}, {"id": "fda:K260669", "company": "Aroa Biosurgery , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260669: Endoform Dermal Template", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260669", "people": [{"name": "Thanh Minh Lam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260669%22"}, {"id": "fda:K253404", "company": "Insera Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253404: CLEAR\u0099 Aspiration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253404", "people": [{"name": "Vallabh Janardhan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253404%22"}, {"id": "fda:K261260", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261260: HD Camera Head OLYMPUS CH-S200-08-LB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261260", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261260%22"}, {"id": "fda:K253393", "company": "Hangzhou AGS MedTech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253393: Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253393", "people": [{"name": "Kai Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253393%22"}, {"id": "fda:K261055", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261055: AMSCO 700 Steam Sterilizer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261055", "people": [{"name": "Karly Eitzman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261055%22"}, {"id": "fda:K261023", "company": "Sonoma Pharmaceuticals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261023: Microdacyn Wound Irrigation Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261023", "people": [{"name": "Arturo Angel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261023%22"}, {"id": "fda:K253560", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253560: Enhanced Boundary for PCCT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253560", "people": [{"name": "Veronica Aguayo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253560%22"}, {"id": "trialreg:NCT07666997", "company": "Elle, MD Biotechnologies Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety of a Contraceptive Copper Vaginal Ring", "source_url": "https://clinicaltrials.gov/study/NCT07666997"}, {"id": "trialreg:NCT07666087", "company": "Diabetis JSC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pilot Usability Study to Set Up and Use the Feetsee\u2122 Foot Monitoring Device in Adults With Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07666087"}, {"id": "trialreg:NCT07664943", "company": "Universal Adherence LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The iD2: A Smart Eye Drop Cap Monitor for Eye Drop Adherence", "source_url": "https://clinicaltrials.gov/study/NCT07664943"}, {"id": "trialreg:NCT07667140", "company": "Wsaud A/s", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Standard Post Market Clinical Follow-up (PMCF) Study WSA 2026", "source_url": "https://clinicaltrials.gov/study/NCT07667140"}, {"id": "trialreg:NCT07664267", "company": "EverEx Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of MORA Cure LBP in Patients With Chronic Low Back Pain", "source_url": "https://clinicaltrials.gov/study/NCT07664267"}, {"id": "trialreg:NCT07666828", "company": "Joey Porter", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Three Neuromuscular Electrical Stimulation Foot Pad Programmes on Lower Limb Haemodynamics in Healthy Adults", "source_url": "https://clinicaltrials.gov/study/NCT07666828"}, {"id": "nih:1R43DK146580-01", "company": "Quintero & Kontopoulos PLLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-23", "observed": "2026-08-06", "amount_usd": 301099, "summary": "NIH award 1R43DK146580-01: The Q-shunt: Prototype development of a medical device to treat fetal bladder outlet obstruction ($301,099)", "source_url": "https://reporter.nih.gov/project-details/11313587", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM159468-01A1", "company": "Potomac Affinity Proteins, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-23", "observed": "2026-08-21", "amount_usd": 377602, "summary": "NIH award 1R43GM159468-01A1: Self-amplifying protease chain reactions for simple, sensitive, and quantitative detection ($377,602)", "source_url": "https://reporter.nih.gov/project-details/11408934", "people": [{"name": "PHILIP N BRYAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44TR005899-01A1", "company": "Cytoterra Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-23", "observed": "2026-08-21", "amount_usd": 957707, "summary": "NIH award 1R44TR005899-01A1: Comprehensive Genomic Integrity Assessment for Allogenic Cell Therapies using Genomic proximity mapping ($957,707)", "source_url": "https://reporter.nih.gov/project-details/11407114", "people": [{"name": "Stephen Matthew Eacker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA065300-01", "company": "Scientific Horizons Consulting LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-23", "observed": "2026-08-21", "amount_usd": 399250, "summary": "NIH award 1R43DA065300-01: Water Inhalable Nicotine (WIN) as An Innovative Orally Inhaled Nicotine Replacement Therapy (NRT) for Smoking Cessation ($399,250)", "source_url": "https://reporter.nih.gov/project-details/11311203", "people": [{"name": "Xiang Gao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44DA062284-02", "company": "Evidation Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-23", "observed": "2026-08-21", "amount_usd": 2023761, "summary": "NIH award 4R44DA062284-02: Research and Engagement on Substance use Harnessing Awareness and Personalized Education (RESHAPE) ($2,023,761)", "source_url": "https://reporter.nih.gov/project-details/11400265", "people": [{"name": "Christian Jules Cerrada", "role": "Principal Investigator"}, {"name": "Monika Jain", "role": "Principal Investigator"}, {"name": "Joyce Nortey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DA064773-01", "company": "Nefer Ka LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-23", "observed": "2026-08-21", "amount_usd": 311380, "summary": "NIH award 1R43DA064773-01: Economical, easy-to-use and highly sensitive illicit drugs detection in bodily fluids using surface-enhanced Raman scattering (SERS). ($311,380)", "source_url": "https://reporter.nih.gov/project-details/11290539", "people": [{"name": "Magued Nasr", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NR021724-02", "company": "Q-rounds Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-23", "observed": "2026-08-21", "amount_usd": 1035750, "summary": "NIH award 5R44NR021724-02: Q-rounds: Making Multi-Disciplinary Family Centered Rounds and Achievable Standard of Care through Novel Virtual Rounding Features ($1,035,750)", "source_url": "https://reporter.nih.gov/project-details/11398043", "people": [{"name": "Michael B Pitt", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K253199", "company": "CG Bio Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253199: CURASYS 2 (EMDN0003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253199", "people": [{"name": "Youngwook Moon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253199%22"}, {"id": "fda:K253211", "company": "Procept Biorobotics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253211: AQUABEAM Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253211", "people": [{"name": "Ankur Kaushal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253211%22"}, {"id": "fda:K253180", "company": "Microlife Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253180: Microlife Digital Peak Flow Meter, Model PF200B (PF200B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253180", "people": [{"name": "Jimmy Deng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253180%22"}, {"id": "fda:K261004", "company": "Integra Lifesciences Production Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261004: Codman\u00ae Distal Peritoneal Catheter, Barium Open End (82-1682); Codman\u00ae HOLTER\u00ae Peritoneal Catheter (SALMON Design) (82-1684)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261004", "people": [{"name": "Leigh Anne Diener", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261004%22"}, {"id": "trialreg:NCT07663305", "company": "Endo Health GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Mobile Menopause Application", "source_url": "https://clinicaltrials.gov/study/NCT07663305"}, {"id": "trialreg:NCT07663487", "company": "Sirtex Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study Evaluating the Safety and Efficacy of Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres\u00ae Y-90 Resin Microspheres to Bridge or Downstage Patients With Hepatocellular Carcinoma (HCC) to Liver Transplant or Resection and Elicit Pathologic Necrosis.", "source_url": "https://clinicaltrials.gov/study/NCT07663487"}, {"id": "fda:K261279", "company": "Nexus Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261279: DeltaNEC Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261279", "people": [{"name": "Jared Crocker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261279%22"}, {"id": "fda:K253148", "company": "Vivaquant, Inc. Dba Rhythm Express", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253148: RX-1 Sleep", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253148", "people": [{"name": "Brian Brockway", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253148%22"}, {"id": "fda:K261075", "company": "GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261075: Manual Wheelchair (MS01);Manual Wheelchair (MA01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261075", "people": [{"name": "Sally Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261075%22"}, {"id": "fda:K254287", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254287: Medline Reusable Blood Pressure Cuff", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254287", "people": [{"name": "Kelsey Closen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254287%22"}, {"id": "fda:K254011", "company": "LBDO Group, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254011: Flow Water-Based Personal Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254011", "people": [{"name": "Joshua Benjamin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254011%22"}, {"id": "fda:K261342", "company": "Prodeon Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261342: Urocross Expander System (UES-2018-C1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261342", "people": [{"name": "Elaine Aplaon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261342%22"}, {"id": "fda:K260316", "company": "Cercare Medical A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260316: CMN Capillary Function with Oncology Virtual Expert", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260316", "people": [{"name": "Mikkel Bo Hansen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260316%22"}, {"id": "fda:K261076", "company": "GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261076: Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261076", "people": [{"name": "Sally Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261076%22"}, {"id": "fda:K253176", "company": "Beyond 700 Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253176: TearView", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253176", "people": [{"name": "Burkhardt Schuett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253176%22"}, {"id": "fda:K261950", "company": "Health Line International Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261950: Health Line Tearaway Introducer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261950", "people": [{"name": "Aaron Faulkner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261950%22"}, {"id": "fda:K253421", "company": "Quantified Imaging Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253421: Perfusion Measurement Platform v1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253421", "people": [{"name": "Armen Bodossian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253421%22"}, {"id": "pma:P240033", "company": "Lung Bioengineering, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-06-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240033: Centralized Lung Evaluation System (CLES)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240033", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240033%22"}, {"id": "trialreg:NCT07660185", "company": "Shenzhen Lifevalve Medical Scientific Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation", "source_url": "https://clinicaltrials.gov/study/NCT07660185"}, {"id": "trialreg:NCT07659288", "company": "Neuro Group XR Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparison of Immersive and Non-Immersive Virtual Reality Rehabilitation in Parkinson's Disease", "source_url": "https://clinicaltrials.gov/study/NCT07659288"}, {"id": "trialreg:NCT07661121", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain Relief", "source_url": "https://clinicaltrials.gov/study/NCT07661121"}, {"id": "trialreg:NCT07661082", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain", "source_url": "https://clinicaltrials.gov/study/NCT07661082"}, {"id": "trialreg:NCT07658651", "company": "Hangzhou Endonom Medtech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: WeFlow-EndoSeal\u2122 Aorta Vascular Plug System for the Treatment of Stanford Type B Aortic Dissection", "source_url": "https://clinicaltrials.gov/study/NCT07658651"}, {"id": "trialreg:NCT07661706", "company": "GE Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Collection of New Spectral CT Imaging Method", "source_url": "https://clinicaltrials.gov/study/NCT07661706"}, {"id": "trialreg:NCT07660354", "company": "Oystershell NV", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).", "source_url": "https://clinicaltrials.gov/study/NCT07660354"}, {"id": "trialreg:NCT07659366", "company": "Nexalin Technology", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: HALO Clarity\u2122 Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia", "source_url": "https://clinicaltrials.gov/study/NCT07659366"}, {"id": "trialreg:NCT07661004", "company": "L'Oreal", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage .", "source_url": "https://clinicaltrials.gov/study/NCT07661004"}, {"id": "fda:K260369", "company": "LEM Surgical AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260369: Dynamis Robotic Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260369", "people": [{"name": "Yossi Bar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260369%22"}, {"id": "nih:5R44NS121555-05", "company": "Rhaeos, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-19", "observed": "2026-08-06", "amount_usd": 965691, "summary": "NIH award 5R44NS121555-05: Enhancing Healthcare Delivery and Patient Outcomes: Noninvasive Wireless Sensors to Improve Ventricular Shunt Monitoring, Reduce Imaging, and Alleviate the Burden on Providers, Patients, and Families ($965,691)", "source_url": "https://reporter.nih.gov/project-details/11241988", "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44DE035026-02", "company": "Matregenix", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-19", "observed": "2026-08-06", "amount_usd": 1119000, "summary": "NIH award 5R44DE035026-02: Enhancing Dental and Craniomaxillofacial Surgery Outcomes with Cost-Effective and Scalable Animal-Free Amino Acid-Based Membranes for Guided Bone Regeneration ($1,119,000)", "source_url": "https://reporter.nih.gov/project-details/11460454", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R41NS137850-02", "company": "Intrinsic Powers, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-19", "observed": "2026-08-21", "amount_usd": 467771, "summary": "NIH award 5R41NS137850-02: Portable TMS-EEG device for bedside detection of covert consciousness ($467,771)", "source_url": "https://reporter.nih.gov/project-details/11353794", "people": [{"name": "Melanie Boly", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43DA064718-01", "company": "Skm Instruments, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-19", "observed": "2026-08-21", "amount_usd": 314317, "summary": "NIH award 1R43DA064718-01: Low-Cost, User-Friendly SERS Technology for Rapid Detection of Emerging Drug Threats ($314,317)", "source_url": "https://reporter.nih.gov/project-details/11286694", "people": [{"name": "Keith Carron", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS143484-02", "company": "Great Lakes Neurotechnologies", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-19", "observed": "2026-08-21", "amount_usd": 926671, "summary": "NIH award 5R44NS143484-02: DBS-Expert Pro: Automated Deep Brain Stimulation Programming Using Functional Mapping ($926,671)", "source_url": "https://reporter.nih.gov/project-details/11398197", "people": [{"name": "Dustin A. Heldman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM159519-02", "company": "Panluminate Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-19", "observed": "2026-08-21", "amount_usd": 1083410, "summary": "NIH award 5R44GM159519-02: pan-XLSM: an AI-powered microscopy platform for imaging and analysis of highly expanded tissue samples ($1,083,410)", "source_url": "https://reporter.nih.gov/project-details/11386488", "people": [{"name": "Ons M'Saad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K261707", "company": "Corcym S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261707: MEMO 4D Curve\u0099 Semirigid mitral annuloplasty ring", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261707", "people": [{"name": "Silvia Contadini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261707%22"}, {"id": "fda:K253050", "company": "Informai", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253050: RadOncAI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253050", "people": [{"name": "Jim Havelka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253050%22"}, {"id": "fda:K253521", "company": "Ecm Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253521: ECMT-100 WMD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253521", "people": [{"name": "Russell Kronengold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253521%22"}, {"id": "fda:K252066", "company": "Vincent Healthcare Products Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252066: inspired\u0099 Heated Breathing Circuit (510-008); inspired\u0099 Heated Breathing Circuit (510-009); inspired\u0099 Auto-feed Humidification Chamber (VHC10); inspired\u0099 Auto-feed Humidification Chamber (VHC20)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252066", "people": [{"name": "Thomas Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252066%22"}, {"id": "fda:K252839", "company": "Zywie, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252839: ZywieZ3 Sensor & Adhesive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252839", "people": [{"name": "Latha Ganeshan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252839%22"}, {"id": "fda:K253776", "company": "W&H Dentalwerk Buermoos GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253776: Implantmed Plus II & Piezomed Plus II Module", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253776", "people": [{"name": "Weidler Gerhard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253776%22"}, {"id": "fda:K260190", "company": "ROPCA ApS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260190: ARTHUR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260190", "people": [{"name": "Trine Winther", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260190%22"}, {"id": "fda:K261713", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261713: Synapse PACS (7.6.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261713", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261713%22"}, {"id": "fda:K260946", "company": "Guangdong Newdermo Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260946: LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260946", "people": [{"name": "Junyi Xing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260946%22"}, {"id": "fda:K261701", "company": "Micro-Energy Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261701: Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261701", "people": [{"name": "Danning Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261701%22"}, {"id": "fda:K253110", "company": "Sol-Millennium Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253110: Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253110", "people": [{"name": "Mike Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253110%22"}, {"id": "fda:K261651", "company": "NuVasive Specialized Orthopedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261651: Precice\u0099 Max System and Precice\u0099 Ankle Salvage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261651", "people": [{"name": "Suganya Gopalakrishnan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261651%22"}, {"id": "fda:K252982", "company": "Avalign Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252982: CONDUIT\u0099 ZERO-P\u0099 VA Secured Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252982", "people": [{"name": "Jennifer Staunton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252982%22"}, {"id": "fda:K253678", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253678: MAMMOMAT B.brilliant (11372950)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253678", "people": [{"name": "Denise Adams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253678%22"}, {"id": "fda:K251559", "company": "True Indicating, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251559: InstaTRU Instant Biological Indicator for Steam (IBI-05)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251559", "people": [{"name": "Thomas Riha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251559%22"}, {"id": "fda:K261665", "company": "Providence Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261665: CORUS\u0099 Navigation System-GN", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261665", "people": [{"name": "Edward Liou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261665%22"}, {"id": "fda:K261246", "company": "GC America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261246: SRGC-06", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261246", "people": [{"name": "Futoshi Fusejima", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261246%22"}, {"id": "fda:K261099", "company": "Daxor Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261099: Blood Volume Analyzer (200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261099", "people": [{"name": "Jonathan Feldschuh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261099%22"}, {"id": "fda:DEN250025", "company": "Autonomous Healthcare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250025: Syncron-E", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250025", "people": [{"name": "Behnood Gholami", "role": "510(k) submission contact"}]}, {"id": "fda:K253131", "company": "Guangzhou Rebornendo Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253131: Curing Light (M-Cure 6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253131", "people": [{"name": "Cuimei Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253131%22"}, {"id": "fda:K253812", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253812: Power Wheelchair (W5915B, W5915C, W5915D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253812", "people": [{"name": "Yolanda Ge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253812%22"}, {"id": "fda:K260820", "company": "Vieworks Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260820: VIVIX-S 4386W (FXRD-4386WA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260820", "people": [{"name": "Juin Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260820%22"}, {"id": "fda:K251232", "company": "Megagen Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251232: MegaGen Zygoma Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251232", "people": [{"name": "Hyo-Eun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251232%22"}, {"id": "fda:K260178", "company": "Shenzhen Konmed Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260178: Pelvic Muscle Trainer (KM510, KM516B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260178", "people": [{"name": "Tong Yin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260178%22"}, {"id": "fda:K253187", "company": "Mastel Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253187: SteriBest\u00ae Sterilization Tray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253187", "people": [{"name": "Patrick Haney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253187%22"}, {"id": "fda:K253824", "company": "Kanglongda Vietnam Protection Technology Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253824: Powder Free Nitrile Examination Gloves Non-Sterile Black", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253824", "people": [{"name": "Thamira Ranasinghe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253824%22"}, {"id": "fda:K253058", "company": "Shantou Institute of Ultrasonic Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253058: Portable DR Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253058", "people": [{"name": "Zeqin Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253058%22"}, {"id": "fda:K254254", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254254: Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254254", "people": [{"name": "Caitlin Liang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254254%22"}, {"id": "fda:K260280", "company": "Hycor Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260280: NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260280", "people": [{"name": "Aashrey Kaul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260280%22"}, {"id": "fda:K260636", "company": "Stryker Sustainability Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260636: Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260636", "people": [{"name": "Scott English", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260636%22"}, {"id": "fda:K253116", "company": "The Surgeon General, Department of the Army (TSG-DA)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253116: 3D MAC Titanium Cranial Plate (TCP) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253116", "people": [{"name": "Emily Badraslioglu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253116%22"}, {"id": "fda:K260729", "company": "GuideAI Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260729: Vascular Assist Occlusion Triage (VAOT) (v1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260729", "people": [{"name": "Raj Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260729%22"}, {"id": "fda:K250806", "company": "A.B. Dental Devices , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250806: Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250806", "people": [{"name": "Victoria Zabit", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250806%22"}, {"id": "fda:K253080", "company": "Suzhou and Science & Technology Development Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253080: AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253080", "people": [{"name": "Limin Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253080%22"}, {"id": "fda:K254169", "company": "Presage Security, Inc. d/b/a Presage Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254169: SmartSpectra Vital Signs Monitor 1.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254169", "people": [{"name": "Michael Kenney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254169%22"}, {"id": "fda:K253126", "company": "Shenzhen Ziqing Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253126: Wrist Blood Pressure Monitor (XW-05)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253126", "people": [{"name": "Yongsheng Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253126%22"}, {"id": "pma:P220016", "company": "Hepquant, LLC", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-06-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P220016: HepQuant SHUNT\u00ae Liver Diagnostic Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220016", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P220016%22"}, {"id": "trialreg:NCT07655895", "company": "Europa Life Sciences Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Case Series of Infants With Anterior Ankyloglossia Being Treated by the Sublingual Neonatal Incision Platform Device", "source_url": "https://clinicaltrials.gov/study/NCT07655895"}, {"id": "trialreg:NCT07658027", "company": "Cereneo AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Vestibular Stimulation in Sleep for Neurorehabilitation Patients", "source_url": "https://clinicaltrials.gov/study/NCT07658027"}, {"id": "trialreg:NCT07655505", "company": "Intuitive Surgical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair", "source_url": "https://clinicaltrials.gov/study/NCT07655505"}, {"id": "trialreg:NCT07657247", "company": "YSLab", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of the Efficacy of a Nasal Spray in the Treatment of Nasal Dryness", "source_url": "https://clinicaltrials.gov/study/NCT07657247"}, {"id": "denovo:DEN250025", "company": "Autonomous Healthcare, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-06-18", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250025 granted: Syncron-E", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250025"}, {"id": "fda:K253155", "company": "Beijing Fule Science & Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253155: Fule Metallic Lockable Intramedullary Nail Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253155", "people": [{"name": "Xiaoliang Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253155%22"}, {"id": "fda:K260916", "company": "Portal Access, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260916: FLEXI-PORT\u0099 Power Injectable Implantable Port", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260916", "people": [{"name": "Hila Ravid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260916%22"}, {"id": "fda:K260538", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260538: Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260538", "people": [{"name": "Baihan Feng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260538%22"}, {"id": "fda:K261638", "company": "Oneness Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261638: Bonvadis\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261638", "people": [{"name": "Angel Hsieh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261638%22"}, {"id": "fda:K261672", "company": "Deka Research and Development", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261672: twiist Automated Insulin Delivery (AID) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261672", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261672%22"}, {"id": "fda:K253045", "company": "Socko Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253045: \u0093Socko\u0094 Vimax Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253045", "people": [{"name": "Ariel Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253045%22"}, {"id": "fda:K260006", "company": "Inosys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260006: INOSS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260006", "people": [{"name": "Calvin Shim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260006%22"}, {"id": "fda:K260428", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260428: RIVOS\u0099 EUS Access Device (M00553900)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260428", "people": [{"name": "Yingying Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260428%22"}, {"id": "fda:K253634", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253634: CoolSeal Generator\u00ae (CSL-200-90)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253634", "people": [{"name": "Brynn Dietzel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253634%22"}, {"id": "fda:K253333", "company": "Hua Yue Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253333: Assisted Reproduction Laser System (Model ILS-400M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253333", "people": [{"name": "Zhenzhi Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253333%22"}, {"id": "fda:K261570", "company": "Cynosure, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261570: PICOSURE WORKSTATION", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261570", "people": [{"name": "Sean Reynolds", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261570%22"}, {"id": "fda:K252399", "company": "Honsun (Nantong) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252399: Portable Oxygen Concentrator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252399", "people": [{"name": "Jian Shen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252399%22"}, {"id": "fda:K253255", "company": "Foshan Pingchuang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253255: Non-Sterile Ultrasound Gel Sterile Ultrasound Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253255", "people": [{"name": "Anthony Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253255%22"}, {"id": "fda:K253055", "company": "Nordic Kinetics AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253055: Sine Monitoring Parkinson\u0092s Disease Tremor Dyskinesia Apple Watch (\u0093SMPDTDAW\u0094)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253055", "people": [{"name": "Jakob V. E. Gerstl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253055%22"}, {"id": "fda:K261631", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261631: Amplatzer TorqVue Exchange System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261631", "people": [{"name": "Nicolette Pedersen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261631%22"}, {"id": "fda:K260867", "company": "Hartalega NGC Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260867: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260867", "people": [{"name": "Kuan Mun Leong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260867%22"}, {"id": "fda:K261544", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261544: Hydro Irrigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261544", "people": [{"name": "Divya Sekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261544%22"}, {"id": "trialreg:NCT07653204", "company": "Austral Diagnostics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Contactless Ultrasound Data Acquisition in Emergency Departments to Discriminate the Origin of Dyspnea and Chest Pain", "source_url": "https://clinicaltrials.gov/study/NCT07653204"}, {"id": "trialreg:NCT07653243", "company": "Aquilo Sports, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Home-Based Lower-Extremity Heat Therapy for Walking Function in Peripheral Artery Disease", "source_url": "https://clinicaltrials.gov/study/NCT07653243"}, {"id": "trialreg:NCT07655401", "company": "Mode Sensors AS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring", "source_url": "https://clinicaltrials.gov/study/NCT07655401"}, {"id": "trialreg:NCT07653295", "company": "TIPMED Medical Device Manufacturing Ltd. Co.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of T\u0131pmed\u2122 Revision Hip Prosthesis System", "source_url": "https://clinicaltrials.gov/study/NCT07653295"}, {"id": "trialreg:NCT07654491", "company": "Withings", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Withings HFRN Retrospective Study", "source_url": "https://clinicaltrials.gov/study/NCT07654491"}, {"id": "nih:5R44HL147734-05", "company": "Retham Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": 1693897, "summary": "NIH award 5R44HL147734-05: An in vitro diagnostic assay for the early and accurate detection of platelet-activating antibodies associated with Heparin-inducedThrombocytopenia ($1,693,897)", "source_url": "https://reporter.nih.gov/project-details/11314485", "people": [{"name": "Curtis Jones", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44HG014445-02", "company": "Vellum Biotechnology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-16", "observed": "2026-08-21", "amount_usd": 1014715, "summary": "NIH award 5R44HG014445-02: Developing a New Nucleic Acid Extraction Technology to Enable High Quality DNA Sequencing for Formalin Fixed Paraffin Embedded Tissue Samples ($1,014,715)", "source_url": "https://reporter.nih.gov/project-details/11337585", "people": [{"name": "Yann Astier", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44DA056161-02A1", "company": "Telesage Research, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-16", "observed": "2026-08-21", "amount_usd": 969713, "summary": "NIH award 2R44DA056161-02A1: Development of a cloud-based, self-report SUD intake system enabling primary care clinicians to routinely complete, implement, document, and bill for biopsychosocial assessments ($969,713)", "source_url": "https://reporter.nih.gov/project-details/11310572", "people": [{"name": "BENJAMIN B BRODEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AI192177-01A1", "company": "Parabon Nanolabs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-16", "observed": "2026-08-21", "amount_usd": 295294, "summary": "NIH award 1R43AI192177-01A1: MetaDx: Rapid Diagnosis of Fungal, Bacterial, and Viral Infections Using Whole Metagenomic Sequencing ($295,294)", "source_url": "https://reporter.nih.gov/project-details/11313726", "people": [{"name": "Janet Cady", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44TR005112-02", "company": "Cellular Vehicles Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-16", "observed": "2026-08-21", "amount_usd": 1022611, "summary": "NIH award 2R44TR005112-02: Development of a novel tool that standardizes and automates the formulation of cell-laden hydrogels ($1,022,611)", "source_url": "https://reporter.nih.gov/project-details/11407576", "people": [{"name": "Nikhil S. Joshi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44DC022220-02", "company": "Qualia Oto, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-16", "observed": "2026-08-21", "amount_usd": 980937, "summary": "NIH award 2R44DC022220-02: Shape-Adaptive Cochlear Implant Electrode Arrays ($980,937)", "source_url": "https://reporter.nih.gov/project-details/11316606", "people": [{"name": "Jimin Maeng", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44TR003744-03", "company": "Biomesense, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-16", "observed": "2026-08-21", "amount_usd": 676980, "summary": "NIH award 5R44TR003744-03: Development of a Novel Biosensor to Accelerate Investigations of the Gut Microbiome ($676,980)", "source_url": "https://reporter.nih.gov/project-details/11292430", "people": [{"name": "Dylan Nichols", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K253374", "company": "Empirical Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253374: LimiFlex\u00ae Dynamic Sagittal Tether Instrument Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253374", "people": [{"name": "Louie Fielding", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253374%22"}, {"id": "fda:K261683", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261683: Augment Off-Axis Instrument System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261683", "people": [{"name": "Eric Van Horn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261683%22"}, {"id": "fda:K260831", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260831: Z1 Hip System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260831", "people": [{"name": "Sean Gleason", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260831%22"}, {"id": "fda:K260844", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260844: ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260844", "people": [{"name": "Shilpa Rapaka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260844%22"}, {"id": "fda:K260425", "company": "Hivox Biotek, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260425: TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260425", "people": [{"name": "Adam Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260425%22"}, {"id": "fda:K253046", "company": "ZheJiang Decans Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253046: HERA Interlocking Intramedullary Nailing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253046", "people": [{"name": "Haifeng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253046%22"}, {"id": "fda:K254025", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254025: LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254025", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254025%22"}, {"id": "fda:K260899", "company": "Zdeer Technology (Henan) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260899: Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260899", "people": [{"name": "Wenlin Xiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260899%22"}, {"id": "fda:K253001", "company": "Hunan Ruijiong Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253001: KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253001", "people": [{"name": "Zen Koo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253001%22"}, {"id": "fda:K253723", "company": "Medpark Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253723: BOSS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253723", "people": [{"name": "Kyonghoon Shin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253723%22"}, {"id": "fda:K261833", "company": "Neurent Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261833: NEUROMARK System (NMK00301)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261833", "people": [{"name": "Fay Dalton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261833%22"}, {"id": "fda:K260693", "company": "80 Beats Medical GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260693: VicorderCS (VCS-SYS-1100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260693", "people": [{"name": "Arnd Warmuth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260693%22"}, {"id": "fda:K253069", "company": "Diazyme Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253069: Lipoprotein (a) Molarity Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253069", "people": [{"name": "Abhijit Datta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253069%22"}, {"id": "fda:K253264", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253264: myAblation Guide (VC10A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253264", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253264%22"}, {"id": "fda:K260958", "company": "I.T.S. GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260958: I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260958", "people": [{"name": "Florian Grill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260958%22"}, {"id": "fda:K253159", "company": "Wright Medical Technology, Inc. (Stryker)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253159: Prophecy Incompass Surgical Planning System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253159", "people": [{"name": "Jonathan DiMotta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253159%22"}, {"id": "fda:K253231", "company": "Hubei Yjt Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253231: Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253231", "people": [{"name": "Jiali Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253231%22"}, {"id": "fda:K253137", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253137: FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253137", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253137%22"}, {"id": "trialreg:NCT07652164", "company": "Francis Medical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Water Vapor Ablation for Grade Group 3 Prostate Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07652164"}, {"id": "trialreg:NCT07650448", "company": "PROCEPT BioRobotics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: WATER IV PCa (AS Sub-study)", "source_url": "https://clinicaltrials.gov/study/NCT07650448"}, {"id": "trialreg:NCT07650201", "company": "Kowa Research Institute, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction", "source_url": "https://clinicaltrials.gov/study/NCT07650201"}, {"id": "trialreg:NCT07650032", "company": "Adagio Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cryoablation for Monomorphic Ventricular Tachycardia (VTS)", "source_url": "https://clinicaltrials.gov/study/NCT07650032"}, {"id": "trialreg:NCT07649798", "company": "Advanced Bifurcation Systems Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS\u2122 DES System (FIH Feasibility Study)", "source_url": "https://clinicaltrials.gov/study/NCT07649798"}, {"id": "trialreg:NCT07651735", "company": "TIPMED Medical Device Manufacturing Ltd. Co.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of T\u0131pmed\u2122 Primary Hip Prosthesis System", "source_url": "https://clinicaltrials.gov/study/NCT07651735"}, {"id": "trialreg:NCT07649772", "company": "BlackFrame.ai", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Ambient Audio-Visual Capture for Clinical Documentation and Assessment", "source_url": "https://clinicaltrials.gov/study/NCT07649772"}, {"id": "trialreg:NCT07651852", "company": "Kardium Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Globe Registry: Globe\u00ae Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07651852"}, {"id": "trialreg:NCT07649720", "company": "AnX Robotica Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NaviCam Patency Capsule to Verify Gastrointestinal Patency", "source_url": "https://clinicaltrials.gov/study/NCT07649720"}, {"id": "trialreg:NCT07649915", "company": "Gordian Surgical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: GRIP: Gordian Robotic Integrated Port Closure Study", "source_url": "https://clinicaltrials.gov/study/NCT07649915"}, {"id": "fda:K260885", "company": "Luma Vision Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260885: VERAFEYE Imaging and Guidance System (VF-VIS-002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260885", "people": [{"name": "Marta Walker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260885%22"}, {"id": "fda:K253922", "company": "JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253922: Neodent Scannable Healing Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253922", "people": [{"name": "Mariana Hartmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253922%22"}, {"id": "fda:K253151", "company": "Beijing Fule Science & Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253151: Fule Interbody Fusion Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253151", "people": [{"name": "Xiaoliang Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253151%22"}, {"id": "fda:K253059", "company": "Tournicare Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253059: Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253059", "people": [{"name": "Niels van Sparrentak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253059%22"}, {"id": "fda:K260126", "company": "USpharma, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260126: Curajel\u0099 Oral Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260126", "people": [{"name": "Rushi Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260126%22"}, {"id": "fda:K260452", "company": "Zdeer Technology (Henan) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260452: Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260452", "people": [{"name": "Wenlin Xiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260452%22"}, {"id": "fda:K253690", "company": "Siemens Healthineers AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253690: LungMaps", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253690", "people": [{"name": "Friederike Hertle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253690%22"}, {"id": "fda:K260333", "company": "Diasorin Molecular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260333: LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260333", "people": [{"name": "Kate Goscha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260333%22"}, {"id": "fda:K253172", "company": "Crescom Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253172: MediAI-OA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253172", "people": [{"name": "Yeong-suk An", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253172%22"}, {"id": "fda:K261265", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261265: Permatage XT Settable Bone Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261265", "people": [{"name": "Alyssa McDermott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261265%22"}, {"id": "fda:K260300", "company": "Anumana, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260300: WatchMate Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260300", "people": [{"name": "Animesh Agarwal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260300%22"}, {"id": "fda:K260335", "company": "Zhongshan Sulenz Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260335: Electric Wheelchair (S500-6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260335", "people": [{"name": "Luo Weiping", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260335%22"}, {"id": "fda:K253121", "company": "Gimbo Medical Technology Shenzhen Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253121: Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253121", "people": [{"name": "Guo Leo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253121%22"}, {"id": "fda:K260036", "company": "Medyssey Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260036: NeckTune\u0099 3D SA Cervical Cage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260036", "people": [{"name": "Hyokyeong Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260036%22"}, {"id": "fda:K260286", "company": "Spine Wave, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260286: Dynamo\u0099 Spinal Cement; Salvo\u00ae Spine System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260286", "people": [{"name": "Ronald Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260286%22"}, {"id": "fda:K253825", "company": "DeepHealth, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253825: Saige-Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253825", "people": [{"name": "B. Nathan Hunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253825%22"}, {"id": "fda:K260482", "company": "Jpi Healthcare Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260482: DRE Duo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260482", "people": [{"name": "Jeong DoAn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260482%22"}, {"id": "trialreg:NCT07646704", "company": "Lifetech Scientific (Shenzhen) Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: HeartR\u2122 PDA Occluder Post-Market Follow-Up Study", "source_url": "https://clinicaltrials.gov/study/NCT07646704"}, {"id": "trialreg:NCT07647354", "company": "Stryker Orthopaedics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Mako-MORE Registry", "source_url": "https://clinicaltrials.gov/study/NCT07647354"}, {"id": "trialreg:NCT07648017", "company": "MeKo Manufacturing e.K.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Resoloy Initial Safety Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT07648017"}, {"id": "trialreg:NCT07646938", "company": "MolecuLight Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MolecuLight All-in-One Oxygenation Clinical Utility", "source_url": "https://clinicaltrials.gov/study/NCT07646938"}, {"id": "trialreg:NCT07647315", "company": "Shanghai StairMed Technology Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT07647315"}, {"id": "trialreg:NCT07647705", "company": "ETS Wound Care, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Borate-based Bioactive Glass Fiber Matrix (BBGFM) in the Treatment of Venus Leg Ulcers (VLU)", "source_url": "https://clinicaltrials.gov/study/NCT07647705"}, {"id": "trialreg:NCT07648693", "company": "Resonova (Shanghai) Medtech Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety and Effectiveness of CHORDS\u00ae Cerebral Protection System During TAVR: DUET Trial", "source_url": "https://clinicaltrials.gov/study/NCT07648693"}, {"id": "fda:K261604", "company": "Neuroelectrics Barcelona S.L.U.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261604: Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261604", "people": [{"name": "Ana Maiques", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261604%22"}, {"id": "nih:5R44HD110306-04", "company": "Mother's Milk Is Best, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": 1172764, "summary": "NIH award 5R44HD110306-04: Point of Care maternal milk concentration device optimizing neonatal growth with targeted nutrition support: Establishing clinical evidence of benefit as an alternative to milk sourced fortification ($1,172,764)", "source_url": "https://reporter.nih.gov/project-details/11345878", "people": [{"name": "Elizabeth Randall Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44MD020606-02", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-12", "observed": "2026-08-21", "amount_usd": 1048499, "summary": "NIH award 5R44MD020606-02: Addressing Challenges in Peripheral Intravenous Catheter Education ($1,048,499)", "source_url": "https://reporter.nih.gov/project-details/11421426", "people": [{"name": "John Paul Condon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K261213", "company": "Lg Electronics.Inc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261213: Medical Monitor (40HT513D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261213", "people": [{"name": "Wonhi Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261213%22"}, {"id": "fda:K260935", "company": "Dexcom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260935: Stelo Glucose Biosensor System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260935", "people": [{"name": "Neeta Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260935%22"}, {"id": "fda:K261207", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261207: Exalta Proximal Tibia Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261207", "people": [{"name": "Chelsea Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261207%22"}, {"id": "fda:K252937", "company": "Dosisoft SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252937: ThinkQA 3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252937", "people": [{"name": "Marc Uszynski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252937%22"}, {"id": "fda:K252932", "company": "Autonomous Medical Devices Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252932: Fast PCR Mini Respiratory Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252932", "people": [{"name": "Aiying Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252932%22"}, {"id": "fda:K252933", "company": "Dyne Medical Group, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252933: DYNE PORT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252933", "people": [{"name": "Young-Hoon Moon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252933%22"}, {"id": "fda:K260635", "company": "Nuvascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260635: HARBOR Occlusion Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260635", "people": [{"name": "Meadow Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260635%22"}, {"id": "fda:K261175", "company": "Whill, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261175: WHILL (WHILL Model C2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261175", "people": [{"name": "Tsuyoshi Iriyama", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261175%22"}, {"id": "fda:K252987", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252987: ADRx\u0099 Admixture Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252987", "people": [{"name": "Freddie LEE", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252987%22"}, {"id": "fda:K261366", "company": "Somnomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261366: Virtus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261366", "people": [{"name": "Mary Kennell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261366%22"}, {"id": "fda:K252323", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252323: cobas pulse blood glucose monitoring system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252323", "people": [{"name": "Teresa Carrow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252323%22"}, {"id": "fda:K252996", "company": "Konica Minolta Healthcare Americas, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252996: Universal 1417PI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252996", "people": [{"name": "Jan Maniscalco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252996%22"}, {"id": "fda:K253437", "company": "Spiro Robotics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253437: Spiro-VISTA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253437", "people": [{"name": "Jackie Dulken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253437%22"}, {"id": "fda:K252963", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252963: BTL-899TT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252963", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252963%22"}, {"id": "fda:K252171", "company": "Sutura Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252171: Barbed PDO Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252171", "people": [{"name": "Annie Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252171%22"}, {"id": "fda:K253688", "company": "Bayer Medical Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253688: MEDRAD\u00ae Imaging Bulk Package Transfer Spike", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253688", "people": [{"name": "Troy Jack", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253688%22"}, {"id": "fda:K260406", "company": "Brainomix Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260406: Brainomix 360 Hyperdensity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260406", "people": [{"name": "Zsolt Szrnka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260406%22"}, {"id": "fda:K253015", "company": "VoxNeuro, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253015: Cognitive Function Neuroimaging (cfNI) Software (1.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253015", "people": [{"name": "Andrew Matiasso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253015%22"}, {"id": "fda:K260102", "company": "Stryker Corporation (Tornier, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260102: Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260102", "people": [{"name": "Jang Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260102%22"}, {"id": "fda:K260346", "company": "Polybell (Guangzhou) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260346: Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260346", "people": [{"name": "Qingliang Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260346%22"}, {"id": "fda:K261204", "company": "Sanhe LEFIS Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261204: Intense Pulsed Light Therapy Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261204", "people": [{"name": "Dandan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261204%22"}, {"id": "fda:K253196", "company": "Midmark Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253196: Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253196", "people": [{"name": "Jessica Hembrey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253196%22"}, {"id": "fda:K260514", "company": "CMT Health PTE., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260514: Profoject\u0099 Safety Needle; Profoject\u0099 Syringe with Safety Needle; Profoject\u0099 Low Dead Space Syringe with Safety Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260514", "people": [{"name": "Monica Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260514%22"}, {"id": "fda:K261634", "company": "SteriLance Medical (Suzhou), Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261634: Disposable Blood Lancet (Soft)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261634", "people": [{"name": "Susan Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261634%22"}, {"id": "fda:K253088", "company": "Micropace Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253088: OneStim-DUO Cardiac Stimulator (MP5003-4CO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253088", "people": [{"name": "Michael Cejnar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253088%22"}, {"id": "pma:P250031", "company": "Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250031: VENTANA PTEN (SP218) RxDx Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250031", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250031%22"}, {"id": "pma:P250021", "company": "Croma-Pharma GmbH", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-06-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250021: saypha\u00ae ChiQ\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250021", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250021%22"}, {"id": "trialreg:NCT07646067", "company": "Ideal Medical Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Closed Loop Glucose Control in a Simulated ICU Setting", "source_url": "https://clinicaltrials.gov/study/NCT07646067"}, {"id": "trialreg:NCT07645820", "company": "Castle Biosciences Incorporated", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Non-Invasive Device for Early Detection of Atopic Dermatitis Flares", "source_url": "https://clinicaltrials.gov/study/NCT07645820"}, {"id": "trialreg:NCT07645313", "company": "Yuwell Group", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Accuracy and Safety of Anytime 5Pro and Anytime 4Pro CGM Systems in Adults With Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07645313"}, {"id": "trialreg:NCT07646483", "company": "PharmaResearch Co.,Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial to Evaluate the Efficacy and Safety of Conjuran\u00ae After First and Second Cycle (Repeat) Administration in Patients With Knee Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07646483"}, {"id": "nih:5R44AR081745-03", "company": "Novopedics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": 1016692, "summary": "NIH award 5R44AR081745-03: Efficacy of MeniscoFix for Sub-Total Meniscal Replacement: A Comprehensive Approach in Cadaver Knees and an Ovine Surgical Model ($1,016,692)", "source_url": "https://reporter.nih.gov/project-details/11372335", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41DA064482-01", "company": "Biosyft Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-11", "observed": "2026-08-21", "amount_usd": 301390, "summary": "NIH award 1R41DA064482-01: AI-Driven Detection of Addiction-Like Reward Signatures Through Automated Multi-View Behavioral Analysis ($301,390)", "source_url": "https://reporter.nih.gov/project-details/11254271", "people": [{"name": "Anthony Edward English", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS125892-04", "company": "Axonova Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-11", "observed": "2026-08-21", "amount_usd": 902542, "summary": "NIH award 5R44NS125892-04: Development of Tissue Engineered Neuromuscular Interfaces from GalSafe Neurons ($902,542)", "source_url": "https://reporter.nih.gov/project-details/11326240", "people": [{"name": "Kritika Katiyar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:4R44DK141289-02", "company": "Sonomotion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-11", "observed": "2026-08-21", "amount_usd": 959892, "summary": "NIH award 4R44DK141289-02: Break Wave lithotripsy to fragment large kidney stones ($959,892)", "source_url": "https://reporter.nih.gov/project-details/11342227", "people": [{"name": "Oren Levy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K260710", "company": "FloShield, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260710: FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260710", "people": [{"name": "Laird Cagan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260710%22"}, {"id": "fda:K260322", "company": "Mighty Oak Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260322: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260322", "people": [{"name": "Mark Wylie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260322%22"}, {"id": "fda:K261209", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261209: Ion-L", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261209", "people": [{"name": "Richard Sharp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261209%22"}, {"id": "fda:K260653", "company": "Distalmotion SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260653: Dexter L6 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260653", "people": [{"name": "Caroline Bonnet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260653%22"}, {"id": "fda:K260859", "company": "Hass Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260859: Rosetta SM, Rosetta SP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260859", "people": [{"name": "Youngsu Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260859%22"}, {"id": "fda:K261292", "company": "PR Personal Care Laboratories", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261292: PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261292", "people": [{"name": "Louie Goryoka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261292%22"}, {"id": "fda:K251326", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251326: Respiration Rate algorithm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251326", "people": [{"name": "Manthan Damani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251326%22"}, {"id": "fda:K250129", "company": "Avita Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250129: AViTA Breast Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250129", "people": [{"name": "Rex Hsieh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250129%22"}, {"id": "fda:K260174", "company": "Hitachi High-Tech Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260174: PROBEAT-CR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260174", "people": [{"name": "Takanari Kuriyama", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260174%22"}, {"id": "fda:K250839", "company": "Changzhou Boen Zhongding Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250839: Dental X-ray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250839", "people": [{"name": "Shuo Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250839%22"}, {"id": "fda:K261251", "company": "Endeavor Commerce, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261251: Snorbliss\u00ae Anti-Snoring Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261251", "people": [{"name": "Hasem Basaran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261251%22"}, {"id": "fda:K253607", "company": "Uneeg Medical A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253607: UNEEG EpiSight System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253607", "people": [{"name": "Camilla Wismar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253607%22"}, {"id": "fda:K254145", "company": "Smart Denture Conversions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut\u0099)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254145", "people": [{"name": "Derrik Conrad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254145%22"}, {"id": "fda:K261610", "company": "Instylla, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261610: Verge\u0099 Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261610", "people": [{"name": "Easwar Prabakaran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261610%22"}, {"id": "fda:K253051", "company": "Abbott Point of Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253051: i-STAT hs-TnI cartridge with the i-STAT Alinity System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253051", "people": [{"name": "Jacquelyn Gesumaria", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253051%22"}, {"id": "fda:K254087", "company": "Synthes (USA) Products, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254087: MAXFRAME AUTOSTRUT\u0099 with Bluetooth Multi-Axial Correction System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254087", "people": [{"name": "Mitchel Bartko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254087%22"}, {"id": "fda:K261256", "company": "Shenzhen Magnet Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261256: Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261256", "people": [{"name": "Xiangshun Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261256%22"}, {"id": "fda:K260849", "company": "Rehasense USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260849: ICON 35; ICON 45; ICON 60; ICON 30FAF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260849", "people": [{"name": "Matthew P Fitman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260849%22"}, {"id": "fda:K253052", "company": "Nagy Oral Technology Qinhuangdao Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253052: Fluoride Varnish (Type A,Type C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253052", "people": [{"name": "Na Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253052%22"}, {"id": "fda:K253650", "company": "Nuralogix Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253650: Anura Mobile Core SDK (M1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253650", "people": [{"name": "Jessica Mavadia-Shukla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253650%22"}, {"id": "trialreg:NCT07640776", "company": "Angiodynamics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)", "source_url": "https://clinicaltrials.gov/study/NCT07640776"}, {"id": "trialreg:NCT07642414", "company": "Hinge Health, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Comprehensive Digital Care Program for Migraine Management", "source_url": "https://clinicaltrials.gov/study/NCT07642414"}, {"id": "trialreg:NCT07642284", "company": "Dentsply Sirona Implants and Consumables", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Performance of AH Plus Jet\u00ae Root Canal Sealers in Single-cone Protocols", "source_url": "https://clinicaltrials.gov/study/NCT07642284"}, {"id": "trialreg:NCT07642973", "company": "Wooshin Labottach Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial Abrasions", "source_url": "https://clinicaltrials.gov/study/NCT07642973"}, {"id": "trialreg:NCT07641218", "company": "Myopowers Medical Technologies France SAS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pilot Study of the ARTUS\u00ae Artificial Urinary Sphincter on Women", "source_url": "https://clinicaltrials.gov/study/NCT07641218"}, {"id": "trialreg:NCT07641296", "company": "SpyGlass Pharma, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety, Efficacy, Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Diagnosed With Open Angle Glaucoma or Ocular Hypertension", "source_url": "https://clinicaltrials.gov/study/NCT07641296"}, {"id": "breakthrough:K253607", "company": "Uneeg Medical A/s", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-06-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K253607: UNEEG EPISIGHT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44DE033934-02", "company": "Oraliva, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": 697404, "summary": "NIH award 5R44DE033934-02: AI-linked cytomics-on-a-chip to enable near-real time identification and management of oral lichenoid lesions in primary care ($697,404)", "source_url": "https://reporter.nih.gov/project-details/11321546", "people": [{"name": "Nicolaos Joseph Christodoulides", "role": "Principal Investigator"}, {"name": "JOHN T MCDEVITT", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K260810", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260810: Anteralign LS coverplate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260810", "people": [{"name": "Rajan Kaur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260810%22"}, {"id": "fda:K261174", "company": "Rxsight, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261174: RxSight\u00ae Insertion Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261174", "people": [{"name": "Maureen O'Connell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261174%22"}, {"id": "fda:K250690", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250690: Penumbra System (Thunderbolt Aspiration Tubing)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250690", "people": [{"name": "Sindokht (Sisi) Soltanzadeh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250690%22"}, {"id": "fda:K261329", "company": "Centerline Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261329: Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261329", "people": [{"name": "Carroll Martin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261329%22"}, {"id": "fda:K261016", "company": "Medacta International, SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261016: MSS - Humeral reverse liners extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261016", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261016%22"}, {"id": "fda:K253192", "company": "Alpha Intelligence Manifolds, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253192: DeepXray Spina", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253192", "people": [{"name": "Qingzong TSENG", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253192%22"}, {"id": "fda:K260414", "company": "Tech-Image CO., LTD.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260414: \u0093Tech-Image\u0094 Video Endoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260414", "people": [{"name": "Hsin-Tzu Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260414%22"}, {"id": "fda:K253919", "company": "Xiamen Weiyou Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253919: Cryo And Thermo Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253919", "people": [{"name": "Kelly Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253919%22"}, {"id": "fda:K253115", "company": "Movmedix S.A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253115: LARS ACJ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253115", "people": [{"name": "Luisa Arcos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253115%22"}, {"id": "fda:K260855", "company": "CMT Health PTE., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260855: Profoject\u0099 Safety Pen Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260855", "people": [{"name": "Monica Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260855%22"}, {"id": "fda:K254121", "company": "DNA Genotek, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254121: Colli-Pee\u0095Dx Urine Collection Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254121", "people": [{"name": "Jonathan Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254121%22"}, {"id": "fda:K260614", "company": "Sivantos GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260614: Tinnitus Therapy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260614", "people": [{"name": "Anja Ravn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260614%22"}, {"id": "trialreg:NCT07639658", "company": "MOQ Collective, Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Temple Massager System Study in Women Ages 35-65", "source_url": "https://clinicaltrials.gov/study/NCT07639658"}, {"id": "trialreg:NCT07639853", "company": "Medtronic Endovascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Case-Specific Health Care Professional Clinical Survey for Concerto Versa\u2122 Detachable Coils", "source_url": "https://clinicaltrials.gov/study/NCT07639853"}, {"id": "trialreg:NCT07639684", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)", "source_url": "https://clinicaltrials.gov/study/NCT07639684"}, {"id": "trialreg:NCT07639944", "company": "Theranica", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders", "source_url": "https://clinicaltrials.gov/study/NCT07639944"}, {"id": "trialreg:NCT07640191", "company": "iVEAcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy", "source_url": "https://clinicaltrials.gov/study/NCT07640191"}, {"id": "nih:5R44HL169034-03", "company": "3dt Holdings, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": 1050048, "summary": "NIH award 5R44HL169034-03: Software-guided Operative Planning of MitraClip Placement ($1,050,048)", "source_url": "https://reporter.nih.gov/project-details/11327319", "people": [{"name": "Julius Matteo Guccione", "role": "Principal Investigator"}, {"name": "GHASSAN S KASSAB", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL170779-03", "company": "Innovative Biotherapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": 797411, "summary": "NIH award 5R44HL170779-03: Cell Directed Immunomodulation Therapy as a Bridge to Left Ventricular Device Implantation in Chronic Heart Failure Patients ($797,411)", "source_url": "https://reporter.nih.gov/project-details/11361118", "people": [{"name": "Kimberly Anne Johnston", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41DA064319-01", "company": "Behavior Change Hub Limited Liability Company", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": 314109, "summary": "NIH award 1R41DA064319-01: Addiction Application Gradebook: Fostering greater public health impact from mHealth applications for SUD ($314,109)", "source_url": "https://reporter.nih.gov/project-details/11240509", "people": [{"name": "Molly Magill", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA254637-03", "company": "Media Rez, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": 696092, "summary": "NIH award 5R44CA254637-03: Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors ($696,092)", "source_url": "https://reporter.nih.gov/project-details/11348878", "people": [{"name": "Daniel J Greenberg", "role": "Principal Investigator"}, {"name": "J. Hunter Groninger", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AI193415-02", "company": "Partillion Bioscience Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-09", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI193415-02: Scaling function-first antibody discovery leveraging memory B cells ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11310825", "people": [{"name": "Joseph de Rutte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DA064245-01", "company": "Doro Mind Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-09", "observed": "2026-08-21", "amount_usd": 398580, "summary": "NIH award 1R43DA064245-01: A digital platform to address adverse effects resulting from non-disordered drug use, focused on mitigating serious mental illness ($398,580)", "source_url": "https://reporter.nih.gov/project-details/11239321", "people": [{"name": "Stephanie Morgan Greer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K260564", "company": "Terrats Medical SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260564: DESS Dental Smart Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260564", "people": [{"name": "Roger Terrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260564%22"}, {"id": "fda:K260864", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260864: Mother's Nature W1 Warming Wearable Breast Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260864", "people": [{"name": "Dale WANG", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260864%22"}, {"id": "fda:K260748", "company": "E-Scopics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260748: ES-Series", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260748", "people": [{"name": "Aurelie Gruener", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260748%22"}, {"id": "fda:K251251", "company": "Chanpin Medtak Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251251: ChanPin Pedicle Screw Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251251", "people": [{"name": "Che-Yung Kuan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251251%22"}, {"id": "fda:K260802", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260802: Materialise Shoulder System\u0099, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260802", "people": [{"name": "Giulia Girola", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260802%22"}, {"id": "fda:K252914", "company": "Hathor Professional Skincare , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252914: Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252914", "people": [{"name": "Carolyn (Mellta) Swift", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252914%22"}, {"id": "fda:K261549", "company": "MicroVention, Inc., d/b/a Terumo Neuro", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261549: BOBBY Balloon Guide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261549", "people": [{"name": "Miranda Beach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261549%22"}, {"id": "fda:K261806", "company": "Erbe Elektromedizin GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261806: ERBECRYO 2 Cryosurgical Unit and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261806", "people": [{"name": "Matthias Kollek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261806%22"}, {"id": "fda:K261621", "company": "Theramicro", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261621: TekBrace Solo Soft Tissue Reinforcement Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261621", "people": [{"name": "Christine Scifert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261621%22"}, {"id": "fda:K253165", "company": "Sejong Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253165: LAP-iX2N", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253165", "people": [{"name": "Jinho Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253165%22"}, {"id": "trialreg:NCT07635823", "company": "Beijing Pins Medical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Adaptive DBS for PD", "source_url": "https://clinicaltrials.gov/study/NCT07635823"}, {"id": "trialreg:NCT07637188", "company": "Nordberg Medical Italy srl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PLLA-LASYNPRO\u2122 Injections for Skin Laxity Treatment", "source_url": "https://clinicaltrials.gov/study/NCT07637188"}, {"id": "trialreg:NCT07636512", "company": "Suisselle", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effectiveness and Safety of Cellbooster Shape in Healthy Subjects", "source_url": "https://clinicaltrials.gov/study/NCT07636512"}, {"id": "trialreg:NCT07635602", "company": "CardiacSense Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Collection Study Using CS BP Pillow System", "source_url": "https://clinicaltrials.gov/study/NCT07635602"}, {"id": "trialreg:NCT07635979", "company": "Kieron.Day", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Physiological Responses to Upper Limb NMES", "source_url": "https://clinicaltrials.gov/study/NCT07635979"}, {"id": "nih:5R44TR005137-03", "company": "Cellchorus Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-08", "observed": "2026-08-21", "amount_usd": 1034752, "summary": "NIH award 5R44TR005137-03: Integrated assays of single-cell dynamics and molecular phenotype for cell therapy manufacturing ($1,034,752)", "source_url": "https://reporter.nih.gov/project-details/11322109", "people": [{"name": "Rebecca L Berdeaux", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K260332", "company": "Pathwai, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260332: EchoNext", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260332", "people": [{"name": "Pierre Elias", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260332%22"}, {"id": "fda:K253542", "company": "Weero Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253542: Apollo Quattro (APQ-10M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253542", "people": [{"name": "Han Moon young", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253542%22"}, {"id": "fda:K253066", "company": "Onkos Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253066: ELEOS\u0099 with NanoCept\u00ae Technology Limb Salvage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253066", "people": [{"name": "Arley Perez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253066%22"}, {"id": "fda:K261352", "company": "One Ortho", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261352: 2D Hip Planning Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261352", "people": [{"name": "Theo Vidal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261352%22"}, {"id": "fda:K251944", "company": "Lipocosm, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251944: Lipocosm Harmonic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251944", "people": [{"name": "Ercan Dilsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251944%22"}, {"id": "fda:K261402", "company": "Dexcom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261402: Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261402", "people": [{"name": "Holly Drake", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261402%22"}, {"id": "fda:K253257", "company": "Jiangsu Intco Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253257: Virgo Mobility Scooter (Virgo-D,Virgo-F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253257", "people": [{"name": "Shiqun Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253257%22"}, {"id": "trialreg:NCT07633847", "company": "AnX Robotica Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Post Market Trial Assessing the Accuracy of Normal Mode Reading vs. ProScan Reading With the NaviCam SB System. This is a Comparison of Retrospectively Obtained Capsule Endoscopy Videos With a New AI Reading Tool; no New Interventions Will be Completed.", "source_url": "https://clinicaltrials.gov/study/NCT07633847"}, {"id": "trialreg:NCT07631988", "company": "Pi-cardia", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The ShortCut Post-Market Study", "source_url": "https://clinicaltrials.gov/study/NCT07631988"}, {"id": "trialreg:NCT07631715", "company": "Withings", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Withings Hypertension Notification Retrospective Study", "source_url": "https://clinicaltrials.gov/study/NCT07631715"}, {"id": "trialreg:NCT07632443", "company": "On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PMCF Study on The Performance and Safety of ON DENT\u00ae PMMA Discs/Blocks and Resin Products for Temporary Restorations", "source_url": "https://clinicaltrials.gov/study/NCT07632443"}, {"id": "trialreg:NCT07632001", "company": "Reprise Biomedical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers", "source_url": "https://clinicaltrials.gov/study/NCT07632001"}, {"id": "trialreg:NCT07632586", "company": "FineHeart", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: First in Human Study of the Icoms Flowmaker", "source_url": "https://clinicaltrials.gov/study/NCT07632586"}, {"id": "trialreg:NCT07631468", "company": "Stryker Endoscopy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PROspect Registry :Post Market Clinical Follow-up Study", "source_url": "https://clinicaltrials.gov/study/NCT07631468"}, {"id": "trialreg:NCT07633665", "company": "De\u011firmenci Otomotiv ve Metal End\u00fcstri A.\u015e.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PMCF Study on the Effectiveness and Safety of BIODENTOSS\u00ae and DWC\u00ae Dental Implants and Superstructures", "source_url": "https://clinicaltrials.gov/study/NCT07633665"}, {"id": "trialreg:NCT07633886", "company": "Corsano Health B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)", "source_url": "https://clinicaltrials.gov/study/NCT07633886"}, {"id": "breakthrough:K260332", "company": "Pathwai, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-06-08", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K260332: ECHONEXT", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K260289", "company": "Balosmark, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260289: Perfect-O Ostial Positioning Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260289", "people": [{"name": "Tim Fischell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260289%22"}, {"id": "fda:K253656", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253656: OsteoCool\u0099 RF Ablation System; OsteoCool\u0099 2.0 RF Ablation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253656", "people": [{"name": "Jeff Sprague", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253656%22"}, {"id": "fda:K261492", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261492: FieldFlex Steerable Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261492", "people": [{"name": "Lauren Marold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261492%22"}, {"id": "fda:K260105", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260105: Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260105", "people": [{"name": "Marcelo Piovarcsik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260105%22"}, {"id": "fda:K260056", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260056: Power Wheelchair (N5515A, N5516, N5517A, N5519)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260056", "people": [{"name": "Yolanda Ge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260056%22"}, {"id": "fda:K254086", "company": "Oculogica, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254086: EyeBOX SNAP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254086", "people": [{"name": "Rosina Samadani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254086%22"}, {"id": "fda:K260754", "company": "Assure Tech., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260754: Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260754", "people": [{"name": "Allen Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260754%22"}, {"id": "fda:K253108", "company": "Steps Ortho", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253108: VEOFIX Snap Off Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253108", "people": [{"name": "Morgane Grenier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253108%22"}, {"id": "fda:K243192", "company": "Nextstep Arthopedix, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243192: iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243192", "people": [{"name": "Garrett Spurgeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243192%22"}, {"id": "fda:K251684", "company": "Alma Lasers, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251684: Alma TED+ System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251684", "people": [{"name": "Jessica Rivera-Montejo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251684%22"}, {"id": "fda:K260761", "company": "Medartis AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260761: APTUS Clavicle System 2.8", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260761", "people": [{"name": "Salvatore Risoli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260761%22"}, {"id": "fda:K253204", "company": "BioTissue Holdings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253204: Catalyze", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253204", "people": [{"name": "Lorraine Chua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253204%22"}, {"id": "fda:K253296", "company": "Allengers Medical Systems Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253296: Digital C-ARM with 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253296", "people": [{"name": "Sanjeev K. Marjara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253296%22"}, {"id": "fda:K260301", "company": "Hangzhou Qiantang Longyue Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260301: Vial Adapter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260301", "people": [{"name": "Meijun Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260301%22"}, {"id": "fda:K253162", "company": "Unimed Medical Supplies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253162: Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253162", "people": [{"name": "Huanyu Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253162%22"}, {"id": "pma:P230038", "company": "Cyndrx, LLC", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-06-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P230038: AbsorbaSeal 5.6.7F Vascular Closure Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230038", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230038%22"}, {"id": "trialreg:NCT07630064", "company": "Flo Health Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Flo Digital Contraceptive Study", "source_url": "https://clinicaltrials.gov/study/NCT07630064"}, {"id": "trialreg:NCT07631078", "company": "Magnetic Tides", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot", "source_url": "https://clinicaltrials.gov/study/NCT07631078"}, {"id": "trialreg:NCT07629206", "company": "IceCure Medical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense\u00ae Cryoablation (ChoICE Trial)", "source_url": "https://clinicaltrials.gov/study/NCT07629206"}, {"id": "trialreg:NCT07628296", "company": "GE Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations", "source_url": "https://clinicaltrials.gov/study/NCT07628296"}, {"id": "trialreg:NCT07629232", "company": "Icare Finland Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Measuring Corneal Parameters", "source_url": "https://clinicaltrials.gov/study/NCT07629232"}, {"id": "trialreg:NCT07629557", "company": "Glaukos Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for Keratoconus", "source_url": "https://clinicaltrials.gov/study/NCT07629557"}, {"id": "trialreg:NCT07630610", "company": "Navari Surgical AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility and Safety of Augmented Reality (AR) in Liver Tumor Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07630610"}, {"id": "trialreg:NCT07628829", "company": "Artemis AI Labs", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Neonatal Neurological Observation With Video AI", "source_url": "https://clinicaltrials.gov/study/NCT07628829"}, {"id": "fda:K260956", "company": "Uzinmedicare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260956: Spectra Platinum Mini", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260956", "people": [{"name": "Soyeon Lim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260956%22"}, {"id": "fda:K253994", "company": "TroCare, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253994: TroKit Laparoscope Lens Wiper", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253994", "people": [{"name": "Gerald Sanders", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253994%22"}, {"id": "fda:K252575", "company": "New York Embroidery Studio (NYES)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252575: Tuff Cuff\u0099 Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252575", "people": [{"name": "Michelle Feinburg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252575%22"}, {"id": "fda:K253893", "company": "Topcon Healthcare Solutions EMEA Oy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253893: Harmony Referral System with Harmony OCT Viewer (Octave)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253893", "people": [{"name": "Tobias Schwarz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253893%22"}, {"id": "fda:K254209", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254209: Radius VSM and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254209", "people": [{"name": "Kertana Shankar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254209%22"}, {"id": "fda:K260690", "company": "Beijing Sano Laser S&T Development Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260690: LumiGlam Laser System (SHE-LSP601-3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260690", "people": [{"name": "Zhu Qi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260690%22"}, {"id": "fda:K253026", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253026: Respiratory Gating for Scanners (2.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253026", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253026%22"}, {"id": "fda:K260662", "company": "Yofo Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260662: Dental Cone Beam Computed Tomography System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260662", "people": [{"name": "Li Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260662%22"}, {"id": "fda:K253602", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253602: Precision S 4K Sinuscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253602", "people": [{"name": "Divya Sekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253602%22"}, {"id": "fda:K253553", "company": "Resmed Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253553: Orion", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253553", "people": [{"name": "Prerana Gurubasavaraj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253553%22"}, {"id": "fda:K253004", "company": "Lap GmbH Laser Applikationen", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253004: LUNA 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253004", "people": [{"name": "Sebastian Boldhaus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253004%22"}, {"id": "fda:K260770", "company": "DiaSorin, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260770: LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260770", "people": [{"name": "Elauteria Earnhardt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260770%22"}, {"id": "fda:K261510", "company": "Orthosoft Inc. (d/b/a) Zimmer CAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261510: Signature\u0099 ONE System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261510", "people": [{"name": "Camilo Aranguren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261510%22"}, {"id": "fda:K261519", "company": "Sonio", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261519: Sonio Suspect", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261519", "people": [{"name": "Florian Akpakpa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261519%22"}, {"id": "fda:K253984", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253984: Instrument Exit Point on Touch Surgery\u0099 Aide", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253984", "people": [{"name": "Atbin Malayeri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253984%22"}, {"id": "fda:K253020", "company": "American Medical Endoscopy, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253020: Strauss Surgical Resection Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253020", "people": [{"name": "Matthew Schwimmer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253020%22"}, {"id": "fda:K253102", "company": "Gt Metabolic Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253102: GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253102", "people": [{"name": "Lisa Griffin Vincent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253102%22"}, {"id": "fda:K260497", "company": "Keya Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260497: DEEPVESSEL Plaque", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260497", "people": [{"name": "Ning Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260497%22"}, {"id": "trialreg:NCT07625670", "company": "Colgate Palmolive", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study to Evaluate Remineralization Using an in Situ Model.", "source_url": "https://clinicaltrials.gov/study/NCT07625670"}, {"id": "trialreg:NCT07626931", "company": "Liberate Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Abdominal Stimulation to Improve Cough After Spinal Cord Injury", "source_url": "https://clinicaltrials.gov/study/NCT07626931"}, {"id": "trialreg:NCT07627984", "company": "Shanghai Shenqi Medical Technology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cerebral Embolic Protection Device During TAVR", "source_url": "https://clinicaltrials.gov/study/NCT07627984"}, {"id": "trialreg:NCT07628179", "company": "Aurimod GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SENECA - Smart Therapies for Chronic Pain", "source_url": "https://clinicaltrials.gov/study/NCT07628179"}, {"id": "trialreg:NCT07628101", "company": "PediaStent LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation", "source_url": "https://clinicaltrials.gov/study/NCT07628101"}, {"id": "nih:5R44GM139391-03", "company": "Cg Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": 765267, "summary": "NIH award 5R44GM139391-03: Low-Cost Platform Technology for Rapid Isolation of Peripheral Blood Mononuclear Cells ($765,267)", "source_url": "https://reporter.nih.gov/project-details/11337608", "people": [{"name": "Lotien Richard Huang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DA065414-01", "company": "Pillsmart Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": 399993, "summary": "NIH award 1R43DA065414-01: Clinical Decision Support for Early Detection of Relapse Risk in Adolescents with Substance Use Disorders ($399,993)", "source_url": "https://reporter.nih.gov/project-details/11316815", "people": [{"name": "Sivabalaji Kaliamurthy", "role": "Principal Investigator"}, {"name": "Artin Perse", "role": "Principal Investigator"}, {"name": "Babak Tofighi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG087872-03", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": 1236964, "summary": "NIH award 5R44AG087872-03: Developing an Integrated Brain State Monitor for Personalized Anesthesia Decision Support: Preventing Postoperative Delirium in Elderly and Patients At Risk for Alzheimer's or Related Dementias ($1,236,964)", "source_url": "https://reporter.nih.gov/project-details/11333063", "people": [{"name": "David Arney", "role": "Principal Investigator"}, {"name": "Tuan Le Mau", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG097250-02", "company": "Hido Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": 1213105, "summary": "NIH award 5R44AG097250-02: Behavioral Shifts in Dementia Patients Using Novel Pharmacy Home Robotics: A Cost-Effective Approach to Aging in Place ($1,213,105)", "source_url": "https://reporter.nih.gov/project-details/11418517", "people": [{"name": "Timothy Cutler", "role": "Principal Investigator"}, {"name": "Charles Gellman", "role": "Principal Investigator"}, {"name": "SARAH E TOMASZEWSKI-FARIAS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R41AI189162-02", "company": "Datirium, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-03", "observed": "2026-08-21", "amount_usd": 306500, "summary": "NIH award 5R41AI189162-02: Bioinformatics pipeline for personalized diagnostics of transplant rejection ($306,500)", "source_url": "https://reporter.nih.gov/project-details/11254890", "people": [{"name": "Artem Barski", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA302122-02", "company": "Surgivance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-03", "observed": "2026-08-21", "amount_usd": 1271776, "summary": "NIH award 5R44CA302122-02: Rapid 3D POC digital cancer pathology by unique confocal microscopy instrumentation and downstream AI: a simple, efficient, robust direct-to-digital approach to meet market demand ($1,271,776)", "source_url": "https://reporter.nih.gov/project-details/11370329", "people": [{"name": "Daniel Summer Gareau", "role": "Principal Investigator"}, {"name": "Adam LaPrad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG066325-05", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-03", "observed": "2026-08-21", "amount_usd": 1499986, "summary": "NIH award 5R44AG066325-05: Developing an Intraoperative EEG-Guided Precision Anesthesia Management System to Prevent Postoperative Delirium in Elderly and Patients at Risk for Alzheimer's & Related Dementias ($1,499,986)", "source_url": "https://reporter.nih.gov/project-details/11382203", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "fda:K254034", "company": "Roosin Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254034: Roosin Collagen Powder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254034", "people": [{"name": "Dayong Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254034%22"}, {"id": "fda:K260726", "company": "Institut Straumann AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260726: Straumann\u00ae ProClean\u0099 Cassette (041.800 ; 041.801)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260726", "people": [{"name": "Mohammed Ghaleb", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260726%22"}, {"id": "fda:K260703", "company": "S&S Glove Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260703: Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260703", "people": [{"name": "Sang Duong Thanh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260703%22"}, {"id": "fda:K253974", "company": "Roosin Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253974: Roosin Collagen Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253974", "people": [{"name": "Dayong Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253974%22"}, {"id": "fda:K260780", "company": "Deski", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260780: HeartFocus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260780", "people": [{"name": "Kelly Porfirio", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260780%22"}, {"id": "fda:K252854", "company": "Case Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252854: SteriTite Container System with MediTray Products", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252854", "people": [{"name": "Marcia Frieze", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252854%22"}, {"id": "fda:K260715", "company": "The Beauty Tech Group, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260715: CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260715", "people": [{"name": "Harriet Cavanagh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260715%22"}, {"id": "fda:K260179", "company": "Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260179: VITA Multi-Function Head Brush (TB-2343F, TB-2442F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260179", "people": [{"name": "Elin Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260179%22"}, {"id": "fda:K253600", "company": "Yurob Rehabilitation Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253600: Scooter (YD-03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253600", "people": [{"name": "Daoping Pan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253600%22"}, {"id": "fda:K260373", "company": "Jiangsu Yveelt Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260373: Electric Wheelchair (DF506)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260373", "people": [{"name": "Peng Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260373%22"}, {"id": "fda:K261826", "company": "3D Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261826: VSP System (Titanium Palatal Splint)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261826", "people": [{"name": "Archana Gopalan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261826%22"}, {"id": "fda:K252904", "company": "Sic Invent AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252904: SIC Abutments including CAD/CAM Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252904", "people": [{"name": "Marcus von Malottki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252904%22"}, {"id": "fda:K261439", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261439: Permatage Flowable, Settable Hemostatic Bone Paste", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261439", "people": [{"name": "Schrayer Howard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261439%22"}, {"id": "fda:K252800", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252800: KARL STORZ Endoscopic Accessories for Urology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252800", "people": [{"name": "Jennifer Downing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252800%22"}, {"id": "fda:K260116", "company": "CustoMED , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260116: CustoMED Viewer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260116", "people": [{"name": "Or Benifla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260116%22"}, {"id": "fda:K261522", "company": "Biowave Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261522: BioWave BioWraps", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261522", "people": [{"name": "Bradford Siff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261522%22"}, {"id": "fda:K261530", "company": "Deka Research and Development", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261530: iiSure Infusion Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261530", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261530%22"}, {"id": "fda:K253124", "company": "Shenzhen Ziqing Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253124: Upper arm electronic blood pressure monitor (XB-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253124", "people": [{"name": "Yongsheng Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253124%22"}, {"id": "fda:K260402", "company": "Wave Neuroscience", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260402: MeRT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260402", "people": [{"name": "Leslie Prichep", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260402%22"}, {"id": "fda:K261484", "company": "Tas Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261484: Tissue Approximation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261484", "people": [{"name": "Thomas Kramer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261484%22"}, {"id": "fda:K260806", "company": "Vista Industries,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260806: Nitrile Disposable Examination Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260806", "people": [{"name": "James Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260806%22"}, {"id": "fda:K261840", "company": "American Orthodontics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261840: BracePaste Prime Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261840", "people": [{"name": "Laura Richmond", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261840%22"}, {"id": "trialreg:NCT07622446", "company": "Shanghai Dynaheart Medtech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).", "source_url": "https://clinicaltrials.gov/study/NCT07622446"}, {"id": "trialreg:NCT07623902", "company": "Jubaan Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population", "source_url": "https://clinicaltrials.gov/study/NCT07623902"}, {"id": "trialreg:NCT07623837", "company": "Thyroscope Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Validation of AI-Based Quantitative Eye Movement Analysis From Smartphone 9-Gaze Videos (Glandy EOM)", "source_url": "https://clinicaltrials.gov/study/NCT07623837"}, {"id": "trialreg:NCT07624539", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Device for Alleviating Temporomandibular Joint (TMJ) Pain", "source_url": "https://clinicaltrials.gov/study/NCT07624539"}, {"id": "trialreg:NCT07622589", "company": "Truway Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NeuroFinance Human Stress Trial During Financial and Informational Volatility", "source_url": "https://clinicaltrials.gov/study/NCT07622589"}, {"id": "trialreg:NCT07624318", "company": "AstraZeneca", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TROP2 NMR Concordance Study", "source_url": "https://clinicaltrials.gov/study/NCT07624318"}, {"id": "trialreg:NCT07622472", "company": "Zoll Medical Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Remote Monitoring and Optimization of Heart Failure Therapy", "source_url": "https://clinicaltrials.gov/study/NCT07622472"}, {"id": "trialreg:NCT07624669", "company": "Microneedle Solutions Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A First in Human Study Investigating the Safety of an Unloaded and Loaded (With a Tetanus-containing Vaccine Booster) Microneedle Patch in Healthy Adults", "source_url": "https://clinicaltrials.gov/study/NCT07624669"}, {"id": "trialreg:NCT07623993", "company": "Thyroscope Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE)", "source_url": "https://clinicaltrials.gov/study/NCT07623993"}, {"id": "trialreg:NCT07624383", "company": "Cellmedis", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial)", "source_url": "https://clinicaltrials.gov/study/NCT07624383"}, {"id": "trialreg:NCT07624435", "company": "HelpWear Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Conventional Lead Opposed to Novel ECG (CLONE)", "source_url": "https://clinicaltrials.gov/study/NCT07624435"}, {"id": "breakthrough:K260402", "company": "Wave Neuroscience", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-06-03", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K260402: MERT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253918", "company": "F Care Systems USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253918: Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253918", "people": [{"name": "Patrick Danciu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253918%22"}, {"id": "fda:K253507", "company": "Orthalign, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253507: Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253507", "people": [{"name": "Michaela Lindemann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253507%22"}, {"id": "fda:K261540", "company": "Fiagon GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261540: Cube 4D Navigation System, VirtuEye Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261540", "people": [{"name": "Magdalena Giba", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261540%22"}, {"id": "fda:K260270", "company": "FindAir Sp. z o.o.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260270: FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260270", "people": [{"name": "Anna Pawlik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260270%22"}, {"id": "fda:K253803", "company": "Lumenis Be, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253803: MILAN System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253803", "people": [{"name": "Shlomit Segman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253803%22"}, {"id": "fda:K260571", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260571: SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260571", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260571%22"}, {"id": "fda:K261002", "company": "Biomet Microfixation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261002: Pectus Blu System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261002", "people": [{"name": "Jose Ponce", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261002%22"}, {"id": "fda:K253302", "company": "Wilson-Cook Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253302: Hemospray Endoscopic Hemostat (HEMO-[X])", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253302", "people": [{"name": "Alicia Altizer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253302%22"}, {"id": "fda:K253195", "company": "ZheJiang Decans Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253195: TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253195", "people": [{"name": "Haifeng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253195%22"}, {"id": "fda:K252532", "company": "Taiwan Surgical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252532: Inno-Port Disposable Bladed Trocar", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252532", "people": [{"name": "Ken Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252532%22"}, {"id": "fda:K252899", "company": "Zhejiang Kindly Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252899: Female Culture Device; Male Culture Device; Transfer Device; Access Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252899", "people": [{"name": "Qian Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252899%22"}, {"id": "fda:K252816", "company": "Mohammadali Nezakati", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252816: High Tone Power therapy (HiToP) (Model: HiToP PNP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252816", "people": [{"name": "Mohammadali Nezakati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252816%22"}, {"id": "fda:K260364", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260364: Device 300419 Strip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260364", "people": [{"name": "Marco Steiner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260364%22"}, {"id": "fda:K261093", "company": "DiaDent Group International", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261093: DIAFIL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261093", "people": [{"name": "Seung-Geun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261093%22"}, {"id": "fda:K260569", "company": "Carbon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260569: DB 4000 High Impact Denture Base", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260569", "people": [{"name": "Gina Policastro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260569%22"}, {"id": "fda:K260642", "company": "Anhui Longway Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260642: Manual Wheelchair (LW01108)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260642", "people": [{"name": "Alan Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260642%22"}, {"id": "fda:K252844", "company": "Tyto Care , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252844: Tyto Insights for Wheeze Detection (with PCCP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252844", "people": [{"name": "Stella Raizelman Perry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252844%22"}, {"id": "trialreg:NCT07619898", "company": "Therakos LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure", "source_url": "https://clinicaltrials.gov/study/NCT07619898"}, {"id": "trialreg:NCT07620470", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Spectral Precise Image Study for Brain Tumors", "source_url": "https://clinicaltrials.gov/study/NCT07620470"}, {"id": "trialreg:NCT07620457", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Spectral Precise Image Study for Coronary Artery", "source_url": "https://clinicaltrials.gov/study/NCT07620457"}, {"id": "trialreg:NCT07621055", "company": "Volta Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: VOLta Medical AI-software in REal-World During AF Ablation", "source_url": "https://clinicaltrials.gov/study/NCT07621055"}, {"id": "trialreg:NCT07621172", "company": "Cellontech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Long-term Safety and Efficacy of CartiFill After Microfracture Surgery in Knee Cartilage Defects", "source_url": "https://clinicaltrials.gov/study/NCT07621172"}, {"id": "trialreg:NCT07620444", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Spectral Precise Image-Colon Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07620444"}, {"id": "trialreg:NCT07619872", "company": "Edwards Lifesciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance", "source_url": "https://clinicaltrials.gov/study/NCT07619872"}, {"id": "trialreg:NCT07620340", "company": "PsyScale", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AI-Supported Therapy for Depression and Anxiety Compared With Standard CBT", "source_url": "https://clinicaltrials.gov/study/NCT07620340"}, {"id": "trialreg:NCT07620522", "company": "Laboratoires Elerte", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Observational Study of RHINOSEDAL in Acute Nasal Obstruction", "source_url": "https://clinicaltrials.gov/study/NCT07620522"}, {"id": "trialreg:NCT07620769", "company": "CLASSYS Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars", "source_url": "https://clinicaltrials.gov/study/NCT07620769"}, {"id": "trialreg:NCT07620353", "company": "Laboratoires Elerte", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07620353"}, {"id": "trialreg:NCT07622043", "company": "Ivoclar Vivadent AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effectiveness of Two Different Desensitizing Dental Varnishes", "source_url": "https://clinicaltrials.gov/study/NCT07622043"}, {"id": "nih:1R43DC023832-01", "company": "Glimpse Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-01", "observed": "2026-08-06", "amount_usd": 314258, "summary": "NIH award 1R43DC023832-01: Closed-Loop Control Algorithms for Adaptive Eustachian Tube Treatment ($314,258)", "source_url": "https://reporter.nih.gov/project-details/11408841", "people": [{"name": "Courtney Hill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG097382-02", "company": "Storii, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-01", "observed": "2026-08-21", "amount_usd": 943464, "summary": "NIH award 5R44AG097382-02: Strengthening Bonds: A Telephone Reminiscence Intervention to Reduce Social Isolation and Improve Mental Health in Rural Older Adults ($943,464)", "source_url": "https://reporter.nih.gov/project-details/11419818", "people": [{"name": "Cameron Graham", "role": "Principal Investigator"}, {"name": "Juliette M Shellman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AR085500-02", "company": "Peer Technologies, PLLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-06-01", "observed": "2026-08-21", "amount_usd": 1256846, "summary": "NIH award 5R44AR085500-02: Smart Cavity Creator Drill for Lumbar Interbody Fusion: Direct to Phase II ($1,256,846)", "source_url": "https://reporter.nih.gov/project-details/11308290", "people": [{"name": "Sohail K Mirza", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K260456", "company": "Traferox Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260456: VI\u00b0Port\u0099 Liver Preservation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260456", "people": [{"name": "Anuradha Iyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260456%22"}, {"id": "fda:K261541", "company": "VisionAir Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261541: VisionAir Enhanced Stock Stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261541", "people": [{"name": "Jacob Marsh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261541%22"}, {"id": "fda:K253882", "company": "CorDx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-06-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253882: CorDx Tyfast COVID-19 Ag Rapid Test Rx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253882", "people": [{"name": "Aiiso Ally yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253882%22"}, {"id": "trialreg:NCT07616895", "company": "Medacta International SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MFinity BE Pre-market Trial", "source_url": "https://clinicaltrials.gov/study/NCT07616895"}, {"id": "trialreg:NCT07617961", "company": "Biointelligent Technology Systems SL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers", "source_url": "https://clinicaltrials.gov/study/NCT07617961"}, {"id": "trialreg:NCT07618364", "company": "Rinsada", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-06-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease", "source_url": "https://clinicaltrials.gov/study/NCT07618364"}, {"id": "fda:K261154", "company": "In2Bones USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261154: CoLink\u00ae & CoLag\u00ae Non-Sterile Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261154", "people": [{"name": "Tina Mornak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261154%22"}, {"id": "fda:K252840", "company": "Global Instrumentation, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252840: M12 Telemetry System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252840", "people": [{"name": "Craig Sellers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252840%22"}, {"id": "fda:K252947", "company": "HistoSonics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252947: HistoSonics\u00ae Planning Tool", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252947", "people": [{"name": "LeeAnne Swiridow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252947%22"}, {"id": "fda:K261369", "company": "Cosmo Artificial Intelligence - Ai, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261369: GI Genius\u0099 Module 300 (GGM300-US);ColonPRO\u0099 US (CPRO403S-US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261369", "people": [{"name": "Nhan Ngo Dinh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261369%22"}, {"id": "fda:K252821", "company": "Philips Medizin Systeme B\u00f6blingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252821: Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252821", "people": [{"name": "Nicole S\u00f6der", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252821%22"}, {"id": "fda:K261202", "company": "Entire Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261202: ENTire IRE System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261202", "people": [{"name": "Hila Wachsler-Avrahami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261202%22"}, {"id": "fda:K260262", "company": "Mirco-Tech (Nanjing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260262: Injection Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260262", "people": [{"name": "Sally He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260262%22"}, {"id": "fda:K252965", "company": "Oxytek Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252965: Oxygen Concentrator (OX-5A, OX-5C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252965", "people": [{"name": "Jenny Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252965%22"}, {"id": "fda:K261038", "company": "Newclip Technics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261038: Xpert PFP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261038", "people": [{"name": "Ga\u00eblle Gourbi\u00e8re", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261038%22"}, {"id": "fda:K260507", "company": "INTEROJO, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260507: Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260507", "people": [{"name": "Youngkyun Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260507%22"}, {"id": "fda:K260077", "company": "OrthoGrid Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260077: OrthoGrid Hip AI\u00ae 4.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260077", "people": [{"name": "Shweta Conner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260077%22"}, {"id": "fda:K254300", "company": "Anker Innovations Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254300: eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254300", "people": [{"name": "Ezra Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254300%22"}, {"id": "fda:K261159", "company": "Spine Wave, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261159: Exceed\u00ae Biplanar Expandable Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261159", "people": [{"name": "Ronald Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261159%22"}, {"id": "fda:K252859", "company": "iRhythm Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252859: ZEUS Platform (FG0501US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252859", "people": [{"name": "Brittany Davis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252859%22"}, {"id": "fda:K261060", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261060: Navigated LLIF Impactable Tracker", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261060", "people": [{"name": "Priscila Saraiva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261060%22"}, {"id": "fda:K252802", "company": "Shenzhen Bi-Rich Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252802: Peak Flow Meter (PF-10(BR-PEF231))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252802", "people": [{"name": "Steve Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252802%22"}, {"id": "fda:K252396", "company": "Avanutri Equipamentos DE Sa\u00fade", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252396: Cryo Sport 2.0 (AVA 501)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252396", "people": [{"name": "Daiana Vieira", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252396%22"}, {"id": "fda:K260489", "company": "Eufoton S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260489: LASEmaR 1500", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260489", "people": [{"name": "Andrea Buoso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260489%22"}, {"id": "fda:K253119", "company": "Capnia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253119: CoSense ETCO Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253119", "people": [{"name": "Ed Baumann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253119%22"}, {"id": "fda:K253103", "company": "Varex Imaging Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253103: Nexus DRF Digital X-ray Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253103", "people": [{"name": "Leah Van De Water", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253103%22"}, {"id": "fda:K260138", "company": "Enamel Pure", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260138: LUNE PureHygiene", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260138", "people": [{"name": "Nathan Monty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260138%22"}, {"id": "fda:K254076", "company": "C.R. Bard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254076: BD Touchless\u0099 Plus Unisex Pre-Lubricated Urethral Catheter Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254076", "people": [{"name": "Marc Persad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254076%22"}, {"id": "trialreg:NCT07613281", "company": "Serene Sleep, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Serene Sleep Palatal Implant System Clinical Confirmatory Trial in Participants Who Snore or Are Diagnosed With Mild-to-moderate Obstructive Sleep Apnea (OSA).", "source_url": "https://clinicaltrials.gov/study/NCT07613281"}, {"id": "trialreg:NCT07615972", "company": "Puressentiel", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis", "source_url": "https://clinicaltrials.gov/study/NCT07615972"}, {"id": "trialreg:NCT07615959", "company": "Medicsensors S.L", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Medicsen Smartpatch: Safety & Performance (SOUNDD)", "source_url": "https://clinicaltrials.gov/study/NCT07615959"}, {"id": "trialreg:NCT07613931", "company": "Tactile Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment", "source_url": "https://clinicaltrials.gov/study/NCT07613931"}, {"id": "trialreg:NCT07615491", "company": "Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials", "source_url": "https://clinicaltrials.gov/study/NCT07615491"}, {"id": "trialreg:NCT07613892", "company": "Medline Industries", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives", "source_url": "https://clinicaltrials.gov/study/NCT07613892"}, {"id": "trialreg:NCT07615738", "company": "GE Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SpO2 Infant and Pediatric Study", "source_url": "https://clinicaltrials.gov/study/NCT07615738"}, {"id": "trialreg:NCT07614997", "company": "Merz North America, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effectiveness and Safety of the Ulthera\u00ae System for Skin Laxity in the Lower Face, Submentum and Neck", "source_url": "https://clinicaltrials.gov/study/NCT07614997"}, {"id": "trialreg:NCT07614568", "company": "Octane Innovation Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain", "source_url": "https://clinicaltrials.gov/study/NCT07614568"}, {"id": "nih:5R43MH140643-02", "company": "Openmindxr LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-28", "observed": "2026-08-21", "amount_usd": 440929, "summary": "NIH award 5R43MH140643-02: Developing virtual reality programs to address social skills deficits in youth with ADHD ($440,929)", "source_url": "https://reporter.nih.gov/project-details/11332972", "people": [{"name": "Kevin Miller", "role": "Principal Investigator"}, {"name": "Zebulun Maxwell Wood", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "fda:K260295", "company": "Motion Composites", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260295: Helio Kids; Apex P", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260295", "people": [{"name": "Catherine Marquis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260295%22"}, {"id": "fda:K261405", "company": "Imeka Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261405: ANDI 2.2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261405", "people": [{"name": "Valerie Lacroix", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261405%22"}, {"id": "fda:K253530", "company": "Medtronic", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253530: Trexon\u0099 Monofilament Synthetic Absorbable Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253530", "people": [{"name": "Nicole Boroumand", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253530%22"}, {"id": "fda:K260423", "company": "Yangzhou Fartley Medical Instrument Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260423: Disposable Endoscopic Distal Attachments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260423", "people": [{"name": "Xi Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260423%22"}, {"id": "fda:K252823", "company": "Dukal, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252823: Dukal Crepe Paper Sterilization Wrap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252823", "people": [{"name": "William Bagnasco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252823%22"}, {"id": "fda:K252702", "company": "Bioptimal International Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252702: Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252702", "people": [{"name": "Francis Joey Eduave", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252702%22"}, {"id": "fda:K253894", "company": "Global Biomedica s.r.o.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253894: BMD Titanium Spinal Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253894", "people": [{"name": "Piotr Koziel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253894%22"}, {"id": "fda:K260213", "company": "BD Diagnostic Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260213: BD BACTEC FXI Culture System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260213", "people": [{"name": "Susan Kircher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260213%22"}, {"id": "fda:K253931", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253931: Arthrex Bioabsorbable PushLock Suture Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253931", "people": [{"name": "Rebecca Homan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253931%22"}, {"id": "fda:K251840", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251840: Zimmer\u00ae Persona\u00ae Personalized Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251840", "people": [{"name": "Dora Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251840%22"}, {"id": "fda:K252712", "company": "Algiamed Technologies USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252712: STIMPOD NMS460 Nerve Stimulator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252712", "people": [{"name": "Irina Proutski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252712%22"}, {"id": "fda:K254092", "company": "Vieworks Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254092: Bellalun 2D (VDMS-1000S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254092", "people": [{"name": "Seonghwan Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254092%22"}, {"id": "fda:K260895", "company": "Guangxi Ulike Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260895: Ulike Clear Zero (YC10 BU)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260895", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260895%22"}, {"id": "fda:K261037", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261037: 780 nm SPY Portable Handheld Imaging (SPY-PHI) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261037", "people": [{"name": "Mark William", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261037%22"}, {"id": "trialreg:NCT07611773", "company": "Ionclinics & Deionic SL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EEG Prediction and Clinical Efficacy of tDCS in Major Depression", "source_url": "https://clinicaltrials.gov/study/NCT07611773"}, {"id": "trialreg:NCT07611708", "company": "Pleryon Therapeutics (Hangzhou) Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Lubricin-inspired Osteoarthritis Treatment: a Unique Solution", "source_url": "https://clinicaltrials.gov/study/NCT07611708"}, {"id": "fda:K260207", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260207: Multimodality Simulation Workspace (MM Sim) (v1.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260207", "people": [{"name": "Veronica Padharia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260207%22"}, {"id": "fda:K260123", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260123: EPIQ Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260123", "people": [{"name": "Aditi Chaubal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260123%22"}, {"id": "fda:K260367", "company": "PDX Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260367: Portable Dental X-ray System Model PDX nova", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260367", "people": [{"name": "Hyuntaek Shim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260367%22"}, {"id": "fda:K254102", "company": "Glytec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254102: Glucommander", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254102", "people": [{"name": "Robby Booth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254102%22"}, {"id": "fda:K252930", "company": "ZheJiang Decans Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252930: AQUA Laminoplasty Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252930", "people": [{"name": "Haifeng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252930%22"}, {"id": "fda:K260142", "company": "Motion Informatics ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260142: StimelMD (SSMD) system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260142", "people": [{"name": "Liora Levi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260142%22"}, {"id": "fda:K260680", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260680: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260680", "people": [{"name": "Chloe Hills", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260680%22"}, {"id": "fda:K254075", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254075: Synapse Lung Nodule AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254075", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254075%22"}, {"id": "fda:K254265", "company": "Videomed Srl ( a Baxter Healthcare Corp company)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254265: Helion Viewer Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254265", "people": [{"name": "Dania Di Pietro Paolo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254265%22"}, {"id": "fda:K260646", "company": "Smith & Nephew Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260646: RENASYS EDGE (66803126)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260646", "people": [{"name": "Chelsea Baker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260646%22"}, {"id": "fda:K253971", "company": "Visby Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253971: Visby Medical Flu and COVID-19 Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253971", "people": [{"name": "Jennifer Albrecht", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253971%22"}, {"id": "fda:K254104", "company": "Resmed Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254104: ResScan Essentials", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254104", "people": [{"name": "Marzia Signoroni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254104%22"}, {"id": "fda:K253130", "company": "ZheJiang Decans Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253130: Dione PEEK Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253130", "people": [{"name": "Haifeng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253130%22"}, {"id": "fda:K253212", "company": "Sysmex America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253212: XR-Series (XR-10, XR-20) Automated Hematology Analyzers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253212", "people": [{"name": "Yvonne Doswell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253212%22"}, {"id": "fda:K261374", "company": "Medicrea International S.A.S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261374: LigaPASS\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261374", "people": [{"name": "Gautier Liegeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261374%22"}, {"id": "trialreg:NCT07608822", "company": "Biotronik SE & Co. KG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BIO|STREAM.CSP CLS", "source_url": "https://clinicaltrials.gov/study/NCT07608822"}, {"id": "trialreg:NCT07609511", "company": "GT Metabolic Solutions, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Magnet System Gastric Outlet Obstruction Study", "source_url": "https://clinicaltrials.gov/study/NCT07609511"}, {"id": "nih:5R44EB035057-03", "company": "Cellia Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-26", "observed": "2026-08-21", "amount_usd": 927466, "summary": "NIH award 5R44EB035057-03: Deep-UV Microscopy for Real-Time Adequacy Analysis of Bone Marrow Aspirates ($927,466)", "source_url": "https://reporter.nih.gov/project-details/11350924", "people": [{"name": "Amy J Castleman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41DA062382-01", "company": "Thrive Genetics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-26", "observed": "2026-08-21", "amount_usd": 305358, "summary": "NIH award 1R41DA062382-01: The Development of a Personalized Feedback Program for Substance Use Disorder Risk ($305,358)", "source_url": "https://reporter.nih.gov/project-details/11060407", "people": [{"name": "DANIELLE M DICK", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DA055161-03", "company": "Rissana, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-26", "observed": "2026-08-21", "amount_usd": 788392, "summary": "NIH award 5R44DA055161-03: A digital intervention to decrease self-stigma among pregnant and postpartum women with opioid use disorder ($788,392)", "source_url": "https://reporter.nih.gov/project-details/11239794", "people": [{"name": "Patricia A Cavazos-Rehg", "role": "Principal Investigator"}, {"name": "Micah Goodman", "role": "Principal Investigator"}, {"name": "Alex Taylor Ramsey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DA064222-01", "company": "Tibbling Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-26", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R43DA064222-01: SmartDrive: AI-Powered Mobile App for Real-Time Detection of Non-Disordered Drug Use in Drivers ($400,000)", "source_url": "https://reporter.nih.gov/project-details/11239715", "people": [{"name": "Asim Iqbal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R41MH139194-02", "company": "Parc Innovations LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-26", "observed": "2026-08-21", "amount_usd": 407411, "summary": "NIH award 5R41MH139194-02: Interactive E-Learning for Therapist Training in Exposure Therapy ($407,411)", "source_url": "https://reporter.nih.gov/project-details/11322112", "people": [{"name": "Kristen G Benito", "role": "Principal Investigator"}, {"name": "Joshua Kemp", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI192170-02", "company": "Mucommune, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-26", "observed": "2026-08-21", "amount_usd": 992780, "summary": "NIH award 5R44AI192170-02: IND-enabling development of MM-009, a reservoir-intravaginal ring for ultra-highrates of month-long lactic acid release to treat and prevent bacterial vaginosis ($992,780)", "source_url": "https://reporter.nih.gov/project-details/11360209", "people": [{"name": "Keiichiro Kushiro", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K254157", "company": "Medos International SARL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254157: CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254157", "people": [{"name": "Marina Minnock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254157%22"}, {"id": "fda:K252833", "company": "Starmed Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252833: VIVA combo RF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252833", "people": [{"name": "Lee Honggeun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252833%22"}, {"id": "fda:K252797", "company": "Sdip Innovations Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252797: JAZBI\u0099 Resorbable Bone Void Filler", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252797", "people": [{"name": "Maryam Parviz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252797%22"}, {"id": "fda:K260318", "company": "Zhejiang Healnoc Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260318: 4K NIR/ICG Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260318", "people": [{"name": "QiongHua Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260318%22"}, {"id": "fda:K260398", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260398: LOGIQ e", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260398", "people": [{"name": "Lee Bush", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260398%22"}, {"id": "fda:K253629", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253629: Momcozy Nasal Aspirator (BN007)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253629", "people": [{"name": "Rex Hsieh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253629%22"}, {"id": "fda:K252790", "company": "Clarus Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252790: Digital ClarusScope System and Digital NeuroPEN System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252790", "people": [{"name": "Mark Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252790%22"}, {"id": "trialreg:NCT07607015", "company": "Getz Pharma", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CGM Experience, Preferences & Blood Glucose Parameters", "source_url": "https://clinicaltrials.gov/study/NCT07607015"}, {"id": "trialreg:NCT07606963", "company": "Neptune Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Triton 1.5 Robotic System for Diagnostic Colonoscopy", "source_url": "https://clinicaltrials.gov/study/NCT07606963"}, {"id": "trialreg:NCT07607860", "company": "Adaptilens, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of the Adaptilens Accommodating IOL", "source_url": "https://clinicaltrials.gov/study/NCT07607860"}, {"id": "trialreg:NCT07607496", "company": "OD-OS MacuTherm GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MacuTherm Performance Study in Patients With iAMD", "source_url": "https://clinicaltrials.gov/study/NCT07607496"}, {"id": "nih:5R44MH126793-04", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-25", "observed": "2026-08-21", "amount_usd": 1062897, "summary": "NIH award 5R44MH126793-04: A Mobile Text Approach to Measurement and Feedback for Wraparound Care Coordination ($1,062,897)", "source_url": "https://reporter.nih.gov/project-details/11289346", "people": [{"name": "ERIC J. BRUNS", "role": "Principal Investigator"}, {"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44MD018239-03", "company": "Rush River Research Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-25", "observed": "2026-08-21", "amount_usd": 991050, "summary": "NIH award 5R44MD018239-03: Modernized Culturally Sensitive Family Medical History Tool ($991,050)", "source_url": "https://reporter.nih.gov/project-details/11419724", "people": [{"name": "Julie Lundstrom", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K260183", "company": "Parallel Robotics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260183: MediBot Needle Driver Uno", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260183", "people": [{"name": "Russell Jahnke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260183%22"}, {"id": "nih:5R44AI188772-02", "company": "Biacure Therapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": 1000000, "summary": "NIH award 5R44AI188772-02: Using Targeted, Controlled High Frequency Energy for Treatment of Onychomycosis ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11311900", "people": [{"name": "Laura King", "role": "Principal Investigator"}, {"name": "Richard William Schefelker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI162202-04", "company": "Trace-ability, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-22", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI162202-04: Improving availability of ImmunoPET via automation of radio-synthesis and quality control of antibody-based HIV imaging PET tracers on a single platform. ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11300991", "people": [{"name": "Arkadij Elizarov", "role": "Principal Investigator"}, {"name": "Henry F. VanBrocklin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44MH140731-02", "company": "Spatial Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-22", "observed": "2026-08-21", "amount_usd": 1244076, "summary": "NIH award 5R44MH140731-02: Next generation spatial genomics tools for the human brain ($1,244,076)", "source_url": "https://reporter.nih.gov/project-details/11337546", "people": [{"name": "Kirsten Frieda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K252772", "company": "Tz Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252772: Arc Adjustable Radial Cuff Compression Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252772", "people": [{"name": "John Lubisich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252772%22"}, {"id": "fda:K260324", "company": "Canon Medical Informatics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260324: Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260324", "people": [{"name": "Jay Vaishnav", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260324%22"}, {"id": "fda:DEN250057", "company": "Cardiosense, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250057: PCWP Analysis Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250057", "people": [{"name": "Arezou Azar", "role": "510(k) submission contact"}]}, {"id": "fda:K252784", "company": "Anatomical Geometry S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252784: eXaSkin Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252784", "people": [{"name": "Eduardo Suarez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252784%22"}, {"id": "fda:K261098", "company": "Senzime AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261098: TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261098", "people": [{"name": "Johanna Faris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261098%22"}, {"id": "fda:K260329", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260329: Ion-C Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260329", "people": [{"name": "Richard Sharp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260329%22"}, {"id": "fda:K253060", "company": "Protect Gloves Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253060: Sterile Latex Powder Free Surgical Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253060", "people": [{"name": "Nathaphon Wachakorn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253060%22"}, {"id": "fda:K253359", "company": "Suzhou Zenith Vascular SciTech Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253359: Zenith Distal Access Long Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253359", "people": [{"name": "Yexia Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253359%22"}, {"id": "fda:K253773", "company": "Taizhou Huangyan Guanhong Plastic Steel Products Factory", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253773: Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253773", "people": [{"name": "Chenghao Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253773%22"}, {"id": "fda:K261280", "company": "Vivachek Biotech (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261280: BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261280", "people": [{"name": "Qingqing Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261280%22"}, {"id": "fda:K252917", "company": "Genesee Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252917: ATLAAS (Atraumatic Left Atrial Appendage System) (AD)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252917", "people": [{"name": "James Cross", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252917%22"}, {"id": "fda:K254137", "company": "Merit Medical Ireland, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254137: InQwire Amplatz Guide Wire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254137", "people": [{"name": "Brian Coughlan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254137%22"}, {"id": "fda:K254129", "company": "Neko Health AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254129: Spectrum-2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254129", "people": [{"name": "Per Sundstr\u00f6m", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254129%22"}, {"id": "fda:K253569", "company": "Atmo Biosciences, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253569: Atmo Gas Capsule System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253569", "people": [{"name": "Ian Macfarlane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253569%22"}, {"id": "fda:K252887", "company": "DePuy Orthopaedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252887: DePuy ATTUNE\u0099 Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252887", "people": [{"name": "Christina Kaucic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252887%22"}, {"id": "fda:K260113", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260113: uMR Astra", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260113", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260113%22"}, {"id": "fda:K252915", "company": "Ai Health Highway India Pvt., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252915: AiSteth\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252915", "people": [{"name": "Satish S. Jeevannavar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252915%22"}, {"id": "fda:K252735", "company": "Pulmera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252735: C-beam", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252735", "people": [{"name": "Bryan Hartley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252735%22"}, {"id": "fda:K260695", "company": "Intuitive Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260695: da Vinci Firefly Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260695", "people": [{"name": "Crystal Ong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260695%22"}, {"id": "fda:K260560", "company": "Mag & More GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260560: Apollo TMS Therapy System;Apollo light TMS Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260560", "people": [{"name": "Norman Erhard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260560%22"}, {"id": "fda:K253949", "company": "CHISON Medical Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253949: SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253949", "people": [{"name": "Qifei Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253949%22"}, {"id": "fda:K260189", "company": "Tonica Elektronik A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260189: MagVenture Accelerated TMS (aTMS) Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260189", "people": [{"name": "Jan Kj\u00f8ller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260189%22"}, {"id": "trialreg:NCT07602790", "company": "Ceric S\u00e0rl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Expand Management of Blood Pressure With Renal Denervation in Patients Undergoing Staged PCI for Advanced Coronary Artery diseasE", "source_url": "https://clinicaltrials.gov/study/NCT07602790"}, {"id": "trialreg:NCT07601997", "company": "Myomed Technology (Shaoxing) Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Feasibility of Transcatheter Injectable Hydrogel in Acute STEMI Reperfusion Injury (REFINE Study)", "source_url": "https://clinicaltrials.gov/study/NCT07601997"}, {"id": "trialreg:NCT07600645", "company": "CooperVision International Limited (CVIL)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Contact Lens Trial Fitting Experience", "source_url": "https://clinicaltrials.gov/study/NCT07600645"}, {"id": "trialreg:NCT07600684", "company": "HiDO Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Preventing Medication Mismanagement in People Living With Dementia", "source_url": "https://clinicaltrials.gov/study/NCT07600684"}, {"id": "trialreg:NCT07603284", "company": "DexCom, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Continuous Glucose Monitoring By DExcom iN PEople Followed for Type 2 DIabeTes on Insulin Therapy in the Kingdom of Saudi Arabia", "source_url": "https://clinicaltrials.gov/study/NCT07603284"}, {"id": "trialreg:NCT07601269", "company": "ReValve Solutions Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Replacement of the Native Mitral Valve Using the ReValve System", "source_url": "https://clinicaltrials.gov/study/NCT07601269"}, {"id": "trialreg:NCT07603752", "company": "Shanghai StairMed Technology Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study", "source_url": "https://clinicaltrials.gov/study/NCT07603752"}, {"id": "denovo:DEN250057", "company": "Cardiosense, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-05-22", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250057 granted: PCWP Analysis Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250057"}, {"id": "breakthrough:DEN250057", "company": "Cardiosense, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-05-22", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN250057: PCWP ANALYSIS SOFTWARE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K260068", "company": "Pjur Group Luxembourg S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260068: pjur NATURE Touch, 100 ml", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260068", "people": [{"name": "Andrea Giebel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260068%22"}, {"id": "fda:K260962", "company": "Taewoong Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260962: Sphincterotome", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260962", "people": [{"name": "Yongjin \"Jeff\" Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260962%22"}, {"id": "fda:K254141", "company": "Guangdong Dayang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254141: Manual Wheelchair (DY01903(2))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254141", "people": [{"name": "Xueqiong Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254141%22"}, {"id": "fda:K260066", "company": "PanopticAI Technologies Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260066: PanopticAI Vital Signs (1.6.1-22)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260066", "people": [{"name": "Nick Chin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260066%22"}, {"id": "fda:K254244", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254244: Wearable Breast Pump (Model S39)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254244", "people": [{"name": "Dale Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254244%22"}, {"id": "fda:K253112", "company": "Hlb Lifescience Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253112: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253112", "people": [{"name": "Jiwon Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253112%22"}, {"id": "fda:K260649", "company": "Olympus Winter & Ibe GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260649: OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260649", "people": [{"name": "Daria Schuriner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260649%22"}, {"id": "fda:K260618", "company": "Ulthera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260618: Ulthera\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260618", "people": [{"name": "Scott Jewett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260618%22"}, {"id": "fda:K252746", "company": "Dr\u00e4gerwerk AG Co. Kgaa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252746: Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252746", "people": [{"name": "Laura Weaver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252746%22"}, {"id": "fda:K260234", "company": "Smart Alfa Teknoloji San. Ve Tic. A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260234: MSK Go", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260234", "people": [{"name": "Utku Kaya", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260234%22"}, {"id": "fda:K260580", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260580: Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260580", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260580%22"}, {"id": "fda:K253720", "company": "Wuhan United Imaging Healthcare Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253720: uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253720", "people": [{"name": "Xin GAO", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253720%22"}, {"id": "fda:K260582", "company": "Orthosoft Inc. (d/b/a) Zimmer CAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260582: ROSA\u00ae Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260582", "people": [{"name": "Viviana Hernandez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260582%22"}, {"id": "fda:K261359", "company": "Dexcom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261359: Stelo Glucose Biosensor System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261359", "people": [{"name": "Ginny Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261359%22"}, {"id": "fda:K253245", "company": "Boston Aesthetics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253245: Boston 2910 (Boston 2910)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253245", "people": [{"name": "Hongmei Cao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253245%22"}, {"id": "fda:K251920", "company": "Dcstar, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251920: Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251920", "people": [{"name": "Leo Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251920%22"}, {"id": "fda:K253191", "company": "Dental Creativ Management GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253191: DCMhotbond zircon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253191", "people": [{"name": "Milija Mitrovic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253191%22"}, {"id": "fda:K253956", "company": "Sofradim Production", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253956: ProGrip\u0099 advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253956", "people": [{"name": "Anne Bertron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253956%22"}, {"id": "fda:DEN250028", "company": "Spectralmd, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250028: DeepView AI\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250028", "people": [{"name": "Trudy Estridge", "role": "510(k) submission contact"}]}, {"id": "fda:K261315", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261315: Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261315", "people": [{"name": "Tabitha Estes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261315%22"}, {"id": "fda:K261325", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261325: Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261325", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261325%22"}, {"id": "fda:K254131", "company": "DeepHealth, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254131: BAC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254131", "people": [{"name": "B. Nathan Hunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254131%22"}, {"id": "fda:K253352", "company": "Pegavision Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253352: Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253352", "people": [{"name": "Estela Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253352%22"}, {"id": "fda:K253816", "company": "MoleculeX Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253816: MuCover (proposed name) Oral Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253816", "people": [{"name": "ShihYung Liao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253816%22"}, {"id": "fda:K261291", "company": "Cork Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261291: Nisus NPWT Canister 500-mL (CPC-500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261291", "people": [{"name": "Antonio Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261291%22"}, {"id": "denovo:DEN250028", "company": "Spectralmd, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-05-21", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250028 granted: DeepView AI\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250028"}, {"id": "breakthrough:DEN250028", "company": "Spectral Md, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-05-21", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN250028: DEEPVIEW AI SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K260351", "company": "MicroPort NeuroTech (Shanghai) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260351: Numen\u0099 Helia Coil Embolization System; NumenFR\u0099 Detachment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260351", "people": [{"name": "Yuying Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260351%22"}, {"id": "fda:K253134", "company": "Lagis Enterprise Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253134: LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253134", "people": [{"name": "Lynn Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253134%22"}, {"id": "fda:K253570", "company": "Shenzhen Jamr Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253570: Blood Pressure Monitor (W06LT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253570", "people": [{"name": "Zhuni Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253570%22"}, {"id": "fda:K261286", "company": "Circadia Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261286: The Circadia C300 System (C300)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261286", "people": [{"name": "Erhan Ilhan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261286%22"}, {"id": "fda:K253774", "company": "Elos Medtech Pinol A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253774: Elos Accurate\u00ae Denture Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253774", "people": [{"name": "Ana Paula Holtz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253774%22"}, {"id": "fda:K253911", "company": "Neko Health AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253911: Derma-2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253911", "people": [{"name": "Per Sundstr\u00f6m", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253911%22"}, {"id": "fda:K260098", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260098: ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260098", "people": [{"name": "Li Lei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260098%22"}, {"id": "fda:K253596", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253596: Aquilion ONE (TSX-308A/TSX-306A) V2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253596", "people": [{"name": "Orlando Tadeo Jr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253596%22"}, {"id": "fda:K260304", "company": "WAVE Medical AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260304: WAVE PTA Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260304", "people": [{"name": "Kym Rupp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260304%22"}, {"id": "fda:K260717", "company": "Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260717: Mobility Scooter (Air Carbon)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260717", "people": [{"name": "Chen Lezhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260717%22"}, {"id": "fda:K252707", "company": "Suzhou Zenith Vascular SciTech Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252707: Zenith Aspiration Catheter; Disposable Aspiration Tubing Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252707", "people": [{"name": "Yexia Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252707%22"}, {"id": "fda:K260594", "company": "Shenzhen Xiazhifeng Electronic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260594: IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260594", "people": [{"name": "Meirong Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260594%22"}, {"id": "fda:K252717", "company": "Varian Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252717: MAASTRO Rectal Applicator Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252717", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252717%22"}, {"id": "trialreg:NCT07599982", "company": "DreaMed Diabetes", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07599982"}, {"id": "trialreg:NCT07598760", "company": "BackBeat Medical Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction", "source_url": "https://clinicaltrials.gov/study/NCT07598760"}, {"id": "trialreg:NCT07600203", "company": "Erchonia Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Double-blind, Placebo-controlled Evaluation of the Effect of the Erchonia\u00ae EVRL on Chronic Jaw Pain Arising From TMJ", "source_url": "https://clinicaltrials.gov/study/NCT07600203"}, {"id": "trialreg:NCT07599085", "company": "Evolve Medicus, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures", "source_url": "https://clinicaltrials.gov/study/NCT07599085"}, {"id": "trialreg:NCT07599904", "company": "Medtronic Neurovascular Clinical Affairs", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: REal-world Clinical evAulation of Medtronic NeurOVascular Products for Acute Ischemic Stroke (RECANOVA Registry)", "source_url": "https://clinicaltrials.gov/study/NCT07599904"}, {"id": "trialreg:NCT07600489", "company": "Molnlycke Health Care AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Randomized Non-Inferiority Study of Mepi\u2122 Press 2 vs UrgoK2\u00ae for Compression Therapy in Venous Leg Ulcers", "source_url": "https://clinicaltrials.gov/study/NCT07600489"}, {"id": "nih:5R44DA058952-03", "company": "Mmj Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": 347237, "summary": "NIH award 5R44DA058952-03: Creation and Validation of the Dose-Opioid-Source Evaluation tool (DOSE) - a Robust Opioid Use Clinical Outcome Assessment for Qualification as an FDA Medical Device Development Tool (MDDT) ($347,237)", "source_url": "https://reporter.nih.gov/project-details/11257679", "people": [{"name": "Amy Lynn Baxter", "role": "Principal Investigator"}, {"name": "Traci J Speed", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42NS112066-03", "company": "Microsurgical Innovations, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": 1005546, "summary": "NIH award 5R42NS112066-03: Tacrolimus-eluting nerve guidance conduit for enhanced regeneration in critical-sized peripheral nerve injuries ($1,005,546)", "source_url": "https://reporter.nih.gov/project-details/11330189", "people": [{"name": "AZUR AZAPAGIC", "role": "Principal Investigator"}, {"name": "Jayant Prasad Agarwal", "role": "Principal Investigator"}, {"name": "Bruce Gale", "role": "Principal Investigator"}, {"name": "JILL E SHEA", "role": "Principal Investigator"}, {"name": "Himanshu Sant", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44NS117294-05", "company": "Noctrix Health, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-19", "observed": "2026-08-21", "amount_usd": 1324304, "summary": "NIH award 5R44NS117294-05: Developing closed-loop tonic motor activation therapy for treatment of refractory restless legs syndrome ($1,324,304)", "source_url": "https://reporter.nih.gov/project-details/11330427", "people": [{"name": "Jonathan David Charlesworth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R43DA064719-01", "company": "Lc Acquisition LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-19", "observed": "2026-08-21", "amount_usd": 313721, "summary": "NIH award 1R43DA064719-01: Miniature Ion Mobility Detector for Compact Liquid Chromatographic Analysis of Novel Psychoactive Substances ($313,721)", "source_url": "https://reporter.nih.gov/project-details/11286662", "people": [{"name": "MILTON L. LEE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K253722", "company": "Luminex Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253722: LIAISON PLEX Gastrointestinal Flex Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253722", "people": [{"name": "Michael Treas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253722%22"}, {"id": "fda:K254024", "company": "Multi Radiance Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254024: MR5 Activ Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254024", "people": [{"name": "Glenn Persello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254024%22"}, {"id": "fda:K253309", "company": "Shenzhen Soga Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253309: SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253309", "people": [{"name": "Zhang Sha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253309%22"}, {"id": "fda:K260577", "company": "Maine Molecular Quality Controls, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260577: FilmArray TF Control Panel M527", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260577", "people": [{"name": "Joan Gordon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260577%22"}, {"id": "fda:K261071", "company": "DiaDent Group International", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261071: DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261071", "people": [{"name": "Seung-Geun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261071%22"}, {"id": "fda:K261299", "company": "Pegavision Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261299: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261299", "people": [{"name": "Maggie Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261299%22"}, {"id": "fda:K251270", "company": "Biomet, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251270: Taperloc\u00ae Complete Hip Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251270", "people": [{"name": "Dora Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251270%22"}, {"id": "fda:K260146", "company": "Orthofix Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260146: FITBONE\u00ae TRANSPORT AND LENGTHENING SYSTEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260146", "people": [{"name": "Elvira Taccarelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260146%22"}, {"id": "fda:K252985", "company": "Sejong Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252985: Laport", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252985", "people": [{"name": "Jinho Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252985%22"}, {"id": "fda:K260268", "company": "Bernhard F\u00f6rster GmbH (Bernhard Foerster Ltd.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260268: OrthoEasy Pal; OrthoEasy Pal Long Neck", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260268", "people": [{"name": "Stefan F\u00f6rster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260268%22"}, {"id": "pma:P250027", "company": "Guardant Health, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250027: Guardant360\u00ae Liquid CDx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250027", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250027%22"}, {"id": "pma:P250020", "company": "Merz North America, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-05-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250020: Belotero Volume (+) Lidocaine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250020", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250020%22"}, {"id": "trialreg:NCT07595016", "company": "Withings", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-Eclampsia", "source_url": "https://clinicaltrials.gov/study/NCT07595016"}, {"id": "trialreg:NCT07594639", "company": "AgNovos Healthcare, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)", "source_url": "https://clinicaltrials.gov/study/NCT07594639"}, {"id": "trialreg:NCT07595848", "company": "Check Point R & D Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of Sepsis", "source_url": "https://clinicaltrials.gov/study/NCT07595848"}, {"id": "nih:5R44AA030512-04", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-18", "observed": "2026-08-06", "amount_usd": 660862, "summary": "NIH award 5R44AA030512-04: Oscillated Insertion Tool for Minimally Invasive, Low-Damage, Accurate Placement of Delivery Cannula to Improve Efficacy for DREADDS Therapy in Alcohol Addiction Treatment ($660,862)", "source_url": "https://reporter.nih.gov/project-details/11362613", "people": [{"name": "Roger Brooks Bagwell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44DC022803-02", "company": "Xyken, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-18", "observed": "2026-08-06", "amount_usd": 674475, "summary": "NIH award 5R44DC022803-02: Smartphone based custom-fit and low-cost hearing aids manufacturing system ($674,475)", "source_url": "https://reporter.nih.gov/project-details/11320732", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DC022498-02", "company": "Estenda Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-18", "observed": "2026-08-06", "amount_usd": 781326, "summary": "NIH award 5R44DC022498-02: Hub4Smell: Advancing Human Olfactory Research through Digital Innovation and Community Engagement ($781,326)", "source_url": "https://reporter.nih.gov/project-details/11322633", "people": [{"name": "Richard Kedziora", "role": "Principal Investigator"}, {"name": "Patricia Lucas-Schnarre", "role": "Principal Investigator"}, {"name": "Valentina Parma", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG080977-03", "company": "Headwaters Innovation, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-18", "observed": "2026-08-21", "amount_usd": 757621, "summary": "NIH award 5R44AG080977-03: Early detection and monitoring of Alzheimers Disease and Related Dementias using non-semantic linguistic and acoustic features of speech derived from hearing aids ($757,621)", "source_url": "https://reporter.nih.gov/project-details/11416519", "people": [{"name": "Brian John Bischoff", "role": "Principal Investigator"}, {"name": "Anand Devaiah", "role": "Principal Investigator"}, {"name": "Huitong Ding", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DC021123-03", "company": "Creare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-18", "observed": "2026-08-21", "amount_usd": 365739, "summary": "NIH award 5R44DC021123-03: Open Source Hearing Assessment System for Open Science ($365,739)", "source_url": "https://reporter.nih.gov/project-details/11247084", "people": [{"name": "ODILE H CLAVIER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44ES036065-03", "company": "Lebrun Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-18", "observed": "2026-08-21", "amount_usd": 1088111, "summary": "NIH award 5R44ES036065-03: An In Chemico Test to Identify Dermal Corrosives ($1,088,111)", "source_url": "https://reporter.nih.gov/project-details/11295387", "people": [{"name": "Stewart Lebrun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K260522", "company": "Aerin Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260522: RhinAer+ Stylus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260522", "people": [{"name": "Teri Feeley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260522%22"}, {"id": "fda:K253831", "company": "Cercare Medical A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253831: CMN Capillary Function with Virtual Expert for MRI, CT and CBCT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253831", "people": [{"name": "Mikkel Bo Hansen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253831%22"}, {"id": "fda:K260100", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260100: MOSES Raydar\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260100", "people": [{"name": "Ilana Sahnovsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260100%22"}, {"id": "fda:K254109", "company": "GC America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254109: G-CEM UNIVERSAL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254109", "people": [{"name": "Futoshi Fusejima", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254109%22"}, {"id": "fda:K253454", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253454: HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253454", "people": [{"name": "Anureet Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253454%22"}, {"id": "fda:K252047", "company": "ETHICON, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252047: STRATAFIX\u0099 Symmetric PDS\u0099 Plus Knotless Tissue Control Devices", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252047", "people": [{"name": "Samantha Mecker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252047%22"}, {"id": "fda:K253295", "company": "Hollister Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253295: Coude Sleeved IC; Coude Plus Sleeved IC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253295", "people": [{"name": "Michelle Schiltz-Taing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253295%22"}, {"id": "trialreg:NCT07592299", "company": "ALPFA Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.", "source_url": "https://clinicaltrials.gov/study/NCT07592299"}, {"id": "trialreg:NCT07593625", "company": "Insulet Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D", "source_url": "https://clinicaltrials.gov/study/NCT07593625"}, {"id": "trialreg:NCT07592377", "company": "Bioteck S.p.A.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multicenter Study on the Use of a Collagen-based Hydrogel for the Treatment of 153 Periodontal Pockets in 38 Adults With Generalized Stage III Periodontitis", "source_url": "https://clinicaltrials.gov/study/NCT07592377"}, {"id": "trialreg:NCT07594483", "company": "Motif Neurotech, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium", "source_url": "https://clinicaltrials.gov/study/NCT07594483"}, {"id": "trialreg:NCT07593456", "company": "North Shore Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NST-SPARK Open-Label Phase 1 STTR (IGNITE)", "source_url": "https://clinicaltrials.gov/study/NCT07593456"}, {"id": "fda:K260840", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260840: BluEX Cervical Expandable Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260840", "people": [{"name": "Kihyang Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260840%22"}, {"id": "fda:K252377", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252377: NxStage System One with NxView", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252377", "people": [{"name": "Caitlin Kalda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252377%22"}, {"id": "fda:K254120", "company": "Subtle Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254120: SubtleHD-CT (1.x)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254120", "people": [{"name": "Alese Devin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254120%22"}, {"id": "fda:K252423", "company": "Bain Medical Equipment (Guangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252423: NovaLine Tubing Set for Hemodialysis (BL 124)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252423", "people": [{"name": "Zoe Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252423%22"}, {"id": "fda:K253642", "company": "Organon, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253642: Jada System (Jada-2002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253642", "people": [{"name": "Riddhish Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253642%22"}, {"id": "fda:K260989", "company": "Kyocera Medical Technologies Inc. (KMTI)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260989: Varion Thoracolumbar Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260989", "people": [{"name": "Joey Thompson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260989%22"}, {"id": "fda:K260506", "company": "Spinal Elements, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260506: Ventana\u00ae P/T Lumbar Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260506", "people": [{"name": "Sartaj Kaur-Hurrle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260506%22"}, {"id": "fda:K252563", "company": "Neurophet., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252563: Neurophet SCALE PET", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252563", "people": [{"name": "Jin Woo Jeong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252563%22"}, {"id": "fda:K252643", "company": "Teleflex Medical Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252643: Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252643", "people": [{"name": "Suguneswary Subramaniam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252643%22"}, {"id": "fda:K253935", "company": "medXion Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253935: medXion NEXUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253935", "people": [{"name": "Kazuhito Tomii", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253935%22"}, {"id": "fda:K261264", "company": "Bausch and Lomb", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261264: Stellaris Elite\u0099 vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite\u0099 Pack (SE5423); 23 ga. Bi-Blade\u0099 Vitreous Cutter Posterior Stellaris Elite\u0099 Pack (SE5423B); 25 ga. Posterior Elite\u0099 Pack (SE5425); 25 ga. Bi-Blade\u0099 Vitreous Cutter Posterior Stellaris Elite\u0099 Pack (SE5425B); 27 ga. Bi-Blade\u0099 Vitreous Cutter Posterior Stellaris Elite\u0099 Pack (SE5427B); 23 ga. Bi-Blade\u0099+ Vitreous Cutter Posterior Stellaris Elite\u0099 Pack (SE5423BB+); 25 ga. Bi-Blade\u0099+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261264", "people": [{"name": "Matthew Harrison", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261264%22"}, {"id": "fda:K260771", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260771: TruSelect\u0099 2.6 Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260771", "people": [{"name": "Rosemary Bushby", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260771%22"}, {"id": "fda:K253235", "company": "B.Braun Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253235: Introcan Safety\u00ae Deep Access XL IV Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253235", "people": [{"name": "Tracy Larish", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253235%22"}, {"id": "fda:K253759", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253759: cobas liat CT/NG/MG nucleic acid test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253759", "people": [{"name": "Deborah Leu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253759%22"}, {"id": "fda:K253756", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253756: cobas liat CT/NG nucleic acid test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253756", "people": [{"name": "Deborah Leu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253756%22"}, {"id": "fda:K253716", "company": "Wuhan United Imaging Healthcare Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253716: uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253716", "people": [{"name": "Xin GAO", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253716%22"}, {"id": "fda:K261289", "company": "Medicrea International S.A.S. (Medtronic)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261289: UNiD\u0099 Spine Analyzer (SW3002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261289", "people": [{"name": "Hajar BOULMAN", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261289%22"}, {"id": "fda:K261273", "company": "Neurophet., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261273: Neurophet AQUA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261273", "people": [{"name": "Yerim Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261273%22"}, {"id": "fda:K254050", "company": "Suzhou AcuVu Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254050: Manual Tissue Removal Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254050", "people": [{"name": "Sam Mostafavi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254050%22"}, {"id": "fda:K250781", "company": "Alife Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250781: Embryo Predict", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250781", "people": [{"name": "Melissa Teran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250781%22"}, {"id": "fda:K260134", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260134: Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260134", "people": [{"name": "Haiyan Wen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260134%22"}, {"id": "fda:K254028", "company": "Sonoscape Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254028: Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254028", "people": [{"name": "Toki Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254028%22"}, {"id": "fda:K252624", "company": "KARL STORZ Endoscopy-America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252624: KARL STORZ Laryngoscopes and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252624", "people": [{"name": "Jennifer Downing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252624%22"}, {"id": "fda:K260536", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260536: Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260536", "people": [{"name": "Megan Palumbo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260536%22"}, {"id": "fda:K260059", "company": "Hycor Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260059: NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260059", "people": [{"name": "Hiromi Kubota", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260059%22"}, {"id": "pma:P260004", "company": "Natera, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-05-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P260004: Signatera\u0099 CDx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P260004", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P260004%22"}, {"id": "trialreg:NCT07589452", "company": "Medtronic Cardiac Rhythm and Heart Failure", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction", "source_url": "https://clinicaltrials.gov/study/NCT07589452"}, {"id": "trialreg:NCT07590063", "company": "United Imaging Healthcare North America, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Technology Development of Diagnostic Ultrasound System for Obstetric Imaging", "source_url": "https://clinicaltrials.gov/study/NCT07590063"}, {"id": "trialreg:NCT07588672", "company": "Polyrizon Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis", "source_url": "https://clinicaltrials.gov/study/NCT07588672"}, {"id": "trialreg:NCT07589023", "company": "Globus Medical Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Retrospective Review: Outcomes of the REFLECT\u2122 System for Idiopathic Scoliosis", "source_url": "https://clinicaltrials.gov/study/NCT07589023"}, {"id": "breakthrough:P260004", "company": "Natera, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-05-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P260004: SIGNATERA CDX", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44HD107718-03", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-14", "observed": "2026-08-21", "amount_usd": 1112943, "summary": "NIH award 5R44HD107718-03: Virtual Activities of Living for Occupational Rehabilitation ($1,112,943)", "source_url": "https://reporter.nih.gov/project-details/11322535", "people": [{"name": "Richard J. Adams", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA287803-03", "company": "Ne Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-14", "observed": "2026-08-21", "amount_usd": 689478, "summary": "NIH award 5R44CA287803-03: Computer Guided Microwave Liver Ablation ($689,478)", "source_url": "https://reporter.nih.gov/project-details/11370564", "people": [{"name": "Andrea Borsic", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44DA059517-02", "company": "Neurotype Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-14", "observed": "2026-08-21", "amount_usd": 870345, "summary": "NIH award 4R44DA059517-02: Cue-induced drug craving monitoring for opioid use disorder with visual evoked potentials ($870,345)", "source_url": "https://reporter.nih.gov/project-details/11360372", "people": [{"name": "Scott Burwell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K254013", "company": "Subtle Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254013: SubtleHD-PET (1.x)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254013", "people": [{"name": "Alese Devin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254013%22"}, {"id": "fda:K254133", "company": "Optim, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254133: ENTity USB Videoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254133", "people": [{"name": "Sheldon Sillyman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254133%22"}, {"id": "fda:K260485", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260485: Any-Etch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260485", "people": [{"name": "Ku Da Hyeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260485%22"}, {"id": "fda:K252776", "company": "ZheJiang Decans Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252776: ARIES Anterior Cervical Plate Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252776", "people": [{"name": "Haifeng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252776%22"}, {"id": "fda:K260111", "company": "Mytech Intelligence (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260111: Palmtop Ultrasound Diagnostic System (MT10P/MT10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260111", "people": [{"name": "Xulei Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260111%22"}, {"id": "fda:K252652", "company": "Fortis Biosolutions Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252652: Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252652", "people": [{"name": "Sharon Au", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252652%22"}, {"id": "fda:K253676", "company": "Providence Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253676: CORUS\u0099 Posterior Cervical Stabilization System 3D (CORUS\u0099 PCSS 3D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253676", "people": [{"name": "Edward Liou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253676%22"}, {"id": "fda:K260565", "company": "Elucent Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260565: SmartClip Delivery Catheter (ADR-1715)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260565", "people": [{"name": "Jake Burke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260565%22"}, {"id": "fda:K261241", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261241: TriMed Compression Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261241", "people": [{"name": "Annika Lind", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261241%22"}, {"id": "fda:K253883", "company": "Bonalive , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253883: Bonalive Maxillofacial", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253883", "people": [{"name": "Jenna Saarim\u00e4ki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253883%22"}, {"id": "fda:K252601", "company": "Hunan Accurate Bio-Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252601: Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252601", "people": [{"name": "Li Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252601%22"}, {"id": "fda:K253078", "company": "Seetreat Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253078: ART.1-US", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253078", "people": [{"name": "Eric Qin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253078%22"}, {"id": "fda:K261134", "company": "Koncept Innovators, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261134: Dormiva Anti-Snoring Mouth Guard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261134", "people": [{"name": "Maureen Garner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261134%22"}, {"id": "fda:K261224", "company": "Medskin Solutions Dr. Suwelack AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261224: MatriDerm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261224", "people": [{"name": "Claudia Doberenz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261224%22"}, {"id": "fda:K261317", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261317: BriefCase-Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261317", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261317%22"}, {"id": "fda:K260892", "company": "Shenzhen HugeMed Medical Technical Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260892: Suction Pump (SU-90)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260892", "people": [{"name": "Joyce Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260892%22"}, {"id": "fda:K253372", "company": "Hiossen, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253372: ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253372", "people": [{"name": "Mateusz Leszczak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253372%22"}, {"id": "fda:K254048", "company": "Shenzhen Urion Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254048: Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254048", "people": [{"name": "Fraser Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254048%22"}, {"id": "fda:K260085", "company": "DRGEM Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260085: RAYMO Mobile X-ray System (Model: RAYMO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260085", "people": [{"name": "Yubin CHO", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260085%22"}, {"id": "trialreg:NCT07586774", "company": "Dentsply Sirona Implants and Consumables", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Outcomes of 3D Printed and Milled Complete Dentures", "source_url": "https://clinicaltrials.gov/study/NCT07586774"}, {"id": "trialreg:NCT07585968", "company": "Medtronic Cardiac Ablation Solutions", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of the Sphere-9\u2122 Catheter and Affera\u2122 Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)", "source_url": "https://clinicaltrials.gov/study/NCT07585968"}, {"id": "trialreg:NCT07586995", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Post-Market Assessment of the Safety and Performance of the TriClip\u2122 System", "source_url": "https://clinicaltrials.gov/study/NCT07586995"}, {"id": "trialreg:NCT07587138", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of a Novel Trifocal IOL", "source_url": "https://clinicaltrials.gov/study/NCT07587138"}, {"id": "trialreg:NCT07585591", "company": "CynosureLutronic", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments", "source_url": "https://clinicaltrials.gov/study/NCT07585591"}, {"id": "trialreg:NCT07588243", "company": "CynosureLutronic", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study to Evaluate the Efficacy and Safety of Ultra in Promoting Hair Regrowth", "source_url": "https://clinicaltrials.gov/study/NCT07588243"}, {"id": "nih:5R44HL142440-06", "company": "Alleviant Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": 996173, "summary": "NIH award 5R44HL142440-06: Transcatheter Device for Congestive Heart Failure Treatment Through Left Atrial Decompression ($996,173)", "source_url": "https://reporter.nih.gov/project-details/11289343", "people": [{"name": "Thomas Diffley Pate", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R42HL167342-03", "company": "Sensydia Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": 816106, "summary": "NIH award 5R42HL167342-03: A non-invasive, automated platform for hemodynamic assessment of patients at risk of heart failure or pulmonary hypertension ($816,106)", "source_url": "https://reporter.nih.gov/project-details/11322000", "people": [{"name": "Anthony Arnold", "role": "Principal Investigator"}, {"name": "Aman Mahajan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL158304-05", "company": "Starlight Cardiovascular, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": 999876, "summary": "NIH award 5R44HL158304-05: DUCTUS ARTERIOSUS STENT TO IMPROVE CONGENITAL HEART DEFECT MORTALITY ($999,876)", "source_url": "https://reporter.nih.gov/project-details/11243516", "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44ES035657-03", "company": "Scitovation, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-13", "observed": "2026-08-21", "amount_usd": 983133, "summary": "NIH award 5R44ES035657-03: Triage of Developmental and Reproductive Toxicants using an In vitro to In Vivo Extrapolation (IVIVE)-Toxicokinetic Computational modeling Application ($983,133)", "source_url": "https://reporter.nih.gov/project-details/11332946", "people": [{"name": "Todor Antonijevic", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AI141283-06", "company": "Prothera Biologics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-13", "observed": "2026-08-21", "amount_usd": 954189, "summary": "NIH award 5R44AI141283-06: Rapid Test to Assist Therapy in Neonatal Sepsis and Necrotizing Enterocolitis ($954,189)", "source_url": "https://reporter.nih.gov/project-details/11324963", "people": [{"name": "ROBERTA L KELLER", "role": "Principal Investigator"}, {"name": "YOW-PIN LIM", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "fda:K252591", "company": "Woorhi Mechatronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252591: Automatic Micro Needle System (CODE-X)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252591", "people": [{"name": "Jungsu Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252591%22"}, {"id": "fda:K260032", "company": "BeauBrain Healthcare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260032: Morph", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260032", "people": [{"name": "Hyojin Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260032%22"}, {"id": "fda:K253181", "company": "Surgimage Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253181: SURGIMAGE SIM 1000H Fluorescence Imaging Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253181", "people": [{"name": "Vince Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253181%22"}, {"id": "fda:K254073", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254073: StatSeal Disc", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254073", "people": [{"name": "Alexander Bohorquez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254073%22"}, {"id": "fda:K252638", "company": "Acist Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252638: VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252638", "people": [{"name": "Bobbie Daughters", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252638%22"}, {"id": "fda:K253241", "company": "Jiangsu Intco Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253241: Electric Wheelchair (Y207BL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253241", "people": [{"name": "Terry Gu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253241%22"}, {"id": "fda:K253061", "company": "Helius Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253061: Portable Neuromodulation Stimulator (PoNS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253061", "people": [{"name": "Lawrence Picciano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253061%22"}, {"id": "fda:K254125", "company": "Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254125: Electric Breast Pump (HL-3058 II Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254125", "people": [{"name": "Shulin Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254125%22"}, {"id": "fda:K261363", "company": "CONMED Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261363: Y-Knotless\u0099 Flex Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261363", "people": [{"name": "Mirela Gjini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261363%22"}, {"id": "fda:K252653", "company": "Acist Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252653: ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252653", "people": [{"name": "Meg Daniel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252653%22"}, {"id": "trialreg:NCT07584811", "company": "Nakhia Impex LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of Overnight Occlusive HA35 Gel for Facial Aesthetic Improvement", "source_url": "https://clinicaltrials.gov/study/NCT07584811"}, {"id": "trialreg:NCT07583056", "company": "Ionclinics & Deionic SL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.", "source_url": "https://clinicaltrials.gov/study/NCT07583056"}, {"id": "trialreg:NCT07582809", "company": "BELL Therapeutics Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation to Observe the Long-term Safety and Efficacy of the Digital Medical Device 'BELL-001' in Patients Diagnosed With Insomnia", "source_url": "https://clinicaltrials.gov/study/NCT07582809"}, {"id": "trialreg:NCT07583108", "company": "Nakhia Impex LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of High-Dose Oral 35 kDa Hyaluronan for Aesthetic Improvement", "source_url": "https://clinicaltrials.gov/study/NCT07583108"}, {"id": "trialreg:NCT07584655", "company": "Nakhia Impex LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of HA35 Gel for Post-Dental Gingival Pain and Swelling", "source_url": "https://clinicaltrials.gov/study/NCT07584655"}, {"id": "trialreg:NCT07584642", "company": "Nakhia Impex LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of HA35 Gel Nighttime Occlusive Application for TMD Pain", "source_url": "https://clinicaltrials.gov/study/NCT07584642"}, {"id": "breakthrough:K253061", "company": "Helius Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-05-13", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K253061: PORTABLE NEUROMODULATION STIMULATOR (PONS)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44DA058531-03", "company": "Nxtech Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": 1037003, "summary": "NIH award 5R44DA058531-03: BoostPrime, A Novel Digital Therapeutic for Craving Mitigation in OUD ($1,037,003)", "source_url": "https://reporter.nih.gov/project-details/11300988", "people": [{"name": "Salil Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R43HL178364-02", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": 289177, "summary": "NIH award 5R43HL178364-02: Magnetic Rotational Platform for Coronary Lesions ($289,177)", "source_url": "https://reporter.nih.gov/project-details/11322013", "people": [{"name": "Richard Gordon Bach", "role": "Principal Investigator"}, {"name": "Francis Milton Creighton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG084487-03", "company": "Biosensics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": 1245571, "summary": "NIH award 5R44AG084487-03: A Multi-Modal Wearable Sensor for Early Detection of Cognitive Decline and Remote Monitoring of Cognitive-Motor Decline Over Time ($1,245,571)", "source_url": "https://reporter.nih.gov/project-details/11378570", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH135605-03", "company": "Ksana Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-21", "amount_usd": 900523, "summary": "NIH award 5R44MH135605-03: BRITE 2.0: A just-in-time adaptive intervention for suicide safety planning in adolescents ($900,523)", "source_url": "https://reporter.nih.gov/project-details/11233252", "people": [{"name": "NICHOLAS B ALLEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HD112248-03", "company": "Spirit Fit & Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-21", "amount_usd": 918117, "summary": "NIH award 5R44HD112248-03: SPIRIT Club CBI Pathway: A novel streaming platform for physical activity and wellness promotion for chronic brain injury survivors ($918,117)", "source_url": "https://reporter.nih.gov/project-details/11263695", "people": [{"name": "Jared Phillip Ciner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44GM156142-03", "company": "Gmj Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-21", "amount_usd": 902099, "summary": "NIH award 5R44GM156142-03: High-Resolution Native Capillary Zone Electrophoresis with Inline UV and Native Mass Spectrometry for Characterizing Charge Variants in Biologics ($902,099)", "source_url": "https://reporter.nih.gov/project-details/11325751", "people": [{"name": "Oluwatosin Dada", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DA059491-03", "company": "Rtm Vital Signs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-21", "amount_usd": 1252788, "summary": "NIH award 5R44DA059491-03: Wearable Wireless Respiratory Monitoring System that Detects and Predicts Opioid Induced Respiratory Depression ($1,252,788)", "source_url": "https://reporter.nih.gov/project-details/11237086", "people": [{"name": "Nance Katherine Dicciani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DA056259-04", "company": "Sonara Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-21", "amount_usd": 704972, "summary": "NIH award 5R44DA056259-04: Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care ($704,972)", "source_url": "https://reporter.nih.gov/project-details/11307618", "people": [{"name": "MICHAEL L. DENNIS", "role": "Principal Investigator"}, {"name": "Michael Giles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44HD118899-02", "company": "Nextgenjane, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-21", "amount_usd": 714095, "summary": "NIH award 5R44HD118899-02: Performance evaluation of a non-invasive menstrual test for endometriosis in infertility patients ($714,095)", "source_url": "https://reporter.nih.gov/project-details/11321735", "people": [{"name": "Stephen Gire", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44TR005339-02", "company": "Captis Diagnostics", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-21", "amount_usd": 1117056, "summary": "NIH award 5R44TR005339-02: Magnetic Lipid Nanoprobe Platform for Rapid, Highly-Efficient, and Cost-Effective Isolation of Extracellular Vesicles from Non-Invasive Bodily Fluids ($1,117,056)", "source_url": "https://reporter.nih.gov/project-details/11300972", "people": [{"name": "Hongzhang He", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL147771-06", "company": "Annoviant, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-21", "amount_usd": 895062, "summary": "NIH award 5R44HL147771-06: Pulmonary Valved Graft with Regeneration Potential for Pediatric Patients ($895,062)", "source_url": "https://reporter.nih.gov/project-details/11314521", "people": [{"name": "Ajay Houde", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R43MH139259-02", "company": "Neuronexus Technologies", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-21", "amount_usd": 449677, "summary": "NIH award 5R43MH139259-02: Advanced culture and recording system for long-term electrophysiological profiling in human brain organoids ($449,677)", "source_url": "https://reporter.nih.gov/project-details/11291833", "people": [{"name": "DARYL R KIPKE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44HD104539-04", "company": "Zsx Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-12", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44HD104539-04: Zip-stitch for Laparoscopic Hysterectomy - Clinical Validation ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11305976", "people": [{"name": "Dan C Mazzucco", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K252731", "company": "Promimic AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252731: Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252731", "people": [{"name": "Oscar Davidsson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252731%22"}, {"id": "fda:K261196", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261196: Promisemed VeriEcto Automatic Biopsy Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261196", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261196%22"}, {"id": "fda:K260235", "company": "Datar Cancer Genetics Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260235: CellDx-Tissue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260235", "people": [{"name": "Dadasaheb Akolkar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260235%22"}, {"id": "fda:K260051", "company": "CorVent\u00ae Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260051: CorVision\u00ae (91-205-Z0014)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260051", "people": [{"name": "Richard Walsh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260051%22"}, {"id": "fda:K260473", "company": "Shenzhen Kingboom Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260473: Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260473", "people": [{"name": "Ma Qiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260473%22"}, {"id": "fda:K260837", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260837: VersaLift Expandable System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260837", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260837%22"}, {"id": "fda:K260850", "company": "Osteomni, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260850: OSTEOMNI SPINAL CAGES SYSTEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260850", "people": [{"name": "Gulten Shurdom", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260850%22"}, {"id": "fda:K260378", "company": "AZmed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260378: Rayvolve", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260378", "people": [{"name": "Shanni Zeitoun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260378%22"}, {"id": "fda:K260415", "company": "Light Tree Ventures Europe B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260415: myLEDmask 2 (MJ-144)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260415", "people": [{"name": "Kim Markwat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260415%22"}, {"id": "fda:K254192", "company": "Asensus Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254192: Senhance Ultrasonic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254192", "people": [{"name": "Madhuvanthi Soundirarajan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254192%22"}, {"id": "fda:K260725", "company": "Hindernis DE Mexico, S.A.P.I. DE C.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260725: BA\u00dcMER Surgical Gowns (COP01, COP04, COP05, COP10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260725", "people": [{"name": "Eduardo Gras", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260725%22"}, {"id": "trialreg:NCT07580911", "company": "Nakhia Impex LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of HA35 Gel for Ultra-Rapid Skin Pruritus Relief", "source_url": "https://clinicaltrials.gov/study/NCT07580911"}, {"id": "trialreg:NCT07580105", "company": "Kenko Imalytics S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women", "source_url": "https://clinicaltrials.gov/study/NCT07580105"}, {"id": "trialreg:NCT07582250", "company": "JW Medical Systems Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Efficacy of Biolimus Drug-Coated Balloon (DCB) Versus Drug-Eluting Stent (DES) in the Treatment of De Novo Coronary Artery Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07582250"}, {"id": "trialreg:NCT07580560", "company": "Aqua Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study", "source_url": "https://clinicaltrials.gov/study/NCT07580560"}, {"id": "trialreg:NCT07582198", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Hearing Outcomes With the Nucleus\u00ae 8 Sound Processor and Nucleus\u00ae 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients", "source_url": "https://clinicaltrials.gov/study/NCT07582198"}, {"id": "trialreg:NCT07580599", "company": "Biointelligent Technology Systems SL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Enhanced Early Soft-Tissue Healing With THERAVEX Technology", "source_url": "https://clinicaltrials.gov/study/NCT07580599"}, {"id": "trialreg:NCT07580664", "company": "Cousin Biotech", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease", "source_url": "https://clinicaltrials.gov/study/NCT07580664"}, {"id": "trialreg:NCT07579702", "company": "Insulet Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy of the Omnipod\u00ae 6 System Compared With the Omnipod\u00ae 5 System", "source_url": "https://clinicaltrials.gov/study/NCT07579702"}, {"id": "nih:5R44HL177945-02", "company": "Corvion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-11", "observed": "2026-08-21", "amount_usd": 1061414, "summary": "NIH award 5R44HL177945-02: Development of a Totally Implanted Left Ventricular Assist Device ($1,061,414)", "source_url": "https://reporter.nih.gov/project-details/11290848", "people": [{"name": "Greg Aber", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM148111-03", "company": "Doty Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-11", "observed": "2026-08-21", "amount_usd": 946077, "summary": "NIH award 5R44GM148111-03: Ultra-low-temperature (6 K) static NMR-DNP for metalloproteins, proteins in cells, and materials ($946,077)", "source_url": "https://reporter.nih.gov/project-details/11251938", "people": [{"name": "Francis DAVID Doty", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K261214", "company": "Speclipse, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261214: PICO SHINING (PICO-K; PICOFY)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261214", "people": [{"name": "HeaJung Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261214%22"}, {"id": "fda:K252655", "company": "Shenzhen Imdk Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252655: Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252655", "people": [{"name": "Yuan Xia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252655%22"}, {"id": "fda:K253696", "company": "Verathon Medical (Canada) Ulc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253696: CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253696", "people": [{"name": "Curtis Jensen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253696%22"}, {"id": "fda:K254228", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254228: KARL STORZ Trocars with Valve Seals", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254228", "people": [{"name": "Mario Trujillo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254228%22"}, {"id": "fda:K252880", "company": "Pytheas Navigation Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252880: Pytheas Your Guided Trajectory", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252880", "people": [{"name": "Marc Forman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252880%22"}, {"id": "fda:K260805", "company": "Vericom Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260805: Dual Core", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260805", "people": [{"name": "Yun Ki Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260805%22"}, {"id": "fda:K250964", "company": "Jiangsu Jumao X-Care Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250964: Protable Phlegm Suction Unit (JMA D01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250964", "people": [{"name": "Yao Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250964%22"}, {"id": "fda:K260842", "company": "Hardy Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260842: HardyDisk AST Gepotidacin 10\u00b5g (GEP10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260842", "people": [{"name": "Lauren Hamilton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260842%22"}, {"id": "fda:K252953", "company": "Velmeni, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252953: Velmeni for Dentists (V4D) Endo-Perio", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252953", "people": [{"name": "Mini Suri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252953%22"}, {"id": "fda:K260846", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260846: Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260846", "people": [{"name": "Xiaolong Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260846%22"}, {"id": "fda:K260196", "company": "Ethicon Endo-Surgery, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260196: ETHICON\u0099 Circular Stapler (CDH21mm); ETHICON\u0099 Circular Stapler (CDH25mm); ETHICON\u0099 Circular Stapler (CDH29mm); ETHICON\u0099 Circular Stapler (CDH33mm); ETHICON\u0099 Circular Stapler - XL Sealed (ECS21mm); ETHICON\u0099 Circular Stapler - XL Sealed (ECS25mm); ETHICON\u0099 Circular Stapler - XL Sealed (ECS29mm); ETHICON\u0099 Circular Stapler - XL Sealed (ECS33mm)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260196", "people": [{"name": "Aysenur Huseyinoglu Erucman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260196%22"}, {"id": "fda:K254178", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254178: SAYA 86 Radial Access Guide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254178", "people": [{"name": "Katsuhiko Fujimura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254178%22"}, {"id": "pma:P250026", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-05-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250026: Atellica IM free PSA II (fPSAII)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250026", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250026%22"}, {"id": "trialreg:NCT07577258", "company": "Nakhia Impex LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of HA35 Gel for Mild Gingival Recession and Periodontal Inflammation", "source_url": "https://clinicaltrials.gov/study/NCT07577258"}, {"id": "trialreg:NCT07578155", "company": "Accexible", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of Accexible Screening and Self-Administered Activities for Emotional Well-Being in a University Hospital (UaDEC)", "source_url": "https://clinicaltrials.gov/study/NCT07578155"}, {"id": "trialreg:NCT07578441", "company": "Bridge to Life Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: VitaSmart HOPE System: Bridge to HOPE Registry", "source_url": "https://clinicaltrials.gov/study/NCT07578441"}, {"id": "trialreg:NCT07578142", "company": "Accexible", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AcceXible Speech-Based Screening for Depression and Anxiety in University Students (UAQ, Mexico)", "source_url": "https://clinicaltrials.gov/study/NCT07578142"}, {"id": "fda:K260385", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260385: aprevo\u00ae anterior and lateral lumbar interbody system; aprevo\u00ae posterior and transforaminal lumbar interbody system; aprevo\u00ae cervical interbody system; corra\u0099 cervical plating system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260385", "people": [{"name": "Stephanie Crossman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260385%22"}, {"id": "fda:K261145", "company": "Avanti Orthopaedics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261145: Avanti Distal Elbow ORIF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261145", "people": [{"name": "Doug Patterson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261145%22"}, {"id": "fda:K252621", "company": "El Global Trade, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252621: DeepSkin (DEP100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252621", "people": [{"name": "Stephanie Khoury", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252621%22"}, {"id": "fda:K253991", "company": "Orthofix Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253991: Fitbone\u0099 Trochanteric, FITBONE\u00ae Transport and Lengthening System, FITBONE\u00ae TAA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253991", "people": [{"name": "Elvira Taccarelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253991%22"}, {"id": "fda:K252617", "company": "Intromedic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252617: MiroCam\u00ae Capsule Endoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252617", "people": [{"name": "Guyeon Jung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252617%22"}, {"id": "fda:K260419", "company": "Hangzhou ChohoTech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260419: LingOral Dental Design System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260419", "people": [{"name": "Cui Jianqiao Cui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260419%22"}, {"id": "fda:K253237", "company": "Elde Medikal Sanayi ve Ticaret Anonim Sirketi", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253237: Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253237", "people": [{"name": "Nurettin Eren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253237%22"}, {"id": "fda:DEN250013", "company": "Neurovalens Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250013: Modius Spero", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250013", "people": [{"name": "Jason Mckeown", "role": "510(k) submission contact"}]}, {"id": "fda:K253679", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253679: Hydro Irrigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253679", "people": [{"name": "Divya Sekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253679%22"}, {"id": "fda:K254215", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254215: Arthrex Beaming System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254215", "people": [{"name": "Konrad Wolfmeyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254215%22"}, {"id": "fda:K250814", "company": "Zeus Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250814: Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250814", "people": [{"name": "Daniel Zweitzig", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250814%22"}, {"id": "fda:K260788", "company": "Smylio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260788: Smylio Aligners", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260788", "people": [{"name": "Ren Menon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260788%22"}, {"id": "fda:K260792", "company": "Stabilix, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260792: AerFrame Patient Immobilization System (AFPIS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260792", "people": [{"name": "Richard Westhoven", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260792%22"}, {"id": "fda:K253013", "company": "Zhejiang Soudon Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253013: Disposable Stone Retrieval Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253013", "people": [{"name": "Junshi Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253013%22"}, {"id": "fda:K253396", "company": "Apyx Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253396: AYON Body Contouring System\u0099 (AYON SYSTEM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253396", "people": [{"name": "Nikita Gajbhiye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253396%22"}, {"id": "fda:K260321", "company": "Orthopedic Driven Imaging, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260321: HipGuide (V 1.0.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260321", "people": [{"name": "Michael McCaig", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260321%22"}, {"id": "trialreg:NCT07576972", "company": "Mother's Milk is Best", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Human Milk Concentrating Device to Optimize Mother's Own Milk", "source_url": "https://clinicaltrials.gov/study/NCT07576972"}, {"id": "trialreg:NCT07574918", "company": "Aerin Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis", "source_url": "https://clinicaltrials.gov/study/NCT07574918"}, {"id": "trialreg:NCT07575269", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07575269"}, {"id": "trialreg:NCT07574593", "company": "Foundry Innovation & Research 1, Limited (FIRE1)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NORM-HF Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT07574593"}, {"id": "trialreg:NCT07576998", "company": "Microvention-Terumo, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PHIL\u2122 Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial", "source_url": "https://clinicaltrials.gov/study/NCT07576998"}, {"id": "trialreg:NCT07575568", "company": "Cagent Vascular LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen", "source_url": "https://clinicaltrials.gov/study/NCT07575568"}, {"id": "trialreg:NCT07575828", "company": "Medtronic Cardiac Ablation Solutions", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07575828"}, {"id": "trialreg:NCT07574632", "company": "Thinks Works, PBC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis.", "source_url": "https://clinicaltrials.gov/study/NCT07574632"}, {"id": "trialreg:NCT07575191", "company": "Smartwise Sweden AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07575191"}, {"id": "denovo:DEN250013", "company": "Neurovalens Limited", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-05-08", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250013 granted: Modius Spero", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250013"}, {"id": "nih:5R44HL178134-02", "company": "Ension, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": 1025048, "summary": "NIH award 5R44HL178134-02: Bearingless flux reversal motor for neonatal and pediatric extracorporeal life support applications ($1,025,048)", "source_url": "https://reporter.nih.gov/project-details/11261620", "people": [{"name": "Patrick Thomas Cahalan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NR017575-04", "company": "Cognifisense, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": 406285, "summary": "NIH award 5R44NR017575-04: Efficacy of a Virtual Reality Neuroscience-based Therapy for Chronic Low Back Pain ($406,285)", "source_url": "https://reporter.nih.gov/project-details/11322088", "people": [{"name": "TASSILO BAEUERLE", "role": "Principal Investigator"}, {"name": "Marta Ceko", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44GM148105-03", "company": "Ligo Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-07", "observed": "2026-08-21", "amount_usd": 762936, "summary": "NIH award 5R44GM148105-03: Dynamical Diffraction Analysis for 3D Electron Crystallography ($762,936)", "source_url": "https://reporter.nih.gov/project-details/11252611", "people": [{"name": "Raquel Bromberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K253826", "company": "Galvanize Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253826: Aliya\u00ae EX System; Aliya\u00ae EX Generator; Aliya\u00ae Needle; Aliya\u00ae Electrode; INUMI\u0099 Flex Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253826", "people": [{"name": "Deborah Sheffield", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253826%22"}, {"id": "fda:K260974", "company": "Nanjing Bestview Laser S&T Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260974: CO2 Laser Machine (Monica-I,Monica-II)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260974", "people": [{"name": "Jing Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260974%22"}, {"id": "fda:K254276", "company": "Q\u0092Apel Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254276: Lynx Aspiration Catheter System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254276", "people": [{"name": "Jennifer Mateus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254276%22"}, {"id": "fda:K254183", "company": "Technomed Europe", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254183: MR Conditional Cup Electrodes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254183", "people": [{"name": "Zara Grimshaw", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254183%22"}, {"id": "fda:K253837", "company": "Heidelberg Engineering GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253837: SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253837", "people": [{"name": "Arianna Schoess Vargas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253837%22"}, {"id": "fda:K253739", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253739: SCRIPT\u0099 Rods, CREO\u0099 Stabilization System, REVERE\u00ae Stabilization System, REVERE\u00ae 4.5 Stabilization System, NuVasive Reline\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253739", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253739%22"}, {"id": "fda:K260460", "company": "Institut Straumann AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260460: Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260460", "people": [{"name": "Andreas Petermann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260460%22"}, {"id": "fda:K253647", "company": "Draegerwerk AG & CO Kgaa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253647: Evita (V800); Evita (V600)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253647", "people": [{"name": "Holger Nadler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253647%22"}, {"id": "fda:K253992", "company": "Restor3D", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253992: Veritas Reverse Total Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253992", "people": [{"name": "Brianna Prindle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253992%22"}, {"id": "pma:P250039", "company": "DiaSorin, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-05-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250039: LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250039", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250039%22"}, {"id": "trialreg:NCT07573059", "company": "Immedica Pharma US Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety of Loargys Arginine Test System in Loargys-treated Patients", "source_url": "https://clinicaltrials.gov/study/NCT07573059"}, {"id": "trialreg:NCT07573150", "company": "NeurOptics Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy", "source_url": "https://clinicaltrials.gov/study/NCT07573150"}, {"id": "trialreg:NCT07572058", "company": "Boehringer Labs LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Large Diameter ViSiGi LUX \u2122 Gastric Sizing and Calibration System", "source_url": "https://clinicaltrials.gov/study/NCT07572058"}, {"id": "trialreg:NCT07571954", "company": "iVascular S.L.U.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy", "source_url": "https://clinicaltrials.gov/study/NCT07571954"}, {"id": "trialreg:NCT07572331", "company": "NIRA Innovations Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study Evaluating the Safety and Effectiveness of the NIRA Laser M2.1 for the Treatment of Full-Face Wrinkles", "source_url": "https://clinicaltrials.gov/study/NCT07572331"}, {"id": "trialreg:NCT07572357", "company": "Rehear Audiology Company LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of the RH210 Hearing Aid", "source_url": "https://clinicaltrials.gov/study/NCT07572357"}, {"id": "fda:K253152", "company": "Biozen, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253152: BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253152", "people": [{"name": "Omer Inan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253152%22"}, {"id": "fda:K260376", "company": "Shandong Huge Dental Material Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260376: Denture Base", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260376", "people": [{"name": "Zheng Maggie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260376%22"}, {"id": "fda:K252552", "company": "Shenzhen Changkun Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252552: Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252552", "people": [{"name": "Qingpeng Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252552%22"}, {"id": "fda:K253855", "company": "Intervention Tech, Inc. ; dba Corvention", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253855: KardiaPSI Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253855", "people": [{"name": "Ryan Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253855%22"}, {"id": "fda:K260775", "company": "Teleflex Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260775: Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260775", "people": [{"name": "Laura Medlin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260775%22"}, {"id": "fda:K253027", "company": "Ortobio S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253027: Anchor with Fiber Wire and Disposable Inserter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253027", "people": [{"name": "Arthur Murakami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253027%22"}, {"id": "fda:K260747", "company": "Nihon Kohden Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260747: YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260747", "people": [{"name": "Charlemagne Chua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260747%22"}, {"id": "fda:K261112", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261112: CastleLoc-P Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261112", "people": [{"name": "Kihyang Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261112%22"}, {"id": "trialreg:NCT07568704", "company": "Intalight, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Image Evaluation of Intalight Dream OCTA Scans With Optos FA & ICGA Images", "source_url": "https://clinicaltrials.gov/study/NCT07568704"}, {"id": "trialreg:NCT07569575", "company": "HuaMg Perfection Med Tech (Suzhou) Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures", "source_url": "https://clinicaltrials.gov/study/NCT07569575"}, {"id": "trialreg:NCT07569978", "company": "Nakhia Impex LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Herpes Zoster-Associated Pain", "source_url": "https://clinicaltrials.gov/study/NCT07569978"}, {"id": "trialreg:NCT07569900", "company": "bioLytical Laboratories", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test", "source_url": "https://clinicaltrials.gov/study/NCT07569900"}, {"id": "trialreg:NCT07570264", "company": "Nunaps Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: LEXURE for Post-Stroke Aphasia", "source_url": "https://clinicaltrials.gov/study/NCT07570264"}, {"id": "trialreg:NCT07569913", "company": "bioLytical Laboratories", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test", "source_url": "https://clinicaltrials.gov/study/NCT07569913"}, {"id": "nih:5R44NS122672-03", "company": "Biosensics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2026-05-05", "observed": "2026-08-06", "amount_usd": 973917, "summary": "NIH award 5R44NS122672-03: Wearable Sensor and Digital Technologies for Quantitative Assessment and Remote Monitoring of Symptoms in Myasthenia Gravis ($973,917)", "source_url": "https://reporter.nih.gov/project-details/11237038", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K260742", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260742: Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260742", "people": [{"name": "Xue Dai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260742%22"}, {"id": "fda:K252558", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252558: Lumify Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252558", "people": [{"name": "Gina Quiram", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252558%22"}, {"id": "fda:K261130", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261130: AccelFix Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261130", "people": [{"name": "Kihyang Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261130%22"}, {"id": "fda:K254202", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254202: MectaLIF 3D Metal Anterior", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254202", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254202%22"}, {"id": "fda:K261132", "company": "Healium Intelliscan Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261132: Healium Intelliscan LX192LC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261132", "people": [{"name": "Biju Jacob", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261132%22"}, {"id": "fda:K254200", "company": "Wenzhou Lingfeng Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254200: Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254200", "people": [{"name": "Xiaoqun Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254200%22"}, {"id": "trialreg:NCT07566286", "company": "Galderma R&D", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study to Evaluate the Safety of Retreatment With Restylane\u00ae Lyft With Lidocaine for Augmentation of the Chin Region", "source_url": "https://clinicaltrials.gov/study/NCT07566286"}, {"id": "trialreg:NCT07568119", "company": "Cognita Labs LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care", "source_url": "https://clinicaltrials.gov/study/NCT07568119"}, {"id": "trialreg:NCT07566234", "company": "CooperVision International Limited (CVIL)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Contact Lenses and Myopia.", "source_url": "https://clinicaltrials.gov/study/NCT07566234"}, {"id": "trialreg:NCT07566793", "company": "Natural Cycles", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of Effectiveness on NaturalCycles Users", "source_url": "https://clinicaltrials.gov/study/NCT07566793"}, {"id": "trialreg:NCT07568132", "company": "Efferon JSC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efferon LPS Hemoadsorption in in Patients With Thermal Burns", "source_url": "https://clinicaltrials.gov/study/NCT07568132"}, {"id": "trialreg:NCT07568548", "company": "Nakhia Impex LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Chronic Nasopharyngitis", "source_url": "https://clinicaltrials.gov/study/NCT07568548"}, {"id": "trialreg:NCT07567365", "company": "Pulse Wave USA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Outcomes of Focused Shockwave Therapy Without Adjunct Rehabilitation Compared to Standard Physical Rehabilitation in Patients With Grade I-III Knee Osteoarthritis: A Single-Blind Randomized Study", "source_url": "https://clinicaltrials.gov/study/NCT07567365"}, {"id": "trialreg:NCT07568015", "company": "Brixton Biosciences, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ReneuRx\u2122 (Nerve Selective Therapy) Utilized in Lateral Hip Pain", "source_url": "https://clinicaltrials.gov/study/NCT07568015"}, {"id": "fda:K252543", "company": "Amsino International, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252543: AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252543", "people": [{"name": "Jane Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252543%22"}, {"id": "fda:K260256", "company": "Shanghai Apolo Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260256: Q-Switched Nd: YAG Laser Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260256", "people": [{"name": "Felix Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260256%22"}, {"id": "fda:K254115", "company": "Artera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254115: ArteraAI Breast", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254115", "people": [{"name": "Candice Bautista", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254115%22"}, {"id": "fda:K252954", "company": "Neurocareai, Inc. (Dba Savelife.Ai)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252954: MammoSightAI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252954", "people": [{"name": "Junaid Siddiq Kalia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252954%22"}, {"id": "fda:K260716", "company": "Cefla S.C.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260716: Neowise", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260716", "people": [{"name": "Ilenia Muccione", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260716%22"}, {"id": "fda:K253251", "company": "Leaseir Technologies, Slu", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253251: Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253251", "people": [{"name": "Sergio Camacho Santiago", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253251%22"}, {"id": "fda:K260688", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260688: Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260688", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260688%22"}, {"id": "fda:K254019", "company": "Bechtel Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254019: Wound Geni NPWT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254019", "people": [{"name": "John Gvodas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254019%22"}, {"id": "fda:K252622", "company": "Okamoto USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252622: Male Latex Condom HA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252622", "people": [{"name": "Kenji Komatsu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252622%22"}, {"id": "trialreg:NCT07565857", "company": "Natera, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Signatera-Guided De-escalation of Adjuvant Therapy in Resectable Stage II-IVa Gastric/Gastric-Esophageal Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07565857"}, {"id": "trialreg:NCT07564375", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MBA Early Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07564375"}, {"id": "trialreg:NCT07565480", "company": "LuminX", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Collection of Training Data for LuminX Probe AI Models", "source_url": "https://clinicaltrials.gov/study/NCT07565480"}, {"id": "trialreg:NCT07565545", "company": "SI-BONE, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes", "source_url": "https://clinicaltrials.gov/study/NCT07565545"}, {"id": "trialreg:NCT07563309", "company": "bioLytical Laboratories", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test", "source_url": "https://clinicaltrials.gov/study/NCT07563309"}, {"id": "trialreg:NCT07563803", "company": "Restor3D", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The restor3d Outcomes Registry", "source_url": "https://clinicaltrials.gov/study/NCT07563803"}, {"id": "trialreg:NCT07564843", "company": "Biointelligent Technology Systems SL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Theravex\u00ae for Burning Mouth Syndrome", "source_url": "https://clinicaltrials.gov/study/NCT07564843"}, {"id": "trialreg:NCT07563790", "company": "Rose Pharma SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Pre-market, Two-stages Interventional Clinical Investigation to Evaluate the Safety and the Performance of Fibroin Syrup in Reducing the Gastroesophageal Reflux Disease (GERD) Symptomatology in Nonerosive Reflux Disease (NERD) Patients", "source_url": "https://clinicaltrials.gov/study/NCT07563790"}, {"id": "trialreg:NCT07563816", "company": "MAIA Labs s.r.o.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ColoMaia II Software to Support Lesion Detection During Colonoscopy", "source_url": "https://clinicaltrials.gov/study/NCT07563816"}, {"id": "trialreg:NCT07564310", "company": "ResMed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: INFORMing Patients With Oximetry Data to Improve MAD Engagement", "source_url": "https://clinicaltrials.gov/study/NCT07564310"}, {"id": "trialreg:NCT07565064", "company": "American Laboratory Products Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ALPCO 25(OH) Vitamin D CLIA Kit - Fresh Versus Frozen Serum and Plasma Stability Study", "source_url": "https://clinicaltrials.gov/study/NCT07565064"}, {"id": "trialreg:NCT07564102", "company": "Mochida Medical USA, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy", "source_url": "https://clinicaltrials.gov/study/NCT07564102"}, {"id": "fda:K252073", "company": "Voco GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252073: VOCO Profluorid Varnish + BioMin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252073", "people": [{"name": "Katrin Froehlich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252073%22"}, {"id": "fda:K253663", "company": "Zeta Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253663: Zeta Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253663", "people": [{"name": "Hieu Le Mau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253663%22"}, {"id": "fda:K252475", "company": "Radiometer Medicals Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252475: ABL90 FLEX PLUS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252475", "people": [{"name": "Andrea Swingle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252475%22"}, {"id": "fda:K253030", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253030: Capnostream\u009935 Portable Respiratory Monitor (PM35MN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253030", "people": [{"name": "Shannon Ryan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253030%22"}, {"id": "fda:K254154", "company": "FX Shoulder Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254154: FX V135 EASYTECH\u00ae Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254154", "people": [{"name": "Cory Trier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254154%22"}, {"id": "fda:K254077", "company": "OSSIO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254077: OSSIOfiber\u00ae Threaded Trimmable Fixation Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254077", "people": [{"name": "Taly Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254077%22"}, {"id": "fda:K260314", "company": "Aspero Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260314: Ancora-SB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260314", "people": [{"name": "Mark Rentschler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260314%22"}, {"id": "fda:K253966", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253966: PERLA\u00ae TL Posterior Thoraco-lumbar Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253966", "people": [{"name": "Estelle Lefeuvre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253966%22"}, {"id": "fda:K261045", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261045: Verifine Safety Lancets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261045", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261045%22"}, {"id": "fda:K252635", "company": "ArthroTAK, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252635: ArthroTAK Tendon Anchor Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252635", "people": [{"name": "Don Running", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252635%22"}, {"id": "fda:K253887", "company": "Philips Medizin Systeme", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253887: Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253887", "people": [{"name": "Jamie Palmer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253887%22"}, {"id": "fda:K260910", "company": "Glooko, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260910: EndoTool IV Cloud 1.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260910", "people": [{"name": "Katherine Rojas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260910%22"}, {"id": "fda:K254234", "company": "Choyang Medics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254234: Phototherapy System (DUV-COMBO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254234", "people": [{"name": "Park Seung-Bum", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254234%22"}, {"id": "fda:K252488", "company": "Radiometer Medicals Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252488: ABL90 FLEX PLUS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252488", "people": [{"name": "Andrea Swingle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252488%22"}, {"id": "fda:K253326", "company": "Fziomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253326: Oxiplex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253326", "people": [{"name": "Paul Mraz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253326%22"}, {"id": "fda:K260819", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260819: Any-Com Seal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260819", "people": [{"name": "Ku Da Hyeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260819%22"}, {"id": "fda:K261074", "company": "Biotronik, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261074: BIOMONITOR IV (471155)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261074", "people": [{"name": "Jon Brumbaugh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261074%22"}, {"id": "fda:K254139", "company": "Applied BioCode, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254139: BioCode\u00ae Respiratory Pathogen Panel (RPP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254139", "people": [{"name": "Alex Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254139%22"}, {"id": "fda:DEN240075", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN240075: Prolystica Pass Thru Disinfectant Wipes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240075", "people": [{"name": "Steve Elliott", "role": "510(k) submission contact"}]}, {"id": "fda:K252439", "company": "Dongguan Tutamen Metalwork Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-05-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252439: Tutamen Self Adhesive Electrodes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252439", "people": [{"name": "Stephen Prior", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252439%22"}, {"id": "trialreg:NCT07560254", "company": "Ayu, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Outcomes and Patient Satisfaction With Velnez Versus Nasopore in Nasal Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07560254"}, {"id": "trialreg:NCT07561502", "company": "Francis Medical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Transurethral Periprostatectomy Treatment of Cancerous Prostate Tissue", "source_url": "https://clinicaltrials.gov/study/NCT07561502"}, {"id": "trialreg:NCT07561268", "company": "Acandis GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent", "source_url": "https://clinicaltrials.gov/study/NCT07561268"}, {"id": "trialreg:NCT07561905", "company": "Kimberly-Clark Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-05-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Tampon Safety-in-Use Study", "source_url": "https://clinicaltrials.gov/study/NCT07561905"}, {"id": "denovo:DEN240075", "company": "Steris", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-05-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240075 granted: Prolystica Pass Thru Disinfectant Wipes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240075"}, {"id": "fda:K254189", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254189: Synapse 3D Base Tools (V7.2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254189", "people": [{"name": "Kulkarni Chaitrali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254189%22"}, {"id": "fda:K260342", "company": "Hangzhou AllTest Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260342: AllTest Strep A Rapid Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260342", "people": [{"name": "Rosa Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260342%22"}, {"id": "fda:K253017", "company": "Lifescience Plus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253017: BloodSTOP iX Trauma Matrix (TM-iX-20)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253017", "people": [{"name": "Audrey Vitale", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253017%22"}, {"id": "fda:K252849", "company": "Tactile Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252849: AffloVest\u00ae Mobile Airway Clearance Therapy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252849", "people": [{"name": "Sunday Hoy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252849%22"}, {"id": "fda:K252858", "company": "Kms Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252858: 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252858", "people": [{"name": "Yi Dai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252858%22"}, {"id": "fda:DEN250023", "company": "Cathbuddy, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250023: Aurie System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250023", "people": [{"name": "Souvik Paul", "role": "510(k) submission contact"}]}, {"id": "fda:K252455", "company": "Balance Ophthalmics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252455: FSYX Ocular Pressure Adjusting Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252455", "people": [{"name": "Gary Mocnik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252455%22"}, {"id": "fda:K261067", "company": "NGMedical GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261067: BEE PLIF Cage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261067", "people": [{"name": "Stella Hahn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261067%22"}, {"id": "fda:K253064", "company": "Xiamen Weiyou Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253064: Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253064", "people": [{"name": "Kelly Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253064%22"}, {"id": "fda:K253976", "company": "Beta Bionics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253976: iLet ACE Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253976", "people": [{"name": "Douglas Ferguson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253976%22"}, {"id": "fda:K261404", "company": "Ultradent Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261404: UltraEZ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261404", "people": [{"name": "Wendy Collard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261404%22"}, {"id": "fda:K260323", "company": "OrthoPediatrics Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260323: OrthoPediatrics\u00ae Locking Cannulated Blade Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260323", "people": [{"name": "Jessica Powers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260323%22"}, {"id": "fda:K250680", "company": "Bayesian Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250680: Bayesian Health Sepsis Flagging Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250680", "people": [{"name": "Rachael Weir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250680%22"}, {"id": "fda:K252503", "company": "Canon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252503: Intelligent NR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252503", "people": [{"name": "Masahiro Abe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252503%22"}, {"id": "fda:K253436", "company": "Cosinuss GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253436: c-med0 alpha", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253436", "people": [{"name": "Ralph Heim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253436%22"}, {"id": "fda:K251583", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251583: Ambu\u00ae Virobac II\u00ae Exhalation Filter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251583", "people": [{"name": "Lenka Vaculciakova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251583%22"}, {"id": "trialreg:NCT07560085", "company": "ForQaly Medical (Shanghai) Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock", "source_url": "https://clinicaltrials.gov/study/NCT07560085"}, {"id": "trialreg:NCT07559188", "company": "Azalea Vision", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus", "source_url": "https://clinicaltrials.gov/study/NCT07559188"}, {"id": "trialreg:NCT07558655", "company": "Bright Uro", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Glean Registry", "source_url": "https://clinicaltrials.gov/study/NCT07558655"}, {"id": "trialreg:NCT07559708", "company": "Sleepnet Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of the Sleepnet Elara APAP Device", "source_url": "https://clinicaltrials.gov/study/NCT07559708"}, {"id": "trialreg:NCT07557862", "company": "Healionics Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multi-Site STARgraft (10401) Trial", "source_url": "https://clinicaltrials.gov/study/NCT07557862"}, {"id": "trialreg:NCT07558902", "company": "Shanghai Golden Leaf MedTec Co. Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: RDN for Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07558902"}, {"id": "denovo:DEN250023", "company": "Cathbuddy, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-04-30", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250023 granted: Aurie System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250023"}, {"id": "breakthrough:K250680", "company": "Bayesian Health, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-04-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K250680: BAYESIAN HEALTH SEPSIS FLAGGING DEVICE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253579", "company": "Scientia Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253579: Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253579", "people": [{"name": "Max Alfonso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253579%22"}, {"id": "fda:K254184", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254184: syngo Application Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254184", "people": [{"name": "Jones Patricia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254184%22"}, {"id": "fda:K253401", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253401: SCRIPT\u0099 Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253401", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253401%22"}, {"id": "fda:K253166", "company": "BMC Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253166: F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253166", "people": [{"name": "Nicole Niu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253166%22"}, {"id": "fda:K253914", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253914: Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253914", "people": [{"name": "Baihan Feng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253914%22"}, {"id": "fda:K260589", "company": "E-Scopics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260589: ES-Series", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260589", "people": [{"name": "Aurelie Gruener", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260589%22"}, {"id": "fda:K252471", "company": "LiViliti Health Products Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252471: Paptizer 360", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252471", "people": [{"name": "Brian Sharpe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252471%22"}, {"id": "fda:K260606", "company": "Echo Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260606: Echo Large Bore Introducer Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260606", "people": [{"name": "Steve Geist", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260606%22"}, {"id": "fda:K252542", "company": "ZheJiang Decans Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252542: LEO Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252542", "people": [{"name": "Haifeng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252542%22"}, {"id": "fda:K253682", "company": "Quantib B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253682: DeepHealth ProstateAI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253682", "people": [{"name": "B. Nathan Hunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253682%22"}, {"id": "fda:K253885", "company": "Geo Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253885: PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253885", "people": [{"name": "Young Joon Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253885%22"}, {"id": "fda:K261086", "company": "Sonomotion, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261086: Break Wave", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261086", "people": [{"name": "Emily Hergenreter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261086%22"}, {"id": "fda:K261094", "company": "Asclepion Laser Technologies GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261094: YellowStar", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261094", "people": [{"name": "Tom Gruender", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261094%22"}, {"id": "trialreg:NCT07556939", "company": "Mitovation, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Light Utilization COX-Inhibitory Device Therapy for Infant Cardiac Arrest (LUTICA Study). The LUCID Device is Used in the Treatment of Ischemic Brain Reperfusion Injury Caused by Cardiac Arrest in Pediatric Patients.", "source_url": "https://clinicaltrials.gov/study/NCT07556939"}, {"id": "trialreg:NCT07557030", "company": "CooperVision International Limited (CVIL)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Optimization for Toric Contact Lenses", "source_url": "https://clinicaltrials.gov/study/NCT07557030"}, {"id": "trialreg:NCT07557147", "company": "Bayer", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor", "source_url": "https://clinicaltrials.gov/study/NCT07557147"}, {"id": "trialreg:NCT07555587", "company": "NRT MedTech Australia Pty Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of NRT6008 Administered in Combination With Chemotherapy in Patients With Unresectable Locally Advanced Pancreatic Carcinoma (LAPC)", "source_url": "https://clinicaltrials.gov/study/NCT07555587"}, {"id": "trialreg:NCT07555717", "company": "Healionics Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: STARgraft (10401) Pilot", "source_url": "https://clinicaltrials.gov/study/NCT07555717"}, {"id": "trialreg:NCT07556588", "company": "XVIVO Perfusion", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: XVIVO Heart Transplant Study in Clinical Practice", "source_url": "https://clinicaltrials.gov/study/NCT07556588"}, {"id": "fda:K253940", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253940: M.U.S.T. Pedicle Screw System - Extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253940", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253940%22"}, {"id": "fda:K252831", "company": "Dolanvy (Suzhou) Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252831: Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252831", "people": [{"name": "Ji Lei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252831%22"}, {"id": "fda:K260248", "company": "Kitazato Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260248: Ultra-Fast Warm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260248", "people": [{"name": "Kyoko Izumi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260248%22"}, {"id": "fda:K260194", "company": "Sheng Sheng Yi (Beijing) Technology Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260194: Vacuum Pump (Model: AD-VPUM-500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260194", "people": [{"name": "Lili Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260194%22"}, {"id": "fda:K252464", "company": "Zumax Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252464: Surgical Microscope (OMS2360, OMS2380)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252464", "people": [{"name": "Alfred Hee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252464%22"}, {"id": "fda:K253243", "company": "Cardinal Health 200, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253243: Cardinal Health\u0099 Poly Reinforced Surgical Gown", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253243", "people": [{"name": "Astha Jaiswal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253243%22"}, {"id": "fda:K252424", "company": "Abbott Laboratories", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252424: Anti-HCV Next", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252424", "people": [{"name": "Linda Sohn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252424%22"}, {"id": "fda:K252501", "company": "Joytech Healthcare Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252501: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252501", "people": [{"name": "Jing Cong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252501%22"}, {"id": "fda:K260121", "company": "Foshan Nanhai Hongchen Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260121: Manual Wheelchair (7101L, 7102LHD)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260121", "people": [{"name": "Jinghan Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260121%22"}, {"id": "fda:K260076", "company": "ZetrOZ Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260076: SAM 3.0 Multi-Hour Continuous Ultrasound Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260076", "people": [{"name": "Sabrina Lewis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260076%22"}, {"id": "fda:K260260", "company": "Honsun (Nantong) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260260: Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260260", "people": [{"name": "Jian Shen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260260%22"}, {"id": "fda:K260065", "company": "Guangzhou Wondfo Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260065: SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260065", "people": [{"name": "Kaiyu Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260065%22"}, {"id": "trialreg:NCT07554976", "company": "Suzhou Hengruihongyuan Medical Technology Co. LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures", "source_url": "https://clinicaltrials.gov/study/NCT07554976"}, {"id": "trialreg:NCT07554352", "company": "RespirAI US Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Early Detection of COPD Exacerbations Using Home Monitoring Device", "source_url": "https://clinicaltrials.gov/study/NCT07554352"}, {"id": "trialreg:NCT07554443", "company": "RxFunction Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity", "source_url": "https://clinicaltrials.gov/study/NCT07554443"}, {"id": "fda:K252628", "company": "Wesper, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252628: CASSIE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252628", "people": [{"name": "Ciaran Lynch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252628%22"}, {"id": "fda:K260182", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260182: Avenir\u00ae M\u00fcller Stem; Avenir Complete\u0099 Hip System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260182", "people": [{"name": "Ana Montoya", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260182%22"}, {"id": "fda:K260660", "company": "Elevation Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260660: SABER-C System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260660", "people": [{"name": "John Kirwan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260660%22"}, {"id": "fda:K261356", "company": "Hangzhou SHINING3D Dental Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261356: Dura-Crown", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261356", "people": [{"name": "Jiachen Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261356%22"}, {"id": "fda:K253658", "company": "Diagnostica Stago, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253658: STA Satellite Max\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253658", "people": [{"name": "Louise Sigismondi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253658%22"}, {"id": "fda:K252409", "company": "Sight Sciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252409: TearCare MGX System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252409", "people": [{"name": "Rachel Franco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252409%22"}, {"id": "fda:K261032", "company": "NovoSource", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261032: NovoKnee (SteriKnee)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261032", "people": [{"name": "Doug Hawkins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261032%22"}, {"id": "fda:K252748", "company": "Hunan Accurate Bio-Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252748: Pelvic Floor Exerciser (PF01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252748", "people": [{"name": "Li Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252748%22"}, {"id": "fda:K252445", "company": "Maquet Cardiovascular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252445: Fusion Bioline Vascular Graft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252445", "people": [{"name": "Suwah Amara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252445%22"}, {"id": "fda:K261357", "company": "Voco GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261357: Grandio disc multicolor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261357", "people": [{"name": "Katrin Froehlich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261357%22"}, {"id": "trialreg:NCT07552272", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Hummingbird ICE Study", "source_url": "https://clinicaltrials.gov/study/NCT07552272"}, {"id": "trialreg:NCT07552805", "company": "Rhythm Diagnostic Systems", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Evaluation of Multisense\u00ae to Ensure a Safe Return Home Following High-risk Gastrointestinal Surgery, Compared With Standard Care.", "source_url": "https://clinicaltrials.gov/study/NCT07552805"}, {"id": "trialreg:NCT07552818", "company": "Igea", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Neuroprotection in Acute Cerebral Ischemia II", "source_url": "https://clinicaltrials.gov/study/NCT07552818"}, {"id": "trialreg:NCT07551921", "company": "Aptatek BioSciences, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PheCheck\u2122 Validation Study", "source_url": "https://clinicaltrials.gov/study/NCT07551921"}, {"id": "trialreg:NCT07551609", "company": "Skin Tech Pharma Group S.L.U.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of RRS\u00ae HA Long Lasting for Improving Facial Wrinkles and Skin Quality", "source_url": "https://clinicaltrials.gov/study/NCT07551609"}, {"id": "trialreg:NCT07553130", "company": "Accexible", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AcceXible Speech-Based Screening for Depression and Anxiety in University Students (BUAP, Mexico)", "source_url": "https://clinicaltrials.gov/study/NCT07553130"}, {"id": "trialreg:NCT07553117", "company": "Accexible", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Accexible Speech Analysis for MCI Detection and Monitoring in Colombia", "source_url": "https://clinicaltrials.gov/study/NCT07553117"}, {"id": "fda:K253580", "company": "Tedan Surgical Innovations", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253580: Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253580", "people": [{"name": "Arya Monticino-Larsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253580%22"}, {"id": "fda:K253805", "company": "Pixee Medical S.A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253805: Knee+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253805", "people": [{"name": "Fran\u00e7ois Beaumont", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253805%22"}, {"id": "fda:K261008", "company": "Stryker Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261008: Vitoss\u00ae BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss\u00ae BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma\u00ae Bioactive Bone Graft Substitute; Vitoss\u00ae BA2X Bioactive Bone Graft Substitute; Vitoss\u00ae Bioactive Foam Bone Graft Substitute Pack; Vitoss\u00ae Bioactive Foam Bone Graft Substitute; Vitoss\u00ae Foam Bone Graft Substitute; Vitoss\u00ae Bone Graft Substitute Filled Canister; Vitoss\u00ae Bone Graft Substitute", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261008", "people": [{"name": "Kristina Daoud", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261008%22"}, {"id": "fda:K260549", "company": "Zsfab, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260549: ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260549", "people": [{"name": "Yuanqiao Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260549%22"}, {"id": "fda:K250349", "company": "Shanghai Draeger Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250349: Vista CMS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250349", "people": [{"name": "Xuguang Miao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250349%22"}, {"id": "fda:K260988", "company": "Mequ A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260988: \u00b0M Warmer System with \u00b0M Station", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260988", "people": [{"name": "Lene Margrete Moesby", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260988%22"}, {"id": "fda:K261043", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261043: AUTOBAHN\u0099 Nailing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261043", "people": [{"name": "Suganya Gopalakrishnan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261043%22"}, {"id": "fda:K252451", "company": "Implantcast GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252451: EPORE\u00ae XO cup system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252451", "people": [{"name": "Juliane H\u00f6ppner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252451%22"}, {"id": "fda:K260993", "company": "Abbott", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260993: Amplatzer TorqVue Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260993", "people": [{"name": "Taylor Lupelow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260993%22"}, {"id": "fda:K260411", "company": "Chest Wall Innovations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260411: PC Fix System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260411", "people": [{"name": "Kenneth Kremer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260411%22"}, {"id": "fda:K260599", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260599: INDIGO\u00ae Aspiration System \u0096 INDIGO Link", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260599", "people": [{"name": "Akshay Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260599%22"}, {"id": "fda:K252810", "company": "Flosonics Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252810: FloPatch FP120", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252810", "people": [{"name": "Caleb Chin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252810%22"}, {"id": "fda:K250242", "company": "Guangzhou Longest Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250242: Compression Therapy Device (LGT-2202DVT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250242", "people": [{"name": "Xiaobing Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250242%22"}, {"id": "fda:K260999", "company": "Wellspect AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260999: LoFric Elle Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260999", "people": [{"name": "Emad Ramzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260999%22"}, {"id": "fda:K260009", "company": "Broncus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260009: LungPoint Virtual Bronchoscopic Navigation (VBN) Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260009", "people": [{"name": "Clay Antoinette", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260009%22"}, {"id": "fda:K253832", "company": "Mirco-Tech (Nanjing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253832: Dilation Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253832", "people": [{"name": "Sally He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253832%22"}, {"id": "fda:K252337", "company": "Edgecare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252337: EdgeFlow Gel Pad", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252337", "people": [{"name": "Beom Ki Cha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252337%22"}, {"id": "fda:K260982", "company": "Applied Medical Resources Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260982: Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260982", "people": [{"name": "Apeksha Shanbhag", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260982%22"}, {"id": "fda:K252492", "company": "Micro-Tech (Nanjing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252492: Visualized Access and Delivery Catheter; PB Digital Controller", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252492", "people": [{"name": "Sally He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252492%22"}, {"id": "fda:K250234", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250234: SMARTeZ\u0099 Elastomeric Infusion Pump (RS series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250234", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250234%22"}, {"id": "fda:K252431", "company": "Roche Diagnostics GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252431: Elecsys Calcitonin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252431", "people": [{"name": "Eva Jad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252431%22"}, {"id": "fda:K253459", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253459: OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253459", "people": [{"name": "Derek Pike", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253459%22"}, {"id": "fda:K254173", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254173: ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254173", "people": [{"name": "Jones Patricia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254173%22"}, {"id": "fda:K260429", "company": "Tandem Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260429: Control-IQ+ technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260429", "people": [{"name": "Amulya Mallavarapu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260429%22"}, {"id": "fda:K260228", "company": "Bonebridge AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260228: POYA 3.5mm Medial Proximal Tibia System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260228", "people": [{"name": "Michelle Gumpelmayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260228%22"}, {"id": "fda:K260054", "company": "I.T.S. GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260054: I.T.S. PRS Phoenix II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260054", "people": [{"name": "Florian Grill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260054%22"}, {"id": "fda:K252336", "company": "Diazyme Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252336: Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252336", "people": [{"name": "Abhijit Datta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252336%22"}, {"id": "trialreg:NCT07549737", "company": "Hartmann Group", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management", "source_url": "https://clinicaltrials.gov/study/NCT07549737"}, {"id": "trialreg:NCT07551336", "company": "Beijing Biotech", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma", "source_url": "https://clinicaltrials.gov/study/NCT07551336"}, {"id": "trialreg:NCT07550361", "company": "Compremium AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of Non-Invasive Intracranial Pressure Estimation Using CPMX3 in the Periorbital Vein: A Feasibility Study in Pediatric Patients", "source_url": "https://clinicaltrials.gov/study/NCT07550361"}, {"id": "trialreg:NCT07550699", "company": "ABLE Human Motion S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton", "source_url": "https://clinicaltrials.gov/study/NCT07550699"}, {"id": "fda:K260152", "company": "Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260152: Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260152", "people": [{"name": "Marcelo Del Guerra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260152%22"}, {"id": "fda:K252407", "company": "Mv Life, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252407: OxyGo Portable Oxygen Concentrator (1400-7000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252407", "people": [{"name": "Chris Carter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252407%22"}, {"id": "fda:K252389", "company": "Smwmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252389: Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252389", "people": [{"name": "Bo Pi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252389%22"}, {"id": "fda:K252815", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252815: ProBeam 360 Proton Therapy System v3.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252815", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252815%22"}, {"id": "fda:K253589", "company": "Medtronic Interventional Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253589: Liberant\u0099 RX Aspiration Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253589", "people": [{"name": "Nikita Ciandra Vaz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253589%22"}, {"id": "fda:K254248", "company": "Cardiocycle Medical(Suzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254248: Introducer Sheath Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254248", "people": [{"name": "Siyu Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254248%22"}, {"id": "fda:K260195", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260195: Elongated One-Piece Arterial (EOPA) 3D\u0099 Arterial Cannulae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260195", "people": [{"name": "Nina Vollmer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260195%22"}, {"id": "fda:K260320", "company": "Lunit, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260320: Lunit INSIGHT MMG (v1.1.10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260320", "people": [{"name": "Sulgue Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260320%22"}, {"id": "fda:K260947", "company": "Neocoil, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260947: 0.55T 12Ch Breast Coil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260947", "people": [{"name": "Judy Yuan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260947%22"}, {"id": "fda:K253752", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253752: ARTIS genio floor; ARTIS icono.explore floor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253752", "people": [{"name": "Jones Patricia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253752%22"}, {"id": "fda:K261012", "company": "Cortex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261012: OptiMap Catheter - 60mm (OPTI-CATH2-60)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261012", "people": [{"name": "Sarah Ware", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261012%22"}, {"id": "fda:K252436", "company": "Tusker Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252436: Tula Tympanostomy Tube Delivery Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252436", "people": [{"name": "Nan McIntosh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252436%22"}, {"id": "fda:K260785", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260785: DS Core CBCT Anatomy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260785", "people": [{"name": "Deepthi Paknikar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260785%22"}, {"id": "fda:K260976", "company": "Monteris Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260976: NeuroBlate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260976", "people": [{"name": "David Mueller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260976%22"}, {"id": "fda:K254237", "company": "CliniComp, Intl.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254237: CCI PACS VIEWER (PACS-US-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254237", "people": [{"name": "Dessi Lyakov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254237%22"}, {"id": "fda:K252341", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252341: EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252341", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252341%22"}, {"id": "trialreg:NCT07548944", "company": "Okuvision GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Observational Study to Investigate the Short-term Effects of Transcorneal Electrical Stimulation on Visual Performance", "source_url": "https://clinicaltrials.gov/study/NCT07548944"}, {"id": "trialreg:NCT07548151", "company": "X9, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Guided Needle Insertion for Vascular Access", "source_url": "https://clinicaltrials.gov/study/NCT07548151"}, {"id": "trialreg:NCT07547488", "company": "Essity Hygiene and Health AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Influence of Dressings on Skin pH Alterations in Simulated Skin Folds in Healthy Subjects", "source_url": "https://clinicaltrials.gov/study/NCT07547488"}, {"id": "trialreg:NCT07548320", "company": "Neurive Co.,Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of the Soricle for Subjective Tinnitus Relief", "source_url": "https://clinicaltrials.gov/study/NCT07548320"}, {"id": "fda:K253163", "company": "Ever Fortune.Ai, Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253163: EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253163", "people": [{"name": "Joseph Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253163%22"}, {"id": "fda:K253765", "company": "Ddc Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253765: VANISH PRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253765", "people": [{"name": "Joseph Buscarello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253765%22"}, {"id": "fda:K260237", "company": "Wuyi Aichi Industry and Trade Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260237: Mobility Scooter (X-12, X-14, X-17)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260237", "people": [{"name": "Wei Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260237%22"}, {"id": "fda:K260570", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260570: corra\u0099 cervical plating system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260570", "people": [{"name": "Jesse Albright", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260570%22"}, {"id": "fda:K253256", "company": "Otto Bock Healthcare Products GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253256: myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253256", "people": [{"name": "Reinhard Wolkerstorfer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253256%22"}, {"id": "fda:K252306", "company": "Steritec Products", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252306: Verrix EVA\u0099 STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA\u0099 STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA\u0099 Auto-Reader (Model: 1100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252306", "people": [{"name": "Darshan Yeliyur Siddegowda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252306%22"}, {"id": "fda:K260150", "company": "Nooance", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260150: LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260150", "people": [{"name": "Carole Amar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260150%22"}, {"id": "fda:K260239", "company": "Jiangxi AOV Maternity & Baby Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260239: Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260239", "people": [{"name": "Liben Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260239%22"}, {"id": "fda:K253077", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253077: uOmnispace.MR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253077", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253077%22"}, {"id": "fda:K253230", "company": "Erbe Elektromedizin GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253230: ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253230", "people": [{"name": "Matthias Kollek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253230%22"}, {"id": "trialreg:NCT07543770", "company": "Jonathan Vaisberg", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Wind Noise Sound Quality Preference and Claims Study", "source_url": "https://clinicaltrials.gov/study/NCT07543770"}, {"id": "trialreg:NCT07544654", "company": "Boehringer Ingelheim", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: DAREON\u00ae-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy", "source_url": "https://clinicaltrials.gov/study/NCT07544654"}, {"id": "trialreg:NCT07546019", "company": "Heuron Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Heuron CTA for Detecting Suspected Large Vessel Occlusion Using Brain CT Angiography", "source_url": "https://clinicaltrials.gov/study/NCT07546019"}, {"id": "trialreg:NCT07545980", "company": "Spiderwort Biotechnologies Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CelluJuve\u00ae for the Treatment of Moderate to Severe NLFs", "source_url": "https://clinicaltrials.gov/study/NCT07545980"}, {"id": "trialreg:NCT07545902", "company": "ICIM International S.r.l.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis", "source_url": "https://clinicaltrials.gov/study/NCT07545902"}, {"id": "trialreg:NCT07546032", "company": "ICIM International S.r.l.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study on the Medical Device PROXERA PSOMED 30 for the Treatment of Nail Psoriasis: Evaluation of Safety and Efficacy", "source_url": "https://clinicaltrials.gov/study/NCT07546032"}, {"id": "fda:K250793", "company": "RhythMedix, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250793: RhythmStar System (SL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250793", "people": [{"name": "Stan Biletsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250793%22"}, {"id": "fda:K260921", "company": "Tigon Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260921: Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260921", "people": [{"name": "Jeremy Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260921%22"}, {"id": "fda:K260573", "company": "EvoEndo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260573: EvoEndo Single-Use Endoscopy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260573", "people": [{"name": "Paul Imaoka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260573%22"}, {"id": "fda:K253982", "company": "Beijing Hanvon Health Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253982: Korotkoff sound blood pressure monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253982", "people": [{"name": "Qingjun Yi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253982%22"}, {"id": "fda:K260447", "company": "bioM\u00e9rieux SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260447: ETEST Gepotidacin (GEP) (0.016-256 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260447", "people": [{"name": "St\u00e9phanie Millon-Serme", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260447%22"}, {"id": "fda:K260518", "company": "Shenzhen Semlamp Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260518: IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260518", "people": [{"name": "Wenjun Qi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260518%22"}, {"id": "fda:K260216", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260216: CD Horizon\u0099 ModuLeX\u0099 Fenestrated Screw Set; CD Horizon\u0099 ModuLeX\u0099 Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260216", "people": [{"name": "Kelly McDonnell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260216%22"}, {"id": "fda:K254046", "company": "Sonorous NV, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254046: BosCATH Support Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254046", "people": [{"name": "Ryan Kenney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254046%22"}, {"id": "trialreg:NCT07542184", "company": "Nanochon, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Panama", "source_url": "https://clinicaltrials.gov/study/NCT07542184"}, {"id": "trialreg:NCT07542886", "company": "Pfizer", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Learn How Different Injector Pens Affect the Study Medicine Called Genotropin (Somatropin) Delivery and Taken up Into the Blood in Healthy Adults", "source_url": "https://clinicaltrials.gov/study/NCT07542886"}, {"id": "trialreg:NCT07542041", "company": "Artidis Ag", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens", "source_url": "https://clinicaltrials.gov/study/NCT07542041"}, {"id": "trialreg:NCT07543406", "company": "Neurosoft Bioelectronics SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MINDZ-- Minimally Invasive Approach Pilot Study", "source_url": "https://clinicaltrials.gov/study/NCT07543406"}, {"id": "trialreg:NCT07543302", "company": "taVNS AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Can External Vagus Nerve Stimulation Reduce Systemic Levels of Inflammatory Mediators in Duchenne Muscular Dystrophy Patients?", "source_url": "https://clinicaltrials.gov/study/NCT07543302"}, {"id": "trialreg:NCT07542743", "company": "Barron Associates, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A System to Help With Freezing of Gait in Parkinson's Patients", "source_url": "https://clinicaltrials.gov/study/NCT07542743"}, {"id": "trialreg:NCT07541404", "company": "Arsenal Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma", "source_url": "https://clinicaltrials.gov/study/NCT07541404"}, {"id": "trialreg:NCT07541235", "company": "Ladera Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Ladera Suture-Mediated Large Bore Closure Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT07541235"}, {"id": "trialreg:NCT07543367", "company": "Synchron, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07543367"}, {"id": "fda:K253558", "company": "Luminoah", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253558: Luminoah FLOW\u0099 Enteral Nutrition System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253558", "people": [{"name": "Neal Piper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253558%22"}, {"id": "fda:K253003", "company": "Hubei Xinxin Non-Woven Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253003: Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253003", "people": [{"name": "Nicole Jin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253003%22"}, {"id": "fda:K252332", "company": "Mim Fertility", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252332: Folliscan", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252332", "people": [{"name": "Ula Sankowska", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252332%22"}, {"id": "fda:K253213", "company": "ZheJiang Decans Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253213: SAGI Cervical Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253213", "people": [{"name": "Haifeng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253213%22"}, {"id": "fda:K252718", "company": "GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252718: Lunar Astra", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252718", "people": [{"name": "Christopher Paulik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252718%22"}, {"id": "fda:K260212", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260212: EnSite\u0099 X EP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260212", "people": [{"name": "Christine Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260212%22"}, {"id": "fda:K242163", "company": "SmartsurgN, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242163: SmartSurgN Visualization System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242163", "people": [{"name": "Jocelyn Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242163%22"}, {"id": "fda:K253806", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253806: Power Wheelchair (N5919 series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253806", "people": [{"name": "Yolanda Ge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253806%22"}, {"id": "fda:K253638", "company": "Spinex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253638: xStep (xStep)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253638", "people": [{"name": "Parag Gad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253638%22"}, {"id": "fda:K260153", "company": "Nanjing Bestview Laser S&T Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260153: Q-Switched Nd: YAG Laser System (Glamor Q)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260153", "people": [{"name": "Jing Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260153%22"}, {"id": "trialreg:NCT07538622", "company": "Zenflow, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry", "source_url": "https://clinicaltrials.gov/study/NCT07538622"}, {"id": "trialreg:NCT07539064", "company": "Colgate Palmolive", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Children in the Operating Room: Kids That go Thru Operating Room Will be Given a Connected Health Toothbrush, Kids Anticavity Toothpaste and Behavioral Health Intervention to Reduce Claim Costs", "source_url": "https://clinicaltrials.gov/study/NCT07539064"}, {"id": "trialreg:NCT07539389", "company": "COSMO ROBOTICS CO., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of Bambini Kids Robot-Assisted Gait Training (RAGT) in Children With Cerebral Palsy", "source_url": "https://clinicaltrials.gov/study/NCT07539389"}, {"id": "trialreg:NCT07540494", "company": "GH Research Ireland Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects", "source_url": "https://clinicaltrials.gov/study/NCT07540494"}, {"id": "trialreg:NCT07540312", "company": "PGP Health", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome", "source_url": "https://clinicaltrials.gov/study/NCT07540312"}, {"id": "trialreg:NCT07539194", "company": "Innate srl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance) in the Treatment of Non-traumatic Degenerative Meniscus Tears", "source_url": "https://clinicaltrials.gov/study/NCT07539194"}, {"id": "trialreg:NCT07539324", "company": "Genoss Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD", "source_url": "https://clinicaltrials.gov/study/NCT07539324"}, {"id": "trialreg:NCT07540507", "company": "JOTEC GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)", "source_url": "https://clinicaltrials.gov/study/NCT07540507"}, {"id": "trialreg:NCT07538141", "company": "Hyalex Orthopaedics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Hyalex MTP Study", "source_url": "https://clinicaltrials.gov/study/NCT07538141"}, {"id": "trialreg:NCT07538609", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The GORE\u00ae VIABAHN\u00ae FORTEGRA Venous Stent Post-Approval Study", "source_url": "https://clinicaltrials.gov/study/NCT07538609"}, {"id": "fda:K252945", "company": "Conavi Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252945: Novasight Hybrid System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252945", "people": [{"name": "David Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252945%22"}, {"id": "fda:K252334", "company": "Pontemedag", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252334: PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252334", "people": [{"name": "Remo Schneider", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252334%22"}, {"id": "fda:DEN250033", "company": "Hjarta Care, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250033: XplantR Explant Tool", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250033", "people": [{"name": "Brian Thorson", "role": "510(k) submission contact"}]}, {"id": "fda:K260696", "company": "Liofilchem s.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260696: MTS Gepotidacin 0.016-256 \u00b5g/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260696", "people": [{"name": "Fabio Brocco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260696%22"}, {"id": "fda:K252237", "company": "Edgecare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252237: EdgeFlow UW20", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252237", "people": [{"name": "Beom Ki Cha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252237%22"}, {"id": "fda:K261261", "company": "Hangzhou SHINING3D Dental Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K261261: Dura-Arch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261261", "people": [{"name": "Yuqi Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K261261%22"}, {"id": "fda:K254279", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254279: Edwards eSheath+ introducer set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254279", "people": [{"name": "Venkatesh Rane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254279%22"}, {"id": "fda:K260934", "company": "Medartis AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260934: TITAN Nail; APTUS K-Wire System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260934", "people": [{"name": "Salvatore Risoli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260934%22"}, {"id": "fda:K253970", "company": "Sensomedical Labs, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253970: Wovyn Depth Electrode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253970", "people": [{"name": "Maroun Farah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253970%22"}, {"id": "fda:K252279", "company": "Chirana T.Injecta,A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252279: Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252279", "people": [{"name": "Rastislav Broska", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252279%22"}, {"id": "fda:K252338", "company": "Somnetics International, Inc. (Dba Transcend Inc)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252338: MySleepDash", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252338", "people": [{"name": "William Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252338%22"}, {"id": "fda:K260900", "company": "Vilex, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260900: DYNEX\u00ae External Fixation Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260900", "people": [{"name": "Brock Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260900%22"}, {"id": "fda:K260929", "company": "Navi Medical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260929: Neonav ECG Tip Location System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260929", "people": [{"name": "Zorana Mayooran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260929%22"}, {"id": "trialreg:NCT07537530", "company": "g.tec medical engineering GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback", "source_url": "https://clinicaltrials.gov/study/NCT07537530"}, {"id": "trialreg:NCT07536386", "company": "Wandercraft", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Self-balancing Personal Exoskeleton for SCI (WIP)", "source_url": "https://clinicaltrials.gov/study/NCT07536386"}, {"id": "trialreg:NCT07536724", "company": "Medira GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation", "source_url": "https://clinicaltrials.gov/study/NCT07536724"}, {"id": "trialreg:NCT07537478", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Respiration Measured Via End-tidal CO2 and Spirometry Study (RESPI)", "source_url": "https://clinicaltrials.gov/study/NCT07537478"}, {"id": "denovo:DEN250033", "company": "Hjarta Care, LLC", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-04-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250033 granted: XplantR Explant Tool", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250033"}, {"id": "fda:K253048", "company": "Shenzhen Maiwei Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253048: High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253048", "people": [{"name": "Woody Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253048%22"}, {"id": "fda:K260011", "company": "Foundation Surgical Group, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260011: Foundation Surgical Navigated Lateral Disc Prep Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260011", "people": [{"name": "Asher Breverman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260011%22"}, {"id": "fda:K253260", "company": "SpineCraft", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253260: ORIO-3D Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253260", "people": [{"name": "Ami Akallal-Asaad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253260%22"}, {"id": "fda:K254273", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254273: Verisafe Safety Sterile Needles (SSN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254273", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254273%22"}, {"id": "fda:K254101", "company": "Golden Isles Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254101: Julva Velv\u00e9 Water-Based Personal Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254101", "people": [{"name": "Louie Goryoka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254101%22"}, {"id": "fda:K253907", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253907: Disposable Radiofrequency Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253907", "people": [{"name": "Katee Perez Anderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253907%22"}, {"id": "fda:K253170", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253170: uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253170", "people": [{"name": "Lei Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253170%22"}, {"id": "fda:K260903", "company": "Xodus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260903: Hot Pink Pad Warming System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260903", "people": [{"name": "Paul Lloyd", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260903%22"}, {"id": "fda:K251658", "company": "Medi-Globe GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251658: Endoflux\u0099 Biliary & Pancreatic Stent Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251658", "people": [{"name": "Stephan Schneider", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251658%22"}, {"id": "fda:K253537", "company": "Bright Uro, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253537: Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253537", "people": [{"name": "Suranjan Roychowdhury", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253537%22"}, {"id": "fda:K254216", "company": "Hinge Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254216: Enso for Migraine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254216", "people": [{"name": "Roop Pandher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254216%22"}, {"id": "fda:K253892", "company": "Strauss Surgical USA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253892: Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0\u00b0, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0\u00b0, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30\u00b0, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30\u00b0,", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253892", "people": [{"name": "Antonio Nava", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253892%22"}, {"id": "fda:K253804", "company": "Terrats Medical SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253804: DESS Dental Smart Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253804", "people": [{"name": "Roger Terrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253804%22"}, {"id": "fda:K251478", "company": "Finemedix Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251478: ClearTip TBNA Type", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251478", "people": [{"name": "Young-Hun Do", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251478%22"}, {"id": "fda:K254223", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254223: Next Generation 088 Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254223", "people": [{"name": "Subha Elango", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254223%22"}, {"id": "fda:K252318", "company": "Guangdong Optomedic Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252318: Insufflator (OPTO-IFL1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252318", "people": [{"name": "Weijuan Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252318%22"}, {"id": "fda:K254274", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254274: ARx\u00ae SAI Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254274", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254274%22"}, {"id": "fda:K253523", "company": "Spinal Simplicity", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253523: Freedom DS\u0099 Decompression System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253523", "people": [{"name": "Adam Rogers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253523%22"}, {"id": "fda:K252317", "company": "Suzhou Zenith Vascular SciTech Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252317: Zenith Micro Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252317", "people": [{"name": "Yexia Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252317%22"}, {"id": "fda:K260020", "company": "Beijing Kreate Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260020: Redermo Wound Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260020", "people": [{"name": "Gary Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260020%22"}, {"id": "trialreg:NCT07533149", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Targeted Lens Intervention for Myopic Anisometropia in Children", "source_url": "https://clinicaltrials.gov/study/NCT07533149"}, {"id": "trialreg:NCT07533903", "company": "Synchron, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Functional Outcomes and Control Using Synchron BCI - Australia", "source_url": "https://clinicaltrials.gov/study/NCT07533903"}, {"id": "fda:K260722", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260722: SureSmile Aligner (ASSY500020)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260722", "people": [{"name": "Brianne Yaryan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260722%22"}, {"id": "fda:K260938", "company": "Crossroads Neurovascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260938: PATH BGC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260938", "people": [{"name": "Ryan Breckenridge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260938%22"}, {"id": "fda:K252728", "company": "Immunodiagnostic Systems Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252728: IDS-iSYS Total Testosterone", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252728", "people": [{"name": "Mick Henderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252728%22"}, {"id": "fda:K253573", "company": "Q-Linea AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253573: ASTar BC G- Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253573", "people": [{"name": "Camilla Russell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253573%22"}, {"id": "fda:K260129", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260129: Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260129", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260129%22"}, {"id": "fda:K252774", "company": "ZheJiang Decans Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252774: Uni-C Cervical Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252774", "people": [{"name": "Haifeng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252774%22"}, {"id": "fda:K260282", "company": "bioMerieux, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260282: VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260282", "people": [{"name": "Jennifer McMurtrie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260282%22"}, {"id": "fda:K254107", "company": "Biomet France", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254107: Refobacin Bone Cement R (110034355)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254107", "people": [{"name": "Vanessa Gautier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254107%22"}, {"id": "fda:K252258", "company": "Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252258: VERIQA RT EPID 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252258", "people": [{"name": "Ats Sandor-Csaba", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252258%22"}, {"id": "fda:K253337", "company": "Inter-Med, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253337: REGEN Bioactive Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253337", "people": [{"name": "Alex Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253337%22"}, {"id": "fda:K260307", "company": "Weifang Mingliang Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260307: Diode Laser Therapy Systems (V19)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260307", "people": [{"name": "MingLiang Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260307%22"}, {"id": "fda:K260128", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260128: BD Preset\u0099 and BD A-Line\u0099 Arterial Blood Collection Syringes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260128", "people": [{"name": "Sharanya Jangiti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260128%22"}, {"id": "fda:K260661", "company": "Sprintray, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260661: Midas Restore", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260661", "people": [{"name": "Sara Moghtadernejad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260661%22"}, {"id": "fda:K252843", "company": "Advanced Sterilization Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252843: STERRAD 100NX Sterilization System with ALLClear Technology (10104)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252843", "people": [{"name": "Brandon Roberts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252843%22"}, {"id": "fda:K252404", "company": "Biomet Orthopedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252404: Comprehensive Reverse Shoulder - HA Glenosphere Baseplates", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252404", "people": [{"name": "Julie Gantenberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252404%22"}, {"id": "trialreg:NCT07532369", "company": "Occlutech International AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Occlutech AFR Fontan Study", "source_url": "https://clinicaltrials.gov/study/NCT07532369"}, {"id": "trialreg:NCT07530133", "company": "Hangzhou Kangji Weijing Medical Robotics Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07530133"}, {"id": "trialreg:NCT07531927", "company": "Okuvision GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy", "source_url": "https://clinicaltrials.gov/study/NCT07531927"}, {"id": "trialreg:NCT07530510", "company": "SleepRes Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: KPAP vs EPR for Comfort", "source_url": "https://clinicaltrials.gov/study/NCT07530510"}, {"id": "trialreg:NCT07530523", "company": "SleepRes Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: KPAP vs EPR for Efficacy", "source_url": "https://clinicaltrials.gov/study/NCT07530523"}, {"id": "trialreg:NCT07532174", "company": "Efferon JSC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efferon LPS Hemoadsorption in Cardiac Surgery Patients", "source_url": "https://clinicaltrials.gov/study/NCT07532174"}, {"id": "trialreg:NCT07530731", "company": "Bulbitech", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Platforms Comparison Study - NIXOS-COMPARISON", "source_url": "https://clinicaltrials.gov/study/NCT07530731"}, {"id": "trialreg:NCT07530328", "company": "WMAS SpA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of Copesilcup", "source_url": "https://clinicaltrials.gov/study/NCT07530328"}, {"id": "trialreg:NCT07530497", "company": "SI-BONE, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures", "source_url": "https://clinicaltrials.gov/study/NCT07530497"}, {"id": "trialreg:NCT07532317", "company": "Meril Life Sciences Pvt. Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparison of Myval THV Series With Guideline-Directed Medical Therapy in Participants With Moderate Aortic Stenosis", "source_url": "https://clinicaltrials.gov/study/NCT07532317"}, {"id": "fda:K260498", "company": "Corcym S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260498: TriMemo\u0099 SEMIRIGID ANNULOPLASTY RING", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260498", "people": [{"name": "Silvia Contadini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260498%22"}, {"id": "fda:K260931", "company": "Unimed Medical Supplies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260931: Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260931", "people": [{"name": "Huanyu Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260931%22"}, {"id": "fda:K252663", "company": "Iconic Solutions by Murcia, SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252663: Inbentus Versatile", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252663", "people": [{"name": "Antonio Alarc\u00f3n Mi\u00f1arro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252663%22"}, {"id": "fda:K240974", "company": "Spr Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K240974: SPRINT PNS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240974", "people": [{"name": "Kathryn Stager", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240974%22"}, {"id": "fda:K253107", "company": "Shenzhen Dongjiang Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253107: Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253107", "people": [{"name": "Junjie Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253107%22"}, {"id": "fda:K260583", "company": "Exactech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260583: Equinoxe\u00ae Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260583", "people": [{"name": "Pedro Ravelo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260583%22"}, {"id": "fda:K253502", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253502: Critical Care Suite with Enteric Tube Positioning AI Algorithm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253502", "people": [{"name": "Chris Paulik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253502%22"}, {"id": "fda:K252587", "company": "Shenzhen RF Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252587: HD 8Ch Wrist Array", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252587", "people": [{"name": "Wang Gary", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252587%22"}, {"id": "trialreg:NCT07529028", "company": "Lifetech Scientific (Shenzhen) Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of the AbsnowTM II Absorbable Atrial Septal Defect Closure System for Atrial Septal Defect Closure Therapy", "source_url": "https://clinicaltrials.gov/study/NCT07529028"}, {"id": "trialreg:NCT07527000", "company": "All Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SpO2 Validation Study - All.Health Algo Oximeter Software", "source_url": "https://clinicaltrials.gov/study/NCT07527000"}, {"id": "trialreg:NCT07529275", "company": "iVascular S.L.U.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Performance and Safety Assessment of the Use of iCover Balloon Expandable Covered Stent (iVascular) Implanted as Bridging Stent in FEVAR (Fenestrated Endovascular Aortic Repair) for the Treatment of Complex Abdominal Aortic Aneurysms", "source_url": "https://clinicaltrials.gov/study/NCT07529275"}, {"id": "trialreg:NCT07526896", "company": "Medtronic Cardiac Rhythm and Heart Failure", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing", "source_url": "https://clinicaltrials.gov/study/NCT07526896"}, {"id": "trialreg:NCT07528326", "company": "TRiCares", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The TRICURE US IDE Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT07528326"}, {"id": "trialreg:NCT07527299", "company": "Biosense Webster, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation", "source_url": "https://clinicaltrials.gov/study/NCT07527299"}, {"id": "trialreg:NCT07529756", "company": "Intervene, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry", "source_url": "https://clinicaltrials.gov/study/NCT07529756"}, {"id": "trialreg:NCT07527559", "company": "Fuzzle Operating Co.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Fuzzle System for Appetite Control and Weight Management", "source_url": "https://clinicaltrials.gov/study/NCT07527559"}, {"id": "fda:K260965", "company": "Calyxo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260965: CVAC Aspiration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260965", "people": [{"name": "Joseph Catanese III", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260965%22"}, {"id": "fda:K260340", "company": "HC Biologics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260340: HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260340", "people": [{"name": "Onur Basol", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260340%22"}, {"id": "fda:K253357", "company": "B-One Ortho, Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253357: b-ONE\u00ae Bipolar Head", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253357", "people": [{"name": "Allison Gecik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253357%22"}, {"id": "fda:K253592", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253592: Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253592", "people": [{"name": "Alexandria Irwin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253592%22"}, {"id": "fda:K254128", "company": "Shoulder Innovations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254128: InSet Reverse Total Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254128", "people": [{"name": "Mark D. Hanes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254128%22"}, {"id": "fda:K260095", "company": "Healgen Scientific,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260095: Heal-Check Rapid COVID-19 Antigen Self-Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260095", "people": [{"name": "Bingliang Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260095%22"}, {"id": "fda:K252280", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252280: Elecsys Anti-SARS-CoV-2 S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252280", "people": [{"name": "Amy Pierce", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252280%22"}, {"id": "fda:K253861", "company": "Corify Care S.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253861: ACORYS MAPPING SYSTEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253861", "people": [{"name": "Javier Milagro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253861%22"}, {"id": "fda:K260091", "company": "Inquis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260091: Aventus Introducer Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260091", "people": [{"name": "Zachary Woodson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260091%22"}, {"id": "fda:K254078", "company": "Vapotherm, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254078: HVT 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254078", "people": [{"name": "Michael Webb", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254078%22"}, {"id": "trialreg:NCT07526389", "company": "Shanghai Vision Science Engineer Medical Equipment Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Efficacy and Safety of Aspheric Keratoprosthesis in the Treatment of Patients With Corneal Blindness: A Clinical Study", "source_url": "https://clinicaltrials.gov/study/NCT07526389"}, {"id": "trialreg:NCT07523750", "company": "Biosense Webster, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07523750"}, {"id": "trialreg:NCT07525518", "company": "Okami Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Okami Medical ALPHA Registry", "source_url": "https://clinicaltrials.gov/study/NCT07525518"}, {"id": "trialreg:NCT07523620", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration", "source_url": "https://clinicaltrials.gov/study/NCT07523620"}, {"id": "trialreg:NCT07521735", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NEXT GEN - PHILIPS OPTIMUS", "source_url": "https://clinicaltrials.gov/study/NCT07521735"}, {"id": "trialreg:NCT07523269", "company": "Aktiia SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control", "source_url": "https://clinicaltrials.gov/study/NCT07523269"}, {"id": "trialreg:NCT07526428", "company": "Sonova AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Investigating the DNN Noise Reduction Feature in Phonak Hearing Aids Using Ecological Momentary Assessment", "source_url": "https://clinicaltrials.gov/study/NCT07526428"}, {"id": "trialreg:NCT07521475", "company": "Insulet Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Fully Closed Loop Omnipod\u00ae System in Type 2 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07521475"}, {"id": "trialreg:NCT07521462", "company": "Isispharma", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy", "source_url": "https://clinicaltrials.gov/study/NCT07521462"}, {"id": "trialreg:NCT07523685", "company": "Acacia Clinics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD)", "source_url": "https://clinicaltrials.gov/study/NCT07523685"}, {"id": "fda:K253777", "company": "Ascblue Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253777: Ascblue (8010)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253777", "people": [{"name": "Yuexin Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253777%22"}, {"id": "fda:K253917", "company": "Plasma Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253917: ARION ARC System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253917", "people": [{"name": "Rupanshi Naik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253917%22"}, {"id": "fda:K252485", "company": "1987 Media Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252485: ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252485", "people": [{"name": "Thomas Hartnett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252485%22"}, {"id": "fda:K260244", "company": "Eximo Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260244: Auryon Atherectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260244", "people": [{"name": "Kasey Newcomb", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260244%22"}, {"id": "fda:K253926", "company": "ShenB Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253926: Diacore", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253926", "people": [{"name": "Sun Young Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253926%22"}, {"id": "fda:K253361", "company": "OrbusNeich Medical (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253361: Teleport Glide Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253361", "people": [{"name": "Dora Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253361%22"}, {"id": "fda:K252757", "company": "Cequr SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252757: CeQur Simplicity\u0099 On-Demand Insulin Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252757", "people": [{"name": "Michael Simpson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252757%22"}, {"id": "fda:K253930", "company": "Overjet, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253930: Overjet Iris Intelligent Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253930", "people": [{"name": "Gayatri Sekaran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253930%22"}, {"id": "fda:K253510", "company": "Medela, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253510: Freestyle Mini Hands-free", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253510", "people": [{"name": "Jenni Vescovo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253510%22"}, {"id": "fda:K253657", "company": "Covidien (Part of Medtronic)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253657: Tri-staple 2.0\u0099 Reloads; Endo GIA\u0099 Reloads with Tri-Staple\u0099 Technology; Endo GIA\u0099 Gray Articulating Reloads; Signia\u0099 Small Diameter Reloads", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253657", "people": [{"name": "Fei Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253657%22"}, {"id": "fda:K252190", "company": "Aitewan Biomedical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252190: DeepBT Detector-Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252190", "people": [{"name": "Wan-Yuo Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252190%22"}, {"id": "fda:K252241", "company": "Sophysa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252241: Pressio 3 Multi-parameter Neuromonitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252241", "people": [{"name": "Julie Lopez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252241%22"}, {"id": "fda:K252506", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252506: BD Vacutainer\u00ae Safety-Lok\u0099 Blood Collection Set; BD Vacutainer\u00ae Safety-Lok\u0099 Blood Collection Set with Pre-Attached Holder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252506", "people": [{"name": "Kelly Hilliger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252506%22"}, {"id": "fda:K252708", "company": "Relu BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252708: Relu Cloud", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252708", "people": [{"name": "Holger Willems", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252708%22"}, {"id": "fda:K252207", "company": "Radiometer Medicals Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252207: ABL90 FLEX PLUS System, safeCLINITUBES", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252207", "people": [{"name": "Andrea Swingle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252207%22"}, {"id": "fda:K260508", "company": "Okami Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260508: LOBO Vascular Occlusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260508", "people": [{"name": "Cora Sim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260508%22"}, {"id": "fda:K260082", "company": "3Shape TRIOS A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260082: TRIOS Dx (R1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260082", "people": [{"name": "Jenny Axel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260082%22"}, {"id": "fda:K252378", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252378: BD\u00ae MiniDraw\u0099 Capillary Blood Collection System with BD\u00ae MiniDraw\u0099 SST\u0099 Capillary Blood Collection Tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252378", "people": [{"name": "Alexandra Kirby", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252378%22"}, {"id": "fda:K260090", "company": "Actis Medical Pty., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260090: SMART Osteotomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260090", "people": [{"name": "Josh Balfour", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260090%22"}, {"id": "fda:K252942", "company": "Shaeferh, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252942: ShaeferH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252942", "people": [{"name": "Andy Cheung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252942%22"}, {"id": "fda:K252699", "company": "University of Utah, Department of Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252699: CoAptix S System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252699", "people": [{"name": "Wade Fallin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252699%22"}, {"id": "fda:K260430", "company": "Belport Company, Inc., Gingi-Pak", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260430: Porcelain Etch Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260430", "people": [{"name": "Jingtian Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260430%22"}, {"id": "fda:K252250", "company": "Shanghai Draeger Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252250: Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252250", "people": [{"name": "Xuguang Miao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252250%22"}, {"id": "fda:K253446", "company": "Dk Medical Systems Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253446: AeroDR TX c02", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253446", "people": [{"name": "Young Woo Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253446%22"}, {"id": "fda:K254004", "company": "Cognifisense, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254004: VRNT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254004", "people": [{"name": "Amanda Way", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254004%22"}, {"id": "fda:K252548", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252548: AI-Rad Companion Organs RT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252548", "people": [{"name": "Kira Morales", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252548%22"}, {"id": "fda:K260839", "company": "Protaryx Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260839: Protaryx Transseptal Puncture Device (PTX2-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260839", "people": [{"name": "David Mester", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260839%22"}, {"id": "fda:K253689", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253689: syngo Dynamics (VA41F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253689", "people": [{"name": "Jiayan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253689%22"}, {"id": "fda:K260317", "company": "International Life Sciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260317: Artelon Convenience Kits", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260317", "people": [{"name": "Rachel Roberts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260317%22"}, {"id": "fda:K254158", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254158: SPINEART Navigation Instrument System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254158", "people": [{"name": "Estelle Lefeuvre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254158%22"}, {"id": "fda:K254021", "company": "Rivanna Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254021: Accuro XV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254021", "people": [{"name": "F. William Mauldin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254021%22"}, {"id": "fda:K252251", "company": "CG Bio Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252251: EASYMADE-TI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252251", "people": [{"name": "Youngwook Moon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252251%22"}, {"id": "fda:K260067", "company": "Shandong Huge Dental Material Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260067: Eternal Art Porcelain Powders", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260067", "people": [{"name": "Zheng Maggie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260067%22"}, {"id": "fda:K260462", "company": "Ray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260462: RCT800", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260462", "people": [{"name": "Suyeon Baek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260462%22"}, {"id": "fda:K260017", "company": "Shanghai Apolo Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260017: Picosecond Nd:YAG Laser Systems (Model: HS-298)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260017", "people": [{"name": "Felix Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260017%22"}, {"id": "fda:K260245", "company": "KLISBio S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260245: SILKBridge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260245", "people": [{"name": "Gabriele Grecchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260245%22"}, {"id": "fda:K252228", "company": "Checkcells, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252228: Seaman Pro/Seaman", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252228", "people": [{"name": "Martin Kosela", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252228%22"}, {"id": "fda:K253975", "company": "Maduro Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253975: Radical 6F Access Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253975", "people": [{"name": "Janice Kemp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253975%22"}, {"id": "fda:K252929", "company": "Anhui Happiness Workshop Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252929: Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252929", "people": [{"name": "Jamie Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252929%22"}, {"id": "fda:K260555", "company": "Zest Anchors, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260555: LOCATOR\u00ae Angled Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260555", "people": [{"name": "DAVID LIN", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260555%22"}, {"id": "trialreg:NCT07520591", "company": "Cardiawave SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Valvosoft Outcomes Registry for Real-World Evidence", "source_url": "https://clinicaltrials.gov/study/NCT07520591"}, {"id": "trialreg:NCT07520708", "company": "Fidia Farmaceutici s.p.a.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance and Safety of HyalganBio\u00ae Intra-Articular Injections as Add-On to Physical Exercise for Symptomatic Glenohumeral Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07520708"}, {"id": "trialreg:NCT07518836", "company": "Cellontech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of SurgiFill\u2122in Patients With Femur or Tibia Fracture", "source_url": "https://clinicaltrials.gov/study/NCT07518836"}, {"id": "fda:K251666", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251666: SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251666", "people": [{"name": "Jennifer Nalepka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251666%22"}, {"id": "fda:K251889", "company": "Resmed Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251889: myAir", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251889", "people": [{"name": "Rose Malonzo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251889%22"}, {"id": "fda:K253534", "company": "Modular Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253534: Pivot Insulin Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253534", "people": [{"name": "Shahzaib Rai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253534%22"}, {"id": "fda:K260033", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260033: Wearable Breast Pump (Model S21A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260033", "people": [{"name": "Dale Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260033%22"}, {"id": "fda:K260197", "company": "Suzhou Shenyun Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260197: Shogun Axis\u0099 Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260197", "people": [{"name": "Yuan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260197%22"}, {"id": "fda:K260477", "company": "Tenon Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260477: CATAMARAN\u0099 SI Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260477", "people": [{"name": "Richard Ginn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260477%22"}, {"id": "fda:K252270", "company": "Hangzhou AGS MedTech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252270: Hemoclip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252270", "people": [{"name": "Bingru Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252270%22"}, {"id": "fda:K252224", "company": "Changzhou Sifary Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252224: Apex Locator (FindPex)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252224", "people": [{"name": "Jie Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252224%22"}, {"id": "fda:K260420", "company": "MacroLux Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260420: LoopView\u00ae Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260420", "people": [{"name": "Ye Linbin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260420%22"}, {"id": "fda:K253268", "company": "CMT Health PTE., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253268: Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253268", "people": [{"name": "Monica Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253268%22"}, {"id": "fda:K260766", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260766: Celerity 5 HP Biological Indicator (LCB052)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260766", "people": [{"name": "Logan Persons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260766%22"}, {"id": "fda:K254258", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254258: Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254258", "people": [{"name": "Caitlin Liang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254258%22"}, {"id": "fda:K260816", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260816: OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260816", "people": [{"name": "Brian Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260816%22"}, {"id": "fda:K260089", "company": "Scopix , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260089: TL-10 Laparoscopic Scope Cleaner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260089", "people": [{"name": "Orly Maor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260089%22"}, {"id": "trialreg:NCT07518615", "company": "Institut Straumann AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon", "source_url": "https://clinicaltrials.gov/study/NCT07518615"}, {"id": "trialreg:NCT07516977", "company": "Daewoong Pharmaceutical Co. LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Noseguard for Prevention of Respiratory Infections in Real-World Use", "source_url": "https://clinicaltrials.gov/study/NCT07516977"}, {"id": "trialreg:NCT07516457", "company": "Allegro NV/SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Hydrogel Assessment for Local Treatment of Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07516457"}, {"id": "trialreg:NCT07517588", "company": "Polares Medical SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)", "source_url": "https://clinicaltrials.gov/study/NCT07517588"}, {"id": "trialreg:NCT07518004", "company": "Senseonics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ROME GS System Study", "source_url": "https://clinicaltrials.gov/study/NCT07518004"}, {"id": "trialreg:NCT07516444", "company": "VDyne, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)", "source_url": "https://clinicaltrials.gov/study/NCT07516444"}, {"id": "trialreg:NCT07516470", "company": "Signal House Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparison of Acoustic Variability Index (AVI) and Pulse Pressure Variation (PPV) for Predicting Fluid Responsiveness in Mechanically Ventilated Patients", "source_url": "https://clinicaltrials.gov/study/NCT07516470"}, {"id": "fda:K252979", "company": "Belkin Vision, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252979: Voyager DSLT (430840610)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252979", "people": [{"name": "Tamar Mor-Yosef Weizman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252979%22"}, {"id": "fda:K254191", "company": "InnovaCorium, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254191: IWD-Gel\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254191", "people": [{"name": "Marcelo Buzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254191%22"}, {"id": "fda:K253952", "company": "Beijing OrionStar Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253952: Power Wheelchair (OS-R-M01S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253952", "people": [{"name": "Shengnan Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253952%22"}, {"id": "fda:K260048", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260048: Elecsys Anti-HAV IgM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260048", "people": [{"name": "Samantha Logan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260048%22"}, {"id": "fda:K260860", "company": "Basic Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260860: Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260860", "people": [{"name": "Amy Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260860%22"}, {"id": "fda:K253946", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253946: Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253946", "people": [{"name": "Caitlin Liang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253946%22"}, {"id": "fda:K260942", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260942: AuST Steerable Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260942", "people": [{"name": "Conner Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260942%22"}, {"id": "fda:K252861", "company": "Hangzhou Tappa Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252861: Warming System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252861", "people": [{"name": "Na Ban", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252861%22"}, {"id": "fda:K253801", "company": "Anumana, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253801: ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253801", "people": [{"name": "Vyaas Shankar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253801%22"}, {"id": "fda:K252116", "company": "Shanghai MicroPort Medical (Group) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252116: Firefighter\u0099 Pro PTCA Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252116", "people": [{"name": "Huasheng Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252116%22"}, {"id": "fda:K253905", "company": "Cogentix Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253905: PrimeSight UltraView System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253905", "people": [{"name": "Chanrasmey White", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253905%22"}, {"id": "fda:K260046", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260046: Elecsys Anti-HBc II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260046", "people": [{"name": "Ailsa Grieve", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260046%22"}, {"id": "fda:K260049", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260049: Elecsys Anti-HBc IgM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260049", "people": [{"name": "Ailsa Grieve", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260049%22"}, {"id": "fda:K260466", "company": "Zhejiang shuyou Surgical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260466: Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260466", "people": [{"name": "Jialong Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260466%22"}, {"id": "trialreg:NCT07516184", "company": "AstraZeneca", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis", "source_url": "https://clinicaltrials.gov/study/NCT07516184"}, {"id": "trialreg:NCT07513519", "company": "BioM\u00e9rieux", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Impact of a Multiplex Respiratory PCR Test on Outcomes for Patients Presenting With Respiratory Illness in the Urgent Care Setting: A Hybrid-Effectiveness Quasi-Experimental Trial", "source_url": "https://clinicaltrials.gov/study/NCT07513519"}, {"id": "trialreg:NCT07515781", "company": "V-Flow 21", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: VivaStent Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07515781"}, {"id": "trialreg:NCT07513415", "company": "Endovision Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Comparative Study on the Safety and Efficacy of the Intra-Articular Injectable Filler ALLOHEAL in Patients With Knee Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07513415"}, {"id": "trialreg:NCT07514286", "company": "Rhythm Diagnostic Systems", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of the Feasibility and Organisational Impact of a Care Pathway Incorporating the MultiSense\u00ae Medical Device for Post-operative Home Monitoring of Elderly Patients.", "source_url": "https://clinicaltrials.gov/study/NCT07514286"}, {"id": "trialreg:NCT07515872", "company": "ZetrOZ, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07515872"}, {"id": "breakthrough:K253801", "company": "Anumana, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-04-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K253801: ECG-AI CARDIAC AMYLOIDOSIS (CA) 12-LEAD ALGORITHM (1040)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253036", "company": "Aidite (Qinhuangdao) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253036: Light-curing Coloring Materials (ALCM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253036", "people": [{"name": "Hang Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253036%22"}, {"id": "fda:K253862", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253862: APERTO Lucent MRI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253862", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253862%22"}, {"id": "fda:K260459", "company": "Zoll Respicardia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260459: VANES Delivery System (VDS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260459", "people": [{"name": "Abby VanHaren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260459%22"}, {"id": "fda:K253288", "company": "Esaote, S.p.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253288: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253288", "people": [{"name": "Vanessa Ronconi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253288%22"}, {"id": "fda:K250208", "company": "Uzinmedicare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250208: SPECTRA Wearable 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250208", "people": [{"name": "Dain Jang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250208%22"}, {"id": "fda:K252809", "company": "Virility Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252809: in2 Smart (in2S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252809", "people": [{"name": "Natalie Shukrun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252809%22"}, {"id": "fda:K254091", "company": "YAMAHACHI DENTAL MFG., Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254091: GLOSSY COAT (15ML)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254091", "people": [{"name": "Toyama Masashi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254091%22"}, {"id": "fda:K252182", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252182: SV70 Ventilator (SV70)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252182", "people": [{"name": "Lei Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252182%22"}, {"id": "fda:K253025", "company": "Ricoh 3D For Healthcare, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253025: Ricoh 3D for Healthcare Bolus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253025", "people": [{"name": "Kim Torluemke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253025%22"}, {"id": "fda:K254084", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254084: AETOS Shoulder System - CONCELOC Glenoids", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254084", "people": [{"name": "Cassidy Whipple", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254084%22"}, {"id": "fda:K252765", "company": "Prosomnus Sleep Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252765: ProSomnus RPMO2 OSA Device (RPMO2 OSA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252765", "people": [{"name": "Divya Mavalli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252765%22"}, {"id": "fda:K260521", "company": "Zhuhai Pusen Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260521: ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260521", "people": [{"name": "Changshen Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260521%22"}, {"id": "fda:K260397", "company": "Hironic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260397: SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260397", "people": [{"name": "Byoungkook Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260397%22"}, {"id": "trialreg:NCT07510880", "company": "Ionclinics & Deionic SL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Home tDCS for the Treatment of Major Depression.", "source_url": "https://clinicaltrials.gov/study/NCT07510880"}, {"id": "trialreg:NCT07511777", "company": "Cellontech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial to Assess the Safety and Efficacy of Intra-articular Injection Collagen Versus Hyaluronic Acid on Knee Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07511777"}, {"id": "trialreg:NCT07512128", "company": "Shockwave Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)", "source_url": "https://clinicaltrials.gov/study/NCT07512128"}, {"id": "fda:K253056", "company": "Zhejiang Soudon Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253056: Disposable Stone Extraction Basket", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253056", "people": [{"name": "Junshi Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253056%22"}, {"id": "fda:K260724", "company": "Magentiq Eye, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260724: MAGENTIQ-COLO (ME-APDS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260724", "people": [{"name": "Dror Zur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260724%22"}, {"id": "fda:K260720", "company": "MED-EL Elektromedizinische Ger\u00e4te GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260720: mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260720", "people": [{"name": "Vladislav Morozov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260720%22"}, {"id": "fda:K260718", "company": "MED-EL Elektromedizinische Ger\u00e4te GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260718: mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260718", "people": [{"name": "Vladislav Morozov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260718%22"}, {"id": "fda:K260719", "company": "MED-EL Elektromedizinische Ger\u00e4te GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260719: mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260719", "people": [{"name": "Vladislav Morozov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260719%22"}, {"id": "fda:K252495", "company": "Newpong Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252495: LSSA (NP-200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252495", "people": [{"name": "JongMyung Shin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252495%22"}, {"id": "fda:K253042", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253042: Tyber Medical Trauma Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253042", "people": [{"name": "Nicole Merlini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253042%22"}, {"id": "fda:K252744", "company": "Cixi Ruihong Electric Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252744: Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252744", "people": [{"name": "Feng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252744%22"}, {"id": "fda:K253962", "company": "Radformation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253962: ClearCheck (RADCC V2.7)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253962", "people": [{"name": "Jennifer Wampler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253962%22"}, {"id": "fda:DEN240071", "company": "Automated Imaging Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN240071: neuropacs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240071", "people": [{"name": "David Vaillancourt", "role": "510(k) submission contact"}]}, {"id": "fda:K250074", "company": "Hyalex Orthopaedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250074: HYALEX\u00ae MTP Hemiarthroplasty Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250074", "people": [{"name": "Chris Cain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250074%22"}, {"id": "fda:K254066", "company": "Etiometry, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254066: Etiometry Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254066", "people": [{"name": "Timothy Hanson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254066%22"}, {"id": "fda:K254153", "company": "Mirco-Tech (Nanjing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254153: Single-use Video Scope; PB Digital Controller", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254153", "people": [{"name": "Sally He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254153%22"}, {"id": "fda:K260786", "company": "S.m.a.i.o", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260786: KHEIRON\u00ae Spinal Fixation System, including patient specific K-ROD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260786", "people": [{"name": "Jean-Charles ROUSSOULY", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260786%22"}, {"id": "fda:K254060", "company": "TW Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254060: Life Saving Tourniquet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254060", "people": [{"name": "Yaakov Tsadik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254060%22"}, {"id": "fda:K253674", "company": "Stryker Corporation (Tornier, S.A.S.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253674: Blueprint Patient-Specific Instrumentation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253674", "people": [{"name": "Aymen Azaiez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253674%22"}, {"id": "fda:K260524", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260524: uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260524", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260524%22"}, {"id": "fda:K252386", "company": "Chengdu Cryo-Push Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252386: Hot and Cold Compression System (A02-C-032)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252386", "people": [{"name": "Peiyong Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252386%22"}, {"id": "fda:K253340", "company": "Zhongshan A&J Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253340: Electric Wheelchair (AL-208S-063)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253340", "people": [{"name": "Yong Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253340%22"}, {"id": "fda:K260363", "company": "Ceribell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260363: Ceribell Brain Monitor Headband", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260363", "people": [{"name": "Raymond Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260363%22"}, {"id": "trialreg:NCT07510438", "company": "Amplitude Vascular Systems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AVS Pulse Intravascular Lithotripsy\u2122 (Pulse IVL\u2122) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease", "source_url": "https://clinicaltrials.gov/study/NCT07510438"}, {"id": "trialreg:NCT07510646", "company": "Vielight Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Transcranial Photobiomodulation for Bipolar Depression", "source_url": "https://clinicaltrials.gov/study/NCT07510646"}, {"id": "trialreg:NCT07510581", "company": "Therabody, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluatation of a Microcurrent + Cold Therapy Device", "source_url": "https://clinicaltrials.gov/study/NCT07510581"}, {"id": "trialreg:NCT07510464", "company": "Qviti S.a.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Transcranial Alternating Current Stimulation in Post Stroke Aphasia Therapy", "source_url": "https://clinicaltrials.gov/study/NCT07510464"}, {"id": "trialreg:NCT07509658", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TriClip Japan Post-Approval Study", "source_url": "https://clinicaltrials.gov/study/NCT07509658"}, {"id": "denovo:DEN240071", "company": "Automated Imaging Diagnostics, LLC", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-04-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240071 granted: neuropacs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240071"}, {"id": "fda:K252229", "company": "Genoray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252229: BELLIGER ACE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252229", "people": [{"name": "Dongwon Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252229%22"}, {"id": "fda:K260184", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260184: Onclarity\u0099 Self-Collection Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260184", "people": [{"name": "Joseph Basore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260184%22"}, {"id": "fda:K252130", "company": "Icu Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252130: LifeShield Infusion Safety Software Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252130", "people": [{"name": "Pernell Abrantes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252130%22"}, {"id": "fda:K254022", "company": "Verge Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254022: FLASH Flex\u0099 Aorto-Ostial Angioplasty System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254022", "people": [{"name": "Michael Buck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254022%22"}, {"id": "fda:K253076", "company": "Chengdu Cryo-Push Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253076: Cryopush Cold Compression Device (A02-P-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253076", "people": [{"name": "Lifang Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253076%22"}, {"id": "fda:K252137", "company": "Becton Dickinson Infusion Therapy Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252137: BD Insyte\u0099 IV Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252137", "people": [{"name": "Teresa Do-McCage", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252137%22"}, {"id": "fda:K250516", "company": "Miracell Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250516: SMART M-CELL PRP Concentration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250516", "people": [{"name": "Sy Koo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250516%22"}, {"id": "fda:K250518", "company": "Miracell Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250518: SMART M-CELL Bone Marrow Concentration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250518", "people": [{"name": "Sy Koo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250518%22"}, {"id": "fda:K252198", "company": "Medical Brands Laboratories B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252198: Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252198", "people": [{"name": "Pieternella Bouter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252198%22"}, {"id": "fda:K252079", "company": "Beijing L&Z Medical Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252079: Disposable Infusion Bag for Parenteral Nutrition", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252079", "people": [{"name": "Li Zhiling", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252079%22"}, {"id": "fda:K260026", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260026: Tina-quant Cardiac high sensitivity CRP III", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260026", "people": [{"name": "Elina Voronovsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260026%22"}, {"id": "fda:K260647", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260647: SPECCHIO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260647", "people": [{"name": "Peruzzi Paolo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260647%22"}, {"id": "fda:K260796", "company": "Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260796: Tahoe Unicondylar Knee System with TiNbN Overcoat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260796", "people": [{"name": "Romil Sheth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260796%22"}, {"id": "fda:K252246", "company": "Jeil Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252246: Leforte MMF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252246", "people": [{"name": "Jinwoo Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252246%22"}, {"id": "fda:K252709", "company": "Xuzhou Yongkang Electronic Science Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252709: Wireless Probe Type Ultrasound Scanner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252709", "people": [{"name": "Xiao Wan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252709%22"}, {"id": "pma:P250033", "company": "Endospan , Ltd.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-04-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250033: NEXUS Aortic Arch Stent Graft System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250033", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250033%22"}, {"id": "trialreg:NCT07507903", "company": "Aktiia SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device", "source_url": "https://clinicaltrials.gov/study/NCT07507903"}, {"id": "trialreg:NCT07507422", "company": "Medtronic", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv\u2122 Spinal Cord Stimulation Therapy", "source_url": "https://clinicaltrials.gov/study/NCT07507422"}, {"id": "trialreg:NCT07507136", "company": "Albos d.o.o. Beograd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Novel Dental Cements (ALBO-MPCA) in Patients With Caries", "source_url": "https://clinicaltrials.gov/study/NCT07507136"}, {"id": "trialreg:NCT07508592", "company": "Seger Surgical Solutions", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study of the SEGER Device in Laparoscopic Gastrointestinal Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07508592"}, {"id": "breakthrough:P250033", "company": "Endospan, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-04-02", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P250033: NEXUS AORTIC ARCH STENT GRAFT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K242303", "company": "Orthomod, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242303: MOD-C", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242303", "people": [{"name": "David Kirschman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242303%22"}, {"id": "fda:K253582", "company": "Apple, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253582: Medical Imaging Calibration Feature (MICF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253582", "people": [{"name": "Lynda Ikejimba", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253582%22"}, {"id": "fda:K252876", "company": "Shenzhen RF Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252876: GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252876", "people": [{"name": "Gary Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252876%22"}, {"id": "fda:K260007", "company": "Hudi Pharma Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260007: Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260007", "people": [{"name": "Marco Mattielli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260007%22"}, {"id": "fda:K253405", "company": "Prana Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253405: Prana System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253405", "people": [{"name": "Carolyne Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253405%22"}, {"id": "fda:K254225", "company": "Shenzhen HanHan Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254225: Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254225", "people": [{"name": "Yong Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254225%22"}, {"id": "fda:K260276", "company": "Shenzhen AOJ Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260276: Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260276", "people": [{"name": "Jack Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260276%22"}, {"id": "fda:K252943", "company": "Convatec Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252943: GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252943", "people": [{"name": "Danielle Gibboney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252943%22"}, {"id": "fda:K254015", "company": "Smart Soft Healthcare AD", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254015: CoLumbo C-Spine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254015", "people": [{"name": "Nedelcho Georgiev", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254015%22"}, {"id": "fda:K253718", "company": "Nvision Biomedical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253718: enHAnce PEEK Bunion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253718", "people": [{"name": "Marisa Zink", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253718%22"}, {"id": "fda:K253473", "company": "Stereotaxis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253473: Synchrony", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253473", "people": [{"name": "Angela McKnight", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253473%22"}, {"id": "fda:K252513", "company": "Poly Medicure Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252513: Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252513", "people": [{"name": "Ramdas Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252513%22"}, {"id": "fda:K253586", "company": "Retmap, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-04-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253586: RM Electrode (RMH 25-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253586", "people": [{"name": "Shresta Patangay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253586%22"}, {"id": "trialreg:NCT07505797", "company": "iSono Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-04-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)", "source_url": "https://clinicaltrials.gov/study/NCT07505797"}, {"id": "fda:K253029", "company": "Mediott, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253029: RW-1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253029", "people": [{"name": "Abe Takehiko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253029%22"}, {"id": "fda:K260375", "company": "Sanhe Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260375: Nd: YAG Laser Therapy Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260375", "people": [{"name": "Xiaoxia Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260375%22"}, {"id": "fda:K260191", "company": "Tianjin Huahong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260191: Safety lancet (XXXVII)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260191", "people": [{"name": "Ningning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260191%22"}, {"id": "fda:K253598", "company": "Carbon Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253598: InjecSURE Injection System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253598", "people": [{"name": "Jared Klein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253598%22"}, {"id": "fda:K260093", "company": "VATECH Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260093: Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260093", "people": [{"name": "Daniel Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260093%22"}, {"id": "fda:K260319", "company": "Zhenjiang Assure Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260319: K5 wheelchair (16\u0094 with swing-away footrest 18\u0094 with swing-away footrest 20\u0094 with swing-away footrest 16\u0094 with elevated foot rest(ELR) 18\u0094 with elevated foot rest(ELR) 20\u0094 with elevated foot rest(ELR))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260319", "people": [{"name": "Ying Mei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260319%22"}, {"id": "trialreg:NCT07503171", "company": "Nihon Kohden", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Hypoxia and Hemodilution Testing in Healthy Adult Volunteers", "source_url": "https://clinicaltrials.gov/study/NCT07503171"}, {"id": "trialreg:NCT07503236", "company": "Nyra Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System", "source_url": "https://clinicaltrials.gov/study/NCT07503236"}, {"id": "trialreg:NCT07502456", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clareon TruPlus Study", "source_url": "https://clinicaltrials.gov/study/NCT07502456"}, {"id": "trialreg:NCT07502599", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)", "source_url": "https://clinicaltrials.gov/study/NCT07502599"}, {"id": "trialreg:NCT07503769", "company": "Shanghai MicroPort EP MedTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CHU Dual-Energy Ablation in Ventricular Arrhythmia", "source_url": "https://clinicaltrials.gov/study/NCT07503769"}, {"id": "trialreg:NCT07503873", "company": "TG Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)", "source_url": "https://clinicaltrials.gov/study/NCT07503873"}, {"id": "fda:K252269", "company": "Baebies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252269: FINDER Flu A&B/SARS-CoV-2 Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252269", "people": [{"name": "Vijay Srinivasan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252269%22"}, {"id": "fda:K253654", "company": "Philips Medizin Systeme B\u00f6blingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253654: IntelliVue Measurement Rack 6000 (867317)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253654", "people": [{"name": "Monica da Silva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253654%22"}, {"id": "fda:K260037", "company": "Implantcast GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260037: implantcast Packaging System Update", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260037", "people": [{"name": "Juliane H\u00f6ppner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260037%22"}, {"id": "fda:K254207", "company": "ViTAA Medical Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254207: AiORTA - Plan v2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254207", "people": [{"name": "Mitchel Benovoy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254207%22"}, {"id": "fda:K260370", "company": "Bloomden Bioceramics (HuNan) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260370: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260370", "people": [{"name": "Shengyong Liao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260370%22"}, {"id": "fda:K252240", "company": "Spectrum Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252240: Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252240", "people": [{"name": "James Robinson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252240%22"}, {"id": "fda:K254122", "company": "ArthroCare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254122: FLOW FLEXTEND Wand (72290039)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254122", "people": [{"name": "Alexander Brankner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254122%22"}, {"id": "fda:K253950", "company": "Avatar Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253950: Avatar Medical Vision", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253950", "people": [{"name": "Adeline Francois", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253950%22"}, {"id": "fda:K252158", "company": "Mayer Laboratories", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252158: Sagami Original 002 Polyurethane Male Condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252158", "people": [{"name": "David Mayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252158%22"}, {"id": "fda:K260812", "company": "Centers for Disease Control and Prevention", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260812: Francisella tularensis Real-time PCR Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260812", "people": [{"name": "Jasmine Chaitram", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260812%22"}, {"id": "trialreg:NCT07499180", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study on Body Posture and Eye Movements During Screen Usage on Adults Aged 18 to 65 Wearing Various Types of Eyeglasses", "source_url": "https://clinicaltrials.gov/study/NCT07499180"}, {"id": "trialreg:NCT07501442", "company": "Wooshin Labottach Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)", "source_url": "https://clinicaltrials.gov/study/NCT07501442"}, {"id": "trialreg:NCT07500961", "company": "Albos d.o.o. Beograd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Novel Bone Substitute (ALBO-OS) in Patients With Periodontal Disease or Who Need Alveolar Preservation", "source_url": "https://clinicaltrials.gov/study/NCT07500961"}, {"id": "trialreg:NCT07501949", "company": "Electronic Waveform Lab", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: H-Wave\u00ae Device Stimulation for Post-operative Rotator Cuff Repair Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07501949"}, {"id": "trialreg:NCT07500155", "company": "Keuro MedTech", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Postmarket Study of Tarvos Microguidewire in Neurovascular Interventional Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07500155"}, {"id": "trialreg:NCT07500311", "company": "Med-El Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparison of Performance Using MED-EL Automatic Sound Management", "source_url": "https://clinicaltrials.gov/study/NCT07500311"}, {"id": "trialreg:NCT07501312", "company": "Sonova AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Remote Microphone Performance Comparison in Adults With Hearing Loss", "source_url": "https://clinicaltrials.gov/study/NCT07501312"}, {"id": "trialreg:NCT07501234", "company": "Mitrassist Lifesciences Limited Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Feasibility Study of the MitraFix\u00ae Transcatheter Mitral Valve System", "source_url": "https://clinicaltrials.gov/study/NCT07501234"}, {"id": "trialreg:NCT07499258", "company": "Axonics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence", "source_url": "https://clinicaltrials.gov/study/NCT07499258"}, {"id": "trialreg:NCT07501819", "company": "SymKardia", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Sympathetic Ablation for Ventricular Arrhythmias", "source_url": "https://clinicaltrials.gov/study/NCT07501819"}, {"id": "trialreg:NCT07500532", "company": "Medentum Innovations", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma", "source_url": "https://clinicaltrials.gov/study/NCT07500532"}, {"id": "hde:H230002", "company": "Serenity Medical, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2026-03-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H230002: River Stent System\u2122", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "fda:K252360", "company": "Anumana, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252360: ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252360", "people": [{"name": "Taylor Gold West", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252360%22"}, {"id": "fda:K260257", "company": "Sanhe Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260257: CO2 Laser System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260257", "people": [{"name": "Xiaoxia Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260257%22"}, {"id": "breakthrough:K252360", "company": "Anumana, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-03-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K252360: ECG-AI PULMONARY HYPERTENSION (PH) 12-LEAD ALGORITHM (1020)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253270", "company": "Mim Software, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253270: Contour Prot\u00e9g\u00e9AI+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253270", "people": [{"name": "Sydney Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253270%22"}, {"id": "fda:K252006", "company": "Icu Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252006: OTTO\u0099 Disinfecting Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252006", "people": [{"name": "Nichelle Cato", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252006%22"}, {"id": "fda:K252893", "company": "Aneuvo", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252893: ExaStim\u00ae Stimulation System (EXA-001); ExaStim\u00ae Stimulation System (EXA-011); ReCure\u00ae Electrode Pad (PAD-003); ReCure\u00ae Electrode Pad (PAD-013)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252893", "people": [{"name": "Amelia Striegel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252893%22"}, {"id": "fda:K254099", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254099: EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254099", "people": [{"name": "Yoojung Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254099%22"}, {"id": "fda:K252148", "company": "Butterfly Network, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252148: Butterfly Gestational Age Tool", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252148", "people": [{"name": "Nathan Sabich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252148%22"}, {"id": "fda:K254206", "company": "Ningbo Zhishan Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254206: Power wheelchair (ZS-EW8026)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254206", "people": [{"name": "Stone Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254206%22"}, {"id": "fda:K253572", "company": "ETHICON, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253572: STRATAFIX\u0099 Spiral PRONOVA\u0099 Unidirectional Knotless Tissue Control Device STRATAFIX\u0099 Spiral PRONOVA\u0099 Bidirectional Knotless Tissue Control Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253572", "people": [{"name": "Jenny Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253572%22"}, {"id": "fda:K260271", "company": "American Medical Endoscopy, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260271: Strauss Surgical cystoscope, hysteroscope and accessories Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260271", "people": [{"name": "Matthew Schwimmer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260271%22"}, {"id": "fda:K253980", "company": "Yurob Rehabilitation Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253980: Electrically Powered Wheelchair (Model YC-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253980", "people": [{"name": "Daoping Pan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253980%22"}, {"id": "fda:K252081", "company": "Lincotek Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252081: SportLinc Syndesmosis Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252081", "people": [{"name": "Troy Walters", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252081%22"}, {"id": "fda:K252064", "company": "Medcad", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252064: MedCAD\u00ae AccuStride\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252064", "people": [{"name": "Brian Buss", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252064%22"}, {"id": "fda:K260746", "company": "Esaote, S.p.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260746: S-scan Open (100001800)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260746", "people": [{"name": "Antonia Perrella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260746%22"}, {"id": "fda:K260697", "company": "Vy Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260697: VyPlate\u0099 Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260697", "people": [{"name": "Hendrickson Jordan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260697%22"}, {"id": "fda:K260255", "company": "Aventix Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260255: AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260255", "people": [{"name": "Jetmir Palushi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260255%22"}, {"id": "fda:K260294", "company": "Surgical Fusion Technologies GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260294: SF Push-in Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260294", "people": [{"name": "Mayer Joerg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260294%22"}, {"id": "fda:K253595", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253595: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253595", "people": [{"name": "Lakshmi Sanjana Gondesi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253595%22"}, {"id": "fda:K252295", "company": "Terumo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252295: Ryurei", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252295", "people": [{"name": "Kirsten Steinmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252295%22"}, {"id": "fda:K254239", "company": "Ss Global", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254239: CyClean Cord", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254239", "people": [{"name": "Jun Hwan Ahn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254239%22"}, {"id": "fda:K260041", "company": "Streck, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260041: MDx-Chex for BCP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260041", "people": [{"name": "Iris Servellon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260041%22"}, {"id": "fda:K253649", "company": "Philips Medical Systems Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253649: Spectral CT Verida Family", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253649", "people": [{"name": "Siwar Assi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253649%22"}, {"id": "fda:K253392", "company": "Synergy Spine Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253392: Synergy Disc Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253392", "people": [{"name": "Josh Butters", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253392%22"}, {"id": "fda:K253625", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253625: Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253625", "people": [{"name": "Orlando Tadeo, Jr.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253625%22"}, {"id": "fda:K252195", "company": "Artiness S.R.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252195: ARTICOR planner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252195", "people": [{"name": "Monica R. Montanez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252195%22"}, {"id": "fda:K253307", "company": "Foshan Dahao Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253307: Electric wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253307", "people": [{"name": "Zehui Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253307%22"}, {"id": "fda:K254161", "company": "GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254161: Automated Aortic Stenosis Software (AutoAS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254161", "people": [{"name": "Tahir Rizvi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254161%22"}, {"id": "fda:K260240", "company": "Medos International SARL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260240: SYMPHONY Navigation Ready Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260240", "people": [{"name": "Sophia Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260240%22"}, {"id": "fda:K251273", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251273: Asurys Fluid Management System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251273", "people": [{"name": "Spencer Duncan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251273%22"}, {"id": "fda:K253822", "company": "Zhuhai Fitlens Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253822: GPA (hexafocon A) Rigid Gas Permeable Contact Lenses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253822", "people": [{"name": "Grace Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253822%22"}, {"id": "trialreg:NCT07497672", "company": "Myoptechs, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Novel Spectacles Intended for Myopia Management in a Short-Term Study", "source_url": "https://clinicaltrials.gov/study/NCT07497672"}, {"id": "trialreg:NCT07495345", "company": "Lightfield Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study of a Novel Automated Slit Lamp Camera (Lightfield Medical Ophthalmic Camera Model Vscan001)", "source_url": "https://clinicaltrials.gov/study/NCT07495345"}, {"id": "trialreg:NCT07497321", "company": "A.M.I. Agency for Medical Innovations GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)", "source_url": "https://clinicaltrials.gov/study/NCT07497321"}, {"id": "trialreg:NCT07496164", "company": "Haleon", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study to Assess the Effectiveness of Use of Three Experimental Denture Adhesives Compared to Using No-Adhesive", "source_url": "https://clinicaltrials.gov/study/NCT07496164"}, {"id": "trialreg:NCT07495787", "company": "iIDEAS Group Holdings Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Magnetic Compression Anastomosis Procedure for Partial Jejunoileal Anastomosis: Assessing the Viability of an Innovative Metabolic Approach", "source_url": "https://clinicaltrials.gov/study/NCT07495787"}, {"id": "breakthrough:K254161", "company": "Ge Medical Systems Ultrasound & Primary Care Diagnostics, LLC.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-03-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K254161: AUTOMATED AORTIC STENOSIS SOFTWARE (AUTOAS)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253775", "company": "Airs Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253775: SwiftMR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253775", "people": [{"name": "Markus Cho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253775%22"}, {"id": "fda:K260601", "company": "Blue Belt Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260601: REAL INTELLIGENCE\u0099 CORI\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260601", "people": [{"name": "Samantha Zanetti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260601%22"}, {"id": "fda:K253796", "company": "Lunit, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253796: Lunit INSIGHT DBT (V1.2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253796", "people": [{"name": "Hyeseung Yoo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253796%22"}, {"id": "fda:K260273", "company": "Shenzhen Urion Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260273: Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260273", "people": [{"name": "Vivian Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260273%22"}, {"id": "fda:K252926", "company": "Restore Robotics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252926: Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252926", "people": [{"name": "Kevin May", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252926%22"}, {"id": "fda:K253627", "company": "Surgify Medical OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253627: Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253627", "people": [{"name": "Jukka Kreander", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253627%22"}, {"id": "fda:K260626", "company": "Vizaramed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260626: Multiflex Steerable Sheath 17.5F", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260626", "people": [{"name": "Jack Douglas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260626%22"}, {"id": "fda:K253379", "company": "Medtronic Navigation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253379: Stealth AXiS Cranial clinical application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253379", "people": [{"name": "Victoria Baldock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253379%22"}, {"id": "fda:K260281", "company": "Biomerieux", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260281: VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260281", "people": [{"name": "Neal Bertels", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260281%22"}, {"id": "fda:K253549", "company": "Devilbiss Healthcare, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253549: DeVilbiss 5 Liter Oxygen Concentrator (555)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253549", "people": [{"name": "Susan Scott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253549%22"}, {"id": "fda:K252023", "company": "Letus Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252023: MiraChlor Antimicrobial Wound Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252023", "people": [{"name": "Gia-Thanh Tu Le", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252023%22"}, {"id": "fda:K253322", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253322: Hudson RCI\u00ae Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78\u0094 Infant Circuit, HUD99060KIT / Dri-Tech with 78\u0094 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60\u0094 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44\u0094 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253322", "people": [{"name": "Phyllis Kondor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253322%22"}, {"id": "fda:K260291", "company": "Nvision Biomedical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260291: Vortex5 Tailor's Bunion Correction System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260291", "people": [{"name": "Zink Marisa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260291%22"}, {"id": "fda:K253406", "company": "Mevion Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253406: S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253406", "people": [{"name": "Jason Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253406%22"}, {"id": "fda:K253680", "company": "ArthroCare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253680: LYNX COBLATION Laryngeal Wand (72290254)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253680", "people": [{"name": "Srividya Pothana", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253680%22"}, {"id": "fda:K260274", "company": "Novastep SAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260274: Airlock\u00ae Ankle Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260274", "people": [{"name": "Manon Dupleichs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260274%22"}, {"id": "fda:K253615", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253615: Invictus Bands System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253615", "people": [{"name": "Griffin Riggs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253615%22"}, {"id": "fda:K252432", "company": "Spinepoint, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252432: Flex-Z\u0099 Cervical Cage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252432", "people": [{"name": "Lali Sekhon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252432%22"}, {"id": "fda:K252037", "company": "Curexo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252037: CUVIS-joint (CJ150)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252037", "people": [{"name": "Jay Koh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252037%22"}, {"id": "fda:K252052", "company": "Bausch and Lomb, Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252052: Stellaris Elite\u0099 vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252052", "people": [{"name": "Emily Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252052%22"}, {"id": "fda:K252908", "company": "Sandstone Medical (Suzhou), Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252908: Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252908", "people": [{"name": "Susan Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252908%22"}, {"id": "fda:K254278", "company": "Spectrum Vascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254278: Arterial Pressure Monitoring Set/Tray", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254278", "people": [{"name": "Sharon Klugewicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254278%22"}, {"id": "fda:K253184", "company": "Zhuhai Wesee Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253184: Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253184", "people": [{"name": "Ruiliang Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253184%22"}, {"id": "trialreg:NCT07492420", "company": "Amenity Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy", "source_url": "https://clinicaltrials.gov/study/NCT07492420"}, {"id": "trialreg:NCT07492381", "company": "ALPFA Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Single-Arm, Pilot Study of the ALPFA BPH PFA System in Men With Low, Intermediate and High-Risk Prostate Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07492381"}, {"id": "trialreg:NCT07491952", "company": "Imperative Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Continuous Dual Aspiration Technique With Zoom System for Stroke", "source_url": "https://clinicaltrials.gov/study/NCT07491952"}, {"id": "fda:K252421", "company": "JLK, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252421: JLK-NCCT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252421", "people": [{"name": "Dongmin Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252421%22"}, {"id": "fda:K252099", "company": "Shimadzu Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252099: Trinias", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252099", "people": [{"name": "Koichi Kataoka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252099%22"}, {"id": "fda:K253047", "company": "Nipro Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253047: PRESSONE\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253047", "people": [{"name": "Jessica Oswald-McLeod", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253047%22"}, {"id": "fda:K254253", "company": "Aap Implantate AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254253: LOQTEQ\u00ae VA Proximal Humerus Plate 3.5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254253", "people": [{"name": "Andreas Reuter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254253%22"}, {"id": "fda:K260087", "company": "GE Medical Systems SCS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260087: Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260087", "people": [{"name": "Fay\u00e7al Kherra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260087%22"}, {"id": "fda:K260787", "company": "Lumos Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260787: FebriDx Bacterial/Non-bacterial Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260787", "people": [{"name": "Susan Hibbeln", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260787%22"}, {"id": "fda:K254012", "company": "Nanjing CareMoving Rehabilitation Equipment Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254012: Electric Wheelchair (E201)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254012", "people": [{"name": "James Gu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254012%22"}, {"id": "fda:K252169", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252169: Access BNP II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252169", "people": [{"name": "Neha Desai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252169%22"}, {"id": "fda:K253198", "company": "Angiodynamics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253198: NanoKnife Generator (H78720300351US0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253198", "people": [{"name": "Brandon Brackett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253198%22"}, {"id": "fda:K260673", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260673: LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260673", "people": [{"name": "Lee Bush", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260673%22"}, {"id": "trialreg:NCT07491107", "company": "Scitech Produtos Medicos SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07491107"}, {"id": "trialreg:NCT07491029", "company": "Neurophet", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AI-based Customized tDCS for Finger Motor Recovery After Subacute Stroke", "source_url": "https://clinicaltrials.gov/study/NCT07491029"}, {"id": "trialreg:NCT07489326", "company": "SetPoint Medical Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The SetPoint System Safety & Performance Post-Approval Study", "source_url": "https://clinicaltrials.gov/study/NCT07489326"}, {"id": "trialreg:NCT07491731", "company": "Radiometer Medical ApS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Zeus (510K) - 24024 - Stability in Venous and Arterial Blood", "source_url": "https://clinicaltrials.gov/study/NCT07491731"}, {"id": "fda:K254275", "company": "Threadstone, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254275: HyperSuture All Green Extension Line", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254275", "people": [{"name": "Steven Boudouris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254275%22"}, {"id": "fda:K260202", "company": "Guangdong Newdermo Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260202: LED Light Therapy Masks (LumiLips FAC07NA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260202", "people": [{"name": "Jun Yi Xing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260202%22"}, {"id": "fda:K254166", "company": "Streck", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254166: MDx-Chex for BCN", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254166", "people": [{"name": "Iris Servellon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254166%22"}, {"id": "fda:K254288", "company": "Skeletal Dynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254288: Clavicle Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254288", "people": [{"name": "Alexandra Rodriguez Rojas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254288%22"}, {"id": "fda:K252031", "company": "Adin Dental Implant Systems , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252031: Adin Long Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252031", "people": [{"name": "Beliavsky Dimitry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252031%22"}, {"id": "fda:K260112", "company": "Stabiliz Orthopaedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260112: QuikFix External Fixator: Knee-Spanning Pack", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260112", "people": [{"name": "Douglas Cerynik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260112%22"}, {"id": "fda:K253686", "company": "Ge Healthcare Japan Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253686: True Definition DL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253686", "people": [{"name": "Yonghui Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253686%22"}, {"id": "fda:K252992", "company": "Philips Healthcare (Suzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252992: CT Rembra RT; CT Areta RT; CT Rembra", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252992", "people": [{"name": "Tiffany Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252992%22"}, {"id": "trialreg:NCT07487701", "company": "Theranica", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study", "source_url": "https://clinicaltrials.gov/study/NCT07487701"}, {"id": "trialreg:NCT07487194", "company": "Paragonix Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)", "source_url": "https://clinicaltrials.gov/study/NCT07487194"}, {"id": "trialreg:NCT07487064", "company": "Galvanize Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Galvanize Aliya\u00ae EX Pulsed Electric Field (PEF) Treat and Resect Study", "source_url": "https://clinicaltrials.gov/study/NCT07487064"}, {"id": "fda:K252005", "company": "Liviwell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252005: Livi Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252005", "people": [{"name": "Michael Ingber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252005%22"}, {"id": "fda:K252606", "company": "Voco GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252606: Bifix Veneer LC, Bifix Veneer Try-In", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252606", "people": [{"name": "Katrin Froehlich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252606%22"}, {"id": "fda:K260551", "company": "Instrumentation Laboratory (IL) Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260551: HemosIL Factor V Leiden (APC Resistance V)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260551", "people": [{"name": "Kirivann Chhoeun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260551%22"}, {"id": "fda:K254170", "company": "Degania Silicone , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254170: Percutaneous Endoscopic Gastrostomy (PEG) Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254170", "people": [{"name": "Tal Gafni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254170%22"}, {"id": "fda:K253520", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253520: Photonova Spectra, Photonova Spectra Select", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253520", "people": [{"name": "Laura Turner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253520%22"}, {"id": "fda:K253098", "company": "Nexstim Oyj", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253098: Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253098", "people": [{"name": "Jarmo Laine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253098%22"}, {"id": "fda:K253864", "company": "Dental Imaging Technologies Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253864: NOMAD Pro 3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253864", "people": [{"name": "Peter Schmidt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253864%22"}, {"id": "fda:K253574", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253574: SOMATOM X.cite; SOMATOM X.ceed", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253574", "people": [{"name": "Kenny M Bello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253574%22"}, {"id": "fda:K260519", "company": "Philips Healthcare (Suzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260519: Smart Fit TorsoCardiac 1.5T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260519", "people": [{"name": "Sherry Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260519%22"}, {"id": "fda:K252358", "company": "Nexstim Oyj", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252358: Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252358", "people": [{"name": "Jarmo Laine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252358%22"}, {"id": "fda:K252050", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252050: Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252050", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252050%22"}, {"id": "fda:K253849", "company": "ZheJiang J&J Mobility Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253849: Electric wheelchair (JJW-7002, JJW-7003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253849", "people": [{"name": "Linda Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253849%22"}, {"id": "fda:K251980", "company": "Icu Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251980: ClaveQS\u0099 Bag", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251980", "people": [{"name": "Jeffrey Wan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251980%22"}, {"id": "fda:K251937", "company": "Nordicneurolab AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251937: nordicAudio (1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251937", "people": [{"name": "Chandana Gurung Bhandari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251937%22"}, {"id": "fda:K260561", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260561: Arthrex FiberTak Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260561", "people": [{"name": "Ethan Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260561%22"}, {"id": "fda:K252016", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252016: Arthrex Humeral Nails", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252016", "people": [{"name": "Tiffany Mentzel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252016%22"}, {"id": "fda:K260544", "company": "FMD Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260544: FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260544", "people": [{"name": "Mayumi Ito", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260544%22"}, {"id": "fda:K254208", "company": "Expanse Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254208: FLOWRUNNER Aspiration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254208", "people": [{"name": "Shiva Ardakani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254208%22"}, {"id": "fda:K251950", "company": "Hangzhou Tappa Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251950: Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251950", "people": [{"name": "Kaixiu Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251950%22"}, {"id": "fda:K260437", "company": "Dongguan TT Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260437: Valvuloplasty Balloon Catheter (ValvuloPro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260437", "people": [{"name": "Bi Yuying", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260437%22"}, {"id": "fda:K253604", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253604: TiLink-L Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253604", "people": [{"name": "Richard Sharp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253604%22"}, {"id": "fda:K260585", "company": "Nox Medical Ehf", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260585: Noxturnal Web", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260585", "people": [{"name": "El\u00edsabet Finnbogad\u00f3ttir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260585%22"}, {"id": "trialreg:NCT07484191", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Contralateral Claims Study of Clareon Vivity Pro", "source_url": "https://clinicaltrials.gov/study/NCT07484191"}, {"id": "trialreg:NCT07485829", "company": "Zimmer Biomet", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Zimmer Biomet-RibFix Titan", "source_url": "https://clinicaltrials.gov/study/NCT07485829"}, {"id": "trialreg:NCT07485153", "company": "Eli Lilly and Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Compare Two Different Sleep Tests in Participants With No Symptoms or Early Symptoms of Alzheimer's Disease", "source_url": "https://clinicaltrials.gov/study/NCT07485153"}, {"id": "trialreg:NCT07485244", "company": "Ceribell Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EEG Abnormalities in Adult ICU Patients With High Risk of Delirium", "source_url": "https://clinicaltrials.gov/study/NCT07485244"}, {"id": "trialreg:NCT07485205", "company": "Bright Uro", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults", "source_url": "https://clinicaltrials.gov/study/NCT07485205"}, {"id": "trialreg:NCT07485582", "company": "ResMed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Exploration of Current and New Technologies for Accuracy of Diagnosing OSA", "source_url": "https://clinicaltrials.gov/study/NCT07485582"}, {"id": "fda:K260509", "company": "Radformation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260509: AutoContour (RADAC V5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260509", "people": [{"name": "Jennifer Wampler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260509%22"}, {"id": "fda:K260448", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260448: CastleLoc Pectus Bar System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260448", "people": [{"name": "Kihyang Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260448%22"}, {"id": "fda:K260533", "company": "Nipro Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260533: ELISIO\u0099-H", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260533", "people": [{"name": "Jessica Oswald-Mcleod", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260533%22"}, {"id": "fda:K253965", "company": "Wuhan PHOMED Technology Company , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253965: CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253965", "people": [{"name": "Huang Bill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253965%22"}, {"id": "fda:K252101", "company": "Yamaha Motor Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252101: JWG-1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252101", "people": [{"name": "Ai Takahashi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252101%22"}, {"id": "fda:K260532", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260532: Derma-Gide", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260532", "people": [{"name": "Erik Wirth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260532%22"}, {"id": "fda:K260537", "company": "Arbor Endovascular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260537: Willow 24 Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260537", "people": [{"name": "Kathy Tansey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260537%22"}, {"id": "fda:K253432", "company": "Vy Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253432: DiversiVy\u0099 Facet Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253432", "people": [{"name": "Jordan Hendrickson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253432%22"}, {"id": "fda:K254269", "company": "St. shine Optical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254269: Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254269", "people": [{"name": "Lee Mina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254269%22"}, {"id": "fda:K253139", "company": "Mirco-Tech (Nanjing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253139: Disposable Distal Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253139", "people": [{"name": "Sally He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253139%22"}, {"id": "fda:K253746", "company": "Lake Region Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253746: Enroute 0.014'' Transcarotid Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253746", "people": [{"name": "Amy Carter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253746%22"}, {"id": "fda:K254112", "company": "DiaDent Group International", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254112: Dia-X Sil Bite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254112", "people": [{"name": "Jin An", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254112%22"}, {"id": "fda:K260188", "company": "LimFlow, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260188: LimFlow Vector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260188", "people": [{"name": "Haley Ritchie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260188%22"}, {"id": "fda:K251967", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251967: HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251967", "people": [{"name": "Anureet Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251967%22"}, {"id": "fda:K253622", "company": "Ningbo Medsun Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253622: Safety Pen Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253622", "people": [{"name": "Ping Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253622%22"}, {"id": "fda:K254110", "company": "MedShape, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254110: DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254110", "people": [{"name": "Lauren Livsey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254110%22"}, {"id": "fda:K253834", "company": "Carl Zeiss Vision GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253834: VISUREF 600", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253834", "people": [{"name": "Oliver Jucha-Schade", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253834%22"}, {"id": "fda:K260830", "company": "Sangi Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260830: APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260830", "people": [{"name": "Tetsuya Yoshioka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260830%22"}, {"id": "fda:K252304", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252304: syngo.via RT Image Suite VC10", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252304", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252304%22"}, {"id": "fda:K253444", "company": "MiRus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253444: EUROPA\u0099 Posterior Cervical Fusion Navigated Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253444", "people": [{"name": "Anuradha Nagulapati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253444%22"}, {"id": "fda:K252961", "company": "Fusion Orthopedics USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252961: Fusion FibFix Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252961", "people": [{"name": "Catalina Pardo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252961%22"}, {"id": "fda:K253012", "company": "Vision Rt, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253012: AlignRT Plus (8.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253012", "people": [{"name": "Chelsey Moore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253012%22"}, {"id": "pma:P250013", "company": "LivaNova USA, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-03-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250013: aura6000\u0099 system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250013", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250013%22"}, {"id": "trialreg:NCT07480941", "company": "Beijing Biotech", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma", "source_url": "https://clinicaltrials.gov/study/NCT07480941"}, {"id": "trialreg:NCT07479992", "company": "Idoven 1903 S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study", "source_url": "https://clinicaltrials.gov/study/NCT07479992"}, {"id": "trialreg:NCT07478926", "company": "Rhaeos, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Flow Detection in Open and Closed Shunt Valve Periods", "source_url": "https://clinicaltrials.gov/study/NCT07478926"}, {"id": "trialreg:NCT07480603", "company": "Rheon Medical SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pilot Study on a New Self Adjustable Glaucoma Drainage Device", "source_url": "https://clinicaltrials.gov/study/NCT07480603"}, {"id": "trialreg:NCT07480421", "company": "Silimed Industria de Implantes Ltda", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of Neorepair\u2122 Acellular Matrix in Immediate Implant-Based Breast Reconstruction", "source_url": "https://clinicaltrials.gov/study/NCT07480421"}, {"id": "fda:K254167", "company": "Streck, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254167: MDx-Chex for BCY", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254167", "people": [{"name": "Megan Hiveley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254167%22"}, {"id": "fda:K260546", "company": "K2m, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260546: Q Pedicle Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260546", "people": [{"name": "Katie Walko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260546%22"}, {"id": "fda:K253614", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253614: EchoNavigator R5.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253614", "people": [{"name": "Yesheshvi Anush Puvvada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253614%22"}, {"id": "fda:K260632", "company": "Elesta S.P.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260632: LASER THERMAL THERAPY KIT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260632", "people": [{"name": "Alessia Blundo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260632%22"}, {"id": "fda:K253587", "company": "Cala Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253587: Cala kIQ Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253587", "people": [{"name": "Khushboo Surendran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253587%22"}, {"id": "fda:K252078", "company": "Compal Electronics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252078: BreathePal Bilevel (GFM50-MD2201)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252078", "people": [{"name": "Casper Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252078%22"}, {"id": "fda:K252971", "company": "C.R. Bard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252971: Elyra\u0099 Thulium Fiber Laser System and Elyra\u0099 Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252971", "people": [{"name": "Matthew Rather", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252971%22"}, {"id": "fda:K254053", "company": "A Plus Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254053: APS Spear Locking Plate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254053", "people": [{"name": "Helen Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254053%22"}, {"id": "fda:K252813", "company": "Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252813: Electrical Scooter (SM4226)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252813", "people": [{"name": "Ke-Min Jen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252813%22"}, {"id": "fda:K253863", "company": "Serim Research", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253863: GUARDIAN\u0099 Quick Dip Residual Chlorine (5212)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253863", "people": [{"name": "Amy Sheets", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253863%22"}, {"id": "fda:K253750", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253750: BTL-785NEH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253750", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253750%22"}, {"id": "fda:DEN250014", "company": "Tyto Care , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250014: Tyto Insights for Eardrum Bulging Detection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250014", "people": [{"name": "Stella Raizelman Perry", "role": "510(k) submission contact"}]}, {"id": "fda:K251926", "company": "Encore Guards", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251926: enCore Impression Material", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251926", "people": [{"name": "Benjamin Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251926%22"}, {"id": "fda:K253886", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253886: Grappler Suture Anchor PCFD Tether System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253886", "people": [{"name": "Edward Wells-Spicer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253886%22"}, {"id": "fda:K260390", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260390: Super Upper Limbs Versalock Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260390", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260390%22"}, {"id": "pma:P250024", "company": "JenaValve Technology, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-03-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250024: Trilogy Transcatheter Heart Valve System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250024", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250024%22"}, {"id": "trialreg:NCT07476313", "company": "Beacon Biosignals", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.", "source_url": "https://clinicaltrials.gov/study/NCT07476313"}, {"id": "trialreg:NCT07477860", "company": "Joint & Vascular Institute", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Achilles Tendinopathy Embolization", "source_url": "https://clinicaltrials.gov/study/NCT07477860"}, {"id": "trialreg:NCT07477054", "company": "Lungpacer Medical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace\u00ae System", "source_url": "https://clinicaltrials.gov/study/NCT07477054"}, {"id": "denovo:DEN250014", "company": "Tyto Care , Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-03-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250014 granted: Tyto Insights for Eardrum Bulging Detect", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250014"}, {"id": "breakthrough:P250024", "company": "Jenavalve Technology, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-03-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P250024: TRILOGY TRANSCATHETER HEART VALVE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253395", "company": "Medtronic Navigation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253395: Stealth AXiS\u0099 ENT clinical application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253395", "people": [{"name": "Victoria Baldock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253395%22"}, {"id": "fda:K254045", "company": "CarboFix Orthopedics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254045: CarboClear\u00ae Posterior Cervical Screw System; CarboClear\u00ae Hybrid Posterior Cervical Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254045", "people": [{"name": "Yael Rubin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254045%22"}, {"id": "fda:K253838", "company": "Lifemotion Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253838: Lifemotion Disposable Membrane Oxygenator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253838", "people": [{"name": "Giuseppe Tomasini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253838%22"}, {"id": "fda:K253447", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253447: Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253447", "people": [{"name": "Howard Schrayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253447%22"}, {"id": "fda:K253334", "company": "Izenimplant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253334: ZENEX Implant System_Short (R-System)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253334", "people": [{"name": "Kim Nayoung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253334%22"}, {"id": "fda:K253590", "company": "Perfuze, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253590: Millipede System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253590", "people": [{"name": "Anne-Marie Gannon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253590%22"}, {"id": "fda:K253916", "company": "Medartis AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253916: APTUS Shoulder Proximal Humerus System, PentaLock 3.5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253916", "people": [{"name": "Salvatore Risoli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253916%22"}, {"id": "fda:K252282", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252282: SurgiCount+ System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252282", "people": [{"name": "Michael Mazelin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252282%22"}, {"id": "fda:K252122", "company": "Shanghai Achieva Medical Suzhou Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252122: DCwire Micro-guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252122", "people": [{"name": "Christine Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252122%22"}, {"id": "fda:K254079", "company": "Shenzhen Desida Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254079: LED Light Therapy Mask (Models: T2, RLD10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254079", "people": [{"name": "Yong Gong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254079%22"}, {"id": "fda:K254176", "company": "BAAT Medical Products B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254176: SINEFIX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254176", "people": [{"name": "Jasper Springer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254176%22"}, {"id": "fda:K253705", "company": "Healgen Scientific,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253705: Healgen\u00ae Accurate Oral Fluid Drug Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253705", "people": [{"name": "Fang Jianqiu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253705%22"}, {"id": "fda:K260511", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260511: Ulike Reglow Light Therapy Device (UM10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260511", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260511%22"}, {"id": "fda:K252433", "company": "Sonio", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252433: Sonio Detect (v3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252433", "people": [{"name": "Florian Akpakpa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252433%22"}, {"id": "fda:K253944", "company": "Voronoi Health Analytics Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253944: Data Analysis Facilitation Suite (DAFS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253944", "people": [{"name": "Mirza Faisal Beg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253944%22"}, {"id": "trialreg:NCT07473817", "company": "HepQuant, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of Different Methods for HepQuant DuO\u00ae Blood Sample Collection", "source_url": "https://clinicaltrials.gov/study/NCT07473817"}, {"id": "trialreg:NCT07472439", "company": "Angiodynamics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone in Europe", "source_url": "https://clinicaltrials.gov/study/NCT07472439"}, {"id": "trialreg:NCT07473947", "company": "Inion Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients", "source_url": "https://clinicaltrials.gov/study/NCT07473947"}, {"id": "trialreg:NCT07474935", "company": "Phenox GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Targeting Real World Usage In Stroke Treatment", "source_url": "https://clinicaltrials.gov/study/NCT07474935"}, {"id": "trialreg:NCT07473622", "company": "Qufora A/S", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence", "source_url": "https://clinicaltrials.gov/study/NCT07473622"}, {"id": "trialreg:NCT07475455", "company": "Croma-Pharma GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Filler Post Market Survey (FIPS)", "source_url": "https://clinicaltrials.gov/study/NCT07475455"}, {"id": "breakthrough:K254045", "company": "Carbofix Orthopedics, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-03-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K254045: CARBOCLEAR POSTERIOR CERVICAL SCREW SYSTEM; CARBOCLEAR HYBRID POSTERIOR CERVICAL SCREW SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K253590", "company": "Perfuze, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-03-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K253590: MILIPEDE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253581", "company": "Technomed Europe", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253581: Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253581", "people": [{"name": "Alan Yik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253581%22"}, {"id": "fda:K253391", "company": "Medtronic Navigation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253391: Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253391", "people": [{"name": "Sharon McDermott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253391%22"}, {"id": "fda:K251999", "company": "Solventum Germany GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251999: Promogran Prisma\u0099 Collagen Matrix with ORC and Silver", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251999", "people": [{"name": "Bernadette Rauch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251999%22"}, {"id": "fda:K252923", "company": "Iasis Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252923: IASIS i2 Relaxation Neurofeedback System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252923", "people": [{"name": "Larry Wedekind", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252923%22"}, {"id": "fda:K251848", "company": "Oculus Optikger\u00e4te GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251848: Pentacam\u00ae Cornea OCT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251848", "people": [{"name": "Agata Kufel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251848%22"}, {"id": "fda:K253261", "company": "Weero Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253261: Apollo Quattro (APQ-10M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253261", "people": [{"name": "Han Moon Young", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253261%22"}, {"id": "fda:K253799", "company": "Pressure Products Medical Device Manufacturing, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253799: SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253799", "people": [{"name": "Andrew Armour", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253799%22"}, {"id": "fda:K253987", "company": "GIE Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253987: BARE Wireguided Balloon Dilation Catheter (1235)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253987", "people": [{"name": "Ian Schorn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253987%22"}, {"id": "fda:K260455", "company": "Zeto, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260455: New Wave System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260455", "people": [{"name": "Florian Strelzyk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260455%22"}, {"id": "fda:K252249", "company": "Mars Bioimaging , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252249: Extremity CT Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252249", "people": [{"name": "Homi Dalal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252249%22"}, {"id": "fda:K260078", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260078: Aquilion ServeSP (TSX-307B) V2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260078", "people": [{"name": "Orlando Tadeo Jr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260078%22"}, {"id": "fda:K254059", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254059: Access anti-HBc IgM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254059", "people": [{"name": "Veronica Colinayo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254059%22"}, {"id": "fda:K251916", "company": "Genbody.Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251916: GenBody COVID-19 Ag Home Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251916", "people": [{"name": "Han-bum Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251916%22"}, {"id": "fda:K252648", "company": "Taewoong Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252648: Niti-S SPAXUS Stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252648", "people": [{"name": "Yongjin \"Jeff\" Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252648%22"}, {"id": "fda:K260479", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260479: TheraSphere 360\u0099 Y-90 Management Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260479", "people": [{"name": "Amy McKinney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260479%22"}, {"id": "fda:K252385", "company": "Pegavision Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252385: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252385", "people": [{"name": "Estela Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252385%22"}, {"id": "fda:K260147", "company": "Shenzhen Kingboom Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260147: Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260147", "people": [{"name": "Qiang Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260147%22"}, {"id": "fda:K253111", "company": "Good Methods Global, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253111: Aeka Imaging", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253111", "people": [{"name": "Arjun Satheesh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253111%22"}, {"id": "fda:K253732", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253732: Permatage Flowable, Settable Bone Paste", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253732", "people": [{"name": "Howard L. Schrayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253732%22"}, {"id": "fda:K260499", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260499: Amplatzer\u0099 Trevisio\u0099 Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260499", "people": [{"name": "Meghann Kayoum", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260499%22"}, {"id": "fda:K254277", "company": "Aspect Imaging, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254277: Embrace Neonatal MRI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254277", "people": [{"name": "Yaron Eshel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254277%22"}, {"id": "fda:K253205", "company": "Cortex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253205: OptiMap Catheter - 50mm (OPTI-CATH2-50)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253205", "people": [{"name": "Sarah Ware", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253205%22"}, {"id": "fda:K252040", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252040: BD Vacutainer\u00ae Plasma Separator Tubes (PST\u0099), BD Vacutainer\u00ae Sodium Heparin Blood Collection Tubes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252040", "people": [{"name": "Angela Mariani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252040%22"}, {"id": "fda:K252261", "company": "Beijing Infervision Healthcare Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252261: InferCare RECIST", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252261", "people": [{"name": "Matt Deng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252261%22"}, {"id": "trialreg:NCT07470411", "company": "Levita Magnetics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study", "source_url": "https://clinicaltrials.gov/study/NCT07470411"}, {"id": "trialreg:NCT07470827", "company": "WAYCEN Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of 'WAYMED Endo CL CS' for Automated Detection and Diagnosis of Colorectal Adenoma and Non-Adenoma Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07470827"}, {"id": "trialreg:NCT07471399", "company": "CLASSYS Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy Assessment for the Temporary Facial Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device", "source_url": "https://clinicaltrials.gov/study/NCT07471399"}, {"id": "trialreg:NCT07471308", "company": "CathVision ApS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation", "source_url": "https://clinicaltrials.gov/study/NCT07471308"}, {"id": "trialreg:NCT07471295", "company": "Carl Zeiss Meditec AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Toric Performance And Constant Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT07471295"}, {"id": "trialreg:NCT07470788", "company": "Vesalius Cardiovascular Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation", "source_url": "https://clinicaltrials.gov/study/NCT07470788"}, {"id": "trialreg:NCT07471750", "company": "Fujifilm Medical Systems USA, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Acquisition and Clinical Image Evaluation of Fujifilm's High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images.", "source_url": "https://clinicaltrials.gov/study/NCT07471750"}, {"id": "fda:K252401", "company": "Implantcast GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252401: implaFit\u00ae short stems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252401", "people": [{"name": "Juliane H\u00f6ppner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252401%22"}, {"id": "fda:K251888", "company": "Hsiner Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251888: VPAP Pediatric Face Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251888", "people": [{"name": "Sandy Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251888%22"}, {"id": "fda:K252583", "company": "A Cute Baby, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252583: Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252583", "people": [{"name": "Matthew Kho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252583%22"}, {"id": "fda:K253566", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253566: Affixus Retrograde Femoral Nailing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253566", "people": [{"name": "Akash Savalia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253566%22"}, {"id": "fda:K253743", "company": "Medtronic Minimed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253743: MiniMed Flex pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253743", "people": [{"name": "Omar Becerra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253743%22"}, {"id": "fda:K253734", "company": "Taurus Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253734: Taurus Clip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253734", "people": [{"name": "Mariel Bolhouse", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253734%22"}, {"id": "fda:K253636", "company": "Termosalud S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253636: Zionic Pro Max (EMS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253636", "people": [{"name": "Cristina Cifuentes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253636%22"}, {"id": "fda:K260502", "company": "HR Healthcare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260502: Liv Pre-lubricated Intermittent Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260502", "people": [{"name": "Colby Wiesman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260502%22"}, {"id": "fda:K251964", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251964: Mimics Thoracic Planner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251964", "people": [{"name": "Victoria Becheva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251964%22"}, {"id": "fda:K253062", "company": "Rapid Medical Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253062: Tigertriever 25 Revascularization Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253062", "people": [{"name": "Ina Gutman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253062%22"}, {"id": "fda:K252089", "company": "Tyto Care , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252089: Tyto Stethoscope (G3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252089", "people": [{"name": "Stella Raizelman Perry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252089%22"}, {"id": "fda:K253936", "company": "Nanjing Mijo Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253936: Power Mobility Scooter (MJMA01, MJMA02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253936", "people": [{"name": "Leo Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253936%22"}, {"id": "fda:K252546", "company": "Allevion Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252546: VantageTM Lumbar Decompression Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252546", "people": [{"name": "Stephen Inglese", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252546%22"}, {"id": "fda:K252110", "company": "Guangzhou Ajax Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252110: Dental X-RAY Unit (AJX200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252110", "people": [{"name": "Sophia Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252110%22"}, {"id": "fda:K252824", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252824: Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252824", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252824%22"}, {"id": "fda:K251750", "company": "Trax Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251750: Trax EX Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251750", "people": [{"name": "Shalain Siddiqui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251750%22"}, {"id": "fda:K250655", "company": "Digestaid - Artificial Intelligence Development SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250655: Deep Capsule\u00ae (Deep Capsule US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250655", "people": [{"name": "Miguel Mascarenhas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250655%22"}, {"id": "fda:K252541", "company": "Spectrum Medical S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252541: Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252541", "people": [{"name": "Raffaella Tommasini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252541%22"}, {"id": "fda:K240934", "company": "Spectrum Medical S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K240934: Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240934", "people": [{"name": "Raffaella Tommasini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240934%22"}, {"id": "fda:K253525", "company": "Prodeon Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253525: Urocross Expander System (Model Numbers ES2018 and ES3025)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253525", "people": [{"name": "Elaine Aplaon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253525%22"}, {"id": "fda:K254040", "company": "Free Flow Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254040: LungFlow Basket Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254040", "people": [{"name": "Mark Mathis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254040%22"}, {"id": "fda:K260453", "company": "Bionit Labs Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260453: Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260453", "people": [{"name": "Aventaggiato Matteo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260453%22"}, {"id": "fda:K251584", "company": "AIRICU, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251584: Medical Mesh Nebulizer (AirICU Max+)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251584", "people": [{"name": "Jay Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251584%22"}, {"id": "fda:K250794", "company": "Invera Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250794: InVera Infusion Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250794", "people": [{"name": "Nigel Phelan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250794%22"}, {"id": "fda:K253429", "company": "Genadyne Biotechnologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253429: Genadyne ASTRA NPWT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253429", "people": [{"name": "Chien Ming Goh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253429%22"}, {"id": "fda:K254233", "company": "Stryker Leibinger GmbH & Co KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254233: MEDPOR Customized Implant Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254233", "people": [{"name": "Stephani Herbert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254233%22"}, {"id": "trialreg:NCT07466264", "company": "Robert Bosch GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Contactless Human-Machine-Interface Based on Magnetometers for Consumer Applications", "source_url": "https://clinicaltrials.gov/study/NCT07466264"}, {"id": "trialreg:NCT07468617", "company": "CSA Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Repeat Treatment With Metered Cryospray in Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis", "source_url": "https://clinicaltrials.gov/study/NCT07468617"}, {"id": "trialreg:NCT07467239", "company": "Samyang Biopharmaceuticals Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds", "source_url": "https://clinicaltrials.gov/study/NCT07467239"}, {"id": "trialreg:NCT07466589", "company": "Vivonics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)", "source_url": "https://clinicaltrials.gov/study/NCT07466589"}, {"id": "trialreg:NCT07467811", "company": "Tentech Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Single-Blind, Investigational Device Exemption Paired-Design, Non-Inferiority Trial With Confirmation for the Assessment of the Efficacy and Safety of a Universal Electrosurgical Device for Temporary Improvement of Mild and Moderate Wrinkles Around Both Eye Corners and Both Cheek Folds", "source_url": "https://clinicaltrials.gov/study/NCT07467811"}, {"id": "trialreg:NCT07468045", "company": "Daewoong Group Indonesia", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Functional Outcomes After Hyaluronic Acid Injections Following Arthroscopy", "source_url": "https://clinicaltrials.gov/study/NCT07468045"}, {"id": "trialreg:NCT07465796", "company": "Coherence Neuro Australia Pty Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma", "source_url": "https://clinicaltrials.gov/study/NCT07465796"}, {"id": "trialreg:NCT07468370", "company": "Brainlab AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real Time Craniotomy Planning Using Mixed Reality", "source_url": "https://clinicaltrials.gov/study/NCT07468370"}, {"id": "trialreg:NCT07466745", "company": "Edwards Lifesciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Autus Valve Continued Access Study (CAS)", "source_url": "https://clinicaltrials.gov/study/NCT07466745"}, {"id": "trialreg:NCT07468409", "company": "ForSight Robotics Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: JASPER\u2122 Robotic Surgical System (Formerly Known as the ORYOM\u2122 Robotic Surgical System) in Cataract Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07468409"}, {"id": "trialreg:NCT07467837", "company": "Stratpharma AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prevention of Stretch Marks in Expectant Mothers", "source_url": "https://clinicaltrials.gov/study/NCT07467837"}, {"id": "trialreg:NCT07468266", "company": "Fisher and Paykel Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Nasal Airflow in Post-operative Patients", "source_url": "https://clinicaltrials.gov/study/NCT07468266"}, {"id": "fda:K254047", "company": "Shenzhen Chuangtong Yigou Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254047: Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254047", "people": [{"name": "Kingway Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254047%22"}, {"id": "fda:K253906", "company": "Newclip Technics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253906: Xpert Hand", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253906", "people": [{"name": "Ga\u00eblle Gourbi\u00e8re", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253906%22"}, {"id": "fda:K253693", "company": "Riverpoint Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253693: Strut Suture; No-Tie Button", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253693", "people": [{"name": "Palmira Obeso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253693%22"}, {"id": "fda:K253185", "company": "Carestream Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253185: Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253185", "people": [{"name": "Gina Maiolo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253185%22"}, {"id": "fda:K260783", "company": "Kulzer, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260783: Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260783", "people": [{"name": "Aiden Lane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260783%22"}, {"id": "fda:K253624", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253624: INHANCE\u0099 Reverse Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253624", "people": [{"name": "Yayoi Fujimaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253624%22"}, {"id": "fda:K250937", "company": "LivaNova USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250937: Venous Return Cannulae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250937", "people": [{"name": "Luigi Vecchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250937%22"}, {"id": "fda:K254197", "company": "CAO Group, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254197: Picasso Pro Diode Laser (002-00460)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254197", "people": [{"name": "Robert Larsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254197%22"}, {"id": "fda:K253986", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253986: da Vinci Force Feedback Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253986", "people": [{"name": "Claire Bao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253986%22"}, {"id": "fda:K252028", "company": "Huizhou Foryou Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252028: LUOFUCON\u00ae Antimicrobial Wound Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252028", "people": [{"name": "Huiqi Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252028%22"}, {"id": "trialreg:NCT07464171", "company": "Ufonia", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Dora Care for Supporting Fracture Liaison Services (FLS)", "source_url": "https://clinicaltrials.gov/study/NCT07464171"}, {"id": "trialreg:NCT07464353", "company": "xDot Medical, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: xDot Access Management System Early Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07464353"}, {"id": "trialreg:NCT07464275", "company": "Future Fertility Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction", "source_url": "https://clinicaltrials.gov/study/NCT07464275"}, {"id": "trialreg:NCT07463716", "company": "Fisher and Paykel Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers", "source_url": "https://clinicaltrials.gov/study/NCT07463716"}, {"id": "trialreg:NCT07463703", "company": "Cognitive FX", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder", "source_url": "https://clinicaltrials.gov/study/NCT07463703"}, {"id": "fda:K260765", "company": "Azena Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260765: Gemini NOVA 810+980 Soft Tissue Laser", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260765", "people": [{"name": "Lindsay Tilton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260765%22"}, {"id": "fda:K254093", "company": "Synthes GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254093: DePuy Synthes VOLT\u0099 Medial Distal Femur 3.5 Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254093", "people": [{"name": "Gengqiao Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254093%22"}, {"id": "fda:K253953", "company": "Ivoclar Vivadent, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253953: IPS e.max Zirconia", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253953", "people": [{"name": "Anderjeet Gulati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253953%22"}, {"id": "fda:K252168", "company": "Institut Straumann AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252168: Straumann\u00ae BLC Implants - Indication Widening", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252168", "people": [{"name": "Jose Vitor Araujo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252168%22"}, {"id": "fda:K252353", "company": "Cefla S.C.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252353: myray ProXIma X6", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252353", "people": [{"name": "Simona Daidone", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252353%22"}, {"id": "fda:K253517", "company": "Reselute, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253517: Reselute Tibial Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253517", "people": [{"name": "Brianna Prindle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253517%22"}, {"id": "fda:K260595", "company": "FUJIFILM Sonosite, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260595: Sonosite iLOOK Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260595", "people": [{"name": "Anoush Frankian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260595%22"}, {"id": "fda:K260773", "company": "Nakanishi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260773: Varios Combi Pro2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260773", "people": [{"name": "Kikuchi Masaaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260773%22"}, {"id": "fda:K253584", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253584: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253584", "people": [{"name": "Orlando Tadeo, Jr.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253584%22"}, {"id": "pma:P130030", "company": "Boston Scientific Corp", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-03-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P130030: REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130030", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P130030%22"}, {"id": "trialreg:NCT07462897", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Effectiveness of a New Generation of Myopia Control Lens on the Progression of Myopia in Children Aged 6 to 14 Years", "source_url": "https://clinicaltrials.gov/study/NCT07462897"}, {"id": "trialreg:NCT07461506", "company": "nCap Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks", "source_url": "https://clinicaltrials.gov/study/NCT07461506"}, {"id": "trialreg:NCT07461259", "company": "Twiice", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Feasibility of TWIICE Rise - Phase 2", "source_url": "https://clinicaltrials.gov/study/NCT07461259"}, {"id": "trialreg:NCT07460323", "company": "Hollister Incorporated", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of TRE Seals on Early Post-operative Subjects", "source_url": "https://clinicaltrials.gov/study/NCT07460323"}, {"id": "fda:K252888", "company": "S&M Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252888: NeoSculpt Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252888", "people": [{"name": "Young Ok Jo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252888%22"}, {"id": "fda:K260355", "company": "WEBEST Biotech,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260355: Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260355", "people": [{"name": "Wei Midori", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260355%22"}, {"id": "fda:K253189", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253189: Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253189", "people": [{"name": "Gregory Foster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253189%22"}, {"id": "fda:K260405", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260405: FiberTape Button", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260405", "people": [{"name": "Alex Underberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260405%22"}, {"id": "fda:K254032", "company": "QIAGEN GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254032: QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254032", "people": [{"name": "Kristen Kanack", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254032%22"}, {"id": "fda:K253413", "company": "Perspectum, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253413: LiverMultiScan (v6.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253413", "people": [{"name": "Bhaskar Chikkanna", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253413%22"}, {"id": "fda:K260069", "company": "Synthes GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260069: DePuy Synthes VOLT\u0099 Proximal Tibia 3.5 Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260069", "people": [{"name": "Enrico Gindro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260069%22"}, {"id": "fda:K253934", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253934: Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253934", "people": [{"name": "Haiyan Wen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253934%22"}, {"id": "fda:K253960", "company": "Medicell Healthcare Co.,LTD", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253960: Medicell Mycosis Laser (MCML24004)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253960", "people": [{"name": "Kangsoo Lim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253960%22"}, {"id": "fda:K251861", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251861: FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251861", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251861%22"}, {"id": "trialreg:NCT07458217", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Combined CM and STN Stimulation for Motor Epilepsy", "source_url": "https://clinicaltrials.gov/study/NCT07458217"}, {"id": "trialreg:NCT07456865", "company": "MedtronicNeuro", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post Approval Effectiveness and Durability Evaluation of the Altaviva\u2122 Tibial Device", "source_url": "https://clinicaltrials.gov/study/NCT07456865"}, {"id": "trialreg:NCT07458243", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population", "source_url": "https://clinicaltrials.gov/study/NCT07458243"}, {"id": "trialreg:NCT07457593", "company": "Sedana Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Expanded Access for Inhaled Isoflurane Delivered Via the Sedaconda ACD-S for Sedation of Difficult-to-Sedate Adult Mechanically Ventilated Intensive Care Unit Patients", "source_url": "https://clinicaltrials.gov/study/NCT07457593"}, {"id": "breakthrough:P240036/S004", "company": "Medtronic, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-03-09", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P240036/S004: OMNIASECURE MRI SURESCAN LEAD MODEL 3930M", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253668", "company": "Onera B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253668: Onera SleepMap (SLEEPMAP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253668", "people": [{"name": "Pieter Ermers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253668%22"}, {"id": "fda:K260166", "company": "BunkerHill Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260166: Bunkerhill Contrast CAC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260166", "people": [{"name": "Eren Alkan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260166%22"}, {"id": "fda:K253772", "company": "Adeor Medical AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253772: Velocity Alpha MR High Speed Surgical Drill System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253772", "people": [{"name": "Silvia Laube", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253772%22"}, {"id": "fda:K253262", "company": "Nano4imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253262: EmeryGlide\u0099 (EG18008901)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253262", "people": [{"name": "Natalie Theisen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253262%22"}, {"id": "fda:K253983", "company": "Guangzhou Haoyimai Trading Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253983: Water-based lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253983", "people": [{"name": "Coco Ling", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253983%22"}, {"id": "fda:K251818", "company": "Hudens Bio Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251818: BONTREE PLUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251818", "people": [{"name": "Hun Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251818%22"}, {"id": "fda:K260167", "company": "BunkerHill Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260167: Bunkerhill Contrast AVC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260167", "people": [{"name": "Eren Alkan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260167%22"}, {"id": "fda:K253538", "company": "Theramicro", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253538: TeKBrace Knotless Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253538", "people": [{"name": "Christine Scifert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253538%22"}, {"id": "fda:K260013", "company": "Calyxo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260013: CVAC Image Processor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260013", "people": [{"name": "Joseph Catanese", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260013%22"}, {"id": "fda:K251807", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251807: Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251807", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251807%22"}, {"id": "fda:K253132", "company": "Zhejiang Chuangxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253132: Single use stone retrieval balloons", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253132", "people": [{"name": "Lucius Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253132%22"}, {"id": "fda:K252208", "company": "Ford Medtech, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252208: JFord Speculum Sleeve\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252208", "people": [{"name": "Jacqueline Ford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252208%22"}, {"id": "fda:K253951", "company": "Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253951: Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253951", "people": [{"name": "Zhengzhou Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253951%22"}, {"id": "fda:K253551", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253551: VELYS\u0099 Hip Navigation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253551", "people": [{"name": "Erin Combs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253551%22"}, {"id": "fda:K260361", "company": "Treace Medical Concepts, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260361: Treace Medical Concepts (TMC) Screw Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260361", "people": [{"name": "Melissa Coloroso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260361%22"}, {"id": "trialreg:NCT07454980", "company": "Jenscare Innovation Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)", "source_url": "https://clinicaltrials.gov/study/NCT07454980"}, {"id": "trialreg:NCT07455747", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE\u2122 Transcarotid Neuroprotection System", "source_url": "https://clinicaltrials.gov/study/NCT07455747"}, {"id": "trialreg:NCT07454356", "company": "Ermi LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Knee Flexionater to Avoid Motion Restoring Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07454356"}, {"id": "trialreg:NCT07453797", "company": "Activ Surgical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Study Assessing ActivSight Imaging for Intraoperative Perfusion Evaluation in Left-Sided Colectomy", "source_url": "https://clinicaltrials.gov/study/NCT07453797"}, {"id": "trialreg:NCT07454512", "company": "Mstatt LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Laser Otoscope for Middle Ear Effusion Detection", "source_url": "https://clinicaltrials.gov/study/NCT07454512"}, {"id": "trialreg:NCT07455058", "company": "Francis Medical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Water Vapor Ablation for Prostate Cancer: Long-Term Registry", "source_url": "https://clinicaltrials.gov/study/NCT07455058"}, {"id": "fda:K253267", "company": "Nanosonics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253267: CORIS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253267", "people": [{"name": "Nancy Kaiser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253267%22"}, {"id": "fda:K252450", "company": "Ivoclar Vivadent, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252450: Adhese 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252450", "people": [{"name": "Anderjeet Gulati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252450%22"}, {"id": "fda:K252779", "company": "Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252779: YUWELL\u00ae Electronic Blood Pressure Monitor (YE630CR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252779", "people": [{"name": "Zhang Fang (Fawn)", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252779%22"}, {"id": "fda:K260169", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260169: AV Cardiac CT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260169", "people": [{"name": "Elena Aizik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260169%22"}, {"id": "fda:K251901", "company": "Esaote, S.p.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251901: Magnifico Open (100009900)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251901", "people": [{"name": "Antonia Perrella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251901%22"}, {"id": "fda:K252538", "company": "Orca Dental AI , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252538: CEPHX3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252538", "people": [{"name": "Moshe Melamed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252538%22"}, {"id": "fda:K252196", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252196: Arthrex FibuLock Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252196", "people": [{"name": "Jessica Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252196%22"}, {"id": "fda:K253442", "company": "Earlitec Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253442: EarliPoint Assessment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253442", "people": [{"name": "Ryan Bormann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253442%22"}, {"id": "fda:K251788", "company": "Zhuhai DR Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251788: Extension tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251788", "people": [{"name": "Guanglong Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251788%22"}, {"id": "fda:K253591", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253591: Phantom\u00ae Hindfoot TTC/TC Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253591", "people": [{"name": "Brittanie Dogue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253591%22"}, {"id": "trialreg:NCT07450911", "company": "ReValve Solutions Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The REValve Clinical Trial an Evaluation Of the ReValve Palmetto Valve for the Replacement of the Native Mitral VaLVE", "source_url": "https://clinicaltrials.gov/study/NCT07450911"}, {"id": "trialreg:NCT07452211", "company": "Hangzhou Dinova EP Technology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: First in Man Study of Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 1 Patient", "source_url": "https://clinicaltrials.gov/study/NCT07452211"}, {"id": "trialreg:NCT07452549", "company": "RevBio", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware", "source_url": "https://clinicaltrials.gov/study/NCT07452549"}, {"id": "fda:K260015", "company": "SpineCraft", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260015: ANTERIS Thoracolumbar Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260015", "people": [{"name": "Ami Akallal-Asaad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260015%22"}, {"id": "fda:K254306", "company": "Aevumed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254306: Aevumed FENIX Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254306", "people": [{"name": "Saif Khalil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254306%22"}, {"id": "fda:K251434", "company": "Osstem Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251434: Healing Abutment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251434", "people": [{"name": "Kang Yeseul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251434%22"}, {"id": "fda:K253878", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253878: LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253878", "people": [{"name": "Dijkstra Alain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253878%22"}, {"id": "fda:K260365", "company": "Devicor Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260365: Mammotome Prima\u0099 MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima\u0099 MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima\u0099 MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima\u0099 MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima\u0099 MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima\u0099 MR Dual Vacuum-Assisted Breast Biopsy System Battery Char", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260365", "people": [{"name": "Jamie Edenborg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260365%22"}, {"id": "fda:K260380", "company": "Escala Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260380: Mendit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260380", "people": [{"name": "Edit Goldberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260380%22"}, {"id": "fda:K252025", "company": "Satori Orthopaedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252025: Active Intramedullary (AIM) Tibial Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252025", "people": [{"name": "Navid Ziran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252025%22"}, {"id": "fda:K253871", "company": "Radcliffe Watts, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253871: Kl\u00e4r Lite (RCW-KL1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253871", "people": [{"name": "Dan Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253871%22"}, {"id": "fda:DEN250012", "company": "Lifevac, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250012: LifeVac", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250012", "people": [{"name": "Arthur Lih", "role": "510(k) submission contact"}]}, {"id": "fda:K253870", "company": "Suzhou Master Machinery Manufacturing Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253870: Electric Wheelchair (MP148)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253870", "people": [{"name": "Hongying Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253870%22"}, {"id": "fda:K253565", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253565: SureSmile Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253565", "people": [{"name": "John Van Hoven", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253565%22"}, {"id": "fda:K253898", "company": "QT Imaging Holdings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253898: QT Scanner 2000 Model A", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253898", "people": [{"name": "Bilal Malik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253898%22"}, {"id": "fda:K253493", "company": "Dentis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253493: Dentis SQ-SL AXEL Fixture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253493", "people": [{"name": "Ju Mi Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253493%22"}, {"id": "fda:K253896", "company": "Globalcare Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253896: TENS/EMS device (GUSE01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253896", "people": [{"name": "Valentina Sassi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253896%22"}, {"id": "trialreg:NCT07449715", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Respiration From Pleth Validation", "source_url": "https://clinicaltrials.gov/study/NCT07449715"}, {"id": "trialreg:NCT07449416", "company": "Ceribell Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Ceribell Delirium Monitor Outcomes Pilot Study", "source_url": "https://clinicaltrials.gov/study/NCT07449416"}, {"id": "trialreg:NCT07448129", "company": "i+Med S.Coop.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial to Evaluate the Efficacy and Safety of SUBMO\u00ae as a Submucosal Injection Agent in Endoscopic Resection of Superficial Gastrointestinal Lesions.", "source_url": "https://clinicaltrials.gov/study/NCT07448129"}, {"id": "trialreg:NCT07449975", "company": "StimLabs", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal DFUs", "source_url": "https://clinicaltrials.gov/study/NCT07449975"}, {"id": "trialreg:NCT07449988", "company": "StimLabs", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal VLUs", "source_url": "https://clinicaltrials.gov/study/NCT07449988"}, {"id": "trialreg:NCT07450586", "company": "Barron Associates, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Virtual Activities of Living for Occupational Rehabilitation", "source_url": "https://clinicaltrials.gov/study/NCT07450586"}, {"id": "trialreg:NCT07449325", "company": "VahatiCor, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)", "source_url": "https://clinicaltrials.gov/study/NCT07449325"}, {"id": "denovo:DEN250012", "company": "Lifevac, LLC", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-03-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250012 granted: LifeVac", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250012"}, {"id": "fda:K260010", "company": "THINK Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260010: TMINI\u00ae Miniature Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260010", "people": [{"name": "Anand Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260010%22"}, {"id": "fda:K260353", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260353: Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260353", "people": [{"name": "Osiris Rios", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260353%22"}, {"id": "fda:K252534", "company": "Zhejiang Hangkang Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252534: Surgical Face Mask (Ear mount)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252534", "people": [{"name": "Xiaocan Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252534%22"}, {"id": "fda:K253818", "company": "Harrison-AI Medical Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253818: Annalise Enterprise", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253818", "people": [{"name": "Haylee Bosshard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253818%22"}, {"id": "fda:K251940", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251940: PathLoc Lumbar Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251940", "people": [{"name": "Kihyang Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251940%22"}, {"id": "fda:K254245", "company": "New Stetic, SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254245: ZAFIRA\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254245", "people": [{"name": "Juan David Jaramillo Gomez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254245%22"}, {"id": "fda:K251793", "company": "Sota Cloud Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251793: SOTA Cloud Smart Sensor (1.5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251793", "people": [{"name": "Dustin Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251793%22"}, {"id": "fda:K253874", "company": "Shenzhen Hanhua Opto Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253874: LED Therapy Light (COB1400, HP1800PRO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253874", "people": [{"name": "Taishan Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253874%22"}, {"id": "fda:K260682", "company": "Premier Dental Products Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260682: Bond-PR\u0099 Universal Adhesive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260682", "people": [{"name": "Jessica Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260682%22"}, {"id": "fda:K253920", "company": "Haidari Beauty Technology (Beijing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253920: CO2 Laser Treatment Machine (CFR3M1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253920", "people": [{"name": "Yuehong Zhong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253920%22"}, {"id": "fda:K253845", "company": "Ram.Shaw Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253845: Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253845", "people": [{"name": "Emma Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253845%22"}, {"id": "pma:P250008", "company": "Perimeter Medical Imaging Ai, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-03-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250008: Claire\u0099 OCT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250008", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250008%22"}, {"id": "trialreg:NCT07446582", "company": "AI-Spectral", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection", "source_url": "https://clinicaltrials.gov/study/NCT07446582"}, {"id": "trialreg:NCT07446088", "company": "Ceragem Clinical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Electric Stimulation Home Use(CGM MEPC_2401) for Improving Blood Circulation", "source_url": "https://clinicaltrials.gov/study/NCT07446088"}, {"id": "trialreg:NCT07446114", "company": "Synchron, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Functional Outcomes and Control Using Synchron BCI - Canada", "source_url": "https://clinicaltrials.gov/study/NCT07446114"}, {"id": "trialreg:NCT07444658", "company": "CooperVision International Limited (CVIL)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance of Two Daily Disposable Multifocal Contact Lenses", "source_url": "https://clinicaltrials.gov/study/NCT07444658"}, {"id": "trialreg:NCT07444593", "company": "Biodynamik, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds", "source_url": "https://clinicaltrials.gov/study/NCT07444593"}, {"id": "breakthrough:P250008", "company": "Perimeter Medical Imaging AI, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-03-03", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P250008: CLAIRE OCT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K253818", "company": "Harrison-ai Medical Pty, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-03-03", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K253818: ANNALISE ENTERPRISE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253771", "company": "Nanjing Devin Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253771: Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253771", "people": [{"name": "Qiuling Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253771%22"}, {"id": "fda:K260003", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260003: KARL STORZ Mediastinoscopes and Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260003", "people": [{"name": "Jordan Lydia Verla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260003%22"}, {"id": "fda:K252632", "company": "Nanjing Dewen Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252632: Microwave Ablation Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252632", "people": [{"name": "Qiuling Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252632%22"}, {"id": "fda:K252487", "company": "Gyrus Acmi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252487: POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252487", "people": [{"name": "Apurva Joshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252487%22"}, {"id": "fda:K253593", "company": "Clarius Mobile Health Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253593: Clarius Ejection Fraction AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253593", "people": [{"name": "Agatha Szeliga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253593%22"}, {"id": "fda:K254229", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254229: Arthrex Nano FiberTak Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254229", "people": [{"name": "Rebecca Homan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254229%22"}, {"id": "fda:K253380", "company": "Liaoning Upcera Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253380: \u0093FLNT Base\u0094 and \u0093FLNT Temp\u0094", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253380", "people": [{"name": "Li Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253380%22"}, {"id": "fda:K252531", "company": "Myofunctional Research Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252531: Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252531", "people": [{"name": "Vikas Kundu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252531%22"}, {"id": "fda:K253798", "company": "Guangzhou Heygears IMC., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253798: UltraPrint-Dental Hard Splint UV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253798", "people": [{"name": "Meifang Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253798%22"}, {"id": "fda:K254054", "company": "Synthes GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254054: VOLT\u0099 Ankle Trauma 2.7/3.5 Plating System; VOLT\u0099 Calcaneus 2.7 Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254054", "people": [{"name": "Brendan Daly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254054%22"}, {"id": "fda:K251777", "company": "Mesi D.O.O.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-03-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251777: MESI mTABLET SPIRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251777", "people": [{"name": "Nejc Ludvik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251777%22"}, {"id": "trialreg:NCT07444320", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Novel Waveforms Delivered Using the FARAPULSE\u2122 PFA System", "source_url": "https://clinicaltrials.gov/study/NCT07444320"}, {"id": "trialreg:NCT07443215", "company": "Johnson & Johnson Vision Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Effect of Scatter on Visual Performance", "source_url": "https://clinicaltrials.gov/study/NCT07443215"}, {"id": "trialreg:NCT07443124", "company": "Inogen Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-03-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Simeox 200 US Study", "source_url": "https://clinicaltrials.gov/study/NCT07443124"}, {"id": "fda:K253829", "company": "Beijing HuaCheng Taike Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253829: Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253829", "people": [{"name": "Wang Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253829%22"}, {"id": "fda:K253778", "company": "Elevate Oral Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253778: Allday Moisturizing Rinse", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253778", "people": [{"name": "Steve Pardue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253778%22"}, {"id": "fda:K252714", "company": "Vigor Medical Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252714: C-Lant Port", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252714", "people": [{"name": "Irina Kavounovski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252714%22"}, {"id": "fda:K252448", "company": "Avita Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252448: AViTA Pulse Oximeter (SP61)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252448", "people": [{"name": "Hsieh Rex", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252448%22"}, {"id": "fda:K253828", "company": "Beijing HuaCheng Taike Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253828: Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253828", "people": [{"name": "Wang Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253828%22"}, {"id": "fda:K253797", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253797: One-Stop", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253797", "people": [{"name": "Ku Da Hyeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253797%22"}, {"id": "fda:K253535", "company": "Ligence Uab", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253535: Ligence Heart", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253535", "people": [{"name": "Alvaro Perez-Moreno", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253535%22"}, {"id": "fda:K253536", "company": "Epineuron Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253536: Evala Nerve Stimulator (EPNR002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253536", "people": [{"name": "Mike Willand", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253536%22"}, {"id": "fda:K254249", "company": "Hankil Tech Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254249: HKT Anatomical Locking Trauma System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254249", "people": [{"name": "Jeong-Yup Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254249%22"}, {"id": "fda:K253695", "company": "Riverpoint Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253695: LigaMend", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253695", "people": [{"name": "Palmira Obeso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253695%22"}, {"id": "fda:K251998", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251998: Atellica CH Diazo Total Bilirubin (D_TBil)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251998", "people": [{"name": "Anthony Calabro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251998%22"}, {"id": "fda:K260292", "company": "Atraverse Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260292: HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260292", "people": [{"name": "Charles Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260292%22"}, {"id": "trialreg:NCT07440134", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Visual and Postural Behavior in Myopic and Non-Myopic Teenagers", "source_url": "https://clinicaltrials.gov/study/NCT07440134"}, {"id": "trialreg:NCT07437651", "company": "AbleLink Smart Living Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: WayFinder Ride Phase I Study", "source_url": "https://clinicaltrials.gov/study/NCT07437651"}, {"id": "trialreg:NCT07436156", "company": "Route 92 Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SUMMIT RISE Study of Acute Ischemic Stroke Patients", "source_url": "https://clinicaltrials.gov/study/NCT07436156"}, {"id": "trialreg:NCT07441135", "company": "i+Med S.Coop.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of BtH Body 2.2% (Injectable Hyaluronic Acid) in Volumizing and Contouring Large Areas of the Body: Prospective Clinical Investigation.", "source_url": "https://clinicaltrials.gov/study/NCT07441135"}, {"id": "trialreg:NCT07436676", "company": "Alviv Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence", "source_url": "https://clinicaltrials.gov/study/NCT07436676"}, {"id": "trialreg:NCT07440927", "company": "Ceragem Clinical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Stress Urinary Incontinence for Female Patients (CGM MUIT-2301)", "source_url": "https://clinicaltrials.gov/study/NCT07440927"}, {"id": "trialreg:NCT07440797", "company": "Laboratoires URGO", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD", "source_url": "https://clinicaltrials.gov/study/NCT07440797"}, {"id": "trialreg:NCT07439315", "company": "Icarus Medical Innovations", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07439315"}, {"id": "trialreg:NCT07438951", "company": "ConvaTec Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing in the Treatment of Diabetes Related Foot Ulcers.", "source_url": "https://clinicaltrials.gov/study/NCT07438951"}, {"id": "fda:K253578", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253578: BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253578", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253578%22"}, {"id": "fda:K253764", "company": "Disior, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253764: ENOS Software Guided External Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253764", "people": [{"name": "Aarno Jussila", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253764%22"}, {"id": "fda:K253328", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253328: GMK 3D Metal Tibial Tray Extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253328", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253328%22"}, {"id": "fda:K254271", "company": "ORO Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254271: CAPRI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254271", "people": [{"name": "James Hoon Lim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254271%22"}, {"id": "fda:K254251", "company": "Shanghai AnQing Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254251: InnovexView (GC146-17, GC150-20, GC155-23)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254251", "people": [{"name": "Shuwen Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254251%22"}, {"id": "fda:K260254", "company": "Enbio Group AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260254: Enbio PRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260254", "people": [{"name": "Lukasz Rogowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260254%22"}, {"id": "fda:K252166", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252166: RIB LINK\u0099 Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252166", "people": [{"name": "Krunal Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252166%22"}, {"id": "fda:K253021", "company": "Sibel Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253021: ANNE Maternal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253021", "people": [{"name": "Kevin Dwyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253021%22"}, {"id": "fda:K253641", "company": "Owl Dental Lab, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253641: Owl Night Guard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253641", "people": [{"name": "Jason Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253641%22"}, {"id": "fda:K254242", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254242: KARL STORZ ICG Imaging System with RUBINA\u00ae Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254242", "people": [{"name": "Jordan Lydia Verla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254242%22"}, {"id": "fda:K254182", "company": "Osteonic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254182: Aster", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254182", "people": [{"name": "Jisun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254182%22"}, {"id": "fda:K251860", "company": "Copioumed International, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251860: Copioumed AAMI 3 Surgical Gown", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251860", "people": [{"name": "James Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251860%22"}, {"id": "fda:K253791", "company": "DePuy Mitek, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253791: PUREVUE\u0099 Quick Connect Cannula System Tray; PUREVUE\u0099 Quick Connect Cannula System Lid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253791", "people": [{"name": "Jeffrey Dzialo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253791%22"}, {"id": "fda:K251700", "company": "Speciality Fibres and Materials Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251700: Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251700", "people": [{"name": "Graeme Kettlewell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251700%22"}, {"id": "fda:K254017", "company": "Implanet", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254017: SWINGO-3D Lumbar Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254017", "people": [{"name": "Regis Le Couedic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254017%22"}, {"id": "pma:P250028", "company": "Synergy Spine Solutions, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-02-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250028: Synergy Disc", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250028", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250028%22"}, {"id": "fda:K253789", "company": "Zhejiang Yikang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253789: Electric wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253789", "people": [{"name": "David Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253789%22"}, {"id": "fda:K253472", "company": "Mighty Oak Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253472: FIREFLY\u00ae Pedicle Screw Navigation Guide", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253472", "people": [{"name": "Mark Wylie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253472%22"}, {"id": "fda:K253559", "company": "Spinal Elements, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253559: Ventana\u0099 A Anterior Lumbar Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253559", "people": [{"name": "Cheryl Allen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253559%22"}, {"id": "fda:K251687", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251687: Konig Bell Circumcision Clamp", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251687", "people": [{"name": "Jennifer Mason", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251687%22"}, {"id": "fda:K253996", "company": "Becton, Dickinson and Company (BD)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253996: BD Surgiphor\u0099 Antimicrobial Irrigation System (910110)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253996", "people": [{"name": "Daniel Ehrhardt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253996%22"}, {"id": "fda:K260222", "company": "Mako Surgical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260222: Mako Total Knee Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260222", "people": [{"name": "Rita Koremblum", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260222%22"}, {"id": "fda:K251724", "company": "Grindguard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251724: Remi Impression Material", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251724", "people": [{"name": "Oscar Adelman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251724%22"}, {"id": "trialreg:NCT07433504", "company": "Shanghai Huihe Medical Technology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.", "source_url": "https://clinicaltrials.gov/study/NCT07433504"}, {"id": "trialreg:NCT07432191", "company": "Iconic Solutions By Murcia SL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.", "source_url": "https://clinicaltrials.gov/study/NCT07432191"}, {"id": "trialreg:NCT07431723", "company": "GT Metabolic Solutions, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Creation of Compression Anastomosis Using the GT Metabolic Magnet System", "source_url": "https://clinicaltrials.gov/study/NCT07431723"}, {"id": "fda:K253978", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253978: Universal Seal (5-12 mm)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253978", "people": [{"name": "Taian Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253978%22"}, {"id": "fda:K260217", "company": "Exo Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260217: AI Platform 2.2 (AIP002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260217", "people": [{"name": "Dornoosh Zonoobi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260217%22"}, {"id": "fda:K254055", "company": "OSSIO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254055: OSSIOfiber\u00ae Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254055", "people": [{"name": "Taly Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254055%22"}, {"id": "fda:K253707", "company": "Shenzhen Zhimahuaerkai Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253707: Electric wheelchair (W1,W3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253707", "people": [{"name": "Xianwei Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253707%22"}, {"id": "fda:K252599", "company": "Wingderm Electro-Optics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252599: Diode Laser Therapy Systems (WLA-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252599", "people": [{"name": "Juan Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252599%22"}, {"id": "fda:K260377", "company": "IceCure Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260377: XSense Cryoablation System with CryoProbes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260377", "people": [{"name": "Maayan Levi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260377%22"}, {"id": "fda:K254267", "company": "Mego Afek , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254267: NanoPress 760A-BT (760A-BT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254267", "people": [{"name": "Reuven Yunger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254267%22"}, {"id": "fda:K260287", "company": "Single Pass, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260287: SP Electrocautery Device (SP20)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260287", "people": [{"name": "Greg Geissinger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260287%22"}, {"id": "fda:K251678", "company": "Swift Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251678: Swift Ray 1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251678", "people": [{"name": "Tenzin Yangzom", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251678%22"}, {"id": "fda:K254247", "company": "Osteomni, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254247: OSTEOMNI SPINAL FIXATION SYSTEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254247", "people": [{"name": "Gulten Shurdom", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254247%22"}, {"id": "fda:K253714", "company": "Philips Image Guided Therapy Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253714: IntraSight Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253714", "people": [{"name": "Jeff Rongero", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253714%22"}, {"id": "fda:K253186", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253186: HemoSphere Nano Monitor (HSNANO1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253186", "people": [{"name": "Kshama Pai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253186%22"}, {"id": "trialreg:NCT07428915", "company": "AI Labs Group S.L", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Legit.Health Plus Support for Improving Diagnosis of Generalized Pustular Psoriasis and Other Skin Conditions Among Primary Care Physicians and Dermatologists", "source_url": "https://clinicaltrials.gov/study/NCT07428915"}, {"id": "trialreg:NCT07430878", "company": "Withings", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Smart Devices-based Longitudinal Assessment of Patterns of Insomnia", "source_url": "https://clinicaltrials.gov/study/NCT07430878"}, {"id": "trialreg:NCT07429123", "company": "AI Labs Group S.L", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Using an Artificial Intelligence Medical Device to Help Primary Care Practitioners Identify and Manage Skin Conditions (Tumor, Inflammatory, and Infectious Diseases) in Adult Patients at Pozuelo and Majadahonda Health Centers", "source_url": "https://clinicaltrials.gov/study/NCT07429123"}, {"id": "trialreg:NCT07429838", "company": "eGenesis, INC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EGEN-5784 Porcine Liver With the Metra\u00ae ELC Device", "source_url": "https://clinicaltrials.gov/study/NCT07429838"}, {"id": "trialreg:NCT07428954", "company": "AI Labs Group S.L", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Using Artificial Intelligence to Help Doctors Identify Different Skin Conditions and Improve Patient Care", "source_url": "https://clinicaltrials.gov/study/NCT07428954"}, {"id": "trialreg:NCT07430605", "company": "LASARRUS Clinic and Research Center", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).", "source_url": "https://clinicaltrials.gov/study/NCT07430605"}, {"id": "trialreg:NCT07429214", "company": "Biosense Webster, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF", "source_url": "https://clinicaltrials.gov/study/NCT07429214"}, {"id": "trialreg:NCT07431385", "company": "Fidia Farmaceutici s.p.a.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance and Safety of IRIDIUM GARZE in Blepharitis or Blepharconjunctivitis Adjuvant Treatment", "source_url": "https://clinicaltrials.gov/study/NCT07431385"}, {"id": "trialreg:NCT07430709", "company": "Technopulm", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of the STS Device for Pulmonary Function Test in Pediatric Population", "source_url": "https://clinicaltrials.gov/study/NCT07430709"}, {"id": "trialreg:NCT07430410", "company": "CorDx, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Validation of an At-Home Flu A/B and COVID-19 Rapid Test", "source_url": "https://clinicaltrials.gov/study/NCT07430410"}, {"id": "trialreg:NCT07429799", "company": "Ellele Health", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Exploratory Study of Detection of Endometrial and Ovarian Cancers in Vaginal Samples Retrieved by the Ellele Sampling Device", "source_url": "https://clinicaltrials.gov/study/NCT07429799"}, {"id": "trialreg:NCT07428941", "company": "AI Labs Group S.L", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating an Artificial Intelligence Tool to Help Primary Care Doctors Diagnose Skin Conditions.", "source_url": "https://clinicaltrials.gov/study/NCT07428941"}, {"id": "trialreg:NCT07429110", "company": "Averto Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ColoSeal\u2122 ICD System Anastomotic Protection Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT07429110"}, {"id": "fda:K251864", "company": "C.R. Bard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251864: Rubber Utility Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251864", "people": [{"name": "Cameron Boyd", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251864%22"}, {"id": "fda:K253583", "company": "Xenix Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253583: LUX Expandable Lumbar Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253583", "people": [{"name": "Teresa Cherry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253583%22"}, {"id": "fda:K253648", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253648: Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253648", "people": [{"name": "Younkyung Oh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253648%22"}, {"id": "fda:K253631", "company": "Zhejiang Wei Ling New Energy Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253631: Mobility Scooter (CL-Q3, CL-Q4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253631", "people": [{"name": "Zhe Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253631%22"}, {"id": "fda:K260265", "company": "Siemens Shenzhen Magnetic Resonance , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260265: MAGNETOM Flow.Ace; MAGNETOM Flow.Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260265", "people": [{"name": "Li Hai Ting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260265%22"}, {"id": "fda:K253531", "company": "Applied Medical Resources Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253531: Alexis\u00ae Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis\u00ae Lighted Wound Protector-Retractor, Flexible, Medium (CL302)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253531", "people": [{"name": "Apeksha Shanbhag", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253531%22"}, {"id": "fda:K253486", "company": "Skia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253486: SKIA-Head (Model: SKIA-ST00)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253486", "people": [{"name": "Jong Myoung Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253486%22"}, {"id": "fda:K253068", "company": "CMT Health PTE., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253068: Profoject\u0099 Insulin Syringes; Profoject\u0099 Safelock Disposable Insulin Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253068", "people": [{"name": "Monica Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253068%22"}, {"id": "fda:K260043", "company": "Smart Reactors", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260043: Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260043", "people": [{"name": "Mark Brassil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260043%22"}, {"id": "fda:K253228", "company": "Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253228: YUWELL\u00ae Electronic Blood Pressure Monitor (YE650AR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253228", "people": [{"name": "Zhang Fang (Fawn)", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253228%22"}, {"id": "fda:K252795", "company": "Argon Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252795: ZeniCore\u0099 Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore\u0099 Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore\u0099 Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore\u0099 Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252795", "people": [{"name": "Jacquelyn Huyghue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252795%22"}, {"id": "fda:K253169", "company": "Box Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253169: Duet\u0099 Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253169", "people": [{"name": "Troy Walters", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253169%22"}, {"id": "fda:K251661", "company": "Resmed Pty , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251661: Mariana Minerva; Mariana Nimbus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251661", "people": [{"name": "Nerida Hunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251661%22"}, {"id": "fda:K253244", "company": "Poskom Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253244: AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253244", "people": [{"name": "Seong Jeong Hyun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253244%22"}, {"id": "fda:K253666", "company": "Shenzhen Mlay Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253666: IPL Hair Removal Device (Models: T31A, T32A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253666", "people": [{"name": "Libin Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253666%22"}, {"id": "fda:K251587", "company": "Vita Zahnfabrik H. Rauter GmbH & Co. Kg.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251587: VITA VMLC Primer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251587", "people": [{"name": "Lindsay Tilton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251587%22"}, {"id": "trialreg:NCT07427407", "company": "AURA Health Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Ultrasound Data Collection Study for AI-Based Detection of Breast Biopsy Markers", "source_url": "https://clinicaltrials.gov/study/NCT07427407"}, {"id": "trialreg:NCT07427823", "company": "Microsure", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of MUSA-3 in Microsurgical Anastomoses", "source_url": "https://clinicaltrials.gov/study/NCT07427823"}, {"id": "trialreg:NCT07428564", "company": "Biosense Webster, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF", "source_url": "https://clinicaltrials.gov/study/NCT07428564"}, {"id": "fda:K253646", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253646: Single Use Distal Cover MAJ-2315 (MAJ-2315)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253646", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253646%22"}, {"id": "fda:K251692", "company": "Micro-Tech (Nanjing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251692: Advanced Tissue Resection Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251692", "people": [{"name": "Sally Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251692%22"}, {"id": "fda:K253660", "company": "KLS-Martin L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253660: KLS Martin Pure Pectus System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253660", "people": [{"name": "Melissa Bachorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253660%22"}, {"id": "fda:K252672", "company": "Casebioscience, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252672: CaseBio\u0099 Culture w/HSA (CMH5); CaseBio\u0099 Handling w/HSA (WHH5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252672", "people": [{"name": "Monica Mezezi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252672%22"}, {"id": "fda:K252619", "company": "Qstag, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252619: QSCHECK UISACR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252619", "people": [{"name": "Junhyuck Jang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252619%22"}, {"id": "fda:K254162", "company": "KLS Martin L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254162: KLS Martin Ixos System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254162", "people": [{"name": "Melissa Bachorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254162%22"}, {"id": "fda:K260181", "company": "Intertape Polymer Group", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260181: LF Process Indicator Tape for Steam Sterilization", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260181", "people": [{"name": "Michael Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260181%22"}, {"id": "fda:K253683", "company": "Foreo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253683: FAQ\u0099 (LED Panel); FAQ\u0099 (Dual LED Panel)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253683", "people": [{"name": "Feldstein Evan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253683%22"}, {"id": "fda:K252500", "company": "Cara Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252500: CARA System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252500", "people": [{"name": "Yael Goode", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252500%22"}, {"id": "fda:K253605", "company": "Ningbo Medsun Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253605: Safety Heel Lancet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253605", "people": [{"name": "Ping Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253605%22"}, {"id": "fda:K253445", "company": "Bd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253445: BD Surgiphor\u0099 1000 mL Antimicrobial Irrigation System (910120)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253445", "people": [{"name": "Dainel Ehrhardt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253445%22"}, {"id": "fda:K252989", "company": "Point Robotics MedTech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252989: \u0093POINT\u0094 Kinguide Agile Hybrid Navigation System; DRF Accessories Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252989", "people": [{"name": "Wayne Kao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252989%22"}, {"id": "fda:K253653", "company": "Cepheid", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253653: Xpert Hemorrhagic Fever", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253653", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253653%22"}, {"id": "fda:K252972", "company": "Biosense Webster, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252972: CARTO\u0099 3 EP Navigation System V8.4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252972", "people": [{"name": "Caleb Lau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252972%22"}, {"id": "fda:K251653", "company": "Soterix Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251653: SPRY TMS Therapy System (0550)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251653", "people": [{"name": "Abhishek Datta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251653%22"}, {"id": "fda:K251890", "company": "Zhejiang Chuangxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251890: Disposable Ureteral Stents", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251890", "people": [{"name": "Lucius Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251890%22"}, {"id": "pma:P250023", "company": "Allurion Technologies, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-02-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250023: Allurion\u0099 Gastric Balloon System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250023", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250023%22"}, {"id": "trialreg:NCT07422623", "company": "Incrediwear Holdings, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves", "source_url": "https://clinicaltrials.gov/study/NCT07422623"}, {"id": "trialreg:NCT07425015", "company": "Bright Uro", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Ambulatory Long Length URodynamics Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT07425015"}, {"id": "trialreg:NCT07422675", "company": "Serina Therapeutics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SAD Study in Patients With Parkinson's Disease and Motor Fluctuations", "source_url": "https://clinicaltrials.gov/study/NCT07422675"}, {"id": "trialreg:NCT07425236", "company": "KOS Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Argus 2.0 Adoption Study", "source_url": "https://clinicaltrials.gov/study/NCT07425236"}, {"id": "fda:K253002", "company": "Esthetic Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253002: SkinStylus SteriLock MicroSystem (MP1209SL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253002", "people": [{"name": "Sean Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253002%22"}, {"id": "fda:K254018", "company": "Guilin Refine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254018: Portable Dental X-ray Device (GT-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254018", "people": [{"name": "Su Qin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254018%22"}, {"id": "fda:K252002", "company": "Elekta Solutions AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252002: Monaco RTP System (6.3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252002", "people": [{"name": "Elinor Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252002%22"}, {"id": "fda:K254148", "company": "Silony Medical GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254148: VERTICALE GPS Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254148", "people": [{"name": "Raphael Venzin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254148%22"}, {"id": "fda:K253623", "company": "Stryker Leibinger GmbH & Co KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253623: Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253623", "people": [{"name": "Andrea Wallen-Gerding", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253623%22"}, {"id": "fda:K252597", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252597", "people": [{"name": "Garima Shrivastava", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252597%22"}, {"id": "fda:K253612", "company": "Acclarent, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253612: Acclarent AERA Eustachian Tube Balloon Dilation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253612", "people": [{"name": "Kweku Biney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253612%22"}, {"id": "fda:K253398", "company": "Efofex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253398: Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253398", "people": [{"name": "Siddhant Doshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253398%22"}, {"id": "fda:K260205", "company": "AS Software, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260205: AS Software Version Asera", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260205", "people": [{"name": "Becky Piroga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260205%22"}, {"id": "fda:K251903", "company": "Erchonia Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251903: Erchonia DPN Laser (Model# EVRL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251903", "people": [{"name": "Travis Sammons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251903%22"}, {"id": "fda:K253687", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253687: Access anti-HBc Total", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253687", "people": [{"name": "Fatima Pacheco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253687%22"}, {"id": "fda:K252814", "company": "CMT Health PTE., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252814: Profoject\u0099 Low Dead Space Syringe /Profoject\u0099 Tuberculin Syringe; Profoject\u0099 Low Dead Space Syringe with Needle /Profoject\u0099 Tuberculin Syringe with Needle; Profoject\u0099 Low Dead Space Syringe with Permanent Needle /Profoject\u0099 Tuberculin Syringe with Permanent Needle; Profoject\u0099 Low Dead Space Safety Syringe /Profoject\u0099 Tuberculin Safety Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252814", "people": [{"name": "Monica Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252814%22"}, {"id": "fda:K260308", "company": "Adaptiiv Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260308: TrueFit Bolus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260308", "people": [{"name": "Olga Zhuk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260308%22"}, {"id": "fda:K252733", "company": "MiRus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252733: ATLAS\u0099 Expandable Osteotomy Wedge System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252733", "people": [{"name": "Anuradha Nagulapati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252733%22"}, {"id": "fda:K253203", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253203: Retrograde Coronary Sinus Perfusion Cannulae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253203", "people": [{"name": "Megan Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253203%22"}, {"id": "fda:K254188", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254188: Meniscus Versaflex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254188", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254188%22"}, {"id": "fda:K260163", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260163: AuST CSP Introducer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260163", "people": [{"name": "Conner Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260163%22"}, {"id": "fda:K260218", "company": "Lacerta Life Sciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260218: LacertaMatrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260218", "people": [{"name": "Ted Bundrick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260218%22"}, {"id": "trialreg:NCT07421245", "company": "Zimmer Biomet", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: OsseoFit Stemless Shoulder System (Anatomic)", "source_url": "https://clinicaltrials.gov/study/NCT07421245"}, {"id": "trialreg:NCT07422259", "company": "Medivis SRL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Tolerability and Efficacy Study of Reinnerva/Lubristil+G vs Vismed", "source_url": "https://clinicaltrials.gov/study/NCT07422259"}, {"id": "trialreg:NCT07421713", "company": "Promedius Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older", "source_url": "https://clinicaltrials.gov/study/NCT07421713"}, {"id": "trialreg:NCT07421076", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Grid eXplore Mapping Study", "source_url": "https://clinicaltrials.gov/study/NCT07421076"}, {"id": "trialreg:NCT07421648", "company": "SynchroHealth LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BandPass: A Remote Monitoring System for Sarcopenia and Functional Decline Phase II Aim 4", "source_url": "https://clinicaltrials.gov/study/NCT07421648"}, {"id": "trialreg:NCT07421557", "company": "Occlutech International AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Expanded Access of Occlutech's Atrial Flow Regulator", "source_url": "https://clinicaltrials.gov/study/NCT07421557"}, {"id": "trialreg:NCT07420140", "company": "ResMed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Wearable PAP Device in a Tethered Configuration for the Treatment of Obstructive Sleep Apnoea.", "source_url": "https://clinicaltrials.gov/study/NCT07420140"}, {"id": "fda:K253539", "company": "Axis-Shield Diagnostics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253539: Alere NT-proBNP for Alinity i", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253539", "people": [{"name": "Claire Dora", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253539%22"}, {"id": "fda:K253637", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253637: Triathlon\u00ae Total Knee System - Triathlon\u00ae X3\u00ae Medial Stabilized Tibial Bearing Insert", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253637", "people": [{"name": "Nora Armstrong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253637%22"}, {"id": "fda:K253643", "company": "Shenzhen Zhimahuaerkai Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253643: Mobility Scooter (S3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253643", "people": [{"name": "Xianwei Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253643%22"}, {"id": "fda:K260185", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260185: 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260185", "people": [{"name": "Divya Sekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260185%22"}, {"id": "fda:K252197", "company": "Nobel Biocare AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252197: Nobel Biocare S Series Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252197", "people": [{"name": "Bernice Jim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252197%22"}, {"id": "fda:K252561", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252561: BTL-754FF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252561", "people": [{"name": "Chmel David", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252561%22"}, {"id": "fda:K252098", "company": "Methyl Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252098: PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252098", "people": [{"name": "Stephanie Hsieh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252098%22"}, {"id": "trialreg:NCT07417540", "company": "Neurophet", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of SCALE PET Software for Quantitative Brain PET Analysis in Alzheimer's Disease", "source_url": "https://clinicaltrials.gov/study/NCT07417540"}, {"id": "trialreg:NCT07418333", "company": "VISUfarma SpA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy of EPD-09-25 for Eyelid Hygiene Before and After Eye Surgery.", "source_url": "https://clinicaltrials.gov/study/NCT07418333"}, {"id": "trialreg:NCT07417683", "company": "Trans-Duodenal Concepts GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity", "source_url": "https://clinicaltrials.gov/study/NCT07417683"}, {"id": "fda:K253524", "company": "Biomendex OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253524: Adaptos\u00aeFuse Bone Graft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253524", "people": [{"name": "Pasi Kankaanp\u00e4\u00e4", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253524%22"}, {"id": "fda:K254089", "company": "Centerline Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254089: IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254089", "people": [{"name": "Carroll Martin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254089%22"}, {"id": "fda:K253599", "company": "Ningbo Shenyu Medical Equipment Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253599: Electric Wheelchair (W-A807, W-A807L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253599", "people": [{"name": "Song Zhenyong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253599%22"}, {"id": "fda:K260149", "company": "Liquet Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260149: Versus\u0099 Catheter (VS110-9NB)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260149", "people": [{"name": "John Schnidler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260149%22"}, {"id": "fda:K252805", "company": "Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252805: YUWELL\u00ae Finger Pulse Oximeter (YX105, YX106, YX110, YX310)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252805", "people": [{"name": "Fang (Fawn) Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252805%22"}, {"id": "fda:K250550", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250550: FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250550", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250550%22"}, {"id": "fda:K251680", "company": "Biocomposites, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251680: Biosteon\u00ae Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251680", "people": [{"name": "Ciara Airey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251680%22"}, {"id": "trialreg:NCT07414342", "company": "Beijing Balance Medical Technology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of the RENATUS\u00ae Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis", "source_url": "https://clinicaltrials.gov/study/NCT07414342"}, {"id": "trialreg:NCT07415330", "company": "Demaod Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction", "source_url": "https://clinicaltrials.gov/study/NCT07415330"}, {"id": "trialreg:NCT07414576", "company": "Takeoff41, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AI-driven Total Parenteral Nutrition Platform", "source_url": "https://clinicaltrials.gov/study/NCT07414576"}, {"id": "trialreg:NCT07414745", "company": "Medtronic Spinal and Biologics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MDT-0123 Japan Study", "source_url": "https://clinicaltrials.gov/study/NCT07414745"}, {"id": "trialreg:NCT07414329", "company": "Sonova AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit", "source_url": "https://clinicaltrials.gov/study/NCT07414329"}, {"id": "trialreg:NCT07413445", "company": "303 Pharma s.r.l.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE\u00ae (Injectable Recombinant Collagen-based Product)", "source_url": "https://clinicaltrials.gov/study/NCT07413445"}, {"id": "trialreg:NCT07412392", "company": "Hyundae Meditech", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds", "source_url": "https://clinicaltrials.gov/study/NCT07412392"}, {"id": "trialreg:NCT07412860", "company": "FB Vision S.p.A", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hyaluronic Acid 0.3% (FBV_01) vs Hyaluronic Acid 0.3% in Subjects in the Treatment From Moderate to Severe DED", "source_url": "https://clinicaltrials.gov/study/NCT07412860"}, {"id": "trialreg:NCT07415902", "company": "DK Medical Technology (Suzhou) Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol", "source_url": "https://clinicaltrials.gov/study/NCT07415902"}, {"id": "trialreg:NCT07413705", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women", "source_url": "https://clinicaltrials.gov/study/NCT07413705"}, {"id": "trialreg:NCT07413692", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women", "source_url": "https://clinicaltrials.gov/study/NCT07413692"}, {"id": "trialreg:NCT07413926", "company": "Artivion Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Mitral Valve Repair With the Chord-X System: A Long Term Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT07413926"}, {"id": "trialreg:NCT07412626", "company": "Robert Pickett", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the HeartLogic Diagnostic in Optimizing Guideline-directed Medical Therapy in Patients With Congestive Heart Failure and Chronically Low Ejection Fractions (EFs)", "source_url": "https://clinicaltrials.gov/study/NCT07412626"}, {"id": "trialreg:NCT07414368", "company": "StimLabs", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate for Acute and Chronic Wounds", "source_url": "https://clinicaltrials.gov/study/NCT07414368"}, {"id": "trialreg:NCT07414121", "company": "Asklepios proresearch", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: VASC-AF Study: Vascular Closure vs Manual Compression", "source_url": "https://clinicaltrials.gov/study/NCT07414121"}, {"id": "fda:K253089", "company": "Shenzhen Best Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253089: NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253089", "people": [{"name": "Martin Wong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253089%22"}, {"id": "fda:K260130", "company": "Arbor Endovascular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260130: Willow 18 Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260130", "people": [{"name": "Kathy Tansey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260130%22"}, {"id": "fda:K253092", "company": "Retia Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253092: Argos Infinity (Rev. 1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253092", "people": [{"name": "Alexander Markovic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253092%22"}, {"id": "fda:K252420", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252420: Wearable Breast Pump (Model W12)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252420", "people": [{"name": "Dale Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252420%22"}, {"id": "fda:K253096", "company": "Pulmonx Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253096: Chartis Precision Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253096", "people": [{"name": "Leah Andre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253096%22"}, {"id": "fda:K252891", "company": "Bayer Medical Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252891: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252891", "people": [{"name": "Troy Jack", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252891%22"}, {"id": "fda:K254052", "company": "Alcon Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254052: DAILIES TOTAL1\u00ae; DAILIES TOTAL1\u00ae Multifocal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254052", "people": [{"name": "Andreas Friese", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254052%22"}, {"id": "fda:K251802", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251802: STAR RF Ablation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251802", "people": [{"name": "Sandeep Saboo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251802%22"}, {"id": "fda:K253149", "company": "Medela, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253149: Motion InBra (YM-8801) wearable breast pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253149", "people": [{"name": "Jenni Vescovo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253149%22"}, {"id": "fda:K252400", "company": "Endo Tools Therapeutics S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252400: Endomina EZFuse system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252400", "people": [{"name": "Marine Rouyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252400%22"}, {"id": "fda:K252512", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252512: Armada\u0099 14 NC PTA Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252512", "people": [{"name": "Daire Farrell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252512%22"}, {"id": "fda:K251619", "company": "Dr\u00e4gerwerk AG & Co. KGaA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251619: Babyleo TN500", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251619", "people": [{"name": "Lyubov Lange", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251619%22"}, {"id": "fda:K253133", "company": "Shenzhen Imdk Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253133: Wrist Blood Pressure Monitor (BPM-W1VL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253133", "people": [{"name": "Yuan Xia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253133%22"}, {"id": "fda:K253564", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253564: uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253564", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253564%22"}, {"id": "fda:K251581", "company": "Shenzhen Hingmed Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251581: Wearable Ambulatory Blood Pressure Monitor (WBP-02A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251581", "people": [{"name": "Dien Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251581%22"}, {"id": "fda:K243854", "company": "Contour Research, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243854: Contour Light (CL-100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243854", "people": [{"name": "Douglas Dreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243854%22"}, {"id": "fda:K254105", "company": "NanoHive Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254105: Hive\u0099 Standalone Cervical System and Hive\u0099 C Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254105", "people": [{"name": "Ian Helmar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254105%22"}, {"id": "fda:K251928", "company": "Medinice S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251928: CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251928", "people": [{"name": "Sanjeev Choudhary", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251928%22"}, {"id": "fda:K250233", "company": "Measure Labs, Inc. (Dba Preemptiveai, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250233: PreemptiveAI Clinical SDK", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250233", "people": [{"name": "Matt Whitehill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250233%22"}, {"id": "fda:K252685", "company": "Joytech Healthcare Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252685: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252685", "people": [{"name": "Jing Cong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252685%22"}, {"id": "fda:K252422", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252422: Wearable Breast Pump (Model W2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252422", "people": [{"name": "Dale Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252422%22"}, {"id": "fda:K252565", "company": "Clouds of Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252565: PreOp v3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252565", "people": [{"name": "Gregor Strobbe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252565%22"}, {"id": "fda:K251852", "company": "VPIX Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251852: cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251852", "people": [{"name": "Kyungmin Hwang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251852%22"}, {"id": "fda:K251742", "company": "Lex Diagnostics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251742: VELO Respiratory Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251742", "people": [{"name": "Heather Danks", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251742%22"}, {"id": "trialreg:NCT07409675", "company": "Vichy Laboratoires", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Development of a Clinical Photographic Atlas for Skin Aging Based on the Characterization of Facial Dermal Collagen Using LC-OCT Technology", "source_url": "https://clinicaltrials.gov/study/NCT07409675"}, {"id": "trialreg:NCT07410962", "company": "SuZhou Sinus Medical Technologies Co.,Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Initial Efficacy Study of a Cardiac Surgical Pulsed Field Ablation System for the Treatment of Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07410962"}, {"id": "trialreg:NCT07409090", "company": "Cytrellis Biosystems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Micro-Coring\u00ae for the Treatment of Skin Laxity of the Knees", "source_url": "https://clinicaltrials.gov/study/NCT07409090"}, {"id": "trialreg:NCT07408388", "company": "Nihon Kohden", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pulse Oximeter Accuracy During Stable Hypoxia Plateaus", "source_url": "https://clinicaltrials.gov/study/NCT07408388"}, {"id": "trialreg:NCT07408141", "company": "Medtronic MiniMed, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MiniMed Fit Payload Wear Study", "source_url": "https://clinicaltrials.gov/study/NCT07408141"}, {"id": "breakthrough:P000058/S096", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-02-13", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P000058/S096: INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253491", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253491: ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253491", "people": [{"name": "Noel Mencias", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253491%22"}, {"id": "fda:K251732", "company": "Met One Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251732: Wrist Fracture System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251732", "people": [{"name": "Evan Carbonell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251732%22"}, {"id": "fda:K260177", "company": "Xenocor, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260177: Saberscope\u0099 Laparoscope (SAS-A-536L); Xenocor\u00ae Video Processing Unit (VPUX-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260177", "people": [{"name": "Brandon Kessler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260177%22"}, {"id": "fda:K253201", "company": "4Web, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253201: Lumbar Spine Truss System - Plating Solution (LSTS-PS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253201", "people": [{"name": "Jarod Oldham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253201%22"}, {"id": "fda:K253354", "company": "Guangzhou Hehong Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253354: Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253354", "people": [{"name": "Yu Feng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253354%22"}, {"id": "fda:K253490", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253490: Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253490", "people": [{"name": "Noel Mencias", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253490%22"}, {"id": "fda:K251375", "company": "Puracath Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251375: PuraCath Firefly Needleless Connector IT (9005)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251375", "people": [{"name": "Julia Rasooly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251375%22"}, {"id": "fda:K252490", "company": "Tianjin Huahong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252490: Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252490", "people": [{"name": "Ningning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252490%22"}, {"id": "fda:K260108", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260108: L12 LED Light Source with AIM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260108", "people": [{"name": "Irina Glazkova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260108%22"}, {"id": "fda:K253972", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253972: IMAGE1 (TC400US); X-to-4U Adapter (TC040)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253972", "people": [{"name": "Winkie Wong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253972%22"}, {"id": "fda:K254007", "company": "SZ KKS Silicone&Electronic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254007: LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254007", "people": [{"name": "Yongquan Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254007%22"}, {"id": "fda:K252523", "company": "Healgen Scientific,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252523: Healgen\u00ae Accurate Oral Fluid Drug Test COT/THC; Healgen\u00ae Accurate Oral Fluid Drug Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252523", "people": [{"name": "Jianqiu Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252523%22"}, {"id": "fda:K251760", "company": "Well-Life Healthcare , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251760: Well-Life Incontinence Stimulation System (WL-2405i(P))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251760", "people": [{"name": "Jenny Hsieh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251760%22"}, {"id": "fda:K253381", "company": "Medtronic Navigation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253381: Stealth AXiS\u0099 Surgical System with Stealth AXiS\u0099 Spine clinical application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253381", "people": [{"name": "Victoria Baldock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253381%22"}, {"id": "pma:P220031", "company": "Empirical Spine, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-02-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P220031: LimiFlex Dynamic Sagittal Tether", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220031", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P220031%22"}, {"id": "trialreg:NCT07405866", "company": "Heart Input Output Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Analysis To Assess The Potential Use Of ECGio In Clinical Practice", "source_url": "https://clinicaltrials.gov/study/NCT07405866"}, {"id": "trialreg:NCT07405983", "company": "Keri Medical SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TOUCH\u00ae CMC 1 New Enrollment US Study", "source_url": "https://clinicaltrials.gov/study/NCT07405983"}, {"id": "trialreg:NCT07406152", "company": "i+Med S.Coop.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of ZKARE\u00ae Gel and Its Accessory ZKAPI\u00ae in the Treatment of Chronic Ulcers.", "source_url": "https://clinicaltrials.gov/study/NCT07406152"}, {"id": "trialreg:NCT07405398", "company": "OpiAID", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Train a Machine Learning Algorithm for an Evaluation of the Use of Biometric Data Captured at the Wrist for the Identification of Acute Opioid Use Events and the Quantification of Opioid Withdrawal in Opioid Dependent Individuals", "source_url": "https://clinicaltrials.gov/study/NCT07405398"}, {"id": "trialreg:NCT07407816", "company": "Supira Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure", "source_url": "https://clinicaltrials.gov/study/NCT07407816"}, {"id": "trialreg:NCT07407738", "company": "Shunmei Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07407738"}, {"id": "trialreg:NCT07405138", "company": "Lumenis Be Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion", "source_url": "https://clinicaltrials.gov/study/NCT07405138"}, {"id": "trialreg:NCT07405853", "company": "Gedea Biotech AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Vulvovaginal Candidiasis Compared With an Untreated Control Group", "source_url": "https://clinicaltrials.gov/study/NCT07405853"}, {"id": "breakthrough:P220031", "company": "Empirical Spine, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-02-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P220031: LIMIFLEX DYNAMIC SAGITTAL TETHER", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:DEN250007", "company": "Ultrasound AI", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250007: Delivery Date AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250007", "people": [{"name": "Robert Bunn", "role": "510(k) submission contact"}]}, {"id": "fda:K253049", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253049: Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253049", "people": [{"name": "Jiahong Jin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253049%22"}, {"id": "fda:K251592", "company": "1World Vista Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251592: SteriHub\u0099 Disinfecting Device and Protective Cover", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251592", "people": [{"name": "Steven McQuillan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251592%22"}, {"id": "fda:K251992", "company": "Savfe Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251992: ArmSure Fluoroscopic Positioning System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251992", "people": [{"name": "Hsiao Man Hsu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251992%22"}, {"id": "fda:K252084", "company": "Ai4medimaging Medical Solutions S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252084: AI4CMR v2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252084", "people": [{"name": "Carla Almeida", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252084%22"}, {"id": "fda:K251813", "company": "Sutter Medizintechnik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251813: CURIS II RF Generator (REF 360100-05)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251813", "people": [{"name": "Simone Peschl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251813%22"}, {"id": "fda:K253032", "company": "Stryker Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253032: AXS Lift Intracranial Base Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253032", "people": [{"name": "Natalie Allen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253032%22"}, {"id": "fda:K253488", "company": "SI-BONE, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253488: iFuse INTRA Ti\u0099 Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253488", "people": [{"name": "Jayasri Prabakaran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253488%22"}, {"id": "pma:P250034", "company": "Novocure, GmbH", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-02-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250034: Optune Pax", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250034", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250034%22"}, {"id": "trialreg:NCT07403669", "company": "Aventyn, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment", "source_url": "https://clinicaltrials.gov/study/NCT07403669"}, {"id": "trialreg:NCT07401901", "company": "Medtronic MiniMed, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07401901"}, {"id": "trialreg:NCT07404761", "company": "Motion Informatics LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments", "source_url": "https://clinicaltrials.gov/study/NCT07404761"}, {"id": "trialreg:NCT07402239", "company": "United Innomed(Shanghai) Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management", "source_url": "https://clinicaltrials.gov/study/NCT07402239"}, {"id": "trialreg:NCT07403084", "company": "Euros", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-market Clinical Follow-up Study of NEMOST V2", "source_url": "https://clinicaltrials.gov/study/NCT07403084"}, {"id": "trialreg:NCT07402941", "company": "Auricle Health Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)", "source_url": "https://clinicaltrials.gov/study/NCT07402941"}, {"id": "trialreg:NCT07403058", "company": "Axon Therapies, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction", "source_url": "https://clinicaltrials.gov/study/NCT07403058"}, {"id": "trialreg:NCT07402395", "company": "i+Med S.Coop.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study on the Safety and Efficacy of an Injectable Hyaluronic Acid for Improving the Aesthetic Rejuvenation of the Vulvovaginal Area", "source_url": "https://clinicaltrials.gov/study/NCT07402395"}, {"id": "trialreg:NCT07404657", "company": "Centervue SpA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening", "source_url": "https://clinicaltrials.gov/study/NCT07404657"}, {"id": "trialreg:NCT07403565", "company": "Suzhou Hechun Medical Technology Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: To Evaluate the Efficacy and Safety of the Insulin Patch Pump System in Patients With Diabetes.", "source_url": "https://clinicaltrials.gov/study/NCT07403565"}, {"id": "denovo:DEN250007", "company": "Ultrasound AI", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-02-11", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250007 granted: Delivery Date AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250007"}, {"id": "breakthrough:P250034", "company": "Novocure Gmbh", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-02-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P250034: OPTUNE PAX", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K251672", "company": "Medtronic Xomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251672: NIM Essence\u0099 EMG Endotracheal Tube (NIMEID060); NIM Essence\u0099 EMG Endotracheal Tube (NIMEID065); NIM Essence\u0099 EMG Endotracheal Tube (NIMEID070); NIM Essence\u0099 EMG Endotracheal Tube (NIMEID075); NIM Essence\u0099 EMG Endotracheal Tube (NIMEID080)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251672", "people": [{"name": "Emily Davis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251672%22"}, {"id": "fda:K251515", "company": "CreoDent Hudson Valley", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251515: Solidex\u00ae Ti-Links and Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251515", "people": [{"name": "Calvin Shim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251515%22"}, {"id": "fda:K254016", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254016: MI View&GO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254016", "people": [{"name": "Brian Wui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254016%22"}, {"id": "fda:K252751", "company": "Earflo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252751: Earflo (EF001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252751", "people": [{"name": "Intan Oldakowska", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252751%22"}, {"id": "fda:K253545", "company": "K2m, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253545: Vulcan Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253545", "people": [{"name": "Tee Pamon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253545%22"}, {"id": "fda:K260073", "company": "Biodynamik, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260073: XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260073", "people": [{"name": "Johnny Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260073%22"}, {"id": "fda:K252175", "company": "Fourth Axis, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252175: LANDR Contact LENS Case", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252175", "people": [{"name": "Christine Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252175%22"}, {"id": "fda:K252459", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252459: multiFlux 130 (F00013123); multiFlux 160 (F00013124)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252459", "people": [{"name": "Timothy Groves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252459%22"}, {"id": "fda:K260119", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260119: SpaceOAR Vue System (SV-2101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260119", "people": [{"name": "Cassidy Yeomans", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260119%22"}, {"id": "fda:K252179", "company": "Shenzhen RF Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252179: GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252179", "people": [{"name": "Gary Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252179%22"}, {"id": "fda:K253140", "company": "Ovigenex, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253140: CollOvine\u0099 Wound Powder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253140", "people": [{"name": "Thomas Hyland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253140%22"}, {"id": "pma:P240045", "company": "Contamac, Ltd.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-02-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240045: Optimum Infinite (tisilfocon A) Orthokeratology Lenses II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240045", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240045%22"}, {"id": "trialreg:NCT07400861", "company": "ResMed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of Min-Max APAP Recommender Tool", "source_url": "https://clinicaltrials.gov/study/NCT07400861"}, {"id": "trialreg:NCT07399028", "company": "Galderma R&D", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging", "source_url": "https://clinicaltrials.gov/study/NCT07399028"}, {"id": "trialreg:NCT07400666", "company": "Dotspace Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Intra-gastrointestinal Monitoring Device (PressureDOT\u00ae) and Centurion IAP Monitoring Device Comparison Study: Pivotal Study of Safety and Performance.", "source_url": "https://clinicaltrials.gov/study/NCT07400666"}, {"id": "trialreg:NCT07400718", "company": "QHSLab, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Head-to-Head Comparison Study Between Different FDA Registered Allergy Skin Test Applicators", "source_url": "https://clinicaltrials.gov/study/NCT07400718"}, {"id": "trialreg:NCT07400731", "company": "Stoparkinson Healthcare Systems LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Short and Long-term Responses of PD Symptoms to Earstim", "source_url": "https://clinicaltrials.gov/study/NCT07400731"}, {"id": "trialreg:NCT07400289", "company": "Echosens", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Development of a FibroScan Liver Examination Using a Single Probe", "source_url": "https://clinicaltrials.gov/study/NCT07400289"}, {"id": "fda:K254033", "company": "Ceribell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254033: Ceribell Instant EEG Headset", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254033", "people": [{"name": "Raymond Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254033%22"}, {"id": "fda:K251591", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251591: Holter ECG and ABP system (HolterABP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251591", "people": [{"name": "Tracy Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251591%22"}, {"id": "fda:K254236", "company": "VascuTech Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254236: Peel-Away Introducer Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254236", "people": [{"name": "Katy Feeny", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254236%22"}, {"id": "trialreg:NCT07395128", "company": "Joint & Vascular Institute", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Lateral Plantar Artery Embolization For Plantar Fasciitis", "source_url": "https://clinicaltrials.gov/study/NCT07395128"}, {"id": "trialreg:NCT07396649", "company": "Notos Medical Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility of Upper Airway Stimulation in OSA", "source_url": "https://clinicaltrials.gov/study/NCT07396649"}, {"id": "trialreg:NCT07396389", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Understanding How Young Adults Perceive Blurred Image Quality and Creating a Model Predicting Their Quality Ratings", "source_url": "https://clinicaltrials.gov/study/NCT07396389"}, {"id": "trialreg:NCT07397065", "company": "Murata Vios, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Accuracy Validation of the Moni-Patc Temperature Monitoring Patch During Surgery (Compared With Esophageal and Bladder Temperature)", "source_url": "https://clinicaltrials.gov/study/NCT07397065"}, {"id": "trialreg:NCT07397780", "company": "ProSomnus Sleep Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: RPMO2 Oximeter Accuracy During Sleep 1 Trial", "source_url": "https://clinicaltrials.gov/study/NCT07397780"}, {"id": "trialreg:NCT07397078", "company": "Murata Vios, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Accuracy Validation of the Moni-Patch Temperature Monitoring Patch System", "source_url": "https://clinicaltrials.gov/study/NCT07397078"}, {"id": "trialreg:NCT07397845", "company": "Translumina GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Stents Versus PAclitaxel Coated Balloons for Revascularization of CompleX and Small Coronary Vessels (SPARX) Trial", "source_url": "https://clinicaltrials.gov/study/NCT07397845"}, {"id": "trialreg:NCT07397247", "company": "Noctrix Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Tonic Motor Activation (TOMAC) Therapy in Patients With Restless Legs Syndrome and Dopaminergic Augmentation", "source_url": "https://clinicaltrials.gov/study/NCT07397247"}, {"id": "trialreg:NCT07396922", "company": "Motion Informatics LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments", "source_url": "https://clinicaltrials.gov/study/NCT07396922"}, {"id": "fda:K251423", "company": "Uzinmedicare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251423: Spectra S1 Pro; Spectra S2 Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251423", "people": [{"name": "Soyeon Lim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251423%22"}, {"id": "fda:K252076", "company": "Kneevoice, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252076: Kneevoice Cartilage Evaluation System (750-3600-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252076", "people": [{"name": "Gustavo DeGreiff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252076%22"}, {"id": "fda:K243979", "company": "Inova Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243979: Aptiva APS IgA Reagent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243979", "people": [{"name": "Melissa Sanchez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243979%22"}, {"id": "fda:K253927", "company": "Live Medica, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253927: LiveMedica Enterprise PACS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253927", "people": [{"name": "Nick Ponder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253927%22"}, {"id": "fda:K243348", "company": "Athelas, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243348: Athelas Home", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243348", "people": [{"name": "Tanay Tandon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243348%22"}, {"id": "fda:K251507", "company": "Quantel Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251507: INTEGRE LIO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251507", "people": [{"name": "Bruno Pages", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251507%22"}, {"id": "fda:K253221", "company": "Eieling Technology (Shenzhen) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253221: Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253221", "people": [{"name": "Chen Salon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253221%22"}, {"id": "fda:K252871", "company": "Stryker Leibinger GmbH & Co KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252871: Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252871", "people": [{"name": "Andrea Wallen-Gerding", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252871%22"}, {"id": "fda:DEN250006", "company": "Amferia AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250006: Amferia Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250006", "people": [{"name": "Anand Rajasekharan", "role": "510(k) submission contact"}]}, {"id": "fda:K253568", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253568: Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253568", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253568%22"}, {"id": "fda:K251836", "company": "Shenzhen Gsd Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251836: Dermatrix Duo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251836", "people": [{"name": "Gordon Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251836%22"}, {"id": "fda:K251218", "company": "SafeBeat Rx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251218: SafeBeat Rx App", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251218", "people": [{"name": "Rachita Navara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251218%22"}, {"id": "fda:K252873", "company": "K2m, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252873: Q Interbody Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252873", "people": [{"name": "Renee Maciag", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252873%22"}, {"id": "fda:K252058", "company": "Balmoral Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252058: ROSA Knee System with UltraSound Imaging Platform (USIP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252058", "people": [{"name": "Brett Zarda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252058%22"}, {"id": "fda:K252726", "company": "Philips Medizin Systeme Boeblingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252726: IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252726", "people": [{"name": "Daniel Potocic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252726%22"}, {"id": "fda:K253852", "company": "ETHICON, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253852: MONOCRYL\u0099 Plus Antibacterial Poliglecaprone \u0096 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253852", "people": [{"name": "Anju Malhotra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253852%22"}, {"id": "fda:K251543", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251543: Atellica\u00ae IM TSH3-Ultra II (TSH3ULII)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251543", "people": [{"name": "Kelly Scuderi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251543%22"}, {"id": "fda:K253780", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253780: SIGNA\u0099 Bolt", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253780", "people": [{"name": "Emily Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253780%22"}, {"id": "fda:K251577", "company": "Augmented Reality Software S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251577: LAIA XR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251577", "people": [{"name": "Santiago Gonz\u00e1lez Izard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251577%22"}, {"id": "fda:K251614", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251614: Stainless Steel Surgical Kits", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251614", "people": [{"name": "Laura Sobrin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251614%22"}, {"id": "fda:K251474", "company": "Median Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251474: Median LCS (internal name) / eyonis LCS (trade name) (1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251474", "people": [{"name": "Laurence Boy-Machefer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251474%22"}, {"id": "trialreg:NCT07393009", "company": "Biotronik SE & Co. KG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BIO|STREAM.CSP Study", "source_url": "https://clinicaltrials.gov/study/NCT07393009"}, {"id": "trialreg:NCT07392359", "company": "Zhicheng Medical Technology (Jiaxing) Co, Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Zhicheng TAVR Robot", "source_url": "https://clinicaltrials.gov/study/NCT07392359"}, {"id": "trialreg:NCT07393295", "company": "Monath Electronic", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Tolerability of TENS in Endometriosis-related Pain", "source_url": "https://clinicaltrials.gov/study/NCT07393295"}, {"id": "trialreg:NCT07392333", "company": "Stryker Instruments", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Cohort Study of Basivertebral Nerve Ablation Using the Stryker OptaBlate BVN System for the Treatment of Vertebrogenic Low Back Pain", "source_url": "https://clinicaltrials.gov/study/NCT07392333"}, {"id": "trialreg:NCT07394140", "company": "GE Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NMT EasyFit Sensor and Cable", "source_url": "https://clinicaltrials.gov/study/NCT07394140"}, {"id": "trialreg:NCT07391592", "company": "MicroPort Orthopedics Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post Market Clinical Follow-Up Study for EVOLUTION\u00ae NitrX\u2122 Keeled Tibia and EVOLUTION\u00ae NitrX\u2122 CS/CR Femur With Cruciate Sacrificing Insert", "source_url": "https://clinicaltrials.gov/study/NCT07391592"}, {"id": "trialreg:NCT07394777", "company": "Gedea Biotech AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis", "source_url": "https://clinicaltrials.gov/study/NCT07394777"}, {"id": "denovo:DEN250006", "company": "Amferia AB", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-02-06", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250006 granted: Amferia Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250006"}, {"id": "fda:K253959", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253959: Primevision 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253959", "people": [{"name": "Deepthi Paknikar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253959%22"}, {"id": "fda:K260028", "company": "Argon Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260028: CLEANER\u0099 Vac Thrombectomy System, CLEANER\u0099 Vac Aspiration Catheter with Handpiece, CLEANER\u0099 Vac Aspiration Canister", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260028", "people": [{"name": "Ana Jimenez-Hughes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260028%22"}, {"id": "fda:K253779", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253779: SIGNA\u0099 Sprint Select", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253779", "people": [{"name": "Xinyu Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253779%22"}, {"id": "fda:K251949", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251949: INDIGO\u00ae Aspiration System - Lightning Flash Aspiration Tubing with LINK", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251949", "people": [{"name": "Deanna Kimlinger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251949%22"}, {"id": "fda:K251517", "company": "Encora, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251517: Encora X1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251517", "people": [{"name": "Allison Davanzo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251517%22"}, {"id": "trialreg:NCT07388355", "company": "Wearlinq", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Usability Study of a Multi-channel ECG Monitoring Device", "source_url": "https://clinicaltrials.gov/study/NCT07388355"}, {"id": "trialreg:NCT07388784", "company": "Sebastian Griepentrog", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility", "source_url": "https://clinicaltrials.gov/study/NCT07388784"}, {"id": "trialreg:NCT07390500", "company": "NovaSight", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of the Efficacy and Safety of a DYnaMic Peripheral DegradatiON Myopia Disorder Control in Myopic Children \u05f4DYMOND Study\u05f4", "source_url": "https://clinicaltrials.gov/study/NCT07390500"}, {"id": "trialreg:NCT07390344", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: VIATORR\u00ae TIPS Study Evaluating 6-10mm Diameters (VIATIPS)", "source_url": "https://clinicaltrials.gov/study/NCT07390344"}, {"id": "fda:K260012", "company": "Bard Peripheral Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260012: UltraScore\u0099 Focused Force PTA Balloon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260012", "people": [{"name": "Laurissa Brantley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260012%22"}, {"id": "fda:K260038", "company": "Evolution Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260038: E3D\u0099-C Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260038", "people": [{"name": "Quynh Tran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260038%22"}, {"id": "fda:K250773", "company": "Spinal Elements, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250773: Luna\u00ae Ti Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250773", "people": [{"name": "Cheryl Allen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250773%22"}, {"id": "fda:K252623", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252623: G7\u00ae Revision Acetabular System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252623", "people": [{"name": "Serena Guiducci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252623%22"}, {"id": "fda:K252301", "company": "Yadu Medical (Henan) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252301: Henan Yadu Level 4 Surgical Gowns (Reinforced)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252301", "people": [{"name": "Peilong Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252301%22"}, {"id": "fda:K260104", "company": "Orthosoft Inc. (d/b/a) Zimmer CAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260104: Signature\u0099 ONE System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260104", "people": [{"name": "Nilam Dave", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260104%22"}, {"id": "trialreg:NCT07387250", "company": "Shape Memory Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_CHL)", "source_url": "https://clinicaltrials.gov/study/NCT07387250"}, {"id": "trialreg:NCT07386340", "company": "Senseonics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature", "source_url": "https://clinicaltrials.gov/study/NCT07386340"}, {"id": "trialreg:NCT07385625", "company": "Tau-MEDICAL Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation", "source_url": "https://clinicaltrials.gov/study/NCT07385625"}, {"id": "trialreg:NCT07385599", "company": "Lifetech Scientific (Shenzhen) Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FIM Study of the LAmbre\u2122 II LAA Occluder in Non-Valvular AF Patients", "source_url": "https://clinicaltrials.gov/study/NCT07385599"}, {"id": "trialreg:NCT07387380", "company": "Lucie Medical Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: KIRA Uterine Drain Device Evaluation- First-In- Human Study", "source_url": "https://clinicaltrials.gov/study/NCT07387380"}, {"id": "trialreg:NCT07388030", "company": "Shanghai Bluesail Boyuan Medical Technology Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tomography evaluatION", "source_url": "https://clinicaltrials.gov/study/NCT07388030"}, {"id": "trialreg:NCT07385313", "company": "Aroa Biosurgery Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures", "source_url": "https://clinicaltrials.gov/study/NCT07385313"}, {"id": "trialreg:NCT07387159", "company": "Hoya Lens Rus LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children", "source_url": "https://clinicaltrials.gov/study/NCT07387159"}, {"id": "fda:K252438", "company": "Applied Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252438: Explant Express", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252438", "people": [{"name": "Steven Curtis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252438%22"}, {"id": "fda:K252676", "company": "Circadia Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252676: The Circadia C300 System (C300)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252676", "people": [{"name": "Timo Lauteslager", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252676%22"}, {"id": "fda:K252048", "company": "Xi'An Taibo Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252048: 808nm semiconductor laser hair removal machine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252048", "people": [{"name": "Shuai Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252048%22"}, {"id": "fda:K253282", "company": "Dror Orthodesign , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253282: ZSmile System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253282", "people": [{"name": "Orly Maor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253282%22"}, {"id": "fda:K250644", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250644: MSS - Monobloc stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250644", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250644%22"}, {"id": "fda:K252909", "company": "Ningbo Runyes Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252909: Diagnostic X-Ray Equipment Model POCT22", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252909", "people": [{"name": "Weiqiong Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252909%22"}, {"id": "fda:K253701", "company": "Medtronic Minimed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253701: SmartGuard Technology; Predictive Low Glucose Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253701", "people": [{"name": "Shivani Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253701%22"}, {"id": "fda:K253737", "company": "Dexcom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253737: Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253737", "people": [{"name": "Holly Drake", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253737%22"}, {"id": "fda:K253640", "company": "Stryker GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253640", "people": [{"name": "Ileana Freige", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253640%22"}, {"id": "fda:K252087", "company": "Ulrich Medical USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252087: Navigation Module of the Cortium\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252087", "people": [{"name": "Eric Lucas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252087%22"}, {"id": "trialreg:NCT07383688", "company": "Neuspera Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FREEDOM Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics", "source_url": "https://clinicaltrials.gov/study/NCT07383688"}, {"id": "trialreg:NCT07385053", "company": "Symatese", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real-Life Evaluation of the HA Dermal Filler ESTYME\u00ae LIFT", "source_url": "https://clinicaltrials.gov/study/NCT07385053"}, {"id": "trialreg:NCT07384182", "company": "Perfect Lens, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Outcomes of Femtosecond Laser Presbyopia Treatment in Monofocal IOLs", "source_url": "https://clinicaltrials.gov/study/NCT07384182"}, {"id": "trialreg:NCT07382635", "company": "Cornerstone Robotics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial Protocol for Evaluating the Efficacy and Safety of Thoracoabdominal Endoscopic Surgery System in Remote Laparoscopic Surgery for Urology, General Surgery, Gynecology and Thoracic Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07382635"}, {"id": "trialreg:NCT07383597", "company": "Efferon JSC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Ulcerative Colitis and Crohn Disease", "source_url": "https://clinicaltrials.gov/study/NCT07383597"}, {"id": "fda:K252011", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252011: CHIKAI Nexus petit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252011", "people": [{"name": "Katsuhiko Fujimura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252011%22"}, {"id": "fda:K252286", "company": "Chengdu Besmile Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252286: BIORES Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252286", "people": [{"name": "Moushan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252286%22"}, {"id": "fda:K251582", "company": "Beijing Kreate Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251582: Redermax Antibacterial Wound Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251582", "people": [{"name": "Sean Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251582%22"}, {"id": "fda:K252649", "company": "Nano-X Imaging , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252649: TAP2D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252649", "people": [{"name": "Ofir Koren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252649%22"}, {"id": "fda:K251200", "company": "Oxehealth Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-02-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251200: Vital Signs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251200", "people": [{"name": "John Kemeny", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251200%22"}, {"id": "trialreg:NCT07381127", "company": "inTumo Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms", "source_url": "https://clinicaltrials.gov/study/NCT07381127"}, {"id": "trialreg:NCT07382258", "company": "Novlead Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease", "source_url": "https://clinicaltrials.gov/study/NCT07382258"}, {"id": "trialreg:NCT07380490", "company": "Giuseppe Tarantini", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-02-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA", "source_url": "https://clinicaltrials.gov/study/NCT07380490"}, {"id": "fda:K253847", "company": "Merit Medical Ireland, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253847: Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253847", "people": [{"name": "Brian Coughlan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253847%22"}, {"id": "fda:K254290", "company": "Shenzhen Peninsula Medical Group", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254290: ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254290", "people": [{"name": "Chunyan Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254290%22"}, {"id": "fda:K251769", "company": "Precision Medical Ventures, Inc. Dba Revealdx", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251769: RevealAI-Lung", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251769", "people": [{"name": "Michael Calhoun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251769%22"}, {"id": "fda:K253318", "company": "Hangzhou Clongene Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253318: Clungene RSV Antigen Rapid Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253318", "people": [{"name": "Frank Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253318%22"}, {"id": "fda:K252457", "company": "Shanghai SeeGen Photoelectric Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252457: Disposable Distal End Tape Hood", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252457", "people": [{"name": "Wang Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252457%22"}, {"id": "fda:K251981", "company": "Boston Aesthetics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251981: Boston PICO (Boston PICO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251981", "people": [{"name": "Cao Hongmei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251981%22"}, {"id": "fda:K250983", "company": "Asistan Medikal", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250983: Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250983", "people": [{"name": "Ibrahim Muhittin Tuzcu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250983%22"}, {"id": "fda:K251407", "company": "Saeshin Precision Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251407: Motor Handpiece and Control Unit (SDI10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251407", "people": [{"name": "San NamGung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251407%22"}, {"id": "fda:K253671", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253671: Dual Stage Venous Cannulae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253671", "people": [{"name": "Luigi Vecchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253671%22"}, {"id": "fda:K254283", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254283: BruxZir\u00ae Shaded 16 PLUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254283", "people": [{"name": "Park So Hyun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254283%22"}, {"id": "fda:K253833", "company": "Shenzhen Jianchao Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253833: Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253833", "people": [{"name": "Fred Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253833%22"}, {"id": "fda:K254305", "company": "Paragonix Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254305: BAROguard Donor Lung Preservation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254305", "people": [{"name": "Julia Bryant", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254305%22"}, {"id": "pma:P250009", "company": "Balt USA, LLC", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-01-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250009: SQUID Liquid Embolic Agent (LEA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250009", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250009%22"}, {"id": "trialreg:NCT07379112", "company": "Meril Life Sciences Pvt. Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement", "source_url": "https://clinicaltrials.gov/study/NCT07379112"}, {"id": "trialreg:NCT07378956", "company": "VUNO Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus", "source_url": "https://clinicaltrials.gov/study/NCT07378956"}, {"id": "trialreg:NCT07377487", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TheraSphere Japan Pre-Market Study", "source_url": "https://clinicaltrials.gov/study/NCT07377487"}, {"id": "trialreg:NCT07379008", "company": "Biovico Sp. z o.o.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of Non-Setting Paste in Bone Defect Reconstruction", "source_url": "https://clinicaltrials.gov/study/NCT07379008"}, {"id": "trialreg:NCT07377474", "company": "Bausch & Lomb Incorporated", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Investigate the Safety and Effectiveness of the Technolas\u00ae TENEO 317 Model 2 Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Myopia or Myopic Astigmatism", "source_url": "https://clinicaltrials.gov/study/NCT07377474"}, {"id": "fda:K252275", "company": "Zhejiang Nysin Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252275: Electric Scooter (DDF100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252275", "people": [{"name": "Xiaoying Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252275%22"}, {"id": "fda:K253611", "company": "Mcnicoll Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253611: Falco Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253611", "people": [{"name": "Etienne Robichaud", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253611%22"}, {"id": "fda:K252347", "company": "Dongguan Smarfody Mobility Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252347: Electric Scooter (Mojo-T580)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252347", "people": [{"name": "Alex Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252347%22"}, {"id": "fda:K253632", "company": "Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253632: Manual Wheelchair (W50)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253632", "people": [{"name": "Weixia Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253632%22"}, {"id": "fda:K251274", "company": "HR Healthcare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251274: EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251274", "people": [{"name": "Colby Wiesman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251274%22"}, {"id": "fda:K251354", "company": "UV Smart Technologies B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251354: UV Smart D60", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251354", "people": [{"name": "Thijs Kea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251354%22"}, {"id": "fda:K252349", "company": "Dongguan Smarfody Mobility Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252349: Electric Scooter (Mojo-T330)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252349", "people": [{"name": "Alex Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252349%22"}, {"id": "fda:K251923", "company": "Hangzhou Hawk Optical Electronic Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251923: Medical Shaver System (Morcellator) (YSB-IIIA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251923", "people": [{"name": "Yayan Ding", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251923%22"}, {"id": "fda:K243732", "company": "Talladium Espa\u00f1a, SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243732: Multi-Unit DAS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243732", "people": [{"name": "Xavier Soca Filella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243732%22"}, {"id": "fda:K252684", "company": "Medtox Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252684: Labcorp Fentanyl Urine Visual Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252684", "people": [{"name": "Elizabeth Brock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252684%22"}, {"id": "fda:K251427", "company": "Hiossen, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251427: EK MULTI ANGLED 30 ABUTMENT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251427", "people": [{"name": "Mateusz Leszczak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251427%22"}, {"id": "fda:K253462", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253462: NaturaLyte\u00ae Dry Bicarbonate Concentrate (08-4112-2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253462", "people": [{"name": "Laura Reed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253462%22"}, {"id": "fda:K252496", "company": "Neurophet., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252496: Neurophet AQUA AD Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252496", "people": [{"name": "Yerim Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252496%22"}, {"id": "fda:K252091", "company": "Medicalvr B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252091: Surgical Reality Viewer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252091", "people": [{"name": "Chris Hordijk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252091%22"}, {"id": "fda:K253763", "company": "Conmed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253763: Y-Knotless\u0099 Flex Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253763", "people": [{"name": "Mirela Gjini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253763%22"}, {"id": "trialreg:NCT07376122", "company": "Pacla Medical Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pilot Study of Robotic Spinal Mobilization in Parkinson's Disease", "source_url": "https://clinicaltrials.gov/study/NCT07376122"}, {"id": "trialreg:NCT07376447", "company": "iVascular S.L.U.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of iNstroke Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study", "source_url": "https://clinicaltrials.gov/study/NCT07376447"}, {"id": "trialreg:NCT07375810", "company": "Heart Input Output Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Analysis of ECGio to Predict Coronary Stenosis Against a Mixed Reference Standard", "source_url": "https://clinicaltrials.gov/study/NCT07375810"}, {"id": "trialreg:NCT07376421", "company": "Coloplast A/S", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation Exploring a Newly Developed Ostomy Baseplate", "source_url": "https://clinicaltrials.gov/study/NCT07376421"}, {"id": "fda:K252164", "company": "Imricor Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252164: NorthStar\u0099 Mapping System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252164", "people": [{"name": "Oksana Alswager", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252164%22"}, {"id": "fda:K253254", "company": "E.M.S Electro Medical Systems S.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253254: GBT Machine Airflow Prophylaxis Master", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253254", "people": [{"name": "Florian Bertrand", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253254%22"}, {"id": "fda:K253842", "company": "Vena Medical Holdings Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253842: Vena MicroAngioscope\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253842", "people": [{"name": "Joseph De Croos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253842%22"}, {"id": "fda:K251347", "company": "Sterivic Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251347: Sterilization Pouch/Roll", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251347", "people": [{"name": "Wanggen Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251347%22"}, {"id": "fda:K260004", "company": "Aevumed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260004: Aevumed PROTEKT Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260004", "people": [{"name": "Saif Khalil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260004%22"}, {"id": "fda:K252834", "company": "4Web Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252834: Sacroiliac Joint Truss System (SJTS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252834", "people": [{"name": "Jonathan Hires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252834%22"}, {"id": "fda:K251896", "company": "Xelite Biomed , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251896: XeliteMed SuperM-Fix Spinal Bone Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251896", "people": [{"name": "Wei Chun Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251896%22"}, {"id": "fda:K253388", "company": "Sleepiz AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253388: Sleepiz One+ (Model 2.5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253388", "people": [{"name": "Marta Stepien", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253388%22"}, {"id": "fda:K251306", "company": "Ever Fortune.Ai, Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251306: Seg Pro V3 (RT-300)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251306", "people": [{"name": "Joseph Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251306%22"}, {"id": "fda:K251043", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251043: Mpact 3D Metal Implants Extension \u0096 DMLS Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251043", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251043%22"}, {"id": "fda:K253224", "company": "ImpediMed Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253224: MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253224", "people": [{"name": "Richard Hines", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253224%22"}, {"id": "fda:K252015", "company": "Koru Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252015: FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252015", "people": [{"name": "Emily DiMambro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252015%22"}, {"id": "fda:K252603", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252603: HIGHERDOSE Body Sculptor (Model: GS-03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252603", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252603%22"}, {"id": "fda:K251622", "company": "Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251622: Hand Massager (SM004D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251622", "people": [{"name": "Honglie Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251622%22"}, {"id": "trialreg:NCT07373353", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Evaluation of AMJ-401", "source_url": "https://clinicaltrials.gov/study/NCT07373353"}, {"id": "fda:K251195", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251195: BriefCase-Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251195", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251195%22"}, {"id": "fda:K251995", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251995: Access anti-HAV IgM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251995", "people": [{"name": "Loretta Lydon O'Toole", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251995%22"}, {"id": "fda:K254220", "company": "Soniquence, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254220: Reusable 3 Button Fingerswitch Wand", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254220", "people": [{"name": "Suzanne Lucas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254220%22"}, {"id": "fda:K254221", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254221: Optima Coil System (OptiOne Coil System)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254221", "people": [{"name": "Kavita Chandrashekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254221%22"}, {"id": "fda:K251435", "company": "Inbella Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251435: InbellaIgnite RF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251435", "people": [{"name": "Michael Kreindel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251435%22"}, {"id": "trialreg:NCT07369362", "company": "MotilityCount aps", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: To Investigate if the Harvester\u00ae Improves Sperm Motility and Blastocyst Utilization (the Percent of Fertilized Eggs That Develop to the Point That They Are Able to be Transferred) in IVF Cycles.", "source_url": "https://clinicaltrials.gov/study/NCT07369362"}, {"id": "trialreg:NCT07368933", "company": "Advanced NanoTherapies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease", "source_url": "https://clinicaltrials.gov/study/NCT07368933"}, {"id": "trialreg:NCT07370493", "company": "Centinel Spine", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc\u00ae C Vivo Devices", "source_url": "https://clinicaltrials.gov/study/NCT07370493"}, {"id": "trialreg:NCT07369180", "company": "NeuroQore Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NQ Square TMS for MDD 1Dx3S Adults Multi-site Sham-controlled Protocol", "source_url": "https://clinicaltrials.gov/study/NCT07369180"}, {"id": "trialreg:NCT07369375", "company": "VISUfarma SpA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of VMX Eye Drops for Dry Eye Disease", "source_url": "https://clinicaltrials.gov/study/NCT07369375"}, {"id": "fda:K253412", "company": "Outset Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253412: Tablo Hemodialysis System (PN-0008000, PN-0006000U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253412", "people": [{"name": "Dinamarie Stefani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253412%22"}, {"id": "fda:K251670", "company": "Ge Medical Systems Information Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251670: MAC 7 Resting ECG Analysis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251670", "people": [{"name": "Yang Honghong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251670%22"}, {"id": "fda:K253499", "company": "Eyas Medical Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253499: Ascent3T Neonatal Magnetic Resonance Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253499", "people": [{"name": "Michelle Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253499%22"}, {"id": "trialreg:NCT07367204", "company": "Chongqing Jinsaixing Medical Technology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Randomized Masked Trial of Injectable Cross-Linked Hyaluronic Acid for Moderate-to-Severe Nasolabial Folds", "source_url": "https://clinicaltrials.gov/study/NCT07367204"}, {"id": "trialreg:NCT07367698", "company": "BellaSeno Pty Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07367698"}, {"id": "trialreg:NCT07366281", "company": "Atos Medical AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-operative Use of New Adhesive After Total Laryngectomy", "source_url": "https://clinicaltrials.gov/study/NCT07366281"}, {"id": "trialreg:NCT07366203", "company": "NEOS Surgery", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure", "source_url": "https://clinicaltrials.gov/study/NCT07366203"}, {"id": "trialreg:NCT07368049", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MR 7700 Multinuclear Application Clinical Study", "source_url": "https://clinicaltrials.gov/study/NCT07368049"}, {"id": "trialreg:NCT07366892", "company": "Leica Microsystems (Schweiz) AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use", "source_url": "https://clinicaltrials.gov/study/NCT07366892"}, {"id": "trialreg:NCT07368036", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MR 7700 Multinuclear Application Clinical Trial", "source_url": "https://clinicaltrials.gov/study/NCT07368036"}, {"id": "trialreg:NCT07365735", "company": "Sight Sciences, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TearCare MGX\u2122 System With and Without Warming Hold", "source_url": "https://clinicaltrials.gov/study/NCT07365735"}, {"id": "trialreg:NCT07367061", "company": "Innate srl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)", "source_url": "https://clinicaltrials.gov/study/NCT07367061"}, {"id": "fda:K252753", "company": "Vydence Medical Industria E Commercio Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252753: Vydence Family of Lasers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252753", "people": [{"name": "Eduardo Gabriel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252753%22"}, {"id": "fda:K253633", "company": "Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253633: Holmium Laser Therapeutic Apparatus (HZ-40)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253633", "people": [{"name": "Zhengzhou Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253633%22"}, {"id": "fda:K243349", "company": "Boston Scientific Cardiac Diagnostic Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243349: BodyGuardian Remote Monitoring System (BGRMS v3.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243349", "people": [{"name": "Meghan Styles", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243349%22"}, {"id": "fda:K253761", "company": "Devicor Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253761: HydroMARK\u0099 Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK\u0099 Plus Breast Biopsy Site Marker (Hummingbird Shape)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253761", "people": [{"name": "Katy Austin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253761%22"}, {"id": "fda:K252755", "company": "Point Robotics MedTech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252755: POINT Kinguide Agile Robotic Arm Surgical Stereotactic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252755", "people": [{"name": "Wayne Kao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252755%22"}, {"id": "fda:K253160", "company": "Basic Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253160: Syntex Exam Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253160", "people": [{"name": "Amy Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253160%22"}, {"id": "fda:K250741", "company": "Randox Laboratories Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250741: Evidence MultiSTAT DOA Urine MultiPlex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250741", "people": [{"name": "Karena Shaw", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250741%22"}, {"id": "fda:K253748", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253748: Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253748", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253748%22"}, {"id": "fda:K252957", "company": "Ab Medica Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252957: Pneumo Dissector Hook", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252957", "people": [{"name": "Alexandre Blanc", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252957%22"}, {"id": "fda:K253738", "company": "Ge Healthcare Coils (Usa Instruments, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253738: 3.0T AIR 32CH HNA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253738", "people": [{"name": "Sahra Nur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253738%22"}, {"id": "fda:K253285", "company": "Elidah, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253285: Elitone for Men", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253285", "people": [{"name": "Gloria Kolb", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253285%22"}, {"id": "fda:K251351", "company": "Manteia Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251351: AccuContour 4.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251351", "people": [{"name": "Chao Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251351%22"}, {"id": "fda:K253712", "company": "Shenzhen Rainbow Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253712: LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253712", "people": [{"name": "Layla Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253712%22"}, {"id": "fda:K252568", "company": "Silk Holdings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252568: New Day Skin Spray", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252568", "people": [{"name": "Suzanne Cheang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252568%22"}, {"id": "fda:K253669", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253669: TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253669", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253669%22"}, {"id": "trialreg:NCT07363902", "company": "Tesai Care SL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.", "source_url": "https://clinicaltrials.gov/study/NCT07363902"}, {"id": "trialreg:NCT07362121", "company": "Hemitec Finland Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of the Verus Frame in Tibial Intramedullary Nailing", "source_url": "https://clinicaltrials.gov/study/NCT07362121"}, {"id": "trialreg:NCT07363161", "company": "B. Braun Melsungen AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BASel Kosten-Effektivit\u00e4ts-Trial: Drug-coated BALLoon (DCB) vs. Drug-eluting Stent (DES) Strategy in High-risk Patients With Coronary Artery Disease (CAD)", "source_url": "https://clinicaltrials.gov/study/NCT07363161"}, {"id": "trialreg:NCT07363473", "company": "JC Medical, Inc., an affiliate of Edwards Lifesciences LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: JOURNEY LVAD: JOURNEY Left Ventricular Assist Device", "source_url": "https://clinicaltrials.gov/study/NCT07363473"}, {"id": "trialreg:NCT07361445", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Agilis RF TSP Early Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07361445"}, {"id": "trialreg:NCT07362862", "company": "Health Discovery Labs", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients", "source_url": "https://clinicaltrials.gov/study/NCT07362862"}, {"id": "trialreg:NCT07361653", "company": "Ryme Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The REVIVE Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT07361653"}, {"id": "trialreg:NCT07362303", "company": "Neuralert Technologies LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Neuralert Stroke Monitor Trial", "source_url": "https://clinicaltrials.gov/study/NCT07362303"}, {"id": "trialreg:NCT07361588", "company": "NeuroIntact Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study for VCool\u2122 Intranasal Cooling System in Healthy Volunteers", "source_url": "https://clinicaltrials.gov/study/NCT07361588"}, {"id": "trialreg:NCT07362043", "company": "Helix Surgical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)", "source_url": "https://clinicaltrials.gov/study/NCT07362043"}, {"id": "trialreg:NCT07362641", "company": "Presage Technologies, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Validation of Non-Contact Vital Signs", "source_url": "https://clinicaltrials.gov/study/NCT07362641"}, {"id": "fda:K251323", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251323: Device 104 Particulate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251323", "people": [{"name": "Jan Van der Ploeg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251323%22"}, {"id": "fda:K252885", "company": "Astura Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252885: OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252885", "people": [{"name": "Parker Kelch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252885%22"}, {"id": "fda:K253652", "company": "Cultiv8 1, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253652: Genie MAX Large Bore Introducer Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253652", "people": [{"name": "Robert Atkinson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253652%22"}, {"id": "fda:K253498", "company": "Medela, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253498: Pump In Style\u00ae Pro+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253498", "people": [{"name": "Jenni Vescovo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253498%22"}, {"id": "fda:K252352", "company": "Lima Corporate S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252352: SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252352", "people": [{"name": "Lilia Maestripieri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252352%22"}, {"id": "fda:K252984", "company": "Perin Health Devices, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252984: Perin Health System (PHD80060-2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252984", "people": [{"name": "Ian McLane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252984%22"}, {"id": "fda:K253735", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253735: AV Vascular", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253735", "people": [{"name": "Arbel Shezaf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253735%22"}, {"id": "fda:K253057", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253057: AI-Rad Companion Brain MR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253057", "people": [{"name": "Kira Morales", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253057%22"}, {"id": "fda:K253253", "company": "Implant Protesis Dental 2004, S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253253: IPDmilled Blanks", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253253", "people": [{"name": "Francesc Fumanal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253253%22"}, {"id": "fda:K253315", "company": "Institut Straumann AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253315: Straumann Variobase Abutments XC for Bridge/Bar", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253315", "people": [{"name": "Olivier Russo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253315%22"}, {"id": "fda:K251511", "company": "Copan Wasp Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251511: PhenoMATRIX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251511", "people": [{"name": "Chiara Congiu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251511%22"}, {"id": "fda:K252307", "company": "Maquet GmbH (A Getinge Group Company)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252307: Getinge GSS67N Series Steam Sterilizer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252307", "people": [{"name": "Silke Avieny", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252307%22"}, {"id": "trialreg:NCT07358351", "company": "Mendaera, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility of Robotic Instrument Guidance System to Perform Safe Ultrasound-Guided Percutaneous Procedures During Routine Medical Procedures.", "source_url": "https://clinicaltrials.gov/study/NCT07358351"}, {"id": "trialreg:NCT07357285", "company": "iVascular S.L.U.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)", "source_url": "https://clinicaltrials.gov/study/NCT07357285"}, {"id": "trialreg:NCT07360522", "company": "Eko Devices, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Collection For Adventitious Lung Sounds Algorithm Using Eko Digital Devices in a Clinical Setting", "source_url": "https://clinicaltrials.gov/study/NCT07360522"}, {"id": "trialreg:NCT07357428", "company": "Paradromics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Connect-One: Early Feasibility Study of Connexus\u00ae Brain-Computer Interface (BCI)", "source_url": "https://clinicaltrials.gov/study/NCT07357428"}, {"id": "trialreg:NCT07360808", "company": "Cytori Therapeutics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis", "source_url": "https://clinicaltrials.gov/study/NCT07360808"}, {"id": "trialreg:NCT07360158", "company": "Biotronik SE & Co. KG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs", "source_url": "https://clinicaltrials.gov/study/NCT07360158"}, {"id": "trialreg:NCT07358650", "company": "Hexiris Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma", "source_url": "https://clinicaltrials.gov/study/NCT07358650"}, {"id": "trialreg:NCT07361120", "company": "Next Life Sciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Plan A Occlusion and Reversal System Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07361120"}, {"id": "fda:K252369", "company": "Boston Aesthetics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252369: Boston Pico755", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252369", "people": [{"name": "Hongmei Cao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252369%22"}, {"id": "fda:K254165", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254165: Infinity\u0099 OCT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254165", "people": [{"name": "Wafa Mustafa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254165%22"}, {"id": "fda:K251385", "company": "Merit Medical Ireland, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251385: InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251385", "people": [{"name": "Shane Costello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251385%22"}, {"id": "fda:K253730", "company": "Verge Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253730: RoVo Mechanical Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253730", "people": [{"name": "Michael Buck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253730%22"}, {"id": "fda:K260170", "company": "Hangzhou SHINING3D Dental Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K260170: LumiCera", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260170", "people": [{"name": "Yuzhuo Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K260170%22"}, {"id": "fda:K253713", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253713: Arthrex Variable Angle (VA) Proximal Tibia Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253713", "people": [{"name": "Stacy Valdez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253713%22"}, {"id": "fda:K252977", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252977: Halcyon, Ethos Radiotherapy System (5.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252977", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252977%22"}, {"id": "fda:K251286", "company": "Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251286: Affirm 400", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251286", "people": [{"name": "Lu Ju", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251286%22"}, {"id": "fda:K251281", "company": "Nova Biomedical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251281: Nova Max Creat eGFR Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251281", "people": [{"name": "Mariya Cesnulevicius", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251281%22"}, {"id": "trialreg:NCT07355270", "company": "Aqua Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOleRability, and Effectiveness for Proximal Intestinal Mucosal Ablation in Patients With Type 2 Diabetes Mellitus (RESTORE-1 Study)", "source_url": "https://clinicaltrials.gov/study/NCT07355270"}, {"id": "trialreg:NCT07355959", "company": "Thuasne", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study to Assess the Efficacy and Pressure Maintenance of MOBIDERM Autofit Versus Bandages in the Management of Breast Cancer Related Lymphedema (BCRL) in Night-time Maintenance Phase.", "source_url": "https://clinicaltrials.gov/study/NCT07355959"}, {"id": "trialreg:NCT07355491", "company": "Intalight, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance Evaluation of Dream OCT: AP Study", "source_url": "https://clinicaltrials.gov/study/NCT07355491"}, {"id": "trialreg:NCT07354035", "company": "Shanghai MicroPort Rhythm MedTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Coronary Sinus Balloon Pump in STEMI", "source_url": "https://clinicaltrials.gov/study/NCT07354035"}, {"id": "trialreg:NCT07356531", "company": "JIANGSU SHENMING Medical Technology CO., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial Evaluating the Safety and Efficacy of Tumor Thermosensitive Embolic Agent in Transcatheter Arterial Chemoembolization for Primary Liver Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07356531"}, {"id": "trialreg:NCT07354178", "company": "DALIM TISSEN Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of Collagen-Based Thrombin Hemostat for the Control of Bleeding in Spinal Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07354178"}, {"id": "trialreg:NCT07355400", "company": "Neofunction d.o.o.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances", "source_url": "https://clinicaltrials.gov/study/NCT07355400"}, {"id": "trialreg:NCT07356323", "company": "Solventum US LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07356323"}, {"id": "trialreg:NCT07354841", "company": "Eurosets S.r.l.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Performance Evaluation of CPB Venous and Arterial Cannulas", "source_url": "https://clinicaltrials.gov/study/NCT07354841"}, {"id": "trialreg:NCT07354945", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children", "source_url": "https://clinicaltrials.gov/study/NCT07354945"}, {"id": "trialreg:NCT07356089", "company": "Deka Research and Development", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Twiist Postmarket Surveillance Study for Type 1 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07356089"}, {"id": "trialreg:NCT07355543", "company": "Oystershell NV", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluate the Effectiveness and Safety of a Cryogenic Pen to Treat Skin Tags Versus a Comparator.", "source_url": "https://clinicaltrials.gov/study/NCT07355543"}, {"id": "fda:K251318", "company": "Argon Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251318: VariFuse Adjustable Infusion Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251318", "people": [{"name": "Ana Jimenez-Hughes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251318%22"}, {"id": "fda:K253173", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253173: uCT 780 with uWS-CT-Dual Energy Analysis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253173", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253173%22"}, {"id": "fda:K253291", "company": "Blue Ocean Global", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253291: Excelsior System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253291", "people": [{"name": "Scott Ludecker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253291%22"}, {"id": "fda:K253698", "company": "Cooper Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253698: Milex\u0099 Incontinence Dish Pessaries; Milex\u0099 Incontinence Dish Pessaries with Support; Milex\u0099 Cube Pessaries; Milex\u0099 Cube Pessaries with Drainage Holes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253698", "people": [{"name": "Timothy Good", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253698%22"}, {"id": "fda:K253998", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253998: Clearview Intracoronary Shunts", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253998", "people": [{"name": "Cassie Rominski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253998%22"}, {"id": "fda:K251338", "company": "Scivita Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251338: Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251338", "people": [{"name": "Wu Ruqin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251338%22"}, {"id": "fda:K250954", "company": "Carestream Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250954: DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250954", "people": [{"name": "Gina Maiolo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250954%22"}, {"id": "fda:K253597", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253597: Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253597", "people": [{"name": "Orlando Tadeo, Jr.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253597%22"}, {"id": "fda:K252537", "company": "Teleflex Medical Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252537: Rusch SoftSimplastic Foley Catheters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252537", "people": [{"name": "Yuvaanesswary Nallappan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252537%22"}, {"id": "trialreg:NCT07349797", "company": "MediBeacon", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MediBeacon\u00ae Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07349797"}, {"id": "trialreg:NCT07350499", "company": "Imperative Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Aspiration Thrombectomy Using the Symphony or Prodigy System", "source_url": "https://clinicaltrials.gov/study/NCT07350499"}, {"id": "trialreg:NCT07350967", "company": "iIDEAS Group Holdings Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy", "source_url": "https://clinicaltrials.gov/study/NCT07350967"}, {"id": "trialreg:NCT07351071", "company": "Medtronic - MITG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections", "source_url": "https://clinicaltrials.gov/study/NCT07351071"}, {"id": "trialreg:NCT07353710", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure", "source_url": "https://clinicaltrials.gov/study/NCT07353710"}, {"id": "trialreg:NCT07350759", "company": "CHFDX,Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Observational Study Designed to Detect Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device", "source_url": "https://clinicaltrials.gov/study/NCT07350759"}, {"id": "fda:K254085", "company": "Biosense Webster, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254085: CARTO\u0099 3 EP Navigation System V9.0 with PIU Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254085", "people": [{"name": "Caleb Lau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254085%22"}, {"id": "fda:K254114", "company": "Baylis Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254114: Baylis Connector Cable", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254114", "people": [{"name": "Barb Boyce", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254114%22"}, {"id": "fda:K253363", "company": "Auxilium Biotechnologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253363: NeuroSpan Bridge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253363", "people": [{"name": "Jacob Koffler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253363%22"}, {"id": "fda:K251970", "company": "Medtronic, Ireland", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251970: Sprinter Legend Rapid Exchange Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251970", "people": [{"name": "Michelle Greaney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251970%22"}, {"id": "fda:K251721", "company": "Cepheid", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251721: Xpert GI Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251721", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251721%22"}, {"id": "fda:K252775", "company": "Hycor Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252775: NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 \u00df-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252775", "people": [{"name": "Aashrey Kaul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252775%22"}, {"id": "fda:K254186", "company": "Philips Medical Systems B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254186: Azurion R3.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254186", "people": [{"name": "Supriya Dalvi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254186%22"}, {"id": "fda:K253082", "company": "Lin-Zhi International, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253082: LZI Buprenorphine II Enzyme Immunoassay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253082", "people": [{"name": "Thet Wai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253082%22"}, {"id": "fda:K251367", "company": "Opsens, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251367: OptoMonitor 3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251367", "people": [{"name": "Dany Simard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251367%22"}, {"id": "fda:K252960", "company": "Solius Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252960: SOLIUS PRO UVB Light Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252960", "people": [{"name": "Chris Kiple", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252960%22"}, {"id": "fda:K251739", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251739: da Vinci Surgical System (IS5000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251739", "people": [{"name": "Emily Hovick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251739%22"}, {"id": "fda:K251249", "company": "Truvian Sciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251249: Tru Hematology Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251249", "people": [{"name": "Tho Tran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251249%22"}, {"id": "fda:K251744", "company": "Medtronic", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251744: Affinity Pixie\u0099 Arterial Filter with Balance\u0099 Biosurface; Affinity\u00ae Pediatric Arterial Blood Filter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251744", "people": [{"name": "Makella Daley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251744%22"}, {"id": "fda:K252634", "company": "Softlink International Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252634: Imagine\u00ae Enterprise Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252634", "people": [{"name": "Parkash S Kamat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252634%22"}, {"id": "fda:K251790", "company": "Spirair, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251790: SeptAlign", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251790", "people": [{"name": "Tracey Henry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251790%22"}, {"id": "fda:K253408", "company": "Zimmer Medizinsysteme GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253408: CoolTone", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253408", "people": [{"name": "Ute Killet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253408%22"}, {"id": "fda:K251714", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251714: Ion-C", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251714", "people": [{"name": "Guilherme Pires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251714%22"}, {"id": "fda:K252297", "company": "Toro Neurovascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252297: Toro 88 Superbore Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252297", "people": [{"name": "Ryan Walker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252297%22"}, {"id": "fda:K251341", "company": "Vital Healthcare Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251341: VITAL Tubing Sets for Hemodialysis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251341", "people": [{"name": "Hui Zhen Ch'ng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251341%22"}, {"id": "fda:K254126", "company": "AbbVie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254126: Natrelle 133S Tissue Expanders", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254126", "people": [{"name": "Melissa Pathmajeyan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254126%22"}, {"id": "fda:DEN250005", "company": "Sana Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250005: Sana Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250005", "people": [{"name": "Richard Hanbury", "role": "510(k) submission contact"}]}, {"id": "fda:K250135", "company": "Baxter Healthcare Corp/ Excel Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250135: WAVE Clinical Platform (2.0.000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250135", "people": [{"name": "Gena Wolfe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250135%22"}, {"id": "fda:K252205", "company": "Curiteva, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252205: Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252205", "people": [{"name": "Eric Linder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252205%22"}, {"id": "fda:K251353", "company": "Phelcom Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251353: Eyer 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251353", "people": [{"name": "Fl\u00e1vio Pascoal Vieira", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251353%22"}, {"id": "fda:K252767", "company": "Sublimed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252767: actiTENS mini", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252767", "people": [{"name": "Adrien Hallet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252767%22"}, {"id": "fda:K251934", "company": "Qure.Ai Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251934: qXR-Detect", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251934", "people": [{"name": "Sri Anusha Matta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251934%22"}, {"id": "fda:K251900", "company": "MY01, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251900: MY01 Continuous Compartmental Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251900", "people": [{"name": "Jennifer Robb", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251900%22"}, {"id": "fda:K253556", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253556: da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253556", "people": [{"name": "Manjunath Ramappa Bisalehalli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253556%22"}, {"id": "fda:K251448", "company": "Flexicare Medical Limited.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251448: FL-10000U Respiratory Humidifier", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251448", "people": [{"name": "Rebecca Funston", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251448%22"}, {"id": "trialreg:NCT07348458", "company": "iiShield", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Kidney Protective Jacket", "source_url": "https://clinicaltrials.gov/study/NCT07348458"}, {"id": "trialreg:NCT07347379", "company": "RxSight, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Long-Term Clinical Outcomes Of Subjects Enrolled In The RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study", "source_url": "https://clinicaltrials.gov/study/NCT07347379"}, {"id": "trialreg:NCT07348341", "company": "Ceric S\u00e0rl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Coronary Laser Atherectomy Registry From an International Taskforce", "source_url": "https://clinicaltrials.gov/study/NCT07348341"}, {"id": "trialreg:NCT07346287", "company": "Stratpharma AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy", "source_url": "https://clinicaltrials.gov/study/NCT07346287"}, {"id": "trialreg:NCT07347275", "company": "Yaqrit Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.", "source_url": "https://clinicaltrials.gov/study/NCT07347275"}, {"id": "trialreg:NCT07349121", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: OPTION-EMEA Clinical Trial", "source_url": "https://clinicaltrials.gov/study/NCT07349121"}, {"id": "denovo:DEN250005", "company": "Sana Health", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-01-16", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250005 granted: Sana Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250005"}, {"id": "fda:K251961", "company": "BAAT Medical Products B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251961: SDS Growing Rod", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251961", "people": [{"name": "Jasper Springer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251961%22"}, {"id": "fda:K251308", "company": "Thera B Medical Products", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251308: SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251308", "people": [{"name": "Alexa Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251308%22"}, {"id": "fda:K251831", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251831: Bio-Medicus Life Support Catheter and Introducer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251831", "people": [{"name": "Elizabeth Rose", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251831%22"}, {"id": "fda:K253023", "company": "Siemens Healthineers AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253023: BIOGRAPH One", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253023", "people": [{"name": "Friederike Hertle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253023%22"}, {"id": "fda:DEN250009", "company": "Bridge TO Life, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250009: VitaSmart Hypothermic Oxygenated Perfusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250009", "people": [{"name": "Stephen Howerton", "role": "510(k) submission contact"}]}, {"id": "fda:K253470", "company": "Medtronic Minimed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253470: MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253470", "people": [{"name": "Amber Street", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253470%22"}, {"id": "fda:K251458", "company": "Foshan Dahao Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251458: Electric Wheelchair (DH01168)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251458", "people": [{"name": "Yixie Bao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251458%22"}, {"id": "fda:K252567", "company": "Encore Medical L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252567: AltiVate Reverse\u00ae ADLC Glenosphere", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252567", "people": [{"name": "Patricia Kontoudis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252567%22"}, {"id": "fda:K252934", "company": "Dgnct, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252934: Diagnocat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252934", "people": [{"name": "Anastasya Melnikov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252934%22"}, {"id": "fda:K253171", "company": "Maxx Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253171: Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253171", "people": [{"name": "Donald Guthner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253171%22"}, {"id": "fda:K251847", "company": "Sleepnet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251847: Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251847", "people": [{"name": "Jennifer Kennedy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251847%22"}, {"id": "fda:K252516", "company": "Shoulder Innovations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252516: N22 EZ Glenosphere", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252516", "people": [{"name": "Mark Hanes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252516%22"}, {"id": "fda:K252188", "company": "Elekta Solutions AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252188: EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252188", "people": [{"name": "Lorenzo Muratori", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252188%22"}, {"id": "fda:K251254", "company": "InMode , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251254: Ignite RF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251254", "people": [{"name": "Suhair Francis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251254%22"}, {"id": "fda:K254061", "company": "Curiteva, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254061: Curiteva Porous PEEK Cervical Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254061", "people": [{"name": "Eric Linder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254061%22"}, {"id": "fda:K251357", "company": "Phenox, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251357: Esperance pHLO Aspiration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251357", "people": [{"name": "Rachel McDaid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251357%22"}, {"id": "fda:K253925", "company": "Inquis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253925: Aventus Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253925", "people": [{"name": "Zachary Woodson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253925%22"}, {"id": "fda:K252283", "company": "Nano-Ditech Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252283: Nano-Check Influenza A+B Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252283", "people": [{"name": "James B Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252283%22"}, {"id": "fda:K253276", "company": "Shanghai Bangbang Robotics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253276: Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253276", "people": [{"name": "Yihua Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253276%22"}, {"id": "fda:K254002", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254002: TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254002", "people": [{"name": "Sneha Potlapally", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254002%22"}, {"id": "trialreg:NCT07342608", "company": "MicroPort CRM", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum", "source_url": "https://clinicaltrials.gov/study/NCT07342608"}, {"id": "trialreg:NCT07342049", "company": "ConvaTec Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ConvaVAC\u2122 Ag+ Negative Pressure Wound Therapy System in Chronic Wounds", "source_url": "https://clinicaltrials.gov/study/NCT07342049"}, {"id": "trialreg:NCT07343362", "company": "Zeus Sleep Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea", "source_url": "https://clinicaltrials.gov/study/NCT07343362"}, {"id": "trialreg:NCT07343141", "company": "SciVision Biotech Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds", "source_url": "https://clinicaltrials.gov/study/NCT07343141"}, {"id": "trialreg:NCT07345416", "company": "Menicon Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Trial Assessing the Efficacy and Safety of ST-1 Silicone Hydrogel Daily Disposable Soft Contact Lenses Compared to Miru 1day UpSide", "source_url": "https://clinicaltrials.gov/study/NCT07345416"}, {"id": "trialreg:NCT07344090", "company": "Qwince Innovation S.r.l.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: USING A DECISION-MAKING SYSTEM TO SUPPORT THE MANAGEMENT OF FEVER AND ACUTE PAIN IN CHILDREN", "source_url": "https://clinicaltrials.gov/study/NCT07344090"}, {"id": "trialreg:NCT07344168", "company": "Eye-yon Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EndoArt\u00ae Implantation in Subjects With Chronic Corneal Edema - US Study", "source_url": "https://clinicaltrials.gov/study/NCT07344168"}, {"id": "trialreg:NCT07344584", "company": "Galderma R&D", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles in the Cheek Area", "source_url": "https://clinicaltrials.gov/study/NCT07344584"}, {"id": "trialreg:NCT07342400", "company": "Galderma R&D", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages", "source_url": "https://clinicaltrials.gov/study/NCT07342400"}, {"id": "trialreg:NCT07343973", "company": "i+Med S.Coop.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Market Study on the Safety and Effectiveness of the OpHLINE OVD in Cataract Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07343973"}, {"id": "denovo:DEN250009", "company": "Bridge TO Life, Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2026-01-15", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250009 granted: VitaSmart Hypothermic Oxygenated Perfusi", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250009"}, {"id": "breakthrough:K251961", "company": "Baat Medical Products B.v.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-01-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K251961: SDS GROWING ROD", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K251419", "company": "Laboratorios Biogalenic S.A. DE C.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251419: Laboratorios Biogalenic Sterile Water for Inhalation, USP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251419", "people": [{"name": "Roberto Qui\u00f1onez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251419%22"}, {"id": "fda:K252579", "company": "Ziehm-Orthoscan, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252579: Orthoscan TAU MVP Mini C-Arm System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252579", "people": [{"name": "Kevin Bridgman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252579%22"}, {"id": "fda:K252219", "company": "Sync Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252219: Cervical Interbody and VBR Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252219", "people": [{"name": "Shawn Culbertson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252219%22"}, {"id": "fda:K253585", "company": "Medtronic Minimed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253585: SmartGuard technology; Predictive Low Glucose technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253585", "people": [{"name": "Maria Hategan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253585%22"}, {"id": "fda:K253511", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253511: Concerto Versa\u0099 Detachable Coil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253511", "people": [{"name": "Rishu Rathee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253511%22"}, {"id": "fda:K254190", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254190: dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254190", "people": [{"name": "Ketaki Bendre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254190%22"}, {"id": "fda:K254010", "company": "Brainlab SE", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254010: ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254010", "people": [{"name": "Sadwini Suresh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254010%22"}, {"id": "fda:K252958", "company": "Meticuly Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252958: METICULY Patient-specific titanium mesh implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252958", "people": [{"name": "Lohwongwatana Peeranoot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252958%22"}, {"id": "fda:K252313", "company": "Cardinalhealth", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252313: Cardinal Health Nitrile Examination Gloves Extended Cuff", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252313", "people": [{"name": "Vani Bala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252313%22"}, {"id": "fda:K251996", "company": "Entire Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251996: ENTire IRE System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251996", "people": [{"name": "Daniela Heimlich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251996%22"}, {"id": "trialreg:NCT07338890", "company": "Cordis US Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease", "source_url": "https://clinicaltrials.gov/study/NCT07338890"}, {"id": "trialreg:NCT07340710", "company": "TransMedics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Decreasing Edema With a Novel OCS Solution Trial", "source_url": "https://clinicaltrials.gov/study/NCT07340710"}, {"id": "trialreg:NCT07339358", "company": "World Medica USA, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety & Performance of the World Medica World Diverter Embolization Device", "source_url": "https://clinicaltrials.gov/study/NCT07339358"}, {"id": "trialreg:NCT07339098", "company": "Anasonic", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of the Ultrasound Stimulation Device NEFRONIX in Patients With Chronic Kidney Disease", "source_url": "https://clinicaltrials.gov/study/NCT07339098"}, {"id": "trialreg:NCT07340632", "company": "Plexaa Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: B4P Trial - BLOOM43 for Preconditioning", "source_url": "https://clinicaltrials.gov/study/NCT07340632"}, {"id": "trialreg:NCT07338864", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults", "source_url": "https://clinicaltrials.gov/study/NCT07338864"}, {"id": "trialreg:NCT07339384", "company": "Natera, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Signatera Assessment in Early-Stage Endometrial Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07339384"}, {"id": "fda:K252549", "company": "Kossan International Sdn Bhd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252549: Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252549", "people": [{"name": "Cho Sow Fong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252549%22"}, {"id": "fda:K253248", "company": "Dmp Dental Industry S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253248: Bright Cavity Liner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253248", "people": [{"name": "Konstantinos Kyritsis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253248%22"}, {"id": "fda:K254001", "company": "Spectrum Dynamics Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254001: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254001", "people": [{"name": "Igor Naroditsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254001%22"}, {"id": "fda:K254014", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254014: Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254014", "people": [{"name": "Rubi Runton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254014%22"}, {"id": "fda:K252461", "company": "Spinal Resources, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252461: Swedge\u0099 Pedicle Screw Fixation System Bezier Rod", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252461", "people": [{"name": "Bernie Bedor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252461%22"}, {"id": "fda:K251214", "company": "Miach Orthopaedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251214: BEAR\u00ae (Bridge-Enhanced ACL Restoration) Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251214", "people": [{"name": "Rita Paparazzo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251214%22"}, {"id": "trialreg:NCT07335484", "company": "Axonics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Aquarius Pilot Study to Evaluate the New Axonics Trial System", "source_url": "https://clinicaltrials.gov/study/NCT07335484"}, {"id": "trialreg:NCT07336433", "company": "SyMap Medical (Suzhou), Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SMART-IC-Pilot Study", "source_url": "https://clinicaltrials.gov/study/NCT07336433"}, {"id": "trialreg:NCT07335146", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Eye Imaging for the Study of Childhood Myopia", "source_url": "https://clinicaltrials.gov/study/NCT07335146"}, {"id": "trialreg:NCT07335861", "company": "NuScience Medical Biologics, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Efficacy of Hyalomatrix\u00ae in the Healing of Chronic Venous Leg Ulcers", "source_url": "https://clinicaltrials.gov/study/NCT07335861"}, {"id": "trialreg:NCT07336654", "company": "ResMed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Circadian Rhythm Monitoring Study", "source_url": "https://clinicaltrials.gov/study/NCT07336654"}, {"id": "trialreg:NCT07338461", "company": "Heidelberg Engineering GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: High Resolution Imaging OCT Study", "source_url": "https://clinicaltrials.gov/study/NCT07338461"}, {"id": "trialreg:NCT07336420", "company": "Theranica", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Treatment Patterns Among US Veterans Using Remote Electrical Neuromodulation (REN) for Migraine Treatment", "source_url": "https://clinicaltrials.gov/study/NCT07336420"}, {"id": "trialreg:NCT07335341", "company": "Medtronic Endovascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Case-Specific Health Care Professional Clinical Survey of Liberant\u2122 Thrombectomy System", "source_url": "https://clinicaltrials.gov/study/NCT07335341"}, {"id": "trialreg:NCT07336056", "company": "Theranica", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Nerivio Efficacy Under High-Frequency Use", "source_url": "https://clinicaltrials.gov/study/NCT07336056"}, {"id": "trialreg:NCT07337590", "company": "Exero Medical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar", "source_url": "https://clinicaltrials.gov/study/NCT07337590"}, {"id": "trialreg:NCT07336407", "company": "Smart Alfa Teknoloji San. ve Tic. A.S.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Collection for the Validation of an Artificial Intelligence Software to Support Musculoskeletal Ultrasound Examination", "source_url": "https://clinicaltrials.gov/study/NCT07336407"}, {"id": "trialreg:NCT07337616", "company": "KeriCure Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Field Shield Wound Dressing Study", "source_url": "https://clinicaltrials.gov/study/NCT07337616"}, {"id": "trialreg:NCT07335614", "company": "MediBeacon", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Protein Loading on Measurement of Renal Reserve", "source_url": "https://clinicaltrials.gov/study/NCT07335614"}, {"id": "trialreg:NCT07335185", "company": "Gravity Medical Technology, INC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes", "source_url": "https://clinicaltrials.gov/study/NCT07335185"}, {"id": "fda:K252830", "company": "Beatles Medical Supplies (Xiantao) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252830: Disposable Surgical Face Mask (3P00B, C2900)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252830", "people": [{"name": "Paul Stark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252830%22"}, {"id": "fda:K253167", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253167: Any-Paste", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253167", "people": [{"name": "Da Hyeon Ku", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253167%22"}, {"id": "fda:K251701", "company": "Dentalez, Inc., Stardental Division", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251701: Star E900 Electric System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251701", "people": [{"name": "Robert Young", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251701%22"}, {"id": "fda:K251388", "company": "Foshan Topmed Dental Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251388: Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251388", "people": [{"name": "Salon Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251388%22"}, {"id": "fda:K251524", "company": "Theotclab Healthcare B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251524: Dr. Yglo Skin Tag Remover", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251524", "people": [{"name": "Jill Matzat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251524%22"}, {"id": "fda:K252962", "company": "Promethean Restorative, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252962: DYNAMIS\u0099 Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252962", "people": [{"name": "Glenn Bowman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252962%22"}, {"id": "fda:K250890", "company": "Sioxmed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250890: SBC1 Cream", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250890", "people": [{"name": "Mitchell Dellinger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250890%22"}, {"id": "fda:K251988", "company": "Boston Aesthetics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251988: Boston iFace (Boston iFace)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251988", "people": [{"name": "Hongmei Cao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251988%22"}, {"id": "fda:K251389", "company": "Foshan Topmed Dental Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251389: High speed air turbine handpiece", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251389", "people": [{"name": "Salon Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251389%22"}, {"id": "fda:K251558", "company": "Precision AI Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251558: Precision AI Surgical Planning System (PAI-SPS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251558", "people": [{"name": "Sara Baniadam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251558%22"}, {"id": "fda:K251886", "company": "Empower Ride, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251886: EmpowerRide NAVIGATOR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251886", "people": [{"name": "Peter Anaradian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251886%22"}, {"id": "fda:K252913", "company": "Sonomotion, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252913: Break Wave", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252913", "people": [{"name": "Oren Levy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252913%22"}, {"id": "fda:K252807", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252807: Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252807", "people": [{"name": "Stacy Valdez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252807%22"}, {"id": "fda:K251307", "company": "Shenzhen Hingmed Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251307: Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251307", "people": [{"name": "Huang YongBan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251307%22"}, {"id": "trialreg:NCT07333547", "company": "Idoven 1903 S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform", "source_url": "https://clinicaltrials.gov/study/NCT07333547"}, {"id": "trialreg:NCT07334691", "company": "Cardiovalve Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System", "source_url": "https://clinicaltrials.gov/study/NCT07334691"}, {"id": "trialreg:NCT07332182", "company": "Fin-Ceramica Faenza Spa", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MaioRegen Prime Study for the Treatment of Deep Osteochondral Lesion of the Knee", "source_url": "https://clinicaltrials.gov/study/NCT07332182"}, {"id": "trialreg:NCT07333183", "company": "Pulmovant, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD", "source_url": "https://clinicaltrials.gov/study/NCT07333183"}, {"id": "trialreg:NCT07334717", "company": "Ennogen Healthcare Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Observational Clinical Study to Collect Photographic Data of Wounds With Hypergranulation to Aid Development of a Hypergranulation Clinical Endpoint and Assessment Tool, And Generate Participant Reported Data to Inform Trial Design", "source_url": "https://clinicaltrials.gov/study/NCT07334717"}, {"id": "trialreg:NCT07331857", "company": "Digma Medical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Digma System First in Human (FIH) Study", "source_url": "https://clinicaltrials.gov/study/NCT07331857"}, {"id": "trialreg:NCT07332650", "company": "Nordberg Medical AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Clinical Investigation to Evaluate the Safety and Effectiveness of Jul\u00e4ine\u2122 in Improving Gluteal Skin Laxity in Adults.", "source_url": "https://clinicaltrials.gov/study/NCT07332650"}, {"id": "breakthrough:K252913", "company": "Sonomotion, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-01-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K252913: BREAK WAVE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K252842", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252842: SafeOp 3: Neural Informatix System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252842", "people": [{"name": "Garima Shrivastava", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252842%22"}, {"id": "fda:K251157", "company": "Truvian Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251157: Core Metabolic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251157", "people": [{"name": "Tho Tran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251157%22"}, {"id": "fda:K253957", "company": "Instrumentation Laboratory (IL) Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253957: HemosIL Silica Clotting Time", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253957", "people": [{"name": "Kirivann Chhoeun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253957%22"}, {"id": "fda:K252906", "company": "Ethicon Endo-Surgery, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252906: ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252906", "people": [{"name": "Roberta Cabral Franca", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252906%22"}, {"id": "fda:K253973", "company": "Liaoning Upcera Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253973: Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253973", "people": [{"name": "Li Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253973%22"}, {"id": "fda:K253964", "company": "Unimed Medical Supplies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253964: Disposable Neonatal NIBP Cuff (U1681S-C51N)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253964", "people": [{"name": "Huanyu Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253964%22"}, {"id": "fda:K252206", "company": "Nova Biomedical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252206: Nova Allegro UACR Assay, Nova Allegro Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252206", "people": [{"name": "Glen D'Souza", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252206%22"}, {"id": "fda:K253550", "company": "GI Windows, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253550: Self-Forming Magnet (Flexagon Plus OTOLoc)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253550", "people": [{"name": "Westwood Bobay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253550%22"}, {"id": "fda:K251139", "company": "Fresenius Kabi AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251139: KabiHelp\u00ae Uno; KabiHelp\u00ae Advance plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251139", "people": [{"name": "Rhoda Lynn Valera", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251139%22"}, {"id": "fda:K254003", "company": "FH Industrie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254003: JARVIS Metaphyseal Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254003", "people": [{"name": "Naoual Rahimi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254003%22"}, {"id": "fda:K252589", "company": "AliveCor, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252589: Corvair Monza", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252589", "people": [{"name": "Samip Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252589%22"}, {"id": "fda:K252674", "company": "Solo Pace, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252674: Solo Pace Fusion System (SOLOFUSE1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252674", "people": [{"name": "Matt Olson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252674%22"}, {"id": "fda:K252847", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252847: NextAR Hip Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252847", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252847%22"}, {"id": "fda:K253075", "company": "Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253075: Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253075", "people": [{"name": "Lezhang Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253075%22"}, {"id": "fda:K253142", "company": "Ningbo Ranor Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253142: Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253142", "people": [{"name": "Jia'nan Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253142%22"}, {"id": "fda:K252339", "company": "Iotamotion, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252339: iotaSOFT\u00ae Insertion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252339", "people": [{"name": "Khamporn Pendergrass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252339%22"}, {"id": "trialreg:NCT07331181", "company": "Innate srl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Performance and Safety of INNEA and INNEA AQUA for the Treatment of Cheek and d\u00e9colletage Wrinkles", "source_url": "https://clinicaltrials.gov/study/NCT07331181"}, {"id": "trialreg:NCT07330817", "company": "Cardionovum GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis", "source_url": "https://clinicaltrials.gov/study/NCT07330817"}, {"id": "trialreg:NCT07330960", "company": "Qbtech AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Augmenting Existing Normative Data for QbMobile in Healthy Children Aged 6-11 Years", "source_url": "https://clinicaltrials.gov/study/NCT07330960"}, {"id": "trialreg:NCT07329673", "company": "Qbtech AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms", "source_url": "https://clinicaltrials.gov/study/NCT07329673"}, {"id": "trialreg:NCT07331285", "company": "Nyxoah Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation", "source_url": "https://clinicaltrials.gov/study/NCT07331285"}, {"id": "trialreg:NCT07330752", "company": "Angiolutions GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: First-in-Human Trial of the A3-Shield System for Stabilizing Abdominal Aortic Aneurysms", "source_url": "https://clinicaltrials.gov/study/NCT07330752"}, {"id": "fda:K253784", "company": "Singular Health Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253784: 3DICOM MD Cloud", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253784", "people": [{"name": "Andre Marchezini Rocha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253784%22"}, {"id": "fda:K253266", "company": "Spine Innovation, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253266: Titanium Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253266", "people": [{"name": "Jude Paganelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253266%22"}, {"id": "fda:K253512", "company": "Medtronic Minimed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253512: MiniMed Go App", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253512", "people": [{"name": "Ajay Aluru", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253512%22"}, {"id": "fda:K252794", "company": "Imricor Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252794: Vision-MR\u0099 Diagnostic Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252794", "people": [{"name": "Jordan Todd", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252794%22"}, {"id": "fda:K253639", "company": "GE Healthcare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253639: View", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253639", "people": [{"name": "Tong Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253639%22"}, {"id": "fda:K252759", "company": "Kane Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252759: revyve\u00ae Antimicrobial Skin and Wound Cleanser", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252759", "people": [{"name": "Valerie Acosta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252759%22"}, {"id": "fda:K252788", "company": "Tornier, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252788: Tornier Perform\u0099 Reversed Monopost Glenoid (Perform Mono)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252788", "people": [{"name": "Lamia Askri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252788%22"}, {"id": "fda:K252669", "company": "Zhongshan Xiaolan Town Senlan Electronic Factory", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252669: Fetal Doppler U8-25, U9-25", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252669", "people": [{"name": "Runtong Zhong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252669%22"}, {"id": "fda:K253370", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253370: LOGIQ Totus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253370", "people": [{"name": "Lee Bush", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253370%22"}, {"id": "fda:K252585", "company": "Izenimplant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252585: ZENEX Implant System_R-System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252585", "people": [{"name": "Kim Nayoung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252585%22"}, {"id": "fda:K251160", "company": "Shenzhen Med-Link Electronics Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251160: Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251160", "people": [{"name": "Summer Xia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251160%22"}, {"id": "fda:K252711", "company": "Intelivation Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252711: Advantage-C\u0099 Ti3D Cervical Interbody Fusion Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252711", "people": [{"name": "Thara Moussaoui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252711%22"}, {"id": "trialreg:NCT07326657", "company": "Kerecis Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Whether Intact Fish Skin Graft Can Decrease the Need for Autograft in the Treatment of Deep Partial-Thickness Burns", "source_url": "https://clinicaltrials.gov/study/NCT07326657"}, {"id": "trialreg:NCT07325578", "company": "Precision IO Group", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures", "source_url": "https://clinicaltrials.gov/study/NCT07325578"}, {"id": "trialreg:NCT07326722", "company": "Spark Biomedical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Delivering tAN to Reduce HMB: The LUNA Study", "source_url": "https://clinicaltrials.gov/study/NCT07326722"}, {"id": "trialreg:NCT07327528", "company": "Relief srl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Monocentric Pilot Study for the Application of an Endourethral Device for the Treatment of Stress Urinary Incontinence", "source_url": "https://clinicaltrials.gov/study/NCT07327528"}, {"id": "trialreg:NCT07325162", "company": "Cassini Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Development of Optical Biometer", "source_url": "https://clinicaltrials.gov/study/NCT07325162"}, {"id": "trialreg:NCT07326215", "company": "Vantive Health LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+", "source_url": "https://clinicaltrials.gov/study/NCT07326215"}, {"id": "trialreg:NCT07325708", "company": "Phantom Neuro Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control", "source_url": "https://clinicaltrials.gov/study/NCT07325708"}, {"id": "trialreg:NCT07325214", "company": "IMGT Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Chemotherapy With or Without IMD10 (Focused Ultrasound) in the Treatment of Borderline Resectable or Locally Advanced Pancreatic Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07325214"}, {"id": "trialreg:NCT07326735", "company": "Frisch Medical Device Private Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon", "source_url": "https://clinicaltrials.gov/study/NCT07326735"}, {"id": "trialreg:NCT07325461", "company": "Tandem Diabetes Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07325461"}, {"id": "fda:K252890", "company": "Kerr Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252890: ZenSeal Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252890", "people": [{"name": "Maria Rao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252890%22"}, {"id": "fda:K253109", "company": "Shenzhen Best Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253109: Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253109", "people": [{"name": "Martin Wong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253109%22"}, {"id": "fda:K253924", "company": "3-D Matrix Europe SAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253924: PuraStat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253924", "people": [{"name": "Audrey Vion", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253924%22"}, {"id": "fda:K253308", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253308: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253308", "people": [{"name": "Polliane Carvalho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253308%22"}, {"id": "fda:K252970", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252970: BriefCase-Triage: CARE Multi-triage CT Body", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252970", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252970%22"}, {"id": "fda:K252727", "company": "JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252727: Neodent InLab Validated Workflow", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252727", "people": [{"name": "Mariana Hartmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252727%22"}, {"id": "fda:K253941", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253941: CD Horizon\u0099 ModuLeX\u0099 Spinal System (LigaMAS Head Assembly)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253941", "people": [{"name": "Justin O'Connor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253941%22"}, {"id": "fda:K251454", "company": "Beame Medical Technology (Shenzhen) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251454: Clear Aligner (SCF-3348)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251454", "people": [{"name": "Yajuan Ou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251454%22"}, {"id": "fda:K253990", "company": "S.m.a.i.o", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253990: KHEIRON\u00ae Spinal Fixation System, including patient specific K-ROD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253990", "people": [{"name": "Jean-Charles Roussouly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253990%22"}, {"id": "fda:K250305", "company": "Innovative Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250305: Reprocessed Agilis NxT Steerable Introducer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250305", "people": [{"name": "Rick Ferreira", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250305%22"}, {"id": "fda:K253158", "company": "Vy Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253158: VyBrate\u0099 VBR System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253158", "people": [{"name": "Jordan Hendrickson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253158%22"}, {"id": "fda:K253939", "company": "RemSleep Holdings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253939: DeltaWave Nasal Pillow System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253939", "people": [{"name": "Tom Wood", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253939%22"}, {"id": "fda:K253009", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253009: DS Core Detect", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253009", "people": [{"name": "Deepthi Paknikar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253009%22"}, {"id": "fda:K253366", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253366: LOGIQ Fortis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253366", "people": [{"name": "Lee Bush", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253366%22"}, {"id": "fda:K252507", "company": "Amv Consulting, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252507: SmileInspector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252507", "people": [{"name": "Alexey Vishnevskiy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252507%22"}, {"id": "fda:K253923", "company": "3-D Matrix Europe SAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253923: PuraStat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253923", "people": [{"name": "Audrey Vion", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253923%22"}, {"id": "fda:K251207", "company": "Avantec Vascular Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251207: Sangria\u0099 Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251207", "people": [{"name": "Jack Hoshino", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251207%22"}, {"id": "trialreg:NCT07324031", "company": "AtaCor Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study", "source_url": "https://clinicaltrials.gov/study/NCT07324031"}, {"id": "trialreg:NCT07322432", "company": "VapeAway", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction", "source_url": "https://clinicaltrials.gov/study/NCT07322432"}, {"id": "trialreg:NCT07322913", "company": "Intervascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Intervascular Post-Market Clinical Follow-Up (PMCF) Registry", "source_url": "https://clinicaltrials.gov/study/NCT07322913"}, {"id": "trialreg:NCT07321925", "company": "Endra Lifesciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Thermoacoustic Method for Estimating Liver Fat Fraction", "source_url": "https://clinicaltrials.gov/study/NCT07321925"}, {"id": "trialreg:NCT07322211", "company": "Unicon Optical Co. Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses", "source_url": "https://clinicaltrials.gov/study/NCT07322211"}, {"id": "trialreg:NCT07322770", "company": "Contrad Swiss SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Retrospective Evaluation of the Long-term Effectiveness of the CR500\u2122 SINGLE-DOSE GEL Medical Device in Patients With Knee Osteoarthritis (KOA)", "source_url": "https://clinicaltrials.gov/study/NCT07322770"}, {"id": "trialreg:NCT07324421", "company": "Resolve Stroke", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparison of Ultrasound Cerebral Perfusion Imaging With Routine Perfusion CT", "source_url": "https://clinicaltrials.gov/study/NCT07324421"}, {"id": "trialreg:NCT07321938", "company": "Owlet Baby Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers", "source_url": "https://clinicaltrials.gov/study/NCT07321938"}, {"id": "trialreg:NCT07321899", "company": "Medtronic Cardiovascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid\u2122 Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation", "source_url": "https://clinicaltrials.gov/study/NCT07321899"}, {"id": "breakthrough:K252970", "company": "Aidoc Medical, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2026-01-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K252970: BRIEFCASE-TRIAGE: CARE MULTI-TRIAGE CT BODY", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K251097", "company": "Vesalio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251097: V-DAC Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251097", "people": [{"name": "Sharon Shachar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251097%22"}, {"id": "fda:K253178", "company": "Crossroads Extremity Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253178: TRILEAP Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253178", "people": [{"name": "Jacqueline Gorberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253178%22"}, {"id": "fda:K252894", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252894: aprevo\u00ae cervical interbody system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252894", "people": [{"name": "Jesse Albright", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252894%22"}, {"id": "fda:K251165", "company": "Innaccel Technologies Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251165: Saans (F4-01-00-000-000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251165", "people": [{"name": "Vijayarajan Alagumalai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251165%22"}, {"id": "fda:K253618", "company": "Abanza Tecnomed S.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253618: QuadLock\u0099 Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253618", "people": [{"name": "Andrea Larranaga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253618%22"}, {"id": "fda:K252749", "company": "Shanghai Medconn Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252749: Medconn 8K Glycated Hemoglobin Test System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252749", "people": [{"name": "Judan Guan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252749%22"}, {"id": "fda:K250341", "company": "El Global Trade, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250341: Sensilift Pro (ST300XXYYZZZ)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250341", "people": [{"name": "Stephanie Khoury", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250341%22"}, {"id": "fda:K252886", "company": "Hh Global Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252886: Pen Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252886", "people": [{"name": "Grace Hammond", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252886%22"}, {"id": "fda:K253793", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253793: Materialise TKA Guide System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253793", "people": [{"name": "Giulia Girola", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253793%22"}, {"id": "trialreg:NCT07318792", "company": "Estar Medical dba Medical Technologies, LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Using TropoCells(R) Autologous Platelet-Rich Fibrin (PRF) to Treat Chronic Non-Healing Wounds", "source_url": "https://clinicaltrials.gov/study/NCT07318792"}, {"id": "trialreg:NCT07319910", "company": "NovoCure GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Continued Access Program for Tumor Treating Fields (TTFields) Used With Chemotherapy (Gemcitabine and Nab-Paclitaxel) in Adults With Locally Advanced Pancreatic Cancer (PANOVA-3CA)", "source_url": "https://clinicaltrials.gov/study/NCT07319910"}, {"id": "trialreg:NCT07319377", "company": "Exosystems", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Safety and Efficacy of a Digital Therapeutic Device to Improve Strength in Sarcopenia (Sarc-DTx)", "source_url": "https://clinicaltrials.gov/study/NCT07319377"}, {"id": "fda:K252650", "company": "Makrite Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252650: Disposable Medical Face Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252650", "people": [{"name": "Bob Wen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252650%22"}, {"id": "fda:K251630", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251630: Atellica IM Total PSA II (tPSAII)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251630", "people": [{"name": "Kira Gordon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251630%22"}, {"id": "fda:K252018", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252018: HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252018", "people": [{"name": "So-Yeon Jang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252018%22"}, {"id": "fda:K253008", "company": "Maihub Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253008: maiLink", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253008", "people": [{"name": "Gyungeun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253008%22"}, {"id": "fda:K251668", "company": "Kaneka Americas Holding, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251668: SurfRider 13 Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251668", "people": [{"name": "Takuji Nishide", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251668%22"}, {"id": "fda:K251757", "company": "Innovacyn, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251757: Puracyn\u00ae Plus Antimicrobial Irrigation Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251757", "people": [{"name": "Hungnan Lo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251757%22"}, {"id": "fda:K252988", "company": "Radformation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252988: ChartCheck (RADCH V1.6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252988", "people": [{"name": "Jennifer Wampler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252988%22"}, {"id": "pma:P240014", "company": "Stereotaxis, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2026-01-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240014: MAGiC Ablation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240014", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240014%22"}, {"id": "trialreg:NCT07316517", "company": "CMR Surgical Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07316517"}, {"id": "trialreg:NCT07317648", "company": "Becton, Dickinson and Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ClearSight NextGen1 Study", "source_url": "https://clinicaltrials.gov/study/NCT07317648"}, {"id": "trialreg:NCT07316530", "company": "Coloplast A/S", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.", "source_url": "https://clinicaltrials.gov/study/NCT07316530"}, {"id": "trialreg:NCT07317115", "company": "GT Metabolic Solutions, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07317115"}, {"id": "trialreg:NCT07316088", "company": "Oui Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms", "source_url": "https://clinicaltrials.gov/study/NCT07316088"}, {"id": "trialreg:NCT07317076", "company": "GT Metabolic Solutions, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: GT Metabolic Magnet System in Adults With Gastrointestinal Disorders", "source_url": "https://clinicaltrials.gov/study/NCT07317076"}, {"id": "trialreg:NCT07317102", "company": "Insulet Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)", "source_url": "https://clinicaltrials.gov/study/NCT07317102"}, {"id": "fda:K253854", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253854: MONTAGE XT Cranial Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253854", "people": [{"name": "Alyssa McDermott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253854%22"}, {"id": "fda:K252817", "company": "Ningbo Baichen Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252817: Mobility Scooter (BC-MS310)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252817", "people": [{"name": "Xiaolong Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252817%22"}, {"id": "fda:K251178", "company": "Jamjoom Fullcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251178: Ready to use Nelaton Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251178", "people": [{"name": "Yinan Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251178%22"}, {"id": "fda:K253867", "company": "ZuriMED Technologies AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2026-01-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253867: FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253867", "people": [{"name": "Elias Bachmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253867%22"}, {"id": "trialreg:NCT07315867", "company": "Kairon Connect, PBC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Better Social, Emotional Communication, Healthy Relationship and ASD Accommodation Skills: Emotional Intelligence (\"EQ\") Training for Autistic People and ASD Accommodation Training for People Who Care", "source_url": "https://clinicaltrials.gov/study/NCT07315867"}, {"id": "trialreg:NCT07313800", "company": "Cortex Neurovascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization", "source_url": "https://clinicaltrials.gov/study/NCT07313800"}, {"id": "trialreg:NCT07314047", "company": "MicroPort NeuroTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation", "source_url": "https://clinicaltrials.gov/study/NCT07314047"}, {"id": "trialreg:NCT07313930", "company": "SurgiQuest, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2026-01-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Gastrectomy at Low Pressure Trial - (GALPT)", "source_url": "https://clinicaltrials.gov/study/NCT07313930"}, {"id": "fda:K252951", "company": "Neurofield, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252951: Genesis Sleep", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252951", "people": [{"name": "Nicholas Dogris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252951%22"}, {"id": "fda:K252901", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252901: Tyber Medical Trauma Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252901", "people": [{"name": "Stacie Geffner-Atiya", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252901%22"}, {"id": "fda:K253888", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253888: MOLLI 2 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253888", "people": [{"name": "Michelle Stephens", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253888%22"}, {"id": "fda:K243627", "company": "Arc Trauma, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243627: Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243627", "people": [{"name": "Jeffrey Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243627%22"}, {"id": "fda:K253305", "company": "Shenzhen Jiantuo Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253305: TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253305", "people": [{"name": "Jin Liang Zou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253305%22"}, {"id": "pma:P250010", "company": "Neurolief , Ltd.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-12-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250010: Proliv\u0099Rx System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250010", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250010%22"}, {"id": "trialreg:NCT07312383", "company": "ODI Medical AS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Skin Microcirculation in Patients With Lower Limb Atherosclerosis", "source_url": "https://clinicaltrials.gov/study/NCT07312383"}, {"id": "trialreg:NCT07311733", "company": "ivWatch, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Milky Way Sensor: Device Validation for Infiltrated Tissues", "source_url": "https://clinicaltrials.gov/study/NCT07311733"}, {"id": "trialreg:NCT07312513", "company": "Lohmann & Rauscher", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft\u00ae Duo With Debrisoft\u00ae Pad in the Debridement of Wounds", "source_url": "https://clinicaltrials.gov/study/NCT07312513"}, {"id": "trialreg:NCT07311876", "company": "MMI (Medical Microinstruments, Inc.)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani", "source_url": "https://clinicaltrials.gov/study/NCT07311876"}, {"id": "trialreg:NCT07312006", "company": "SurgiQuest, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparison of AirSeal to DV5 Insufflation in Gastric Sleeve Procedures - The \"CAT5-GS\" Study", "source_url": "https://clinicaltrials.gov/study/NCT07312006"}, {"id": "breakthrough:P250010", "company": "Neurolief, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-12-31", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P250010: PROLIV RX SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "hde:H240004", "company": "MicroVention, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2025-12-31", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H240004: PHIL Liquid Embolic System", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "fda:K253895", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253895: Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253895", "people": [{"name": "Stacy Valdez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253895%22"}, {"id": "fda:K251091", "company": "Truvian Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251091: Lipids", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251091", "people": [{"name": "Tho Tran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251091%22"}, {"id": "fda:K250168", "company": "Lucas Lifecare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250168: Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250168", "people": [{"name": "Joseph Paul Vincent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250168%22"}, {"id": "fda:K253844", "company": "Mediso Medical Imaging Systems, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253844: AnyScan 3.0 NM Scanner Family", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253844", "people": [{"name": "Daniel Cser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253844%22"}, {"id": "fda:K253532", "company": "Spectrum Dynamics Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253532: TruSPECT Processing Station", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253532", "people": [{"name": "Igor Naroditsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253532%22"}, {"id": "fda:K242492", "company": "Techno-Path Manufacturing , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242492: Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242492", "people": [{"name": "Alan McDonagh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242492%22"}, {"id": "trialreg:NCT07308665", "company": "ConvaTec Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Aquacel With Strengthening Fiber (WSF) Ribbon Dressings", "source_url": "https://clinicaltrials.gov/study/NCT07308665"}, {"id": "trialreg:NCT07309809", "company": "GE Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Portrait Mobile Monitoring Solution V2.0 External Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT07309809"}, {"id": "trialreg:NCT07308847", "company": "Medtronic Cardiac Ablation Solutions", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360\u2122 Catheter and Affera\u2122 Mapping and Ablation System (Horizon 360)", "source_url": "https://clinicaltrials.gov/study/NCT07308847"}, {"id": "trialreg:NCT07310862", "company": "Clarity Health Technologies, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Virtual Reality - Gamma Sensory Stimulation for Improving Fatigue in People With Multiple Sclerosis", "source_url": "https://clinicaltrials.gov/study/NCT07310862"}, {"id": "fda:K251025", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251025: Mon-a-Therm\u0099 Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251025", "people": [{"name": "Angelica Medina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251025%22"}, {"id": "fda:K253881", "company": "Shenzhen Fansizhe Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253881: Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253881", "people": [{"name": "Endang Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253881%22"}, {"id": "fda:K253343", "company": "Celebrace", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253343: Celebrace Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253343", "people": [{"name": "Sarah Moss", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253343%22"}, {"id": "fda:K251313", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251313: Shiley\u0099 Adult Flexible Tracheostomy Tube XLT with TaperGuard\u0099 Cuff, Distal with Disposable Inner Cannula; Shiley\u0099 Adult Flexible Tracheostomy Tube XLT with TaperGuard\u0099 Cuff, Proximal with Disposable Inner Cannula; Shiley\u0099 Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley\u0099 Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley\u0099 Adult Flexible Disposable Inner Cannula XLT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251313", "people": [{"name": "Shruti Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251313%22"}, {"id": "fda:K251123", "company": "Taewoong Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251123: Niti-S Biliary Stent; Niti-S Biliary Slim M Stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251123", "people": [{"name": "Yongjin \"Jeff\" Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251123%22"}, {"id": "fda:K253325", "company": "Toetal Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253325: ZipToe\u0099 Hammertoe Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253325", "people": [{"name": "Bill Rhoda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253325%22"}, {"id": "fda:K251534", "company": "Foshan Kycare Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251534: Oxygen Concentrator (J10A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251534", "people": [{"name": "Leona Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251534%22"}, {"id": "trialreg:NCT07308418", "company": "Magnes AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Influence of Vibrotactile Stimulation on Self-selected Walking Speed in People With Parkinson's Disease", "source_url": "https://clinicaltrials.gov/study/NCT07308418"}, {"id": "trialreg:NCT07304531", "company": "NOWDiagnostics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: First To Know Pregnancy Test - Clinical Evaluation Protocol", "source_url": "https://clinicaltrials.gov/study/NCT07304531"}, {"id": "trialreg:NCT07304102", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of GORE\u00ae EXCLUDER\u00ae IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization", "source_url": "https://clinicaltrials.gov/study/NCT07304102"}, {"id": "fda:K253400", "company": "Shenzhen Saidi Light Therapy Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253400: LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253400", "people": [{"name": "Zaijun Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253400%22"}, {"id": "fda:K253342", "company": "Speclipse, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253342: PICO-K", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253342", "people": [{"name": "Myung Seo Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253342%22"}, {"id": "fda:K253349", "company": "Light Tree Ventures Europe B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253349: Hair Regrowth Cap (Model: T-119-HRC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253349", "people": [{"name": "Kim Markwat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253349%22"}, {"id": "fda:K253279", "company": "Heat IN A Click, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253279: Feather/numiere 05 06 07 (05)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253279", "people": [{"name": "Guy Levi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253279%22"}, {"id": "trialreg:NCT07301619", "company": "i+Med S.Coop.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-market Study on BtHCROSS\u00ae for Restoring Facial Volume After a Single Injection", "source_url": "https://clinicaltrials.gov/study/NCT07301619"}, {"id": "trialreg:NCT07303452", "company": "Restera, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Restera\u2122 Serene\u2122 System in Adults With Obstructive Sleep Apnea", "source_url": "https://clinicaltrials.gov/study/NCT07303452"}, {"id": "trialreg:NCT07302581", "company": "OrganTech, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament", "source_url": "https://clinicaltrials.gov/study/NCT07302581"}, {"id": "trialreg:NCT07300904", "company": "Stimuli Technology", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Tensi+ for Treating Overactive Bladder", "source_url": "https://clinicaltrials.gov/study/NCT07300904"}, {"id": "trialreg:NCT07301346", "company": "Precisis US, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EASEE\u00ae System Pivotal Study for the United States of America", "source_url": "https://clinicaltrials.gov/study/NCT07301346"}, {"id": "trialreg:NCT07301749", "company": "Amber Implants B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures", "source_url": "https://clinicaltrials.gov/study/NCT07301749"}, {"id": "fda:K252187", "company": "Aura Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252187: Aura Glide (FC40)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252187", "people": [{"name": "Connie Lefkowitz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252187%22"}, {"id": "fda:K253217", "company": "Medimaging Integrated Solution, Inc (Miis)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253217: MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253217", "people": [{"name": "Sandy Chou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253217%22"}, {"id": "fda:K253281", "company": "Updoc, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253281: UpDoc", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253281", "people": [{"name": "Kendal Dinsmore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253281%22"}, {"id": "fda:K251800", "company": "Healgen Scientific,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251800: Healgen\u00ae URS Test Strips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251800", "people": [{"name": "Jianqui Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251800%22"}, {"id": "fda:K251958", "company": "Dynapulse Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251958: VEINOPLUS Back", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251958", "people": [{"name": "Steffen Magnell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251958%22"}, {"id": "fda:K253135", "company": "Dongguan Yijiaming Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253135: LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253135", "people": [{"name": "Qiang Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253135%22"}, {"id": "fda:K253341", "company": "Medentika GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253341: Custom Abutments AS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253341", "people": [{"name": "Alexandra Schulz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253341%22"}, {"id": "fda:K253091", "company": "Therapanacea Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253091: ART-Plan+ (v3.1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253091", "people": [{"name": "Ajachandra Bhairavi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253091%22"}, {"id": "fda:K253122", "company": "Sim&Cure", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253122: Sim&Size", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253122", "people": [{"name": "Lucile Azema", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253122%22"}, {"id": "fda:K253312", "company": "Orangecad Med GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253312: OrangeCAD Med Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253312", "people": [{"name": "Markus Munz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253312%22"}, {"id": "fda:K252379", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252379: AIR Recon DL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252379", "people": [{"name": "Derek Schmidtke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252379%22"}, {"id": "fda:K251268", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251268: Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251268", "people": [{"name": "Tracy Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251268%22"}, {"id": "fda:DEN250032", "company": "DiaSorin, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250032: LIAISON\u00ae XL MUREX Anti-HDV (318260); LIAISON\u00ae XL MUREX Control Anti-HDV (318261)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250032", "people": [{"name": "Kerrie Oetter", "role": "510(k) submission contact"}]}, {"id": "fda:K250476", "company": "Paragon Implant Mfg., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250476: NizPlant Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250476", "people": [{"name": "Renee Bennett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250476%22"}, {"id": "fda:K252835", "company": "Guangdong Prestige Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252835: Electric Scooter (S202572J, S2060, M2089, S2050)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252835", "people": [{"name": "Zhao Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252835%22"}, {"id": "fda:K252633", "company": "Cylite Pty. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252633: UNITY DX (UDX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252633", "people": [{"name": "Arnold Ouyang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252633%22"}, {"id": "fda:K254163", "company": "Nakanishi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254163: VarioSurg 4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254163", "people": [{"name": "Kikuchi Masaaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254163%22"}, {"id": "fda:K251991", "company": "Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251991: SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251991", "people": [{"name": "Lee Parker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251991%22"}, {"id": "fda:K251978", "company": "Diasorin Molecular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251978: LIAISON NES FLU A/B, RSV & COVID-19", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251978", "people": [{"name": "Sarah Baumann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251978%22"}, {"id": "fda:K253072", "company": "Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253072: Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253072", "people": [{"name": "Caitlin Liang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253072%22"}, {"id": "fda:K252493", "company": "Hycor Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252493: NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252493", "people": [{"name": "Aashrey Kaul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252493%22"}, {"id": "fda:K253740", "company": "Hong Qiangxing (Shenzhen) Electronics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253740: TENS&EMS (HZ9151B, HZ9151C, HZ9151D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253740", "people": [{"name": "Jiaxuan Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253740%22"}, {"id": "fda:K252146", "company": "Shenzhen Siken 3D Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252146: Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252146", "people": [{"name": "Jing Quan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252146%22"}, {"id": "fda:K253754", "company": "Philips Consumer Lifestyle B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253754: Philips Lumea IPL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253754", "people": [{"name": "Martijn Halbesma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253754%22"}, {"id": "fda:K253567", "company": "Healgen Scientific,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253567: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253567", "people": [{"name": "Fang Jianqiu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253567%22"}, {"id": "fda:K253675", "company": "Osteoremedies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253675: OsteoRemedies Hip Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253675", "people": [{"name": "Eric Stookey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253675%22"}, {"id": "fda:K252145", "company": "Paragon Implant Mfg., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252145: GEN5\u0099 and GEN5+\u0099 3.3mmD Dental Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252145", "people": [{"name": "Renee Bennett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252145%22"}, {"id": "fda:DEN250004", "company": "Hai Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250004: QIKCAP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250004", "people": [{"name": "Brittany Batts", "role": "510(k) submission contact"}]}, {"id": "fda:K253239", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253239: Active-V Total Knee System; World Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253239", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253239%22"}, {"id": "fda:K251683", "company": "Bruno Vision Care, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251683: Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251683", "people": [{"name": "Eddie Catalfamo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251683%22"}, {"id": "trialreg:NCT07298473", "company": "Medtronic Cardiac Ablation Solutions", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)", "source_url": "https://clinicaltrials.gov/study/NCT07298473"}, {"id": "trialreg:NCT07300163", "company": "Diabetis JSC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FeetSee Thermal Images Collection Protocol in Diabetes Patients", "source_url": "https://clinicaltrials.gov/study/NCT07300163"}, {"id": "trialreg:NCT07298499", "company": "Starkey Laboratories, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Amplification and Tinnitus Masker Performance and Benefit for Adults With Hearing Loss and Tinnitus", "source_url": "https://clinicaltrials.gov/study/NCT07298499"}, {"id": "trialreg:NCT07298317", "company": "Auris Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair", "source_url": "https://clinicaltrials.gov/study/NCT07298317"}, {"id": "trialreg:NCT07298369", "company": "Efforia, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cracking Consciousness Study With Monroe & Neuphoria (Cohort 2&3)", "source_url": "https://clinicaltrials.gov/study/NCT07298369"}, {"id": "trialreg:NCT07298382", "company": "Efforia, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: See the Impact Beem's Blue Light Therapy Has on Your Skin Health!", "source_url": "https://clinicaltrials.gov/study/NCT07298382"}, {"id": "trialreg:NCT07298252", "company": "Carebot s.r.o.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Diagnostic Accuracy of Carebot AI MMG in Mammography Screening: Multicenter MRMC Study", "source_url": "https://clinicaltrials.gov/study/NCT07298252"}, {"id": "denovo:DEN250032", "company": "DiaSorin, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-12-23", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250032 granted: LIAISON\u00ae XL MUREX Anti-HDV (318260); LIA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250032"}, {"id": "denovo:DEN250004", "company": "Hai Solutions", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-12-23", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250004 granted: QIKCAP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250004"}, {"id": "breakthrough:DEN250032", "company": "Diasorin, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-12-23", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN250032: LIAISON XL MUREX ANTI-HDV (318260); LIAISON XL MUREX CONTROL ANTI-HDV (318261)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253781", "company": "Taiwan Surgical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253781: InnoClip Clip Applier", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253781", "people": [{"name": "Ken Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253781%22"}, {"id": "fda:K253661", "company": "THINK Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253661: TMINI Miniature Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253661", "people": [{"name": "Meliha Mulalic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253661%22"}, {"id": "fda:K253769", "company": "Instylla, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253769: Instylla Delivery Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253769", "people": [{"name": "Jennifer Greer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253769%22"}, {"id": "fda:K253903", "company": "Taiwan Surgical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253903: InnoClip Disposable Clip Applier", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253903", "people": [{"name": "Ken Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253903%22"}, {"id": "fda:K252673", "company": "Lacerta Life Science", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252673: LacertaMatrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252673", "people": [{"name": "Ted Bundrick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252673%22"}, {"id": "fda:K251783", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251783: Inspire HCR and HCR DUAL cardiotomy reservoirs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251783", "people": [{"name": "Martina Carlini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251783%22"}, {"id": "fda:K251605", "company": "DIMPLO, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251605: DIMPLO Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251605", "people": [{"name": "Jiyeon Sung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251605%22"}, {"id": "fda:K252616", "company": "Shenzhen Homed Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252616: Portable oxygen concentrator (JLO-190P)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252616", "people": [{"name": "Shengming Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252616%22"}, {"id": "fda:K253339", "company": "Stimlabs, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253339: Theracor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253339", "people": [{"name": "Melissa O'Connor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253339%22"}, {"id": "fda:K252611", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252611: aprevo\u00ae cervical plating system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252611", "people": [{"name": "Jesse Albright", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252611%22"}, {"id": "fda:K251019", "company": "Bioteque Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251019: BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251019", "people": [{"name": "Stella Hsu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251019%22"}, {"id": "fda:K251105", "company": "Emed Technologies Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251105: Tetra (TM-20); Tetra (TM-50)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251105", "people": [{"name": "Olena Whalen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251105%22"}, {"id": "fda:K252109", "company": "RaySearch Laboratories AB (PUBL)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252109: RayStation (2024A SP3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252109", "people": [{"name": "Olympiada Lachana", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252109%22"}, {"id": "fda:K251159", "company": "Zhenjiang Assure Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251159: Power wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251159", "people": [{"name": "Mei Ying", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251159%22"}, {"id": "fda:K252068", "company": "Oxos Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252068: MC2 Portable X-ray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252068", "people": [{"name": "Dhruv Vishwakarma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252068%22"}, {"id": "fda:K253664", "company": "Iterative Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253664: SKOUT system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253664", "people": [{"name": "Caitlyn Seidl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253664%22"}, {"id": "fda:K252856", "company": "Peek Health, S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252856: PeekMed web", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252856", "people": [{"name": "Sara Silva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252856%22"}, {"id": "fda:K251764", "company": "Qingdao Kingon Medical Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251764: Oxygen Concentrator-P2-O5E", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251764", "people": [{"name": "Zhang Benrong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251764%22"}, {"id": "fda:K243342", "company": "Kp Trading Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243342: KP Protective Face Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243342", "people": [{"name": "Ji Hye Kwon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243342%22"}, {"id": "fda:K252743", "company": "ETHICON, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252743: STRATAFIX\u0099 Spiral PDS\u0099 Plus Knotless Tissue Control Device; STRATAFIX\u0099 Spiral MONOCRYL\u0099 Plus Knotless Tissue Control Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252743", "people": [{"name": "Samantha Mecker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252743%22"}, {"id": "fda:K250756", "company": "Pression, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250756: Pression Wave PRO External Counter-Pulsation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250756", "people": [{"name": "Adam Salamon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250756%22"}, {"id": "fda:K253222", "company": "Zhejiang Gongdong Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253222: Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253222", "people": [{"name": "Jingxiang Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253222%22"}, {"id": "fda:K252981", "company": "Empatica S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252981: EmbraceMini", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252981", "people": [{"name": "Alberto Poli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252981%22"}, {"id": "fda:K253876", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253876: HEDRON\u0099 Cervical Spacers (HEDRON C-MIS\u0099 Spacer)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253876", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253876%22"}, {"id": "fda:K252361", "company": "Accurkardia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252361: AccurECG Analysis System (v2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252361", "people": [{"name": "Juan Jimenez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252361%22"}, {"id": "fda:K253727", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253727: Syndesmosis TightRope PRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253727", "people": [{"name": "Stacy Valdez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253727%22"}, {"id": "fda:K250959", "company": "Bioticsai, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250959: BioticsAI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250959", "people": [{"name": "Salman Khan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250959%22"}, {"id": "fda:K252557", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252557: Lumify Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252557", "people": [{"name": "Gina Quiram", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252557%22"}, {"id": "pma:P250019", "company": "Edwards Lifesciences, LLC", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-12-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250019: SAPIEN M3 Transcatheter Mitral Valve Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250019", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250019%22"}, {"id": "trialreg:NCT07297810", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Development of a New Device and Method to Assess the Degree of Myopia and/or Astigmatism in Myopic People", "source_url": "https://clinicaltrials.gov/study/NCT07297810"}, {"id": "trialreg:NCT07296263", "company": "Hyperfine", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems", "source_url": "https://clinicaltrials.gov/study/NCT07296263"}, {"id": "trialreg:NCT07296744", "company": "Supira Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)", "source_url": "https://clinicaltrials.gov/study/NCT07296744"}, {"id": "trialreg:NCT07296419", "company": "Raydiant Oximetry, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems", "source_url": "https://clinicaltrials.gov/study/NCT07296419"}, {"id": "trialreg:NCT07296276", "company": "i-SENS, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM", "source_url": "https://clinicaltrials.gov/study/NCT07296276"}, {"id": "breakthrough:P250019", "company": "Edwards Lifesciences, LLC.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-12-22", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P250019: SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253409", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253409: C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253409", "people": [{"name": "Ryan Peterfeso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253409%22"}, {"id": "fda:K253054", "company": "Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253054: LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253054", "people": [{"name": "Tianfei He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253054%22"}, {"id": "fda:K253161", "company": "Ortho Development Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253161: Balanced Knee System TriMax Porous Femoral Components", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253161", "people": [{"name": "Drew Weaver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253161%22"}, {"id": "fda:K251037", "company": "Nucletron B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251037: Rectal Applicator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251037", "people": [{"name": "Loes Vloet-Emonts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251037%22"}, {"id": "fda:K253373", "company": "Southern Medical (Pty) , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253373: Southern Craniomaxillofacial (CMF) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253373", "people": [{"name": "Dalene Styger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253373%22"}, {"id": "fda:K251011", "company": "Unipack, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251011: Chiavaye Personal Moisturizer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251011", "people": [{"name": "Dinesh Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251011%22"}, {"id": "fda:K251143", "company": "Ningbo Ranor Medical Science & Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251143: Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251143", "people": [{"name": "Jia'nan Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251143%22"}, {"id": "fda:K252780", "company": "Shenzhen Beacon Display Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252780: LCD Monitor (CL1902A, CL2103F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252780", "people": [{"name": "Yafei Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252780%22"}, {"id": "fda:K253202", "company": "Stryker GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253202: Hoffmann LRF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253202", "people": [{"name": "Amy Noccioli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253202%22"}, {"id": "fda:K253733", "company": "Rhythm AI, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253733: STAR Apollo\u0099 Mapping System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253733", "people": [{"name": "D'Abate Linda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253733%22"}, {"id": "fda:K253358", "company": "Diazyme Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253358: Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (\u00bf) Free Light Chain Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253358", "people": [{"name": "Abhijit Datta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253358%22"}, {"id": "fda:K251074", "company": "Truvian Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251074: Tru Liver Health Test Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251074", "people": [{"name": "Tho Tran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251074%22"}, {"id": "fda:K253479", "company": "Fisher & Paykel Healthcare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253479: Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253479", "people": [{"name": "Jung Yun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253479%22"}, {"id": "fda:K251050", "company": "Gm Dos Reis Industria E Comercio", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251050: Pectus Versa System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251050", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251050%22"}, {"id": "fda:K251751", "company": "Shenzhen Ykd Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251751: Spo2 Sensor CSS032D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251751", "people": [{"name": "Long Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251751%22"}, {"id": "fda:K253086", "company": "Sunglor Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253086: LED Light Therapy Device (Models: SG-FM, SG-FE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253086", "people": [{"name": "Allen Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253086%22"}, {"id": "fda:K252974", "company": "Encore Medical L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252974: EMPOWR Knee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252974", "people": [{"name": "Morgan Paronish", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252974%22"}, {"id": "fda:K232365", "company": "Oconnell Regulatory Consultants, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K232365: Vivo 45 LS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232365", "people": [{"name": "Maureen OConnell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232365%22"}, {"id": "fda:K250864", "company": "Medskin Solutions Dr. Suwelack AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250864: MatriDerm pluS+ Bi-Layer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250864", "people": [{"name": "Jan Hermes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250864%22"}, {"id": "fda:K252781", "company": "Mikron Makina Sanayi VE Tic. Ltd. Sti.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252781: MSFX MIKRON PEEK CAGES", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252781", "people": [{"name": "Mustafa Ekiz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252781%22"}, {"id": "fda:K252838", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252838: MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252838", "people": [{"name": "Hertle Friederike", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252838%22"}, {"id": "fda:K252284", "company": "Csd Labs", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252284: eMurmur Heart AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252284", "people": [{"name": "Andreas Reinisch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252284%22"}, {"id": "fda:K253577", "company": "Medicrea International S.A.S. (Medtronic)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253577: IB3D\u0099 PL Spinal System (A24000000 / IB3D Universal Implant Inserter)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253577", "people": [{"name": "Gautier Liegeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253577%22"}, {"id": "fda:K250314", "company": "Surgical Instrument Service and Savings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250314: Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250314", "people": [{"name": "Stephanie Boyle Mays", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250314%22"}, {"id": "fda:K251572", "company": "Pari Respiratory Equipment, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251572: eRapid with eTrack System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251572", "people": [{"name": "Michael Judge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251572%22"}, {"id": "fda:K252480", "company": "CapsoVision, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252480: CE Deliver (DLV)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252480", "people": [{"name": "Azimun Jamal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252480%22"}, {"id": "fda:K251152", "company": "Diabeloop", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251152: DBLG2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251152", "people": [{"name": "Erik Huneker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251152%22"}, {"id": "fda:K251077", "company": "Sciton, Inc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251077: JOULE 1064nm System and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251077", "people": [{"name": "Jay Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251077%22"}, {"id": "fda:K252892", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252892: SCOUT MD Surgical Guidance System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252892", "people": [{"name": "Sandeep Saboo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252892%22"}, {"id": "fda:K253613", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253613: Monkey Rings External Ring Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253613", "people": [{"name": "Jacqueline Sloan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253613%22"}, {"id": "fda:K252754", "company": "Guangdong Youmeng Electrical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252754: Wearable Electric Breast Pump (YM-8803)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252754", "people": [{"name": "Zongjun Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252754%22"}, {"id": "fda:K252863", "company": "Radformation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252863: ClearCalc Model RADCA V2.6", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252863", "people": [{"name": "Jennifer Wampler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252863%22"}, {"id": "fda:K252029", "company": "HeartLung Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252029: AI-CVD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252029", "people": [{"name": "Mark Scott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252029%22"}, {"id": "fda:K252670", "company": "Topia Medtech Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252670: Alzevita", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252670", "people": [{"name": "Akshay Sojitra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252670%22"}, {"id": "fda:K251469", "company": "Cathegenix (Xiamen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251469: Endura\u0099 Ureteral Stent and Stent Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251469", "people": [{"name": "Deyuan Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251469%22"}, {"id": "fda:K250976", "company": "Poskom Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250976: Airbile-100", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250976", "people": [{"name": "Seong Jeong Hyun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250976%22"}, {"id": "fda:K251402", "company": "Leadoptik, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251402: LIA-1 Catheter (542-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251402", "people": [{"name": "Mohammadreza Khorasaninejad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251402%22"}, {"id": "fda:K251730", "company": "Leadoptik, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251730: LIA Console (542-7)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251730", "people": [{"name": "Mohammadreza Khorasaninejad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251730%22"}, {"id": "fda:K252167", "company": "Qingdao Bright Moon Biomedical Materials Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252167: Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252167", "people": [{"name": "Yunlong Deng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252167%22"}, {"id": "fda:K254063", "company": "Kulzer, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K254063: iCEM Universal Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254063", "people": [{"name": "Lucas Harmon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K254063%22"}, {"id": "fda:K253616", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253616: ProtekDilate Vascular Access Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253616", "people": [{"name": "Luigi Vecchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253616%22"}, {"id": "fda:K250998", "company": "Sanhe Lefis Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250998: CO2 Laser Therapy System (Model: LFS-D9U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250998", "people": [{"name": "Dandan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250998%22"}, {"id": "fda:K252342", "company": "Guangdong Youmeng Electrical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252342: Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252342", "people": [{"name": "Zongjun Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252342%22"}, {"id": "fda:K252877", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252877: SANDRO Dual", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252877", "people": [{"name": "Hyunsik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252877%22"}, {"id": "pma:P250022", "company": "Abbott Medical", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250022: Volt\u0099 PFA System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250022", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250022%22"}, {"id": "pma:P250017", "company": "W. L. Gore & Associates, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-12-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250017: GORE\u00ae VIABAHN\u00ae FORTEGRA Venous Stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250017", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250017%22"}, {"id": "trialreg:NCT07294976", "company": "Oticon Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Actual Maximum Gain in Bone Anchored Devices", "source_url": "https://clinicaltrials.gov/study/NCT07294976"}, {"id": "trialreg:NCT07295145", "company": "Bentley InnoMed GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Bentley Bridging Stent Graft Study", "source_url": "https://clinicaltrials.gov/study/NCT07295145"}, {"id": "trialreg:NCT07293871", "company": "Surf Therapeutics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis", "source_url": "https://clinicaltrials.gov/study/NCT07293871"}, {"id": "trialreg:NCT07295379", "company": "Advanced Medical Solutions Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: LIQUIBAND FIX8\u00ae for Ventral Incisional Hernia", "source_url": "https://clinicaltrials.gov/study/NCT07295379"}, {"id": "trialreg:NCT07293208", "company": "Phonix Health", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Characterization of Smartphone-related Diseases Using the Phonix Care Application", "source_url": "https://clinicaltrials.gov/study/NCT07293208"}, {"id": "trialreg:NCT07293923", "company": "Magenta Medical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Magenta Elevate\u2122 Clinical Feasibility Study in Cardiogenic Shock", "source_url": "https://clinicaltrials.gov/study/NCT07293923"}, {"id": "trialreg:NCT07293611", "company": "Levita Magnetics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.", "source_url": "https://clinicaltrials.gov/study/NCT07293611"}, {"id": "trialreg:NCT07295431", "company": "BELL Therapeutics Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Sleep Efficacy Randomized Evaluation of a Novel Digital Therapeutic for Insomnia", "source_url": "https://clinicaltrials.gov/study/NCT07295431"}, {"id": "breakthrough:P250017", "company": "W.l. Gore & Associates, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-12-19", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P250017: GORE VIABAHN FORTEGRA VENOUS STENT", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253915", "company": "Erbe Elektromedizin GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253915: MOVIVA\u00ae Hybrid Ablation Probe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253915", "people": [{"name": "Matthias Kollek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253915%22"}, {"id": "fda:K253516", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253516: Assert-IQ (DM5100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253516", "people": [{"name": "Komal Panchal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253516%22"}, {"id": "fda:K252793", "company": "Jiangsu Jiyuan Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252793: ARMI\u00ae Endoscopic Video Image Processor (JY-MIP-3000); ARMI\u00ae Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252793", "people": [{"name": "Yunfeng Zong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252793%22"}, {"id": "fda:K251562", "company": "Ovesco Endoscopy AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251562: OTSCneo System Set (100.03n-14n, 100.27n-31n)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251562", "people": [{"name": "Christoph Mielke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251562%22"}, {"id": "fda:K250914", "company": "Crescom Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250914: MediAI-BA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250914", "people": [{"name": "Rosa Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250914%22"}, {"id": "fda:K251915", "company": "Natec Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251915: Amethyst HP PTA OTW 0.035 Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251915", "people": [{"name": "Pallippatt Roy Devassy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251915%22"}, {"id": "fda:K250993", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250993: Single Use Cytology Brush V (BC-V600P-3010)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250993", "people": [{"name": "Eve Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250993%22"}, {"id": "fda:K252348", "company": "Tomey Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252348: Tomey Optical Biometer OA-2000 (OA-2000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252348", "people": [{"name": "Yuko Matsushita", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252348%22"}, {"id": "fda:K253758", "company": "Medizin Produkte Neustadt GmbH (Mpn)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253758: Dental Cone; Dental Sponge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253758", "people": [{"name": "Danielle Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253758%22"}, {"id": "fda:K252956", "company": "Endovascular Engineering, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252956: Helo Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252956", "people": [{"name": "Debra Cogan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252956%22"}, {"id": "fda:K252976", "company": "Park Dental Research Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252976: Park Dental Nylon MAD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252976", "people": [{"name": "Ron Bulard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252976%22"}, {"id": "fda:K252402", "company": "Terumo Medical Products (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252402: Midline Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252402", "people": [{"name": "Kimberly Jacob-Paredes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252402%22"}, {"id": "fda:K252320", "company": "Simda Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252320: SIMDA Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252320", "people": [{"name": "Cha Young Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252320%22"}, {"id": "fda:K252235", "company": "Ultrasight , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252235: PVAD IQ Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252235", "people": [{"name": "Noa Avisar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252235%22"}, {"id": "fda:K253518", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253518: FX CorAL 40; FX CorAL 50", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253518", "people": [{"name": "Timothy Groves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253518%22"}, {"id": "fda:K252533", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252533: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252533", "people": [{"name": "Niharika Mirji", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252533%22"}, {"id": "fda:K252071", "company": "Reflexion Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252071: RefleXion Medical Radiotherapy System, Reflexion X2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252071", "people": [{"name": "Leena Kadakia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252071%22"}, {"id": "trialreg:NCT07291973", "company": "Endowave Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation Evaluating the Performance, Safety and Clinical Benefit of the Endowave FlexAblate\u2122 Microwave Ablation System in Patients Undergoing Lung Ablation Procedures.", "source_url": "https://clinicaltrials.gov/study/NCT07291973"}, {"id": "trialreg:NCT07290998", "company": "Alpha Tau Medical LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Recurrent Prostate Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07290998"}, {"id": "trialreg:NCT07291739", "company": "Staar Surgical Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Evaluation of a Phakic Intraocular Lens", "source_url": "https://clinicaltrials.gov/study/NCT07291739"}, {"id": "trialreg:NCT07290101", "company": "Biotyx Medical (Shenzhen) Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of ICS-Elpis in Patients With Iliac Artery Stenosis or Occlusion Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07290101"}, {"id": "trialreg:NCT07290556", "company": "Optimal Mobility, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Establishing the Preliminary Utility of a Novel Pediatric Manual Mobile Standing Wheelchair", "source_url": "https://clinicaltrials.gov/study/NCT07290556"}, {"id": "trialreg:NCT07292779", "company": "Samyang Biopharmaceuticals Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds", "source_url": "https://clinicaltrials.gov/study/NCT07292779"}, {"id": "trialreg:NCT07290426", "company": "Candela Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions", "source_url": "https://clinicaltrials.gov/study/NCT07290426"}, {"id": "trialreg:NCT07290790", "company": "Dentsply Sirona Implants and Consumables", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile\u00ae Aligners.", "source_url": "https://clinicaltrials.gov/study/NCT07290790"}, {"id": "fda:K252191", "company": "Bonebridge AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252191: BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252191", "people": [{"name": "Michelle Gumpelmayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252191%22"}, {"id": "fda:K253093", "company": "Highridge Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253093: Vital\u0099 Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253093", "people": [{"name": "Eliot Teal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253093%22"}, {"id": "fda:K253839", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253839: Elecsys Anti-SARS-CoV-2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253839", "people": [{"name": "Kelly Brennan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253839%22"}, {"id": "fda:K252518", "company": "Duopross Meditech Corporate", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252518: DuoprossTM Smart Cap (Type I)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252518", "people": [{"name": "Vincent Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252518%22"}, {"id": "fda:K252398", "company": "Terumo Medical Products (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252398: SURFLO Hybria Closed System Safety IV Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252398", "people": [{"name": "Tien Trinh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252398%22"}, {"id": "fda:K252983", "company": "Shenzhen Goodwind Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252983: Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252983", "people": [{"name": "Ziming Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252983%22"}, {"id": "fda:K250854", "company": "Shenzhen Comen Medical Instruments Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250854: Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250854", "people": [{"name": "Charlotte Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250854%22"}, {"id": "fda:K253710", "company": "Dexcom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253710: Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253710", "people": [{"name": "Holly Drake", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253710%22"}, {"id": "fda:K252417", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252417: Amplatzer Piccolo\u0099 Delivery System (9-PDS-04F-045)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252417", "people": [{"name": "Nicolette Pedersen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252417%22"}, {"id": "fda:K253721", "company": "S.m.a.i.o", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253721: KHEIRON\u00ae Spinal Fixation System, including patient specific K-ROD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253721", "people": [{"name": "Jean-Charles Roussouly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253721%22"}, {"id": "fda:K253719", "company": "Unibeauty (Hubei) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253719: Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253719", "people": [{"name": "Zhou Guan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253719%22"}, {"id": "fda:K252508", "company": "Inari Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252508: Intri26 Introducer Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252508", "people": [{"name": "Kaitlyn Weinkauf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252508%22"}, {"id": "fda:K252922", "company": "Neosoma, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252922: Neosoma Brain Mets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252922", "people": [{"name": "Kenneth Kolodziej", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252922%22"}, {"id": "fda:K251416", "company": "Ultrasight , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251416: UltraSight Guidance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251416", "people": [{"name": "Noa Avisar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251416%22"}, {"id": "fda:K252739", "company": "Ethicon Endo-Surgery, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252739: ETHICON\u0099 4000 45mm Compact Stapler (EC3DT45C); ETHICON\u0099 4000 45mm Standard Stapler (EC3DT45S); ETHICON\u0099 4000 45mm Long Stapler (EC3DT45L); ETHICON\u0099 3D 45mm White Reload (ER45W); ETHICON\u0099 3D 45mm Blue Reload (ER45B); ETHICON\u0099 3D 45mm Green Reload (ER45G); ETHICON\u0099 3D 45mm Black Reload (ER45T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252739", "people": [{"name": "Heidi Calderon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252739%22"}, {"id": "trialreg:NCT07287111", "company": "BeamWorks Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound", "source_url": "https://clinicaltrials.gov/study/NCT07287111"}, {"id": "trialreg:NCT07287423", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: LEAP 2 Chronic EFS", "source_url": "https://clinicaltrials.gov/study/NCT07287423"}, {"id": "trialreg:NCT07289295", "company": "CMR Surgical Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Versius Gynecology Study", "source_url": "https://clinicaltrials.gov/study/NCT07289295"}, {"id": "trialreg:NCT07287839", "company": "Soterix Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Parcel-guided rTMS for Major Depressive Disorder", "source_url": "https://clinicaltrials.gov/study/NCT07287839"}, {"id": "trialreg:NCT07287176", "company": "Pulse Biosciences, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Evaluation of the Pulse Biosciences nPulse\u2122 Vybrance\u2122 Percutaneous Electrode System", "source_url": "https://clinicaltrials.gov/study/NCT07287176"}, {"id": "trialreg:NCT07287449", "company": "Dymicron", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effectiveness of Triadyme-C to a Total Disc Replacement Control Cohort in the Treatment of Symptomatic Cervical Disc Disease (SCDD) at a Single Level", "source_url": "https://clinicaltrials.gov/study/NCT07287449"}, {"id": "trialreg:NCT07287124", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults", "source_url": "https://clinicaltrials.gov/study/NCT07287124"}, {"id": "fda:K252268", "company": "Shenzhen Harveymed Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252268: V series portable oxygen concentrator (V5, V5C, V6, V6C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252268", "people": [{"name": "Zhi\u0092ang Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252268%22"}, {"id": "fda:K250925", "company": "Fujirebio Diagnostics,Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250925: ADVIA Centaur Cytokeratin Fragment 21-1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250925", "people": [{"name": "Kristin Maddaloni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250925%22"}, {"id": "fda:K252373", "company": "Spectrum Vascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252373: BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252373", "people": [{"name": "Sharon Klugewicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252373%22"}, {"id": "fda:K252111", "company": "Cmr Surgical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252111: Versius Surgical System (Versius Plus)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252111", "people": [{"name": "Robert Lally", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252111%22"}, {"id": "fda:K251951", "company": "Guangzhou Red Pine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251951: Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251951", "people": [{"name": "Weihua Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251951%22"}, {"id": "fda:K251256", "company": "Pentax of America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251256: PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251256", "people": [{"name": "Gurvinder Singh Nanda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251256%22"}, {"id": "fda:K252468", "company": "Zhejiang Geyi Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252468: Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252468", "people": [{"name": "Cathy Tan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252468%22"}, {"id": "fda:K251771", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251771: Cambridge Partial Knee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251771", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251771%22"}, {"id": "fda:K251745", "company": "Baxter Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251745: Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251745", "people": [{"name": "Aravinda Yellina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251745%22"}, {"id": "fda:K252919", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252919: IDENTIFY (5.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252919", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252919%22"}, {"id": "fda:K253620", "company": "Gordian Surgical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253620: TroClose 1200", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253620", "people": [{"name": "Eddie Shaw", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253620%22"}, {"id": "fda:K253118", "company": "Companion Spine France", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253118: Companion Spine DIAM\u0099 Instrumentation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253118", "people": [{"name": "Nazanine Cloix", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253118%22"}, {"id": "fda:K251893", "company": "Skanray Technologies Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251893: SKAN C PULSAR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251893", "people": [{"name": "Vasundhara R", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251893%22"}, {"id": "fda:K252940", "company": "PolyConversions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252940: VR\u00ae Personal Protective Level 3 Gown (VR Gowns)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252940", "people": [{"name": "William B. Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252940%22"}, {"id": "fda:K252204", "company": "Prolaio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252204: prolaio eVO2peak Module (Version 1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252204", "people": [{"name": "George Allen Hides", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252204%22"}, {"id": "fda:K251763", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251763: IRISeg", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251763", "people": [{"name": "Jyh-Shyan Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251763%22"}, {"id": "trialreg:NCT07286357", "company": "Orthofix Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Data Collection Protocol to Evaluate the Real World Usage of the Orthofix AccelStim Device to Treat Fresh Metatarsal Fractures", "source_url": "https://clinicaltrials.gov/study/NCT07286357"}, {"id": "trialreg:NCT07284810", "company": "Cionic, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Tracking Self-Reported Functional Needs and Quality of Life", "source_url": "https://clinicaltrials.gov/study/NCT07284810"}, {"id": "trialreg:NCT07286201", "company": "Polyganics BV", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)", "source_url": "https://clinicaltrials.gov/study/NCT07286201"}, {"id": "trialreg:NCT07286890", "company": "Maquet Cardiovascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study", "source_url": "https://clinicaltrials.gov/study/NCT07286890"}, {"id": "trialreg:NCT07286513", "company": "Zimmer Biomet", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Persona SoluTion PPS Femur PMCF", "source_url": "https://clinicaltrials.gov/study/NCT07286513"}, {"id": "trialreg:NCT07284823", "company": "Cionic, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease", "source_url": "https://clinicaltrials.gov/study/NCT07284823"}, {"id": "trialreg:NCT07287007", "company": "Wellell Inc. Taiwan", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Hemodynamic Performance of the VenAir Sequential Compression System", "source_url": "https://clinicaltrials.gov/study/NCT07287007"}, {"id": "trialreg:NCT07285252", "company": "SuperPatch Limited LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Non-Invasive Haptics During Extreme Exercise", "source_url": "https://clinicaltrials.gov/study/NCT07285252"}, {"id": "fda:K253741", "company": "Argon Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253741: V\u0095Stick\u0099 Vascular Access Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253741", "people": [{"name": "Ana Jimenez-Hughes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253741%22"}, {"id": "fda:K251302", "company": "Spineology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251302: OptiMesh Multiplanar Expandable Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251302", "people": [{"name": "Megan Polos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251302%22"}, {"id": "fda:K252935", "company": "Foshan Pingchuang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252935: Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252935", "people": [{"name": "Anthony Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252935%22"}, {"id": "fda:K253403", "company": "Femasys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253403: FemVue\u00ae Controlled Saline-Air Device (FSA-300)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253403", "people": [{"name": "Christine Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253403%22"}, {"id": "fda:K252675", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252675: da Vinci SP Surgical System (SP1098)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252675", "people": [{"name": "Mike Yramategui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252675%22"}, {"id": "fda:K250319", "company": "Machina Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250319: MFUSE (MS001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250319", "people": [{"name": "Tiffini Wittwer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250319%22"}, {"id": "fda:K253101", "company": "Spectrawave, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253101: HyperVue\u0099 Imaging System - Integrated", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253101", "people": [{"name": "Ankit Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253101%22"}, {"id": "fda:K252574", "company": "Erchonia Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252574: Erchonia CLX (Model # CFL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252574", "people": [{"name": "Travis Sammons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252574%22"}, {"id": "fda:K251770", "company": "Sleepres, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251770: SleepRes PAP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251770", "people": [{"name": "John Columbo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251770%22"}, {"id": "fda:K252898", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252898: Triathlon\u00ae Tritanium\u00ae Asymmetric Patella; Triathlon\u00ae Tritanium\u00ae Symmetric Patella; Triathlon\u00ae Symmetric Patella; Triathlon\u00ae Asymmetric Patella; Scorpio\u00ae Universal Dome Patella; Triathlon\u00ae Hinge Bumper", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252898", "people": [{"name": "Richa Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252898%22"}, {"id": "fda:K253677", "company": "Instylla, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253677: Tembo Embolic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253677", "people": [{"name": "Jennifer Greer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253677%22"}, {"id": "fda:K252950", "company": "Proprio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252950: Paradigm System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252950", "people": [{"name": "Shannon Eubranks", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252950%22"}, {"id": "pma:P240035", "company": "ETHICON, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-12-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240035: ETHIZIA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240035", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240035%22"}, {"id": "trialreg:NCT07282275", "company": "Efforia, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: How Does Continued Use of Green Light Therapy Impact Outcomes?", "source_url": "https://clinicaltrials.gov/study/NCT07282275"}, {"id": "trialreg:NCT07281599", "company": "Qurasense", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer", "source_url": "https://clinicaltrials.gov/study/NCT07281599"}, {"id": "trialreg:NCT07282067", "company": "Orthofix Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Orthofix PhysioStim PEMF Ankle Fusion Retrospective", "source_url": "https://clinicaltrials.gov/study/NCT07282067"}, {"id": "trialreg:NCT07282860", "company": "C. R. Bard", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Evaluation of the PureWick\u2122 Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males", "source_url": "https://clinicaltrials.gov/study/NCT07282860"}, {"id": "trialreg:NCT07282002", "company": "Angiodynamics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Percutaneous AngioVac Vegetation Extraction (PAVE) to Remove Right Heart Vegetations in Patients With Infective Endocarditis", "source_url": "https://clinicaltrials.gov/study/NCT07282002"}, {"id": "trialreg:NCT07281261", "company": "Spark Biomedical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: tAN for Substance Use Disorder", "source_url": "https://clinicaltrials.gov/study/NCT07281261"}, {"id": "trialreg:NCT07281521", "company": "CardioFocus", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07281521"}, {"id": "trialreg:NCT07282119", "company": "Efforia, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Can EmeraldLED Reshape Your Body With Continued Use?", "source_url": "https://clinicaltrials.gov/study/NCT07282119"}, {"id": "trialreg:NCT07281989", "company": "Efforia, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Sound Stops Stress Study: Evaluating the WAVwatch Effect", "source_url": "https://clinicaltrials.gov/study/NCT07281989"}, {"id": "trialreg:NCT07282080", "company": "Efforia, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Discover Better Body Composition With Green Light!", "source_url": "https://clinicaltrials.gov/study/NCT07282080"}, {"id": "trialreg:NCT07282028", "company": "Nuance Hearing", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy", "source_url": "https://clinicaltrials.gov/study/NCT07282028"}, {"id": "trialreg:NCT07282678", "company": "Pulvinar Neuro, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder", "source_url": "https://clinicaltrials.gov/study/NCT07282678"}, {"id": "trialreg:NCT07281963", "company": "Efforia, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Chilipad Sleep Optimization Study", "source_url": "https://clinicaltrials.gov/study/NCT07281963"}, {"id": "fda:K250851", "company": "Cadwell Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250851: Hypnos (369054-200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250851", "people": [{"name": "James Blevins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250851%22"}, {"id": "fda:K252120", "company": "Remidio Innovative Solutions Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252120: Fundus On Phone Non Mydriatic (FOP NM-10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252120", "people": [{"name": "Sundeep Agarwal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252120%22"}, {"id": "fda:K252745", "company": "Micro-Energy Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252745: Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252745", "people": [{"name": "Danning Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252745%22"}, {"id": "fda:K252273", "company": "Dmc Importa\u00e7\u00e3o E Exporta\u00e7\u00e3o DE Equipamentos Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252273: Therapy US", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252273", "people": [{"name": "Renaldo Massini Junior", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252273%22"}, {"id": "fda:K250863", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250863: FUJIFILM Ultrasonic Endoscope EB-710US", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250863", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250863%22"}, {"id": "fda:K250488", "company": "Ansella Therapeutics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250488: Ceryn\u00eb Intimate Care", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250488", "people": [{"name": "Maria Carrasco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250488%22"}, {"id": "fda:K253749", "company": "Zimmer Switzerland Manufacturing GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253749: Affixus\u00ae Natural Nail\u00ae Proximal Humeral System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253749", "people": [{"name": "Melanie Mitrov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253749%22"}, {"id": "fda:K251092", "company": "Ihealth Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251092: iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251092", "people": [{"name": "Yange Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251092%22"}, {"id": "fda:K242817", "company": "Botiss Biomaterials GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242817: Jason membrane", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242817", "people": [{"name": "Thomas Unsoeld", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242817%22"}, {"id": "fda:K253489", "company": "Hyperfine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253489: Swoop\u00ae Portable MR Imaging\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253489", "people": [{"name": "Kristen Evenson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253489%22"}, {"id": "fda:K251177", "company": "Guangdong Maidi Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251177: Self-Seal Sterilization Pouch and Roll", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251177", "people": [{"name": "Shi Xiong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251177%22"}, {"id": "fda:K252391", "company": "Bluewind Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252391: Revi System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252391", "people": [{"name": "Angel Estrada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252391%22"}, {"id": "fda:K252090", "company": "JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252090: Pterygoid Indication for GM Helix Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252090", "people": [{"name": "Mariana Hartmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252090%22"}, {"id": "fda:K252681", "company": "Bard Peripheral Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252681: EnCor EnCompass\u0099 Breast Biopsy and Tissue Removal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252681", "people": [{"name": "Jessica Meyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252681%22"}, {"id": "fda:K252785", "company": "Rizhao Huge Biomaterials Company, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252785: TopCEM Vigor SA Self-Adhesive Resin Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252785", "people": [{"name": "Maggie Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252785%22"}, {"id": "fda:K251089", "company": "Exelint International, Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251089: EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch\u00ae Safety Needle; EXEL Disposable Hypodermic Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251089", "people": [{"name": "Stefanie Ng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251089%22"}, {"id": "fda:K251085", "company": "Ihealth Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251085: iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251085", "people": [{"name": "Yange Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251085%22"}, {"id": "fda:K253609", "company": "Cresilon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253609: TRAUMAGEL\u00ae 2.0 Hemostatic Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253609", "people": [{"name": "Hassaan Ahmad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253609%22"}, {"id": "fda:K251989", "company": "Breast-Med, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251989: VizMark Preloaded Tissue Marker Device (VM-0001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251989", "people": [{"name": "Michael Nelson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251989%22"}, {"id": "fda:K250847", "company": "Vault Paragon Group, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250847: VaporShield", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250847", "people": [{"name": "Sari Luciano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250847%22"}, {"id": "fda:K250821", "company": "Eurosets S.R.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250821: Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250821", "people": [{"name": "Katia Vescovini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250821%22"}, {"id": "fda:K250974", "company": "Bio Compression Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250974: Bio Arterial Deluxe (IC-BAP-DX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250974", "people": [{"name": "Marc Somelofski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250974%22"}, {"id": "trialreg:NCT07280065", "company": "Senseye, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool", "source_url": "https://clinicaltrials.gov/study/NCT07280065"}, {"id": "trialreg:NCT07279220", "company": "Shanghai Bomaian Medical Technology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture", "source_url": "https://clinicaltrials.gov/study/NCT07279220"}, {"id": "trialreg:NCT07280247", "company": "Angiodynamics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness", "source_url": "https://clinicaltrials.gov/study/NCT07280247"}, {"id": "trialreg:NCT07278869", "company": "Append Medical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Applause Study I - Append System Early Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07278869"}, {"id": "trialreg:NCT07279649", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: GORE\u00ae VIABAHN\u00ae VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)", "source_url": "https://clinicaltrials.gov/study/NCT07279649"}, {"id": "trialreg:NCT07278310", "company": "MiRus", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)", "source_url": "https://clinicaltrials.gov/study/NCT07278310"}, {"id": "fda:K252941", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252941: HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252941", "people": [{"name": "Anureet Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252941%22"}, {"id": "fda:K253141", "company": "Medicalgorithmics S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253141: DeepRhythmAI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253141", "people": [{"name": "Agnieszka Romowicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253141%22"}, {"id": "fda:K252694", "company": "Stryker Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252694: Target Detachable Coil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252694", "people": [{"name": "Genae Tripp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252694%22"}, {"id": "fda:K252482", "company": "Medcognetics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252482: CogNet AI-MT+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252482", "people": [{"name": "John Jenkins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252482%22"}, {"id": "fda:K253200", "company": "4Web Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253200: Cervical Spine Truss System - Stand Alone (CSTS-SA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253200", "people": [{"name": "Jonathan Hires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253200%22"}, {"id": "fda:K251883", "company": "Mim Software, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251883: MIM \u0096 LesionID Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251883", "people": [{"name": "Sydney Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251883%22"}, {"id": "fda:K252897", "company": "A Plus Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252897: APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252897", "people": [{"name": "Helen Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252897%22"}, {"id": "fda:K250988", "company": "KLS-Martin L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250988: KLS Martin Pure Pectus System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250988", "people": [{"name": "Melissa Bachorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250988%22"}, {"id": "fda:K252997", "company": "Hyperflex Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252997: HyperFlex\u00ae Bunion Correction System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252997", "people": [{"name": "Robert Peterhans", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252997%22"}, {"id": "pma:P250007", "company": "Zenflow, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-12-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250007: Zenflow Spring\u00ae Implant and Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250007", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250007%22"}, {"id": "trialreg:NCT07276776", "company": "Insulet Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Evaluation of the Omnipod\u00ae M System in Adults With Type 2 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07276776"}, {"id": "trialreg:NCT07276529", "company": "GI Windows, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses", "source_url": "https://clinicaltrials.gov/study/NCT07276529"}, {"id": "trialreg:NCT07276347", "company": "CooperVision International Limited (CVIL)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comprehensive Assessment of Multiple Products (CAMP)", "source_url": "https://clinicaltrials.gov/study/NCT07276347"}, {"id": "trialreg:NCT07276711", "company": "EmStop Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material", "source_url": "https://clinicaltrials.gov/study/NCT07276711"}, {"id": "trialreg:NCT07276815", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: OverStitch NXT Endoscopic Suture System", "source_url": "https://clinicaltrials.gov/study/NCT07276815"}, {"id": "trialreg:NCT07277946", "company": "Tissium", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE", "source_url": "https://clinicaltrials.gov/study/NCT07277946"}, {"id": "trialreg:NCT07276555", "company": "Neurocytonix, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of Functional Neurogenesis Stimulation Therapy in Children With Autism Spectrum Disorder (ASD)", "source_url": "https://clinicaltrials.gov/study/NCT07276555"}, {"id": "trialreg:NCT07277296", "company": "InspireMD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CGUARDIANS III IDE Pivotal Trial", "source_url": "https://clinicaltrials.gov/study/NCT07277296"}, {"id": "fda:K250192", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250192: Verisafe Safety Retractable Insulin Syringes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250192", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250192%22"}, {"id": "fda:K252826", "company": "Jeil Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252826: ARIX Femur Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252826", "people": [{"name": "Dajung Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252826%22"}, {"id": "fda:K252497", "company": "Huxley Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252497: SANSA HSAT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252497", "people": [{"name": "Daniel Burnham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252497%22"}, {"id": "fda:K251598", "company": "Brainspace, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251598: Intellidrop", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251598", "people": [{"name": "Caitlin Morse", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251598%22"}, {"id": "pma:P240043", "company": "Companion Spine France Sas", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-12-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240043: DIAM\u00ad\u0099 Spinal Stabilization System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240043", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240043%22"}, {"id": "trialreg:NCT07273877", "company": "Shanghai Golden Leaf MedTec Co. Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: \"Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System\" - REACH-RDN", "source_url": "https://clinicaltrials.gov/study/NCT07273877"}, {"id": "trialreg:NCT07275723", "company": "Shanghai Shengdi Pharmaceutical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Body Parts (Non-Central Nervous System) Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07275723"}, {"id": "trialreg:NCT07273773", "company": "Rigicon, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Rigicon Infla10\u00ae Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction", "source_url": "https://clinicaltrials.gov/study/NCT07273773"}, {"id": "trialreg:NCT07275814", "company": "Shanghai Shengdi Pharmaceutical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Central Nervous System (CNS) Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07275814"}, {"id": "trialreg:NCT07275151", "company": "CathVision ApS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA", "source_url": "https://clinicaltrials.gov/study/NCT07275151"}, {"id": "trialreg:NCT07274293", "company": "noiVita Srls", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EVALUATION OF THE TOLERABILITY AND BIOMEDICAL POTENTIAL OF A GARMENT CONTAINING PRINTED CERAMICS IN MUSCULAR PAIN", "source_url": "https://clinicaltrials.gov/study/NCT07274293"}, {"id": "breakthrough:P240043", "company": "Companion Spine France S.a.s", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-12-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P240043: DIAM\u00ac SPINAL STABILIZATION SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K252343", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252343: Atlantis\u00ae Abutments in Titanium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252343", "people": [{"name": "Laura Sobrin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252343%22"}, {"id": "fda:K252808", "company": "Shofu Dental Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252808: GlasIonomer FX-LC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252808", "people": [{"name": "Malzyner Mauro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252808%22"}, {"id": "fda:K253706", "company": "Tianjin Huahong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253706: Lancing device (HH-XV-T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253706", "people": [{"name": "Ningning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253706%22"}, {"id": "fda:K243449", "company": "Infinitt Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243449: INFINITT DPS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243449", "people": [{"name": "Josh Baker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243449%22"}, {"id": "fda:K251199", "company": "GE Medical Systems SCS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251199: Allia Moveo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251199", "people": [{"name": "Bessou Anne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251199%22"}, {"id": "fda:K252154", "company": "Guangzhou Longest Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252154: Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252154", "people": [{"name": "Xiaobing Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252154%22"}, {"id": "fda:K250805", "company": "Devilbiss Healthcare, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250805: DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250805", "people": [{"name": "Christy Foreman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250805%22"}, {"id": "fda:K250742", "company": "Focused Cryo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250742: Focused Cryotherapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250742", "people": [{"name": "Yogi Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250742%22"}, {"id": "pma:P250011", "company": "Proverum, Ltd.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-12-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250011: ProVee System for BPH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250011", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250011%22"}, {"id": "trialreg:NCT07271238", "company": "LUMA Vision Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures", "source_url": "https://clinicaltrials.gov/study/NCT07271238"}, {"id": "trialreg:NCT07273149", "company": "Haleon", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Assess the Effectiveness of a Marketed Denture Adhesive in Real-World Setting", "source_url": "https://clinicaltrials.gov/study/NCT07273149"}, {"id": "trialreg:NCT07272720", "company": "Storz Medical AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PMCF Investigation of MODULITH\u00ae SLX-F2 With StorM-Track in Patients With Kidney Stones", "source_url": "https://clinicaltrials.gov/study/NCT07272720"}, {"id": "fda:K251936", "company": "Ceribell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251936: Ceribell Delirium Monitor System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251936", "people": [{"name": "Raymond Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251936%22"}, {"id": "fda:K252789", "company": "Shenzhen Xiangtong Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252789: Glass Ceramic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252789", "people": [{"name": "Xue Gong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252789%22"}, {"id": "fda:K252862", "company": "Foshan Dahao Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252862: Electric Wheelchair (DH01126)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252862", "people": [{"name": "Baoyi Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252862%22"}, {"id": "fda:K252294", "company": "Brightheart", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252294: Fetal EchoScan (v1.2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252294", "people": [{"name": "Christophe Gardella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252294%22"}, {"id": "fda:K251829", "company": "Degen Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251829: DeGen Medical Patient Specific Implant (PSI) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251829", "people": [{"name": "Craig Black", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251829%22"}, {"id": "fda:K252994", "company": "Guangdong Ace-Tec Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252994: LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252994", "people": [{"name": "Fate Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252994%22"}, {"id": "fda:K250190", "company": "Shenzhen Comen Medical Instruments Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250190: Sequential Compression System (SCD600)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250190", "people": [{"name": "Zitong Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250190%22"}, {"id": "fda:K250258", "company": "Heartbeam, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250258: HeartBeam AIMIGo with 12-L ECG Synthesis Software System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250258", "people": [{"name": "Deborah Castillo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250258%22"}, {"id": "pma:P230024", "company": "Flow Neuroscience AB", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-12-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P230024: Flow FL-100", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230024", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230024%22"}, {"id": "trialreg:NCT07270692", "company": "Eko Devices, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence", "source_url": "https://clinicaltrials.gov/study/NCT07270692"}, {"id": "trialreg:NCT07270601", "company": "ContextVision AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis", "source_url": "https://clinicaltrials.gov/study/NCT07270601"}, {"id": "trialreg:NCT07270705", "company": "ENIKAM d.o.o.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of the Efficacy and Safety of OROXID\u00ae Oral Solution in Patients With Gingivitis", "source_url": "https://clinicaltrials.gov/study/NCT07270705"}, {"id": "trialreg:NCT07270380", "company": "Biocomposites Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.", "source_url": "https://clinicaltrials.gov/study/NCT07270380"}, {"id": "trialreg:NCT07270744", "company": "Eko Devices, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Collection Using Eko Devices in a Clinical Setting", "source_url": "https://clinicaltrials.gov/study/NCT07270744"}, {"id": "breakthrough:K251936", "company": "Ceribell, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-12-08", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K251936: CERIBELL DELIRIUM MONITOR SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P230024", "company": "Flow Neuroscience Ab", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-12-08", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230024: FLOW FL-100", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K252296", "company": "Oncopatch, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252296: OncoPatch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252296", "people": [{"name": "Sam Murray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252296%22"}, {"id": "fda:K252494", "company": "Nanjing Kangni Smart Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252494: Electrically powered wheelchair (KZ301B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252494", "people": [{"name": "Huilin Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252494%22"}, {"id": "fda:K251731", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251731: KARL STORZ Flexible Intubation Video Endoscope \u0096 Sterile (FIVE-S) (0916612)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251731", "people": [{"name": "Trujillo Mario", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251731%22"}, {"id": "fda:K252498", "company": "Sonoscape Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252498: Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252498", "people": [{"name": "Toki Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252498%22"}, {"id": "fda:K251657", "company": "Resmed Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251657: Personalized Therapy Comfort Settings (PTCS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251657", "people": [{"name": "Rose Malonzo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251657%22"}, {"id": "fda:K252142", "company": "Shenzhen Siken 3D Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252142: Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252142", "people": [{"name": "Jing Quan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252142%22"}, {"id": "fda:K250764", "company": "Lincotek Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250764: SpineLinc Anterior Cervical Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250764", "people": [{"name": "Troy Walters", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250764%22"}, {"id": "fda:K251337", "company": "Thermo Fisher Scientific (Oxoid Ltd.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251337: Thermo Scientific Oxoid Gepotidacin Disc (10 \u00b5g) GEP10", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251337", "people": [{"name": "Sonali Karnik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251337%22"}, {"id": "fda:K251403", "company": "Dornier Medtech America Inc (Dmta)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251403: Dornier Bi-Polar Electrode BIP12CLM Bipolar 12\u00b0 Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12\u00b0 Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30\u00b0 Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30\u00b0 Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251403", "people": [{"name": "John Hoffer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251403%22"}, {"id": "fda:K250743", "company": "Remvia", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250743: Remvia NightGuard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250743", "people": [{"name": "Nephi Zufelt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250743%22"}, {"id": "fda:K252828", "company": "Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252828: Manual Wheelchair (W47)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252828", "people": [{"name": "Weixia Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252828%22"}, {"id": "fda:K243438", "company": "Huinno Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243438: MEMO Patch M (MPT-E08R-UNC01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243438", "people": [{"name": "Kang Yongwan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243438%22"}, {"id": "fda:K252151", "company": "Saremco Dental AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252151: els unibond", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252151", "people": [{"name": "Christoph Evers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252151%22"}, {"id": "fda:K252465", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252465: Any-Core", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252465", "people": [{"name": "Ku Da Hyeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252465%22"}, {"id": "fda:K250780", "company": "Manteia Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250780: ARTAssistant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250780", "people": [{"name": "Chao Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250780%22"}, {"id": "fda:K252504", "company": "Alimetry , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252504: Gastric Alimetry", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252504", "people": [{"name": "Yaara Yarmut", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252504%22"}, {"id": "fda:K250512", "company": "Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250512: Augmented Gingival Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250512", "people": [{"name": "Jade Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250512%22"}, {"id": "fda:K251514", "company": "Overjet, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251514: Overjet CBCT Assist", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251514", "people": [{"name": "Alireza Sojoudi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251514%22"}, {"id": "fda:K251722", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251722: ProSeal\u0099 Transfer Injector (421120, 421130, 421140)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251722", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251722%22"}, {"id": "fda:K252841", "company": "Blue Belt Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252841: REAL INTELLIGENCE\u0099 CORI\u0099 XT (CORI XT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252841", "people": [{"name": "Amy Zhi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252841%22"}, {"id": "fda:K250711", "company": "3D Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250711: VSP Orthopedics System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250711", "people": [{"name": "Ashley Dawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250711%22"}, {"id": "fda:K253868", "company": "QuietLab, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253868: QuietLab Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253868", "people": [{"name": "Candriella Pietro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253868%22"}, {"id": "fda:K250795", "company": "W.O.M. World of Medicine GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250795: PUREVUE\u0099 FMS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250795", "people": [{"name": "Soeren Markworth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250795%22"}, {"id": "fda:K252825", "company": "Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252825: Manual Wheelchair (W45)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252825", "people": [{"name": "Weixia Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252825%22"}, {"id": "fda:K252605", "company": "Medspira, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252605: mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252605", "people": [{"name": "Evan Johnston", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252605%22"}, {"id": "fda:K252067", "company": "Restor3D, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252067: Velora Acetabular System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252067", "people": [{"name": "Knox Pittman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252067%22"}, {"id": "trialreg:NCT07268482", "company": "Feeltect Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes", "source_url": "https://clinicaltrials.gov/study/NCT07268482"}, {"id": "trialreg:NCT07266454", "company": "\u00d6ssur Iceland ehf", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Stumble Recovery Functions of Prosthetic Knees", "source_url": "https://clinicaltrials.gov/study/NCT07266454"}, {"id": "trialreg:NCT07267169", "company": "Efferon JSC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis", "source_url": "https://clinicaltrials.gov/study/NCT07267169"}, {"id": "trialreg:NCT07267793", "company": "DALIM TISSEN Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage", "source_url": "https://clinicaltrials.gov/study/NCT07267793"}, {"id": "trialreg:NCT07267689", "company": "Laboratoires Gilbert", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children", "source_url": "https://clinicaltrials.gov/study/NCT07267689"}, {"id": "trialreg:NCT07266584", "company": "Science Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration", "source_url": "https://clinicaltrials.gov/study/NCT07266584"}, {"id": "trialreg:NCT07265778", "company": "Jetema Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation for Evaluating the Safety and Efficacy of JTM102 to Mid Face Volume Deficiency", "source_url": "https://clinicaltrials.gov/study/NCT07265778"}, {"id": "fda:K250679", "company": "Sc Medica", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250679: FFX Facet Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250679", "people": [{"name": "Camille Srour", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250679%22"}, {"id": "fda:K250791", "company": "Asustek Computer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250791: ASUS Ultrasound Imaging System (LU800 series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250791", "people": [{"name": "Wu Andy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250791%22"}, {"id": "fda:K250816", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250816: ADVIA Centaur Anti-Thyroglobulin II (aTgII)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250816", "people": [{"name": "Mey Vasquez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250816%22"}, {"id": "fda:K251943", "company": "Spineology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251943: Spineology Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251943", "people": [{"name": "Megan Polos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251943%22"}, {"id": "fda:K252588", "company": "Zhejiang Taotao Vehicle Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252588: Mobility Scooter (T5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252588", "people": [{"name": "Guangqin Yao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252588%22"}, {"id": "fda:K252596", "company": "Tigon Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252596: Tigon Medical Knotless and Dual Javelin All-Suture Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252596", "people": [{"name": "Jeremy Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252596%22"}, {"id": "fda:K252126", "company": "Chawla Heart Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252126: MitraPatch Mitral Valve Repair System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252126", "people": [{"name": "Surendra Chawla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252126%22"}, {"id": "fda:K252429", "company": "Vektor Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252429: Vektor Computational ECG Mapping System (vMap\u00ae)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252429", "people": [{"name": "Mihir Naik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252429%22"}, {"id": "fda:K251257", "company": "Np Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251257: nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251257", "people": [{"name": "Albert Sanford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251257%22"}, {"id": "trialreg:NCT07262827", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users", "source_url": "https://clinicaltrials.gov/study/NCT07262827"}, {"id": "fda:K250564", "company": "Yadu Medical (Henan) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250564: Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250564", "people": [{"name": "Peilong Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250564%22"}, {"id": "fda:K253293", "company": "Vitalograph , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253293: VitaloJAK Clinic (Model 7100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253293", "people": [{"name": "James O'Keeffe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253293%22"}, {"id": "fda:K251881", "company": "Hippoclinic", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251881: HippoMind (v1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251881", "people": [{"name": "Zhuhua Cai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251881%22"}, {"id": "fda:K251203", "company": "Coreline Soft Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251203: AVIEW Lung Nodule CAD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251203", "people": [{"name": "Hyeyi Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251203%22"}, {"id": "fda:K252213", "company": "Bend IT Technologies, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252213: Bendit17 Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252213", "people": [{"name": "Simona Beilin Nissan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252213%22"}, {"id": "fda:K250692", "company": "Voxel Ray Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250692: GentleBeam (GB1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250692", "people": [{"name": "Nicolas Soro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250692%22"}, {"id": "fda:K251601", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251601: Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251601", "people": [{"name": "Jing Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251601%22"}, {"id": "fda:K251779", "company": "Insulet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251779: Omnipod 5 algorithm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251779", "people": [{"name": "Alexander Hamad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251779%22"}, {"id": "fda:K250725", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250725: Hugo\u0099 RAS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250725", "people": [{"name": "Shriya Kafle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250725%22"}, {"id": "pma:P240021", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-12-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240021: Atellica IM Total PSA II (tPSAII)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240021", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240021%22"}, {"id": "trialreg:NCT07261137", "company": "Solventum US LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy of Solventum\u2122 Vitrebond\u2122 Pulp Protect Liner/Base Used as a Liner/Base Under Dental Restorations", "source_url": "https://clinicaltrials.gov/study/NCT07261137"}, {"id": "trialreg:NCT07262255", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: WATCHMAN FLX Pro European Registry", "source_url": "https://clinicaltrials.gov/study/NCT07262255"}, {"id": "trialreg:NCT07260578", "company": "Cytrellis Biosystems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of Ellacor\u00ae Micro-coring\u00ae Following Best Practices on Technique and Post-Procedural Care", "source_url": "https://clinicaltrials.gov/study/NCT07260578"}, {"id": "trialreg:NCT07262645", "company": "Danyang Huichuang Medical Equipment Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Near-infrared Light Therapy Device for Mild-Moderate Alzheimer's Disease (NirsCure-03A)", "source_url": "https://clinicaltrials.gov/study/NCT07262645"}, {"id": "trialreg:NCT07262450", "company": "Laboratoire de la Mer", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms", "source_url": "https://clinicaltrials.gov/study/NCT07262450"}, {"id": "fda:K252103", "company": "Mighty Oak Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252103: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252103", "people": [{"name": "Mark Wylie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252103%22"}, {"id": "fda:K250884", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250884: 0.9 % Sodium Chloride Injection, USP, BD PosiFlush\u0099 SP Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250884", "people": [{"name": "Michael Pacelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250884%22"}, {"id": "fda:K250896", "company": "Aura Wellness, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250896: Aura Wave", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250896", "people": [{"name": "Scott Blomberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250896%22"}, {"id": "fda:K252069", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252069: da Vinci SP Surgical System (SP1098)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252069", "people": [{"name": "Mike Yramategui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252069%22"}, {"id": "fda:K252021", "company": "Changzhou New Med Micro-Medtech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252021: Disposable Endoscopic Injection Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252021", "people": [{"name": "Ashe Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252021%22"}, {"id": "trialreg:NCT07259759", "company": "Intuitive Surgical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: JURA Study - Observational First-in-human Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07259759"}, {"id": "trialreg:NCT07257770", "company": "Lo.Li.Pharma s.r.l", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Local Treatment of Breast Pain Based on the Daily Use of a Topical Gel", "source_url": "https://clinicaltrials.gov/study/NCT07257770"}, {"id": "trialreg:NCT07258069", "company": "Aesculap AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)", "source_url": "https://clinicaltrials.gov/study/NCT07258069"}, {"id": "trialreg:NCT07259811", "company": "Amber Implants B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Vertebral Augmentation Using VCFix Spinal System in Stand-alone Configuration", "source_url": "https://clinicaltrials.gov/study/NCT07259811"}, {"id": "trialreg:NCT07258290", "company": "Teleflex", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07258290"}, {"id": "trialreg:NCT07257224", "company": "Laboratoires Quinton International S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-market Clinical Follow-up Study of an Isotonic Saline Solution to Manage Nasal Congestion in Case of Flu Symptoms, Colds, Allergic Rhinitis and Rhinosinusitis in Infants and Toddlers", "source_url": "https://clinicaltrials.gov/study/NCT07257224"}, {"id": "trialreg:NCT07257887", "company": "ENIKAM d.o.o.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of the Efficacy and Safety of OROXID\u00ae Oral Solution in Patients With Periodontitis", "source_url": "https://clinicaltrials.gov/study/NCT07257887"}, {"id": "trialreg:NCT07259668", "company": "Efferon JSC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns", "source_url": "https://clinicaltrials.gov/study/NCT07259668"}, {"id": "trialreg:NCT07259018", "company": "LuSeed Vascular LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan", "source_url": "https://clinicaltrials.gov/study/NCT07259018"}, {"id": "trialreg:NCT07258940", "company": "Nobel Biocare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NobelZygoma TiUltra Implant System Study", "source_url": "https://clinicaltrials.gov/study/NCT07258940"}, {"id": "fda:K251370", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251370: Cartesion Prime (PCD-1000A/3) V10.21", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251370", "people": [{"name": "Orlando Tadeo, Jr.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251370%22"}, {"id": "fda:K251696", "company": "Unimed Medical Supplies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251696: Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251696", "people": [{"name": "Huanyu Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251696%22"}, {"id": "fda:K251691", "company": "Unimed Medical Supplies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251691: Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251691", "people": [{"name": "Huanyu Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251691%22"}, {"id": "fda:K250713", "company": "Exactech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250713: Equinoxe\u00ae Humeral Reconstruction Prosthesis; Equinoxe\u00ae Stemless Shoulder Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250713", "people": [{"name": "Kiel Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250713%22"}, {"id": "fda:K252786", "company": "Shenzhen Suyzeko Limited.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252786: Led Light Phototherapy Bed (Pro 450/ GY-680A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252786", "people": [{"name": "Meng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252786%22"}, {"id": "fda:K252827", "company": "Dr\u00e4gerwerk AG & Co. KGaA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252827: IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252827", "people": [{"name": "Jan Upmeier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252827%22"}, {"id": "fda:K253250", "company": "Spinal Simplicity, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-12-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253250: Minuteman\u00ae G6 MIS Fusion Plate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253250", "people": [{"name": "Adam Rogers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253250%22"}, {"id": "trialreg:NCT07256951", "company": "Baxter Healthcare Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Gen 2 Battrode Wear Study", "source_url": "https://clinicaltrials.gov/study/NCT07256951"}, {"id": "trialreg:NCT07255261", "company": "Symatese", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Facial HA Dermal Fillers in Real-Life Conditions", "source_url": "https://clinicaltrials.gov/study/NCT07255261"}, {"id": "trialreg:NCT07256626", "company": "Efforia, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Tune Up Your Back: Soundwave Wellness Study", "source_url": "https://clinicaltrials.gov/study/NCT07256626"}, {"id": "trialreg:NCT07255937", "company": "Advanced Medical Solutions Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PMCF Study of Debridement Pad", "source_url": "https://clinicaltrials.gov/study/NCT07255937"}, {"id": "trialreg:NCT07256665", "company": "Efforia, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-12-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Cracking Consciousness Study With Monroe & Neuphoria", "source_url": "https://clinicaltrials.gov/study/NCT07256665"}, {"id": "fda:K252658", "company": "Baoding Te'Anzhou Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252658: Medical Diode Laser Systems (TR-B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252658", "people": [{"name": "Wenjia Shang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252658%22"}, {"id": "fda:K252217", "company": "Canon Medical Informatics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252217: CT VScore+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252217", "people": [{"name": "Jay Vaishnav", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252217%22"}, {"id": "fda:K253303", "company": "Dendrite Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253303: Dendrite Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253303", "people": [{"name": "Ali Amiri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253303%22"}, {"id": "fda:K250636", "company": "Sophysa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250636: Sophy Mini Monopressure Valve (SM1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250636", "people": [{"name": "Lucie Dubois", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250636%22"}, {"id": "pma:P200048", "company": "Cleveland Diagnostics, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-11-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P200048: IsoPSA Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200048", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P200048%22"}, {"id": "trialreg:NCT07253064", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study Comparing Eye Growth Over Time in Children Using Two Myopia Control Lenses", "source_url": "https://clinicaltrials.gov/study/NCT07253064"}, {"id": "trialreg:NCT07252895", "company": "Otto Bock France SNC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis", "source_url": "https://clinicaltrials.gov/study/NCT07252895"}, {"id": "trialreg:NCT07254845", "company": "VPIX Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A PROSPECTIVE, SINGLE-CENTERED, ASSESSOR-BLINDED STUDY TO EVALUATE THE CLINICAL EFFICACY OF THE PROPOSED CELL/TISSUE HISTOPATHOLOGY PROCESSOR CCELL (CONFOCAL FLUORESCENCE ENDOMICROSCOPY) FOR INTRAOPERATIVE DIAGNOSIS IN BRAIN TUMORS", "source_url": "https://clinicaltrials.gov/study/NCT07254845"}, {"id": "trialreg:NCT07254247", "company": "Little Room Innovations, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Unique Body-Powered Terminal Device With Enhanced Grasping Capabilities for Individuals With Upper Limb Loss", "source_url": "https://clinicaltrials.gov/study/NCT07254247"}, {"id": "trialreg:NCT07254884", "company": "FA Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring", "source_url": "https://clinicaltrials.gov/study/NCT07254884"}, {"id": "trialreg:NCT07254013", "company": "MicroPort CRM", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution", "source_url": "https://clinicaltrials.gov/study/NCT07254013"}, {"id": "breakthrough:P200048", "company": "Cleveland Diagnostics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-11-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P200048: ISOPSA ASSAY", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K252760", "company": "Ortho Organizers, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252760: Carriere\u00ae Motion Pro\u00ae Clear Bite Corrector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252760", "people": [{"name": "Thomas Arnold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252760%22"}, {"id": "fda:K252388", "company": "Francis Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252388: Vanquish Water Vapor Ablation Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252388", "people": [{"name": "Mike Kujak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252388%22"}, {"id": "fda:K252000", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252000: uDR Arria & uDR Aris", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252000", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252000%22"}, {"id": "fda:K252260", "company": "Li Medical Corporation , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252260: RELIEEV HSG Catheter (HSG7FA1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252260", "people": [{"name": "Jago Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252260%22"}, {"id": "fda:K253168", "company": "Arbor Endovascular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253168: 0.014\u0094 Willow Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253168", "people": [{"name": "Kim Otto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253168%22"}, {"id": "fda:K251697", "company": "ACON Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251697: Flowflex\u00ae Plus Strep A Rapid Test Cassette; Flowflex\u00ae Plus Strep A Rapid Test Strip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251697", "people": [{"name": "Catherine Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251697%22"}, {"id": "fda:K252248", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252248: CEREC Tessera Abutment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252248", "people": [{"name": "Rebecca Sporer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252248%22"}, {"id": "fda:K242976", "company": "Medical Wire & Equipment Company (Bath), Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242976: Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242976", "people": [{"name": "Shedden Douglas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242976%22"}, {"id": "fda:K251058", "company": "Truvian Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251058: Tru Kidney Health Test Panel; Tru Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251058", "people": [{"name": "Tho Tran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251058%22"}, {"id": "fda:K251674", "company": "Mgc Diagnostics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251674: Fenom Flo\u0099 FeNO Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251674", "people": [{"name": "Arathi Sundaresan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251674%22"}, {"id": "fda:K252355", "company": "Sb-Kawasumi Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252355: K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252355", "people": [{"name": "Kenichi Inamura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252355%22"}, {"id": "fda:K252405", "company": "Surgical Instrument Service and Savings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252405: Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252405", "people": [{"name": "Kelsey LeMay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252405%22"}, {"id": "fda:K253269", "company": "Ge Hualun Medical Systems Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253269: OEC One CFD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253269", "people": [{"name": "Lifeng Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253269%22"}, {"id": "fda:DEN240077", "company": "Mureva Phototherapy, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN240077: MuReva OM\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240077", "people": [{"name": "Vedang Kothari", "role": "510(k) submission contact"}]}, {"id": "trialreg:NCT07250828", "company": "TriCity Research Center", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy", "source_url": "https://clinicaltrials.gov/study/NCT07250828"}, {"id": "trialreg:NCT07252492", "company": "Archean Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Performances, Clinical Benefits and Safety of the 'Audiocap' Connected Hearing Rehabilitation Device for Improving Audibility in Hearing-impaired People in the Context of CE Marking - AUDIOCAP-2", "source_url": "https://clinicaltrials.gov/study/NCT07252492"}, {"id": "trialreg:NCT07252531", "company": "BrioHealth BV", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: European Study of the BrioVAD Heart Pump for Advanced Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07252531"}, {"id": "trialreg:NCT07250139", "company": "Osheru Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation", "source_url": "https://clinicaltrials.gov/study/NCT07250139"}, {"id": "denovo:DEN240077", "company": "Mureva Phototherapy, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-11-26", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240077 granted: MuReva OM\u2122", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240077"}, {"id": "breakthrough:DEN240077", "company": "Mureva Phototherapy, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-11-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN240077: MUREVA OM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K252388", "company": "Francis Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-11-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K252388: VANQUISH WATER VAPOR ABLATION DEVICE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K251932", "company": "Uzinmedicare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251932: Spectra Platinum", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251932", "people": [{"name": "Soyeon Lim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251932%22"}, {"id": "fda:K253344", "company": "Speclipse, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253344: BELLUS-Q", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253344", "people": [{"name": "Myung Seo Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253344%22"}, {"id": "fda:K253365", "company": "LuxCreo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253365: LuxCreo Flexible Partial Denture Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253365", "people": [{"name": "Tao Feng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253365%22"}, {"id": "fda:K251550", "company": "Naox Technologies Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251550: NX01 (NX01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251550", "people": [{"name": "John Pappan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251550%22"}, {"id": "fda:K250694", "company": "Mlhealth 360", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250694: Scaida BrainCT-ICH (v1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250694", "people": [{"name": "Kumar Surender Sinwar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250694%22"}, {"id": "fda:K252161", "company": "Good Sleep CO Pte , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252161: Hushd Avera", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252161", "people": [{"name": "Alwin Ngai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252161%22"}, {"id": "fda:K251798", "company": "Ray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251798: RCT700", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251798", "people": [{"name": "Suyeon Baek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251798%22"}, {"id": "fda:K252762", "company": "Indica Labs, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252762: HALO AP Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252762", "people": [{"name": "Michele Fredrickson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252762%22"}, {"id": "fda:K252555", "company": "Medusa Orthopedics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252555: Medusa Orthopedics Boa External Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252555", "people": [{"name": "Nicholas V. Riccione", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252555%22"}, {"id": "fda:K253304", "company": "Dongguan Lide Electric Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253304: IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253304", "people": [{"name": "Jinfeng Xiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253304%22"}, {"id": "fda:K250635", "company": "Feops NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250635: FEops HEARTguide Simulation Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250635", "people": [{"name": "Franky Dubois", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250635%22"}, {"id": "fda:K252610", "company": "Zsfab, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252610: ZSFab Lumbar Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252610", "people": [{"name": "Sijin Ren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252610%22"}, {"id": "fda:K251401", "company": "Trustees of the University of Pennsylvania", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251401: PennPET Explorer Positron Emission Tomograph", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251401", "people": [{"name": "Joel Karp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251401%22"}, {"id": "fda:K252004", "company": "Encore Guards", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252004: enCore Night Guard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252004", "people": [{"name": "Benjamin Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252004%22"}, {"id": "fda:K252289", "company": "Stemtech Medical Devices Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252289: Eva Scalp Cooling System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252289", "people": [{"name": "Subrai Pai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252289%22"}, {"id": "fda:K252889", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252889: Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252889", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252889%22"}, {"id": "fda:K253219", "company": "Shenzhen Leaflife Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253219: LeafPure-Echo (LM-LPNdA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253219", "people": [{"name": "Qiang Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253219%22"}, {"id": "fda:K251070", "company": "Akura Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251070: Akura Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251070", "people": [{"name": "Theresa Brandner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251070%22"}, {"id": "fda:K253310", "company": "Esaote, S.p.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253310: 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253310", "people": [{"name": "Antonia Perrella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253310%22"}, {"id": "fda:K252253", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252253: Geistlich Mucograft\u00ae /Geistlich Mucograft\u00ae Seal; Geistlich Fibro-Gide\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252253", "people": [{"name": "Marco Steiner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252253%22"}, {"id": "trialreg:NCT07247136", "company": "Neuspera Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System", "source_url": "https://clinicaltrials.gov/study/NCT07247136"}, {"id": "trialreg:NCT07249489", "company": "Nanochon, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Canada", "source_url": "https://clinicaltrials.gov/study/NCT07249489"}, {"id": "trialreg:NCT07247032", "company": "Implicity", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Heart Failure Management for Patient With CIED Remotely Monitored", "source_url": "https://clinicaltrials.gov/study/NCT07247032"}, {"id": "trialreg:NCT07248930", "company": "Efferon JSC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Thermal Burns", "source_url": "https://clinicaltrials.gov/study/NCT07248930"}, {"id": "fda:K252509", "company": "AngioDynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252509: AlphaVac Multipurpose Mechanical Aspiration System F1885", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252509", "people": [{"name": "Kasey Newcomb", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252509%22"}, {"id": "fda:K251631", "company": "Laerdal Medical AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251631: The BAG manual resuscitator and accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251631", "people": [{"name": "Claudia Pajares Ibanez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251631%22"}, {"id": "fda:K252328", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252328: Voluson Expert 18; Voluson Expert 20; Voluson Expert 22", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252328", "people": [{"name": "Behn Bryan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252328%22"}, {"id": "fda:K242503", "company": "Eurosets S.R.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242503: Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242503", "people": [{"name": "Katia Vescovini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242503%22"}, {"id": "fda:K253407", "company": "Vesalio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253407: NeVa PV Thrombectomy Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253407", "people": [{"name": "Sharon Shachar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253407%22"}, {"id": "fda:K252704", "company": "F Care Systems USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252704: F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252704", "people": [{"name": "Danciu Patrick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252704%22"}, {"id": "fda:K252366", "company": "A2z Radiology Ai, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252366: a2z-Unified-Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252366", "people": [{"name": "Samir Rajpurkar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252366%22"}, {"id": "fda:K250769", "company": "Precision Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250769: Dakota LP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250769", "people": [{"name": "Michael Dawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250769%22"}, {"id": "fda:K252771", "company": "Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252771: Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252771", "people": [{"name": "Zhengzhou Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252771%22"}, {"id": "fda:K252688", "company": "Bozhou Rongjian Medical Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252688: Transcutaneous Electrical Nerve Stimulator (RJTENS-2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252688", "people": [{"name": "Zhifang Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252688%22"}, {"id": "fda:K252787", "company": "Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252787: Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252787", "people": [{"name": "Zhengzhou Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252787%22"}, {"id": "fda:K250634", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250634: BCM2-Body Composition Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250634", "people": [{"name": "Christopher Doherty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250634%22"}, {"id": "trialreg:NCT07244523", "company": "Oystershell NV", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.", "source_url": "https://clinicaltrials.gov/study/NCT07244523"}, {"id": "trialreg:NCT07245758", "company": "Stryker Craniomaxillofacial", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Facial iD Customized Mandible Reconstruction Plates", "source_url": "https://clinicaltrials.gov/study/NCT07245758"}, {"id": "trialreg:NCT07246902", "company": "Cordis US Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Mobilization and Outcomes After Venous Closure", "source_url": "https://clinicaltrials.gov/study/NCT07246902"}, {"id": "trialreg:NCT07246980", "company": "Tulavi Therapeutics,Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Continuous Observational Monitoring Program for Allay\u2122 Hydrogel Cap Safety and Success Study", "source_url": "https://clinicaltrials.gov/study/NCT07246980"}, {"id": "trialreg:NCT07245719", "company": "Stryker Craniomaxillofacial", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up", "source_url": "https://clinicaltrials.gov/study/NCT07245719"}, {"id": "trialreg:NCT07244939", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cephea South America Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07244939"}, {"id": "trialreg:NCT07246200", "company": "Reparel", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TED Stocking vs. Reparel Garment After Hip Replacement", "source_url": "https://clinicaltrials.gov/study/NCT07246200"}, {"id": "trialreg:NCT07245810", "company": "Stryker Craniomaxillofacial", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up", "source_url": "https://clinicaltrials.gov/study/NCT07245810"}, {"id": "fda:K250927", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250927: KARL STORZ Cholangiography Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250927", "people": [{"name": "Jordan Lydia Verla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250927%22"}, {"id": "fda:K252590", "company": "Intradin (Shanghai) Machinery Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252590: Powered Mobility Scooter (PMS105, GUT177, GCAT047)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252590", "people": [{"name": "Mark Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252590%22"}, {"id": "fda:K250700", "company": "Terumo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250700: Pen Injector Needle 32.5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250700", "people": [{"name": "Brian Byrd", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250700%22"}, {"id": "fda:K252666", "company": "Joint Preservation Innovations, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252666: Articulator Arthroscopic Bur", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252666", "people": [{"name": "Sanjeev Bhatia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252666%22"}, {"id": "fda:K250560", "company": "NGMedical GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250560: BEE HA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250560", "people": [{"name": "Stella Hahn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250560%22"}, {"id": "fda:K251293", "company": "Icardio.Ai", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251293: CardioVision", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251293", "people": [{"name": "Roman Sandler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251293%22"}, {"id": "fda:K253681", "company": "Graphy, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253681: TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253681", "people": [{"name": "Moon-Soo Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253681%22"}, {"id": "fda:K251607", "company": "Foshan Kycare Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251607: Oxygen Concentrator (J5A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251607", "people": [{"name": "Leona Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251607%22"}, {"id": "fda:K251880", "company": "Archy Dental, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251880: Archy Dental Imaging", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251880", "people": [{"name": "Benjamin Kolin Kolin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251880%22"}, {"id": "fda:K250714", "company": "Centrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250714: FluoroDose Varnish", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250714", "people": [{"name": "Tim White", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250714%22"}, {"id": "fda:K251849", "company": "Staclear, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251849: StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251849", "people": [{"name": "Jackson Thornton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251849%22"}, {"id": "fda:K252686", "company": "Effortmed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252686: EffortMed PEEK Cages & Corpectomy Cages", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252686", "people": [{"name": "Steven Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252686%22"}, {"id": "fda:K252687", "company": "Suzhou Master Machinery Manufacturing Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252687: Manual Wheelchair (HM305-Air1, HM305-Air2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252687", "people": [{"name": "Wu Hongying", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252687%22"}, {"id": "fda:K252696", "company": "Phasor Health, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252696: LEGACY", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252696", "people": [{"name": "Ray King", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252696%22"}, {"id": "fda:K252070", "company": "Ceribell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252070: Ceribell Infant Seizure Detection Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252070", "people": [{"name": "Raymond Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252070%22"}, {"id": "fda:K250586", "company": "Deroyal Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250586: Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250586", "people": [{"name": "Mary Catherine Reeves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250586%22"}, {"id": "fda:K251205", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251205: Atlantis\u00ae Abutments in Titanium for Straumann BLX and Neodent GM Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251205", "people": [{"name": "Laura Sobrin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251205%22"}, {"id": "fda:K251506", "company": "Neuro Event Labs OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251506: Nelli (Version 7.11)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251506", "people": [{"name": "Pierre Pelletier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251506%22"}, {"id": "fda:K251856", "company": "Everyway Medical Instruments Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251856: Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251856", "people": [{"name": "Jimmy Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251856%22"}, {"id": "trialreg:NCT07243405", "company": "Lunair Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Neurostimulation for Sleep Disordered Breathing (SDB)", "source_url": "https://clinicaltrials.gov/study/NCT07243405"}, {"id": "trialreg:NCT07241884", "company": "CrannMed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization", "source_url": "https://clinicaltrials.gov/study/NCT07241884"}, {"id": "trialreg:NCT07243184", "company": "Shanghai HeartEpoch Medical Technology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Feasibility Study of Polymer Artificial Heart Valve for the Treatment the Mitral Valve Disease.", "source_url": "https://clinicaltrials.gov/study/NCT07243184"}, {"id": "trialreg:NCT07241871", "company": "Rolf Kullgren AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis", "source_url": "https://clinicaltrials.gov/study/NCT07241871"}, {"id": "trialreg:NCT07243197", "company": "Hangzhou Valgen Medtech Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: DragonFly M2 Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT07243197"}, {"id": "trialreg:NCT07243158", "company": "Hangzhou Valgen Medtech Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation", "source_url": "https://clinicaltrials.gov/study/NCT07243158"}, {"id": "trialreg:NCT07242625", "company": "Neudive Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD", "source_url": "https://clinicaltrials.gov/study/NCT07242625"}, {"id": "trialreg:NCT07240831", "company": "Biobeat Technologies Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)", "source_url": "https://clinicaltrials.gov/study/NCT07240831"}, {"id": "breakthrough:K251506", "company": "Neuro Event Labs Oy", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-11-21", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K251506: NELLI (VERSION 7.11)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K252666", "company": "Joint Preservation Innovations, LLC.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-11-21", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K252666: ARTICULATOR ARTHROSCOPIC BUR", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K252846", "company": "Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252846: TaperSet\u0099 Hip System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252846", "people": [{"name": "Romil Sheth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252846%22"}, {"id": "fda:K250963", "company": "Cosylab Jsc, Control System Laboratory", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250963: PlanOne 1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250963", "people": [{"name": "Matija Rupnik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250963%22"}, {"id": "fda:K253495", "company": "Siemens Healthineers AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253495: syngo.MR Applications (VB80)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253495", "people": [{"name": "Vijay Ramadas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253495%22"}, {"id": "fda:K253070", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253070: Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253070", "people": [{"name": "Payal Solanki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253070%22"}, {"id": "fda:K251822", "company": "Siemens Shenzhen Magnetic Resonance , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251822: MAGNETOM Free.Max; MAGNETOM Free.Star", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251822", "people": [{"name": "Li Hai Ting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251822%22"}, {"id": "fda:K253007", "company": "Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253007: Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253007", "people": [{"name": "Zhengzhou Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253007%22"}, {"id": "fda:K253123", "company": "Classys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253123: CuRAS hybrid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253123", "people": [{"name": "Judy Seung-yeon Cho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253123%22"}, {"id": "fda:K253190", "company": "Providence Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253190: CORUS-LX Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253190", "people": [{"name": "Edward Liou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253190%22"}, {"id": "fda:K253105", "company": "Hardy Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253105: HardyDisk AST Cefiderocol 30\u00b5g (FDC30)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253105", "people": [{"name": "Lauren Hamilton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253105%22"}, {"id": "fda:K250643", "company": "Hangzhou Kangji Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250643: Disposable Polymer Ligation Clips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250643", "people": [{"name": "Martin Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250643%22"}, {"id": "fda:K251365", "company": "Si Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251365: OptumSI Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251365", "people": [{"name": "Craig Meyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251365%22"}, {"id": "fda:K243753", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243753: cobas liat Bordetella panel nucleic acid test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243753", "people": [{"name": "Khushvanreep Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243753%22"}, {"id": "fda:K242606", "company": "Integrated Endoscopy, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242606: Nuvis\u00ae Wireless HD Camera System (Nuvis-2K)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242606", "people": [{"name": "Albert Rego", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242606%22"}, {"id": "fda:K253324", "company": "Guangzhou Heygears IMC., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253324: UltraPrint-Dental Denture UV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253324", "people": [{"name": "Mingyang Qu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253324%22"}, {"id": "fda:K251904", "company": "Remington Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251904: VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251904", "people": [{"name": "Dorothy Frieser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251904%22"}, {"id": "fda:K252625", "company": "Response Ortho Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252625: The Response Ortho Smart Fixator - Hexapod System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252625", "people": [{"name": "Isin Sehmuz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252625%22"}, {"id": "trialreg:NCT07239310", "company": "Deepsonbio", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease", "source_url": "https://clinicaltrials.gov/study/NCT07239310"}, {"id": "fda:K253035", "company": "Gu'An Yeolight Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253035: IPL Hair Removal Device (SYL001AZ, SYL002AZ)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253035", "people": [{"name": "Junrui Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253035%22"}, {"id": "fda:K251910", "company": "Edap Technomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251910: Focal One\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251910", "people": [{"name": "Hugo Embert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251910%22"}, {"id": "fda:K250912", "company": "Cytovale, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250912: IntelliSep Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250912", "people": [{"name": "Sarah Esterquest", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250912%22"}, {"id": "fda:K252661", "company": "Fusion Innovations, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252661: SternaFuse Ti Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252661", "people": [{"name": "Adam Cowick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252661%22"}, {"id": "fda:K253197", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253197: ATTUNE\u0099 Total Knee System; ATTUNE\u0099 Revision Sleeve LPS\u0099 Femoral Adaptors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253197", "people": [{"name": "Sierra Robinson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253197%22"}, {"id": "fda:K250651", "company": "Fisher & Paykel Healthcare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250651: OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250651", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250651%22"}, {"id": "fda:K253073", "company": "Sunglor Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253073: LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253073", "people": [{"name": "Allen Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253073%22"}, {"id": "fda:K250642", "company": "Huizhou Foryou Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250642: LUOFUCON\u00ae Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250642", "people": [{"name": "Guosheng Tan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250642%22"}, {"id": "fda:K242603", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242603: MyPAO SA guides", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242603", "people": [{"name": "Baj Stefano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242603%22"}, {"id": "fda:K252642", "company": "Shenzhen Dachi Communication Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252642: Microcurrent Facial Device (CEC101, EEI101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252642", "people": [{"name": "Chunhua Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252642%22"}, {"id": "fda:K252884", "company": "Varian Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252884: Guided Aarhus Applicator Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252884", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252884%22"}, {"id": "trialreg:NCT07235592", "company": "Santen SAS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PRESERFLO\u2122 MicroShunt XI Observational PMCF Study With no Control Group", "source_url": "https://clinicaltrials.gov/study/NCT07235592"}, {"id": "trialreg:NCT07236515", "company": "Mynerva Ag", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy", "source_url": "https://clinicaltrials.gov/study/NCT07236515"}, {"id": "fda:K252521", "company": "Suretex Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252521: LifeStyles\u00ae HydraFeel Natural Rubber Latex Condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252521", "people": [{"name": "Nicolas Coltel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252521%22"}, {"id": "fda:K252729", "company": "Double Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252729: Universal Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252729", "people": [{"name": "Joy Zuo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252729%22"}, {"id": "fda:K252281", "company": "Ulrich GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252281: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252281", "people": [{"name": "Erdmann Sven", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252281%22"}, {"id": "fda:K252818", "company": "Dexcom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252818: Dexcom Smart Basal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252818", "people": [{"name": "Neeta Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252818%22"}, {"id": "fda:K253423", "company": "Nvision Biomedical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253423: ToeJack MIS Bunion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253423", "people": [{"name": "Marisa Zack", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253423%22"}, {"id": "fda:K252636", "company": "The Surgical Company International B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252636: Fluido Compact System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252636", "people": [{"name": "Gianpaolo Soares", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252636%22"}, {"id": "fda:K252582", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252582: Inclusive\u00ae Titanium Abutments compatible with: Camlog\u00ae CONELOG\u00ae Implant System, Dentium\u00ae NR Line Implant Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252582", "people": [{"name": "So Hyun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252582%22"}, {"id": "fda:K243981", "company": "Carre Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243981: Hexoskin Medical System (7100-00016)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243981", "people": [{"name": "Jean-Fran\u00e7ois Roy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243981%22"}, {"id": "fda:K251693", "company": "Unimed Medical Supplies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251693: Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251693", "people": [{"name": "Huanyu Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251693%22"}, {"id": "fda:K253411", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253411: Miniature Telescope for Urology (27033AA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253411", "people": [{"name": "Jordan Lydia Verla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253411%22"}, {"id": "fda:K251695", "company": "Unimed Medical Supplies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251695: Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251695", "people": [{"name": "Xiaobin Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251695%22"}, {"id": "fda:K251191", "company": "Collagen Matrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251191: Collagen Dura Regeneration Membrane - Repair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251191", "people": [{"name": "Victoria Augustine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251191%22"}, {"id": "fda:K252550", "company": "Guangzhou Wondfo Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252550: SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252550", "people": [{"name": "Kaiyu Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252550%22"}, {"id": "trialreg:NCT07232030", "company": "CVRx, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07232030"}, {"id": "trialreg:NCT07233876", "company": "Shenzhen Core Medical Technology CO.,LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: DuoCor 2 DOMINATE Study", "source_url": "https://clinicaltrials.gov/study/NCT07233876"}, {"id": "trialreg:NCT07234240", "company": "Millet Innovation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Blinded Consumer Study for the Evaluation of the Usability and Efficacy of One Medical Device in Venous Return", "source_url": "https://clinicaltrials.gov/study/NCT07234240"}, {"id": "trialreg:NCT07232784", "company": "Fapon Biotech Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Serial Measurement of Pancreatic Stone Protein (PSP) for Sepsis Early Detection in ICU Patients", "source_url": "https://clinicaltrials.gov/study/NCT07232784"}, {"id": "trialreg:NCT07232615", "company": "Biotech Healthcare Holding Gmbh", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Planned Study at Multiple Sites is Being Done to Compare the Results of Two Types of Trifocal Toric Intraocular Lenses Used in Cataract Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07232615"}, {"id": "trialreg:NCT07233473", "company": "Karo Pharma AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections", "source_url": "https://clinicaltrials.gov/study/NCT07233473"}, {"id": "trialreg:NCT07234786", "company": "Karo Pharma AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections", "source_url": "https://clinicaltrials.gov/study/NCT07234786"}, {"id": "fda:K252330", "company": "Nox Medical Ehf", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252330: DeepRESP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252330", "people": [{"name": "El\u00edsabet Finnbogad\u00f3ttir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252330%22"}, {"id": "fda:K251566", "company": "Starmed Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251566: TS-RF Generator (STS10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251566", "people": [{"name": "Honggeun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251566%22"}, {"id": "fda:K252792", "company": "Piccolo Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252792: PM2\u0099 System with ECGuide\u0099 Connector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252792", "people": [{"name": "Augustus Shanahan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252792%22"}, {"id": "fda:K250588", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250588: Access Rubella IgG", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250588", "people": [{"name": "Audree Demmers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250588%22"}, {"id": "fda:K252086", "company": "Nobel Biocare C/O Medicim NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252086: DTX Studio Assist", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252086", "people": [{"name": "Mieke Roelants", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252086%22"}, {"id": "fda:K251141", "company": "Mercator Medical (Thailand), Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251141: Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251141", "people": [{"name": "Praneet Inthajak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251141%22"}, {"id": "fda:K253487", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253487: ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253487", "people": [{"name": "Rapaka Shilpa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253487%22"}, {"id": "trialreg:NCT07229352", "company": "SightGlass Vision, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses", "source_url": "https://clinicaltrials.gov/study/NCT07229352"}, {"id": "trialreg:NCT07229365", "company": "SightGlass Vision, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Children's Viewing Behavior", "source_url": "https://clinicaltrials.gov/study/NCT07229365"}, {"id": "trialreg:NCT07229430", "company": "CLASSYS Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue", "source_url": "https://clinicaltrials.gov/study/NCT07229430"}, {"id": "trialreg:NCT07230964", "company": "Dermed Diagnostics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis", "source_url": "https://clinicaltrials.gov/study/NCT07230964"}, {"id": "trialreg:NCT07231757", "company": "ReCor Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The RADIANCE CED Study", "source_url": "https://clinicaltrials.gov/study/NCT07231757"}, {"id": "trialreg:NCT07231237", "company": "Solventum US LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study Evaluating Solventum\u2122 Vitrebond\u2122 Pulp Protect Liner/Base for Direct Capping of Pulpal Exposure", "source_url": "https://clinicaltrials.gov/study/NCT07231237"}, {"id": "fda:K252618", "company": "Alovea Healthcare Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252618: IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252618", "people": [{"name": "Bingying Hou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252618%22"}, {"id": "fda:K251872", "company": "Biomoneta Research Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251872: Biomoneta Avata Rx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251872", "people": [{"name": "Arindam Ghatak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251872%22"}, {"id": "fda:DEN250015", "company": "Fusmobile, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250015: Neurolyser XR (NXR100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250015", "people": [{"name": "Ron Aginsky", "role": "510(k) submission contact"}]}, {"id": "fda:K250525", "company": "Pearl, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250525: Second Opinion\u00ae Panoramic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250525", "people": [{"name": "Ashley Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250525%22"}, {"id": "fda:K250865", "company": "KLS-Martin L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250865: KLS Martin IPS Forearm System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250865", "people": [{"name": "Melissa Bachorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250865%22"}, {"id": "fda:K251078", "company": "Eos Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251078: AutoDensity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251078", "people": [{"name": "Mathilde Masurel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251078%22"}, {"id": "fda:K250501", "company": "This AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250501: System Sophi", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250501", "people": [{"name": "Mr. Kai Kremnitzer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250501%22"}, {"id": "fda:K251538", "company": "Princeton BioMeditech Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251538: Status\u0099 COVID-19/Flu A&B", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251538", "people": [{"name": "Young-A Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251538%22"}, {"id": "fda:K251756", "company": "Paragon Implant Mfg., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251756: Sterilization Trays", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251756", "people": [{"name": "Renee Bennett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251756%22"}, {"id": "fda:K250471", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250471: AquaC UNO H", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250471", "people": [{"name": "Greg Calder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250471%22"}, {"id": "fda:K252627", "company": "Inanovate, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252627: Lyme-ID IgG Test; Bio-ID800", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252627", "people": [{"name": "Aaron Harmon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252627%22"}, {"id": "fda:K251659", "company": "Qingdao Future Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251659: Mesh Nebulizer (H6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251659", "people": [{"name": "Xinxin Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251659%22"}, {"id": "fda:K251821", "company": "Onward Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251821: ARC-EX System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251821", "people": [{"name": "Nathalie Gilat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251821%22"}, {"id": "trialreg:NCT07228091", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Surgical Procedure Efficiency Evaluation stuDy", "source_url": "https://clinicaltrials.gov/study/NCT07228091"}, {"id": "trialreg:NCT07228117", "company": "Medtronic MiniMed, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: GATEWAY: Safety Evaluation of the MiniMed\u2122 NMX8-AID System in Children and Adults Living With Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07228117"}, {"id": "trialreg:NCT07228416", "company": "ivWatch, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Milky Way Sensor Motion Validation", "source_url": "https://clinicaltrials.gov/study/NCT07228416"}, {"id": "denovo:DEN250015", "company": "Fusmobile, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-11-14", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250015 granted: Neurolyser XR (NXR100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250015"}, {"id": "fda:K251662", "company": "Shenzhen Future Electronic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251662: Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251662", "people": [{"name": "Xiongxiu Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251662%22"}, {"id": "fda:K251842", "company": "Fussen Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251842: Dental Computed Tomography X-ray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251842", "people": [{"name": "Guiqin Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251842%22"}, {"id": "fda:K252949", "company": "Skeletal Dynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252949: Geminus Volar Distal Radius Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252949", "people": [{"name": "Daniel E. Gallego", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252949%22"}, {"id": "fda:K252308", "company": "Atop Lighting Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252308: LED Beauty Mask (RLBXX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252308", "people": [{"name": "Tse Adrian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252308%22"}, {"id": "fda:K253457", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253457: ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253457", "people": [{"name": "Rapaka Shilpa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253457%22"}, {"id": "fda:K252592", "company": "Telltale, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252592: TELLTALE Electrosurgical Guidewire System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252592", "people": [{"name": "Koosha Rafiee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252592%22"}, {"id": "fda:K251314", "company": "Orthosoft Inc. (d/b/a) Zimmer CAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251314: Rosa\u00ae Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251314", "people": [{"name": "Kruti Gosalia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251314%22"}, {"id": "trialreg:NCT07227805", "company": "Medtronic MiniMed, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)", "source_url": "https://clinicaltrials.gov/study/NCT07227805"}, {"id": "trialreg:NCT07227675", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR", "source_url": "https://clinicaltrials.gov/study/NCT07227675"}, {"id": "trialreg:NCT07228026", "company": "Biometry Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Use of fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Uncontrolled Asthma Subjects and Controlled Asthma Subjects", "source_url": "https://clinicaltrials.gov/study/NCT07228026"}, {"id": "breakthrough:K252592", "company": "Telltale, LLC.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-11-13", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K252592: TELLTALE ELECTROSURGICAL GUIDEWIRE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K253290", "company": "Revmedx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253290: XSTAT P15", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253290", "people": [{"name": "Amy K. Pointer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253290%22"}, {"id": "fda:K243897", "company": "ETHICON, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243897: PDS\u0099 Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243897", "people": [{"name": "Anju Malhotra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243897%22"}, {"id": "fda:K252271", "company": "Hangzhou AGS MedTech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252271: Hemoclip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252271", "people": [{"name": "Xufan Chi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252271%22"}, {"id": "fda:K252829", "company": "Suzhou KD Intelligent Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252829: Powered Wheelchair (PL001-9001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252829", "people": [{"name": "Zhongying Xia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252829%22"}, {"id": "fda:K243715", "company": "Synthes GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243715: Synthes Patient Specific Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243715", "people": [{"name": "Thomas Shea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243715%22"}, {"id": "fda:K252327", "company": "Icotec AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252327: CMORE\u00ae CT System; CMORE\u00ae CT System Navigated Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252327", "people": [{"name": "Vanessa Faessler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252327%22"}, {"id": "fda:K252959", "company": "Intrauma S.P.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252959: WRISTAR MultiAx Distal Radius Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252959", "people": [{"name": "Stefano Pullega", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252959%22"}, {"id": "fda:K252452", "company": "Peek Health, S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252452: PeekMed web", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252452", "people": [{"name": "Sara Silva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252452%22"}, {"id": "fda:K251336", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251336: VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251336", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251336%22"}, {"id": "fda:K251833", "company": "Encore Medical L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251833: EMPOWR Acetabular\u00ae Liner Extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251833", "people": [{"name": "Katrina Dombovari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251833%22"}, {"id": "trialreg:NCT07227532", "company": "Biosense Webster, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System", "source_url": "https://clinicaltrials.gov/study/NCT07227532"}, {"id": "trialreg:NCT07226869", "company": "NE Scientific INC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Computer Guided Microwave Liver Ablation", "source_url": "https://clinicaltrials.gov/study/NCT07226869"}, {"id": "trialreg:NCT07227376", "company": "Eko Devices, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Collection Using Eko Digital Devices in a Clinical Setting", "source_url": "https://clinicaltrials.gov/study/NCT07227376"}, {"id": "trialreg:NCT07227103", "company": "NeuroRx, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Robotic Transcranial Magnetic Stimulation for Treatment Resistant Depression: The SPARC-TMS Trial", "source_url": "https://clinicaltrials.gov/study/NCT07227103"}, {"id": "breakthrough:K252327", "company": "Icotec Ag", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-11-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K252327: CMORE CT SYSTEM; CMORE CT SYSTEM NAVIGATED INSTRUMENTS", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K252560", "company": "Atlas Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252560: Atlas Spine HiRISE\u0099 Expandable Cervical Corpectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252560", "people": [{"name": "Thomas Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252560%22"}, {"id": "fda:K251006", "company": "Vesalio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251006: NeVasc Aspiration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251006", "people": [{"name": "Sharon Shachar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251006%22"}, {"id": "fda:K252573", "company": "KLS-Martin L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252573: KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252573", "people": [{"name": "Melissa Bachorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252573%22"}, {"id": "fda:K252287", "company": "Medical Microinstruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252287: Symani Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252287", "people": [{"name": "Zainab Amini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252287%22"}, {"id": "fda:K252474", "company": "Withings", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252474: Withings BeamO (SCT02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252474", "people": [{"name": "Aline Criton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252474%22"}, {"id": "fda:K252570", "company": "Qpix Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252570: EzSensor HD, EzSensor UHD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252570", "people": [{"name": "Seungman Yun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252570%22"}, {"id": "fda:K251702", "company": "Philips Medizin Systeme B\u00f6blingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251702: IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251702", "people": [{"name": "Alicia Honemeyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251702%22"}, {"id": "trialreg:NCT07225751", "company": "Kuros Biosurgery AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions.", "source_url": "https://clinicaltrials.gov/study/NCT07225751"}, {"id": "trialreg:NCT07225933", "company": "Calyxo, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC\u00ae System", "source_url": "https://clinicaltrials.gov/study/NCT07225933"}, {"id": "trialreg:NCT07226648", "company": "SPIRE Therapeutics Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia", "source_url": "https://clinicaltrials.gov/study/NCT07226648"}, {"id": "fda:K251596", "company": "William Cook Europe Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251596: Lunderquist Extra Stiff Wire Guide", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251596", "people": [{"name": "Mie Dyrholm", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251596%22"}, {"id": "fda:K251853", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251853: Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251853", "people": [{"name": "Lu Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251853%22"}, {"id": "fda:K243131", "company": "Sigma Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243131: Triathlon Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243131", "people": [{"name": "Jorge Millan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243131%22"}, {"id": "fda:K253513", "company": "Premier Dental Products Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253513: MultiMatch Flow Chameleon AntiMicrobial Composite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253513", "people": [{"name": "Jessica Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253513%22"}, {"id": "fda:K251295", "company": "Ulrich GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251295: ulrichINJECT CT Motion (XD 8000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251295", "people": [{"name": "Sven Erdmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251295%22"}, {"id": "fda:K252519", "company": "Hebei Keylaser Sci-Tech Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252519: CO2 Laser Therapy System (K106)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252519", "people": [{"name": "Zhen Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252519%22"}, {"id": "fda:K251391", "company": "Brainsway , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251391: BrainsWay Deep TMS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251391", "people": [{"name": "Colleen Hanlon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251391%22"}, {"id": "fda:K252564", "company": "Baoding Te'Anzhou Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252564: Medical Diode Laser Systems (VeinCure)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252564", "people": [{"name": "Ji chuan Cao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252564%22"}, {"id": "fda:K250264", "company": "Bench7, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250264: SugarBug (1.x)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250264", "people": [{"name": "John Persson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250264%22"}, {"id": "fda:K251441", "company": "Inion OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251441: Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251441", "people": [{"name": "Hanne Kankaanp\u00e4\u00e4", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251441%22"}, {"id": "fda:K250739", "company": "Dreve Dentamid GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250739: Primeprint Direct Aligner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250739", "people": [{"name": "Anke H\u00fcttenbrauck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250739%22"}, {"id": "fda:K251129", "company": "S.I.N. Implant System Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251129: S.I.N. Tapered Pro Conical Zygoma Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251129", "people": [{"name": "Denise Domiciano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251129%22"}, {"id": "fda:K253039", "company": "Topcon Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253039: AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253039", "people": [{"name": "Tomoka Nishiyama", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253039%22"}, {"id": "fda:K250819", "company": "Rollz International BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250819: Electric Wheelchair (Rollz Motion Electric 2M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250819", "people": [{"name": "Martijn Schaaper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250819%22"}, {"id": "fda:K252041", "company": "Imvaria, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252041: Fibresolve (with PCCP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252041", "people": [{"name": "Joshua Reicher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252041%22"}, {"id": "fda:K250423", "company": "Medical Bees GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250423: mb-FIX Cranial Stabilization Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250423", "people": [{"name": "Laura Sperle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250423%22"}, {"id": "fda:K252418", "company": "Catalyst Orthoscience, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252418: Catalyst F1x Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252418", "people": [{"name": "Dale Davison", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252418%22"}, {"id": "fda:K253265", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253265: BriefCase-Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253265", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253265%22"}, {"id": "fda:K253478", "company": "Motive Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253478: Motive\u0099 Muscle Stimulator for Lower Back (OT01-1003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253478", "people": [{"name": "Pete Kilpatrick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253478%22"}, {"id": "fda:K253074", "company": "Tandem Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253074: Tandem Mobi insulin pump with interoperable technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253074", "people": [{"name": "Omar Mirza", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253074%22"}, {"id": "fda:K252133", "company": "Adaptix Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252133: Adaptix Ortho350", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252133", "people": [{"name": "Martin Stofanko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252133%22"}, {"id": "fda:K252515", "company": "Hebei Keylaser Sci-Tech Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252515: Q-Switched Nd:Yag laser (K690)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252515", "people": [{"name": "Yang Zhen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252515%22"}, {"id": "fda:K251004", "company": "Hefei Chimed Intelligent Machine Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251004: Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251004", "people": [{"name": "Min Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251004%22"}, {"id": "fda:K251792", "company": "Stereotaxis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251792: Stereotaxis GenesisX RMN with Navigant \u0099 Workstation (NWS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251792", "people": [{"name": "Angela McKnight", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251792%22"}, {"id": "fda:K252525", "company": "Aiomega, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252525: AIO Breathe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252525", "people": [{"name": "Raghavendra Ghuge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252525%22"}, {"id": "fda:K250815", "company": "Hubly, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250815: Hubly Drill (H100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250815", "people": [{"name": "Casey Qadir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250815%22"}, {"id": "fda:K251555", "company": "Pace Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251555: Ultra\u0099 Compression Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251555", "people": [{"name": "Bill Rhoda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251555%22"}, {"id": "fda:K252845", "company": "Venus Concept, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252845: Venus Nova (FP-2001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252845", "people": [{"name": "Danielle Fulk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252845%22"}, {"id": "fda:K252469", "company": "Dmp Dental Industry S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252469: MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252469", "people": [{"name": "Konstantinos Kyritsis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252469%22"}, {"id": "trialreg:NCT07225231", "company": "Byteflies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS", "source_url": "https://clinicaltrials.gov/study/NCT07225231"}, {"id": "trialreg:NCT07225478", "company": "Colgate Palmolive", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study to Evaluate the Tooth Whitening Efficacy of a New NextGen In-office Whitening System", "source_url": "https://clinicaltrials.gov/study/NCT07225478"}, {"id": "fda:K252677", "company": "Poly Medicure Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252677: Polyshield Safety IV Catheters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252677", "people": [{"name": "S. S. Rawat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252677%22"}, {"id": "fda:K252514", "company": "Phasor Health, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252514: EVAC-MRI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252514", "people": [{"name": "Ray King", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252514%22"}, {"id": "fda:K250375", "company": "Waldemar Link GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250375: Allure Hip Stem and Intramedullary Plugs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250375", "people": [{"name": "Pia M\u00fcller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250375%22"}, {"id": "fda:K250363", "company": "Beijing Sinovation Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250363: Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250363", "people": [{"name": "Lina Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250363%22"}, {"id": "fda:K250376", "company": "Viatherm Therapeutics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250376: ViVY", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250376", "people": [{"name": "Maria Fattore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250376%22"}, {"id": "fda:K250599", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250599: ExcelsiusGPS\u0099 Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250599", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250599%22"}, {"id": "pma:P240026", "company": "Promega Corporation", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-11-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240026: OncoMate\u00ae MSI Dx Analysis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240026", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240026%22"}, {"id": "trialreg:NCT07224919", "company": "Jonathan Vaisberg", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AutoFocus360 Sound Quality Preference and Claims Study", "source_url": "https://clinicaltrials.gov/study/NCT07224919"}, {"id": "trialreg:NCT07224880", "company": "Cytrellis Biosystems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Ellacor\u00ae Micro-Coring Technology\u00ae in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists", "source_url": "https://clinicaltrials.gov/study/NCT07224880"}, {"id": "trialreg:NCT07225075", "company": "Balt USA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)", "source_url": "https://clinicaltrials.gov/study/NCT07225075"}, {"id": "fda:K252664", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252664: GMReis Suture Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252664", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252664%22"}, {"id": "fda:K250576", "company": "Karma Mobility Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250576: Flexx Junior (FLX-J00, FLX-J50)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250576", "people": [{"name": "Anoohya Pulipaka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250576%22"}, {"id": "fda:K251709", "company": "Medcad", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251709: MedCAD\u00ae AccuStride\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251709", "people": [{"name": "Brian Buss", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251709%22"}, {"id": "fda:K251410", "company": "Vieworks Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251410: VXvue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251410", "people": [{"name": "Serin Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251410%22"}, {"id": "fda:K251303", "company": "Menovex Medical Technology (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251303: Tamburo Thulium Fiber Laser System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251303", "people": [{"name": "Xueying Qin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251303%22"}, {"id": "fda:K250853", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250853: Merit Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250853", "people": [{"name": "Kirk McIntosh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250853%22"}, {"id": "fda:K250241", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250241: Cios Select", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250241", "people": [{"name": "Patricia D. Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250241%22"}, {"id": "fda:K252964", "company": "Primed Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252964: PRIMED Surgical and Procedure Masks", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252964", "people": [{"name": "Mitra Fard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252964%22"}, {"id": "fda:K252740", "company": "Applied Medical Resources Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252740: Voyant\u00ae Open Fusion Device (EB240/Open Fusion)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252740", "people": [{"name": "Derek Greene", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252740%22"}, {"id": "trialreg:NCT07224464", "company": "New Phase Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia.", "source_url": "https://clinicaltrials.gov/study/NCT07224464"}, {"id": "trialreg:NCT07224256", "company": "Neuralink Corp", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration", "source_url": "https://clinicaltrials.gov/study/NCT07224256"}, {"id": "fda:K251626", "company": "Midmark Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251626: Midmark Dental Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251626", "people": [{"name": "Rachel Schwieterman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251626%22"}, {"id": "fda:K252481", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252481: cobas CMV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252481", "people": [{"name": "Sun Austin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252481%22"}, {"id": "fda:K251532", "company": "Mighty Oak Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251532: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251532", "people": [{"name": "Mark Wylie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251532%22"}, {"id": "fda:K252484", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252484: cobas HCV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252484", "people": [{"name": "Nghia Luu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252484%22"}, {"id": "fda:K250330", "company": "Pie Medical Imaging BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250330: 3mensio Workstation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250330", "people": [{"name": "Annemiek Bouts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250330%22"}, {"id": "fda:K250392", "company": "Zap Surgical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250392: ZAP-X Radiosurgery System (ZAP-X)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250392", "people": [{"name": "Junyi Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250392%22"}, {"id": "fda:K253448", "company": "FUJIFILM Sonosite, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253448: Sonosite MT Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253448", "people": [{"name": "Anoush Frankian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253448%22"}, {"id": "fda:K252458", "company": "Shanghai Lange Medtech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252458: Kyphoplasty Balloon Dilatation Catheters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252458", "people": [{"name": "Zhou Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252458%22"}, {"id": "fda:K252671", "company": "Hebei Dansong Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252671: Electric wheelchair (NSDS-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252671", "people": [{"name": "Wendy Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252671%22"}, {"id": "fda:K252698", "company": "Nightguard Express, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-11-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252698: NightGuard Aire Max", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252698", "people": [{"name": "Flavia Alonso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252698%22"}, {"id": "trialreg:NCT07223996", "company": "Nestmedic Spolka Akcyjna", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study", "source_url": "https://clinicaltrials.gov/study/NCT07223996"}, {"id": "trialreg:NCT07223931", "company": "Turtle Shell Technologies Pvt. Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-11-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validating Dozee for Contactless Monitoring of Heart, Breathing, and Movemen", "source_url": "https://clinicaltrials.gov/study/NCT07223931"}, {"id": "fda:K250917", "company": "Shenzhen Sanping Image Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250917: Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250917", "people": [{"name": "Chen Salon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250917%22"}, {"id": "fda:K251547", "company": "Terrats Medical SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251547: DESS Dental Smart Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251547", "people": [{"name": "Roger Terrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251547%22"}, {"id": "fda:K252088", "company": "Orthofix US, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252088: Firebird SI Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252088", "people": [{"name": "Kendal Moulton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252088%22"}, {"id": "fda:K252160", "company": "Persyst Development, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252160: Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252160", "people": [{"name": "Dari Darabbeigi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252160%22"}, {"id": "fda:K250358", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250358: BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250358", "people": [{"name": "Joseph Basore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250358%22"}, {"id": "fda:K252412", "company": "Applied Medical Resources Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252412: Voyant\u00ae Electrosurgical Generator (EA030/Electrosurgical Generator)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252412", "people": [{"name": "Derek Greene", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252412%22"}, {"id": "fda:DEN240074", "company": "Pulsenmore, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN240074: Pulsenmore ES", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240074", "people": [{"name": "Israel Citron", "role": "510(k) submission contact"}]}, {"id": "fda:K253501", "company": "Vigodent Ind\u00fastria E Comercio Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253501: Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253501", "people": [{"name": "Catia Mara da Eira Hoehn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253501%22"}, {"id": "fda:K251381", "company": "Ceribell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251381: Ceribell Instant EEG Headcap (Small: C251, Medium: C252)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251381", "people": [{"name": "Raymond Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251381%22"}, {"id": "fda:K251041", "company": "Actuated Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251041: GripTract-GI\u0099 Endoscopic Tissue Manipulator Upper GI Model GT-GS100", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251041", "people": [{"name": "Douglas Dillon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251041%22"}, {"id": "fda:K252777", "company": "Maxx Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252777: Freedom Metaphyseal Cone Implants (Metaphyseal Cones)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252777", "people": [{"name": "Donald Guthner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252777%22"}, {"id": "fda:K252060", "company": "Phasor Health, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252060: GREEN", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252060", "people": [{"name": "Ray King", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252060%22"}, {"id": "fda:K250338", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250338: MSS - Humeral reverse liners extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250338", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250338%22"}, {"id": "fda:K250306", "company": "Propper Manufacturing Co., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250306: Chex-All Sterilization Pouches and Tubes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250306", "people": [{"name": "Andrew Sharavara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250306%22"}, {"id": "fda:K252074", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252074: Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252074", "people": [{"name": "Orlando Tadeo, Jr.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252074%22"}, {"id": "fda:K252427", "company": "Sanhe Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252427: Diode Laser Hair Removal Machine (GLD01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252427", "people": [{"name": "Xiaoxia Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252427%22"}, {"id": "fda:K252442", "company": "Applied Medical Resources Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-31", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252442: Kii Structural Balloon Access System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252442", "people": [{"name": "Derek Greene", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252442%22"}, {"id": "trialreg:NCT07223164", "company": "Masimo Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease", "source_url": "https://clinicaltrials.gov/study/NCT07223164"}, {"id": "trialreg:NCT07223177", "company": "Masimo Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations", "source_url": "https://clinicaltrials.gov/study/NCT07223177"}, {"id": "denovo:DEN240074", "company": "Pulsenmore, Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-10-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240074 granted: Pulsenmore ES", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240074"}, {"id": "fda:K252430", "company": "Detax GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252430: Freeprint\u00ae denture flex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252430", "people": [{"name": "Barabara Voigt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252430%22"}, {"id": "fda:K250337", "company": "ViTAA Medical Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250337: AiORTA - Plan", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250337", "people": [{"name": "Mitchel Benovoy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250337%22"}, {"id": "fda:K251686", "company": "Tornier, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251686: Tornier Humeral Reconstruction System Max (Tornier HRS Max)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251686", "people": [{"name": "Stefanie Tarara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251686%22"}, {"id": "fda:K243619", "company": "Taewoong Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243619: Niti-S Esophageal Stent; Esophageal TTS Stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243619", "people": [{"name": "Yongjin \"Jeff\" Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243619%22"}, {"id": "fda:K250632", "company": "Arctx Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250632: Arctx Cool Catheter Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250632", "people": [{"name": "Don Gurskis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250632%22"}, {"id": "fda:K252752", "company": "Cytrellis Biosystems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252752: ellacor System with Micro-Coring Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252752", "people": [{"name": "Robert Hinz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252752%22"}, {"id": "fda:K251531", "company": "Merchsource, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251531: AIR COMPRESSION BOOTS 1018195,1018196", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251531", "people": [{"name": "Shirley Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251531%22"}, {"id": "fda:K252414", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252414: Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252414", "people": [{"name": "Dijkstra Alain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252414%22"}, {"id": "fda:K252607", "company": "Hangzhou AllTest Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252607: AllTest Urinary Tract Infection Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252607", "people": [{"name": "Rosa Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252607%22"}, {"id": "fda:K252046", "company": "Imperative Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252046: Zoom System (Zoom 4S Catheter)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252046", "people": [{"name": "Peter Taylor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252046%22"}, {"id": "fda:K252387", "company": "Diasorin Molecular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252387: Simplexa\u0099 COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa\u0099 COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252387", "people": [{"name": "Michael Treas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252387%22"}, {"id": "fda:K251938", "company": "Paragon Implant Mfg., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251938: GEN5 and GEN5+ Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251938", "people": [{"name": "Renee Bennett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251938%22"}, {"id": "fda:K253327", "company": "M.I.Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253327: HANAROSTENT Esophagus Upper (CCC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253327", "people": [{"name": "Jeongeun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253327%22"}, {"id": "fda:K250325", "company": "Carefusion (Bd)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250325: BD Alaris Pump Infusion Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250325", "people": [{"name": "Amy Honey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250325%22"}, {"id": "fda:K252529", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252529: Moses\u0099 200 D/F/L Laser Fiber (M0068130100); Moses\u0099 365 D/F/L Laser Fiber (M0068130110); Moses\u0099 550 D/F/L Laser Fiber (M0068130120)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252529", "people": [{"name": "Brandon Burris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252529%22"}, {"id": "fda:K253376", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253376: OBSIDIO\u0099 Conformable Embolic (M0013972101010)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253376", "people": [{"name": "Liz Johnston", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253376%22"}, {"id": "trialreg:NCT07222813", "company": "Echosens", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Liver Stiffness Performance, by FibroScan\u00ae, to Detect Elevated Central Venous Pressure (CVP)", "source_url": "https://clinicaltrials.gov/study/NCT07222813"}, {"id": "trialreg:NCT07222605", "company": "eQ8Health Corporation d/b/a CareONE Concierge", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Research Study for Patients With Neurological Diseases Which Evaluates the Patient Experience of the MemorEM Device", "source_url": "https://clinicaltrials.gov/study/NCT07222605"}, {"id": "trialreg:NCT07222787", "company": "Providence Medical Technology, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes", "source_url": "https://clinicaltrials.gov/study/NCT07222787"}, {"id": "trialreg:NCT07222826", "company": "Compremium AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Non-invasive Intracranial Pressure Estimation by Measurement of the Occlusion Pressure of the Isolated Periorbital Vein", "source_url": "https://clinicaltrials.gov/study/NCT07222826"}, {"id": "fda:K251772", "company": "Od-Os GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251772: Navilas Laser System 577sl (156691)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251772", "people": [{"name": "Camila Mundt Ilgenfritz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251772%22"}, {"id": "fda:K253153", "company": "Su-Ko Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253153: SER Pen Carain MicroSystem (MP1209SP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253153", "people": [{"name": "Yuan Yuan \"Susie\" Su Korrodi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253153%22"}, {"id": "fda:K253232", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253232: Seguin Annuloplasty Ring", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253232", "people": [{"name": "Bryan Soto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253232%22"}, {"id": "fda:K251643", "company": "Wright Medical Technology, Inc. (Stryker Corporation)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251643: Synchfix EVT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251643", "people": [{"name": "Rachel Warnock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251643%22"}, {"id": "fda:K250882", "company": "Huxley Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250882: SANSA HSAT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250882", "people": [{"name": "Daniel Burnham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250882%22"}, {"id": "fda:K252393", "company": "Ortho-Clinical Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252393: VITROS Immunodiagnostic Products hs Troponin I Reagent Pack", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252393", "people": [{"name": "Kristine Tkacs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252393%22"}, {"id": "fda:K253283", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253283: Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253283", "people": [{"name": "Wendy Wen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253283%22"}, {"id": "fda:K252697", "company": "Guangdong Optomedic Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252697: 3D Laparoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252697", "people": [{"name": "Minghua Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252697%22"}, {"id": "fda:K251985", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251985: LOGIQ E10", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251985", "people": [{"name": "Bryan Behn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251985%22"}, {"id": "fda:K253323", "company": "Inari Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253323: Protrieve Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253323", "people": [{"name": "Rayee Patil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253323%22"}, {"id": "fda:K252314", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252314: Arthrex SutureTak Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252314", "people": [{"name": "Alex Underberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252314%22"}, {"id": "fda:K252416", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252416: AETOS Shoulder System Meta Humeral Prosthesis Size 0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252416", "people": [{"name": "Cassidy Whipple", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252416%22"}, {"id": "fda:K253314", "company": "Maxx Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253314: Freedom Infinia\u0099 Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253314", "people": [{"name": "Corey Perine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253314%22"}, {"id": "fda:K253355", "company": "Fissiontech, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253355: Difiney Advanced Anti Snoring Device 4.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253355", "people": [{"name": "Mike Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253355%22"}, {"id": "fda:K251963", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251963: LOGIQ E10s", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251963", "people": [{"name": "Bryan Behn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251963%22"}, {"id": "fda:K250316", "company": "Meduloc, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250316: Meduloc Intramedullary Fracture Fixation (IFF) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250316", "people": [{"name": "Benjamin Arnold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250316%22"}, {"id": "fda:K250618", "company": "Ya-Man, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250618: Medi Lift Essential Eye Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250618", "people": [{"name": "Jun Takada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250618%22"}, {"id": "fda:K252390", "company": "Medtronic, Ireland", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252390: Telescope Guide Extension Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252390", "people": [{"name": "Denise Keehan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252390%22"}, {"id": "fda:K253242", "company": "Shenzhen Beacon Display Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253242: LCD Monitor (C1216W, C822W, C821W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253242", "people": [{"name": "Li Yafei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253242%22"}, {"id": "fda:K253345", "company": "FH Industrie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253345: JARVIS Diaphyseal Stem Standard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253345", "people": [{"name": "Naoual Rahimi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253345%22"}, {"id": "trialreg:NCT07222410", "company": "Fisher and Paykel Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital", "source_url": "https://clinicaltrials.gov/study/NCT07222410"}, {"id": "trialreg:NCT07222033", "company": "Wandercraft", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Self-balancing Personal Exoskeleton for SCI (WINY)", "source_url": "https://clinicaltrials.gov/study/NCT07222033"}, {"id": "trialreg:NCT07222085", "company": "Infinite Biomedical Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Long-Term Stability of the Glide Control Strategy", "source_url": "https://clinicaltrials.gov/study/NCT07222085"}, {"id": "trialreg:NCT07222397", "company": "FA Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: 2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles", "source_url": "https://clinicaltrials.gov/study/NCT07222397"}, {"id": "fda:K252376", "company": "Neocis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252376: Yomi S Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252376", "people": [{"name": "Jorge Fernandes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252376%22"}, {"id": "fda:K252742", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252742: Navigated Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252742", "people": [{"name": "Chelsea Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252742%22"}, {"id": "fda:K253300", "company": "Bodycad Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253300: Fine Osteotomy\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253300", "people": [{"name": "Nadine Adia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253300%22"}, {"id": "fda:K252351", "company": "Cg Medtech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252351: UniSpace\u00ae TPLIF Cage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252351", "people": [{"name": "Soli Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252351%22"}, {"id": "fda:K252547", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252547: TheraSphere 360\u0099 Y-90 Management Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252547", "people": [{"name": "Amy McKinney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252547%22"}, {"id": "fda:K250275", "company": "Baylis Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250275: PrecisePath\u0099 Radiofrequency Puncture Generator and PrecisePath\u0099 Footswitch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250275", "people": [{"name": "Barb Boyce", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250275%22"}, {"id": "fda:K252165", "company": "Shofu Dental Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252165: ZIRCONOMER P", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252165", "people": [{"name": "Malzyner Mauro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252165%22"}, {"id": "fda:K253399", "company": "Volcano Corporation (Dba Philips Image Guided Therapy Device", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253399: Visions\u00ae PV .014P RX Digital IVUS Catheter ; Visions\u00ae PV .018 Digital IVUS Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253399", "people": [{"name": "Aaron Niklaus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253399%22"}, {"id": "fda:K251466", "company": "Wellell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251466: VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251466", "people": [{"name": "Chieh Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251466%22"}, {"id": "trialreg:NCT07221526", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SPO2 VALIDATION STUDY - PHILIPS FAST 2025", "source_url": "https://clinicaltrials.gov/study/NCT07221526"}, {"id": "trialreg:NCT07221565", "company": "Truway Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT)", "source_url": "https://clinicaltrials.gov/study/NCT07221565"}, {"id": "trialreg:NCT07221916", "company": "Stryker Craniomaxillofacial", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up", "source_url": "https://clinicaltrials.gov/study/NCT07221916"}, {"id": "fda:K251331", "company": "Shenzhen Jamr Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251331: Blood Pressure Monitor (B73, BE23T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251331", "people": [{"name": "Can Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251331%22"}, {"id": "fda:K250297", "company": "Techfit Digital Surgery, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250297: TECHFIT Patient-Specific Cranial System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250297", "people": [{"name": "Angela Lema", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250297%22"}, {"id": "fda:K251824", "company": "Patriot Laser, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251824: Patriot Duo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251824", "people": [{"name": "Frank Ford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251824%22"}, {"id": "fda:K252630", "company": "Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252630: Electric Breast Pump (HL-3060, F5113)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252630", "people": [{"name": "Shulin Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252630%22"}, {"id": "fda:K250520", "company": "Osteocentric Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250520: OsteoCentric Navigated Instruments System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250520", "people": [{"name": "Todd Evans", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250520%22"}, {"id": "fda:K251875", "company": "Affinity Biosensors, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251875: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251875", "people": [{"name": "Ken Babcock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251875%22"}, {"id": "fda:K251027", "company": "Circle Cardiovascular Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251027: cvi42 Coronary Plaque Software Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251027", "people": [{"name": "Omar Naimi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251027%22"}, {"id": "fda:K252629", "company": "Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252629: Electric Breast Pump (HL-3058, F5112)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252629", "people": [{"name": "Shulin Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252629%22"}, {"id": "fda:K252053", "company": "Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252053: VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252053", "people": [{"name": "Elin Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252053%22"}, {"id": "fda:K252467", "company": "Viet Phu Trade and Import Export Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252467: Disposable Vinyl Examination Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252467", "people": [{"name": "Kim Ngan Pham Thi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252467%22"}, {"id": "trialreg:NCT07221097", "company": "BioFire Defense LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses", "source_url": "https://clinicaltrials.gov/study/NCT07221097"}, {"id": "fda:K250904", "company": "Wandercraft SAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250904: Atalante X", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250904", "people": [{"name": "M\u00e9lanie Combes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250904%22"}, {"id": "fda:K253377", "company": "Spectrum Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253377: Expandable Titanium PLIF/TLIF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253377", "people": [{"name": "Scott Baltsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253377%22"}, {"id": "fda:K251827", "company": "Philips Medical Systems B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251827: Azurion R3.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251827", "people": [{"name": "Rithika Gidijala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251827%22"}, {"id": "fda:K253335", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253335: CD Horizon\u0099 Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253335", "people": [{"name": "Wafa Mustafa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253335%22"}, {"id": "fda:K252646", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252646: Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252646", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252646%22"}, {"id": "fda:K252357", "company": "Abbott Ireland", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252357: Glucose2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252357", "people": [{"name": "Cherie Lipowsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252357%22"}, {"id": "fda:K253150", "company": "Jkh Health Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253150: Cryon-X Cold Compression", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253150", "people": [{"name": "Jiang Pu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253150%22"}, {"id": "fda:K250687", "company": "Dexcowin Global, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250687: Cocoon Solo (DX-7020s)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250687", "people": [{"name": "Seung-Bum Ryu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250687%22"}, {"id": "fda:K252730", "company": "Beijing Fule Science & Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252730: Fule Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252730", "people": [{"name": "Xiaoliang Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252730%22"}, {"id": "fda:K251372", "company": "Unity Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251372: VersaD Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251372", "people": [{"name": "Kim E. Aves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251372%22"}, {"id": "fda:K253125", "company": "Medtronic - Sofradim Production", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253125: Parietene\u0099 Flat Sheet Mesh", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253125", "people": [{"name": "Paula Paz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253125%22"}, {"id": "fda:K251784", "company": "Good Sleep CO Pte , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251784: Hushd Pro Z-Link", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251784", "people": [{"name": "Alwin Ngai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251784%22"}, {"id": "fda:K251710", "company": "Solutions For Tomorrow AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251710: Mobile X-ray unit (!M1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251710", "people": [{"name": "Martin Yngvesson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251710%22"}, {"id": "fda:K253106", "company": "AngioDynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253106: AngioVac Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253106", "people": [{"name": "Sameer Mansour", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253106%22"}, {"id": "fda:K253129", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253129: Infinity\u0099 OCT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253129", "people": [{"name": "Wafa Mustafa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253129%22"}, {"id": "fda:K252238", "company": "Coroventis Research AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252238: CoroFlow Cardiovascular System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252238", "people": [{"name": "Johan Svanerud", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252238%22"}, {"id": "fda:K250345", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250345: Medline Bag Decanter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250345", "people": [{"name": "Susan Moynihan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250345%22"}, {"id": "fda:K251059", "company": "Siemens Healthineers AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251059: Syngo Carbon Clinicals (VA41)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251059", "people": [{"name": "Vijay Ramadas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251059%22"}, {"id": "fda:K252044", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252044: Triathlon\u00ae Total Knee System - Triathlon\u00ae Gold Femoral Components", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252044", "people": [{"name": "Shing Jen Tai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252044%22"}, {"id": "fda:K250696", "company": "Manteia Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250696: AccuCheck", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250696", "people": [{"name": "Chao Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250696%22"}, {"id": "fda:K253188", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253188: CoaguChek XS Plus System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253188", "people": [{"name": "Todd Matczak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253188%22"}, {"id": "fda:K252645", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252645: LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252645", "people": [{"name": "Jeanette Becker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252645%22"}, {"id": "fda:K251974", "company": "Medivance, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251974: Arctic Sun Temperature Management System (Model 5000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251974", "people": [{"name": "Lauren Valdes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251974%22"}, {"id": "fda:K251312", "company": "Vesalio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251312: Vesalio Peripheral System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251312", "people": [{"name": "Sharon Shachar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251312%22"}, {"id": "trialreg:NCT07220876", "company": "Avisi Technologies Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma", "source_url": "https://clinicaltrials.gov/study/NCT07220876"}, {"id": "trialreg:NCT07220733", "company": "Wandercraft", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial", "source_url": "https://clinicaltrials.gov/study/NCT07220733"}, {"id": "fda:K252732", "company": "Zhengzhou PZ Laser Slim Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252732: 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252732", "people": [{"name": "Yueming Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252732%22"}, {"id": "fda:K252384", "company": "Terrats Medical SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252384: DESS\u00ae Dental Smart Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252384", "people": [{"name": "Roger Terrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252384%22"}, {"id": "fda:K253100", "company": "Asclepion Laser Technologies GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253100: MultiPulse TFL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253100", "people": [{"name": "Francesco Dell'Antonio", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253100%22"}, {"id": "fda:K250861", "company": "Hartalega NGC Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250861: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250861", "people": [{"name": "Kuan Mun Leong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250861%22"}, {"id": "fda:K253226", "company": "Uroviu Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253226: UV5000W Handle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253226", "people": [{"name": "Thomas Lawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253226%22"}, {"id": "fda:K252931", "company": "Align Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252931: Invisalign\u00ae Palatal Expander System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252931", "people": [{"name": "Ahanitha Ashok", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252931%22"}, {"id": "fda:K250288", "company": "Terarecon,Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250288: TeraRecon Cardiovascular.Calcification.CT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250288", "people": [{"name": "Alexis Ferrier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250288%22"}, {"id": "fda:K252345", "company": "Risu Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252345: Picosecond Laser Device (PF131-BI)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252345", "people": [{"name": "Tianqiang Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252345%22"}, {"id": "fda:K252309", "company": "Vivasure Medical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252309: PerQseal Introducers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252309", "people": [{"name": "Tom Maguire", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252309%22"}, {"id": "fda:K252425", "company": "Sa3, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252425: Silatrix Oral Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252425", "people": [{"name": "Farbod Melamed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252425%22"}, {"id": "trialreg:NCT07220317", "company": "OrthoFX", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: This Study Will Examine Shortened Treatment Wear Time for Patients With Mixed Dentition Using AirFlex Aligner, Sequential Dental Aligners.", "source_url": "https://clinicaltrials.gov/study/NCT07220317"}, {"id": "trialreg:NCT07220330", "company": "Qbtech AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Investigational Study Examining the Cross-Validation of QbMobile in ADHD and Normative Populations", "source_url": "https://clinicaltrials.gov/study/NCT07220330"}, {"id": "trialreg:NCT07220174", "company": "Cosmo Artificial Intelligence-AI Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Use of GI Genius\u2122 XR Software in Virtual Reality Headset During Routine Colonoscopy", "source_url": "https://clinicaltrials.gov/study/NCT07220174"}, {"id": "fda:K251977", "company": "Ningbo Youhe Electrical Appliance Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251977: electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251977", "people": [{"name": "Haifeng Hua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251977%22"}, {"id": "fda:K251749", "company": "ACON Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251749: Flowflex Plus RSV + Flu A/B + COVID Home Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251749", "people": [{"name": "Catherine Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251749%22"}, {"id": "fda:K253147", "company": "Prosidyan, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253147: FIBERGRAFT\u0099 BG Putty GPS Bone Graft Substitute FIBERGRAFT\u0099 BG Putty Bone Graft Substitute FIBERGRAFT\u0099 AERIDYAN\u0099 Matrix Bone Graft Substitute FIBERGRAFT\u0099 BG Matrix Bone Graft Substitute", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253147", "people": [{"name": "Tamala Wampler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253147%22"}, {"id": "fda:K252329", "company": "QIAGEN GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252329: QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252329", "people": [{"name": "Kristen Kanack", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252329%22"}, {"id": "fda:K253144", "company": "Maxx Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253144: Freedom\u00ae Total Knee System \u0096 Titan PCK Components", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253144", "people": [{"name": "Corey Perine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253144%22"}, {"id": "fda:K252325", "company": "Cosmo Far East Technology Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252325: Hair Growth Laser Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252325", "people": [{"name": "Bob An", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252325%22"}, {"id": "fda:K252569", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252569: Carrier XL Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252569", "people": [{"name": "Catherine Chiou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252569%22"}, {"id": "fda:K253145", "company": "Rti Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253145: Pre-Sutured Tendon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253145", "people": [{"name": "Ellen Rounds", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253145%22"}, {"id": "fda:K251628", "company": "Dcstar, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251628: Mandibular Advancement Device L07", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251628", "people": [{"name": "Leo Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251628%22"}, {"id": "fda:K251185", "company": "Intervene", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251185: Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251185", "people": [{"name": "Eric Dooley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251185%22"}, {"id": "fda:K250955", "company": "Yorlabs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250955: XC11 ICE System, USA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250955", "people": [{"name": "Wanda Carpinella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250955%22"}, {"id": "fda:K251663", "company": "Datex-Ohmeda, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251663: Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251663", "people": [{"name": "Jordan Baum", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251663%22"}, {"id": "fda:K251289", "company": "Guangzhou Wondfo Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251289: WELLlife COVID-19 Antigen Test Rx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251289", "people": [{"name": "Kaiyu Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251289%22"}, {"id": "fda:K252322", "company": "Genesys Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252322: SIros-X System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252322", "people": [{"name": "Bill Sowers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252322%22"}, {"id": "fda:K252298", "company": "Imeka Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252298: ANDI 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252298", "people": [{"name": "Valerie Lacroix", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252298%22"}, {"id": "fda:K251030", "company": "Sirona Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251030: Sirona Advanced Imaging Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251030", "people": [{"name": "Patrice Nedelec", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251030%22"}, {"id": "fda:K250666", "company": "Zeus Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250666: Alegria Flash CTD Screen", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250666", "people": [{"name": "Mark Kopnitsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250666%22"}, {"id": "trialreg:NCT07219797", "company": "Imagine Scientific, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of Monochromatic X-ray Mammography System", "source_url": "https://clinicaltrials.gov/study/NCT07219797"}, {"id": "trialreg:NCT07219758", "company": "Intervene, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)", "source_url": "https://clinicaltrials.gov/study/NCT07219758"}, {"id": "trialreg:NCT07219693", "company": "Semler Scientific", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: QuantaFlo HD Clinical Validation Study", "source_url": "https://clinicaltrials.gov/study/NCT07219693"}, {"id": "fda:K250394", "company": "Bodycad Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250394: Fine TTO\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250394", "people": [{"name": "Nadine Adia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250394%22"}, {"id": "fda:K250409", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250409: Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250409", "people": [{"name": "Eve Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250409%22"}, {"id": "fda:K252346", "company": "Astura Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252346: OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252346", "people": [{"name": "Parker Kelch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252346%22"}, {"id": "fda:K250887", "company": "MIPM Mammendorfer Institut f\u00fcr Physik und Medizin GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250887: Neuromuscular Transmission Monitor TOF3D (2510091)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250887", "people": [{"name": "Sebastian W\u00f6rl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250887%22"}, {"id": "fda:K253040", "company": "Aevumed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253040: Aevumed FASE Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253040", "people": [{"name": "Saif Khalil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253040%22"}, {"id": "fda:K251838", "company": "Cardiocycle Medical(Suzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251838: Introducer Sheath Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251838", "people": [{"name": "Ling Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251838%22"}, {"id": "fda:K253249", "company": "Medos International SARL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253249: TriALTIS\u0099 Spine System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253249", "people": [{"name": "Andrew Willwerth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253249%22"}, {"id": "fda:K231897", "company": "Medivis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K231897: NeuroAlign software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231897", "people": [{"name": "Amy Lynn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231897%22"}, {"id": "fda:K250126", "company": "Livsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250126: ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250126", "people": [{"name": "Dong Wook Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250126%22"}, {"id": "fda:K253034", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253034: HemoSphere Stream Module", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253034", "people": [{"name": "Varad Raghuwanshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253034%22"}, {"id": "fda:K253033", "company": "Simplivia Healthcare , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253033: Chemfort\u00ae 28-day 20 mm Vial Adaptor and 13 mm Convertor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253033", "people": [{"name": "Shay Shaham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253033%22"}, {"id": "fda:K252155", "company": "AVAVA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252155: AVAVA\u0099 Skin Treatment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252155", "people": [{"name": "Richard Bankowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252155%22"}, {"id": "fda:K242827", "company": "Allumin8, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242827: A8 INTEGR8\u0099 Porous Pedicle Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242827", "people": [{"name": "Alyssa Huffman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242827%22"}, {"id": "fda:K252640", "company": "Freyja Healthcare, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252640: VereSee Optical Veres Needle and Endoscopic Camera", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252640", "people": [{"name": "Ryan Goff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252640%22"}, {"id": "fda:K251414", "company": "Feeltech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251414: Miracu\u0099 Polydioxanone (PDO) Suture and Needle (MONO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251414", "people": [{"name": "Choi Cheol-Ho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251414%22"}, {"id": "fda:K252665", "company": "Avatar Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252665: brAIn\u0099 Shoulder Positioning", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252665", "people": [{"name": "Adeline Francois", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252665%22"}, {"id": "fda:K253182", "company": "Inkspace Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253182: InkSpace Imaging Small Body Array (SBA12PH30x)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253182", "people": [{"name": "Peter Fischer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253182%22"}, {"id": "fda:K252277", "company": "Vascular Flow Technologies Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252277: Spiral Laminar Flow\u0099 Vascular Arteriovenous Graft (AV0645)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252277", "people": [{"name": "Angela Paterson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252277%22"}, {"id": "fda:K252319", "company": "Sanhe Lefis Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252319: Q-Switched Nd: YAG Laser machine (LFS-C13U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252319", "people": [{"name": "Dandan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252319%22"}, {"id": "trialreg:NCT07218783", "company": "SpyGlass Pharma, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)", "source_url": "https://clinicaltrials.gov/study/NCT07218783"}, {"id": "trialreg:NCT07218796", "company": "SpyGlass Pharma, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)", "source_url": "https://clinicaltrials.gov/study/NCT07218796"}, {"id": "fda:K250945", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250945: Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250945", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250945%22"}, {"id": "fda:K252264", "company": "Shenzhen Zhenxing Ruitong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252264: MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252264", "people": [{"name": "Li Guoyang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252264%22"}, {"id": "fda:K251832", "company": "Stryker Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251832: InZone IST Detachment System; IZDS Connecting Cable", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251832", "people": [{"name": "Ana Conrado", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251832%22"}, {"id": "fda:K252075", "company": "Program Insite, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252075: Program insite\u00ae Powder-Free, Disposable Nitrile Exam Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252075", "people": [{"name": "Emnet Menyahil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252075%22"}, {"id": "fda:K251282", "company": "Medtronic Navigation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251282: StealthStation S8 Spine Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251282", "people": [{"name": "Victoria Baldock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251282%22"}, {"id": "fda:K250250", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250250: ADVIA Centaur Anti-Thyroid Peroxidase II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250250", "people": [{"name": "Mey Vasquez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250250%22"}, {"id": "fda:K250178", "company": "Adin Dental Implant Systems , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250178: Adin Customized Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250178", "people": [{"name": "Dimitry Beliavsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250178%22"}, {"id": "fda:K250227", "company": "Shenzhen Qianyu Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250227: JOVS Electric Stimulation Beauty Device (JE2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250227", "people": [{"name": "Guoyang Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250227%22"}, {"id": "fda:DEN240076", "company": "Neurovalens Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN240076: Modius Lean", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240076", "people": [{"name": "Jason Mckeown", "role": "510(k) submission contact"}]}, {"id": "fda:K250203", "company": "Sureax Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250203: SureAx-Guide\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250203", "people": [{"name": "Ricardo Villanueva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250203%22"}, {"id": "fda:K252266", "company": "S.I.N. Implant System Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252266: S.I.N. Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252266", "people": [{"name": "Denise Domiciano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252266%22"}, {"id": "fda:K250197", "company": "Citieffe S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250197: Estremo Fibular Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250197", "people": [{"name": "Federica Giovetti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250197%22"}, {"id": "fda:K252254", "company": "Sinaptic Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252254: Osteotomy Wedge System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252254", "people": [{"name": "Brian Hockett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252254%22"}, {"id": "fda:K251355", "company": "Spectrawave, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251355: X1-FFR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251355", "people": [{"name": "Ankit Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251355%22"}, {"id": "fda:K250145", "company": "Endosound, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250145: Biopsy Port Adapter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250145", "people": [{"name": "Patrick Herriman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250145%22"}, {"id": "fda:K251146", "company": "Philips Medizin Systeme Boeblingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251146: IntelliVue Patient monitors MX400, MX450, MX500, MX550", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251146", "people": [{"name": "Vasiliki Begkou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251146%22"}, {"id": "fda:K251778", "company": "Remi", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251778: Remi Custom Night Guard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251778", "people": [{"name": "Oscar Adelman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251778%22"}, {"id": "fda:K250911", "company": "Electrogenics Labs, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250911: MOSkin Radiation Measurement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250911", "people": [{"name": "David Rundell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250911%22"}, {"id": "fda:K251673", "company": "X9, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251673: X9 Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251673", "people": [{"name": "Melissa Viotti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251673%22"}, {"id": "fda:K250159", "company": "The Binding Site Group , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250159: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250159", "people": [{"name": "Jolanta Wolff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250159%22"}, {"id": "pma:P230015", "company": "Beckman Coulter, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-10-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P230015: Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230015", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230015%22"}, {"id": "denovo:DEN240076", "company": "Neurovalens Limited", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-10-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240076 granted: Modius Lean", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240076"}, {"id": "fda:K253000", "company": "Cryosurgery, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253000: CryoFreeze Wart and Skin Tag Remover", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253000", "people": [{"name": "Ronald McDow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253000%22"}, {"id": "fda:K252612", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252612: INDIGO\u00ae Aspiration System \u0096 Lightning Flash Aspiration Tubing; INDIGO\u00ae Aspiration System \u0096 Lightning Bolt Aspiration Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252612", "people": [{"name": "Nikita Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252612%22"}, {"id": "fda:K252631", "company": "CMT Health PTE., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252631: Profoject\u0099 Disposable Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252631", "people": [{"name": "Monica Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252631%22"}, {"id": "fda:K251497", "company": "Elos Medtech Pinol A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251497: Elos Accurate Hybrid Base", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251497", "people": [{"name": "Lise Terkelsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251497%22"}, {"id": "fda:K252093", "company": "Merchsource, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252093: Light Therapy Mask (1019055)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252093", "people": [{"name": "Shirley Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252093%22"}, {"id": "fda:K243727", "company": "Mode Sensors AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243727: Re:Balans", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243727", "people": [{"name": "Magnus Nordahl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243727%22"}, {"id": "fda:K252153", "company": "Sc Medica", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252153: FFX Facet Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252153", "people": [{"name": "Camille Srour", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252153%22"}, {"id": "fda:K252476", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252476: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252476", "people": [{"name": "Sadwini Suresh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252476%22"}, {"id": "fda:K250731", "company": "Matelaser, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250731: MateLaser Medical Diode Laser Systems (ML-DLS-30)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250731", "people": [{"name": "Ruth Garcia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250731%22"}, {"id": "fda:K252024", "company": "Neuraxis", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252024: NeurAxis IB-Stim (01-1020)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252024", "people": [{"name": "Thomas Carrico", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252024%22"}, {"id": "fda:K242100", "company": "Maxigen Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242100: SurgiAid Collagen Wound Dressing (HA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242100", "people": [{"name": "Cheng Han Chou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242100%22"}, {"id": "fda:K253024", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253024: ProZip Knotless Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253024", "people": [{"name": "Bianca Silva de Sousa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253024%22"}, {"id": "fda:K253114", "company": "Recensmedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253114: TargetCool\u0099 (RM-DT02W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253114", "people": [{"name": "Yeonui Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253114%22"}, {"id": "fda:K252247", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252247: Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252247", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252247%22"}, {"id": "fda:K251882", "company": "Gcmedica Enterprise Ltd.(Wuxi)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251882: Uterine Aspiration Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251882", "people": [{"name": "Adam Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251882%22"}, {"id": "fda:K251994", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251994: Arthrex Synergy Vision Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251994", "people": [{"name": "Lai Saeteurn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251994%22"}, {"id": "fda:K250852", "company": "Asterasys Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250852: Coolfase", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250852", "people": [{"name": "Chayeon Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250852%22"}, {"id": "fda:K252223", "company": "Shenzhen Superline Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252223: Alpha Endo Handpiece (Alpha Endo)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252223", "people": [{"name": "Jinsong Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252223%22"}, {"id": "trialreg:NCT07217730", "company": "Truway Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Healthcare Integrity & Anti-Fraud Enforcement", "source_url": "https://clinicaltrials.gov/study/NCT07217730"}, {"id": "trialreg:NCT07217392", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Left Bundle Branch Area Pacing (LBBAP) PMCF Study", "source_url": "https://clinicaltrials.gov/study/NCT07217392"}, {"id": "fda:K253348", "company": "Recensmedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253348: TargetCool-e", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253348", "people": [{"name": "Minju Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253348%22"}, {"id": "fda:K252944", "company": "Zest Anchors, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252944: LOCATOR\u00ae Angled Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252944", "people": [{"name": "David Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252944%22"}, {"id": "fda:K252199", "company": "Agfa Healthcare N.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252199: AGFA HealthCare Enterprise Imaging", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252199", "people": [{"name": "Jodi Coleman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252199%22"}, {"id": "fda:K251805", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251805: syngo.CT Dual Energy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251805", "people": [{"name": "Kenny M. Bello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251805%22"}, {"id": "fda:K252920", "company": "Onkos Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252920: ELEOS\u0099 Limb Salvage System with NanoCept\u00ae Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252920", "people": [{"name": "Arley Perez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252920%22"}, {"id": "fda:K250107", "company": "Feeltech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250107: V-soft Line\u0099 Barbed Surgical Suture (Various)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250107", "people": [{"name": "Choi Cheol-Ho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250107%22"}, {"id": "fda:K250510", "company": "Shina Med Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250510: Sure-Fine Insulin Syringes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250510", "people": [{"name": "Taejoo Ha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250510%22"}, {"id": "fda:K252020", "company": "Hand Biomechanics Lab, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252020: TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252020", "people": [{"name": "Egypt Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252020%22"}, {"id": "fda:K251294", "company": "Zentek Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251294: Bonafix Implant Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251294", "people": [{"name": "Michael Vinnik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251294%22"}, {"id": "fda:K252367", "company": "Inbella Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252367: InbellaMulti System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252367", "people": [{"name": "Michael Kreindel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252367%22"}, {"id": "fda:K250979", "company": "Zoll Circulation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250979: Thermogard HQ\u0099 Temperature Management System, Thermogard XP\u00ae Temperature Management System (VitalTemp\u0099 Universal Pad)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250979", "people": [{"name": "Riki Chaudhary", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250979%22"}, {"id": "fda:K252946", "company": "Conmed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252946: BioBrace\u00ae Extra-Articular Ligament Augmentation Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252946", "people": [{"name": "Amy DeLong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252946%22"}, {"id": "trialreg:NCT07216885", "company": "Mozarc Medical US LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Solv Multi-Pass Hemodialysis System In-Center Clinical Study", "source_url": "https://clinicaltrials.gov/study/NCT07216885"}, {"id": "trialreg:NCT07216872", "company": "Brainsway", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)", "source_url": "https://clinicaltrials.gov/study/NCT07216872"}, {"id": "trialreg:NCT07216976", "company": "MedtronicNeuro", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study", "source_url": "https://clinicaltrials.gov/study/NCT07216976"}, {"id": "fda:K250115", "company": "Rapid Nexus Nanotech Wound Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250115: Hemastyl(\u0099) Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250115", "people": [{"name": "Margaret Kalmeta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250115%22"}, {"id": "fda:K250776", "company": "Dawell Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250776: Lithoblast Single Use Holmium Laser Fibers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250776", "people": [{"name": "Carlos Irias", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250776%22"}, {"id": "fda:K253099", "company": "Physio-Control, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253099: LIFEPAK 15 AC Power Adapter (41577-000333)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253099", "people": [{"name": "Elisha McGaff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253099%22"}, {"id": "fda:K251874", "company": "Pureway Compliance, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251874: PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251874", "people": [{"name": "Jeffrey Miglicco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251874%22"}, {"id": "fda:K253461", "company": "Meta Systems Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253461: Demi Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253461", "people": [{"name": "Ray Jeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253461%22"}, {"id": "fda:K252637", "company": "Keter Canada, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252637: Community Containers (Flap and Daisy)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252637", "people": [{"name": "Lovleen Kaur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252637%22"}, {"id": "fda:K252234", "company": "Shenzhen Qiaochengli Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252234: IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252234", "people": [{"name": "Quanhua Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252234%22"}, {"id": "fda:K253010", "company": "Responsive Arthroscopy, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253010: Mini Superhawk Suture Anchor System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253010", "people": [{"name": "Gretchen Hinchley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253010%22"}, {"id": "fda:K253331", "company": "Nexus Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253331: PressON Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253331", "people": [{"name": "Jared Crocker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253331%22"}, {"id": "fda:K251715", "company": "Asset Medikal", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251715: FlowArt\u00ae Vial Access Device Vented", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251715", "people": [{"name": "Ebru Sirali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251715%22"}, {"id": "trialreg:NCT07216170", "company": "Microvention-Terumo, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke", "source_url": "https://clinicaltrials.gov/study/NCT07216170"}, {"id": "trialreg:NCT07216573", "company": "Becton, Dickinson and Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Continuity Study", "source_url": "https://clinicaltrials.gov/study/NCT07216573"}, {"id": "fda:K251522", "company": "Bone Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251522: Mg OSTEOINJECT\u0099; Mg OSTEOREVIVE\u0099; Mg OSTEOCRETE\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251522", "people": [{"name": "Drew Diaz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251522%22"}, {"id": "fda:K251595", "company": "InBios International, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251595: COVID-19 Detect Rapid Self -Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251595", "people": [{"name": "Annabel Tsai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251595%22"}, {"id": "fda:K251034", "company": "Shenzhen Nuon Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251034: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251034", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251034%22"}, {"id": "fda:K242227", "company": "Pollogen, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242227: GENEO X ELITE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242227", "people": [{"name": "Karen Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242227%22"}, {"id": "fda:K251708", "company": "EvoEndo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251708: EvoEndo Single-Use Endoscopy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251708", "people": [{"name": "Paul Imaoka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251708%22"}, {"id": "fda:K251602", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251602: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251602", "people": [{"name": "Orlando Tadeo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251602%22"}, {"id": "fda:K252312", "company": "Dev4", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252312: Eleganz IM Threaded Nail System (IM Threaded Nail System)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252312", "people": [{"name": "Jeff Seavey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252312%22"}, {"id": "fda:K252209", "company": "Foshan Jindi Electric Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252209: IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252209", "people": [{"name": "Zhaozhi Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252209%22"}, {"id": "fda:K251927", "company": "Zeta Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251927: Zeta Navigation System (ZNS131-US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251927", "people": [{"name": "Hieu Le Mau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251927%22"}, {"id": "fda:K250249", "company": "Gold Standard Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250249: Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250249", "people": [{"name": "Douglas McGarvey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250249%22"}, {"id": "fda:K250351", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250351: Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250351", "people": [{"name": "Seiki Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250351%22"}, {"id": "fda:K243815", "company": "Soclean, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243815: SoClean 3+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243815", "people": [{"name": "George Peters", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243815%22"}, {"id": "fda:K251082", "company": "Procept Biorobotics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251082: HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251082", "people": [{"name": "Bijesh Chandran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251082%22"}, {"id": "fda:K252544", "company": "THINK Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252544: TMINI Miniature Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252544", "people": [{"name": "Meliha Mulalic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252544%22"}, {"id": "fda:K251866", "company": "Solventum US, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251866: Tegaderm Post-Op Transparent Antimicrobial Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251866", "people": [{"name": "Jamie Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251866%22"}, {"id": "fda:K251835", "company": "Neocis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251835: Yomi Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251835", "people": [{"name": "Jorge Fernandes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251835%22"}, {"id": "fda:K252903", "company": "Cryosurgery, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252903: Verruca-Freeze H Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252903", "people": [{"name": "Ronald McDow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252903%22"}, {"id": "fda:K250085", "company": "ACON Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250085: On Call\u00ae Sure GK Blood Glucose & Ketone Monitoring System; On Call\u00ae Sure Sync GK Blood Glucose & Ketone Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250085", "people": [{"name": "Catherine Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250085%22"}, {"id": "fda:K243078", "company": "Osseofuse International, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243078: HexaPLUS S OneDrill Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243078", "people": [{"name": "Priscilla Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243078%22"}, {"id": "fda:K252737", "company": "Degen Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252737: DeGen Medical Latitude-C AM Cervical Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252737", "people": [{"name": "Craig Black", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252737%22"}, {"id": "fda:K252001", "company": "Winner Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252001: Collagen Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252001", "people": [{"name": "Ziling Shangguan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252001%22"}, {"id": "trialreg:NCT07215429", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SpO2 Validation Study-Philips Optimus", "source_url": "https://clinicaltrials.gov/study/NCT07215429"}, {"id": "trialreg:NCT07215546", "company": "Abyrx, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Enhanced Sternal Closure With Montage or Montage-CT to Evaluate Post-Operative Opioid Use Following Median Sternotomy", "source_url": "https://clinicaltrials.gov/study/NCT07215546"}, {"id": "fda:K252939", "company": "Cotton High Tech S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252939: COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252939", "people": [{"name": "M\u00edriam Carrero", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252939%22"}, {"id": "fda:K252910", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252910: Orca Air/Water and Suction Valves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252910", "people": [{"name": "Claire Paddock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252910%22"}, {"id": "fda:K252272", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252272: ORA Method LED Gua Sha (GS-04)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252272", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252272%22"}, {"id": "fda:K251851", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251851: DIASAFEplusUS (F00013010)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251851", "people": [{"name": "Timothy Groves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251851%22"}, {"id": "fda:K252911", "company": "Iray Imaging Technology (Haining) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252911: Lux HD 2530 detector (Lux HD 2530)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252911", "people": [{"name": "Junjie Qian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252911%22"}, {"id": "fda:K250645", "company": "Haemoband Surgical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250645: SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250645", "people": [{"name": "Cathal Donnelly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250645%22"}, {"id": "fda:K252870", "company": "Align Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252870: Invisalign Specifix Attachment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252870", "people": [{"name": "Niya Su", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252870%22"}, {"id": "fda:K252600", "company": "OrthoPediatrics Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252600: Pediatric Plating Platform I Small-Mini", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252600", "people": [{"name": "Yan Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252600%22"}, {"id": "fda:K253094", "company": "SI-BONE, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253094: iFuse Bedrock Granite Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253094", "people": [{"name": "Jayasri Prabakaran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253094%22"}, {"id": "fda:K251876", "company": "Ophtecs Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251876: cleadew GP hydra one", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251876", "people": [{"name": "Takeichi Ryohei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251876%22"}, {"id": "fda:K251795", "company": "Honsun (Nantong) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251795: Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251795", "people": [{"name": "Sara Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251795%22"}, {"id": "fda:K252867", "company": "Advin Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252867: VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252867", "people": [{"name": "Ding Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252867%22"}, {"id": "fda:K252553", "company": "Shenzhen Jianchao Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252553: Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252553", "people": [{"name": "Fred Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252553%22"}, {"id": "fda:K251366", "company": "Nihon Kohden Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251366: EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251366", "people": [{"name": "Sandra Gadeyne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251366%22"}, {"id": "fda:K251651", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251651: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251651", "people": [{"name": "Swetha Paritala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251651%22"}, {"id": "trialreg:NCT07214220", "company": "Spryte Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT07214220"}, {"id": "trialreg:NCT07214623", "company": "Kaneka Medical America LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy", "source_url": "https://clinicaltrials.gov/study/NCT07214623"}, {"id": "trialreg:NCT07213739", "company": "Arjo AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Trial to Investigate the New Caulis Pro\u00ae Low Air Loss (LAL) System", "source_url": "https://clinicaltrials.gov/study/NCT07213739"}, {"id": "trialreg:NCT07214974", "company": "Noah Tech, Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Mild Cognitive Impairment Community Screening and Early Intervention Via Stem Cell Therapy and Wearable Brain Computer Interface Device.", "source_url": "https://clinicaltrials.gov/study/NCT07214974"}, {"id": "trialreg:NCT07214532", "company": "Natera, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer", "source_url": "https://clinicaltrials.gov/study/NCT07214532"}, {"id": "trialreg:NCT07214272", "company": "Bausch Health Americas, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing", "source_url": "https://clinicaltrials.gov/study/NCT07214272"}, {"id": "trialreg:NCT07214376", "company": "Pulnovo Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease", "source_url": "https://clinicaltrials.gov/study/NCT07214376"}, {"id": "trialreg:NCT07214493", "company": "Otto Bock France SNC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study on a Prosthetic Foot With Adjustable Heel Height", "source_url": "https://clinicaltrials.gov/study/NCT07214493"}, {"id": "trialreg:NCT07214675", "company": "HistoSonics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy", "source_url": "https://clinicaltrials.gov/study/NCT07214675"}, {"id": "breakthrough:BP251179", "company": "Biolytical Laboratories, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-10-09", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth BP251179: HIV SELF-TESTS", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K252163", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252163: Elecsys Phospho-Tau (181P) Plasma", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252163", "people": [{"name": "Stephan Knierer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252163%22"}, {"id": "fda:K250536", "company": "Extremity Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250536: MetaFore Small Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250536", "people": [{"name": "Mary Hoffman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250536%22"}, {"id": "fda:K251699", "company": "Bellamia Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251699: The Botticelli (Model: Athena)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251699", "people": [{"name": "Ahmed Mohammed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251699%22"}, {"id": "fda:K251422", "company": "Becton Dickinson Infusion Therapy Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251422: BD Saf-T-Intima\u0099 Subcutaneous Catheter System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251422", "people": [{"name": "Sunny Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251422%22"}, {"id": "fda:K252766", "company": "Abiomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252766: 14Fr Low Profile Introducer Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252766", "people": [{"name": "Anshul Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252766%22"}, {"id": "fda:K252874", "company": "Serpex Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252874: Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252874", "people": [{"name": "Neil Zimmerman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252874%22"}, {"id": "fda:K251162", "company": "Integra LifeSciences Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251162: CUSA\u00ae Clarity Ultrasonic Surgical Aspirator System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251162", "people": [{"name": "Alexandra Wells", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251162%22"}, {"id": "fda:K250298", "company": "Clinical Innovations, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250298: Kiwi\u00ae Complete Vacuum Delivery System, OmniCup\u00ae (VAC-DUAL M); Kiwi\u00ae Complete Vacuum Delivery System, OmniCup\u00ae with Traction Force Indicator (VAC-DUAL MT); Kiwi\u00ae Complete Vacuum Delivery System, OmniC Cup\u00ae for Cesarean Section (VAC-DUAL C); Kiwi\u00ae Complete Vacuum Delivery System, ProCup\u00ae (VAC-DUAL S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250298", "people": [{"name": "Alexis Ross", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250298%22"}, {"id": "fda:K250060", "company": "Genoray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250060: GT300; GT300-C", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250060", "people": [{"name": "Nayoung Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250060%22"}, {"id": "fda:K251363", "company": "Elekta Solutions AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251363: ProKnow DS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251363", "people": [{"name": "Mooud Amirkavei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251363%22"}, {"id": "trialreg:NCT07211997", "company": "Lumos Diagnostics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FebriDx\u00ae Pediatric Validation Study", "source_url": "https://clinicaltrials.gov/study/NCT07211997"}, {"id": "trialreg:NCT07212660", "company": "Ivoclar Vivadent AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth", "source_url": "https://clinicaltrials.gov/study/NCT07212660"}, {"id": "trialreg:NCT07211984", "company": "Dalia Care", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Dalia Solution For Depressed Patient", "source_url": "https://clinicaltrials.gov/study/NCT07211984"}, {"id": "breakthrough:K252163", "company": "Roche Diagnostics", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-10-08", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K252163: ELECSYS PHOSPHO-TAU (181P) PLASMA", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:HR0011-26-9-E023", "company": "Abram Scientific Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-10-08", "observed": "2026-09-18", "amount_usd": 1999977, "summary": "DOD SBIR Phase II award $1,999,977: CoagCare: Novel Miniaturized Handheld Thromboelastographic Platform for Rapid Assessment of Coagulopathy and Resuscitation Management of Warfighters", "source_url": "https://www.sbir.gov/awards?search=D2-2885"}, {"id": "fda:K250364", "company": "St. shine Optical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250364: Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250364", "people": [{"name": "Lee Mina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250364%22"}, {"id": "fda:K252851", "company": "Damae Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252851: deepLive (OSP12 + DMS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252851", "people": [{"name": "David Siret", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252851%22"}, {"id": "fda:K250894", "company": "Eminent Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250894: Eminent Spine Posterior SI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250894", "people": [{"name": "Stephen Courtney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250894%22"}, {"id": "fda:K250688", "company": "Acotec Scientific Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250688: Cedar\u0099 Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar\u0099 Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250688", "people": [{"name": "Anna Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250688%22"}, {"id": "fda:K252150", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252150: Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252150", "people": [{"name": "Norikiyo Shibata", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252150%22"}, {"id": "fda:K250187", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250187: Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250187", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250187%22"}, {"id": "fda:K252214", "company": "Metamorphosis GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252214: AIAS Cephalon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252214", "people": [{"name": "Dr. Stefanie Horstmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252214%22"}, {"id": "fda:K252948", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252948: TrueBeam, TrueBeam STX, Edge and VitalBeam", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252948", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252948%22"}, {"id": "fda:K252572", "company": "Prodeon Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252572: Prodeon Urethral Sheath System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252572", "people": [{"name": "Elaine Aplaon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252572%22"}, {"id": "fda:K244041", "company": "Xemis Medical Technology (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K244041: Ultrasound Therapy Workstation (XMS-UET2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244041", "people": [{"name": "Yongfen Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244041%22"}, {"id": "trialreg:NCT07210021", "company": "AccurKardia, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AK+ Guard\u2122 Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring", "source_url": "https://clinicaltrials.gov/study/NCT07210021"}, {"id": "trialreg:NCT07209514", "company": "TriCity Research Center", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Medtronic Inceptiv\u2122 Closed-Loop DTM Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy", "source_url": "https://clinicaltrials.gov/study/NCT07209514"}, {"id": "trialreg:NCT07210255", "company": "Magnus Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SAINT in Postpartum Depression (PPD)", "source_url": "https://clinicaltrials.gov/study/NCT07210255"}, {"id": "trialreg:NCT07209358", "company": "ConvaTec Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EDX110 Randomized Control Trial for Treatment of DFUs", "source_url": "https://clinicaltrials.gov/study/NCT07209358"}, {"id": "trialreg:NCT07211126", "company": "Tandem Diabetes Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France", "source_url": "https://clinicaltrials.gov/study/NCT07211126"}, {"id": "trialreg:NCT07211035", "company": "Amplifi Vascular, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effect of the Amplifi\u2122 Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)", "source_url": "https://clinicaltrials.gov/study/NCT07211035"}, {"id": "trialreg:NCT07209852", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up", "source_url": "https://clinicaltrials.gov/study/NCT07209852"}, {"id": "trialreg:NCT07210151", "company": "LUMA Vision Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Anatomical Navigation for Guided Electrophysiology in AFL and AFib", "source_url": "https://clinicaltrials.gov/study/NCT07210151"}, {"id": "trialreg:NCT07209397", "company": "InMode MD Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women", "source_url": "https://clinicaltrials.gov/study/NCT07209397"}, {"id": "trialreg:NCT07210333", "company": "Braincare USA Corp", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System", "source_url": "https://clinicaltrials.gov/study/NCT07210333"}, {"id": "trialreg:NCT07211243", "company": "Lohmann & Rauscher", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Suprasorb\u00aeX+PHMB Pro vs Suprasorb\u00aeX+PHMB in Treatment of Infected Venous Leg Ulcers", "source_url": "https://clinicaltrials.gov/study/NCT07211243"}, {"id": "trialreg:NCT07209943", "company": "Cognixion", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Augmented Reality BCI Longitudinal Study for Persons With ALS, Stroke, TBI and SCI Utilizing Cognixion + Apple Vision Pro", "source_url": "https://clinicaltrials.gov/study/NCT07209943"}, {"id": "trialreg:NCT07211061", "company": "Procter and Gamble", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study is to Evaluate a Regimen on Gingivitis Using Traditional and Novel Assessment Methods", "source_url": "https://clinicaltrials.gov/study/NCT07211061"}, {"id": "trialreg:NCT07209527", "company": "Truway Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Truway Diagnostic Tools in Primary Care", "source_url": "https://clinicaltrials.gov/study/NCT07209527"}, {"id": "fda:DEN240073", "company": "Painchek Limited (Ltd.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN240073: PainChek (PainChek Adult)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240073", "people": [{"name": "Caleb Ng", "role": "510(k) submission contact"}]}, {"id": "fda:K250173", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250173: Shiley\u0099 Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley\u0099 Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley\u0099 Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley\u0099 Oral RAE Tracheal Tube with TaperGuard\u0099 Cuff, Murphy Eye (115-XXOR) Shiley\u0099 Nasal RAE Tracheal Tube with TaperGuard\u0099 Cuff, Murphy Eye (119-XXNR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250173", "people": [{"name": "Alicia Burkhardt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250173%22"}, {"id": "fda:K252502", "company": "Nanjing Kangni Smart Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252502: Folding Mobility Scooter (KD101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252502", "people": [{"name": "Huilin Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252502%22"}, {"id": "fda:K251603", "company": "Rapid Medical Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251603: Tigertriever 17 Ultra Revascularization Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251603", "people": [{"name": "Gutman Ina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251603%22"}, {"id": "fda:K252007", "company": "Deep Breathe, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252007: BlineSlide", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252007", "people": [{"name": "Robert Arntfield", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252007%22"}, {"id": "fda:K252140", "company": "Coloplast Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252140: Heylo\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252140", "people": [{"name": "Preeti Jain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252140%22"}, {"id": "fda:K251565", "company": "Zhejiang Topwe Tools Manufacturing Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251565: Wheelchair (N817)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251565", "people": [{"name": "Liang Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251565%22"}, {"id": "trialreg:NCT07207369", "company": "AbbVie", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars", "source_url": "https://clinicaltrials.gov/study/NCT07207369"}, {"id": "trialreg:NCT07209098", "company": "Impulse Dynamics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07209098"}, {"id": "trialreg:NCT07209033", "company": "Medical Inventi S.A.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FlexiOss\u00ae - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.", "source_url": "https://clinicaltrials.gov/study/NCT07209033"}, {"id": "trialreg:NCT07208448", "company": "Voll Medical Technologies Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Voll Degradable Shoulder Spacer FIH Study", "source_url": "https://clinicaltrials.gov/study/NCT07208448"}, {"id": "trialreg:NCT07208604", "company": "TECLens, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Open Label, Multi-center, Phase I Study of TECLens Quantitative Refractive Crosslinking in Presbyopia-Aged Patients.", "source_url": "https://clinicaltrials.gov/study/NCT07208604"}, {"id": "trialreg:NCT07209020", "company": "Maxigen Biotech Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07209020"}, {"id": "trialreg:NCT07209085", "company": "FastWave Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Safety and Effectiveness of the FastWave Artero\u2122 Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)", "source_url": "https://clinicaltrials.gov/study/NCT07209085"}, {"id": "denovo:DEN240073", "company": "Painchek Limited (Ltd.)", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-10-06", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240073 granted: PainChek (PainChek Adult)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240073"}, {"id": "fda:K251464", "company": "Jeisys Medical Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251464: TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251464", "people": [{"name": "Jeongwook Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251464%22"}, {"id": "fda:K252129", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252129: AETOS Shoulder System Stemless Humeral Prosthesis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252129", "people": [{"name": "Cassidy Whipple", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252129%22"}, {"id": "fda:K252820", "company": "Internacional Farmac\u00e9utica S.A DE C.V", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252820: PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252820", "people": [{"name": "Alejandro Leonardo von Mohr del Conde", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252820%22"}, {"id": "fda:K251426", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251426: da Vinci SP Surgical System (SP1098)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251426", "people": [{"name": "Connor McCarty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251426%22"}, {"id": "fda:K252178", "company": "Magentiq Eye, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252178: MAGENTIQ-COLO (ME-APDS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252178", "people": [{"name": "Dror Zur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252178%22"}, {"id": "fda:K243968", "company": "Revolve Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243968: Revolve Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243968", "people": [{"name": "Alex Gordon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243968%22"}, {"id": "fda:K242946", "company": "Senbitec Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242946: HESTIA (L200-A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242946", "people": [{"name": "Ga Hee Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242946%22"}, {"id": "fda:K250073", "company": "Tosoh Bioscience, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250073: Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250073", "people": [{"name": "Corike Nuibe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250073%22"}, {"id": "fda:K250039", "company": "Healthhub", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250039: HPACS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250039", "people": [{"name": "SungHyuk Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250039%22"}, {"id": "fda:K251639", "company": "Augmedics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251639: xvision Spine system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251639", "people": [{"name": "Tami Harel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251639%22"}, {"id": "fda:K251468", "company": "Hollister Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251468: Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251468", "people": [{"name": "Sandra Mullen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251468%22"}, {"id": "fda:K251859", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251859: EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251859", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251859%22"}, {"id": "fda:K252517", "company": "Ningbo Shenyu Medical Equipment Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252517: Manual Wheelchair (SYIV100A008)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252517", "people": [{"name": "Song Zhenyong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252517%22"}, {"id": "fda:K250028", "company": "Dongguan Yiyao Science & Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250028: Anti Snore Mouthpiece", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250028", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250028%22"}, {"id": "fda:K250031", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250031: Amplatzer Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250031", "people": [{"name": "Dan Gapp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250031%22"}, {"id": "fda:K251646", "company": "Alleva Medical Devices", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251646: extriCARE\u00ae 1000 Negative Pressure Wound Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251646", "people": [{"name": "Max Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251646%22"}, {"id": "fda:DEN220077", "company": "Icecure Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN220077: ProSense\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220077", "people": [{"name": "Shay Levav", "role": "510(k) submission contact"}]}, {"id": "fda:K252806", "company": "Shanghai AnQing Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252806: Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252806", "people": [{"name": "Shuwen Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252806%22"}, {"id": "fda:K250662", "company": "BunkerHill Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250662: Bunkerhill MAC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250662", "people": [{"name": "Nishith Khandwala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250662%22"}, {"id": "trialreg:NCT07205367", "company": "iRhythm Technologies, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II", "source_url": "https://clinicaltrials.gov/study/NCT07205367"}, {"id": "trialreg:NCT07205120", "company": "Bodyport Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Fluid Guided Heart Failure Treatment at the Cleveland Clinic", "source_url": "https://clinicaltrials.gov/study/NCT07205120"}, {"id": "trialreg:NCT07207122", "company": "Sanmai Technologies PBC dba Sanmai", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease", "source_url": "https://clinicaltrials.gov/study/NCT07207122"}, {"id": "trialreg:NCT07206862", "company": "DEBx Medical B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CHEMfoot: DEBRICHEM\u00ae in Chronic Diabetic Foot Wounds", "source_url": "https://clinicaltrials.gov/study/NCT07206862"}, {"id": "trialreg:NCT07205445", "company": "Stimuli Technology", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Tensi+ European Registry", "source_url": "https://clinicaltrials.gov/study/NCT07205445"}, {"id": "trialreg:NCT07206121", "company": "Innoblative Designs, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study for the SIRA-1000, SIRA\u00ae RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07206121"}, {"id": "denovo:DEN220077", "company": "Icecure Medical", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-10-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220077 granted: ProSense\u2122 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220077"}, {"id": "breakthrough:DEN220077", "company": "Icecure Medical", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-10-03", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220077: PROSENSE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K252059", "company": "Artivion, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252059: CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252059", "people": [{"name": "Karissa Gleason", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252059%22"}, {"id": "fda:K252114", "company": "Liofilchem s.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252114: MTS Aztreonam-Avibactam 0.016/4 - 256/4 \u00b5g/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252114", "people": [{"name": "Fabio Rocco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252114%22"}, {"id": "fda:K252769", "company": "Shenzhen Finicare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252769: Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252769", "people": [{"name": "Li Chao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252769%22"}, {"id": "fda:K250860", "company": "Exemplar Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250860: BreatheBand\u00ae (Model 1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250860", "people": [{"name": "Christian Moore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250860%22"}, {"id": "fda:K251442", "company": "Ningbo Tianyi Medical Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251442: TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251442", "people": [{"name": "Wenyu Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251442%22"}, {"id": "fda:K250766", "company": "Thirona BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250766: LungQ 4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250766", "people": [{"name": "Eva van Rikxoort", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250766%22"}, {"id": "fda:K243152", "company": "Applied Medical Resources Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243152: GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243152", "people": [{"name": "Apeksha Shanbhag", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243152%22"}, {"id": "fda:K252758", "company": "Orthonovis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252758: Cannulated Screw and Kirschner (K wire) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252758", "people": [{"name": "Ken West", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252758%22"}, {"id": "fda:K250523", "company": "Simergent, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250523: Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250523", "people": [{"name": "Steve Lindo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250523%22"}, {"id": "fda:K252440", "company": "Ingeniars S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252440: EasyTeleMed (2.0.2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252440", "people": [{"name": "Silvia Panicacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252440%22"}, {"id": "fda:K251124", "company": "GC America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251124: G-Bond Universal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251124", "people": [{"name": "Futoshi Fusejima", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251124%22"}, {"id": "fda:K250551", "company": "Shenzhen Sophway Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250551: 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250551", "people": [{"name": "Shuting Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250551%22"}, {"id": "fda:K251398", "company": "Shenzhen Enmind Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251398: IPL Hair Removal Device (IPL-001, IPL-002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251398", "people": [{"name": "Junfeng Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251398%22"}, {"id": "fda:K251215", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251215: Philips IntelliSpace Cardiovascular", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251215", "people": [{"name": "Roopak Krishna", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251215%22"}, {"id": "trialreg:NCT07204691", "company": "Dr. Korman Laboratories Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation", "source_url": "https://clinicaltrials.gov/study/NCT07204691"}, {"id": "trialreg:NCT07204678", "company": "Cordis US Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PMCF Study of Precise Pro Rx for Carotid Artery Disease", "source_url": "https://clinicaltrials.gov/study/NCT07204678"}, {"id": "trialreg:NCT07204158", "company": "YSLab", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray", "source_url": "https://clinicaltrials.gov/study/NCT07204158"}, {"id": "fda:K251899", "company": "New Deantronics Taiwan , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251899: E Blator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251899", "people": [{"name": "Hung-Kuei Tsai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251899%22"}, {"id": "fda:K252096", "company": "Merchsource, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252096: Light Therapy Decollete Mask (1019135)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252096", "people": [{"name": "Shirley Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252096%22"}, {"id": "fda:K252804", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252804: Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL,", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252804", "people": [{"name": "Yang Blue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252804%22"}, {"id": "fda:K251825", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251825: Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251825", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251825%22"}, {"id": "fda:K250083", "company": "Nu-Rise, SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250083: PRO-DOSE System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250083", "people": [{"name": "Joana Melo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250083%22"}, {"id": "fda:K251501", "company": "Visby Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251501: Visby Medical Men's Sexual Health Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251501", "people": [{"name": "Jennifer Albrecht", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251501%22"}, {"id": "fda:K252447", "company": "Hebei Newangie Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252447: Picosecond laser device (BMPS4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252447", "people": [{"name": "Ning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252447%22"}, {"id": "fda:K251767", "company": "Vena Medical Holdings Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251767: Vena MicroAngioscope\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251767", "people": [{"name": "Joseph De Croos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251767%22"}, {"id": "fda:K250026", "company": "Wuxi Hisky Medical Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250026: Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250026", "people": [{"name": "Jinhua Shao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250026%22"}, {"id": "fda:K250767", "company": "Newclip Technics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-10-01", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250767: Newclip Patient-matched instrumentation non sterile PSI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250767", "people": [{"name": "Ga\u00eblle Gourbiere", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250767%22"}, {"id": "trialreg:NCT07202104", "company": "Eko Devices, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes", "source_url": "https://clinicaltrials.gov/study/NCT07202104"}, {"id": "trialreg:NCT07202520", "company": "H'ability", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Benefit of the H'Ability Home Device Used in Supervised Self-rehabilitation at Home on the Autonomy of Post-stroke Patients", "source_url": "https://clinicaltrials.gov/study/NCT07202520"}, {"id": "trialreg:NCT07200232", "company": "Zywie, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-10-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Three-phase Study That Will Compare the ECG Data Recorded Using the Test Device With the Data Recorded by a Reference Device, Evaluate the ECG Signal Quality of the Test Device Over a 10-day Simulated Use Period, and Assess the Effects of Variable ECG Electrode Placement for the Test Device", "source_url": "https://clinicaltrials.gov/study/NCT07200232"}, {"id": "fda:K250050", "company": "Midiagnostics NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250050: miDiagnostics HSV-1&2 CSF Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250050", "people": [{"name": "Katrin Martens", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250050%22"}, {"id": "fda:K252106", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252106: External Fixation Mini Rail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252106", "people": [{"name": "Edward Wells-Spicer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252106%22"}, {"id": "fda:K251669", "company": "Shanghai Draeger Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251669: IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251669", "people": [{"name": "Guozhao Pan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251669%22"}, {"id": "fda:K251690", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251690: Arthrex SpeedFLEX\u0099 Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251690", "people": [{"name": "Emmarie Halteman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251690%22"}, {"id": "fda:K243270", "company": "Tigerconnect", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243270: TigerConnect Alarm Management", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243270", "people": [{"name": "Steve Tyler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243270%22"}, {"id": "fda:K251799", "company": "Jiangsu Bangbang Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251799: Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251799", "people": [{"name": "Yihua Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251799%22"}, {"id": "fda:K250331", "company": "Astrasono Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250331: Astrasono A3Pro Bladder Scanner (A3Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250331", "people": [{"name": "Charles Shen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250331%22"}, {"id": "fda:K252722", "company": "Fehling Instruments GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252722: Biopsy Forceps", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252722", "people": [{"name": "Imad Ziate", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252722%22"}, {"id": "fda:K252085", "company": "Wright Medical Technology, Inc. (Stryker Corporation)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252085: Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252085", "people": [{"name": "Alayne Melancon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252085%22"}, {"id": "fda:K252072", "company": "Centers for Disease Control and Prevention", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252072: Francisella tularensis Real-time PCR assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252072", "people": [{"name": "Jasmine Chaitram", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252072%22"}, {"id": "fda:K251197", "company": "Distalmotion SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-30", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251197: Dexter L6 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251197", "people": [{"name": "Larry Carrier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251197%22"}, {"id": "trialreg:NCT07199348", "company": "Embobio Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding", "source_url": "https://clinicaltrials.gov/study/NCT07199348"}, {"id": "trialreg:NCT07197983", "company": "Conceivable Life Sciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Automation of Oocyte and Embryo Vitrification", "source_url": "https://clinicaltrials.gov/study/NCT07197983"}, {"id": "trialreg:NCT07197996", "company": "Firstkind Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The RETRAIN Trial Phase 2", "source_url": "https://clinicaltrials.gov/study/NCT07197996"}, {"id": "trialreg:NCT07199738", "company": "Smith & Nephew, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)", "source_url": "https://clinicaltrials.gov/study/NCT07199738"}, {"id": "nih:2R44FD007709-02", "company": "Advanced Cooling Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-29", "observed": "2026-08-21", "amount_usd": 999890, "summary": "NIH award 2R44FD007709-02: Air Plasma Sterilization Device with Plasma-in-Lumen Technology ($999,890)", "source_url": "https://reporter.nih.gov/project-details/11069151", "people": [{"name": "Prawal Agarwal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K252054", "company": "Surgical Theater, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252054: SpineAR SNAP (SyncAR Spine)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252054", "people": [{"name": "Kevin Murrock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252054%22"}, {"id": "fda:K252594", "company": "Sonex Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252594: UltraGuideCTR\u00ae image guided soft tissue release system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252594", "people": [{"name": "Sara Petrie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252594%22"}, {"id": "fda:K243983", "company": "Paltop Advanced Dental Solutions, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243983: Paltop Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243983", "people": [{"name": "Zina Gurgov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243983%22"}, {"id": "fda:K252770", "company": "Beta Bionics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252770: iLet ACE Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252770", "people": [{"name": "Liz Cooper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252770%22"}, {"id": "fda:K251334", "company": "Hironic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251334: NEW DOUBLO 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251334", "people": [{"name": "Lee Gwijin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251334%22"}, {"id": "fda:K253236", "company": "Graphenano Dental S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253236: G-BLOCK", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253236", "people": [{"name": "Eva Navarro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253236%22"}, {"id": "fda:K251104", "company": "Wilson-Cook Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251104: SureTome\u0099 SW Sphincterotome with DomeTip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251104", "people": [{"name": "Kaylin Davis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251104%22"}, {"id": "fda:K250123", "company": "Hager& Meisinger GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250123: Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250123", "people": [{"name": "Wiebke Eckhardt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250123%22"}, {"id": "fda:K243833", "company": "Longfian Scitech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243833: Portable oxygen concentrator (JAY-1000P)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243833", "people": [{"name": "Lei Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243833%22"}, {"id": "fda:K250023", "company": "Disior, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250023: SMART PCFD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250023", "people": [{"name": "Markuu Laitinen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250023%22"}, {"id": "fda:K252441", "company": "South53, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252441: Primero Safe Access System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252441", "people": [{"name": "Rodney Brenneman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252441%22"}, {"id": "fda:K252051", "company": "Tulavi Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252051: allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252051", "people": [{"name": "Joshua G. Vose", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252051%22"}, {"id": "trialreg:NCT07197788", "company": "Endogenex, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Continued Access to the Endogenex System for Participants in the ReCET Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT07197788"}, {"id": "trialreg:NCT07195708", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')", "source_url": "https://clinicaltrials.gov/study/NCT07195708"}, {"id": "trialreg:NCT07196527", "company": "Puressentiel", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Clinical Efficacy of PURESSENTIEL Allergy Protection Nasal Spray (SNPA\u00ae) in House Dust Mite Allergic Rhinitis- ACARAY Study", "source_url": "https://clinicaltrials.gov/study/NCT07196527"}, {"id": "trialreg:NCT07195656", "company": "FemPulse Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)", "source_url": "https://clinicaltrials.gov/study/NCT07195656"}, {"id": "trialreg:NCT07195877", "company": "Thread and Lift", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real-life Assessement of Safety and Perofmance of the of the \"Infinite-Thread\u00ae\" Permanent Tensor Thread", "source_url": "https://clinicaltrials.gov/study/NCT07195877"}, {"id": "nih:1R43FD008554-01", "company": "Interlink Electronics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-27", "observed": "2026-08-21", "amount_usd": 200000, "summary": "NIH award 1R43FD008554-01: Innovative Amperometric Gas Sensors for Monitoring Post-Harvest Food Quality and Safety ($200,000)", "source_url": "https://reporter.nih.gov/project-details/11254867", "people": [{"name": "Mel FIndlay", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44NR021881-01A1", "company": "Eysz, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": 542373, "summary": "NIH award 1R44NR021881-01A1: Detecting Absence Seizures Using Hyperventilation In a Home Environment ($542,373)", "source_url": "https://reporter.nih.gov/project-details/11254153", "people": [{"name": "Rachel Kuperman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K251919", "company": "Nanjing Bestview Laser S&T Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251919: Thulium Laser System (Deluxlase)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251919", "people": [{"name": "Jing Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251919%22"}, {"id": "fda:K252105", "company": "Ligence Uab", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252105: Ligence Heart", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252105", "people": [{"name": "Alvaro Perez-Moreno", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252105%22"}, {"id": "fda:K251262", "company": "S.I.N. Implant System Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251262: S.I.N. Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251262", "people": [{"name": "Denise Domiciano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251262%22"}, {"id": "fda:K250093", "company": "Linshom Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250093: Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250093", "people": [{"name": "William Stoll", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250093%22"}, {"id": "fda:K252221", "company": "Shoulder Innovations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252221: Inset Reverse Total Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252221", "people": [{"name": "Mark Hanes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252221%22"}, {"id": "fda:K252435", "company": "Levita Magnetics International Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252435: Magnetic Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252435", "people": [{"name": "Donielle Baudin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252435%22"}, {"id": "fda:K251204", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251204: FUJIFILM Stiffening Wire Device (SW-2000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251204", "people": [{"name": "Kotei Aoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251204%22"}, {"id": "fda:K251986", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251986: AUXILIARY WATER TUBE MAJ-855", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251986", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251986%22"}, {"id": "fda:K251208", "company": "Tuned , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251208: Tuned Self-Fitting Mobile App", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251208", "people": [{"name": "Omri Gavish", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251208%22"}, {"id": "fda:K250659", "company": "Wellspect AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250659: LoFric Origo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250659", "people": [{"name": "Emad Ramzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250659%22"}, {"id": "fda:K250318", "company": "Planmed OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250318: Planmed XFI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250318", "people": [{"name": "Niina Vuorikallas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250318%22"}, {"id": "fda:K252700", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252700: Optima Coil System (Optima Packing Coil System)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252700", "people": [{"name": "Kavita Chandrashekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252700%22"}, {"id": "fda:K251645", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251645: Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251645", "people": [{"name": "Orlando Tadeo, Jr.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251645%22"}, {"id": "fda:K251275", "company": "Caretaker Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251275: VitalStream ART Connect; VitalStream-Hemo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251275", "people": [{"name": "Jeff Pompeo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251275%22"}, {"id": "fda:K252921", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252921: Radial Jaw 4 Pulmonary Biopsy Forceps", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252921", "people": [{"name": "Elena Hennessey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252921%22"}, {"id": "trialreg:NCT07195292", "company": "Toivoa Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Reduction of Depression in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching", "source_url": "https://clinicaltrials.gov/study/NCT07195292"}, {"id": "trialreg:NCT07195422", "company": "Japet Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Japet.W+ Medical Device for Low Back Pain Management", "source_url": "https://clinicaltrials.gov/study/NCT07195422"}, {"id": "trialreg:NCT07194395", "company": "PatenSee Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients", "source_url": "https://clinicaltrials.gov/study/NCT07194395"}, {"id": "trialreg:NCT07195461", "company": "MuscleMetrix, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis", "source_url": "https://clinicaltrials.gov/study/NCT07195461"}, {"id": "trialreg:NCT07193888", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Navitor Japan Study", "source_url": "https://clinicaltrials.gov/study/NCT07193888"}, {"id": "trialreg:NCT07194265", "company": "Anteris Technologies Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR\u00ae THV System", "source_url": "https://clinicaltrials.gov/study/NCT07194265"}, {"id": "trialreg:NCT07195591", "company": "GT Medical Technologies, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care", "source_url": "https://clinicaltrials.gov/study/NCT07195591"}, {"id": "sbir:DOD:HT9425-25-C-E053", "company": "Tda Research, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-09-26", "observed": "2026-09-18", "amount_usd": 1299940, "summary": "DOD SBIR Phase II award $1,299,940: Stackable Portable Oxygen Generator for Deployed Army Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2S-0088"}, {"id": "nih:3R44EY033604-03S1", "company": "Theia Imaging LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": 86958, "summary": "NIH award 3R44EY033604-03S1: A Widefield, Handheld OCT system for Patients who are Unable to Cooperate ($86,958)", "source_url": "https://reporter.nih.gov/project-details/11388237", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44MH132156-02", "company": "Outcome Referrals Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-25", "observed": "2026-08-21", "amount_usd": 1102380, "summary": "NIH award 2R44MH132156-02: Consumer-Therapist-Connector: Increasing Access to Quality Behavioral Healthcare ($1,102,380)", "source_url": "https://reporter.nih.gov/project-details/11178045", "people": [{"name": "David R. Kraus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K252013", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252013: EnSite\u0099 X EP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252013", "people": [{"name": "Alexandra Agre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252013%22"}, {"id": "fda:K252063", "company": "Wuhan Dimed Laser Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252063: Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252063", "people": [{"name": "Qiao Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252063%22"}, {"id": "fda:K251812", "company": "Magnolia Medical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251812: Steripath\u00ae Flow\u0099 Blood Collection System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251812", "people": [{"name": "Shilpi Sinha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251812%22"}, {"id": "fda:K252725", "company": "United Orthopedic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252725: Stem Extension Line (U2 Total Knee System\u0097PSA Type)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252725", "people": [{"name": "Lois Ho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252725%22"}, {"id": "fda:K252062", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252062: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252062", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252062%22"}, {"id": "fda:K251789", "company": "Neuravi Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251789: EMBOTRAP III Revascularization Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251789", "people": [{"name": "Marie Seoighe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251789%22"}, {"id": "fda:K251148", "company": "Jdentalcare Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251148: JDEvolution Plus L and JDEvolution Plus LE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251148", "people": [{"name": "Antonio Grandi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251148%22"}, {"id": "fda:K251791", "company": "Auxano Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251791: Auxano\u00ae Wedge Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251791", "people": [{"name": "Stephen Mezget", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251791%22"}, {"id": "fda:K250076", "company": "Innovasis", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250076: Endeavor\u0099 Stand-Alone Cervical IBF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250076", "people": [{"name": "Michael Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250076%22"}, {"id": "fda:K251993", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251993: Panther Fusion GI Expanded Bacterial Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251993", "people": [{"name": "Patricia Villarreal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251993%22"}, {"id": "fda:K251527", "company": "Quantib B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251527: Brain WMH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251527", "people": [{"name": "Nathan Hunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251527%22"}, {"id": "fda:K250837", "company": "Shanghai Berry Electronic Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250837: Pulse Oximeter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250837", "people": [{"name": "Xu Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250837%22"}, {"id": "fda:K251997", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251997: Single-Use Biopsy Valve (MAJ-1555)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251997", "people": [{"name": "Jillian Connery", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251997%22"}, {"id": "fda:K251512", "company": "Bistos Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251512: Hi bebe super (BT-150B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251512", "people": [{"name": "HYE JEONG KIM", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251512%22"}, {"id": "fda:K252102", "company": "Abbott Molecular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252102: Alinity m HCV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252102", "people": [{"name": "Jennifer Peterson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252102%22"}, {"id": "fda:K251971", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251971: RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251971", "people": [{"name": "Susanne Galin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251971%22"}, {"id": "fda:K252371", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252371: uMR 680", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252371", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252371%22"}, {"id": "fda:DEN250016", "company": "Essilor Of America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250016: Essilor\u00ae Stellest\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250016", "people": [{"name": "John Anderson", "role": "510(k) submission contact"}]}, {"id": "fda:K251465", "company": "Enpuno Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251465: Root canal repair materials (nRoot BP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251465", "people": [{"name": "Chengfa Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251465%22"}, {"id": "fda:K244009", "company": "Yung Sheng Optical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K244009: Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244009", "people": [{"name": "Wen-Han Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244009%22"}, {"id": "fda:K251868", "company": "Hologic", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251868: Panther Fusion GI Bacterial Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251868", "people": [{"name": "Patricia Villarreal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251868%22"}, {"id": "fda:K243785", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243785: Shiley\u0099 Oral/Nasal Tracheal Tube with TaperGuard\u0099 Cuff Reinforced, Murphy Eye Shiley\u0099 Tracheal Tube TaperGuard\u0099 Cuff Reinforced with Stylet Shiley\u0099 Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley\u0099 Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley\u0099 Oral/Nasal Tracheal Tube Cuffless Reinforced", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243785", "people": [{"name": "Shruti Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243785%22"}, {"id": "trialreg:NCT07191860", "company": "Airiver Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Central Airway Stenosis", "source_url": "https://clinicaltrials.gov/study/NCT07191860"}, {"id": "trialreg:NCT07191548", "company": "Angiodynamics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE", "source_url": "https://clinicaltrials.gov/study/NCT07191548"}, {"id": "trialreg:NCT07192380", "company": "IMADIS Technologies et Services", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Shift Hours' Impact on Fatigue and Tracking of Eye Dynamics", "source_url": "https://clinicaltrials.gov/study/NCT07192380"}, {"id": "trialreg:NCT07192731", "company": "Angiodynamics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: International Study on Treatment of Liver (HCC) Patients With IRE", "source_url": "https://clinicaltrials.gov/study/NCT07192731"}, {"id": "trialreg:NCT07193407", "company": "INOPASE Pty Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: INOPASE - Performance and Safety Study of a Personalised SNM System", "source_url": "https://clinicaltrials.gov/study/NCT07193407"}, {"id": "denovo:DEN250016", "company": "Essilor Of America, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-09-25", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250016 granted: Essilor\u00ae Stellest\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250016"}, {"id": "breakthrough:DEN250016", "company": "Essilor Of America, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-09-25", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN250016: ESSILOR STELLEST", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R44MH135726-02S1", "company": "Mindtrace Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": 50000, "summary": "NIH award 3R44MH135726-02S1: Development of an innovative neurosurgical planning tool for awake craniotomy ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11308167", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44HL140669-06S1", "company": "Volumetrix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": 175700, "summary": "NIH award 3R44HL140669-06S1: Non-Invasive Venous Waveform Analysis (NIVA) in patients with Heart Failure (HF) ($175,700)", "source_url": "https://reporter.nih.gov/project-details/11248913", "people": [{"name": "Kyle Mitchell Hocking", "role": "Principal Investigator"}, {"name": "JOANN LINDENFELD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:2R44TR004975-02A1", "company": "Syntr Health Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": 1050276, "summary": "NIH award 2R44TR004975-02A1: Device Automation of an FDA-cleared CD-Microfluidic Platform for Rapid Tissue Microsizing ($1,050,276)", "source_url": "https://reporter.nih.gov/project-details/11253865", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:9R44MH144704-02A1", "company": "Quant, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": 1835001, "summary": "NIH award 9R44MH144704-02A1: Ultra-high sensitivity, high spatial resolution single photon emission tomography using mechanical flux manipulation ($1,835,001)", "source_url": "https://reporter.nih.gov/project-details/11254264", "people": [{"name": "Larry Pierce", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41AI188742-01A1", "company": "Luna Bioscience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-24", "observed": "2026-08-21", "amount_usd": 300435, "summary": "NIH award 1R41AI188742-01A1: Antibody Detection for Diagnosis of Acute Leptospirosis ($300,435)", "source_url": "https://reporter.nih.gov/project-details/11184836", "people": [{"name": "Carla Ellen Devillers", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH143569-01", "company": "Neurolux, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-24", "observed": "2026-08-21", "amount_usd": 499781, "summary": "NIH award 1R43MH143569-01: Development and Validation of a Compliant Reversible Actuator and Detector Leveraging Electrophysiology for Organoids (Organoid-CRADLE) ($499,781)", "source_url": "https://reporter.nih.gov/project-details/11186733", "people": [{"name": "Cameron Good", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42MH136878-02", "company": "Mainsquare Co", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-24", "observed": "2026-08-21", "amount_usd": 1240774, "summary": "NIH award 4R42MH136878-02: Engagement and clinical impact of the Teleo virtual therapy platform in clinical settings ($1,240,774)", "source_url": "https://reporter.nih.gov/project-details/11194657", "people": [{"name": "DAVID S HONG", "role": "Principal Investigator"}, {"name": "Eric Roland Kuhn", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R42CA268623-02", "company": "Nanocan Therapeutics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-24", "observed": "2026-08-21", "amount_usd": 998781, "summary": "NIH award 2R42CA268623-02: Liquid Immunotherapeutic Fiducial Eluter (LIFE) Gel for Cervical Cancer ($998,781)", "source_url": "https://reporter.nih.gov/project-details/11070058", "people": [{"name": "Kai Ding", "role": "Principal Investigator"}, {"name": "Sandeep Kakade", "role": "Principal Investigator"}, {"name": "Akila Viswanathan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K252689", "company": "Imaxeon Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252689: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252689", "people": [{"name": "Anhua Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252689%22"}, {"id": "fda:K250071", "company": "Alma Lasers, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250071: Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250071", "people": [{"name": "Jessica Rivera-Montejo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250071%22"}, {"id": "fda:K251734", "company": "Proverum Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251734: ProVee Video Processing Unit (PV-003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251734", "people": [{"name": "Niamh Mahony", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251734%22"}, {"id": "fda:K243910", "company": "Kulzer, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243910: Retraxil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243910", "people": [{"name": "Lucas Harmon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243910%22"}, {"id": "fda:K252680", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252680: Celerity\u0099 20 HP Biological Indicator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252680", "people": [{"name": "Logan Persons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252680%22"}, {"id": "fda:K251206", "company": "Dentimax, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251206: Digital X-Ray DentiMax Pro Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251206", "people": [{"name": "David Arnett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251206%22"}, {"id": "fda:K250792", "company": "Tandem Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250792: t:slim X2 insulin pump with interoperable technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250792", "people": [{"name": "Miriam Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250792%22"}, {"id": "fda:K252682", "company": "Alcon Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252682: LenSx Laser System (8065000944)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252682", "people": [{"name": "Tammy Vu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252682%22"}, {"id": "fda:K252183", "company": "Resitu Medical AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252183: Resitu Slider 09 (RESL09)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252183", "people": [{"name": "Asa Runnas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252183%22"}, {"id": "fda:K250045", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250045: uWS-Angio Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250045", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250045%22"}, {"id": "fda:K252703", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252703: LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252703", "people": [{"name": "Alexandra Skinner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252703%22"}, {"id": "fda:K244029", "company": "Endorobotics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K244029: ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244029", "people": [{"name": "Jihwan Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244029%22"}, {"id": "fda:K252227", "company": "Surmodics,Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-24", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252227: Pounce(TM) Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252227", "people": [{"name": "Peter Bather", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252227%22"}, {"id": "trialreg:NCT07190794", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: RESCUE: Discontinuation of GLP-1", "source_url": "https://clinicaltrials.gov/study/NCT07190794"}, {"id": "trialreg:NCT07189858", "company": "Ondine Biomedical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections - Canada", "source_url": "https://clinicaltrials.gov/study/NCT07189858"}, {"id": "trialreg:NCT07189650", "company": "Esaote S.p.A.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pilot Study for Collecting Data on Liver Adipose Content in Adults by Ultrasound Attenuation and Scattering Imaging and MRI Proton-density", "source_url": "https://clinicaltrials.gov/study/NCT07189650"}, {"id": "trialreg:NCT07191457", "company": "Oystershell NV", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo", "source_url": "https://clinicaltrials.gov/study/NCT07191457"}, {"id": "trialreg:NCT07190807", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control", "source_url": "https://clinicaltrials.gov/study/NCT07190807"}, {"id": "trialreg:NCT07191067", "company": "Synaptrix, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty", "source_url": "https://clinicaltrials.gov/study/NCT07191067"}, {"id": "nih:1R43AG097214-01", "company": "Lo Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": 305621, "summary": "NIH award 1R43AG097214-01: Home-based plasma self-collection device for remote diagnosis and monitoring of AD-associated biomarkers ($305,621)", "source_url": "https://reporter.nih.gov/project-details/11254625", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43PS005314-01", "company": "Esper Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": 423833, "summary": "NIH award 1R43PS005314-01: Rapid Point-of-Care Nucleic Acid Test for Hepatitis C using Nanosensors ($423,833)", "source_url": "https://reporter.nih.gov/project-details/11008032", "people": [{"name": "Jonathan Alden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44EY036316-01A1", "company": "Xr Navigation Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-23", "observed": "2026-08-21", "amount_usd": 1009268, "summary": "NIH award 1R44EY036316-01A1: Developing and Evaluating Visual, Auditory, and Tactile and Text Digital Thematic Map Viewer to Provide Blind and Low Vision Individuals Full Access to Thematic Maps for the First Time ($1,009,268)", "source_url": "https://reporter.nih.gov/project-details/11069983", "people": [{"name": "Brandon Biggs", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44CK000679-02A1", "company": "Nanohmics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-23", "observed": "2026-08-21", "amount_usd": 1047807, "summary": "NIH award 2R44CK000679-02A1: Lateral Flow-Electrochemiluminescent (LF-ECL) Test Strips and Portable Reader for Ultrasensitive Foodborne Pathogen Detection ($1,047,807)", "source_url": "https://reporter.nih.gov/project-details/11255785", "people": [{"name": "John Bruno", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44MD020606-01", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-23", "observed": "2026-08-21", "amount_usd": 1022341, "summary": "NIH award 1R44MD020606-01: Addressing Challenges in Peripheral Intravenous Catheter Education ($1,022,341)", "source_url": "https://reporter.nih.gov/project-details/11183984", "people": [{"name": "John Paul Condon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44PS005271-02", "company": "Lo Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-23", "observed": "2026-08-21", "amount_usd": 994658, "summary": "NIH award 2R44PS005271-02: A novel remote blood separation device for at-home plasma collection for HIV-1 testing ($994,658)", "source_url": "https://reporter.nih.gov/project-details/11184844", "people": [{"name": "Maria de los Angeles JAIME", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44OH012421-03", "company": "Creare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-23", "observed": "2026-08-21", "amount_usd": 356571, "summary": "NIH award 5R44OH012421-03: Refinement of Very Low Leakage Non-Invasive Ventilation Mask for Infectious Patients ($356,571)", "source_url": "https://reporter.nih.gov/project-details/11382584", "people": [{"name": "Daniel Micka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K253053", "company": "Hangzhou SHINING3D Dental Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K253053: Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253053", "people": [{"name": "Jiachen Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K253053%22"}, {"id": "fda:K251483", "company": "Airs Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251483: SwiftSight-Brain", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251483", "people": [{"name": "Lee HaeRi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251483%22"}, {"id": "fda:K251982", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251982: Edwards MC3 Tricuspid annuloplasty ring (4900)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251982", "people": [{"name": "Derrick Dukatz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251982%22"}, {"id": "fda:K251894", "company": "Himaging Technology (Shanghai) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251894: Himaging Bronchscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251894", "people": [{"name": "Shumei Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251894%22"}, {"id": "fda:K252045", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252045: Ion Endoluminal System (IF1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252045", "people": [{"name": "Jyoti Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252045%22"}, {"id": "fda:K252644", "company": "M/s. Meril Endo Surgery Private Limited.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252644: PINION\u0099 PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION\u0099 PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252644", "people": [{"name": "Umesh Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252644%22"}, {"id": "fda:DEN240080", "company": "Biolinq Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN240080: Biolinq Shine Autonomous Time-in-Range Microsensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240080", "people": [{"name": "Kate Hunter", "role": "510(k) submission contact"}]}, {"id": "fda:K250209", "company": "Canyon Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250209: Polyvinyl Alcohol Embolic Microspheres", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250209", "people": [{"name": "Huiqi Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250209%22"}, {"id": "fda:K251987", "company": "Ischemaview, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251987: Rapid Aortic Measurements", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251987", "people": [{"name": "Jim Rosa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251987%22"}, {"id": "fda:K252043", "company": "Olympus Winter & Ibe GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252043: Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252043", "people": [{"name": "Michaela Soukopova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252043%22"}, {"id": "fda:K251140", "company": "Zenflow, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251140: Zenflow Spring Scope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251140", "people": [{"name": "Marianne Jacklyn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251140%22"}, {"id": "fda:K251973", "company": "Luminance Medical Ventures, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-23", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251973: Luminance Red Cold Sore Device (TN1927G)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251973", "people": [{"name": "Troy Stites", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251973%22"}, {"id": "trialreg:NCT07188129", "company": "Zywie, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Test Algorithm for Use to Analyze ECG Data Collected From a Test Device of a 24-hour Simulated Use Period", "source_url": "https://clinicaltrials.gov/study/NCT07188129"}, {"id": "trialreg:NCT07188233", "company": "HVR Cardio Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Mitral Annular Repair With the CathHELIX\u2122 Transcatheter System in Subjects With FMR", "source_url": "https://clinicaltrials.gov/study/NCT07188233"}, {"id": "trialreg:NCT07187518", "company": "POROUS GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device", "source_url": "https://clinicaltrials.gov/study/NCT07187518"}, {"id": "trialreg:NCT07188818", "company": "Bohus Biotech AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation on Lips Treated With HA-filler", "source_url": "https://clinicaltrials.gov/study/NCT07188818"}, {"id": "trialreg:NCT07188948", "company": "Gabriel Sanchez", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: In Vivo Cross-Modal Imaging of Skin", "source_url": "https://clinicaltrials.gov/study/NCT07188948"}, {"id": "trialreg:NCT07189013", "company": "KORU Medical Systems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessing Patient Preference for Infusion Systems", "source_url": "https://clinicaltrials.gov/study/NCT07189013"}, {"id": "denovo:DEN240080", "company": "Biolinq Incorporated", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-09-23", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240080 granted: Biolinq Shine Autonomous Time-in-Range M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240080"}, {"id": "nih:1R44NS139774-01A1", "company": "Wynnvision, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-22", "observed": "2026-08-06", "amount_usd": 306315, "summary": "NIH award 1R44NS139774-01A1: Reducing infections and blockage associated with long-term implantation of ventriculoperitoneal and related shunts ($306,315)", "source_url": "https://reporter.nih.gov/project-details/11186482", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R42AG059475-04A1", "company": "Advanced Smart Systems/evaluation Techno", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-22", "observed": "2026-08-06", "amount_usd": 1150314, "summary": "NIH award 2R42AG059475-04A1: Mitigating Injurious Falls in Older Adults Through Non-Injurious Fall and Gait Analysis From Floor Vibrations ($1,150,314)", "source_url": "https://reporter.nih.gov/project-details/11185349", "people": [{"name": "Stacy Lynne Fritz", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43HL180201-01", "company": "Spheric Bio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-22", "observed": "2026-08-06", "amount_usd": 598636, "summary": "NIH award 1R43HL180201-01: emuLAAte: atraumatic patient-specific stroke prevention technology ($598,636)", "source_url": "https://reporter.nih.gov/project-details/11185891", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL180283-01", "company": "Vena Vitals, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-22", "observed": "2026-08-06", "amount_usd": 306872, "summary": "NIH award 1R43HL180283-01: Continuous Non-Invasive Blood Pressure during Sleep as a Cardiovascular Biomarker ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11186475", "people": [{"name": "Joshua Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA310319-01", "company": "Persistence Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-22", "observed": "2026-08-21", "amount_usd": 314685, "summary": "NIH award 1R44CA310319-01: The SynthNode Paradigm: Reimagining CAR T Cell Therapy for Improved Patient Outcomes ($314,685)", "source_url": "https://reporter.nih.gov/project-details/11314714", "people": [{"name": "Pritha Agarwalla", "role": "Principal Investigator"}, {"name": "Jan Van Deursen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HG012531-03", "company": "Sage Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-22", "observed": "2026-08-21", "amount_usd": 957480, "summary": "NIH award 5R44HG012531-03: High-throughput size-selection system for long-read sequencing library preparation ($957,480)", "source_url": "https://reporter.nih.gov/project-details/11128542", "people": [{"name": "TRUETT C BOLES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44HD114325-02A1", "company": "Analytical Diagnostic Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-22", "observed": "2026-08-21", "amount_usd": 906002, "summary": "NIH award 2R44HD114325-02A1: A point of care-device for the determination of creatinine phosphokinase (CPK), the CPK Now ($906,002)", "source_url": "https://reporter.nih.gov/project-details/11253099", "people": [{"name": "Robert Harper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG097243-01", "company": "Revbio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-22", "observed": "2026-08-21", "amount_usd": 2040626, "summary": "NIH award 1R44AG097243-01: Improved Treatment Options for Vertebral Compression Fractures in Elderly Patients Using Minimally Invasive, Image-Guided Delivery of a Regenerative Bone Adhesive ($2,040,626)", "source_url": "https://reporter.nih.gov/project-details/11255514", "people": [{"name": "Brittany McDonough", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K252315", "company": "AngioSafe, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252315: Santreva\u0099-ATK Endovascular Revasculariztion Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252315", "people": [{"name": "Rebecca Spelich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252315%22"}, {"id": "fda:K250388", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250388: ENDOFLATOR +", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250388", "people": [{"name": "Emily Rhiel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250388%22"}, {"id": "fda:K250205", "company": "Jinan Babio Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250205: Babio\u00ae Virus Transport Kit (Non-inactivating)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250205", "people": [{"name": "Xiaotong Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250205%22"}, {"id": "fda:K243645", "company": "Diagnostic Green GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243645: IC-Flow\u0099 Imaging System 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243645", "people": [{"name": "Ann M Maloney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243645%22"}, {"id": "fda:K251743", "company": "Surgical Principals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251743: SPI LaproSac\u0099 Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251743", "people": [{"name": "Timothy Wynne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251743%22"}, {"id": "trialreg:NCT07185191", "company": "Mastelli S.r.l", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS)", "source_url": "https://clinicaltrials.gov/study/NCT07185191"}, {"id": "trialreg:NCT07185321", "company": "Pulmovant, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Phase 1 Study of Mosliciguat in Healthy, Adult Males", "source_url": "https://clinicaltrials.gov/study/NCT07185321"}, {"id": "trialreg:NCT07186595", "company": "AbbVie", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Safety and Effectiveness of JUV\u00c9DERM Products in Adult Participants for the Change of Their Overall Facial Appearance", "source_url": "https://clinicaltrials.gov/study/NCT07186595"}, {"id": "trialreg:NCT07187297", "company": "Bausch Health Americas, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage\u00ae FLX Radiofrequency Treatment", "source_url": "https://clinicaltrials.gov/study/NCT07187297"}, {"id": "trialreg:NCT07187115", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07187115"}, {"id": "trialreg:NCT07187128", "company": "BrosMed Medical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.", "source_url": "https://clinicaltrials.gov/study/NCT07187128"}, {"id": "trialreg:NCT07185971", "company": "NeuroAEye LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PAVE (Parallactic Visual-Field Enhancement) System for Treatment of Chronic Visual Field Loss Due to Stroke, Traumatic Brain Injury, or Brain Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07185971"}, {"id": "nih:7R44NS122687-05", "company": "Infinite Biomedical Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-20", "observed": "2026-08-06", "amount_usd": 1497205, "summary": "NIH award 7R44NS122687-05: Development and clinical assessment of a robust, 3D printed titanium, myoelectric powered prosthetic digit system ($1,497,205)", "source_url": "https://reporter.nih.gov/project-details/11334753", "people": [{"name": "Rahul Reddy Kaliki", "role": "Principal Investigator"}, {"name": "Levin Sliker", "role": "Principal Investigator"}, {"name": "Richard Fergus ffrench Weir", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R43HG014149-01", "company": "Care Progress, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-20", "observed": "2026-08-21", "amount_usd": 400618, "summary": "NIH award 1R43HG014149-01: Leveraging Large Language Models to Enhance Regional Genomic Medicine eConsults ($400,618)", "source_url": "https://reporter.nih.gov/project-details/11096353", "people": [{"name": "Howard Isenstein", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA287615-02", "company": "Averto Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": 928967, "summary": "NIH award 5R44CA287615-02: Safety and Efficacy Trial of the ColoSeal ICD System for the Treatment of Rectal Cancer Patients ($928,967)", "source_url": "https://reporter.nih.gov/project-details/11195700", "people": [{"name": "Kenton Dodyan Fong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG097237-01", "company": "Healthy Design, Ltd. Co.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": 506399, "summary": "NIH award 1R44AG097237-01: Novel Continuous Predictive Wearable Agitation Monitor and Alert Using Actigraphy and AI for Hospitalized Older Adults to Prevent Delirium and Dementia for Clinical Use and Harmonization of Research ($506,399)", "source_url": "https://reporter.nih.gov/project-details/11256568", "people": [{"name": "Marie T Pavini", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG060779-04A1", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": 1546575, "summary": "NIH award 2R44AG060779-04A1: Non-Contact Point of Care Device for Sleep Studies ($1,546,575)", "source_url": "https://reporter.nih.gov/project-details/11255274", "people": [{"name": "John Paul Condon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43AG087901-01A1", "company": "Amira Health Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": 277391, "summary": "NIH award 1R43AG087901-01A1: Validating Terra, a device for closed-loop hot-flash cooling relief and sleep improvement ($277,391)", "source_url": "https://reporter.nih.gov/project-details/11070109", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG097057-01", "company": "One Health Studio LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": 474092, "summary": "NIH award 1R44AG097057-01: Flourish All: Women's Integrated Stress Reduction for Alzheimer's Risk Prevention Using Digital Tools and Biomarker Monitoring ($474,092)", "source_url": "https://reporter.nih.gov/project-details/11249693", "people": [{"name": "Jin Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG097349-01", "company": "Turing Medical Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": 699964, "summary": "NIH award 1R44AG097349-01: Real-time head motion monitoring for all clinical MR sequences using Universal FIRMM ($699,964)", "source_url": "https://reporter.nih.gov/project-details/11254940", "people": [{"name": "Kevin King", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG097241-01", "company": "Bellage, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": 499396, "summary": "NIH award 1R44AG097241-01: Innovating a Personalized Reinforcement Interface to Motivate Engagement (PRIME) Among Care Partners for People Living with Alzheimer's Disease and Related Dementia in their Communities ($499,396)", "source_url": "https://reporter.nih.gov/project-details/11255595", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG078063-02A1", "company": "Tf Health Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": 831790, "summary": "NIH award 2R44AG078063-02A1: Smart driving technology for non-invasive detection of age-related cognitive decline ($831,790)", "source_url": "https://reporter.nih.gov/project-details/11185442", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41AG092186-01A1", "company": "Independent Feeding Device, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": 306872, "summary": "NIH award 1R41AG092186-01A1: Restoring Self-Feeding with a Sensor Driven Robotic System ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11184101", "people": [{"name": "Jonathan Paul Dekar", "role": "Principal Investigator"}, {"name": "Zackory Erickson", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42NS134505-02", "company": "Neurinsight, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-21", "amount_usd": 973322, "summary": "NIH award 4R42NS134505-02: Towards intra-operative guidance in brain tumor surgery using real-time resting-state functional MRI ($973,322)", "source_url": "https://reporter.nih.gov/project-details/11142186", "people": [{"name": "Dieter W Dennig", "role": "Principal Investigator"}, {"name": "Stefan Posse", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44EB033715-02", "company": "Akna Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-21", "amount_usd": 1949879, "summary": "NIH award 2R44EB033715-02: Assay development for the assessment of pregnancy risks in early pregnancy ($1,949,879)", "source_url": "https://reporter.nih.gov/project-details/11069534", "people": [{"name": "David Randall Armant", "role": "Principal Investigator"}, {"name": "Sascha Drewlo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R42AG097309-01", "company": "Tauvision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-21", "amount_usd": 493384, "summary": "NIH award 1R42AG097309-01: An Eyedrop Diagnostic Test for Alzheimer's Disease ($493,384)", "source_url": "https://reporter.nih.gov/project-details/11254586", "people": [{"name": "Rachel Elise Bennett", "role": "Principal Investigator"}, {"name": "John Dubach", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG065130-03A1", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-21", "amount_usd": 649281, "summary": "NIH award 2R44AG065130-03A1: An Automated System for Caregivers and Staff to Locate Items Misplaced by Personswith Dementia in a Care Facility ($649,281)", "source_url": "https://reporter.nih.gov/project-details/11181987", "people": [{"name": "Paul Gibson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44AG090247-02", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-19", "observed": "2026-08-21", "amount_usd": 1089346, "summary": "NIH award 4R44AG090247-02: Developing an Elderly Patient-Specific, Accurate, Intuitive and Highly Interpretable System for Unconsciousness Management in General Anesthesia Using PASCALL FDA-Cleared Intraoperative EEG Monitor ($1,089,346)", "source_url": "https://reporter.nih.gov/project-details/11375757", "people": [{"name": "EMERY N BROWN", "role": "Principal Investigator"}, {"name": "Tuan Le Mau", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K250128", "company": "Anhui Happiness Workshop Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250128: Single Use Suction-Evacuation Ureteral Access Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250128", "people": [{"name": "Shuanghong Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250128%22"}, {"id": "fda:K251002", "company": "Videahealth, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251002: Videa Dental AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251002", "people": [{"name": "Adam Foresman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251002%22"}, {"id": "fda:K252285", "company": "Vericom Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252285: Well-Root PT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252285", "people": [{"name": "Yunki Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252285%22"}, {"id": "fda:K243920", "company": "Medica USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243920: Purema H Hemoconcentrator - Pediatric", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243920", "people": [{"name": "Greg Collins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243920%22"}, {"id": "fda:K251100", "company": "Ipg Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251100: IPGTFL-02", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251100", "people": [{"name": "Kevin O'Conell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251100%22"}, {"id": "fda:K250649", "company": "BunkerHill Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250649: Bunkerhill ECG-EF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250649", "people": [{"name": "Nishith Khandwala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250649%22"}, {"id": "fda:K250777", "company": "Huntleigh Healthcare , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250777: Sonicaid Team3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250777", "people": [{"name": "Steve Monks", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250777%22"}, {"id": "fda:K242859", "company": "Ibramed Equipamentos M\u00e9dicos", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242859: VEGA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242859", "people": [{"name": "Fabio Alexandre Pinto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242859%22"}, {"id": "fda:K244035", "company": "Shenzhen Jermei Medical Device Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K244035: Portable mesh nebulizer (JM821)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244035", "people": [{"name": "Fang Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244035%22"}, {"id": "fda:K250953", "company": "GC America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250953: EQUIA LC ONE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250953", "people": [{"name": "Futoshi Fusejima", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250953%22"}, {"id": "fda:K241868", "company": "Tempus AI, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K241868: xR IVD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241868", "people": [{"name": "Sarah Piloto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241868%22"}, {"id": "fda:K243990", "company": "Optmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243990: BondEase 2 Topical Skin Adhesive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243990", "people": [{"name": "Nitasha Yajnik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243990%22"}, {"id": "fda:K250450", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250450: Coated hip implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250450", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250450%22"}, {"id": "fda:K252657", "company": "Nvision Biomedical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252657: Impact PEEK Union Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252657", "people": [{"name": "Tom Zink", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252657%22"}, {"id": "fda:K252662", "company": "Nakanishi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252662: UniBur", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252662", "people": [{"name": "Kikuchi Masaaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252662%22"}, {"id": "fda:K251867", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251867: EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251867", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251867%22"}, {"id": "fda:K252613", "company": "Unibeauty (Hubei) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252613: Unscented menstrual three-piece applicator tampon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252613", "people": [{"name": "Guofeng Ou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252613%22"}, {"id": "fda:K250408", "company": "Zeus Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250408: Alegria Flash ENA Screen", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250408", "people": [{"name": "Mark Kopnitsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250408%22"}, {"id": "fda:K251689", "company": "Nakanishi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251689: VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251689", "people": [{"name": "Kikuchi Masaaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251689%22"}, {"id": "fda:K251167", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251167: uDR Aurora CX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251167", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251167%22"}, {"id": "fda:DEN240067", "company": "Cytocell Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN240067: KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240067", "people": [{"name": "Steve Chatters", "role": "510(k) submission contact"}]}, {"id": "fda:K252647", "company": "Embody, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252647: Tapestry Biointegrative Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252647", "people": [{"name": "Brianna Schehr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252647%22"}, {"id": "trialreg:NCT07184437", "company": "Bohus Biotech AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Investigation of MINIVISC\u00ae PLUS 14 mg/ml Fermented Ophthalmic Viscosurgical Device (OVD-F), Used for Cataract Surgery and Implantation of Intraocular Lenses, Glaucoma Surgery, Anterior Segment Surgery and Corneal Transplantation (CGAC)", "source_url": "https://clinicaltrials.gov/study/NCT07184437"}, {"id": "trialreg:NCT07182058", "company": "U: The Mind Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Virtual tES Device Treatment for Parkinson's Disease Motor Symptoms", "source_url": "https://clinicaltrials.gov/study/NCT07182058"}, {"id": "trialreg:NCT07182331", "company": "Neurolab Plus", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Brain Stimulation and Sensory Integration in Children With ASD", "source_url": "https://clinicaltrials.gov/study/NCT07182331"}, {"id": "trialreg:NCT07182344", "company": "Neurolab Plus", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Brain Stimulation and Attention Control in Children With ADHD", "source_url": "https://clinicaltrials.gov/study/NCT07182344"}, {"id": "denovo:DEN240067", "company": "Cytocell Limited", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-09-19", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240067 granted: KMT2A Breakapart FISH Probe Kit PDx (CDA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240067"}, {"id": "nih:1R43AG097223-01", "company": "Dabble Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": 499686, "summary": "NIH award 1R43AG097223-01: Ecological Cognitive Monitoring through AI-Enhanced Personal Photo Activities ($499,686)", "source_url": "https://reporter.nih.gov/project-details/11254288", "people": [{"name": "Lawrence Chernin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG092067-01", "company": "Oscilloscape, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": 467538, "summary": "NIH award 1R43AG092067-01: SynG: a Music-Based Intervention for Alzheimer's and Mild Cognitive Impairment ($467,538)", "source_url": "https://reporter.nih.gov/project-details/11069277", "people": [{"name": "Edward W Large", "role": "Principal Investigator"}, {"name": "Psyche Loui", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG092272-01", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": 499921, "summary": "NIH award 1R43AG092272-01: System to Allow Off Site Monitoring of Pressure Ulcers for Patients in a Rural Long-Term Care Facility ($499,921)", "source_url": "https://reporter.nih.gov/project-details/11090047", "people": [{"name": "Paul Gibson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG097131-01", "company": "Viewmind Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": 495731, "summary": "NIH award 1R43AG097131-01: Evaluation of ViewMind's ability to detect beta-amyloid and tau burden consistent with Alzheimer's disease in persons with MCI using Machine Learning, VR, and eye-tracking technology ($495,731)", "source_url": "https://reporter.nih.gov/project-details/11252627", "people": [{"name": "Gerardo Fernandez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG097383-01", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": 313311, "summary": "NIH award 1R43AG097383-01: Addressing Pressure Injury Disparities in Persons with Darkly Pigmented Skin Using Dynamic Tissue Simulations ($313,311)", "source_url": "https://reporter.nih.gov/project-details/11245553", "people": [{"name": "Adam Becker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG094410-01A1", "company": "Braincheck, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": 497782, "summary": "NIH award 1R43AG094410-01A1: A Primary Care eConsult Platform for Dementia Diagnosis and Care Management ($497,782)", "source_url": "https://reporter.nih.gov/project-details/11254522", "people": [{"name": "Bin Huang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA302113-01A1", "company": "O2m Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": 1164814, "summary": "NIH award 1R44CA302113-01A1: Advanced Imaging Methods in Pulse EPR ($1,164,814)", "source_url": "https://reporter.nih.gov/project-details/11182065", "people": [{"name": "Boris Epel", "role": "Principal Investigator"}, {"name": "Mrignayani Kotecha", "role": "Principal Investigator"}, {"name": "Mark David Pagel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44MH135605-02S1", "company": "Ksana Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44MH135605-02S1: BRITE 2.0: A just-in-time adaptive intervention for suicide safety planning in adolescents ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11311223", "people": [{"name": "NICHOLAS B ALLEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG094520-01", "company": "Posit Science Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 501371, "summary": "NIH award 1R44AG094520-01: Improving Neurological Health with Acetylcholine via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment (INHANCE-MCI) ($501,371)", "source_url": "https://reporter.nih.gov/project-details/11186533", "people": [{"name": "Mouna Attarha", "role": "Principal Investigator"}, {"name": "Etienne de Villers-Sidani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG097165-01", "company": "Tru Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 320511, "summary": "NIH award 1R43AG097165-01: Creation of Dynamic, Non-Stochastic, W Function Informed Methylation Risk Scores (MRS) for Diagnostic/Therapeutic Applications ($320,511)", "source_url": "https://reporter.nih.gov/project-details/11253983", "people": [{"name": "Varun Bhamidipati Dwaraka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA254543-02A1", "company": "Glyciome, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 1039382, "summary": "NIH award 2R44CA254543-02A1: Cervical Cancer Prevention Prebiotic Device ($1,039,382)", "source_url": "https://reporter.nih.gov/project-details/11254991", "people": [{"name": "Joanna Elizabeth Ellington", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG097384-01", "company": "Carevirtue Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 499651, "summary": "NIH award 1R44AG097384-01: A Novel, AI-Enabled Dementia Care Agent to Reduce Disparities for Rural ADRD Care Partners. ($499,651)", "source_url": "https://reporter.nih.gov/project-details/11245340", "people": [{"name": "Christian Elliott", "role": "Principal Investigator"}, {"name": "Nicole E Werner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG097205-01", "company": "Proactive Life, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 499963, "summary": "NIH award 1R43AG097205-01: An Internet of Things Automated Cognitive Behavioral Therapy for Insomnia that Improves Cognition in Older Adults ($499,963)", "source_url": "https://reporter.nih.gov/project-details/11255346", "people": [{"name": "Daniel Gartenberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG097250-01", "company": "Hido Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 1240765, "summary": "NIH award 1R44AG097250-01: Behavioral Shifts in Dementia Patients Using Novel Pharmacy Home Robotics: A Cost-Effective Approach to Aging in Place ($1,240,765)", "source_url": "https://reporter.nih.gov/project-details/11254881", "people": [{"name": "Timothy Cutler", "role": "Principal Investigator"}, {"name": "Charles Gellman", "role": "Principal Investigator"}, {"name": "SARAH E TOMASZEWSKI-FARIAS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG094443-01", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 499993, "summary": "NIH award 1R43AG094443-01: The SoundMind Smart Amplifier: An affordable, accessible, user-friendly hearing solution for persons with memory concerns and their family caregivers ($499,993)", "source_url": "https://reporter.nih.gov/project-details/11183385", "people": [{"name": "Paul Gibson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG097382-01", "company": "Storii, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 817959, "summary": "NIH award 1R44AG097382-01: Strengthening Bonds: A Telephone Reminiscence Intervention to Reduce Social Isolation and Improve Mental Health in Rural Older Adults ($817,959)", "source_url": "https://reporter.nih.gov/project-details/11245606", "people": [{"name": "Cameron Graham", "role": "Principal Investigator"}, {"name": "Juliette M Shellman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R42HD104409-03", "company": "Frd Accel, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 969472, "summary": "NIH award 5R42HD104409-03: BabyStrong II (Stimulating the Tragus for Neural Growth): A Randomized Controlled Trial of taVNS-Paired Bottle Feeding to Improve Oral Feeding ($969,472)", "source_url": "https://reporter.nih.gov/project-details/11178706", "people": [{"name": "DOROTHEA DENISE JENKINS", "role": "Principal Investigator"}, {"name": "Joe Ruscito", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43EY038160-01", "company": "Bluebird Photonics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 305853, "summary": "NIH award 1R43EY038160-01: Novel light source development for robust multi-MHz retinal OCT ($305,853)", "source_url": "https://reporter.nih.gov/project-details/11255590", "people": [{"name": "Jongyoon Joo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG094463-01A1", "company": "Photozig, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 499938, "summary": "NIH award 1R44AG094463-01A1: CaringGPT: Empowering Dementia Caregivers with Personalized and Accessible Resources to Match Their Needs, Enhance Cope with Caregiving, and Reduce Stress ($499,938)", "source_url": "https://reporter.nih.gov/project-details/11256494", "people": [{"name": "BRUNO KAJIYAMA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG094397-01", "company": "Cellsight Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 871261, "summary": "NIH award 1R44AG094397-01: Imaging intracerebral and systemic T cell immunity in patients with Alzheimer's disease using 18F-F-AraG ($871,261)", "source_url": "https://reporter.nih.gov/project-details/11185795", "people": [{"name": "Jelena Levi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44MD018239-02A1", "company": "Rush River Research Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 1051406, "summary": "NIH award 2R44MD018239-02A1: Modernized Culturally Sensitive Family Medical History Tool ($1,051,406)", "source_url": "https://reporter.nih.gov/project-details/11111495", "people": [{"name": "Julie Lundstrom", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HG014126-02", "company": "Cantata Bio LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 746680, "summary": "NIH award 5R44HG014126-02: Commercialization of a rapid, automated Hi-C platform for sensitive genomic profiling of multiple cancer sample types ($746,680)", "source_url": "https://reporter.nih.gov/project-details/11194324", "people": [{"name": "Elizabeth Munding", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41MD020611-01A1", "company": "Popcom Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-18", "observed": "2026-08-21", "amount_usd": 396605, "summary": "NIH award 1R41MD020611-01A1: Project GAME ON!: Empowering urban children to engage in healthy behaviors to reduce obesity risk through an interactive digital comic tool ($396,605)", "source_url": "https://reporter.nih.gov/project-details/11253710", "people": [{"name": "May May Leung", "role": "Principal Investigator"}, {"name": "Charles Platkin", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K250369", "company": "Axial Medical Printing Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250369: Axial3D Insight", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250369", "people": [{"name": "Flatley Joanne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250369%22"}, {"id": "fda:K250883", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250883: ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250883", "people": [{"name": "Toshio Nakamura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250883%22"}, {"id": "fda:K251649", "company": "ShenB Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251649: Sunny Plus (Sunny)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251649", "people": [{"name": "Sunny Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251649%22"}, {"id": "fda:K251479", "company": "Mobarn Medical Devices, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251479: Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251479", "people": [{"name": "Richard Ehret", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251479%22"}, {"id": "fda:K251597", "company": "Perimetrics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251597: InnerView System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251597", "people": [{"name": "Alicia Mszyca", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251597%22"}, {"id": "fda:K251905", "company": "NormaTec Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251905: Normatec Elite Hip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251905", "people": [{"name": "Steve Henderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251905%22"}, {"id": "fda:K251377", "company": "Medela AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251377: Magic InBra", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251377", "people": [{"name": "Tiana Steinhoff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251377%22"}, {"id": "fda:K252428", "company": "Superpi Robot Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252428: Electric Wheelchair (Model P2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252428", "people": [{"name": "Xuan Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252428%22"}, {"id": "pma:P240011", "company": "Medtronic Neuromodulation", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-09-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240011: Medtronic Altaviva System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240011", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240011%22"}, {"id": "trialreg:NCT07181382", "company": "GB002, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)", "source_url": "https://clinicaltrials.gov/study/NCT07181382"}, {"id": "trialreg:NCT07181590", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF", "source_url": "https://clinicaltrials.gov/study/NCT07181590"}, {"id": "trialreg:NCT07181876", "company": "Distalmotion SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System", "source_url": "https://clinicaltrials.gov/study/NCT07181876"}, {"id": "nih:1R44DK143876-01", "company": "Averto Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": 1192362, "summary": "NIH award 1R44DK143876-01: Safety and Efficacy Trial of the ColoSeal ICD System for the Treatment of Diverticular Disease Patients ($1,192,362)", "source_url": "https://reporter.nih.gov/project-details/11184789", "people": [{"name": "Kenton Dodyan Fong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM156148-01A1", "company": "Perfusio Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": 349910, "summary": "NIH award 1R43GM156148-01A1: Project MATCH: Multi-spectral AI/ML powered Burn and Wound Evaluation Technology using a Cost-Effective Handheld Device. ($349,910)", "source_url": "https://reporter.nih.gov/project-details/11255696", "people": [{"name": "Cheng Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA310518-01", "company": "Embiosys Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": 1379442, "summary": "NIH award 1R44CA310518-01: CuRrEnT: Capecitabine in RCB2/3 with a wearable induced Electric field device in Triple Negative Breast Cancer ($1,379,442)", "source_url": "https://reporter.nih.gov/project-details/11313323", "people": [{"name": "Christopher Barron", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44MH135525-02", "company": "Radiation Monitoring Devices, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": 905751, "summary": "NIH award 4R44MH135525-02: Ultra-dense ceramic scintillator for BrainPET scanner ($905,751)", "source_url": "https://reporter.nih.gov/project-details/10951013", "people": [{"name": "JAROSLAW GLODO", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43MD020006-01A1", "company": "Pons Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": 337355, "summary": "NIH award 1R43MD020006-01A1: Development of an automated image enhancement system to improve point-of-care ultrasound imaging for out-of-hospital settings ($337,355)", "source_url": "https://reporter.nih.gov/project-details/11183628", "people": [{"name": "Ilker Hacihaliloglu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MD021154-01", "company": "Malama Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": 313955, "summary": "NIH award 1R44MD021154-01: A Specialized Risk-Stratification Platform and Tailored Diabetes Prevention Program for Post-Partum to Reduce Progression to Type 2 Diabetes ($313,955)", "source_url": "https://reporter.nih.gov/project-details/11256601", "people": [{"name": "Mika Eddy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD021044-01", "company": "Sojourn Medtech LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": 349859, "summary": "NIH award 1R43MD021044-01: Patient-Centered Self-Cannulation Training Simulator to Promote Self-Care and Home Hemodialysis among African American Patients with Kidney Failure ($349,859)", "source_url": "https://reporter.nih.gov/project-details/11246084", "people": [{"name": "ABHIJIT V KSHIRSAGAR", "role": "Principal Investigator"}, {"name": "Lydia Petersen", "role": "Principal Investigator"}, {"name": "Ravikiran Singapogu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD021142-01", "company": "Health Tequity LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": 384883, "summary": "NIH award 1R43MD021142-01: ACTIVATE: An AI-Enabled Multilingual Platform for Connected and Accessible Care Coordination and Remote Monitoring. ($384,883)", "source_url": "https://reporter.nih.gov/project-details/11254481", "people": [{"name": "Katherine K Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD021147-01", "company": "Isa Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-21", "amount_usd": 306003, "summary": "NIH award 1R43MD021147-01: A Mobile Intervention to Reduce the Impact of Chronic Stress on Preterm Birth Risk in African American Women ($306,003)", "source_url": "https://reporter.nih.gov/project-details/11255768", "people": [{"name": "DOUGLAS W BILLINGS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK143865-01", "company": "In Vivo Microsystems Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-21", "amount_usd": 1022055, "summary": "NIH award 1R44DK143865-01: In-vivo study of KSP/QRH heptapeptide dimer for detection of biliary intra-epithelial neoplasia ($1,022,055)", "source_url": "https://reporter.nih.gov/project-details/11185304", "people": [{"name": "Elaine Brady", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44GM145194-03S1", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-21", "amount_usd": 48000, "summary": "NIH award 3R44GM145194-03S1: System for unitary automation of library preparation ($48,000)", "source_url": "https://reporter.nih.gov/project-details/11387349", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44CA302219-01", "company": "Biotex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-21", "amount_usd": 1296385, "summary": "NIH award 1R44CA302219-01: Novel wearable rotating magnetic field therapy device targeting treatment of brain cancers ($1,296,385)", "source_url": "https://reporter.nih.gov/project-details/11186112", "people": [{"name": "Ashok Gowda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44HL172564-02", "company": "Informai, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-21", "amount_usd": 968552, "summary": "NIH award 4R44HL172564-02: Artificial Intelligence Tool to Optimize Organ Transplantation Outcomes (Transplant-AI) ($968,552)", "source_url": "https://reporter.nih.gov/project-details/11165633", "people": [{"name": "Jim Havelka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41CA306611-01", "company": "Navigation Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-21", "amount_usd": 225229, "summary": "NIH award 1R41CA306611-01: Targeted Localization and Optimized Surgical Resection for Lung Cancer ($225,229)", "source_url": "https://reporter.nih.gov/project-details/11253796", "people": [{"name": "Jayender Jagadeesan", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA306785-01", "company": "Safeguard Surgical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-21", "amount_usd": 406500, "summary": "NIH award 1R43CA306785-01: A biodegradable barrier preventing anastomotic leaks after esophagectomy ($406,500)", "source_url": "https://reporter.nih.gov/project-details/11254853", "people": [{"name": "Scott Kelley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HG014743-01", "company": "Micropure Genomics Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-17", "observed": "2026-08-21", "amount_usd": 291232, "summary": "NIH award 1R43HG014743-01: A gel-less, bead-less genomic size selection approach on a rapid and inexpensive microfluidic sample preparation platform ($291,232)", "source_url": "https://reporter.nih.gov/project-details/11256001", "people": [{"name": "Ryan Montes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K251386", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251386: ECHELON Synergy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251386", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251386%22"}, {"id": "fda:K251446", "company": "Manamed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251446: PlasmaFlow X Compression Sleeve Device (XPF0001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251446", "people": [{"name": "Trevor Theriot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251446%22"}, {"id": "fda:K251623", "company": "Shenzhen Yicai Health Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251623: Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251623", "people": [{"name": "Jie Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251623%22"}, {"id": "fda:K251688", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251688: Carpentier-Edwards Physio Annuloplasty Ring (4450)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251688", "people": [{"name": "Abby Geater", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251688%22"}, {"id": "fda:K252615", "company": "Ruthless, LLC Dba Ruthless Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252615: Ruthless Spine RJB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252615", "people": [{"name": "Renita Howard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252615%22"}, {"id": "fda:K251221", "company": "Abbott", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251221: Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251221", "people": [{"name": "Wing Yan (Winnie) Yik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251221%22"}, {"id": "fda:K251095", "company": "Pegavision Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251095: Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251095", "people": [{"name": "Estela Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251095%22"}, {"id": "fda:K252035", "company": "Kamemizu Chemical Industry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252035: DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252035", "people": [{"name": "Tomohiro Kinoshita", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252035%22"}, {"id": "fda:K243752", "company": "The Tmj Clinic PC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243752: Double Tube Herbst Appliance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243752", "people": [{"name": "John Summer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243752%22"}, {"id": "fda:K244006", "company": "Full Golden Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K244006: FG Bone Graft M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244006", "people": [{"name": "Chiyu Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244006%22"}, {"id": "fda:K251902", "company": "Vitacore Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-17", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251902: Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251902", "people": [{"name": "Yuxuan Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251902%22"}, {"id": "trialreg:NCT07179198", "company": "Sinclair Pharmaceuticals Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Safety and Effectiveness of Kytogen Defend in Facial Skin Quality Improvement in Adult Participants", "source_url": "https://clinicaltrials.gov/study/NCT07179198"}, {"id": "trialreg:NCT07179224", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EEG Changes After rTMS Stimulation", "source_url": "https://clinicaltrials.gov/study/NCT07179224"}, {"id": "trialreg:NCT07178210", "company": "MMI (Medical Microinstruments, Inc.)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease", "source_url": "https://clinicaltrials.gov/study/NCT07178210"}, {"id": "trialreg:NCT07178951", "company": "FUSMobile Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07178951"}, {"id": "nih:4R44DA059017-02", "company": "Biomedical Development Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-16", "observed": "2026-08-06", "amount_usd": 778031, "summary": "NIH award 4R44DA059017-02: Real World Adoption of an OUD Digital Health Therapeutic ($778,031)", "source_url": "https://reporter.nih.gov/project-details/11301042", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41HD117576-01A1", "company": "Amahealth LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-16", "observed": "2026-08-06", "amount_usd": 313180, "summary": "NIH award 1R41HD117576-01A1: Accurate and actionable prediction of impending labor using deep learning on maternal physiological data ($313,180)", "source_url": "https://reporter.nih.gov/project-details/11184142", "people": [{"name": "Chinmai Basavaraj", "role": "Principal Investigator"}, {"name": "Elise N Erickson", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA306686-01", "company": "Absco Therapeutics, Inc. D/b/a Abscotx", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-16", "observed": "2026-08-21", "amount_usd": 406500, "summary": "NIH award 1R43CA306686-01: Enhancing Solid Tumor lmmunotherapy with Targeted siRNA Delivery ($406,500)", "source_url": "https://reporter.nih.gov/project-details/11255987", "people": [{"name": "David H Altreuter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41LM015295-01A1", "company": "Spiromatics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-16", "observed": "2026-08-21", "amount_usd": 471544, "summary": "NIH award 1R41LM015295-01A1: Novel Technologies for Detection and Monitoring of Lung Disease ($471,544)", "source_url": "https://reporter.nih.gov/project-details/11183835", "people": [{"name": "Shiv Kumar Bhatt", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA310364-01", "company": "Raiz Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-16", "observed": "2026-08-21", "amount_usd": 1770000, "summary": "NIH award 1R44CA310364-01: Scaling Lymphoma Diagnosis: A Cost-Effective Gene Expression Assay for Broad Implementation ($1,770,000)", "source_url": "https://reporter.nih.gov/project-details/11314071", "people": [{"name": "Edward Briercheck", "role": "Principal Investigator"}, {"name": "Timothy Guyon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI147973-05", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-16", "observed": "2026-08-21", "amount_usd": 906016, "summary": "NIH award 5R44AI147973-05: Biomarker-Based Test of Cure for Chagas Disease ($906,016)", "source_url": "https://reporter.nih.gov/project-details/11145824", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R43AG094486-01", "company": "Advanced Brain Monitoring, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-16", "observed": "2026-08-21", "amount_usd": 325672, "summary": "NIH award 1R43AG094486-01: Characterizing neurocognitive deficits in post-acute sequelae of COVID-19 ($325,672)", "source_url": "https://reporter.nih.gov/project-details/11184718", "people": [{"name": "Jennifer Graves", "role": "Principal Investigator"}, {"name": "Amir Hossein Meghdadi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG097298-01", "company": "Homecare Hub US Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-16", "observed": "2026-08-21", "amount_usd": 1089329, "summary": "NIH award 1R44AG097298-01: Scaling a network of small community-based care homes as a high-value alternative to institutional care ($1,089,329)", "source_url": "https://reporter.nih.gov/project-details/11255482", "people": [{"name": "Vipan Nikore", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS145909-01", "company": "Neurovascular Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-16", "observed": "2026-08-21", "amount_usd": 430957, "summary": "NIH award 1R43NS145909-01: Testing a Blood-Based Assay for Detection and Risk Assessment of Intracranial Aneurysms in Familial Cases ($430,957)", "source_url": "https://reporter.nih.gov/project-details/11255974", "people": [{"name": "Kerry Poppenberg", "role": "Principal Investigator"}, {"name": "Vincent Matthew Tutino", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K242287", "company": "Cowellmedi Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242287: SFIT Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242287", "people": [{"name": "Haejun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242287%22"}, {"id": "fda:K252540", "company": "Medicel AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252540: ACCUJECT Injector Set 2.1-1P (LP604590)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252540", "people": [{"name": "Erik Braziulis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252540%22"}, {"id": "fda:K251650", "company": "Imaging Engineering, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251650: Insight Enhanced\u0099 DRF (EN-1002-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251650", "people": [{"name": "George Jachode", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251650%22"}, {"id": "fda:K251676", "company": "Microtek Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251676: Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251676", "people": [{"name": "Lam Duong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251676%22"}, {"id": "trialreg:NCT07174596", "company": "Johnson & Johnson Vision Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Approved Contact Lenses", "source_url": "https://clinicaltrials.gov/study/NCT07174596"}, {"id": "trialreg:NCT07174505", "company": "Anaconda Biomed S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the CONDA Stent Retriever in Acute Ischemic Stroke", "source_url": "https://clinicaltrials.gov/study/NCT07174505"}, {"id": "trialreg:NCT07175857", "company": "Lyv Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Efficacy of an Innovative Digital Therapeutic Medical Device, Lyv Endo, for the Management of Patients With Endometriosis", "source_url": "https://clinicaltrials.gov/study/NCT07175857"}, {"id": "trialreg:NCT07174622", "company": "Medtronic Vascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation", "source_url": "https://clinicaltrials.gov/study/NCT07174622"}, {"id": "nih:1R43AG092851-01", "company": "Aster Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": 499943, "summary": "NIH award 1R43AG092851-01: Precise Wearable System for Accurate Continuous Gait Monitoring to Indicate Health Decline in Black Adults with Alzheimer's Disease and Related Dementias ($499,943)", "source_url": "https://reporter.nih.gov/project-details/11111223", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL176351-02", "company": "Sanaheal, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": 1249317, "summary": "NIH award 5R44HL176351-02: Hemostatic Bioadhesive Paste for Coagulation-Independent Rapid Control of Bleeding ($1,249,317)", "source_url": "https://reporter.nih.gov/project-details/11196760", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DK127835-05", "company": "Urogenie LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": 879432, "summary": "NIH award 5R44DK127835-05: Digital Uroflowmetry for Office and Home ($879,432)", "source_url": "https://reporter.nih.gov/project-details/11176184", "people": [{"name": "Roman Fedorovsky", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R43AR086046-01", "company": "Penderia Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": 306722, "summary": "NIH award 1R43AR086046-01: Personalized postoperative management and physical therapy enabled by sensorized bone plates for traumatic fractures. ($306,722)", "source_url": "https://reporter.nih.gov/project-details/11183880", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DK135225-02", "company": "Livivos Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": 947354, "summary": "NIH award 2R44DK135225-02: Accurate Point of Care Liver Disease Diagnostics, Phase II ($947,354)", "source_url": "https://reporter.nih.gov/project-details/11069108", "people": [{"name": "PABLO J PRADO", "role": "Principal Investigator"}, {"name": "CLAUDE B SIRLIN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG094503-01", "company": "Brightoutcome Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": 399813, "summary": "NIH award 1R43AG094503-01: WHIM (Women's Health in Menopause): Promoting healthy aging in menopausal women ($399,813)", "source_url": "https://reporter.nih.gov/project-details/11186471", "people": [{"name": "Niina M. Haas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK143120-01", "company": "Integrated Medical Sensors", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": 275275, "summary": "NIH award 1R43DK143120-01: A Miniaturized and Flexible Continuous Glucose Monitoring Platform ($275,275)", "source_url": "https://reporter.nih.gov/project-details/11112222", "people": [{"name": "Muhammad Mujeeb-U-Rahman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42HL182546-01", "company": "Biochip Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": 316800, "summary": "NIH award 1R42HL182546-01: Manufacturing and Analytical Validation of the Microfluidic Impedance Red Cell Assay (MIRCA) for Commercial Viability ($316,800)", "source_url": "https://reporter.nih.gov/project-details/11256148", "people": [{"name": "Chiara Federici", "role": "Principal Investigator"}, {"name": "Umut A. Gurkan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44NR019556-02A1", "company": "Ocuvera LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": 985839, "summary": "NIH award 2R44NR019556-02A1: Refinement of a Digital Monitoring System to Reduce Risk of Hospital Acquired Pressure Injuries ($985,839)", "source_url": "https://reporter.nih.gov/project-details/11185090", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG097403-01", "company": "Redwood Neuro Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-21", "amount_usd": 506061, "summary": "NIH award 1R43AG097403-01: Democratizing Early Detection and Longitudinal Monitoring of Alzheimer's Disease: An Ultra-Sensitive Blood-Based Assay ($506,061)", "source_url": "https://reporter.nih.gov/project-details/11262148", "people": [{"name": "Murat Baday", "role": "Principal Investigator"}, {"name": "Ahmet Ali Yanik", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG080977-02A1", "company": "Headwaters Innovation, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-21", "amount_usd": 926545, "summary": "NIH award 2R44AG080977-02A1: Early detection and monitoring of Alzheimers Disease and Related Dementias using non-semantic linguistic and acoustic features of speech derived from hearing aids ($926,545)", "source_url": "https://reporter.nih.gov/project-details/11181842", "people": [{"name": "Brian John Bischoff", "role": "Principal Investigator"}, {"name": "Anand Devaiah", "role": "Principal Investigator"}, {"name": "Huitong Ding", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41ES038039-01", "company": "Materials Nova Limited Liability Company", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-21", "amount_usd": 314745, "summary": "NIH award 1R41ES038039-01: Ultra-Sensitive, Rapid, Point-of-Use (POU) Mercury Sensor Enabled by Light-Pinpointed Enrichment ($314,745)", "source_url": "https://reporter.nih.gov/project-details/11254274", "people": [{"name": "Donglei Emma Fan", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA247137-04", "company": "Dl Analytics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-21", "amount_usd": 709898, "summary": "NIH award 5R44CA247137-04: Validation of a lab-free low-cost screening test for prevention of cervical cancer: automated visual evaluation ($709,898)", "source_url": "https://reporter.nih.gov/project-details/10933016", "people": [{"name": "David Levitz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43CA301971-01", "company": "Pulse Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-15", "observed": "2026-08-21", "amount_usd": 303475, "summary": "NIH award 1R43CA301971-01: Minimally invasive pancreatic cancer treatment combining nanosecond electric pulses and immune system stimulants ($303,475)", "source_url": "https://reporter.nih.gov/project-details/11179007", "people": [{"name": "RICHARD Lee NUCCITELLI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K250609", "company": "Sober Ip, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250609: Sober Self-Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250609", "people": [{"name": "Timothy Downey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250609%22"}, {"id": "fda:K251869", "company": "Premium Plus (Dongguan) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251869: Disposable Prophy Angle (3399-60, 3399-090, 3399-105)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251869", "people": [{"name": "Jessica Mao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251869%22"}, {"id": "fda:K252128", "company": "Uvx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252128: Zener\u00ae (model ZEN-001-B1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252128", "people": [{"name": "Kunal Sethi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252128%22"}, {"id": "fda:K250237", "company": "Beijing Infervision Healthcare Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250237: InferOperate Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250237", "people": [{"name": "Matt Deng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250237%22"}, {"id": "fda:K252598", "company": "Shanghai AnQing Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252598: Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252598", "people": [{"name": "Shuwen Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252598%22"}, {"id": "fda:K252443", "company": "G21, S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252443: SpaceFix Shoulder Spacer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252443", "people": [{"name": "Filippo Foroni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252443%22"}, {"id": "fda:K251780", "company": "SI-BONE, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251780: iGPS Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251780", "people": [{"name": "Jayasri Prabakaran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251780%22"}, {"id": "fda:K251914", "company": "Miley Technology (Hebei) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251914: IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251914", "people": [{"name": "Caixia Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251914%22"}, {"id": "trialreg:NCT07172464", "company": "Recross Cardio, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study", "source_url": "https://clinicaltrials.gov/study/NCT07172464"}, {"id": "trialreg:NCT07172477", "company": "Tau Medical Australia Pty Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation", "source_url": "https://clinicaltrials.gov/study/NCT07172477"}, {"id": "trialreg:NCT07173439", "company": "Emotiv", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multi-center, Single Blinded, RCT, Pivotal Study to Evaluate the Efficacy and Safety of DTx to Improve ADHD", "source_url": "https://clinicaltrials.gov/study/NCT07173439"}, {"id": "nih:1R44HL180181-01", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-14", "observed": "2026-08-21", "amount_usd": 978191, "summary": "NIH award 1R44HL180181-01: Peptide-based ELISA for laboratory diagnosis of sarcoidosis ($978,191)", "source_url": "https://reporter.nih.gov/project-details/11185844", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K250689", "company": "Teleemg, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250689: CloudTMS Edge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250689", "people": [{"name": "Jabre Joe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250689%22"}, {"id": "fda:K251449", "company": "Brainsway , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251449: BrainsWay Deep TMS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251449", "people": [{"name": "Colleen Hanlon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251449%22"}, {"id": "nih:5R44MH135741-06", "company": "Quasar, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": 947109, "summary": "NIH award 5R44MH135741-06: Neonatal EEG MOnitor (NEMO) Phase IIb ($947,109)", "source_url": "https://reporter.nih.gov/project-details/11166449", "people": [{"name": "Neil J McDonald", "role": "Principal Investigator"}, {"name": "Tammy Tsuchida", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R44CA287952-03", "company": "Xilis, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": 758547, "summary": "NIH award 5R44CA287952-03: An integrated microfluidic device for patient-derived micro-organospheres ($758,547)", "source_url": "https://reporter.nih.gov/project-details/11192335", "people": [{"name": "Daniel Aaron Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HD117677-01A1", "company": "Enhance Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": 306669, "summary": "NIH award 1R43HD117677-01A1: Simple Breath Test for Ammonia for Monitoring Blood Ammonia Levels for UCD Patients ($306,669)", "source_url": "https://reporter.nih.gov/project-details/11182942", "people": [{"name": "Matthew Thomas Leming", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK139847-01A1", "company": "Vivifi Medical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": 325000, "summary": "NIH award 1R43DK139847-01A1: Novel procedure and technology for treatment of BPH ($325,000)", "source_url": "https://reporter.nih.gov/project-details/11066576", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH140651-01A1", "company": "Miresource, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": 313800, "summary": "NIH award 1R44MH140651-01A1: Improving longitudinal mental health monitoring to generate personalized guides and timely referrals ($313,800)", "source_url": "https://reporter.nih.gov/project-details/11253866", "people": [{"name": "Gabriela Asturias", "role": "Principal Investigator"}, {"name": "Arno Klein", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41AR086685-01", "company": "Alleviate Solutions Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": 313012, "summary": "NIH award 1R41AR086685-01: Refinement of a novel at-home kit for contact dermatitis testing and diagnosis. ($313,012)", "source_url": "https://reporter.nih.gov/project-details/11252128", "people": [{"name": "Charles J Bruce", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH136880-01A1", "company": "Ampa Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-21", "amount_usd": 1199261, "summary": "NIH award 1R44MH136880-01A1: Validation of next-generation TMS system optimizing for widely scalable, personalized treatment of depression ($1,199,261)", "source_url": "https://reporter.nih.gov/project-details/11067689", "people": [{"name": "Jonathan Alexander Stewart Downar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL176348-01A1", "company": "Aust Development, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-21", "amount_usd": 313302, "summary": "NIH award 1R43HL176348-01A1: Precision Lead Delivery for Advanced Conduction System Pacing ($313,302)", "source_url": "https://reporter.nih.gov/project-details/11186568", "people": [{"name": "Christian S Eversull", "role": "Principal Investigator"}, {"name": "MICHAEL ORLOV", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HD105575-03", "company": "Claria Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-21", "amount_usd": 2138797, "summary": "NIH award 2R44HD105575-03: A Safe, Fast, and Cost-Effective System for Tissue Removal in Laparoscopic Hysterectomy and Other Minimally Invasive Surgery ($2,138,797)", "source_url": "https://reporter.nih.gov/project-details/11256396", "people": [{"name": "Daniel Francis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44DK137677-02A1", "company": "Kuleana Technology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-21", "amount_usd": 853604, "summary": "NIH award 2R44DK137677-02A1: Dialysate regeneration based on photo-electrochemical urea oxidation and reactive adsorption systems ($853,604)", "source_url": "https://reporter.nih.gov/project-details/11256206", "people": [{"name": "Barry Fulkerson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL182585-01", "company": "Nimble Surgical Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-21", "amount_usd": 314362, "summary": "NIH award 1R43HL182585-01: FlexLock - A novel anchoring guide catheter to simplify transradial complex percutaneous coronary interventions ($314,362)", "source_url": "https://reporter.nih.gov/project-details/11256603", "people": [{"name": "Aman Garg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43PS005315-01", "company": "Aptus Biosciences LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-21", "amount_usd": 501200, "summary": "NIH award 1R43PS005315-01: Rapid affordable aptamer-based diagnostic test for Hepatitis C virus ($501,200)", "source_url": "https://reporter.nih.gov/project-details/10916777", "people": [{"name": "BHARAT GAWANDE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43PS005313-01", "company": "Arete Biosciences", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-21", "amount_usd": 306992, "summary": "NIH award 1R43PS005313-01: Development of an ultrasensitive, rapid and portable nucleic acid based test for detection of acute Hepatitis C Virus infection at the point-of-care. ($306,992)", "source_url": "https://reporter.nih.gov/project-details/11007686", "people": [{"name": "Sujit Jangam", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL176356-01A1", "company": "Berendo Scientific, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-21", "amount_usd": 583718, "summary": "NIH award 1R44HL176356-01A1: SleepFlex head and neck exercise program for the treatment of mild to moderate obstructive sleep apnea ($583,718)", "source_url": "https://reporter.nih.gov/project-details/11184592", "people": [{"name": "Lorig Sima Kalaydjian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD118898-01", "company": "Mucommune, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-21", "amount_usd": 1130880, "summary": "NIH award 1R44HD118898-01: Fast Dissolving MM008 Tablet for Instant On-Demand Non-Hormonal Contraception ($1,130,880)", "source_url": "https://reporter.nih.gov/project-details/11185580", "people": [{"name": "Keiichiro Kushiro", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD116616-01A1", "company": "Ps-fertility, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-21", "amount_usd": 356502, "summary": "NIH award 1R44HD116616-01A1: PS-Detect: A Diagnostic Test for Male Fertility/Infertility ($356,502)", "source_url": "https://reporter.nih.gov/project-details/11181859", "people": [{"name": "JEFFREY J LYSIAK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AI188680-02", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-12", "observed": "2026-08-21", "amount_usd": 1000723, "summary": "NIH award 4R44AI188680-02: A Rapid, Point-of-Care Diagnostic to Identify Viable Sexually Transmitted Infections, Reduce Overtreatment, and Prevent Emerging Antibiotic Resistance ($1,000,723)", "source_url": "https://reporter.nih.gov/project-details/11324406", "people": [{"name": "Rainer Ng", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K251820", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251820: ViewMateTM Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251820", "people": [{"name": "Xiaozhen Ding", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251820%22"}, {"id": "fda:K243864", "company": "Bontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243864: BONX805", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243864", "people": [{"name": "Ki-Chan An", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243864%22"}, {"id": "fda:K252554", "company": "Vivachek Biotech (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252554: Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252554", "people": [{"name": "Chen Qingqing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252554%22"}, {"id": "fda:K251518", "company": "Volta Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251518: Volta AF-Xplorer II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251518", "people": [{"name": "Paola Milpied", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251518%22"}, {"id": "fda:K251170", "company": "Tangent Endoscopy, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251170: Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251170", "people": [{"name": "Daniel Amendola", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251170%22"}, {"id": "fda:K250986", "company": "Mevion Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250986: S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250986", "people": [{"name": "Jason Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250986%22"}, {"id": "fda:K252562", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252562: Spine & Trauma Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252562", "people": [{"name": "Esther Moreno Garcia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252562%22"}, {"id": "fda:K250059", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250059: BD PhaSeal\u0099 Optima Connecting Set (C83-O); BD PhaSeal\u0099 Optima Spike Set (C180-O)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250059", "people": [{"name": "Melissa Iwu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250059%22"}, {"id": "fda:K250040", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250040: uWS-Angio", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250040", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250040%22"}, {"id": "fda:K252593", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252593: LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252593", "people": [{"name": "Emily Bailey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252593%22"}, {"id": "fda:K251083", "company": "Enraf-Nonius, B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251083: Compact II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251083", "people": [{"name": "Lambert Luong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251083%22"}, {"id": "fda:K252576", "company": "Pollogen, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252576: Legend X Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252576", "people": [{"name": "Karen Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252576%22"}, {"id": "fda:K251843", "company": "Erchonia Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251843: Erchonia EVRL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251843", "people": [{"name": "Travis Sammons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251843%22"}, {"id": "fda:K250628", "company": "MedShape, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250628: DynaNail TTC Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250628", "people": [{"name": "Amberlee Soto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250628%22"}, {"id": "fda:K251368", "company": "Diagnoly", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251368: FETOLY", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251368", "people": [{"name": "Ivan Voznyuk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251368%22"}, {"id": "fda:K252595", "company": "Sparrow Acoustics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252595: Stethophone Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252595", "people": [{"name": "Nadia Ivanova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252595%22"}, {"id": "fda:K252027", "company": "Jupiter Endovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252027: Vertex(TM) Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252027", "people": [{"name": "Nicole Barber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252027%22"}, {"id": "fda:K250445", "company": "Fujifilm Irvine Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250445: Fast Warm - NX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250445", "people": [{"name": "Cindy Kha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250445%22"}, {"id": "fda:K252586", "company": "Odin Medical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252586: CADDIE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252586", "people": [{"name": "Luke Sampson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252586%22"}, {"id": "fda:K250047", "company": "mibeTec GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250047: bite away two", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250047", "people": [{"name": "Oliver Grunert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250047%22"}, {"id": "fda:K252225", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252225: PowerKnot High Strength Sutures", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252225", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252225%22"}, {"id": "fda:K252189", "company": "Dongguan Yanxi Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252189: LED Light Therapy Mask (2311, 2344, 2457, 2458)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252189", "people": [{"name": "Xing Liang Lai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252189%22"}, {"id": "trialreg:NCT07170618", "company": "Sinomed Neurovita Technology Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of a New Balloon Microcatheter in the Treatment of Intracranial Artery Stenosis", "source_url": "https://clinicaltrials.gov/study/NCT07170618"}, {"id": "trialreg:NCT07171060", "company": "Laplace Interventional, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Laplace Early Feasibility Study - Canada", "source_url": "https://clinicaltrials.gov/study/NCT07171060"}, {"id": "trialreg:NCT07170332", "company": "Hangzhou Endonom Medtech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ZIPPER\u2122 Stent-Graft Trial for Aortic Arch Dissection", "source_url": "https://clinicaltrials.gov/study/NCT07170332"}, {"id": "trialreg:NCT07170566", "company": "ConvaTec Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Retrospective, Observational Study of the Real-world Safety and Performance of InnovaMatrix\u00ae AC at a Single Centre", "source_url": "https://clinicaltrials.gov/study/NCT07170566"}, {"id": "nih:1R44HL178318-01A1", "company": "Vesteck, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": 1364080, "summary": "NIH award 1R44HL178318-01A1: Endovascular Suturing Device for Augmentation of Endograft Fixation During Endovascular Repair of Abdominal Aortic Aneurysm to Reduce Reinterventions Due to Endograft Migration or Type 1a Endoleak ($1,364,080)", "source_url": "https://reporter.nih.gov/project-details/11185822", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R41MH138258-02", "company": "Esperimage LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": 444693, "summary": "NIH award 5R41MH138258-02: Flexible, scalable, and generalizable photogrammetric head modeling for high-density diffuse optical tomography ($444,693)", "source_url": "https://reporter.nih.gov/project-details/11182677", "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R42AG094389-01", "company": "Keywise, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-11", "observed": "2026-08-21", "amount_usd": 399999, "summary": "NIH award 1R42AG094389-01: Passive cognitive assessment across the menopausal transition ($399,999)", "source_url": "https://reporter.nih.gov/project-details/11183629", "people": [{"name": "Olusola A. Ajilore", "role": "Principal Investigator"}, {"name": "PAULINE M MAKI", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44EY036772-01A1", "company": "Intelon Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-11", "observed": "2026-08-21", "amount_usd": 566288, "summary": "NIH award 1R44EY036772-01A1: Next-generation Brillouin ocular scanner ($566,288)", "source_url": "https://reporter.nih.gov/project-details/11181781", "people": [{"name": "Claire Shelley Barnes", "role": "Principal Investigator"}, {"name": "Giuliano Scarcelli", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG094422-01", "company": "Adeptrix Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-11", "observed": "2026-08-21", "amount_usd": 499940, "summary": "NIH award 1R43AG094422-01: TauTrace\u2122: An ultrasensitive immunoassay for neurodegenerative protein biomarkers ($499,940)", "source_url": "https://reporter.nih.gov/project-details/11184613", "people": [{"name": "Vladislav Bergo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42HD116627-02", "company": "Klein Buendel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-11", "observed": "2026-08-21", "amount_usd": 736654, "summary": "NIH award 4R42HD116627-02: Hybrid Delivery to Increase Access and Sustainability: Evaluating ezParent Implementation ($736,654)", "source_url": "https://reporter.nih.gov/project-details/11380456", "people": [{"name": "Susan M Breitenstein", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44HL167405-02", "company": "Blue Marble Rehab, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-11", "observed": "2026-08-21", "amount_usd": 1072906, "summary": "NIH award 2R44HL167405-02: BREATHE-BRinging Exercise, Asthma Assessments, TeacHing to Everyone ($1,072,906)", "source_url": "https://reporter.nih.gov/project-details/11182373", "people": [{"name": "Sheryl Flynn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44HL178050-01", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-11", "observed": "2026-08-21", "amount_usd": 982086, "summary": "NIH award 1R44HL178050-01: ENT-based Approach to Cervical Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea ($982,086)", "source_url": "https://reporter.nih.gov/project-details/11068282", "people": [{"name": "Mark Gelfand", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA310355-01", "company": "Illuminant Surgical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-11", "observed": "2026-08-21", "amount_usd": 1107943, "summary": "NIH award 1R44CA310355-01: Scanner Agnostic Image-Guided Biopsy Platform Employing Advanced Computer Vision and Computer Graphics to Enable Non-Invasive Registration and Dynamic Projection Mapping ($1,107,943)", "source_url": "https://reporter.nih.gov/project-details/11314158", "people": [{"name": "James Hu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK143903-01", "company": "Persista Bio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-11", "observed": "2026-08-21", "amount_usd": 287250, "summary": "NIH award 1R43DK143903-01: Manufacturing Clinical-Grade Cell Capsule of O2Line(TM) Implant System for T1D ($287,250)", "source_url": "https://reporter.nih.gov/project-details/11185489", "people": [{"name": "BEUM JUN KIM", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AR086074-01", "company": "Flex Orthopaedics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-11", "observed": "2026-08-21", "amount_usd": 306871, "summary": "NIH award 1R41AR086074-01: A Compliant Intramedullary Stem to Increase Longevity of Revision Total Knee Arthroplasty ($306,871)", "source_url": "https://reporter.nih.gov/project-details/11184000", "people": [{"name": "Brandon Peterson", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K242314", "company": "Augment Intelligent Medical System (China) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242314: Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242314", "people": [{"name": "Yili Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242314%22"}, {"id": "fda:K252520", "company": "Immunalysis Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252520: SEFRIA\u0099 Hydrocodone Oral Fluid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252520", "people": [{"name": "Shubhajit Mitra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252520%22"}, {"id": "fda:K251399", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251399: SIGNA\u0099 Sprint", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251399", "people": [{"name": "Xinyu Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251399%22"}, {"id": "fda:K250797", "company": "Uroviu Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250797: UV5000 Handle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250797", "people": [{"name": "Thomas Lawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250797%22"}, {"id": "fda:K243926", "company": "Bosch Healthcare Solutions GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243926: Vivatmo pro-S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243926", "people": [{"name": "Jeannette Stroh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243926%22"}, {"id": "fda:K252374", "company": "Airway Technologies D/B/A Airway Management", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252374: Nylon flexTAP(R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252374", "people": [{"name": "Charles Collins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252374%22"}, {"id": "fda:K251758", "company": "Tns Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251758: Serafin\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251758", "people": [{"name": "Byung Ju Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251758%22"}, {"id": "fda:K250216", "company": "Active Life Scientific, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250216: OsteoProbe (OP-100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250216", "people": [{"name": "Alexander Proctor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250216%22"}, {"id": "fda:K251316", "company": "Mazor Robotics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251316: Mazor X System / Mazor X Stealth Edition", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251316", "people": [{"name": "Anat Marom", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251316%22"}, {"id": "fda:K250507", "company": "Apple, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250507: Hypertension Notification Feature (HTNF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250507", "people": [{"name": "Bonnie Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250507%22"}, {"id": "fda:K251826", "company": "Smith & Nephew Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251826: RENASYS WOUND+ Dressing Kit with AIRLOCK Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251826", "people": [{"name": "Sam Greenhalgh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251826%22"}, {"id": "fda:K251320", "company": "Al.Chi.Mi.A. S.R.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251320: XTRA4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251320", "people": [{"name": "Niccol\u00f2 Bufo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251320%22"}, {"id": "fda:K251158", "company": "Baylis Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251158: PowerWire\u00ae 14 Radiofrequency Guidewire Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251158", "people": [{"name": "Barb Boyce", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251158%22"}, {"id": "trialreg:NCT07168564", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post Marketing Clinical Study on the Efficacy of Lenses From a New Prescription Protocol", "source_url": "https://clinicaltrials.gov/study/NCT07168564"}, {"id": "trialreg:NCT07168798", "company": "Nihon Kohden", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SpO2 Accuracy in Children", "source_url": "https://clinicaltrials.gov/study/NCT07168798"}, {"id": "sbir:DOD:W912CG-25-CA-023", "company": "Oceanit Laboratories Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-09-11", "observed": "2026-09-18", "amount_usd": 1314960, "summary": "DOD SBIR Phase II award $1,314,960: Real Time Physiological Status Monitor for MicroClimate Control", "source_url": "https://www.sbir.gov/awards?search=C2-0712"}, {"id": "nih:1R44CA298351-01A1", "company": "Cordance Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": 999125, "summary": "NIH award 1R44CA298351-01A1: NeuroAccess: a Focused Ultrasound System for SonoBiopsy of the Brain ($999,125)", "source_url": "https://reporter.nih.gov/project-details/11185434", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK143847-01", "company": "Maguro Surgical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": 305368, "summary": "NIH award 1R43DK143847-01: Developing a magnetic system for endoscopic retrieval of kidney stones ($305,368)", "source_url": "https://reporter.nih.gov/project-details/11186796", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44ES033890-02", "company": "Giner, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": 1036179, "summary": "NIH award 2R44ES033890-02: Low-Cost Amperometric Ozone Monitor for Communities Affected by Wildfires ($1,036,179)", "source_url": "https://reporter.nih.gov/project-details/11185491", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL182517-01", "company": "Respair, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": 305218, "summary": "NIH award 1R43HL182517-01: AssuranceET: a novel endotracheal tube sealing mechanism to protect pediatric patients from airway trauma and collapse while empowering clinician decision-making. ($305,218)", "source_url": "https://reporter.nih.gov/project-details/11255247", "people": [{"name": "Ross Beresford", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM163236-01", "company": "Rybodyn, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-10", "observed": "2026-08-21", "amount_usd": 306700, "summary": "NIH award 1R43GM163236-01: A novel spatial biology platform for protein profiling which is cost effective and scalable ($306,700)", "source_url": "https://reporter.nih.gov/project-details/11186610", "people": [{"name": "Corey Michael Dambacher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL182462-01", "company": "Lazarus 3D, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-10", "observed": "2026-08-21", "amount_usd": 400016, "summary": "NIH award 1R43HL182462-01: Development and Validation of a High-Fidelity Cardiac Presurgical Planning Platform for Congenital Heart Defects Using 3D Printing Technology ($400,016)", "source_url": "https://reporter.nih.gov/project-details/11246871", "people": [{"name": "Tyler Kelly", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL178315-01", "company": "Invia, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-10", "observed": "2026-08-21", "amount_usd": 1107749, "summary": "NIH award 1R44HL178315-01: Development of Deep Learning Tools for Widely-Available, Inexpensive Diagnosis of Coronary Microvascular and Vasomotor Dysfunction ($1,107,749)", "source_url": "https://reporter.nih.gov/project-details/11069991", "people": [{"name": "Jonathan Bryan Moody", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:7R41AA031429-02", "company": "Lifespan Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-10", "observed": "2026-08-21", "amount_usd": 399293, "summary": "NIH award 7R41AA031429-02: Innovative Point-of-Care Solutions for Long-term Alcohol Biomarkers ($399,293)", "source_url": "https://reporter.nih.gov/project-details/11381373", "people": [{"name": "PAUL O NEILSEN", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43GM157765-01", "company": "Mediacombo, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-10", "observed": "2026-08-21", "amount_usd": 261620, "summary": "NIH award 1R43GM157765-01: VITaLS: Visual Thinking and Learning Strategies: Enhancing Health Professions Education through Virtual Reality Enabled Art Museum Experiences ($261,620)", "source_url": "https://reporter.nih.gov/project-details/11065320", "people": [{"name": "Gauri Agarwal", "role": "Principal Investigator"}, {"name": "Christina Faye Larson", "role": "Principal Investigator"}, {"name": "Greta Mitzova-Vladinov", "role": "Principal Investigator"}, {"name": "Robin White Owen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K252173", "company": "Fisher & Paykel Healthcare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252173: F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits \u0096 Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits \u0096 Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits \u0096 Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252173", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252173%22"}, {"id": "fda:K252530", "company": "Mr Surgical Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252530: OptiVu\u0099 Shoulder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252530", "people": [{"name": "Brian Karpinski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252530%22"}, {"id": "fda:K251573", "company": "Vizionfocus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251573: VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251573", "people": [{"name": "Angus Shih", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251573%22"}, {"id": "fda:K251817", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251817: da Vinci SP Surgical System (SP1098)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251817", "people": [{"name": "Manjunath Ramappa Bisalehalli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251817%22"}, {"id": "fda:K252580", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252580: iQ200 Series", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252580", "people": [{"name": "Shilpa Pillai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252580%22"}, {"id": "fda:K250734", "company": "Pollogen, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250734: OptiLUV Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250734", "people": [{"name": "Smith Karen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250734%22"}, {"id": "fda:K244002", "company": "Angiowave Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K244002: AngioWaveNet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244002", "people": [{"name": "Aram Salzman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244002%22"}, {"id": "fda:K250464", "company": "Timpel S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250464: Enlight 2100 (TPL-E2103-0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250464", "people": [{"name": "Rafael Holzhacker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250464%22"}, {"id": "fda:K252527", "company": "Merit Medical System, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252527: Surfacer Inside-Out Access Catheter System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252527", "people": [{"name": "Desiree Bond", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252527%22"}, {"id": "pma:P240038", "company": "Beaver Visitec International, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-09-10", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240038: FINEVISION HP Trifocal IOLs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240038", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240038%22"}, {"id": "trialreg:NCT07166341", "company": "Medtronic - MITG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Accuracy Verification of the INVOS PM7100", "source_url": "https://clinicaltrials.gov/study/NCT07166341"}, {"id": "trialreg:NCT07164898", "company": "Essity Hygiene and Health AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: How Wet Pads Affect Elderly Skin: Measuring Changes in the Skin Barrier", "source_url": "https://clinicaltrials.gov/study/NCT07164898"}, {"id": "trialreg:NCT07166133", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: GORE\u00ae TAG\u00ae Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study", "source_url": "https://clinicaltrials.gov/study/NCT07166133"}, {"id": "trialreg:NCT07165080", "company": "ART Medical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparative Evaluation of smART+ REE Module to an FDA-cleared Device, for REE Calculation in ICU Patients", "source_url": "https://clinicaltrials.gov/study/NCT07165080"}, {"id": "nih:4R42HD115517-02", "company": "Takeoff41, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": 1061217, "summary": "NIH award 4R42HD115517-02: An AI-driven total parenteral nutrition platform for cost-effective and scientifically personalized nutrition for premature newborns ($1,061,217)", "source_url": "https://reporter.nih.gov/project-details/11335827", "people": [{"name": "Nima Aghaeepour", "role": "Principal Investigator"}, {"name": "Thanaphong Phongpreecha", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AR083836-03", "company": "Sintx Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": 745427, "summary": "NIH award 5R44AR083836-03: 3D Printed Silicon Nitride Porous PEEK Composite Spinal Cages for Anti-Infection ($745,427)", "source_url": "https://reporter.nih.gov/project-details/10934363", "people": [{"name": "Tabitha Derr", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41NR022031-01", "company": "Care4qol LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": 306817, "summary": "NIH award 1R41NR022031-01: Empowering Direct Care Workers with AI-Integrated Wearable Technology to Prevent Back Injuries ($306,817)", "source_url": "https://reporter.nih.gov/project-details/11252931", "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD113486-01A1", "company": "Charles River Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-09", "observed": "2026-08-21", "amount_usd": 314093, "summary": "NIH award 1R43HD113486-01A1: Rehabilitation Exercises for Cognitive, Oculomotor, and Vestibular Recovery (RECOVER) ($314,093)", "source_url": "https://reporter.nih.gov/project-details/11256139", "people": [{"name": "PHILLIP DESROCHERS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA298055-02", "company": "Data Driven Bioscience Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-09", "observed": "2026-08-21", "amount_usd": 1022841, "summary": "NIH award 2R44CA298055-02: Validation of Duoseq as a Genomic Swiss Army Knife for the Diagnosis of Lymphomas ($1,022,841)", "source_url": "https://reporter.nih.gov/project-details/11316167", "people": [{"name": "Sandeep Dave", "role": "Principal Investigator"}, {"name": "Lanie Elizabeth Happ", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA310398-01", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-09", "observed": "2026-08-21", "amount_usd": 306872, "summary": "NIH award 1R43CA310398-01: Rapid inter-procedural 3D scanning of fine-needle aspiration cytology slides with a parallelized microscope ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11316210", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM157889-01A1", "company": "Xgenomes Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-09", "observed": "2026-08-21", "amount_usd": 349280, "summary": "NIH award 1R43GM157889-01A1: Achieving ultra-high-density, ultra-high-precision single molecule localization microscopy with whole-video deep learning architectures ($349,280)", "source_url": "https://reporter.nih.gov/project-details/11185009", "people": [{"name": "Kalim Ullah Mir", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K252524", "company": "Eventum Orthopaedics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252524: Quadsense (Quadsense and Quadsense Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252524", "people": [{"name": "John Naybour", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252524%22"}, {"id": "fda:K251072", "company": "Dgnct, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251072: Segmentron Viewer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251072", "people": [{"name": "Anastasya Melnikov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251072%22"}, {"id": "fda:K251682", "company": "Springbok, Inc. (Dba Springbok Analytics)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251682: MuscleView 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251682", "people": [{"name": "Scott Magargee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251682%22"}, {"id": "fda:K243846", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243846: Access anti-HAV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243846", "people": [{"name": "Fatima Pacheco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243846%22"}, {"id": "fda:K251891", "company": "Shandong Guyue Healthcare Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251891: Electric Wheelchair (GY-E001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251891", "people": [{"name": "Guangming Gou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251891%22"}, {"id": "fda:K252181", "company": "Fresenius Medical Care North America", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252181: AquaA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252181", "people": [{"name": "Greg Calder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252181%22"}, {"id": "fda:K252477", "company": "Hermes Medical Solutions AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252477: Hybrid Viewer (00859873006240)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252477", "people": [{"name": "Hanne Grinaker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252477%22"}, {"id": "fda:K250922", "company": "Cardioset Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250922: Edema Guard Monitor (EGM) CardioSet-001", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250922", "people": [{"name": "Assaf Gur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250922%22"}, {"id": "fda:K252180", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252180: Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252180", "people": [{"name": "Timothy Groves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252180%22"}, {"id": "fda:K250483", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250483: PhotonBlade 3; PhotonBlade 3 Smoke Evacuation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250483", "people": [{"name": "Miriam Giltinan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250483%22"}, {"id": "fda:K252608", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252608: AI-Rad Companion Prostate MR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252608", "people": [{"name": "Kira Morales", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252608%22"}, {"id": "fda:K251040", "company": "Guangzhou Decheng Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251040: MissLan\u00ae Early Detection Digital Pregnancy Test; MissLan\u00ae Early Result Digital Pregnancy Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251040", "people": [{"name": "Mango Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251040%22"}, {"id": "fda:K251773", "company": "Shenzhen Yongquan Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251773: Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251773", "people": [{"name": "Pei Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251773%22"}, {"id": "pma:P240015", "company": "Womed Sas", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-09-09", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240015: Womed Leaf Resorbable Adhesion Barrier", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240015", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240015%22"}, {"id": "trialreg:NCT07163234", "company": "Iperf Sas", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach", "source_url": "https://clinicaltrials.gov/study/NCT07163234"}, {"id": "trialreg:NCT07161830", "company": "Omeza, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Efficacy of OCM\u2122 (Omeza\u00ae Complete Matrix) in the Treatment of Diabetic Foot Ulcers", "source_url": "https://clinicaltrials.gov/study/NCT07161830"}, {"id": "trialreg:NCT07164040", "company": "Leica Microsystems (Schweiz) AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.", "source_url": "https://clinicaltrials.gov/study/NCT07164040"}, {"id": "trialreg:NCT07162610", "company": "PharmaResearch Co.,Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of Rejuviel V in the Correction of Midface Volume Deficit", "source_url": "https://clinicaltrials.gov/study/NCT07162610"}, {"id": "trialreg:NCT07164053", "company": "Leica Microsystems (Schweiz) AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.", "source_url": "https://clinicaltrials.gov/study/NCT07164053"}, {"id": "trialreg:NCT07163221", "company": "SecondWave Systems Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]", "source_url": "https://clinicaltrials.gov/study/NCT07163221"}, {"id": "nih:2R42CA275587-02A1", "company": "Gradient Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": 1150000, "summary": "NIH award 2R42CA275587-02A1: Commercialization of Algorithmic Non-thermal Ablation Technology for the Treatment of Inoperable Tumors ($1,150,000)", "source_url": "https://reporter.nih.gov/project-details/11316268", "people": [{"name": "Jordan Fong", "role": "Principal Investigator"}, {"name": "Michael Benjamin Sano", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HD113451-02", "company": "Healing Innovations Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": 919517, "summary": "NIH award 5R44HD113451-02: Development of a novel, cost-effective gait training device utilized at home for the neurological patient population ($919,517)", "source_url": "https://reporter.nih.gov/project-details/11231101", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK143762-01", "company": "Exhalix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": 248492, "summary": "NIH award 1R43DK143762-01: A Hydrogen Sulfide Delivery Technology for Organ Preservation Therapy ($248,492)", "source_url": "https://reporter.nih.gov/project-details/11181364", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44HL172541-02", "company": "Rithim Biologics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-08", "observed": "2026-08-21", "amount_usd": 1072629, "summary": "NIH award 4R44HL172541-02: Novel Gene Therapy, Techniques, and Devices to Prevent Ventricular Tachycardia ($1,072,629)", "source_url": "https://reporter.nih.gov/project-details/11165093", "people": [{"name": "Ronald Lee Anderson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44CA281547-02A1", "company": "Vizlitics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-08", "observed": "2026-08-21", "amount_usd": 1154996, "summary": "NIH award 2R44CA281547-02A1: VIPCare: Virtual Predictive Care workflow with EHR integrated surveillance for optimalfollow-up care management for Cancer Patients ($1,154,996)", "source_url": "https://reporter.nih.gov/project-details/11314018", "people": [{"name": "Tarun Kumar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK145258-01", "company": "Minnesota Healthsolutions Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-08", "observed": "2026-08-21", "amount_usd": 314279, "summary": "NIH award 1R43DK145258-01: Improved Dialysis Cannulation Needle ($314,279)", "source_url": "https://reporter.nih.gov/project-details/11252252", "people": [{"name": "Patrick J Boldenow", "role": "Principal Investigator"}, {"name": "Karthik Ramani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44MH134709-02", "company": "Equa Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-08", "observed": "2026-08-21", "amount_usd": 918146, "summary": "NIH award 4R44MH134709-02: Mindfulness Meditation and Respiration Biosignal Feedback ($918,146)", "source_url": "https://reporter.nih.gov/project-details/11393482", "people": [{"name": "John David Creswell", "role": "Principal Investigator"}, {"name": "Mathew Polowitz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA291336-02", "company": "Teal Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-08", "observed": "2026-08-21", "amount_usd": 513576, "summary": "NIH award 5R44CA291336-02: Evaluation of the Teal self-collect device for cervical cancer screening ($513,576)", "source_url": "https://reporter.nih.gov/project-details/11196220", "people": [{"name": "Trena Depel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA302795-01A1", "company": "Media Rez, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-08", "observed": "2026-08-21", "amount_usd": 404295, "summary": "NIH award 1R43CA302795-01A1: Patient-directed technology for non-pharmacologic management of cancer pain ($404,295)", "source_url": "https://reporter.nih.gov/project-details/11314954", "people": [{"name": "Daniel J Greenberg", "role": "Principal Investigator"}, {"name": "J. Hunter Groninger", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA310238-01", "company": "Rush River Research Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-08", "observed": "2026-08-21", "amount_usd": 305040, "summary": "NIH award 1R43CA310238-01: Novel Thermoelectric Scalp Cooling System for Mitigating Chemotherapy-Induced Alopecia ($305,040)", "source_url": "https://reporter.nih.gov/project-details/11314435", "people": [{"name": "Julie Lundstrom", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41MH142265-01", "company": "Carolina Instruments, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-08", "observed": "2026-08-21", "amount_usd": 394708, "summary": "NIH award 1R41MH142265-01: A novel system for tracking arousal-related dynamics in freely moving animals ($394,708)", "source_url": "https://reporter.nih.gov/project-details/11255485", "people": [{"name": "Ellora Mctaggart", "role": "Principal Investigator"}, {"name": "Nicolas Christian Richard Pegard", "role": "Principal Investigator"}, {"name": "Jose Rodriguez-Romaguera", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K251754", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251754: Wearable Breast Pump (Model S33)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251754", "people": [{"name": "Dale Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251754%22"}, {"id": "fda:K251931", "company": "Techsomed Medical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251931: BioTraceIO Vision (V1.7)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251931", "people": [{"name": "Dalia Dickman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251931%22"}, {"id": "fda:K251892", "company": "Maxxos Medical GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251892: MAXXOS P.A.C.E. Foot & Ankle Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251892", "people": [{"name": "Mark Schenk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251892%22"}, {"id": "fda:K250229", "company": "Micro-Tech (Nanjing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250229: Dual Action Tissue Closure Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250229", "people": [{"name": "Sally He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250229%22"}, {"id": "fda:K251394", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251394: Momcozy Wearable Breast Pump (BP223)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251394", "people": [{"name": "Baihan Feng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251394%22"}, {"id": "fda:K251957", "company": "Tissium SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251957: Coaptium Connect with Tissium Light", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251957", "people": [{"name": "Bahija Ikched", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251957%22"}, {"id": "fda:K250960", "company": "Rev Neuro, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250960: DUO Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250960", "people": [{"name": "Shiva Ardakani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250960%22"}, {"id": "fda:K250928", "company": "Neurologica Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250928: OmniTom Elite with PCD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250928", "people": [{"name": "Ninad Gujar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250928%22"}, {"id": "fda:K251227", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251227: da Vinci Surgical System (IS5000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251227", "people": [{"name": "Changxin Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251227%22"}, {"id": "fda:K251610", "company": "Qure.Ai Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251610: qER-CTA (v1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251610", "people": [{"name": "Rajesh Sukhija", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251610%22"}, {"id": "pma:P240008", "company": "Croma-Pharma GmbH", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-09-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240008: saypha\u00ae MagIQ\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240008", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240008%22"}, {"id": "trialreg:NCT07161583", "company": "Atrium Medical Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Advanta VXT and Flixene PMCF Registry", "source_url": "https://clinicaltrials.gov/study/NCT07161583"}, {"id": "trialreg:NCT07159360", "company": "MarsiBionics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.", "source_url": "https://clinicaltrials.gov/study/NCT07159360"}, {"id": "trialreg:NCT07161154", "company": "Oticon Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Sentio Systematic Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT07161154"}, {"id": "trialreg:NCT07159087", "company": "Genoss Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss\u00ae SCB' Versus 'SeQuent\u00ae Please NEO' in Patients With Coronary ISR", "source_url": "https://clinicaltrials.gov/study/NCT07159087"}, {"id": "trialreg:NCT07161635", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric IOLs", "source_url": "https://clinicaltrials.gov/study/NCT07161635"}, {"id": "trialreg:NCT07160777", "company": "Semikal Technology", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation", "source_url": "https://clinicaltrials.gov/study/NCT07160777"}, {"id": "nih:1R41GM162038-01", "company": "Aventusoft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": 349855, "summary": "NIH award 1R41GM162038-01: An Innovative AI-Powered Wearable Physiological Sensor System for Real-Time Pain Monitoring and Management (PainVitals) ($349,855)", "source_url": "https://reporter.nih.gov/project-details/11261347", "people": [{"name": "Kaustubh Kale", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41DK143882-01", "company": "Intailor Bariatrics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": 325408, "summary": "NIH award 1R41DK143882-01: Easy-to-Operate Endoscopic Automatic Gastroplasty Device That Mimics the Effect of Gastric Bypass/Bariatric Surgery for the Treatment of Diabetes and Obesity ($325,408)", "source_url": "https://reporter.nih.gov/project-details/11186035", "people": [{"name": "David Bernard Bjerken", "role": "Principal Investigator"}, {"name": "Edward Lin", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD112243-03", "company": "Sequitur Health Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": 799231, "summary": "NIH award 5R44HD112243-03: Home Monitoring of Metabolic Disorders ($799,231)", "source_url": "https://reporter.nih.gov/project-details/11182502", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DK143858-01A1", "company": "Drive Medical, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": 315747, "summary": "NIH award 1R43DK143858-01A1: A robotic enteroscope for safe and effective access to the small bowel ($315,747)", "source_url": "https://reporter.nih.gov/project-details/11252691", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD103531-04", "company": "Viocare, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": 472510, "summary": "NIH award 5R44HD103531-04: P-FITS: The Pediatric Food Intake Technology System ($472,510)", "source_url": "https://reporter.nih.gov/project-details/11173904", "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43AI186674-01A1", "company": "Cellia Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-05", "observed": "2026-08-21", "amount_usd": 306872, "summary": "NIH award 1R43AI186674-01A1: Point-of-Care Diagnostic for Spontaneous Bacterial Peritonitis ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11178074", "people": [{"name": "Amy J Castleman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD090793-05", "company": "Advanced Tactile Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-05", "observed": "2026-08-21", "amount_usd": 857783, "summary": "NIH award 5R44HD090793-05: Cervix monitor for risk assessment of spontaneous preterm delivery ($857,783)", "source_url": "https://reporter.nih.gov/project-details/11171650", "people": [{"name": "Vladimir Egorov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44DK131644-04", "company": "Sonavex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-05", "observed": "2026-08-21", "amount_usd": 999997, "summary": "NIH award 5R44DK131644-04: Clinical Trial to Demonstrate Impact of an AI-enabled 3D Ultrasound-based Guidance System in Reducing Arteriovenous Fistula Cannulation Injury and Improving Patient Quality of Life ($999,997)", "source_url": "https://reporter.nih.gov/project-details/11193967", "people": [{"name": "Xin Kang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44DK127631-04", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-05", "observed": "2026-08-21", "amount_usd": 1100003, "summary": "NIH award 2R44DK127631-04: Kidney Support in Pediatric Patients using an Ultrafiltration Device ($1,100,003)", "source_url": "https://reporter.nih.gov/project-details/11256219", "people": [{"name": "Robert J Knuesel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44CA275508-02", "company": "Sonalasense Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-05", "observed": "2026-08-21", "amount_usd": 796215, "summary": "NIH award 5R44CA275508-02: Sonodynamic therapy using MRI-guided focused ultrasound in combination with 5-aminolevulinic acid to treat recurrent glioblastoma multiforme ($796,215)", "source_url": "https://reporter.nih.gov/project-details/10813104", "people": [{"name": "Stuart Marcus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44HD118822-01", "company": "Optimal Mobility Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-05", "observed": "2026-08-21", "amount_usd": 739259, "summary": "NIH award 1R44HD118822-01: Kids Standing Up: Promoting Independent Mobility in Children with Neuromuscular Conditions with a Standing Wheelchair ($739,259)", "source_url": "https://reporter.nih.gov/project-details/11179693", "people": [{"name": "Patricia J McCracken", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K252478", "company": "Bard Access Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252478: Vaccess\u0099 CT Low-Profile Power-Injectable Implantable Port; Vaccess\u0099 CT Power-Injectable Implantable Port; PowerPort\u0099 duo M.R.I. \u0099 Implantable Port", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252478", "people": [{"name": "Kaitlyn Nielsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252478%22"}, {"id": "fda:K250460", "company": "Itamar Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250460: WatchPAT400 (WP400)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250460", "people": [{"name": "Dafna Raiman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250460%22"}, {"id": "fda:K243795", "company": "Prytime Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243795: pREBOA-PRO Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243795", "people": [{"name": "Brian Young", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243795%22"}, {"id": "fda:K244038", "company": "Shandong Int Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K244038: High Pressure Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244038", "people": [{"name": "Zhang Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244038%22"}, {"id": "fda:K251022", "company": "3D-Shaper Medical S.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251022: 3D-SHAPER", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251022", "people": [{"name": "Ludovic Humbert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251022%22"}, {"id": "fda:K251317", "company": "Intravent Medical Partners", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251317: SOLOPASS 2.0 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251317", "people": [{"name": "Adam Barner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251317%22"}, {"id": "fda:K250575", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250575: The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250575", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250575%22"}, {"id": "fda:K251250", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251250: ViewMate\u0099 Multi Ultrasound System (VMM-ICE-01); ViewMate\u0099 Multi Ultrasound System (VMM-ICE-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251250", "people": [{"name": "Xiaozhen Ding", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251250%22"}, {"id": "fda:K251753", "company": "Genabio Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251753: GenaCheck COVID-19 Rapid Self-Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251753", "people": [{"name": "Han Si", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251753%22"}, {"id": "fda:K250095", "company": "Suturetech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250095: All-Suture Dual Anchor System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250095", "people": [{"name": "Benjamin Arnold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250095%22"}, {"id": "fda:K250132", "company": "Zhejiang YiGao Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250132: Ureteral Access Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250132", "people": [{"name": "Serena Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250132%22"}, {"id": "fda:K252528", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-05", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252528: Ion Endoluminal System (IF1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252528", "people": [{"name": "Sandi Mar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252528%22"}, {"id": "trialreg:NCT07156461", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients", "source_url": "https://clinicaltrials.gov/study/NCT07156461"}, {"id": "trialreg:NCT07158333", "company": "Baxter Healthcare Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Mobile Cardiac Telemetry (MCT) Study", "source_url": "https://clinicaltrials.gov/study/NCT07158333"}, {"id": "trialreg:NCT07156669", "company": "Xenios AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Performance of the Novalung Ultimate Kit and Xenios 2.0 During Stationary Use in Hospital and Ground-based Transport of Patients on Extracorporeal Life Support (ECLS)", "source_url": "https://clinicaltrials.gov/study/NCT07156669"}, {"id": "trialreg:NCT07156409", "company": "Suzhou Zenith Vascular Scitech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Clinical Application of Peripheral Embolization Coil Systems in Arteriovenous Embolization Within the Peripheral Vasculature", "source_url": "https://clinicaltrials.gov/study/NCT07156409"}, {"id": "trialreg:NCT07156630", "company": "Icare Finland Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Quick Measure Study for iCare ST500 and iCare IC200", "source_url": "https://clinicaltrials.gov/study/NCT07156630"}, {"id": "nih:5R44HD116620-02", "company": "Cx Therapeutics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": 1214257, "summary": "NIH award 5R44HD116620-02: A Novel Device for Cervical Insufficiency in Pregnant Women ($1,214,257)", "source_url": "https://reporter.nih.gov/project-details/11193996", "people": [{"name": "Michael Douglas House", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41EB038858-01", "company": "Eit USA, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": 306508, "summary": "NIH award 1R41EB038858-01: AI-enabled occult bleeding detection and monitoring ($306,508)", "source_url": "https://reporter.nih.gov/project-details/11316787", "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD107729-03", "company": "Meditrace LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": 812852, "summary": "NIH award 5R44HD107729-03: Fast-Track Multimodal monitoring for neonatal neurocritical care ($812,852)", "source_url": "https://reporter.nih.gov/project-details/11160789", "people": [{"name": "Tony Christopher Carnes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL180242-01A1", "company": "Airalux Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": 306872, "summary": "NIH award 1R43HL180242-01A1: DIGITAL INCENTIVE SPIROMETRY EXERCISER TO IMPROVE PATIENT ADHERENCE AND CLINICAL WORKFLOWS ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11256194", "people": [{"name": "Yi-An Hsieh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44TR005381-01A1", "company": "Biosensics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": 1064194, "summary": "NIH award 1R44TR005381-01A1: A Wearable Sensor Platform for Remote Monitoring of Motor Impairment in Huntingtons Disease and Prodromal Huntingtons Disease ($1,064,194)", "source_url": "https://reporter.nih.gov/project-details/11171267", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41HG014101-01A1", "company": "Rtutor, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-04", "observed": "2026-08-21", "amount_usd": 395316, "summary": "NIH award 1R41HG014101-01A1: Commercializing iDEP, an interactive and reproducible tool for analyzing RNA-Seq data ($395,316)", "source_url": "https://reporter.nih.gov/project-details/11186600", "people": [{"name": "Xijin Ge", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41DE035423-01", "company": "Oralmr LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-04", "observed": "2026-08-21", "amount_usd": 341970, "summary": "NIH award 1R41DE035423-01: Redefining Dental Imaging: Low-Cost MRI with Relaxed Field Requirements ($341,970)", "source_url": "https://reporter.nih.gov/project-details/11254137", "people": [{"name": "Beth R Groenke", "role": "Principal Investigator"}, {"name": "Djaudat Idiyatullin", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44CA290912-02", "company": "Aperture Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-04", "observed": "2026-08-21", "amount_usd": 942272, "summary": "NIH award 4R44CA290912-02: Rapid, Single Cell Proteomic Profiling for Biomarker Development in Precision Oncology ($942,272)", "source_url": "https://reporter.nih.gov/project-details/11247614", "people": [{"name": "Hannah Marie Peterson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K251438", "company": "Guilin Woodpecker Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251438: Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251438", "people": [{"name": "Yiwei Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251438%22"}, {"id": "fda:K250770", "company": "Optina Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250770: Optina-4C (MHRC-C1N)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250770", "people": [{"name": "Sarah Lemaire", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250770%22"}, {"id": "fda:K251781", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251781: KALA MINI 2.0 (KALA-04)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251781", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251781%22"}, {"id": "fda:K243700", "company": "Mag & More GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243700: Apollo TMS Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243700", "people": [{"name": "Kerstin Haeringer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243700%22"}, {"id": "fda:K250893", "company": "Bayer Medical Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250893: Ball Joint Guide Array (66295)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250893", "people": [{"name": "Purva Pandya", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250893%22"}, {"id": "fda:K250353", "company": "Oniris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250353: Oniris; Oniris Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250353", "people": [{"name": "Maria Markarova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250353%22"}, {"id": "fda:K243789", "company": "Microbot Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243789: LIBERTY Endovascular Robotic System (LIBERTYOS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243789", "people": [{"name": "Noa Ofer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243789%22"}, {"id": "fda:K251444", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251444: Endoskeleton\u0099 Interbody Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251444", "people": [{"name": "Pamela Hopkins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251444%22"}, {"id": "fda:K251656", "company": "Careverse Technology Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251656: Careverse CoronaryDoc (Careverse CoronaryDoc)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251656", "people": [{"name": "Qi Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251656%22"}, {"id": "fda:K251510", "company": "Medical Microinstruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251510: Symani Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251510", "people": [{"name": "Zainab Amini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251510%22"}, {"id": "fda:K251737", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251737: NextAR(TM) Shoulder Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251737", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251737%22"}, {"id": "fda:K251733", "company": "The Surgical Company International BV (As Tsc Life)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251733: Fluido\u00ae AirGuard System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251733", "people": [{"name": "Gianpaolo Soares", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251733%22"}, {"id": "fda:K251168", "company": "Carestream Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251168: Image Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251168", "people": [{"name": "Jessica DeRyke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251168%22"}, {"id": "fda:K251545", "company": "Micowey Medical Equipment (Guangxi) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251545: Intense Pulsed Light Therapy Device (MMABM-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251545", "people": [{"name": "Angelina Lau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251545%22"}, {"id": "fda:K250064", "company": "Mvision AI OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250064: Dose+ (1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250064", "people": [{"name": "Kalpana Jha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250064%22"}, {"id": "fda:K251298", "company": "Clinical Laserthermia Systems, AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251298: Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251298", "people": [{"name": "Dan Mogren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251298%22"}, {"id": "fda:K251463", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251463: EnSite\u0099 X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite\u0099 X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251463", "people": [{"name": "Alexandra Agre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251463%22"}, {"id": "fda:K251533", "company": "Ischemaview, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-04", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251533: Rapid Obstructive Hydrocephalus, Rapid OH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251533", "people": [{"name": "James Rosa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251533%22"}, {"id": "trialreg:NCT07155031", "company": "Cerus Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Biotin-Acridine Red Cell Exchange Kinetics", "source_url": "https://clinicaltrials.gov/study/NCT07155031"}, {"id": "trialreg:NCT07155005", "company": "Calyxo, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study", "source_url": "https://clinicaltrials.gov/study/NCT07155005"}, {"id": "trialreg:NCT07155668", "company": "Viridian Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)", "source_url": "https://clinicaltrials.gov/study/NCT07155668"}, {"id": "trialreg:NCT07153822", "company": "DALIM TISSEN Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of Ionized Atelocollagen Adhesion Barrier (Collabarrier\u00ae) in Spine Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07153822"}, {"id": "trialreg:NCT07153939", "company": "Venova Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pivotal Study of the Velocity\u2122 pAVF System", "source_url": "https://clinicaltrials.gov/study/NCT07153939"}, {"id": "trialreg:NCT07153900", "company": "SWIMS America Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BACK4 Safety Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT07153900"}, {"id": "trialreg:NCT07153393", "company": "Centro Studi Dermatologici S.r.l.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study Testing How Well the Medical Device HTIC (a Type of Animal-derived Collagen) Works in Treating Skin Problems, Such as Scars, Loss of Firmness, and Volume in Certain Areas of the Face and Body", "source_url": "https://clinicaltrials.gov/study/NCT07153393"}, {"id": "trialreg:NCT07155850", "company": "BetaGlue Therapeutics SpA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Early Feasibility Clinical Investigation to Assess YntraDose\u2122 as a Neoadjuvant Treatment for LA-PDAC", "source_url": "https://clinicaltrials.gov/study/NCT07155850"}, {"id": "trialreg:NCT07155551", "company": "Myoptechs, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Measuring Changes In Choroidal Thickness Induced By Prototype Soft Contact Lenses Worn For 1 Hour", "source_url": "https://clinicaltrials.gov/study/NCT07155551"}, {"id": "nih:5R44CA295373-02", "company": "Wild Dog Physics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": 934326, "summary": "NIH award 5R44CA295373-02: Improving allocation of scarce medical physics resources through a novel, comprehensive quality assurance device. ($934,326)", "source_url": "https://reporter.nih.gov/project-details/11176231", "people": [{"name": "Janelle Arlene Molloy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AR080507-03", "company": "Apex Orthopaedic Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": 853846, "summary": "NIH award 5R44AR080507-03: R-FIX (Rib-FIXation) Spinal Growth System for Early-onset Spinal Deformity ($853,846)", "source_url": "https://reporter.nih.gov/project-details/11196772", "people": [{"name": "Daniel James Bonthius", "role": "Principal Investigator"}, {"name": "Richard H. Gross", "role": "Principal Investigator"}, {"name": "Hai Yao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DK139812-01A1", "company": "Minnesota Healthsolutions Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": 356032, "summary": "NIH award 1R43DK139812-01A1: Novel Bladder Catheterization Device ($356,032)", "source_url": "https://reporter.nih.gov/project-details/11252220", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AR086730-01", "company": "Reselute", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": 314362, "summary": "NIH award 1R44AR086730-01: Local and Sustained Release of Antibiotics in the Surgical Treatment of Diabetic Charcot Foot ($314,362)", "source_url": "https://reporter.nih.gov/project-details/11254958", "people": [{"name": "Fioleda Prifti Kesseli", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44DK136496-02", "company": "Immunoshield Therapeutics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-03", "observed": "2026-08-21", "amount_usd": 913868, "summary": "NIH award 2R44DK136496-02: Hydrogel injection molded islet macroencapsulation devices to treat diabetes in a non-human primate model ($913,868)", "source_url": "https://reporter.nih.gov/project-details/11183246", "people": [{"name": "Matthew Becker", "role": "Principal Investigator"}, {"name": "NORMA S. KENYON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41OD039877-01", "company": "Objective Biotechnology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-03", "observed": "2026-08-21", "amount_usd": 416925, "summary": "NIH award 1R41OD039877-01: High performance miniaturized microscopes for through skull cortex-wide imaging in freely behaving mice ($416,925)", "source_url": "https://reporter.nih.gov/project-details/11255761", "people": [{"name": "Suhasa B Kodandaramaiah", "role": "Principal Investigator"}, {"name": "Daniel A Surinach", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:9R44MH144721-02", "company": "Cytocybernetics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-03", "observed": "2026-08-21", "amount_usd": 1013966, "summary": "NIH award 9R44MH144721-02: Real Time NEURON Simulation for Experimental Applications ($1,013,966)", "source_url": "https://reporter.nih.gov/project-details/11184896", "people": [{"name": "Mark W Nowak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K252446", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252446: BruxZir\u00ae NOW", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252446", "people": [{"name": "So Hyun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252446%22"}, {"id": "fda:K251726", "company": "Forest Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251726: SignalNED System (Model RE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251726", "people": [{"name": "Carmelo Montalvo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251726%22"}, {"id": "fda:K252174", "company": "Blessing Cathay Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252174: AquaCast Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252174", "people": [{"name": "Jerry Su", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252174%22"}, {"id": "fda:K251575", "company": "Alphatec Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251575: IdentiTi\u0099 II ALIF Standalone Interbody System; Transcend\u0099 ALIF Standalone Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251575", "people": [{"name": "Alanna Joshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251575%22"}, {"id": "fda:K252454", "company": "Restor3D", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252454: Kinos Total Ankle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252454", "people": [{"name": "Brianna Prindle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252454%22"}, {"id": "fda:K231952", "company": "Medicreations, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K231952: MEDILIGHT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231952", "people": [{"name": "Anthony Hardy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231952%22"}, {"id": "fda:K252539", "company": "Arterys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252539: Tempus Pixel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252539", "people": [{"name": "Bethany Barrett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252539%22"}, {"id": "fda:K251457", "company": "Beijing Superlaser Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251457: Diode laser therapy device (VADER)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251457", "people": [{"name": "Shuang Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251457%22"}, {"id": "fda:K251909", "company": "A-1 Engineering", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251909: NeurotriS (SX2500); NeurotriS (SX3800)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251909", "people": [{"name": "Anthony Picciano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251909%22"}, {"id": "fda:K250765", "company": "Avita Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250765: AViTA Arm Type Blood Pressure Monitor Cuff", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250765", "people": [{"name": "Rex Hsieh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250765%22"}, {"id": "fda:K250217", "company": "Agnes Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250217: AGNES Ultra", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250217", "people": [{"name": "Heui Kyeong Pak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250217%22"}, {"id": "fda:K250231", "company": "Dongguan E-Test Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-03", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250231: Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250231", "people": [{"name": "Wan Victor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250231%22"}, {"id": "trialreg:NCT07153094", "company": "Ion Beam Applications", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS\u00ae PLUS (Shenzhen)", "source_url": "https://clinicaltrials.gov/study/NCT07153094"}, {"id": "trialreg:NCT07152808", "company": "Nidek Co. LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study for TONOREF III Tested to ANSI Z80.10-2014", "source_url": "https://clinicaltrials.gov/study/NCT07152808"}, {"id": "trialreg:NCT07151638", "company": "inSoma Bio, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: First-in-Human Safety Study for Fractomer\u2122 Biomatrix", "source_url": "https://clinicaltrials.gov/study/NCT07151638"}, {"id": "trialreg:NCT07151950", "company": "Desin LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Obi Medical Robot: Evaluating Effectiveness Related to Usability", "source_url": "https://clinicaltrials.gov/study/NCT07151950"}, {"id": "trialreg:NCT07153185", "company": "Nobel Biocare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Creos Xenoprotect PMCF", "source_url": "https://clinicaltrials.gov/study/NCT07153185"}, {"id": "trialreg:NCT07153237", "company": "Laboratoires Vivacy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Performance and Safety of STYLAGE\u00ae HydroMax", "source_url": "https://clinicaltrials.gov/study/NCT07153237"}, {"id": "trialreg:NCT07152574", "company": "Caranx Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ROTAO 1 - Feasibility and Safety of the TAVIPILOT Tele-operated Robot During Transcatheter Aortic Valve Replacement (TAVR/TAVI)", "source_url": "https://clinicaltrials.gov/study/NCT07152574"}, {"id": "trialreg:NCT07152379", "company": "Cerus Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs", "source_url": "https://clinicaltrials.gov/study/NCT07152379"}, {"id": "trialreg:NCT07152717", "company": "Feeltect Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment", "source_url": "https://clinicaltrials.gov/study/NCT07152717"}, {"id": "trialreg:NCT07152353", "company": "Ion Beam Applications", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS\u00ae PLUS (Sichuan)", "source_url": "https://clinicaltrials.gov/study/NCT07152353"}, {"id": "trialreg:NCT07151859", "company": "Mastelli S.r.l", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration", "source_url": "https://clinicaltrials.gov/study/NCT07151859"}, {"id": "sbir:DOD:HT9425-25-C-E014", "company": "Corvid Technologies, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-09-03", "observed": "2026-09-18", "amount_usd": 1299999, "summary": "DOD SBIR Phase II award $1,299,999: Robotic End-Effector for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2-0831"}, {"id": "nih:4R42HL174259-02", "company": "Third Coast Dynamics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-02", "observed": "2026-08-06", "amount_usd": 812881, "summary": "NIH award 4R42HL174259-02: Anatomic Imaging Derived 4D Hemodynamics using Deep Learning ($812,881)", "source_url": "https://reporter.nih.gov/project-details/11328615", "people": [{"name": "Bradley David Allen", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41CA278032-01A1", "company": "Omnecoil Instruments, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-02", "observed": "2026-08-06", "amount_usd": 399995, "summary": "NIH award 1R41CA278032-01A1: Transforming prostate cancer diagnosis: Feasibility testing of a novel system for integrated endorectal MRI and in-bore biopsy ($399,995)", "source_url": "https://reporter.nih.gov/project-details/11186195", "people": [{"name": "FERGUS V COAKLEY", "role": "Principal Investigator"}, {"name": "Robert Duffy DuFresne", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL180089-01A1", "company": "Perfusion Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-02", "observed": "2026-08-06", "amount_usd": 320838, "summary": "NIH award 1R43HL180089-01A1: A Fail Safe, High Output Failing Fontan Pump ($320,838)", "source_url": "https://reporter.nih.gov/project-details/11253977", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA261360-02A1", "company": "Kubanda Cryotherapy, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-02", "observed": "2026-08-06", "amount_usd": 1399357, "summary": "NIH award 2R44CA261360-02A1: Low Cost Carbon Dioxide-Based Cryoablation for Breast Cancer Treatment in Low Resource Settings ($1,399,357)", "source_url": "https://reporter.nih.gov/project-details/11185492", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA291262-02", "company": "Orbit Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-02", "observed": "2026-08-21", "amount_usd": 999637, "summary": "NIH award 5R44CA291262-02: Development of a lung cancer subtyping diagnostic ($999,637)", "source_url": "https://reporter.nih.gov/project-details/11194291", "people": [{"name": "HAROLD R GARNER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI183961-02", "company": "Ossium Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-02", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI183961-02: Developing a bank of purified myeloid progenitor cells as a bridging therapy for transient pancytopenia resulting from radiation injury ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11249415", "people": [{"name": "Brian H. Johnstone", "role": "Principal Investigator"}, {"name": "Subhrajit Saha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA285039-03", "company": "Exvade Bioscience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-02", "observed": "2026-08-21", "amount_usd": 999038, "summary": "NIH award 5R44CA285039-03: Tumor Monorail Device for Serial Glioblastoma Biopsy ($999,038)", "source_url": "https://reporter.nih.gov/project-details/11191502", "people": [{"name": "Sean Meehan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R43AI186702-02", "company": "Latde Diagnostics Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-02", "observed": "2026-08-21", "amount_usd": 272184, "summary": "NIH award 5R43AI186702-02: Rapid lateral flow-based antibiotic susceptibility testing for urinary tract infections ($272,184)", "source_url": "https://reporter.nih.gov/project-details/11134666", "people": [{"name": "Emily S Melzer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R43MH135599-02", "company": "Neurotrainer Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-02", "observed": "2026-08-21", "amount_usd": 259481, "summary": "NIH award 5R43MH135599-02: A Feasibility and Efficacy Study of NeuroTrainer Cognitive Training in Students With and Without Attention-Related Difficulties ($259,481)", "source_url": "https://reporter.nih.gov/project-details/11174437", "people": [{"name": "Jeff Nyquist", "role": "Principal Investigator"}, {"name": "JULIE B. SCHWEITZER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "fda:K242768", "company": "Chengdu Besmile Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242768: Customized Abutment and Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242768", "people": [{"name": "Moushan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242768%22"}, {"id": "fda:K251408", "company": "Naitive Technologies, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251408: OsteoSight\u0099 Hip (v1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251408", "people": [{"name": "Ioan Wigley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251408%22"}, {"id": "fda:K251615", "company": "Aerogen, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251615: Aerogen Pro-X1 Controller System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251615", "people": [{"name": "Thelma Marley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251615%22"}, {"id": "fda:K250453", "company": "Philips Medizin Systeme B\u00f6blingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250453: IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250453", "people": [{"name": "Monica Da Silva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250453%22"}, {"id": "fda:K250753", "company": "Velmeni, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250753: VELMENI for DENTISTS (V4D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250753", "people": [{"name": "Ishveen Anand", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250753%22"}, {"id": "fda:K251775", "company": "Belport Company, Inc., Gingi-Pak", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251775: RODIN Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251775", "people": [{"name": "Jingtian Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251775%22"}, {"id": "fda:K251975", "company": "Ignite Orthomotion", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-09-02", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251975: Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251975", "people": [{"name": "Russell Parrott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251975%22"}, {"id": "trialreg:NCT07150221", "company": "Zimmer Biomet", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MDR Vivacit-E Elevated Study", "source_url": "https://clinicaltrials.gov/study/NCT07150221"}, {"id": "trialreg:NCT07149740", "company": "Optos, PLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Gathering for A10900", "source_url": "https://clinicaltrials.gov/study/NCT07149740"}, {"id": "trialreg:NCT07150273", "company": "Jetema Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study to Evaluate the Efficacy and Safety of the Injection With UNIVELO Sub-Q, as Compared to Restylane\u00ae Sub-Q, in the Temporary Correction of the Nasolabial Fold", "source_url": "https://clinicaltrials.gov/study/NCT07150273"}, {"id": "trialreg:NCT07151001", "company": "iHealthScreen Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy", "source_url": "https://clinicaltrials.gov/study/NCT07151001"}, {"id": "trialreg:NCT07149376", "company": "Colgate Palmolive", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-09-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: To Assess the Efficacy of a Toothpaste Containing 8% Arginine as Compared to Colgate Cavity Protection Toothpaste in the Reduction of Dentinal Hypersensitivity.", "source_url": "https://clinicaltrials.gov/study/NCT07149376"}, {"id": "breakthrough:K251408", "company": "Naitive Technologies, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-09-02", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K251408: OSTEOSIGHT HIP (V1)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43MH140657-01", "company": "Rebound Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-09-01", "observed": "2026-08-21", "amount_usd": 365506, "summary": "NIH award 1R43MH140657-01: Development and Validation of a Scalable, Self-Guided Trauma Wellness App to Expand Access to Trauma-Focused Mental Health Care ($365,506)", "source_url": "https://reporter.nih.gov/project-details/11183836", "people": [{"name": "Erin C Berenz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA295197-02", "company": "Creosalus, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": 682122, "summary": "NIH award 5R44CA295197-02: Comparison of convection enhanced delivery systems in a randomized controlled clinical study of recurrent Grade 3-4 glioma patients ($682,122)", "source_url": "https://reporter.nih.gov/project-details/11176927", "people": [{"name": "Vasiliy Abramov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL170817-02", "company": "DNA Medicine Institute", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": 1007678, "summary": "NIH award 5R44HL170817-02: 5-Minute Point-of-Care Anti-Factor Xa Test for Emergent Patient Management ($1,007,678)", "source_url": "https://reporter.nih.gov/project-details/11184232", "people": [{"name": "Eugene Yan-ho Chan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK145409-01A1", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": 389019, "summary": "NIH award 1R43DK145409-01A1: Smart Ankle Foot Orthosis with Adjustable Pressure Offloading ($389,019)", "source_url": "https://reporter.nih.gov/project-details/11252856", "people": [{"name": "Jesse Cole", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44HD112248-02S1", "company": "Spirit Fit & Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-29", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44HD112248-02S1: SPIRIT Club CBI Pathway: A novel streaming platform for physical activity and wellness promotion for chronic brain injury survivors ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11383233", "people": [{"name": "Jared Phillip Ciner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K251718", "company": "Lima Corporate S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251718: ArTT Augments and Buttresses and Bone Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251718", "people": [{"name": "Simone De Marco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251718%22"}, {"id": "fda:K252019", "company": "Curvafix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252019: CurvaFix Low Profile System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252019", "people": [{"name": "Mark Foster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252019%22"}, {"id": "fda:K250771", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250771: Primescan 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250771", "people": [{"name": "Diane Rutherford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250771%22"}, {"id": "fda:K250003", "company": "Geneseeq Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250003: GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250003", "people": [{"name": "Xue Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250003%22"}, {"id": "fda:K252392", "company": "Perfuze, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252392: Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252392", "people": [{"name": "Anne-Marie Gannon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252392%22"}, {"id": "fda:K251108", "company": "Erbe Elektromedizin GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251108: Erbe ESU Model VIO\u00ae 3n with Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251108", "people": [{"name": "Matthias Kollek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251108%22"}, {"id": "fda:K251026", "company": "Trinity Medical Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251026: Regenesis EMS Chair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251026", "people": [{"name": "Mark Rohrer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251026%22"}, {"id": "fda:K251727", "company": "Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251727: GLAM LED Facial Mask (TB-2386F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251727", "people": [{"name": "Shidong Qin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251727%22"}, {"id": "fda:K252380", "company": "Align Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252380: Invisalign System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252380", "people": [{"name": "Ahanitha Ashok", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252380%22"}, {"id": "fda:K251324", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251324: da Vinci SP Surgical System (SP1098)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251324", "people": [{"name": "Amrit Rangan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251324%22"}, {"id": "fda:K250335", "company": "K&J Consulting", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250335: IVA & AEON Cervical and Lumbar Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250335", "people": [{"name": "Milan George", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250335%22"}, {"id": "fda:K243745", "company": "Full Golden Biotech Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243745: FG Bone Graft B", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243745", "people": [{"name": "Chiyu Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243745%22"}, {"id": "fda:K243799", "company": "CooperSurgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243799: Fetal Pillow", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243799", "people": [{"name": "Irina Fedorov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243799%22"}, {"id": "fda:K251946", "company": "GC America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251946: G aenial Universal Injectable II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251946", "people": [{"name": "Futoshi Fusejima", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251946%22"}, {"id": "fda:K251217", "company": "Medtronic Minimed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251217: SmartGuard technology; Predictive Low Glucose technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251217", "people": [{"name": "Hemang Kotecha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251217%22"}, {"id": "fda:K250939", "company": "Precision Robotics (Hong Kong) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250939: SIRIUS Endoscope System (PR-SI-1230)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250939", "people": [{"name": "Alan Kwok", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250939%22"}, {"id": "fda:K251181", "company": "Merit Medical Ireland, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251181: Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251181", "people": [{"name": "Shane Costello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251181%22"}, {"id": "fda:K251106", "company": "FUJIFILM Sonosite, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251106: Sonosite LX and Sonosite PX Ultrasound Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251106", "people": [{"name": "Anoush Frankian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251106%22"}, {"id": "fda:K243859", "company": "Nurea", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243859: PRAEVAorta\u00ae2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243859", "people": [{"name": "Lamia Stephan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243859%22"}, {"id": "fda:K250285", "company": "Raumedic AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250285: NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250285", "people": [{"name": "Hannes Engelhardt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250285%22"}, {"id": "fda:K250874", "company": "Sunrise SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250874: Sunrise", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250874", "people": [{"name": "Gr\u00e9goire Lejeune", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250874%22"}, {"id": "fda:K251480", "company": "Neurotronics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251480: PV01 PVDF Effort Sensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251480", "people": [{"name": "James Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251480%22"}, {"id": "fda:K250290", "company": "Twinsight", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250290: SurgiTwin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250290", "people": [{"name": "Meghan McFadden", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250290%22"}, {"id": "fda:K252364", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252364: Edwards eSheath Optima introducer set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252364", "people": [{"name": "Venkatesh Rane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252364%22"}, {"id": "fda:K251814", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-29", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251814: EZ\u0099 IV Administration Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251814", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251814%22"}, {"id": "trialreg:NCT07148323", "company": "Becton, Dickinson and Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: HemoSphere Alta Study", "source_url": "https://clinicaltrials.gov/study/NCT07148323"}, {"id": "trialreg:NCT07149038", "company": "Neurogrin Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment", "source_url": "https://clinicaltrials.gov/study/NCT07149038"}, {"id": "trialreg:NCT07147920", "company": "Perin Health Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy", "source_url": "https://clinicaltrials.gov/study/NCT07147920"}, {"id": "trialreg:NCT07147881", "company": "Neurolutions, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Real-World Evidence Study of the IpsiHand\u00ae System in Adult Stroke Survivors", "source_url": "https://clinicaltrials.gov/study/NCT07147881"}, {"id": "trialreg:NCT07147569", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TAMBE Japan Post-Marketing Surveillance", "source_url": "https://clinicaltrials.gov/study/NCT07147569"}, {"id": "trialreg:NCT07147647", "company": "Select Eye Care", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Eye Pressure in Non-Caucasian Patients With Open Angle Glaucoma", "source_url": "https://clinicaltrials.gov/study/NCT07147647"}, {"id": "trialreg:NCT07147907", "company": "Perin Health Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Respiratory Rate Validation Study", "source_url": "https://clinicaltrials.gov/study/NCT07147907"}, {"id": "trialreg:NCT07147192", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study of an Accommodating IOL Design", "source_url": "https://clinicaltrials.gov/study/NCT07147192"}, {"id": "trialreg:NCT07148154", "company": "MiMARK Diagnostics, S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations", "source_url": "https://clinicaltrials.gov/study/NCT07148154"}, {"id": "trialreg:NCT07147296", "company": "ONWARD Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury", "source_url": "https://clinicaltrials.gov/study/NCT07147296"}, {"id": "nih:5R44CA278186-03", "company": "Ananya Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": 1124942, "summary": "NIH award 5R44CA278186-03: Portable, low-cost cryotherapy system that does not require consumable cryogen gas for the treatment of cervical precancerous lesions ($1,124,942)", "source_url": "https://reporter.nih.gov/project-details/11176179", "people": [{"name": "Wei-Hsiang Chang", "role": "Principal Investigator"}, {"name": "Anubhuti Parvatiyar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH140338-03", "company": "Nalu Scientific, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": 938415, "summary": "NIH award 5R44MH140338-03: Design and Development of SyMPET: System on chip Modular readout for high-resolution TOF-PET ($938,415)", "source_url": "https://reporter.nih.gov/project-details/11182704", "people": [{"name": "Luca Macchiarulo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41MH139347-01A1", "company": "Walnot, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": 449390, "summary": "NIH award 1R41MH139347-01A1: A precision functional neuroimaging platform to enable collection of highly-sampled data at home ($449,390)", "source_url": "https://reporter.nih.gov/project-details/11195446", "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43ES037584-01", "company": "Foundation Instruments, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-21", "amount_usd": 309285, "summary": "NIH award 1R43ES037584-01: SBIR Phase I: Evaluating the Feasibility of a HAA-Meter for Affordable, Onsite Monitoring of Haloacetic Acids in Drinking Water Plants with Advanced Machine Learning Chromatographic Interpretation ($309,285)", "source_url": "https://reporter.nih.gov/project-details/11185774", "people": [{"name": "Paul Clifton Brister", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EY037613-01", "company": "Ovitz Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-21", "amount_usd": 306171, "summary": "NIH award 1R43EY037613-01: AI-Driven Tools for Automated Design of Higher Order Aberration Optics in Contact Lenses ($306,171)", "source_url": "https://reporter.nih.gov/project-details/11184698", "people": [{"name": "Nicolas S Brown", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH142353-01", "company": "Empathy Rocks Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-21", "amount_usd": 447132, "summary": "NIH award 1R43MH142353-01: Standardizing COA Administration with AI Technology: Ensuring Consistency and Accuracy in Clinical End Points ($447,132)", "source_url": "https://reporter.nih.gov/project-details/11257605", "people": [{"name": "Alison Cerezo", "role": "Principal Investigator"}, {"name": "Danielle A. Schlosser", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS097113-07", "company": "Biocircuit Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-21", "amount_usd": 956147, "summary": "NIH award 5R44NS097113-07: Line extension and expanded preclinical evidence for Nerve Tape, a sutureless nerve repair coaptation device ($956,147)", "source_url": "https://reporter.nih.gov/project-details/11194261", "people": [{"name": "Ryan S Clement", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "nih:1R43CA306431-01", "company": "Myolex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-21", "amount_usd": 263052, "summary": "NIH award 1R43CA306431-01: Electrical impedance myography (EIM) to detect and track cancer cachexia ($263,052)", "source_url": "https://reporter.nih.gov/project-details/11252837", "people": [{"name": "David P. Dickinson", "role": "Principal Investigator"}, {"name": "Ishan Roy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH130305-03", "company": "Dimagi, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-21", "amount_usd": 1005963, "summary": "NIH award 5R44MH130305-03: A novel digital platform for measurement-based peer supervision of non-specialist providers conducting brief psychological interventions ($1,005,963)", "source_url": "https://reporter.nih.gov/project-details/11184516", "people": [{"name": "Y. Xian Ho", "role": "Principal Investigator"}, {"name": "Neal Lesh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R43MH138930-02", "company": "Magnify Biosciences Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-21", "amount_usd": 451095, "summary": "NIH award 5R43MH138930-02: Multiplex Magnify Protocol and Kit for High Plex, Superresolution 3D Synaptic Imaging and Analysis in Neuroscience ($451,095)", "source_url": "https://reporter.nih.gov/project-details/11159832", "people": [{"name": "Aleksandra Klimas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:2R44GM146498-02", "company": "Cascade Metrix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-21", "amount_usd": 720920, "summary": "NIH award 2R44GM146498-02: Automated Multiplex Analyzer for Sepsis and Beyond ($720,920)", "source_url": "https://reporter.nih.gov/project-details/11256350", "people": [{"name": "Kislaya Kunjan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44AI149903-05S1", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-21", "amount_usd": 123606, "summary": "NIH award 3R44AI149903-05S1: Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients ($123,606)", "source_url": "https://reporter.nih.gov/project-details/11382998", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44MH128999-03", "company": "Panluminate Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-21", "amount_usd": 726209, "summary": "NIH award 5R44MH128999-03: A 3D super-resolved platform for rapid and highly multiplexed proteomics ($726,209)", "source_url": "https://reporter.nih.gov/project-details/11190941", "people": [{"name": "Ons M'Saad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL169045-03", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-28", "observed": "2026-08-21", "amount_usd": 999362, "summary": "NIH award 5R44HL169045-03: A Near-Patient, Low Blood Volume Platform for Rapid Comprehensive Evaluation of Coagulation in Trauma Patients ($999,362)", "source_url": "https://reporter.nih.gov/project-details/11138591", "people": [{"name": "VAMSEE K. PAMULA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K252505", "company": "Basic Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252505: Powder-Free Vinyl Exam Gloves, clear", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252505", "people": [{"name": "John Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252505%22"}, {"id": "fda:K243767", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243767: SV600, SV800 Ventilator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243767", "people": [{"name": "Yanhong Bai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243767%22"}, {"id": "fda:K252383", "company": "Compumedics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252383: Somfit D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252383", "people": [{"name": "John Joseph", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252383%22"}, {"id": "fda:K251965", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251965: Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251965", "people": [{"name": "Griffin Riggs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251965%22"}, {"id": "fda:K251594", "company": "Syrma Johari Medtech Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251594: truFlex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251594", "people": [{"name": "Sabyasachi Nath", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251594%22"}, {"id": "fda:K252350", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252350: da Vinci SP Firefly Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252350", "people": [{"name": "Connor McCarty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252350%22"}, {"id": "fda:K250148", "company": "Prior Care Science Technology, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250148: Medical Gas Analyzer (AG200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250148", "people": [{"name": "John Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250148%22"}, {"id": "fda:K250788", "company": "Ge Hualun Medical Systems Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250788: Definium Tempo Select", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250788", "people": [{"name": "Ma Kenny", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250788%22"}, {"id": "fda:K252437", "company": "Implanet", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252437: JAZZ Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252437", "people": [{"name": "Regis Le Couedic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252437%22"}, {"id": "fda:K251484", "company": "4Dmedical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251484: CT:VQ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251484", "people": [{"name": "Theresa Poole", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251484%22"}, {"id": "fda:K252057", "company": "Imperative Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252057: Symphony\u0099 Thrombectomy System and Symphony\u0099 16F 82cm Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252057", "people": [{"name": "Shivani Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252057%22"}, {"id": "fda:K252411", "company": "FH Industrie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252411: JARVIS Glenoid Reverse Shoulder Prosthesis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252411", "people": [{"name": "Naoual Rahimi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252411%22"}, {"id": "fda:K251429", "company": "Changsha Anxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251429: OTC 4-Channel Rechargeable TENS Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251429", "people": [{"name": "William Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251429%22"}, {"id": "fda:K252014", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252014: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252014", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252014%22"}, {"id": "fda:K252030", "company": "Eizo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252030: RadiForce GX570; RadiForce GX570-AR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252030", "people": [{"name": "Hiroaki Hashimoto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252030%22"}, {"id": "fda:K243901", "company": "Ypsomed AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-28", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243901: SmartPilot YpsoMate NS-A2.25", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243901", "people": [{"name": "Johannes Schmid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243901%22"}, {"id": "trialreg:NCT07146932", "company": "COSMO ROBOTICS CO., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy", "source_url": "https://clinicaltrials.gov/study/NCT07146932"}, {"id": "trialreg:NCT07145541", "company": "AION Biosystems", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AION BIOSYSTEMS, INC. Tempshield for Continuous Tempreature Monitoring", "source_url": "https://clinicaltrials.gov/study/NCT07145541"}, {"id": "trialreg:NCT07146204", "company": "Robocath", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: First in Human Trial of R-Star: A Novel Robotic System for Minimally Invasive Coronary Artery Procedures.", "source_url": "https://clinicaltrials.gov/study/NCT07146204"}, {"id": "trialreg:NCT07144813", "company": "Neuspera Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Approval Study of the Neuspera Sacral Neuromodulation System", "source_url": "https://clinicaltrials.gov/study/NCT07144813"}, {"id": "trialreg:NCT07145515", "company": "TransMedics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Enhancing Heart Allograft Function With the OCS Heart System Trial", "source_url": "https://clinicaltrials.gov/study/NCT07145515"}, {"id": "trialreg:NCT07146035", "company": "Coloplast A/S", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility of a Newly Developed Ostomy Prototype", "source_url": "https://clinicaltrials.gov/study/NCT07146035"}, {"id": "trialreg:NCT07144852", "company": "Sun Pharmaceutical Industries, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities", "source_url": "https://clinicaltrials.gov/study/NCT07144852"}, {"id": "trialreg:NCT07145905", "company": "Teoxane SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TCRM for Correction of Cheek Including Fine Lines", "source_url": "https://clinicaltrials.gov/study/NCT07145905"}, {"id": "nih:1R43CA298696-01A1", "company": "Flexbiotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": 306872, "summary": "NIH award 1R43CA298696-01A1: Molecular Screening for Human Papilloma Virus (HPV) Associated with Cervical Cancers in LMIC Environments ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11254966", "people": [{"name": "Vi Nguyen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42HL170864-02", "company": "Biomembretics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-21", "amount_usd": 2899006, "summary": "NIH award 4R42HL170864-02: Manufacturable Biomimetic Microfluidic Oxygenator for Safer, Simpler Treatment of Respiratory Failure ($2,899,006)", "source_url": "https://reporter.nih.gov/project-details/11239378", "people": [{"name": "Todd Astor", "role": "Principal Investigator"}, {"name": "Jeffrey T. Borenstein", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA306750-01", "company": "Cereus Diagnostics Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-21", "amount_usd": 764448, "summary": "NIH award 1R44CA306750-01: Lung Cancer FAST (Fragment Analysis, SNP, and Translocations) Testing ($764,448)", "source_url": "https://reporter.nih.gov/project-details/11256325", "people": [{"name": "Justin T Brown", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44NS143670-01", "company": "Eye-predict, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-21", "amount_usd": 497201, "summary": "NIH award 1R44NS143670-01: Complete Mental Counts for Patients Recovering from Brain Injury ($497,201)", "source_url": "https://reporter.nih.gov/project-details/11186797", "people": [{"name": "Ran Carmi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA298398-01A1", "company": "Oraliva, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R41CA298398-01A1: Point of care diagnostic to improve access to gynecological screening in low-resource settings ($400,000)", "source_url": "https://reporter.nih.gov/project-details/11186207", "people": [{"name": "Nicolaos Joseph Christodoulides", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44NS108850-05S1", "company": "Backyard Brains, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44NS108850-05S1: Introducing Neuroscience and Neurocomputation Concepts to High School Students using Brain-based Neurorobots ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11328678", "people": [{"name": "Gregory John Gage", "role": "Principal Investigator"}, {"name": "Christopher Aidan Harris", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44NS143486-01", "company": "Cnd Life Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-21", "amount_usd": 1276662, "summary": "NIH award 1R44NS143486-01: Analysis of Cutaneous Phosphorylated alpha-Synuclein to Identify Patients at Risk of Progressing from Essential Tremor to Parkinson's Disease ($1,276,662)", "source_url": "https://reporter.nih.gov/project-details/11183129", "people": [{"name": "CHRISTOPHER H GIBBONS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL180172-01", "company": "Neurolux, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-21", "amount_usd": 525824, "summary": "NIH award 1R41HL180172-01: Electromechanically monitored engineered heart tissue platform ($525,824)", "source_url": "https://reporter.nih.gov/project-details/11183376", "people": [{"name": "Cameron Good", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44MH111463-04", "company": "Meadowlark Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-21", "amount_usd": 1120423, "summary": "NIH award 2R44MH111463-04: Improving Speed and Cost of Entry for Holographic Optogenetics ($1,120,423)", "source_url": "https://reporter.nih.gov/project-details/11069190", "people": [{"name": "CHRISTOPHER LUK HOY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R43AI181234-02", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-21", "amount_usd": 303250, "summary": "NIH award 5R43AI181234-02: Diagnostic assay for congenital Chagas disease ($303,250)", "source_url": "https://reporter.nih.gov/project-details/11080292", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI149903-05", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-21", "amount_usd": 876394, "summary": "NIH award 5R44AI149903-05: Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients ($876,394)", "source_url": "https://reporter.nih.gov/project-details/11067754", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R41NR022239-01", "company": "The Glimpse Group, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-27", "observed": "2026-08-21", "amount_usd": 225609, "summary": "NIH award 1R41NR022239-01: Life at 100.4: An Immersive Social Virtual Reality Education Tool for Adolescent and Young Adult Cancer Patients and Caregivers ($225,609)", "source_url": "https://reporter.nih.gov/project-details/11065932", "people": [{"name": "Asher Marks", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K251382", "company": "Astra Orthomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251382: Phoenix Sinus Tarsi Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251382", "people": [{"name": "Michael Graham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251382%22"}, {"id": "fda:K243774", "company": "Lesspine Innovations", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243774: ELID (Endoscopic Less Invasive Decompression) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243774", "people": [{"name": "Vito Lore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243774%22"}, {"id": "fda:K251637", "company": "Donnevie Medical Technology (Shanghai) Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251637: Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251637", "people": [{"name": "Hannah Hang Yin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251637%22"}, {"id": "fda:K250080", "company": "QIAGEN GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250080: QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250080", "people": [{"name": "Autumn Collasius", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250080%22"}, {"id": "fda:K251752", "company": "Shanghai AnQing Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251752: Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251752", "people": [{"name": "Shuwen Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251752%22"}, {"id": "fda:K250947", "company": "Durr Dental SE", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250947: VistaSoft 4.0 and VisionX 4.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250947", "people": [{"name": "Oliver Lange", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250947%22"}, {"id": "fda:K252419", "company": "Atraverse Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252419: HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252419", "people": [{"name": "Charles Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252419%22"}, {"id": "fda:K243166", "company": "Infection Elimination Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243166: Dermalage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243166", "people": [{"name": "Patrick Hill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243166%22"}, {"id": "fda:K241766", "company": "Fysicon BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K241766: QMAPP\u00ae (Hemo, Hemo Lite, PCM, GO, Hybrid)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241766", "people": [{"name": "Cornelis (Eric) Van Antwerpen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241766%22"}, {"id": "fda:K251415", "company": "Aidite (Qinhuangdao) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251415: Additively Manufactured Aligner Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251415", "people": [{"name": "Zhanfu Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251415%22"}, {"id": "fda:K250625", "company": "Nanjing Yinuoji Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250625: Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250625", "people": [{"name": "Xiao Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250625%22"}, {"id": "fda:K251716", "company": "Basic Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251716: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251716", "people": [{"name": "John Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251716%22"}, {"id": "fda:K241882", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K241882: Fetal & Maternal Monitor (F15A, F15A Air)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241882", "people": [{"name": "Yue Tracy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241882%22"}, {"id": "fda:K251068", "company": "Uv One Hygienics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251068: KnoxFog Anti-fogging Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251068", "people": [{"name": "Dora Suppes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251068%22"}, {"id": "fda:K252118", "company": "Hangzhou Clongene Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252118: CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252118", "people": [{"name": "Frank Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252118%22"}, {"id": "fda:K243687", "company": "Oxehealth Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243687: Vital Signs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243687", "people": [{"name": "John Kemeny", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243687%22"}, {"id": "pma:P240044", "company": "Kardium, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-08-27", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240044: Globe\u00ae Pulsed Field System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240044", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240044%22"}, {"id": "trialreg:NCT07143019", "company": "phenox Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms", "source_url": "https://clinicaltrials.gov/study/NCT07143019"}, {"id": "trialreg:NCT07144345", "company": "Sun Pharmaceutical Industries, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp", "source_url": "https://clinicaltrials.gov/study/NCT07144345"}, {"id": "trialreg:NCT07144644", "company": "Research Insight LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: 2311 TURGOR Study -Surgical Efficiency and Postoperative Corneal Clarity With Near Physiologic vs High IOP Settings", "source_url": "https://clinicaltrials.gov/study/NCT07144644"}, {"id": "trialreg:NCT07144761", "company": "Osheru Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft\u2122", "source_url": "https://clinicaltrials.gov/study/NCT07144761"}, {"id": "sbir:DOD:FA8649-25-P-0450", "company": "Flosonics Medical LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-08-27", "observed": "2026-09-18", "amount_usd": 1249845, "summary": "DOD SBIR Phase II award $1,249,845: FloPredict - DOPPLER INTELLIGENCE: ADVANCING AI-POWERED HEMODYNAMIC MONITORING FOR EARLY DETECTION OF CLINICAL DETERIORATION", "source_url": "https://www.sbir.gov/awards?search=F2D-17204"}, {"id": "nih:1R43EB036391-01A1", "company": "Evanesc Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-26", "observed": "2026-08-06", "amount_usd": 349908, "summary": "NIH award 1R43EB036391-01A1: Non-invasive Medical Device to Permeabilize the Blood-Brain Barrier Using Low Power Radio Frequency Evanescent Waves ($349,908)", "source_url": "https://reporter.nih.gov/project-details/11181099", "people": [{"name": "Timothy J. Brockett", "role": "Principal Investigator"}, {"name": "MONIQUE F STINS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44AG087868-02", "company": "Senaptec Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-26", "observed": "2026-08-06", "amount_usd": 740698, "summary": "NIH award 4R44AG087868-02: Development of an In-Home Sensory Training Therapy to Mitigate Falls Risk Among the Elderly ($740,698)", "source_url": "https://reporter.nih.gov/project-details/11375768", "people": [{"name": "Elizabeth Ann Fleming", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DC023160-01", "company": "Creare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-26", "observed": "2026-08-21", "amount_usd": 311029, "summary": "NIH award 1R43DC023160-01: A multi-function earplug that measures in-ear noise, standard noise dosimetry and hearing function ($311,029)", "source_url": "https://reporter.nih.gov/project-details/11253508", "people": [{"name": "ODILE H CLAVIER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA298389-01", "company": "Vigilant Laboratories LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-26", "observed": "2026-08-21", "amount_usd": 1021347, "summary": "NIH award 1R44CA298389-01: Development of an effective, low-cost, point-of-care early detection test for oral cancer in low resource settings ($1,021,347)", "source_url": "https://reporter.nih.gov/project-details/11069154", "people": [{"name": "Joseph A Califano", "role": "Principal Investigator"}, {"name": "Xi Steven Chen", "role": "Principal Investigator"}, {"name": "Elizabeth J Franzmann", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41AA032157-01", "company": "Spark Biomedical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-26", "observed": "2026-08-21", "amount_usd": 305545, "summary": "NIH award 1R41AA032157-01: Study of Transcutaneous Auricular Neurostimulation as a Treatment for Alcohol Use Disorder ($305,545)", "source_url": "https://reporter.nih.gov/project-details/11067358", "people": [{"name": "Navid Khodaparast", "role": "Principal Investigator"}, {"name": "Hyuntaek Oh", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH142283-01", "company": "Habitaware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-26", "observed": "2026-08-21", "amount_usd": 422629, "summary": "NIH award 1R43MH142283-01: Developing an Integrated Wearable and Patch System to Address Skin Picking Disorder ($422,629)", "source_url": "https://reporter.nih.gov/project-details/11256064", "people": [{"name": "Christopher A. Flessner", "role": "Principal Investigator"}, {"name": "Sameer Kumar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA295403-01A1", "company": "Xgenomes Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-26", "observed": "2026-08-21", "amount_usd": 399816, "summary": "NIH award 1R43CA295403-01A1: A novel ctDNA analysis solution for the next-generation of liquid biopsy assays ($399,816)", "source_url": "https://reporter.nih.gov/project-details/11254540", "people": [{"name": "Kalim Ullah Mir", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K251305", "company": "Kitazato Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251305: Ultra-Fast Vitri; Ultra-Fast Warm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251305", "people": [{"name": "Kyoko Izumi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251305%22"}, {"id": "fda:K244061", "company": "Imperative Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K244061: X-Wire Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244061", "people": [{"name": "Shivani Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244061%22"}, {"id": "fda:K250049", "company": "Seplou (Zhuhai) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250049: Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250049", "people": [{"name": "QingFu Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250049%22"}, {"id": "fda:K250261", "company": "Heager GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250261: Heager Medical Laser Family (Sabrina/Adolf)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250261", "people": [{"name": "Wolfgang Christiani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250261%22"}, {"id": "fda:K251983", "company": "Brainomix Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251983: Brainomix 360 Triage Stroke", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251983", "people": [{"name": "Delanyo Mensah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251983%22"}, {"id": "fda:K252526", "company": "Ischemaview, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-26", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252526: Rapid DeltaFuse", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252526", "people": [{"name": "James Rosa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252526%22"}, {"id": "trialreg:NCT07140926", "company": "Bright Therapeutics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Stepped-Wedge Cluster Randomized Trial of a Digital App to Support Medication-Assisted Treatment in Individuals With Opioid Use Disorder", "source_url": "https://clinicaltrials.gov/study/NCT07140926"}, {"id": "trialreg:NCT07140822", "company": "Shanghai Shenqi Medical Technology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Randomized Study of Cutting Balloon Catheter for CAD", "source_url": "https://clinicaltrials.gov/study/NCT07140822"}, {"id": "trialreg:NCT07142304", "company": "Luminate Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study", "source_url": "https://clinicaltrials.gov/study/NCT07142304"}, {"id": "nih:5R44EY031202-05", "company": "Ihealthscreen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-25", "observed": "2026-08-06", "amount_usd": 698032, "summary": "NIH award 5R44EY031202-05: A Model for Predicting 2-Year Risk of Incident Late Age-related Macular Degeneration ($698,032)", "source_url": "https://reporter.nih.gov/project-details/11146532", "people": [{"name": "Alauddin Bhuiyan", "role": "Principal Investigator"}, {"name": "Roland THEODORE SMITH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:2R42HL166051-02", "company": "Coram Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-25", "observed": "2026-08-21", "amount_usd": 1051193, "summary": "NIH award 2R42HL166051-02: Non Magnetic MRI Conditional External Defibrillator with Reduced Skeletal Muscle Contraction ($1,051,193)", "source_url": "https://reporter.nih.gov/project-details/11256785", "people": [{"name": "HENRY R HALPERIN", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R42AG084399-02", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-25", "observed": "2026-08-21", "amount_usd": 998162, "summary": "NIH award 4R42AG084399-02: Developing a novel system combining cognitive assessment with PASCALL FDA-cleared intraoperative anesthesia EEG brain monitor to prevent postoperative neurocognitive disorders in aging patients ($998,162)", "source_url": "https://reporter.nih.gov/project-details/11375766", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43JG000003-01A1", "company": "Pace Diagnostics", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-25", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43JG000003-01A1: An Ultrasensitive Urine TB Antigen Rapid Detection Test for the Diagnosis of Active Tuberculosis ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10922508", "people": [{"name": "Hiep-Hoa Nguyen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K243800", "company": "Dermalogica, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243800: PRO Pen Microneedling System (6883)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243800", "people": [{"name": "Nelson Torres", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243800%22"}, {"id": "fda:K251440", "company": "Precision Biologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251440: CRYOcheck Chromogenic Factor VIII", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251440", "people": [{"name": "Karen Black", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251440%22"}, {"id": "fda:K251246", "company": "Spark Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251246: Sparrow Ascent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251246", "people": [{"name": "Brent Croft", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251246%22"}, {"id": "fda:K243709", "company": "Neuroears, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243709: NeuroEars-Anna\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243709", "people": [{"name": "Suh Kyoowon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243709%22"}, {"id": "fda:K243634", "company": "Maxx Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243634: Maxx Libertas Bipolar Hip Head (Bipolar Hip)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243634", "people": [{"name": "Donald Guthner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243634%22"}, {"id": "fda:K251811", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251811: Motor and Apex Module (MaAM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251811", "people": [{"name": "Diane Rutherford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251811%22"}, {"id": "fda:K251593", "company": "Denmat Holding, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251593: DenMat Multilayered Zirconia Disc", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251593", "people": [{"name": "Kimberly Maynes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251593%22"}, {"id": "fda:K243680", "company": "Olea Medical S.A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243680: Neurovascular Insight V1.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243680", "people": [{"name": "Nathalie Palumbo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243680%22"}, {"id": "fda:K243834", "company": "Nobel Biocare AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243834: NobelZygoma TiUltra Implant system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243834", "people": [{"name": "Jim Bernice", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243834%22"}, {"id": "fda:K251404", "company": "Hemosonics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-25", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251404: Quantra QStat Cartridge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251404", "people": [{"name": "Garrett Sparks", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251404%22"}, {"id": "trialreg:NCT07140497", "company": "Toivoa Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Reduction of Anxiety in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching - A Randomized Clinical Trial", "source_url": "https://clinicaltrials.gov/study/NCT07140497"}, {"id": "trialreg:NCT07139327", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults", "source_url": "https://clinicaltrials.gov/study/NCT07139327"}, {"id": "trialreg:NCT07139912", "company": "Shanghai MicroPort Endovascular MedTech\uff08Group\uff09Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective, Multicenter, Single-Arm Study of Aortic Arch Pathology Reconstruction", "source_url": "https://clinicaltrials.gov/study/NCT07139912"}, {"id": "trialreg:NCT07140562", "company": "Tangent Cardiovascular Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation", "source_url": "https://clinicaltrials.gov/study/NCT07140562"}, {"id": "nih:4R44HL172444-02", "company": "Lasarrus Clinic And Research Center, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": 926715, "summary": "NIH award 4R44HL172444-02: Bilateral Acoustic Sensing and Automated Breathing Segmentation for Remote Monitoring of Patients with COPD: A Longitudinal Study ($926,715)", "source_url": "https://reporter.nih.gov/project-details/11196388", "people": [{"name": "Lloyd E Emokpae", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA261381-03", "company": "Malcova Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": 853988, "summary": "NIH award 5R44CA261381-03: A comprehensive imaging solution for dense breast cancer screening and diagnostics ($853,988)", "source_url": "https://reporter.nih.gov/project-details/11138590", "people": [{"name": "Peymon Ghazi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44HL182590-01", "company": "Heartpoint Global Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": 1771084, "summary": "NIH award 1R44HL182590-01: IntelliStent: A minimally Invasive, Adjustable Pulmonary Flow Restrictor System for Congenital and Acquired Heart Disease ($1,771,084)", "source_url": "https://reporter.nih.gov/project-details/11256438", "people": [{"name": "Elena Amin", "role": "Principal Investigator"}, {"name": "Seth Adam Bogner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL169112-03", "company": "Thermedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": 437984, "summary": "NIH award 5R44HL169112-03: Eliminating Ventricular Tachycardia: Pivotal Clinical Trial using the Durablate\u00ae Catheter ($437,984)", "source_url": "https://reporter.nih.gov/project-details/11175368", "people": [{"name": "MICHAEL G CURLEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44LM014847-01", "company": "Clairyon, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-22", "observed": "2026-08-21", "amount_usd": 410924, "summary": "NIH award 1R44LM014847-01: Automating Quality to Accelerate Transformational Improvements in Care (AQUATIC) ($410,924)", "source_url": "https://reporter.nih.gov/project-details/11185950", "people": [{"name": "Hari Kolasani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K251828", "company": "Cerenovus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251828: CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251828", "people": [{"name": "Cara Feely", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251828%22"}, {"id": "fda:K243692", "company": "Advanced Technology Research (A.T.R.) S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243692: EnDrive (EnDriveUS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243692", "people": [{"name": "Lorenzo Baroncelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243692%22"}, {"id": "fda:K251277", "company": "Reflow Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251277: CoraForce Microcatheter, CoraFlex Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251277", "people": [{"name": "Lori Grace", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251277%22"}, {"id": "fda:K252302", "company": "Biosense Webster, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252302: CARTO\u0099 3 EP Navigation System V8.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252302", "people": [{"name": "Caleb Lau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252302%22"}, {"id": "fda:K252362", "company": "Galileo Cds, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252362: GBrain MRI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252362", "people": [{"name": "Abhijeet Pradhan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252362%22"}, {"id": "fda:K243685", "company": "Therapixel", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243685: MammoScreen BD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243685", "people": [{"name": "Pierre Fillard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243685%22"}, {"id": "fda:K251192", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251192: Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251192", "people": [{"name": "Jing Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251192%22"}, {"id": "fda:K252303", "company": "United Orthopedic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252303: Stem Extension Line (USTAR II System)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252303", "people": [{"name": "Lois Ho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252303%22"}, {"id": "fda:K251443", "company": "DRGEM Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251443: PROMO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251443", "people": [{"name": "Doonam Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251443%22"}, {"id": "fda:K250147", "company": "Centerpoint Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250147: CPS Locator 3D Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250147", "people": [{"name": "Jonathan Holmes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250147%22"}, {"id": "fda:K251604", "company": "Access Bio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251604: CareSuperb COVID-19/Flu A&B Antigen Combo Home Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251604", "people": [{"name": "Sung Jang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251604%22"}, {"id": "fda:K243660", "company": "Cardinalhealth", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243660: Monoject\u0099 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject\u0099 3mL Syringe, Luer-Lock Tip (1180300777); Monoject\u0099 6mL Syringe, Luer-Lock Tip (1180600777); Monoject\u0099 12mL Syringe, Luer-Lock Tip (1181200777); Monoject\u0099 20mL Syringe, Luer-Lock Tip (1182000777); Monoject\u0099 35mL Syringe, Luer-Lock Tip (1183500777); Monoject\u0099 60mL Syringe, Luer-Lock Tip (1186000777); Monoject\u0099 3mL Syringe, Luer-Lock Tip (8881513934); Monoject\u0099 6mL Syringe , Luer-Lock Tip (8881516937); Monojec", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243660", "people": [{"name": "Kyle Hooper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243660%22"}, {"id": "fda:K251884", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-22", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251884: One-Fil Putty Injectable", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251884", "people": [{"name": "Ku Da-Hyeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251884%22"}, {"id": "trialreg:NCT07135557", "company": "Cathbot (Shanghai) Robot Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: R-ONE\u00ae Robotically-Enhanced PCI Intervention Study", "source_url": "https://clinicaltrials.gov/study/NCT07135557"}, {"id": "trialreg:NCT07136870", "company": "Essity Hygiene and Health AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of Wound Care Product Skin Adhesion", "source_url": "https://clinicaltrials.gov/study/NCT07136870"}, {"id": "trialreg:NCT07135895", "company": "Inari Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The ArtixASCEND Study", "source_url": "https://clinicaltrials.gov/study/NCT07135895"}, {"id": "trialreg:NCT07135947", "company": "Point Designs", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: To Evaluate the Clinical Impact of the Point Powered System", "source_url": "https://clinicaltrials.gov/study/NCT07135947"}, {"id": "trialreg:NCT07135596", "company": "Tela Bio Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effectiveness and Safety of OviTex\u00ae PRS in Breast Reconstruction", "source_url": "https://clinicaltrials.gov/study/NCT07135596"}, {"id": "trialreg:NCT07138495", "company": "Eodyne Systems SL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Integrating AI in Stroke Neurorehabilitation", "source_url": "https://clinicaltrials.gov/study/NCT07138495"}, {"id": "trialreg:NCT07136272", "company": "Pathway Medtech, LLC.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Detection of Sleep Stages and Arousals Using Neural Network Classifiers", "source_url": "https://clinicaltrials.gov/study/NCT07136272"}, {"id": "trialreg:NCT07138066", "company": "Comeback Mobility Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures", "source_url": "https://clinicaltrials.gov/study/NCT07138066"}, {"id": "trialreg:NCT07137767", "company": "TECLens, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Quantitative Refractive Crosslinking in Presbyopia Aged Patients", "source_url": "https://clinicaltrials.gov/study/NCT07137767"}, {"id": "trialreg:NCT07135284", "company": "Synchrony-Medical, Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS)", "source_url": "https://clinicaltrials.gov/study/NCT07135284"}, {"id": "trialreg:NCT07137195", "company": "Ion Beam Applications", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS\u00ae PLUS (Hebei)", "source_url": "https://clinicaltrials.gov/study/NCT07137195"}, {"id": "nih:1R41DC023169-01", "company": "Omnispeech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": 292543, "summary": "NIH award 1R41DC023169-01: AI-Based Speech Enhancement for Hearing Aids ($292,543)", "source_url": "https://reporter.nih.gov/project-details/11256282", "people": [{"name": "Craig Birkhimer", "role": "Principal Investigator"}, {"name": "Eric C Hoover", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA291498-02", "company": "Isono Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": 956621, "summary": "NIH award 5R44CA291498-02: ATUSA: World's First Wearable and Automated 3D Breast Ultrasound System with AI ($956,621)", "source_url": "https://reporter.nih.gov/project-details/11187050", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA189522-07", "company": "Applikate Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": 1628449, "summary": "NIH award 5R44CA189522-07: Commercial Readiness for Direct-to-Digital Pathology ($1,628,449)", "source_url": "https://reporter.nih.gov/project-details/11166523", "people": [{"name": "Michael John Levene", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "nih:1R43CA298411-01A1", "company": "Cellchorus Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-21", "observed": "2026-08-21", "amount_usd": 399625, "summary": "NIH award 1R43CA298411-01A1: Functional signatures of post-infusion CAR T cells for early indication of patient response ($399,625)", "source_url": "https://reporter.nih.gov/project-details/11186616", "people": [{"name": "Rebecca L Berdeaux", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG080849-02", "company": "Carevirtue Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-21", "observed": "2026-08-21", "amount_usd": 1000334, "summary": "NIH award 2R44AG080849-02: A Novel, Personalized Innovation to Reduce Health Disparities for Rural ADRD Care Partners: CareVirtue Resource Connection. ($1,000,334)", "source_url": "https://reporter.nih.gov/project-details/11112214", "people": [{"name": "Christian Elliott", "role": "Principal Investigator"}, {"name": "Nicole E Werner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44NS143484-01A1", "company": "Great Lakes Neurotechnologies", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-21", "observed": "2026-08-21", "amount_usd": 1134607, "summary": "NIH award 1R44NS143484-01A1: DBS-Expert Pro: Automated Deep Brain Stimulation Programming Using Functional Mapping ($1,134,607)", "source_url": "https://reporter.nih.gov/project-details/11252734", "people": [{"name": "Dustin A. Heldman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AI155075-04A1", "company": "Jan Biotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-21", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 2R44AI155075-04A1: Sequence-based RNA Fluorescence Assay to Measure Latent HIV Reservoirs ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11255357", "people": [{"name": "Janet L Huie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44CA275590-03", "company": "Collagen Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-21", "observed": "2026-08-21", "amount_usd": 1065500, "summary": "NIH award 5R44CA275590-03: Theranostic for gastric cancer ($1,065,500)", "source_url": "https://reporter.nih.gov/project-details/11180167", "people": [{"name": "Valerie Humblet", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AI189008-01", "company": "Mucommune, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-21", "observed": "2026-08-21", "amount_usd": 310136, "summary": "NIH award 1R43AI189008-01: Engineering a physiologically-tuned reservoir intravaginal ring releasing lactic acid for the treatment and prevention of bacterial vaginosis ($310,136)", "source_url": "https://reporter.nih.gov/project-details/11069348", "people": [{"name": "Keiichiro Kushiro", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA291290-02", "company": "Early Is Good Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-21", "observed": "2026-08-21", "amount_usd": 829733, "summary": "NIH award 5R44CA291290-02: Multiplex and multi-omic diagnostic test for bladder cancer recurrence ($829,733)", "source_url": "https://reporter.nih.gov/project-details/11195583", "people": [{"name": "Thakshila Liyanage", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K243965", "company": "Nerv Technology Inc. (D.B.A.) Fluidai Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243965: Origin\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243965", "people": [{"name": "Mariam Al-Lami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243965%22"}, {"id": "fda:K251579", "company": "bioMerieux, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251579: VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251579", "people": [{"name": "Jared Bronson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251579%22"}, {"id": "fda:K252356", "company": "Acumed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252356: The Acumed Wrist Fixation System - 2.4mm Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252356", "people": [{"name": "Marina Bull", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252356%22"}, {"id": "fda:K251647", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251647: MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251647", "people": [{"name": "Melanie Avila", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251647%22"}, {"id": "fda:K250994", "company": "Finemedix Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250994: ClearTip FNA and FNB Types", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250994", "people": [{"name": "Priscilla Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250994%22"}, {"id": "fda:K251135", "company": "Treace Medical Concepts", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251135: Treace Medical Concepts (TMC) Implant Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251135", "people": [{"name": "Brittany Grochala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251135%22"}, {"id": "fda:K250784", "company": "Shenzhen Yicai Health Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250784: Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250784", "people": [{"name": "Jie Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250784%22"}, {"id": "fda:K252244", "company": "Ever Global (Vietnam) Enterprise Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252244: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252244", "people": [{"name": "Elizabeth Deng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252244%22"}, {"id": "fda:K250923", "company": "Bodycad Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250923: Fine Osteotomy\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250923", "people": [{"name": "Nadine Adia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250923%22"}, {"id": "fda:K251588", "company": "Shenzhen Fittop Health Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251588: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251588", "people": [{"name": "Sandy Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251588%22"}, {"id": "fda:K251029", "company": "Vista AI, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251029: Vista OS, Vista AI Scan, RTHawk", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251029", "people": [{"name": "James Rogers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251029%22"}, {"id": "fda:K241152", "company": "Tidal Medical Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K241152: InSee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241152", "people": [{"name": "Mehdi Arani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241152%22"}, {"id": "fda:K251130", "company": "Jiangsu Jumao X-Care Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-21", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251130: Portable Oxygen Concentrator (JM-P50A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251130", "people": [{"name": "Yu Yao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251130%22"}, {"id": "trialreg:NCT07134257", "company": "Comeback Mobility Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures", "source_url": "https://clinicaltrials.gov/study/NCT07134257"}, {"id": "trialreg:NCT07135011", "company": "Establishment Labs", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation", "source_url": "https://clinicaltrials.gov/study/NCT07135011"}, {"id": "trialreg:NCT07134231", "company": "Colgate Palmolive", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices: An In Situ Model", "source_url": "https://clinicaltrials.gov/study/NCT07134231"}, {"id": "nih:1R44NS139730-01A1", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": 936787, "summary": "NIH award 1R44NS139730-01A1: A novel method of non-invasive brain stimulation to enhance motor function in chronic stroke patients ($936,787)", "source_url": "https://reporter.nih.gov/project-details/11180871", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM161199-01", "company": "Cellfe Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-20", "observed": "2026-08-21", "amount_usd": 314000, "summary": "NIH award 1R43GM161199-01: Accelerated, scalable same-day microfluidic sequential gene editing for allogeneic cell therapy ($314,000)", "source_url": "https://reporter.nih.gov/project-details/11254211", "people": [{"name": "Seyeon Bae", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42CA295106-02", "company": "Xanthoshealth, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-20", "observed": "2026-08-21", "amount_usd": 925504, "summary": "NIH award 5R42CA295106-02: ConnectedNest: a digital platform connecting individuals with cancer to social care ($925,504)", "source_url": "https://reporter.nih.gov/project-details/11195638", "people": [{"name": "David A Haynes", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI142903-05", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-20", "observed": "2026-08-21", "amount_usd": 714666, "summary": "NIH award 5R44AI142903-05: Hybrid ELISA: Simple and specific one-tier assay for Lyme disease ($714,666)", "source_url": "https://reporter.nih.gov/project-details/11158727", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "fda:K250721", "company": "Zest Anchors, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250721: LOCATOR\u00ae Angled Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250721", "people": [{"name": "David Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250721%22"}, {"id": "fda:K251837", "company": "Artrya Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251837: Salix Coronary Plaque (V1.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251837", "people": [{"name": "Gabriela Quijada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251837%22"}, {"id": "fda:K251229", "company": "Softac Medical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251229: EndoFix\u0099Tissue Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251229", "people": [{"name": "Rickey Hart", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251229%22"}, {"id": "fda:K251481", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251481: ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251481", "people": [{"name": "Sulgue Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251481%22"}, {"id": "fda:K252061", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252061: Distal Xtremities System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252061", "people": [{"name": "Blesson Abraham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252061%22"}, {"id": "fda:K250383", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250383: Wearable Breast Pump (Model W6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250383", "people": [{"name": "Xiaoyan Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250383%22"}, {"id": "fda:DEN250002", "company": "Quantalx Neuroscience, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) DEN250002: Delphi-MD System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250002", "people": [{"name": "Iftach Dolev", "role": "510(k) submission contact"}]}, {"id": "fda:K251400", "company": "Stryker GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251400: T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251400", "people": [{"name": "Jackie Perri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251400%22"}, {"id": "fda:K251563", "company": "Wondfo USA Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251563: WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251563", "people": [{"name": "Kaiyu Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251563%22"}, {"id": "fda:K252104", "company": "Comerge AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252104: T1D1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252104", "people": [{"name": "Andreas Pedroni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252104%22"}, {"id": "fda:K251590", "company": "Methinks Software, S.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251590: Methinks CTA Stroke", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251590", "people": [{"name": "Claudia Carbonell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251590%22"}, {"id": "fda:K243804", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243804: MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 \u00b5g/mL) (MicroScan)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243804", "people": [{"name": "Ashley Austerman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243804%22"}, {"id": "fda:K250417", "company": "Rebotix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250417: Remanufactured EndoWrist Cobra Grasper (420190)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250417", "people": [{"name": "Chris Gibson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250417%22"}, {"id": "fda:K251471", "company": "Implant Protesis Dental 2004, S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251471: IPD Dental Implant Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251471", "people": [{"name": "Francesc Fumanal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251471%22"}, {"id": "fda:K251580", "company": "Liofilchem s.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-20", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251580: MTS Sulbactam-Durlobactam 0.004/4 - 64/4 \u00b5g/mL (SUD)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251580", "people": [{"name": "Fabio Rocco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251580%22"}, {"id": "trialreg:NCT07133100", "company": "DigitalRehab", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Upper Limb Movement Precision With AuReha in People With One-Sided Motor Impairment", "source_url": "https://clinicaltrials.gov/study/NCT07133100"}, {"id": "trialreg:NCT07132255", "company": "Cathbot (Shanghai) Robot Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Efficacy and Safety Evaluation of 5G Tele-PCI Using R-OneTM", "source_url": "https://clinicaltrials.gov/study/NCT07132255"}, {"id": "trialreg:NCT07132970", "company": "Aesculap AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy", "source_url": "https://clinicaltrials.gov/study/NCT07132970"}, {"id": "denovo:DEN250002", "company": "Quantalx Neuroscience, Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-08-20", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN250002 granted: Delphi-MD System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250002"}, {"id": "sbir:DOD:W51701-25-C-A187", "company": "Kitware Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-08-20", "observed": "2026-09-18", "amount_usd": 249969, "summary": "DOD SBIR Phase I award $249,969: Bridging the Gap in Prolonged Field Care: Integrated Visualization and Predictive Modeling for Extended Combat Casualty Training", "source_url": "https://www.sbir.gov/awards?search=A254-029-1373"}, {"id": "nih:5R44AI179440-03", "company": "Orlance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-19", "observed": "2026-08-21", "amount_usd": 977255, "summary": "NIH award 5R44AI179440-03: Clinic-Ready MACH-1 Gene Gun for delivery of a universal influenza DNA vaccine ($977,255)", "source_url": "https://reporter.nih.gov/project-details/11168940", "people": [{"name": "Hannah Frizzell", "role": "Principal Investigator"}, {"name": "Deborah H. Fuller", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DK139895-02", "company": "Biomedinnovations, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-19", "observed": "2026-08-21", "amount_usd": 1657705, "summary": "NIH award 5R44DK139895-02: Platform for Extended Kidney Preservation Via Subnormothermic Perfusion ($1,657,705)", "source_url": "https://reporter.nih.gov/project-details/11195058", "people": [{"name": "Andrew Serghios Barbas", "role": "Principal Investigator"}, {"name": "Varun Lingaiah Kopparthy", "role": "Principal Investigator"}, {"name": "PRABIR ROY-CHAUDHURY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K252022", "company": "OSSIO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252022: OSSIOfiber\u00ae Interference Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252022", "people": [{"name": "Taly Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252022%22"}, {"id": "fda:K250387", "company": "Rebotix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250387: Remanufactured EndoWrist Long Tip Forceps (420048)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250387", "people": [{"name": "Chris Gibson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250387%22"}, {"id": "fda:K250539", "company": "Rebotix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250539: Remanufactured EndoWrist Tenaculum Forceps (420207)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250539", "people": [{"name": "Chris Gibson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250539%22"}, {"id": "fda:K252316", "company": "Venclose, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252316: Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252316", "people": [{"name": "Kulveen Dhatt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252316%22"}, {"id": "fda:K250399", "company": "Rebotix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250399: Remanufactured EndoWrist Cadiere Forceps (420049)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250399", "people": [{"name": "Chris Gibson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250399%22"}, {"id": "fda:K243713", "company": "Agnes Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243713: Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243713", "people": [{"name": "Heui Kyeong Pak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243713%22"}, {"id": "fda:K250313", "company": "Harps Europe Manufacturing GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-19", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250313: Sterile Powder Free Synthetic Rubber Surgeon\u0092s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250313", "people": [{"name": "Alexander Weinert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250313%22"}, {"id": "trialreg:NCT07130955", "company": "Shanghai Golden Leaf MedTec Co. Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Randomized Trial of Six-Channel RF Ablation System for Renal Denervation in Uncontrolled Hypertension and Chronic Kidney Disease", "source_url": "https://clinicaltrials.gov/study/NCT07130955"}, {"id": "trialreg:NCT07130994", "company": "InnovHeart", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Reduction or Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US)", "source_url": "https://clinicaltrials.gov/study/NCT07130994"}, {"id": "trialreg:NCT07129421", "company": "Emblok, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR", "source_url": "https://clinicaltrials.gov/study/NCT07129421"}, {"id": "trialreg:NCT07129694", "company": "CoreTissue BioEngineering Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Obtain Safety and Effectiveness of CT-ACL001, a Regenerative Ligament Using Biological Tissue, in ACLR", "source_url": "https://clinicaltrials.gov/study/NCT07129694"}, {"id": "trialreg:NCT07130136", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients", "source_url": "https://clinicaltrials.gov/study/NCT07130136"}, {"id": "nih:1R43HL176353-01A1", "company": "Limax Biosciences Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-18", "observed": "2026-08-06", "amount_usd": 464229, "summary": "NIH award 1R43HL176353-01A1: Tough Adhesive Sealants for Vascular Surgery ($464,229)", "source_url": "https://reporter.nih.gov/project-details/11068592", "people": [{"name": "Benjamin Ross Freedman", "role": "Principal Investigator"}, {"name": "Phoebe S Kwon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH142142-01", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-18", "observed": "2026-08-06", "amount_usd": 1651499, "summary": "NIH award 1R44MH142142-01: Efficacy of kTMP, a novel non-invasive brain stimulation method, for the treatment of anhedonia patients. ($1,651,499)", "source_url": "https://reporter.nih.gov/project-details/11252829", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41EB038146-01", "company": "Boston AI LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-18", "observed": "2026-08-06", "amount_usd": 326813, "summary": "NIH award 1R41EB038146-01: An AI Enabled Training Tool for Complex Surgical Suturing Skills ($326,813)", "source_url": "https://reporter.nih.gov/project-details/11253812", "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41EB037527-01", "company": "Dogpatch Medical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-18", "observed": "2026-08-06", "amount_usd": 306463, "summary": "NIH award 1R41EB037527-01: MAGNETIC (MRI-Assisted Guidance via NeuroInterventional Targeted Imaging Catheters) ($306,463)", "source_url": "https://reporter.nih.gov/project-details/11183371", "people": [{"name": "Steven William Hetts", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DC022815-01A1", "company": "Mstatt LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-18", "observed": "2026-08-21", "amount_usd": 306872, "summary": "NIH award 1R43DC022815-01A1: Improving otitis media with effusion diagnosis in the primary care setting with the laser otoscope ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11255766", "people": [{"name": "Steven Burns", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43JG000004-01A1", "company": "Skm Instruments, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-18", "observed": "2026-08-21", "amount_usd": 306872, "summary": "NIH award 1R43JG000004-01A1: Ultra-Rapid Optical Platform for Antimicrobial Susceptibility Testing (AST) of Pulmonary Non-Tuberculous Mycobacterial (NTM) Infections ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11183634", "people": [{"name": "Keith Carron", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44EB038123-01", "company": "Capesym, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-18", "observed": "2026-08-21", "amount_usd": 925411, "summary": "NIH award 1R44EB038123-01: High-Resolution Direct-Conversion X-ray Detectors for Low-Dose Imaging ($925,411)", "source_url": "https://reporter.nih.gov/project-details/11253149", "people": [{"name": "Amlan Datta", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44OD035392-02", "company": "Cryocrate, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-18", "observed": "2026-08-21", "amount_usd": 922420, "summary": "NIH award 5R44OD035392-02: Establishment of a First-in-Class Biocompatible and Efficient Cryopreservation Technology Platform for the Next Generation of Cell-Based Therapeutics in Regenerative Medicine and Drug Discovery ($922,420)", "source_url": "https://reporter.nih.gov/project-details/11190815", "people": [{"name": "Xu Han", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA291456-02", "company": "Onc.ai, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-18", "observed": "2026-08-21", "amount_usd": 375000, "summary": "NIH award 5R44CA291456-02: Prospective validation of a radiomics-based multi-modal predictive model for metastatic non-small cell lung cancer patients treated with PD-1 immunotherapy ($375,000)", "source_url": "https://reporter.nih.gov/project-details/11192898", "people": [{"name": "Petr Jordan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R43NS137871-02", "company": "Microstructure Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-18", "observed": "2026-08-21", "amount_usd": 364885, "summary": "NIH award 5R43NS137871-02: Reporting Quantitative Microstructural MRI Metrics to Stage and Monitor Multiple Sclerosis ($364,885)", "source_url": "https://reporter.nih.gov/project-details/11189717", "people": [{"name": "Grigoriy Lemberskiy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "fda:K243539", "company": "Mag & More GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243539: Apollo TMS Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243539", "people": [{"name": "Kerstin Haeringer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243539%22"}, {"id": "fda:K250271", "company": "JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250271: Neodent Implant System - Zirconia Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250271", "people": [{"name": "Leticia Milani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250271%22"}, {"id": "fda:K251086", "company": "Biotab, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251086: PnueAira (PNCU-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251086", "people": [{"name": "Evan Hall", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251086%22"}, {"id": "fda:K250167", "company": "Evolution Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250167: Evolution Spine Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250167", "people": [{"name": "James Mirda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250167%22"}, {"id": "fda:K243604", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243604: Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243604", "people": [{"name": "Caitlin Senter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243604%22"}, {"id": "fda:K251161", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-18", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251161: ANTHEM\u00ae Fracture System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251161", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251161%22"}, {"id": "trialreg:NCT07127575", "company": "Livotion, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Scalable Intervention for Stress Management", "source_url": "https://clinicaltrials.gov/study/NCT07127575"}, {"id": "trialreg:NCT07126327", "company": "Coloplast A/S", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Peristeen Light Explorative Clinical Investigation", "source_url": "https://clinicaltrials.gov/study/NCT07126327"}, {"id": "trialreg:NCT07127172", "company": "Neuralink Corp", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices", "source_url": "https://clinicaltrials.gov/study/NCT07127172"}, {"id": "trialreg:NCT07126912", "company": "Espad Pharmed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Efficacy and Safety of Alcarisa (Hyaluronic Acid Produced by Espad Pharmed Co.) for Restoration of Mid-face Volume", "source_url": "https://clinicaltrials.gov/study/NCT07126912"}, {"id": "fda:K251913", "company": "OsteoCentric Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-16", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251913: OsteoCentric\u00ae UnifiMI\u00ae TCS Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251913", "people": [{"name": "Todd Evans", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251913%22"}, {"id": "nih:1R44HL176399-01A1", "company": "Aveera Medical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": 1032585, "summary": "NIH award 1R44HL176399-01A1: Preventing major amputations and preserving functional limbs in no option critical limb-threating ischemia patients ($1,032,585)", "source_url": "https://reporter.nih.gov/project-details/11183401", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG087855-02", "company": "Neuroscope Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": 1245800, "summary": "NIH award 5R44AG087855-02: Development of perivascular space mapping toolset as a diagnostic aid for Alzheimer's disease ($1,245,800)", "source_url": "https://reporter.nih.gov/project-details/11143789", "people": [{"name": "Jeiran Choupan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DK135256-03", "company": "Cerulean Scientific Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": 536210, "summary": "NIH award 5R44DK135256-03: Slippery Omniphobic Coating for Hemodialysis Catheter to Resist Fibrin Sheathing and Infection and Improve Patient Outcomes ($536,210)", "source_url": "https://reporter.nih.gov/project-details/11126044", "people": [{"name": "Todd McFarland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DK139891-02", "company": "Wearable Artificial Organs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": 1407179, "summary": "NIH award 5R44DK139891-02: Dialyzing at home with a new model of the Wearable Artificial Kidney ($1,407,179)", "source_url": "https://reporter.nih.gov/project-details/11124817", "people": [{"name": "Victor Gura", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43EB038158-01", "company": "Sound Innovation LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-15", "observed": "2026-08-21", "amount_usd": 263749, "summary": "NIH award 1R43EB038158-01: SoundScape: A portable small animal imager to accelerate drug development ($263,749)", "source_url": "https://reporter.nih.gov/project-details/11256029", "people": [{"name": "Melanie King", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42GM154550-02", "company": "Biosensing Instrument, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-15", "observed": "2026-08-21", "amount_usd": 932810, "summary": "NIH award 4R42GM154550-02: Plasmonic Scattering Microscopy for high-throughput in-situ quantification of molecular binding kinetics on single cells ($932,810)", "source_url": "https://reporter.nih.gov/project-details/11179709", "people": [{"name": "Nguyen Ly", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K251243", "company": "Neuroone Medical Technologies Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251243: OneRF Trigeminal Nerve Radiofrequency Probes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251243", "people": [{"name": "Debra Kridner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251243%22"}, {"id": "fda:K250867", "company": "Dunamis Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250867: Dunamis Screw and Suture Locking System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250867", "people": [{"name": "PrithviRaj Chavan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250867%22"}, {"id": "fda:K251969", "company": "Atlas Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251969: Atlas Spine Project X Expandable Posterior Lumbar Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251969", "people": [{"name": "Thomas Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251969%22"}, {"id": "fda:K250170", "company": "Brightonix Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250170: PHAROS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250170", "people": [{"name": "Radcheck Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250170%22"}, {"id": "fda:K252259", "company": "Assure Tech., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252259: AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252259", "people": [{"name": "Allen Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252259%22"}, {"id": "fda:K252236", "company": "N & C Holdings, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252236: CP Relief Wand Rx - TENS/NMES", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252236", "people": [{"name": "Norm Schroeder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252236%22"}, {"id": "fda:K243851", "company": "Fairtility , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243851: CHLOE BLAST", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243851", "people": [{"name": "Maya Baranes Zeevi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243851%22"}, {"id": "fda:K251834", "company": "Zimmer Biomet", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251834: Persona Partial Knee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251834", "people": [{"name": "Courtney Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251834%22"}, {"id": "fda:K250818", "company": "Smart Alfa Teknoloji San. Ve Tic. A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250818: Nerveblox", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250818", "people": [{"name": "Utku Kaya", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250818%22"}, {"id": "fda:K251747", "company": "Eos Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251747: VEA Align; spineEOS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251747", "people": [{"name": "Mathilde Masurel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251747%22"}, {"id": "fda:K251871", "company": "Heat IN A Click, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251871: FEATHER 01 02 03 04 (Model:01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251871", "people": [{"name": "Guy Levi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251871%22"}, {"id": "fda:K251972", "company": "Healgen Scientific,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251972: Healgen\u00ae AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen\u00ae Immunofluorescence Analyzer (OG-H180)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251972", "people": [{"name": "Lin Yoyo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251972%22"}, {"id": "fda:K250620", "company": "KLS Martin L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250620: KLS Martin Ixos System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250620", "people": [{"name": "Melissa Bachorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250620%22"}, {"id": "fda:K251877", "company": "JMS North America Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251877: JMS CAVEO A.V. Fistula Needle Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251877", "people": [{"name": "Sho Hososki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251877%22"}, {"id": "fda:K250036", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250036: MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250036", "people": [{"name": "Elisabeth Warriner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250036%22"}, {"id": "fda:K250397", "company": "Helios Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250397: Helios Dermal Scaffold", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250397", "people": [{"name": "Yiannis Monovoukas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250397%22"}, {"id": "fda:K243650", "company": "iRhythm Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243650: Zio\u00ae monitor (DFG0001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243650", "people": [{"name": "Kiran Sorathia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243650%22"}, {"id": "pma:P250005", "company": "Biocartis Us, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250005: Idylla CDx MSI Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250005", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250005%22"}, {"id": "pma:P250004", "company": "Agilent Technologies, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-08-15", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250004: MMR IHC Panel pharmDx (Dako Omnis)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250004", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250004%22"}, {"id": "trialreg:NCT07125092", "company": "Thuasne", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Clinical Benefit and Safety of Medical Compression Garments in the Management of Patients With Lipedema", "source_url": "https://clinicaltrials.gov/study/NCT07125092"}, {"id": "breakthrough:K251877", "company": "Jms North America Corporation", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-08-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K251877: JMS CAVEO A.V. FISTULA NEEDLE SET", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43DC022809-01", "company": "Auricle, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": 305995, "summary": "NIH award 1R43DC022809-01: A Novel Technology to Treat the Underlying Cause of Tinnitus ($305,995)", "source_url": "https://reporter.nih.gov/project-details/11183590", "people": [{"name": "David Thomas Martel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI157650-04", "company": "Aldatu Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": 975023, "summary": "NIH award 5R44AI157650-04: PANDAA for universal, pan-lineage molecular detection of Crimean-Congo Hemorrhagic Fever virus. ($975,023)", "source_url": "https://reporter.nih.gov/project-details/11145788", "people": [{"name": "Iain James MacLeod", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R41EB036929-01A1", "company": "Thormed Innovation LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": 294886, "summary": "NIH award 1R41EB036929-01A1: Non Invasive Urine Output Monitor ($294,886)", "source_url": "https://reporter.nih.gov/project-details/11251173", "people": [{"name": "Katherine Gengler Brown", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK139828-02", "company": "Biodevek Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": 1094074, "summary": "NIH award 5R44DK139828-02: Production of a Hydrogel-based Mucosal Sealant for Gastrointestinal Bleeding Prevention ($1,094,074)", "source_url": "https://reporter.nih.gov/project-details/11092336", "people": [{"name": "Gonzalo Munoz Taboada", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA236253-05", "company": "Friendi.fi Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": 365505, "summary": "NIH award 5R44CA236253-05: A Bedside Relational Agent to Improve Hematopoietic Cell Transplantation Outcomes in Cancer Patients ($365,505)", "source_url": "https://reporter.nih.gov/project-details/11173832", "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44CA285041-03", "company": "Binary Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-21", "amount_usd": 1009228, "summary": "NIH award 5R44CA285041-03: Monitoring Immunotherapy Response via Gene Silencing Landscapes in Cell-Free DNA ($1,009,228)", "source_url": "https://reporter.nih.gov/project-details/11193928", "people": [{"name": "Michael T Barrett", "role": "Principal Investigator"}, {"name": "Abhijit Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL179155-01", "company": "Immunomatics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-21", "amount_usd": 207740, "summary": "NIH award 1R43HL179155-01: Eliminating Donor Availability Disparities in Hematopoietic Stem Cell Transplantation with AI-based Prediction of Permissive HLA Mismatches in the Context of Posttransplant Cyclophosphamide ($207,740)", "source_url": "https://reporter.nih.gov/project-details/11111249", "people": [{"name": "Lidio Marx Carvalho Meireles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG084351-02", "company": "Revel Pharmaceuticals Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-21", "amount_usd": 1364162, "summary": "NIH award 2R44AG084351-02: Development of enzymatic tools for rapid measurement of Advanced Glycation and Lipoxidation End Product-protein adducts ($1,364,162)", "source_url": "https://reporter.nih.gov/project-details/11064102", "people": [{"name": "Aaron Cravens", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NS130864-04", "company": "Neurodex Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-21", "amount_usd": 518202, "summary": "NIH award 5R44NS130864-04: Development of a Blood-based Test for Identifying Synucleinopathy in Patients with Dementia ($518,202)", "source_url": "https://reporter.nih.gov/project-details/11169963", "people": [{"name": "Erez Eitan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44NS137845-02", "company": "Neurologic Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-21", "amount_usd": 1215146, "summary": "NIH award 5R44NS137845-02: EpiScalp: An EEG Analytics Solution to Improve Diagnosis of Epilepsy ($1,215,146)", "source_url": "https://reporter.nih.gov/project-details/11168672", "people": [{"name": "Andrew Gotshalk", "role": "Principal Investigator"}, {"name": "Babitha Haridas", "role": "Principal Investigator"}, {"name": "Jennifer L. Hopp", "role": "Principal Investigator"}, {"name": "Michael R Sperling", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HD117514-01", "company": "Good Nutrition Ideas, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-21", "amount_usd": 385000, "summary": "NIH award 1R43HD117514-01: HOMEals: A Science-Based Clinical Decision Support System for Nutrition in IDD Group Homes ($385,000)", "source_url": "https://reporter.nih.gov/project-details/11065233", "people": [{"name": "KATHLEEN HUMPHRIES", "role": "Principal Investigator"}, {"name": "Bethany Rigles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG074812-02A1", "company": "Toi Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-21", "amount_usd": 1210170, "summary": "NIH award 2R44AG074812-02A1: Use of a Novel Toilet Seat to Passively Collect Digital Biomarkers in Assisted Living Settings ($1,210,170)", "source_url": "https://reporter.nih.gov/project-details/11183149", "people": [{"name": "Vikram Kashyap", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL174670-01A1", "company": "Careevolution LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-21", "amount_usd": 498576, "summary": "NIH award 1R43HL174670-01A1: Advancing Techquity: Optimization of the FAITH! App for Dissemination to Promote Cardiovascular Health among African Americans ($498,576)", "source_url": "https://reporter.nih.gov/project-details/11111885", "people": [{"name": "LaPrincess C Brewer", "role": "Principal Investigator"}, {"name": "Vikas Kheterpal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42NS129395-03", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-21", "amount_usd": 1255373, "summary": "NIH award 5R42NS129395-03: Developing Active Stimulation and Monitoring Technologies to Optimize Pain and Nociception Management During Regional Anesthesia, General Anesthesia, and Post-Operative Care ($1,255,373)", "source_url": "https://reporter.nih.gov/project-details/11176849", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42HL174371-02", "company": "Pip Care, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-21", "amount_usd": 1003059, "summary": "NIH award 4R42HL174371-02: Novel Digital Health Platform with Virtual Health Coach for Improving Perioperative Patient Outcomes and Care Coordination ($1,003,059)", "source_url": "https://reporter.nih.gov/project-details/11263822", "people": [{"name": "Jennifer Holder-Murray", "role": "Principal Investigator"}, {"name": "Kathy Kaluhiokalani", "role": "Principal Investigator"}, {"name": "Aman Mahajan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AA032450-01", "company": "Bd Holding, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-14", "observed": "2026-08-21", "amount_usd": 406412, "summary": "NIH award 1R43AA032450-01: A Test for Heavy Alcohol Consumption in First Episode Coronary Heart Disease ($406,412)", "source_url": "https://reporter.nih.gov/project-details/11179757", "people": [{"name": "Robert A Philibert", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K251526", "company": "Maine Molecular Quality Controls, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251526: FilmArray GI Control Panel M238", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251526", "people": [{"name": "Joan Gordon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251526%22"}, {"id": "fda:K251062", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251062: Geistlich Bio-Gide; Geistlich Bio-Gide\u00ae Shape; Geistlich Bio-Gide\u00ae Compressed; Geistlich Bio-Gide\u00ae Forte; Geistlich Bio-Gide\u00ae Perio; Geistlich Combi-Kit Collagen\u00ae; Geistlich Perio-System Combi Pack", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251062", "people": [{"name": "Marco Steiner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251062%22"}, {"id": "fda:K250898", "company": "Stryker Sustainability Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250898: Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250898", "people": [{"name": "Scott English", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250898%22"}, {"id": "fda:K243600", "company": "Forus Health Pvt.Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243600: 3nethra neo HD FA; 3nethra neo HD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243600", "people": [{"name": "RJ Venkataramanan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243600%22"}, {"id": "fda:K243544", "company": "Biofire Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243544: BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243544", "people": [{"name": "Karli Plenert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243544%22"}, {"id": "fda:K251176", "company": "Shenzhen Mlay Intelligent Technology Co., , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251176: IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251176", "people": [{"name": "Libin Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251176%22"}, {"id": "fda:K251012", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251012: TRUDERMAL Pro (ZLD-390)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251012", "people": [{"name": "Dijkstra Alain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251012%22"}, {"id": "fda:K243905", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243905: Stitch Cerclage \u0096 Suture Tapes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243905", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243905%22"}, {"id": "fda:K250164", "company": "Guangzhou Ajax Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250164: Cassette Autoclave (ACA5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250164", "people": [{"name": "Dien Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250164%22"}, {"id": "fda:K243437", "company": "Mom Incubators Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243437: mOm Essential Incubator (ME1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243437", "people": [{"name": "Rosalyn Archer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243437%22"}, {"id": "fda:K250916", "company": "Shenzhen Leaflife Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-14", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250916: WinForth (LM-E470KA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250916", "people": [{"name": "Cheng Qiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250916%22"}, {"id": "trialreg:NCT07123766", "company": "Suzhou Hearthill Medical Technology Co.,LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation for the PoliaValve Aortic Heart Valve- India", "source_url": "https://clinicaltrials.gov/study/NCT07123766"}, {"id": "trialreg:NCT07123051", "company": "Distalmotion SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System", "source_url": "https://clinicaltrials.gov/study/NCT07123051"}, {"id": "trialreg:NCT07122518", "company": "Cordis US Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Approval Study of PALMAZ MULLINS XD\u2122 in Treating Pulmonary Artery Stenosis", "source_url": "https://clinicaltrials.gov/study/NCT07122518"}, {"id": "trialreg:NCT07121907", "company": "Caranx Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI) in Australia", "source_url": "https://clinicaltrials.gov/study/NCT07121907"}, {"id": "trialreg:NCT07122583", "company": "AbbVie", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Assess Non-Invasive Subcutaneous Fat Reduction in the Submental, Inner Thigh and Back/Bra Areas With the CoolSculpting Elite System", "source_url": "https://clinicaltrials.gov/study/NCT07122583"}, {"id": "trialreg:NCT07122349", "company": "Gaize", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cannabis Impairment Detection Device Study", "source_url": "https://clinicaltrials.gov/study/NCT07122349"}, {"id": "trialreg:NCT07121933", "company": "Erchonia Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Erchonia PPL Laser as a Pretreatment Adjunct to Enhance Standard Erchonia Red Laser for the Relief of Pain", "source_url": "https://clinicaltrials.gov/study/NCT07121933"}, {"id": "trialreg:NCT07122258", "company": "Tau Medical Australia Pty Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Early Feasibility Study (EFS) of the 'CAROL' for Treatment of Lung Cancer Stage 1", "source_url": "https://clinicaltrials.gov/study/NCT07122258"}, {"id": "trialreg:NCT07123935", "company": "CardioRenal Systems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety & Efficacy of RenalGuard\u00ae Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury", "source_url": "https://clinicaltrials.gov/study/NCT07123935"}, {"id": "trialreg:NCT07121790", "company": "Bioretec Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Mg Alloy DrillPins in Hammertoe Deformity Correction", "source_url": "https://clinicaltrials.gov/study/NCT07121790"}, {"id": "sbir:DOD:HT9425-25-P-E013", "company": "Applied Nanotech, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-08-14", "observed": "2026-09-18", "amount_usd": 249962, "summary": "DOD SBIR Phase I award $249,962: MicrobeID: A Point-of-Care, Electronics-Free Molecular Diagnostic Platform for Microbial Detection", "source_url": "https://www.sbir.gov/awards?search=H252-001-0022"}, {"id": "nih:5R44HL167294-02", "company": "Safebeat Rx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": 977252, "summary": "NIH award 5R44HL167294-02: Novel, automated mobile heart rhythm analysis technology to start antiarrhythmic medications safely at home ($977,252)", "source_url": "https://reporter.nih.gov/project-details/11141594", "people": [{"name": "Edward Paul Gerstenfeld", "role": "Principal Investigator"}, {"name": "Rachita Navara", "role": "Principal Investigator"}, {"name": "Kunj G. Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44EB035459-02", "company": "Qscint Imaging Solutions, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": 811877, "summary": "NIH award 5R44EB035459-02: Novel Isotopic Spectroscopy Imaging Tools for Advancing Targeted Alpha Cancer Therapies ($811,877)", "source_url": "https://reporter.nih.gov/project-details/11177757", "people": [{"name": "Jared William Moore", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL140669-06", "company": "Volumetrix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": 1000000, "summary": "NIH award 5R44HL140669-06: Non-Invasive Venous Waveform Analysis (NIVA) in patients with Heart Failure (HF) ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11070348", "people": [{"name": "Kyle Mitchell Hocking", "role": "Principal Investigator"}, {"name": "JOANN LINDENFELD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R44EY033604-03", "company": "Theia Imaging LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": 970759, "summary": "NIH award 5R44EY033604-03: A Widefield, Handheld OCT system for Patients who are Unable to Cooperate ($970,759)", "source_url": "https://reporter.nih.gov/project-details/11170026", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44HL174221-02", "company": "Pgxl Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": 960998, "summary": "NIH award 4R44HL174221-02: UroMarker Test Panel for Obstructive Sleep Apnea ($960,998)", "source_url": "https://reporter.nih.gov/project-details/11330126", "people": [{"name": "Christopher Thomas Burns", "role": "Principal Investigator"}, {"name": "Roland Valdes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM148126-03", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-13", "observed": "2026-08-21", "amount_usd": 1261092, "summary": "NIH award 5R44GM148126-03: Improving extraction success of FFPE samples with automated and reliable microfluidic sample preparation ($1,261,092)", "source_url": "https://reporter.nih.gov/project-details/11131120", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HD110346-03", "company": "Ovaryit, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-13", "observed": "2026-08-21", "amount_usd": 865931, "summary": "NIH award 5R44HD110346-03: Development and commercialization of support tools to improve safety and efficiency of pharmacist-prescribed contraceptive services ($865,931)", "source_url": "https://reporter.nih.gov/project-details/11143677", "people": [{"name": "Mary Kucek", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43MH143230-01", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-13", "observed": "2026-08-21", "amount_usd": 557588, "summary": "NIH award 1R43MH143230-01: Non-invasive brain stimulation using two-coil kTMP: simultaneous stimulation at two cortical targets and deep brain stimulation at a single target ($557,588)", "source_url": "https://reporter.nih.gov/project-details/11180817", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44NR021724-01", "company": "Q-rounds Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-13", "observed": "2026-08-21", "amount_usd": 1021840, "summary": "NIH award 1R44NR021724-01: Q-rounds: Making Multi-Disciplinary Family Centered Rounds and Achievable Standard of Care through Novel Virtual Rounding Features ($1,021,840)", "source_url": "https://reporter.nih.gov/project-details/11111212", "people": [{"name": "Michael B Pitt", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K243653", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243653: KARL STORZ HOPKINS Telescopes for Urology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243653", "people": [{"name": "Emily Rhiel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243653%22"}, {"id": "fda:K251519", "company": "Appliedvr", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251519: RelieVRx (Pico G3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251519", "people": [{"name": "Gabriela Pastushenko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251519%22"}, {"id": "fda:K250931", "company": "Unimed Medical Supplies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250931: Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250931", "people": [{"name": "Huanyu Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250931%22"}, {"id": "fda:K251033", "company": "Unibeauty (Hubei) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251033: Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251033", "people": [{"name": "Guofeng Ou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251033%22"}, {"id": "fda:K250841", "company": "Baisheng Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250841: Electrotherapy Electrodes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250841", "people": [{"name": "Xi Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250841%22"}, {"id": "fda:K251046", "company": "S.I.N. Implant System Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251046: S.I.N. Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251046", "people": [{"name": "Denise Domiciano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251046%22"}, {"id": "fda:K252201", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252201: HS Fiber", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252201", "people": [{"name": "Paul Vagts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252201%22"}, {"id": "fda:K252192", "company": "Huizhou Lvb Maternal and Infant Supplies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252192: Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252192", "people": [{"name": "Zhang Dongan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252192%22"}, {"id": "fda:K250163", "company": "Stryker GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250163: T2 Alpha Femur Retrograde Nailing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250163", "people": [{"name": "Ileana Freige", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250163%22"}, {"id": "fda:K251495", "company": "Bruker Daltonics GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251495: MBT Compass HT CA Software; MBT FAST Shuttle US IVD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251495", "people": [{"name": "Kirsten Webner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251495%22"}, {"id": "fda:K243279", "company": "E.M.S Electro Medical Systems S.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243279: DOLORCLAST Focused Shock Waves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243279", "people": [{"name": "Vivian Yee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243279%22"}, {"id": "fda:K243579", "company": "Pipeline Medical Products, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243579: AeroJet Ventilation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243579", "people": [{"name": "John Morgan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243579%22"}, {"id": "fda:K251569", "company": "Osstem Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251569: Bone Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251569", "people": [{"name": "Kang Seungju", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251569%22"}, {"id": "fda:K252226", "company": "Nuwellis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-13", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252226: Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252226", "people": [{"name": "Neil Ayotte", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252226%22"}, {"id": "trialreg:NCT07120048", "company": "Edwards Lifesciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real World Data Collection on the INSPIRIS RESILIA Aortic Valve", "source_url": "https://clinicaltrials.gov/study/NCT07120048"}, {"id": "trialreg:NCT07120945", "company": "Medtronic - MITG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Hugo\u2122 Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)", "source_url": "https://clinicaltrials.gov/study/NCT07120945"}, {"id": "trialreg:NCT07120191", "company": "Concentra AI, inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Open Label Data Collection Study of My Connect Post-Op, a Post-Operative Communication Tool", "source_url": "https://clinicaltrials.gov/study/NCT07120191"}, {"id": "trialreg:NCT07119229", "company": "Pulmair Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Multi Center Study Testing a New Implant for Adults With Severe Emphysema", "source_url": "https://clinicaltrials.gov/study/NCT07119229"}, {"id": "nih:5R42AG080886-03", "company": "Tritonx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-12", "observed": "2026-08-06", "amount_usd": 860515, "summary": "NIH award 5R42AG080886-03: Clinical effectiveness of a wearable hydration device ($860,515)", "source_url": "https://reporter.nih.gov/project-details/11184499", "people": [{"name": "Eamon Johnson", "role": "Principal Investigator"}, {"name": "Joseph Piktel", "role": "Principal Investigator"}, {"name": "MARY Joan ROACH", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42EY033266-03", "company": "Chromologic, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-12", "observed": "2026-08-06", "amount_usd": 898365, "summary": "NIH award 5R42EY033266-03: NGS based metagenomic screening of ocular infections ($898,365)", "source_url": "https://reporter.nih.gov/project-details/11192272", "people": [{"name": "Espoir Kyubwa", "role": "Principal Investigator"}, {"name": "Edmund Tsui", "role": "Principal Investigator"}, {"name": "Russell N. Van Gelder", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41TR005388-01", "company": "D4z4 Medicine, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-12", "observed": "2026-08-21", "amount_usd": 313372, "summary": "NIH award 1R41TR005388-01: Long-read sequencing-based diagnosis for complex genomic and DNA methylation changes ($313,372)", "source_url": "https://reporter.nih.gov/project-details/11067939", "people": [{"name": "YI-WEN CHEN", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44GM156127-02S1", "company": "Nirrin Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-12", "observed": "2026-08-21", "amount_usd": 146702, "summary": "NIH award 3R44GM156127-02S1: A tunable laser scanning system for rapid analysis of biopharmaceutical formulations ($146,702)", "source_url": "https://reporter.nih.gov/project-details/11324147", "people": [{"name": "Bryan Hassell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42HD104305-03", "company": "Nuborn Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-12", "observed": "2026-08-21", "amount_usd": 761233, "summary": "NIH award 5R42HD104305-03: A Novel Non-Invasive Method of Dysphagia Detection in Preterm Infants: Bottle Finalization & Validation ($761,233)", "source_url": "https://reporter.nih.gov/project-details/11175450", "people": [{"name": "Katlyn Elizabeth McGrattan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44GM159469-01", "company": "Alida Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-12", "observed": "2026-08-21", "amount_usd": 1146785, "summary": "NIH award 1R44GM159469-01: Pseudouridine detection with single-base resolution in a multiplexed epitranscriptomics assay ($1,146,785)", "source_url": "https://reporter.nih.gov/project-details/11183884", "people": [{"name": "Zachary Miles", "role": "Principal Investigator"}, {"name": "Gudrun Stengel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K250836", "company": "Medical Components, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250836: 14F Duo-Flow\u00ae Side X Side Double Lumen Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250836", "people": [{"name": "Danielle McKinney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250836%22"}, {"id": "fda:K250294", "company": "Institut Straumann AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250294: Straumann\u00ae RidgeFit Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250294", "people": [{"name": "Ninda Syam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250294%22"}, {"id": "fda:K252083", "company": "Atraverse Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252083: HOTWIRE\u0099 System RF Generator and Footswitch (optional accessory)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252083", "people": [{"name": "Charles Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252083%22"}, {"id": "fda:K251494", "company": "Eko Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251494: Eko Foundation Analysis Software with Transformers (EFAST)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251494", "people": [{"name": "Sam Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251494%22"}, {"id": "fda:K243562", "company": "Idmed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243562: CuffGuard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243562", "people": [{"name": "Aurelie Gruener", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243562%22"}, {"id": "fda:K250755", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250755: DS Core Diagnosis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250755", "people": [{"name": "Deepthi Paknikar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250755%22"}, {"id": "fda:K251879", "company": "Liofilchem", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-12", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251879: Sulopenem SPM 2 \u00b5g", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251879", "people": [{"name": "Emily Hodgkins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251879%22"}, {"id": "trialreg:NCT07118124", "company": "iRhythm Technologies, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pediatric Adhesion and New Dermal Approach Study", "source_url": "https://clinicaltrials.gov/study/NCT07118124"}, {"id": "trialreg:NCT07117383", "company": "Aspargo Labs, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Hezkue\u00ae, Hezkue Turbo\u00ae, and Commercial Sildenafil Products in Fed Healthy Male Subject", "source_url": "https://clinicaltrials.gov/study/NCT07117383"}, {"id": "trialreg:NCT07118358", "company": "Biotronik, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System", "source_url": "https://clinicaltrials.gov/study/NCT07118358"}, {"id": "trialreg:NCT07117682", "company": "Cytori Therapeutics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of Autologous Adipose-Derived Regenerative Cells (ADRCs) Injection for Improving Diminished Ovarian Reserve", "source_url": "https://clinicaltrials.gov/study/NCT07117682"}, {"id": "trialreg:NCT07118501", "company": "Stryker Trauma and Extremities", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Post-Market, Clinical Follow-up Study of the Incompass\u2122 Total Ankle System", "source_url": "https://clinicaltrials.gov/study/NCT07118501"}, {"id": "trialreg:NCT07117526", "company": "Nuvascular Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Nuvascular Harbor Occlusion Device Pilot Study", "source_url": "https://clinicaltrials.gov/study/NCT07117526"}, {"id": "trialreg:NCT07119151", "company": "Neodent", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multicentric Prospective Observational Study of Neodent Implantable Devices of Helix Short System", "source_url": "https://clinicaltrials.gov/study/NCT07119151"}, {"id": "nih:5R44AG066263-04", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": 789449, "summary": "NIH award 5R44AG066263-04: Using Structured Light Sensing with Machine Learning to Detect Unwitnessed In-Home Falls ($789,449)", "source_url": "https://reporter.nih.gov/project-details/11177677", "people": [{"name": "Paul Gibson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44NS120394-03", "company": "Soterya, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": 1348207, "summary": "NIH award 5R44NS120394-03: A Device to Prevent Sudden Unexpected Death in Epilepsy (SUDEP) ($1,348,207)", "source_url": "https://reporter.nih.gov/project-details/11180278", "people": [{"name": "Pranav Bansal", "role": "Principal Investigator"}, {"name": "Jong Woo Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DK143874-01", "company": "Integrated Medical Sensors", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": 284999, "summary": "NIH award 1R43DK143874-01: Development and Validation of Efficient Algorithms for Real-Time Glucose Monitoring on a Multi-Sensor Integrated Platform ($284,999)", "source_url": "https://reporter.nih.gov/project-details/11185858", "people": [{"name": "Narges Honarvar Nazari", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG071034-04", "company": "Active Life Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": 1155353, "summary": "NIH award 5R44AG071034-04: Measuring Whole and Tissue Level Bone Strength in men ($1,155,353)", "source_url": "https://reporter.nih.gov/project-details/11196738", "people": [{"name": "Peter Burks", "role": "Principal Investigator"}, {"name": "Simon Yue-Cheong Tang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AG090216-02", "company": "Flint Rehabilitation Devices", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": 1071097, "summary": "NIH award 5R44AG090216-02: MiGo Tracker: Seamless Remote Therapeutic Monitoring of Exercise Adherence After Stroke ($1,071,097)", "source_url": "https://reporter.nih.gov/project-details/11196751", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R41AG085838-02", "company": "Weinberg Medical Physics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": 304684, "summary": "NIH award 5R41AG085838-02: Treating Balance Impairment of the Elderly with TMS-induced Brain Connectivity ($304,684)", "source_url": "https://reporter.nih.gov/project-details/11196750", "people": [{"name": "Pranav J Parikh", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG074825-03", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": 1173858, "summary": "NIH award 5R44AG074825-03: A Novel Instrument to Address Freezing of Gait in Parkinson's Patients ($1,173,858)", "source_url": "https://reporter.nih.gov/project-details/11194250", "people": [{"name": "Brian R Clark", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG063679-03", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": 880400, "summary": "NIH award 5R44AG063679-03: A Gait and Path Tortuosity System for Monitoring Cognitive Decline in Individuals at Risk for Alzheimer's Disease and/or Alzheimer's Disease Related Dementias (AD/ADRD) ($880,400)", "source_url": "https://reporter.nih.gov/project-details/11192383", "people": [{"name": "John Paul Condon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG084395-02", "company": "Vest Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-11", "observed": "2026-08-21", "amount_usd": 1066321, "summary": "NIH award 5R44AG084395-02: Mobius Accessibility Mounting System and Assistive Technology Product Line to Support Independence and Safety for Older Adults and Persons with Disabilities ($1,066,321)", "source_url": "https://reporter.nih.gov/project-details/11196766", "people": [{"name": "Chris Chovan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241731", "company": "Resnent, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K241731: Outlook Surgical Versa One System (8900139)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241731", "people": [{"name": "Willard Noyes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241731%22"}, {"id": "fda:K232456", "company": "Mediott, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K232456: RW-1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232456", "people": [{"name": "Akio Oki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232456%22"}, {"id": "fda:K251873", "company": "DeepHealth, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251873: Saige-Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251873", "people": [{"name": "B. Nathan Hunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251873%22"}, {"id": "fda:K250462", "company": "Univlabs Technologies Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250462: UL UHD-Clear View 4K Camera System (UL-3Chip 4K)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250462", "people": [{"name": "Sunil Kumar Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250462%22"}, {"id": "fda:K251327", "company": "Lutronic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251327: XERF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251327", "people": [{"name": "Cynthia Aguirre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251327%22"}, {"id": "fda:K251098", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251098: Identity Revision Humeral Stems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251098", "people": [{"name": "Patricia Beres", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251098%22"}, {"id": "fda:K252211", "company": "Cnc Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252211: Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252211", "people": [{"name": "Euna Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252211%22"}, {"id": "fda:K250207", "company": "Anker Innovations Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250207: eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250207", "people": [{"name": "Darren Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250207%22"}, {"id": "fda:K251125", "company": "Tonica Elektronik A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251125: MagVenture TMS Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251125", "people": [{"name": "Jan Kj\u00f8ller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251125%22"}, {"id": "fda:K251823", "company": "Zhejiang UE Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251823: UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251823", "people": [{"name": "Carol He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251823%22"}, {"id": "fda:K251245", "company": "Bio-Med Device, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251245: OxyMinder Pro (10310)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251245", "people": [{"name": "Max Le", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251245%22"}, {"id": "fda:K251862", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-11", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251862: External Fixation Bone Distractor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251862", "people": [{"name": "Jacqueline Sloan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251862%22"}, {"id": "trialreg:NCT07116551", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis", "source_url": "https://clinicaltrials.gov/study/NCT07116551"}, {"id": "trialreg:NCT07116668", "company": "SafeHeal Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT07116668"}, {"id": "trialreg:NCT07116135", "company": "Sonova AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Speech Understanding and Listening Effort Benefits of Hearing Instruments", "source_url": "https://clinicaltrials.gov/study/NCT07116135"}, {"id": "trialreg:NCT07114679", "company": "Smart Breast Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Molecular Breast Imaging (MBI)-Guided Biopsy", "source_url": "https://clinicaltrials.gov/study/NCT07114679"}, {"id": "trialreg:NCT07115953", "company": "Medtronic Vascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension", "source_url": "https://clinicaltrials.gov/study/NCT07115953"}, {"id": "trialreg:NCT07115732", "company": "JRI Orthopaedics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ACE Acetabular Cup Spanish PMCF Study", "source_url": "https://clinicaltrials.gov/study/NCT07115732"}, {"id": "trialreg:NCT07114562", "company": "Laser team Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety and Performance of Epicare for the Treatment of Periorbital Wrinkles", "source_url": "https://clinicaltrials.gov/study/NCT07114562"}, {"id": "trialreg:NCT07114718", "company": "Starlight Cardiovascular Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study", "source_url": "https://clinicaltrials.gov/study/NCT07114718"}, {"id": "trialreg:NCT07116525", "company": "Biosense Webster, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter", "source_url": "https://clinicaltrials.gov/study/NCT07116525"}, {"id": "nih:1R41HL180169-01", "company": "Pulseimaging.ai, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-09", "observed": "2026-08-21", "amount_usd": 304415, "summary": "NIH award 1R41HL180169-01: Cardiovascular risk prediction from AI analysis of coronary calcifications ($304,415)", "source_url": "https://reporter.nih.gov/project-details/11183552", "people": [{"name": "Ammar Hoori", "role": "Principal Investigator"}, {"name": "Juhwan Lee", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL164325-03", "company": "Ivos Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": 926634, "summary": "NIH award 5R44HL164325-03: IVOS Medical: Intubation, Optimized. ($926,634)", "source_url": "https://reporter.nih.gov/project-details/11193843", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DA064271-01", "company": "Altrumed LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": 404078, "summary": "NIH award 1R43DA064271-01: Device-Agnostic Hypoxia Detection Software for Overdose Prediction and Positive Reversal Monitoring ($404,078)", "source_url": "https://reporter.nih.gov/project-details/11239728", "people": [{"name": "Anush Lingamoorthy", "role": "Principal Investigator"}, {"name": "Olumuyiwa Oni", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DE033312-02", "company": "Innotech Precision Medicine, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": 1414853, "summary": "NIH award 2R44DE033312-02: Point of Care Detection of HPV and P16 in Saliva ($1,414,853)", "source_url": "https://reporter.nih.gov/project-details/11185068", "people": [{"name": "ROYA KHOSRAVI-FAR", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI152654-05", "company": "Miravista Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-08", "observed": "2026-08-21", "amount_usd": 988914, "summary": "NIH award 5R44AI152654-05: Development of Coccidioides Cytokine Release Assay ($988,914)", "source_url": "https://reporter.nih.gov/project-details/11142519", "people": [{"name": "Eric Holbrook", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "fda:K250817", "company": "Vive Health, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250817: Coretech Compression System (Coretech RHB3003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250817", "people": [{"name": "Joe Fleming", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250817%22"}, {"id": "fda:K250540", "company": "Elevation Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250540: SABER-C System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250540", "people": [{"name": "Frank Larosa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250540%22"}, {"id": "fda:K251713", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251713: BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251713", "people": [{"name": "Kamisha Gray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251713%22"}, {"id": "fda:K252170", "company": "Mr Surgical Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252170: OptiVu\u0099 Shoulder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252170", "people": [{"name": "Brian Karpinski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252170%22"}, {"id": "fda:K243972", "company": "Global Protection Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243972: Plain Water-based Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243972", "people": [{"name": "Christina Cataldo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243972%22"}, {"id": "fda:K250472", "company": "Amdt Holdings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250472: SixFix\u0099 Hexapod Fixator and Deformity Analysis and Correction Software (DACS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250472", "people": [{"name": "Patrick Mullaney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250472%22"}, {"id": "fda:K252176", "company": "Guangzhou Red Pine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252176: Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252176", "people": [{"name": "Weihua Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252176%22"}, {"id": "fda:K243395", "company": "Carl Zeiss Meditec Cataract Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243395: MICOR 700 with Auto I/A", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243395", "people": [{"name": "Andrew Rybold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243395%22"}, {"id": "fda:K250718", "company": "Emblation Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250718: swiftPro System (SWF-SPS); Swift System (SWF-SYS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250718", "people": [{"name": "Jack Ozer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250718%22"}, {"id": "fda:K251119", "company": "Tonica Elektronik A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251119: MagVenture TMS Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251119", "people": [{"name": "Jan Kj\u00f8ller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251119%22"}, {"id": "fda:K243254", "company": "Parkell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243254: Parkell Pit and Fissure Sealant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243254", "people": [{"name": "David Mott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243254%22"}, {"id": "fda:K243531", "company": "Integra Lifesciences Production Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243531: Codman Libert\u00eds Shunt Catheter with Bactiseal and Endexo Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243531", "people": [{"name": "David Arroyo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243531%22"}, {"id": "fda:K251801", "company": "Hebei Newangie Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251801: Diode laser device (BM091)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251801", "people": [{"name": "Ning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251801%22"}, {"id": "fda:K250142", "company": "Global Protection Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250142: Water-based Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250142", "people": [{"name": "Christina Cataldo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250142%22"}, {"id": "fda:K251226", "company": "Aqua Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251226: Aqua Medical RF Vapor Ablation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251226", "people": [{"name": "Scott McGill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251226%22"}, {"id": "pma:P240024", "company": "Nyxoah S.A.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-08-08", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P240024: Genio\u00ae System 2.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240024", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240024%22"}, {"id": "trialreg:NCT07113470", "company": "Salvia BioElectronics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache", "source_url": "https://clinicaltrials.gov/study/NCT07113470"}, {"id": "trialreg:NCT07113288", "company": "Inspire Medical Systems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study", "source_url": "https://clinicaltrials.gov/study/NCT07113288"}, {"id": "trialreg:NCT07113223", "company": "Idoven 1903 S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)", "source_url": "https://clinicaltrials.gov/study/NCT07113223"}, {"id": "nih:5R44MH122028-04", "company": "Champaign Imaging, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-07", "observed": "2026-08-06", "amount_usd": 1358125, "summary": "NIH award 5R44MH122028-04: Next Generation Pediatric Neuroimaging (NGPN) Development ($1,358,125)", "source_url": "https://reporter.nih.gov/project-details/11168945", "people": [{"name": "Curtis Andrew Corum", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44DA061662-02", "company": "Pink Cloud LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-07", "observed": "2026-08-06", "amount_usd": 960746, "summary": "NIH award 5R44DA061662-02: Digital Aftercare Assessed: An Evaluation of the Pink Cloud Application in Post-Treatment Substance Use Disorder Support. ($960,746)", "source_url": "https://reporter.nih.gov/project-details/11191566", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DE035036-01", "company": "Rytek Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-07", "observed": "2026-08-21", "amount_usd": 296171, "summary": "NIH award 1R43DE035036-01: Impedance-based bone health characterization for predictive osseointegration and patient-specific treatment ($296,171)", "source_url": "https://reporter.nih.gov/project-details/11186384", "people": [{"name": "Alicia Everitt", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA291420-02", "company": "Radiopharmaceutical Imaging And Dosimetry, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-07", "observed": "2026-08-21", "amount_usd": 749606, "summary": "NIH award 5R44CA291420-02: Cloud/Subscription based, Customer-Responsive Dosimetry Tool for alpha-Particle Emitters ($749,606)", "source_url": "https://reporter.nih.gov/project-details/11161557", "people": [{"name": "ERIC C. FREY", "role": "Principal Investigator"}, {"name": "Michael Ghaly", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K243021", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243021: Longboard Revision Hip Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243021", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243021%22"}, {"id": "fda:K243765", "company": "Sentec AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243765: LuMon(TM) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243765", "people": [{"name": "Caroline Moller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243765%22"}, {"id": "fda:K250664", "company": "UC-CARE , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250664: Navigo Workstation 2.3 (FPRMC00039)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250664", "people": [{"name": "Hadas Sheynise", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250664%22"}, {"id": "fda:K251667", "company": "Shenzhen Liyoutong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251667: LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251667", "people": [{"name": "Zhenwen Lai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251667%22"}, {"id": "fda:K250309", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250309: BTL-199", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250309", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250309%22"}, {"id": "fda:K250622", "company": "Ortho Solutions UK , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250622: Succession\u0099 AFN System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250622", "people": [{"name": "Alex Faley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250622%22"}, {"id": "fda:K251629", "company": "Medicrea International S.A.S. (Medtronic)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251629: UNiD\u0099 Spine Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251629", "people": [{"name": "Cecile Humbert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251629%22"}, {"id": "fda:K251247", "company": "Boston Scientific Neuromodulation Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-07", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251247: GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251247", "people": [{"name": "Alex Hoang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251247%22"}, {"id": "trialreg:NCT07110337", "company": "Epiminder America, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Diagnosing Epilepsy To EffeCT Change", "source_url": "https://clinicaltrials.gov/study/NCT07110337"}, {"id": "trialreg:NCT07109479", "company": "Spectrumedics Medical Technology(Shanghai)Co.,Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device", "source_url": "https://clinicaltrials.gov/study/NCT07109479"}, {"id": "trialreg:NCT07110454", "company": "Epiminder America, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up", "source_url": "https://clinicaltrials.gov/study/NCT07110454"}, {"id": "trialreg:NCT07109349", "company": "Spark Biomedical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: tAN for First Responders", "source_url": "https://clinicaltrials.gov/study/NCT07109349"}, {"id": "nih:5R43AI179513-02", "company": "Biological Mimetics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": 291139, "summary": "NIH award 5R43AI179513-02: An instrument-free malaria diagnostic ($291,139)", "source_url": "https://reporter.nih.gov/project-details/11098601", "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R41CA306716-01", "company": "Daignostx L.l.c.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-06", "observed": "2026-08-21", "amount_usd": 306798, "summary": "NIH award 1R41CA306716-01: System for Malignant Lymph Node Identification ($306,798)", "source_url": "https://reporter.nih.gov/project-details/11254551", "people": [{"name": "Jiang Hao", "role": "Principal Investigator"}, {"name": "Jing Wang", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44GM159519-01", "company": "Panluminate Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-06", "observed": "2026-08-21", "amount_usd": 1416590, "summary": "NIH award 1R44GM159519-01: pan-XLSM: an AI-powered microscopy platform for imaging and analysis of highly expanded tissue samples ($1,416,590)", "source_url": "https://reporter.nih.gov/project-details/11186242", "people": [{"name": "Ons M'Saad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AA030953-03", "company": "Thrive Digital Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-06", "observed": "2026-08-21", "amount_usd": 952214, "summary": "NIH award 5R44AA030953-03: DEVELOPMENT OF A NOVEL PEER RECOVERY SUPPORTER TRAINING PLATFORM TO DISSEMINATE EVIDENCE-BASED TRAINING AT SCALE ($952,214)", "source_url": "https://reporter.nih.gov/project-details/11163445", "people": [{"name": "Christopher Neil Pesce", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K252239", "company": "Imris Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252239: InVision\u0099 3T Recharge Operating Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252239", "people": [{"name": "Disha Kabrawala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252239%22"}, {"id": "fda:K250569", "company": "Philips France Commercial", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250569: Cardiologs Holter Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250569", "people": [{"name": "Sean Gibbons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250569%22"}, {"id": "fda:K251038", "company": "Shen Zhen Cambridge-Hit Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251038: Digital Radiographic Imaging Acquisition Software - DR (RiasDR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251038", "people": [{"name": "Zhao Ming", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251038%22"}, {"id": "fda:K252326", "company": "Tecres S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K252326: InterSpace GV Hip Spacer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252326", "people": [{"name": "Giuseppe Gazzara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252326%22"}, {"id": "fda:K242895", "company": "Aevumed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K242895: Aevumed PHANTOM Suture Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242895", "people": [{"name": "Saif Khalil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242895%22"}, {"id": "fda:K250124", "company": "Hangzhou Viction Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250124: Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250124", "people": [{"name": "Zhicong Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250124%22"}, {"id": "fda:K251120", "company": "Microlife Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251120: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251120", "people": [{"name": "Ariel Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251120%22"}, {"id": "fda:K251432", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251432: Olo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251432", "people": [{"name": "Paolo Peruzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251432%22"}, {"id": "fda:K251854", "company": "Tandem Diabetes Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K251854: SteadiSet infusion set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251854", "people": [{"name": "Karen Mudd", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251854%22"}, {"id": "fda:K250130", "company": "Hangzhou Viction Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K250130: Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250130", "people": [{"name": "Zhicong Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250130%22"}, {"id": "fda:K243552", "company": "Integra Lifesciences Production Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA 510(k) K243552: Codman Libert\u00eds\u0099 1.5 mm EVD Catheter with Bactiseal\u00ae and Endexo\u00ae Technology with Luer Connection (821761); Codman Libert\u00eds\u0099 1.9 mm EVD Catheter with Bactiseal\u00ae and Endexo\u00ae Technology with Luer Connection (821762)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243552", "people": [{"name": "Kali Sacco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243552%22"}, {"id": "pma:P250012", "company": "Medtronic Minimed, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-08-06", "observed": "2026-08-06", "amount_usd": null, "summary": "FDA PMA approval P250012: Simplera Sync Sensor, Guardian 4 Sensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250012", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250012%22"}, {"id": "trialreg:NCT07108088", "company": "\u00d6SSUR France", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the NEUROSWING Orthosis on Walking Speed in a Population With Dorsal and/or Plantar Flexor Deficits, With a View to a Reimbursement Application", "source_url": "https://clinicaltrials.gov/study/NCT07108088"}, {"id": "trialreg:NCT07106788", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Aveir Leadless Pacemaker Japan PMS", "source_url": "https://clinicaltrials.gov/study/NCT07106788"}, {"id": "trialreg:NCT07106242", "company": "MedtronicNeuro", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Adaptive Deep Brain Stimulation (aDBS) Study (Early Adapter) Part II", "source_url": "https://clinicaltrials.gov/study/NCT07106242"}, {"id": "trialreg:NCT07106021", "company": "Kenai Therapeutics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease", "source_url": "https://clinicaltrials.gov/study/NCT07106021"}, {"id": "trialreg:NCT07108205", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Image Quality Study of Spectral Precise Image CT 7700", "source_url": "https://clinicaltrials.gov/study/NCT07108205"}, {"id": "trialreg:NCT07108179", "company": "Sinocare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Continuous Glucose Monitoring System: Accuracy and Prognostic Value in Critically Ill Patients", "source_url": "https://clinicaltrials.gov/study/NCT07108179"}, {"id": "trialreg:NCT07107022", "company": "Penumbra Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study to Collect Real-world Performance and Safety Data on Penumbra System\u00ae in Population With Acute Ischemic Stroke (AIS).", "source_url": "https://clinicaltrials.gov/study/NCT07107022"}, {"id": "trialreg:NCT07107581", "company": "Exactech", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Exactech Knee Systems Post Market Clinical Follow-up", "source_url": "https://clinicaltrials.gov/study/NCT07107581"}, {"id": "nih:5R44AG072981-03", "company": "Amissa, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": 1103635, "summary": "NIH award 5R44AG072981-03: Empowering Advanced Alzheimers Disease and Dementia Research Through Remote Patient Monitoring and Cloud-Connected Wearable Devices ($1,103,635)", "source_url": "https://reporter.nih.gov/project-details/11196719", "people": [{"name": "Jon Andrew Corkey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DA059519-02", "company": "Dynamicare Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": 1011586, "summary": "NIH award 5R44DA059519-02: Decentralized clinical trial of contingency management digital therapeutic to treat stimulant use disorder ($1,011,586)", "source_url": "https://reporter.nih.gov/project-details/11184245", "people": [{"name": "David R Gastfriend", "role": "Principal Investigator"}, {"name": "Carla J Rash", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG063589-03", "company": "Tymora Analytical Operations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": 854102, "summary": "NIH award 5R44AG063589-03: Validation and clinicaldevelopment of plasma EV protein biomarkers for minimally-invasive detection of Alzheimersdisease ($854,102)", "source_url": "https://reporter.nih.gov/project-details/11195528", "people": [{"name": "Anton Iliuk", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG084365-03", "company": "Plans4care Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": 571950, "summary": "NIH award 5R44AG084365-03: Plans4Care: Personalized Dementia Care On-Demand ($571,950)", "source_url": "https://reporter.nih.gov/project-details/11184513", "people": [{"name": "Eric Jutkowitz", "role": "Principal Investigator"}, {"name": "Sokha Koeuth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG061985-07", "company": "Zetroz Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": 2359304, "summary": "NIH award 5R44AG061985-07: Daily & Localized NSAID Sonophoresis for Symptomatic Treatment of Knee Osteoarthritis ($2,359,304)", "source_url": "https://reporter.nih.gov/project-details/11194246", "people": [{"name": "George Kenneth Lewis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "nih:5R44AG082637-03", "company": "Moai Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": 851210, "summary": "NIH award 5R44AG082637-03: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in at-risk Older Adults ($851,210)", "source_url": "https://reporter.nih.gov/project-details/11177954", "people": [{"name": "Olu Olofinboba", "role": "Principal Investigator"}, {"name": "Dereck L Salisbury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44ES035679-02", "company": "Ondavia, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": 567645, "summary": "NIH award 5R44ES035679-02: Automated, in-line hexavalent chromium analyzer ($567,645)", "source_url": "https://reporter.nih.gov/project-details/11181257", "people": [{"name": "Mark C Peterman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07105332", "company": "EyeSense GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Trial of a Sub-conjunctival Insert", "source_url": "https://clinicaltrials.gov/study/NCT07105332"}, {"id": "trialreg:NCT07104279", "company": "Zimmer Biomet", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Z1 Hip System: Post-Market Clinical Follow Up Study", "source_url": "https://clinicaltrials.gov/study/NCT07104279"}, {"id": "trialreg:NCT07104773", "company": "CooperVision International Limited (CVIL)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation of Proclear\u00ae 1 Day and MyDay\u00ae Sphere Contact Lenses", "source_url": "https://clinicaltrials.gov/study/NCT07104773"}, {"id": "trialreg:NCT07103330", "company": "Abyrx, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Cranial Flap Fixation With Montage Flowable Settable Bone Paste", "source_url": "https://clinicaltrials.gov/study/NCT07103330"}, {"id": "trialreg:NCT07103057", "company": "Viz.ai, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: VIZ ACCESS HCM - Multi-Site Registry", "source_url": "https://clinicaltrials.gov/study/NCT07103057"}, {"id": "trialreg:NCT07104253", "company": "Endocision Technologies Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Establishing Feasibility of Transbronchial Cryoablation With an In-Development Cryoprobe: An Ex-Vivo Human Lung Model", "source_url": "https://clinicaltrials.gov/study/NCT07104253"}, {"id": "fda:K252113", "company": "Bethesda Medical Devices", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K252113: PRADO\u0099 Lumbar Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252113", "people": [{"name": "Amanda Shade", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252113%22"}, {"id": "fda:K250434", "company": "Nanosonics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250434: trophon2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250434", "people": [{"name": "Nancy Kaiser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250434%22"}, {"id": "fda:K250246", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250246: uMR Jupiter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250246", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250246%22"}, {"id": "fda:K251411", "company": "Simplivia Healthcare , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251411: Chemfort Female Luer Lock Adaptor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251411", "people": [{"name": "Shay Shaham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251411%22"}, {"id": "fda:K252141", "company": "Encore Medical L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K252141: AltiVate Reverse\u00ae Glenoid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252141", "people": [{"name": "Patricia Kontoudis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252141%22"}, {"id": "fda:K250934", "company": "Respiree Pte, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250934: Respiree Cardio- Respiratory Monitor System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250934", "people": [{"name": "Samantha Chow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250934%22"}, {"id": "fda:K244016", "company": "Claritas Healthtech Pte, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244016: iPETcertum (v1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244016", "people": [{"name": "Devika Dutt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244016%22"}, {"id": "pma:P250003", "company": "Instylla, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P250003: Embrace(TM) Hydrogel Embolic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250003", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250003%22"}, {"id": "nih:5R44MD019611-02", "company": "Pavmed Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-04", "observed": "2026-08-21", "amount_usd": 931489, "summary": "NIH award 5R44MD019611-02: Bridging the Gap: Enhancing Cancer Care for Underserved Populations with the Veris Health Cancer Care Platform ($931,489)", "source_url": "https://reporter.nih.gov/project-details/11196216", "people": [{"name": "Brian deGuzman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44EB033725-03", "company": "Health Discovery Labs LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-04", "observed": "2026-08-21", "amount_usd": 1095012, "summary": "NIH award 5R44EB033725-03: Closed Loop Electrical Muscle Stimulation System (CL-EMS) with improved safety for ICU environment to mitigate ICU Acquired Weakness ($1,095,012)", "source_url": "https://reporter.nih.gov/project-details/11182586", "people": [{"name": "Oussama Hassan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43OD037840-01", "company": "Geegah LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-04", "observed": "2026-08-21", "amount_usd": 246718, "summary": "NIH award 1R43OD037840-01: Transforming C. Elegans Research Through Gigahertz Ultrasonic Imaging Microscopy ($246,718)", "source_url": "https://reporter.nih.gov/project-details/11008422", "people": [{"name": "Justin C Kuo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K251223", "company": "H&abyz Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251223: HnX-P1, HnX-PB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251223", "people": [{"name": "Jimin Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251223%22"}, {"id": "fda:K251762", "company": "Spectrum Medical S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251762: Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251762", "people": [{"name": "Raffaella Tommasini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251762%22"}, {"id": "fda:K250950", "company": "Okapi Medical, LLC Dba Resivant Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250950: CUTIVA\u0099 Topical Skin Adhesive (RM1700); CUTIVA\u0099 PLUS Skin Closure System (RM1739)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250950", "people": [{"name": "Stephens Tom", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250950%22"}, {"id": "fda:K251113", "company": "Andon Health Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251113: iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251113", "people": [{"name": "Liu Yi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251113%22"}, {"id": "fda:K251122", "company": "Terragene", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251122: Terragene\u00ae Bionova\u00ae BT20 Biological Indicator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251122", "people": [{"name": "Hernando Carrizo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251122%22"}, {"id": "fda:K251087", "company": "Daxor Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251087: Blood Volume Analyzer (200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251087", "people": [{"name": "Jonathan Feldschuh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251087%22"}, {"id": "trialreg:NCT07102160", "company": "Argon Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking", "source_url": "https://clinicaltrials.gov/study/NCT07102160"}, {"id": "trialreg:NCT07100626", "company": "Incisive Technologies Pty Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: In-situ Clinical Trial Assessing Ability to Detect and Monitor Active Caries and Their Remineralization", "source_url": "https://clinicaltrials.gov/study/NCT07100626"}, {"id": "trialreg:NCT07102537", "company": "Espad Pharmed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Efficacy and Safety of Intella Dermal Filler in Moderate to Severe Nasolabial Folds", "source_url": "https://clinicaltrials.gov/study/NCT07102537"}, {"id": "trialreg:NCT07100340", "company": "Caranx Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)", "source_url": "https://clinicaltrials.gov/study/NCT07100340"}, {"id": "trialreg:NCT07101809", "company": "Calyxo, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology", "source_url": "https://clinicaltrials.gov/study/NCT07101809"}, {"id": "trialreg:NCT07100522", "company": "Luxottica Group S.p.A.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of the Nuance Audio Hearing Aid in Adults With Mild to Moderate Hearing Difficulties", "source_url": "https://clinicaltrials.gov/study/NCT07100522"}, {"id": "nih:5R44HL167296-03", "company": "Aventusoft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-02", "observed": "2026-08-21", "amount_usd": 860397, "summary": "NIH award 5R44HL167296-03: A mobile health framework for left ventricular end diastolic pressure diagnostics and monitoring. ($860,397)", "source_url": "https://reporter.nih.gov/project-details/11138551", "people": [{"name": "Kaustubh Kale", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43TR005404-01", "company": "Capienda Biotech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": 329272, "summary": "NIH award 1R43TR005404-01: High-throughput kinetic system for small-molecule drug discovery ($329,272)", "source_url": "https://reporter.nih.gov/project-details/11069377", "people": [{"name": "Mark Aguirre Bernard", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44EB036883-01A1", "company": "Glimpse Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": 1535084, "summary": "NIH award 1R44EB036883-01A1: Deep learning image classification model for pediatric ear disease ($1,535,084)", "source_url": "https://reporter.nih.gov/project-details/11185784", "people": [{"name": "Courtney Hill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH142264-01", "company": "Spikegadgets, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": 1266318, "summary": "NIH award 1R44MH142264-01: A Commercial Platform for High-Volume Behavior and Electrophysiology Research ($1,266,318)", "source_url": "https://reporter.nih.gov/project-details/11255648", "people": [{"name": "Loren M Frank", "role": "Principal Investigator"}, {"name": "Mattias Peter Karlsson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44MH140129-02", "company": "In Vivo Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": 1092787, "summary": "NIH award 4R44MH140129-02: A modular bioluminescence imaging platform using a novel multi-aperture method ($1,092,787)", "source_url": "https://reporter.nih.gov/project-details/11194643", "people": [{"name": "Alexander D. Klose", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07098572", "company": "MED-EL Elektromedizinische Ger\u00e4te GesmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparison of Four-Channel Functional Electrical Stimulation vs. One-Channel Electrical Stimulation on Moderate Arm/Hand Paresis in Subacute Stroke Patients", "source_url": "https://clinicaltrials.gov/study/NCT07098572"}, {"id": "trialreg:NCT07098195", "company": "Poly Medicure Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: To Evaluate the Performance and Safety of RisoR Crest Everolimus Eluting Coronary Stent System", "source_url": "https://clinicaltrials.gov/study/NCT07098195"}, {"id": "trialreg:NCT07098858", "company": "EBR Systems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The WiSE\u00ae-UP Registry (The WiSE System Utilization & Performance Registry)", "source_url": "https://clinicaltrials.gov/study/NCT07098858"}, {"id": "trialreg:NCT07099716", "company": "Aktiia SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-08-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: OBPM_HARMONY: Physiological Data Recording Over 24 Hours Using the Continual Optical Hilo Blood Pressure Monitor and an Ambulatory Blood Pressure Monitor", "source_url": "https://clinicaltrials.gov/study/NCT07099716"}, {"id": "fda:K243448", "company": "Exactech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243448: Equinoxe\u00ae Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243448", "people": [{"name": "Liz Howell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243448%22"}, {"id": "fda:K250508", "company": "Vantive US Healthcare, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250508: AK 98 Dialysis Machine (955607)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250508", "people": [{"name": "Kristen Bozzelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250508%22"}, {"id": "fda:K251707", "company": "Shenzhen Huachuangtong Industrial Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251707: IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251707", "people": [{"name": "Qixin Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251707%22"}, {"id": "fda:K243496", "company": "Pearl Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243496: MycoMEIA Aspergillus Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243496", "people": [{"name": "Irina Baburina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243496%22"}, {"id": "fda:K250941", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250941: Revolution Vibe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250941", "people": [{"name": "Helen Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250941%22"}, {"id": "fda:K250315", "company": "AIRS, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250315: RONAVIS \u0096 FX (FX-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250315", "people": [{"name": "Sanghyun Joung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250315%22"}, {"id": "fda:K251652", "company": "American Medical Endoscopy, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251652: Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251652", "people": [{"name": "Matthew Schwimmer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251652%22"}, {"id": "fda:K252094", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K252094: eZSURE\u0099 Empty Fluid Container", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252094", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252094%22"}, {"id": "fda:K250495", "company": "Avizor S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250495: MINI VP1 (PL67_F); MINI VP1 (PL61_F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250495", "people": [{"name": "Alberto Rodr\u00edguez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250495%22"}, {"id": "fda:K243462", "company": "Diazyme Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243462: Diazyme Colorimetric Lithium Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243462", "people": [{"name": "Abhijit Datta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243462%22"}, {"id": "fda:K250790", "company": "Dk Medical Systems Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250790: INNOVISION-DXII", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250790", "people": [{"name": "Sung-moon Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250790%22"}, {"id": "fda:K250541", "company": "GI Windows, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250541: Self-Forming Magnet (Flexagon Plus OTOLoc)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250541", "people": [{"name": "Yverre Bobay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250541%22"}, {"id": "fda:K251252", "company": "Shandong Huge Dental Material Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251252: NOBILCAM IMPAK Disc", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251252", "people": [{"name": "Maggie Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251252%22"}, {"id": "fda:K243427", "company": "Dentalhitec", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243427: QuickSleeper 5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243427", "people": [{"name": "Olivier Villette", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243427%22"}, {"id": "fda:K243841", "company": "Deka Research and Development", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243841: Sparta Infusion Set for Insulin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243841", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243841%22"}, {"id": "fda:K250381", "company": "DeepSight Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250381: Deepsight NeedleVue LC1 Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250381", "people": [{"name": "David Surber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250381%22"}, {"id": "fda:K243458", "company": "Access Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243458: HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243458", "people": [{"name": "Brian Hanley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243458%22"}, {"id": "fda:K243483", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243483: Access hsTnI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243483", "people": [{"name": "Stephanie Garth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243483%22"}, {"id": "nih:5R44AI170131-03", "company": "Big Eye Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": 842379, "summary": "NIH award 5R44AI170131-03: Ultrasensitive, High-Specificity Rapid Test to Support the End-Game of the Global Program to Eliminate Lymphatic Filariasis ($842,379)", "source_url": "https://reporter.nih.gov/project-details/11137772", "people": [{"name": "Marco Antonio Biamonte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AI179310-03", "company": "Scanogen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": 999828, "summary": "NIH award 5R44AI179310-03: Highly Multiplexed Single Molecule Tethering ($999,828)", "source_url": "https://reporter.nih.gov/project-details/11139424", "people": [{"name": "Alfredo Andres Celedon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43GM159454-01", "company": "Doty Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": 299985, "summary": "NIH award 1R43GM159454-01: An HR-MAS H/F/X/Y UHF NMR Probe for Allosteric Drug Research at Physiological Conditions ($299,985)", "source_url": "https://reporter.nih.gov/project-details/11183538", "people": [{"name": "Francis DAVID Doty", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44NS139748-01A1", "company": "Savanna Biotherapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": 1489811, "summary": "NIH award 1R44NS139748-01A1: Engineered microglia for the treatment of Adult-onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP) ($1,489,811)", "source_url": "https://reporter.nih.gov/project-details/11181342", "people": [{"name": "Sunil Gandhi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA062438-01", "company": "Biomotivate, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": 306872, "summary": "NIH award 1R43DA062438-01: PEACE Platform for Non-Invasive Narrative Neuromodulation (Personalized Evocative Audiovisual Content for Everyone) ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11068353", "people": [{"name": "Jeremy Guttman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EB034605-03", "company": "Axioforce Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": 893313, "summary": "NIH award 5R44EB034605-03: 3D force sensing insoles for wearable, AI empowered, high-fidelity gait monitoring ($893,313)", "source_url": "https://reporter.nih.gov/project-details/11178697", "people": [{"name": "Jonathan Daniel Miller", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA287829-02", "company": "Precision Epigenomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": 1041709, "summary": "NIH award 5R44CA287829-02: Development of a Molecular Assay to Diagnose Malignant Pleural Effusions ($1,041,709)", "source_url": "https://reporter.nih.gov/project-details/11143911", "people": [{"name": "Mark Anthony Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07094971", "company": "Sofwave Medical LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles", "source_url": "https://clinicaltrials.gov/study/NCT07094971"}, {"id": "trialreg:NCT07097740", "company": "Mitrassist Lifesciences Limited Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve", "source_url": "https://clinicaltrials.gov/study/NCT07097740"}, {"id": "trialreg:NCT07095660", "company": "Intervene, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)", "source_url": "https://clinicaltrials.gov/study/NCT07095660"}, {"id": "trialreg:NCT07096856", "company": "CMR Surgical Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System", "source_url": "https://clinicaltrials.gov/study/NCT07096856"}, {"id": "fda:K243571", "company": "Zimmer Biomet", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243571: Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243571", "people": [{"name": "Sean Gleason", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243571%22"}, {"id": "fda:DEN240068", "company": "Artera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240068: ArteraAI Prostate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240068", "people": [{"name": "Candice Bautista-Biddle", "role": "510(k) submission contact"}]}, {"id": "fda:K244060", "company": "Lutronic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244060: eCO2 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244060", "people": [{"name": "Sarah Dunne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244060%22"}, {"id": "fda:K251574", "company": "Ambulatory Monitoring, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251574: Sleep Watch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251574", "people": [{"name": "Paul Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251574%22"}, {"id": "fda:K243455", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243455: cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243455", "people": [{"name": "Claudia Machay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243455%22"}, {"id": "fda:K251561", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251561: Biograph Trinion", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251561", "people": [{"name": "Alaine Medio", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251561%22"}, {"id": "fda:K250597", "company": "Remedi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250597: REMEX Xcam6", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250597", "people": [{"name": "Seong-Geun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250597%22"}, {"id": "fda:K242728", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242728: BeneVision Central Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242728", "people": [{"name": "Lei Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242728%22"}, {"id": "fda:K243656", "company": "United Orthopedic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243656: U2 Total Knee System \u0096 PF+ Patella; USTAR II System\u0096 PF+ Patella", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243656", "people": [{"name": "Lois Ho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243656%22"}, {"id": "fda:K250843", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250843: Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250843", "people": [{"name": "Xiaoyan Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250843%22"}, {"id": "fda:K243341", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243341: Genius AI Detection 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243341", "people": [{"name": "Julia Vaillancourt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243341%22"}, {"id": "fda:K241461", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241461: Mpact Constrained Liner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241461", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241461%22"}, {"id": "fda:K250477", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250477: NextAR(TM) Spine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250477", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250477%22"}, {"id": "fda:K250738", "company": "Siemens Medical Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250738: YSIO X.pree", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250738", "people": [{"name": "Camila Rodriguez Valentin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250738%22"}, {"id": "denovo:DEN240068", "company": "Artera, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-07-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240068 granted: ArteraAI Prostate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240068"}, {"id": "breakthrough:DEN240068", "company": "Artera, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-07-31", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN240068: ARTERA AI PROSTATE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:2R44DK104299-04", "company": "Silicon Kidney, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 2R44DK104299-04: An intravascular Bioartificial Pancreas (iBAP) ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11068853", "people": [{"name": "Charles Blaha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:3R44HD112264-03S1", "company": "Inherent Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44HD112264-03S1: Novel Epigenetic Test for the Treatment and Improvement of Longitudinal Health-Outcomes for Men with Severe Infertility ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11370929", "people": [{"name": "Kristin R Brogaard", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41AG094413-01", "company": "Vest Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": 397982, "summary": "NIH award 1R41AG094413-01: Development and Feasibility Testing of PrivyPod - a modular bathroom to support aging in place ($397,982)", "source_url": "https://reporter.nih.gov/project-details/11185075", "people": [{"name": "Chris Chovan", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM145205-02", "company": "Bioinvision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": 1221189, "summary": "NIH award 2R44GM145205-02: TissueReM: Whole-Organism, Real-time Decision-enabled 3D Tissue Imaging and Recovery for Molecular Analysis ($1,221,189)", "source_url": "https://reporter.nih.gov/project-details/11068695", "people": [{"name": "SUSANN M BRADY-KALNAY", "role": "Principal Investigator"}, {"name": "Madhusudhana Gargesha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44DK141388-02", "company": "Vortex Medical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": 804215, "summary": "NIH award 4R44DK141388-02: Developing a novel vesico-amniotic shunt to treat fetal lower urinary tract obstruction ($804,215)", "source_url": "https://reporter.nih.gov/project-details/11248666", "people": [{"name": "Eric Johnson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL174366-02", "company": "Inspire Rx LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": 986477, "summary": "NIH award 5R44HL174366-02: Personal Respiratory Isolation System for Safe Transport and Treatment of Patients with Highly Transmissible Infectious Diseases ($986,477)", "source_url": "https://reporter.nih.gov/project-details/11194439", "people": [{"name": "Sridhar Kota", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL180139-01", "company": "Panluminate Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": 312148, "summary": "NIH award 1R43HL180139-01: High-throughput spatial proteomics in pulmonary research with FLASH multiplex imaging ($312,148)", "source_url": "https://reporter.nih.gov/project-details/11184674", "people": [{"name": "Ons M'Saad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM159290-03", "company": "Alida Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": 1082339, "summary": "NIH award 5R44GM159290-03: Engineered RNA Modification Recognition ($1,082,339)", "source_url": "https://reporter.nih.gov/project-details/11173669", "people": [{"name": "Zachary Miles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43NS145940-01", "company": "Arsenal Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": 314363, "summary": "NIH award 1R43NS145940-01: Engineering a Middle Meningeal Artery Embolization Model with Hydrophilicity and Hydraulic Resistance ($314,363)", "source_url": "https://reporter.nih.gov/project-details/11255722", "people": [{"name": "QUYNH P PHAM", "role": "Principal Investigator"}, {"name": "Chander Sadasivan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07093736", "company": "Fisher Wallace Laboratories", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study Comparing Immediate Treatment to Deferred Treatment With the Fisher Wallace (FW) Stimulator FW-200 Device for the Treatment of Self-reported Anxiety in First Responders", "source_url": "https://clinicaltrials.gov/study/NCT07093736"}, {"id": "trialreg:NCT07092579", "company": "Comeback Mobility Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures", "source_url": "https://clinicaltrials.gov/study/NCT07092579"}, {"id": "fda:K244007", "company": "Cardio Ring Technologies, Inc. Taiwan Branch", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244007: ArteVu", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244007", "people": [{"name": "Wen-Pin Shih", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244007%22"}, {"id": "fda:K251735", "company": "Acuity Surgical Devices, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251735: Stabilis SA Cervical Stand-Alone System (Various PNs)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251735", "people": [{"name": "Chuck Forton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251735%22"}, {"id": "fda:K241990", "company": "Hydrocision, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241990: SpineSite Endoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241990", "people": [{"name": "Mark Lewis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241990%22"}, {"id": "fda:K242855", "company": "E.O.S Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242855: P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242855", "people": [{"name": "Junghwa Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242855%22"}, {"id": "fda:K243919", "company": "Hermes Medical Solutions AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243919: Voxel Dosimetry (00859873006226)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243919", "people": [{"name": "Hanne Grinaker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243919%22"}, {"id": "fda:K250724", "company": "Spectrum Vascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250724: Intraosseous Infusion Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250724", "people": [{"name": "Sharon Klugewicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250724%22"}, {"id": "fda:K252032", "company": "Tonica Elektronik A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K252032: T65 (9016E061-)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252032", "people": [{"name": "Jan Kj\u00f8ller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252032%22"}, {"id": "fda:K251060", "company": "Providence Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251060: CORUS\u0099 Navigation System-GX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251060", "people": [{"name": "Edward Liou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251060%22"}, {"id": "fda:K251706", "company": "Changsha Anxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251706: TENS and EMS Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251706", "people": [{"name": "William (Qunqi) Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251706%22"}, {"id": "fda:K251361", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251361: Tyber Medical Distal Radius Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251361", "people": [{"name": "Nicole Merlini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251361%22"}, {"id": "fda:K251234", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251234: EnSite\u0099 X EP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251234", "people": [{"name": "Hailey Christain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251234%22"}, {"id": "fda:K252144", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K252144: Iconix Speed Anchor; Iconix Speed HA+ Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252144", "people": [{"name": "Bianca Silva de Sousa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252144%22"}, {"id": "fda:K251076", "company": "Shenzhen Lifotronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251076: Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251076", "people": [{"name": "Lei Xiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251076%22"}, {"id": "fda:K250127", "company": "Tsk Laboratory, Japan", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250127: TSK Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250127", "people": [{"name": "Yumi Ueda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250127%22"}, {"id": "fda:K251319", "company": "Hartalega NGC Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251319: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) \u0096 Extended Cuff", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251319", "people": [{"name": "Kuan Mun Leong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251319%22"}, {"id": "fda:K243534", "company": "Suzhou Zenith Vascular SciTech Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243534: Micro Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243534", "people": [{"name": "Xia Jie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243534%22"}, {"id": "pma:P240039", "company": "SetPoint Medical", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240039: SetPoint System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240039", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240039%22"}, {"id": "breakthrough:P240039", "company": "Setpoint Medical", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-07-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P240039: SETPOINT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44TR003071-03", "company": "Insightfil", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": 705586, "summary": "NIH award 5R44TR003071-03: Personalized multi-medication packaging with integrated real-time instrumentation to improve adherence ($705,586)", "source_url": "https://reporter.nih.gov/project-details/11196731", "people": [{"name": "Edward Acworth", "role": "Principal Investigator"}, {"name": "Kimberly Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42TR005299-02", "company": "Cellchorus Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": 1128853, "summary": "NIH award 4R42TR005299-02: LF-TIMING: Large-scale label-free profiling of cell-cell interactions ($1,128,853)", "source_url": "https://reporter.nih.gov/project-details/11167085", "people": [{"name": "Rebecca L Berdeaux", "role": "Principal Investigator"}, {"name": "BADRINATH ROYSAM", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43ES038032-01", "company": "Biota Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": 306789, "summary": "NIH award 1R43ES038032-01: Bringing PFAS Monitoring Home: An Integrated Magnetic Nanoparticle and Lateral Flow Assay System ($306,789)", "source_url": "https://reporter.nih.gov/project-details/11253902", "people": [{"name": "Rose T Byrne-Nash", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AR078728-03", "company": "Penderia Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": 871149, "summary": "NIH award 5R44AR078728-03: Real-time Feedback for Post-Operative Rehabilitation of Rotator Cuff Repairs using Wireless Force-Sensing Suture Anchors ($871,149)", "source_url": "https://reporter.nih.gov/project-details/11170023", "people": [{"name": "Salil Sidharthan Karipott", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43GM161135-01", "company": "Molecular Intelligence LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": 217941, "summary": "NIH award 1R43GM161135-01: Modeling Receptor-ligand interactions for Drug Discoveryfrom Cryo-EM data using AI ($217,941)", "source_url": "https://reporter.nih.gov/project-details/11252427", "people": [{"name": "Dongwook Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG066325-04A1", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": 1499986, "summary": "NIH award 2R44AG066325-04A1: Developing an Intraoperative EEG-Guided Precision Anesthesia Management System to Prevent Postoperative Delirium in Elderly and Patients at Risk for Alzheimer's & Related Dementias ($1,499,986)", "source_url": "https://reporter.nih.gov/project-details/11184607", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44CA285081-02A1", "company": "Am Operating LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": 1116368, "summary": "NIH award 2R44CA285081-02A1: Development of a novel visualization, labeling, and tracking engine for human anatomy. ($1,116,368)", "source_url": "https://reporter.nih.gov/project-details/11182402", "people": [{"name": "Matthew Alexander Molenda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07091682", "company": "Biotronik AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07091682"}, {"id": "trialreg:NCT07092072", "company": "Novar Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Tolerance of Full Field Peripheral Defocus Spectacles for the Control of Myopia Progression (Myofix Study)", "source_url": "https://clinicaltrials.gov/study/NCT07092072"}, {"id": "trialreg:NCT07092059", "company": "DynamiCare Health", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Smartphone Services for Stimulant Use Disorder", "source_url": "https://clinicaltrials.gov/study/NCT07092059"}, {"id": "trialreg:NCT07090811", "company": "Solo Pace, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement", "source_url": "https://clinicaltrials.gov/study/NCT07090811"}, {"id": "trialreg:NCT07090005", "company": "Nitinotes Surgical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients", "source_url": "https://clinicaltrials.gov/study/NCT07090005"}, {"id": "trialreg:NCT07091825", "company": "Avizor SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Efficacy and Safety of Contact Lens Lubricant in Rigid Gas Permeable Corneal Contact Lens Wearers", "source_url": "https://clinicaltrials.gov/study/NCT07091825"}, {"id": "trialreg:NCT07090395", "company": "ProSomnus Sleep Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Severe Label Expansion for EVO Products Trial", "source_url": "https://clinicaltrials.gov/study/NCT07090395"}, {"id": "trialreg:NCT07092020", "company": "Carl Zeiss Meditec AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL)", "source_url": "https://clinicaltrials.gov/study/NCT07092020"}, {"id": "trialreg:NCT07091773", "company": "LTBIO Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty", "source_url": "https://clinicaltrials.gov/study/NCT07091773"}, {"id": "trialreg:NCT07091916", "company": "Medtronic Cardiac Rhythm and Heart Failure", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study", "source_url": "https://clinicaltrials.gov/study/NCT07091916"}, {"id": "fda:K251523", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251523: Cios Spin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251523", "people": [{"name": "Patricia Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251523%22"}, {"id": "fda:K250356", "company": "Infobionic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250356: MoMe ARC\u00ae Wireless Ambulatory ECG Monitoring and Detection System (32000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250356", "people": [{"name": "Dave MacCutcheon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250356%22"}, {"id": "fda:K251350", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251350: BD Plastipak\u0099 Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251350", "people": [{"name": "Anamika Tiwari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251350%22"}, {"id": "fda:K251364", "company": "Sleepiz AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251364: Sleepiz One+ (2.5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251364", "people": [{"name": "Marta Stepien", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251364%22"}, {"id": "fda:K250179", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250179: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250179", "people": [{"name": "Tracy Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250179%22"}, {"id": "fda:K243473", "company": "Prognosys Medical Systems Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243473: PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243473", "people": [{"name": "Krishna Prasad Vajapeyam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243473%22"}, {"id": "fda:K243407", "company": "Forcyte Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243407: Forcyte Autograft Harvest Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243407", "people": [{"name": "Robert Assell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243407%22"}, {"id": "fda:K251664", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251664: Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251664", "people": [{"name": "Jillian Connery", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251664%22"}, {"id": "fda:K250442", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250442: da Vinci Surgical System, IS5000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250442", "people": [{"name": "Justin Florence", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250442%22"}, {"id": "fda:K250647", "company": "Sivantage", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250647: SImmetry+ System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250647", "people": [{"name": "Brian Ranft", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250647%22"}, {"id": "nih:5R44HL176464-02", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-28", "observed": "2026-08-21", "amount_usd": 894687, "summary": "NIH award 5R44HL176464-02: Leveraging Interactive Digital Technology to Increase Access to Family-Based Behavioral Treatment for Childhood Obesity ($894,687)", "source_url": "https://reporter.nih.gov/project-details/11142410", "people": [{"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}, {"name": "Leonard H Epstein", "role": "Principal Investigator"}, {"name": "Denise Ella Wilfley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK142209-01", "company": "Klein Buendel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-28", "observed": "2026-08-21", "amount_usd": 300172, "summary": "NIH award 1R43DK142209-01: NoWeigh: Development of a Physical Activity Promotion Mobile App for WomenBased on Body Neutrality and Self-Determination Theory ($300,172)", "source_url": "https://reporter.nih.gov/project-details/11062968", "people": [{"name": "Kayla Nuss", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS122713-03", "company": "Imggyd LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-28", "observed": "2026-08-21", "amount_usd": 1178417, "summary": "NIH award 5R44NS122713-03: AccuGyd: Accelerated Guidance for Accurate MRI-Guided Neurosurgery ($1,178,417)", "source_url": "https://reporter.nih.gov/project-details/11141751", "people": [{"name": "TERRENCE R OAKES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07087639", "company": "Eurosets S.r.l.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Novel Venous Cannula Trial", "source_url": "https://clinicaltrials.gov/study/NCT07087639"}, {"id": "trialreg:NCT07087353", "company": "Resilience", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy of Remote Monitoring in Patients Treated for Moderate to Severe Major Depressive Episodes", "source_url": "https://clinicaltrials.gov/study/NCT07087353"}, {"id": "trialreg:NCT07088055", "company": "Myo Munchee (Operations) Pty Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Trial to Compare the Effects of Myo Munchee Therapy and Oral Motor Therapy (OMT) in Pediatric Patients to Treat Maxillary Deficiency and Orofacial Myofunctional Dysfunction (OMD).", "source_url": "https://clinicaltrials.gov/study/NCT07088055"}, {"id": "trialreg:NCT07089615", "company": "Capso Vision, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference", "source_url": "https://clinicaltrials.gov/study/NCT07089615"}, {"id": "trialreg:NCT07089420", "company": "American Laboratory Products Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects", "source_url": "https://clinicaltrials.gov/study/NCT07089420"}, {"id": "trialreg:NCT07089836", "company": "American Laboratory Products Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.", "source_url": "https://clinicaltrials.gov/study/NCT07089836"}, {"id": "trialreg:NCT07087613", "company": "Eko Devices, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG", "source_url": "https://clinicaltrials.gov/study/NCT07087613"}, {"id": "trialreg:NCT07089355", "company": "Toro Neurovascular, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study Evaluating Toro 88 Super Bore Aspiration Catheter for Acute Ischemic Stroke", "source_url": "https://clinicaltrials.gov/study/NCT07089355"}, {"id": "trialreg:NCT07089576", "company": "Artivion Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA", "source_url": "https://clinicaltrials.gov/study/NCT07089576"}, {"id": "fda:K251640", "company": "Baxter Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251640: SIGMA Spectrum Infusion Pump with Master Drug Library", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251640", "people": [{"name": "Jessica Andreshak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251640%22"}, {"id": "fda:K250652", "company": "Anumana, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250652: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250652", "people": [{"name": "Taylor Gold West", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250652%22"}, {"id": "fda:K251061", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251061: NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251061", "people": [{"name": "Tabitha Estes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251061%22"}, {"id": "fda:K251220", "company": "Infinitum Eta, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251220: NUVENTUS NV.C\u0099 Prosthetic Components", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251220", "people": [{"name": "Avital Barlev", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251220%22"}, {"id": "fda:K251636", "company": "Baxter Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251636: Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251636", "people": [{"name": "Jessica Andreshak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251636%22"}, {"id": "fda:K241183", "company": "Seum Medi Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241183: ISO Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241183", "people": [{"name": "Lee Kyen Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241183%22"}, {"id": "fda:K251187", "company": "Changsha Anxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251187: 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251187", "people": [{"name": "William Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251187%22"}, {"id": "fda:K243489", "company": "Abbott Molecular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243489: Alinity m EBV (09N43-095)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243489", "people": [{"name": "Jennifer Peterson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243489%22"}, {"id": "trialreg:NCT07086534", "company": "Sierra Valve LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.", "source_url": "https://clinicaltrials.gov/study/NCT07086534"}, {"id": "trialreg:NCT07086339", "company": "Pulmair Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema", "source_url": "https://clinicaltrials.gov/study/NCT07086339"}, {"id": "trialreg:NCT07085741", "company": "GT Metabolic Solutions, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico", "source_url": "https://clinicaltrials.gov/study/NCT07085741"}, {"id": "trialreg:NCT07086742", "company": "Pathway Medtech, LLC.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate", "source_url": "https://clinicaltrials.gov/study/NCT07086742"}, {"id": "trialreg:NCT07084883", "company": "iHealthScreen Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration", "source_url": "https://clinicaltrials.gov/study/NCT07084883"}, {"id": "trialreg:NCT07086248", "company": "Merz North America, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Determine if RADIESSE\u00ae Dilute Treatment in D\u00e9collet\u00e9 of Adult Women Affects Radiographic Imaging Assessments", "source_url": "https://clinicaltrials.gov/study/NCT07086248"}, {"id": "fda:K243244", "company": "Guangdong Eda Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243244: Heated Breathing Tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243244", "people": [{"name": "Kant Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243244%22"}, {"id": "fda:K250244", "company": "Guangzhou Longest Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250244: Compression Therapy Device (LGT-2210DS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250244", "people": [{"name": "Xiaobing Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250244%22"}, {"id": "fda:K243403", "company": "Becton Dickinson Infusion Therapy Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243403: BD Nexiva\u0099 Closed IV Catheter System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243403", "people": [{"name": "Amy Moore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243403%22"}, {"id": "fda:K251665", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251665: Triathlon\u00ae Hinge Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251665", "people": [{"name": "Niyati Dave", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251665%22"}, {"id": "fda:K251322", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251322: Venue; Venue Go; Venue Fit; Venue Sprint", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251322", "people": [{"name": "Karin Shimoni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251322%22"}, {"id": "fda:K250232", "company": "Hunan Vathin Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250232: Vathin\u00ae Video Bronchoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250232", "people": [{"name": "Jing Du", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250232%22"}, {"id": "fda:K250859", "company": "Genesee Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250859: TransForm McCarthy Mitral Annuloplasty Ring (TF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250859", "people": [{"name": "James Cross", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250859%22"}, {"id": "fda:K252033", "company": "CMT Health PTE., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K252033: Profoject\u0099 Disposable Syringe, Profoject\u0099 Disposable Syringe with Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252033", "people": [{"name": "Monica Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252033%22"}, {"id": "fda:K251620", "company": "Zimmer Biomet", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251620: A.L.P.S. Proximal Humerus Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251620", "people": [{"name": "Sonayya Achalla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251620%22"}, {"id": "fda:K250334", "company": "Kelyniam Global, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250334: Fusion Craniofacial Implant; Fusion Skull Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250334", "people": [{"name": "Elise Bozzuto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250334%22"}, {"id": "fda:K251339", "company": "Zhengzhou PZ Laser Slim Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251339: Medical Diode Laser Hair Removal Device (PZ-606\u00bf, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251339", "people": [{"name": "Xiaojie Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251339%22"}, {"id": "fda:K250552", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250552: Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250552", "people": [{"name": "Irina Ignatenko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250552%22"}, {"id": "fda:K252215", "company": "Inbella Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K252215: InbellaMAX System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252215", "people": [{"name": "Michael Kreindel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252215%22"}, {"id": "fda:K250989", "company": "Howmedica Osteonics Corp (Dba Stryker Orthopaedics)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250989: Stryker and Serf hip devices", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250989", "people": [{"name": "Gregg Ritter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250989%22"}, {"id": "fda:K250970", "company": "Leo Cancer Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250970: Marie", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250970", "people": [{"name": "Nickie Power", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250970%22"}, {"id": "sbir:DOD:HT942525CE002", "company": "Coalesenz Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-07-25", "observed": "2026-09-18", "amount_usd": 1649914, "summary": "DOD STTR Phase II award $1,649,914: Point of Care Blood Coagulopathy Diagnostics", "source_url": "https://www.sbir.gov/awards?search=H2-0598"}, {"id": "nih:1R44GM161237-01", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": 969833, "summary": "NIH award 1R44GM161237-01: PhysioSim: Innovative Physiology Simulation Education Kits for Pre-College Students and Teachers ($969,833)", "source_url": "https://reporter.nih.gov/project-details/11255321", "people": [{"name": "Adam Becker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA298515-01", "company": "Intus Biosciences LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": 405973, "summary": "NIH award 1R43CA298515-01: Breakthrough High-Accuracy, High-Throughput Colorectal Cancer Screening Platform ($405,973)", "source_url": "https://reporter.nih.gov/project-details/11069172", "people": [{"name": "Mark David Driscoll", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07084207", "company": "MMI (Medical Microinstruments, Inc.)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Expand the Use of Symani\u00ae Surgical System for Peripheral Nerve Repair", "source_url": "https://clinicaltrials.gov/study/NCT07084207"}, {"id": "trialreg:NCT07082426", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study", "source_url": "https://clinicaltrials.gov/study/NCT07082426"}, {"id": "trialreg:NCT07084545", "company": "Carl Zeiss Meditec AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens", "source_url": "https://clinicaltrials.gov/study/NCT07084545"}, {"id": "trialreg:NCT07082010", "company": "Dimagi Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Measurement-Based Peer Supervision App for Non-Specialist Providers", "source_url": "https://clinicaltrials.gov/study/NCT07082010"}, {"id": "trialreg:NCT07082153", "company": "Shanghai MicroPort Rhythm MedTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The First-In-Man Use of Coronary Sinus Balloon Pump in STEMI Patients Treated by Primary PCI", "source_url": "https://clinicaltrials.gov/study/NCT07082153"}, {"id": "fda:K252010", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K252010: SPY Laparoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252010", "people": [{"name": "Michelle Ross", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252010%22"}, {"id": "fda:K250284", "company": "Tsk Laboratory, Japan", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250284: TSK SELECT\u0099 Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250284", "people": [{"name": "Yumi Ueda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250284%22"}, {"id": "fda:K243392", "company": "B.Braun Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243392: Infusomat\u00ae Space Volumetric Infusion Pump Administration Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243392", "people": [{"name": "Rushtin Chaklader", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243392%22"}, {"id": "fda:K251618", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251618: MOTO Partial Knee System Extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251618", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251618%22"}, {"id": "fda:K250322", "company": "Responsive Respiratory", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250322: Respond OC Conserving Regulator (130-0800)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250322", "people": [{"name": "Steve Bannon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250322%22"}, {"id": "fda:K251455", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251455: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251455", "people": [{"name": "Patricia Beauregard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251455%22"}, {"id": "fda:K251968", "company": "Instrumentation Laboratory (IL) Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251968: HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251968", "people": [{"name": "Kirivann Chhoeun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251968%22"}, {"id": "fda:K251984", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251984: Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251984", "people": [{"name": "Yang Blue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251984%22"}, {"id": "fda:K243711", "company": "Wuxi Hisky Medical Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243711: Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243711", "people": [{"name": "Jinhua Shao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243711%22"}, {"id": "fda:K252056", "company": "AtriCure, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K252056: Isolator\u00ae Synergy\u0099 EnCompass Clamp and Guide system (OLH, OSH, GPM100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252056", "people": [{"name": "Ingrid Dirtzu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252056%22"}, {"id": "fda:K251955", "company": "Davol Inc., Subsidiary of C. R. Bard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251955: Onflex\u0099 Mesh", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251955", "people": [{"name": "Mohammed Ahmed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251955%22"}, {"id": "fda:K251297", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251297: MIS LYNX Conical Connection Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251297", "people": [{"name": "Jesus Valencia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251297%22"}, {"id": "pma:P250002", "company": "Quest Diagnostics Nichols Institute", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P250002: Quest Diagnostics AAVrh74 Antibody ELISA CDx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250002", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P250002%22"}, {"id": "breakthrough:P250002", "company": "Quest Diagnostics Nichols Institute", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-07-24", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P250002: QUEST DIAGNOSTICS AAVRH74 ANTIBODY ELISA CDXQUEST DIAGNOSTICS AAVRH74 ANTIBODY ELISA CDX", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44AI184015-02", "company": "Big Eye Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": 396523, "summary": "NIH award 5R44AI184015-02: Supporting WHO Lymphatic Filariasis Elimination Programs: Progressing a Highly Sensitive and Specific Rapid Diagnostic Test for Brugia Species Infection to Commercialization Readiness ($396,523)", "source_url": "https://reporter.nih.gov/project-details/11079584", "people": [{"name": "Marco Antonio Biamonte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH132234-04", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": 994219, "summary": "NIH award 5R44MH132234-04: System for Volumetric 2-photon Imaging of Neuroactivity Using Light Beads Microscopy ($994,219)", "source_url": "https://reporter.nih.gov/project-details/11143762", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AG063683-06", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": 862564, "summary": "NIH award 5R44AG063683-06: A Mobile Informatics Solution to Assist Caregivers with Care Coordination and Social Engagement ($862,564)", "source_url": "https://reporter.nih.gov/project-details/11194395", "people": [{"name": "GARY D HAVEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R43HD117483-01A1", "company": "Orygyn Medical Devices, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": 306778, "summary": "NIH award 1R43HD117483-01A1: A simple device for office evaluation of tubal patency during the workup for infertility. ($306,778)", "source_url": "https://reporter.nih.gov/project-details/11183526", "people": [{"name": "JEFFREY T. JENSEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL180234-01", "company": "Peca Labs", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": 306102, "summary": "NIH award 1R43HL180234-01: A Novel Fully-Polymeric, Biomimetic Prosthetic Mitral Valve Constructed from Clinically-Proven Materials to Improve Durability, Performance, and Overall Outcomes ($306,102)", "source_url": "https://reporter.nih.gov/project-details/11186225", "people": [{"name": "Arush Kalra", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44GM161221-01", "company": "Calis Books Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": 333846, "summary": "NIH award 1R44GM161221-01: Introducing Young Children to Biomedical Science with a Screenless Interactive Device (infinibook) ($333,846)", "source_url": "https://reporter.nih.gov/project-details/11255025", "people": [{"name": "Carinne Meyrignac", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07079774", "company": "Orthofix s.r.l.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TrueLok Elevate PMCF Study", "source_url": "https://clinicaltrials.gov/study/NCT07079774"}, {"id": "trialreg:NCT07081347", "company": "Sanoculis Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: This Follow-up Extension Study is Aimed to Monitor the Long-term IOP-lowering Performance/Efficacy and Safety of the MINT\u00ae Procedure in Open Angle Glaucoma Eyes.", "source_url": "https://clinicaltrials.gov/study/NCT07081347"}, {"id": "trialreg:NCT07081243", "company": "Medtronic Vascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Symplicity China Study", "source_url": "https://clinicaltrials.gov/study/NCT07081243"}, {"id": "trialreg:NCT07079956", "company": "NVMedTech", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms", "source_url": "https://clinicaltrials.gov/study/NCT07079956"}, {"id": "trialreg:NCT07079813", "company": "Shanghai MicroPort EP MedTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars\u2122 High Density Mapping Catheter Applications", "source_url": "https://clinicaltrials.gov/study/NCT07079813"}, {"id": "trialreg:NCT07081828", "company": "Asensus Surgical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Asensus Paediatric Robotic Registry", "source_url": "https://clinicaltrials.gov/study/NCT07081828"}, {"id": "trialreg:NCT07080008", "company": "MediBeacon", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries", "source_url": "https://clinicaltrials.gov/study/NCT07080008"}, {"id": "trialreg:NCT07081815", "company": "ARC Medical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: JOCOAT Safety and Tolerability Clinical Trial GLAD-04", "source_url": "https://clinicaltrials.gov/study/NCT07081815"}, {"id": "fda:K250716", "company": "Infomed Software, S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250716: IMAGE ONE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250716", "people": [{"name": "Iris L\u00f3pez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250716%22"}, {"id": "fda:K251748", "company": "Carbon Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251748: MammoSTAR Biopsy Site Identifier", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251748", "people": [{"name": "Yidi Hou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251748%22"}, {"id": "fda:K250590", "company": "Stereotaxis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250590: MAGiC Sweep\u0099 EP Mapping Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250590", "people": [{"name": "Desmond Lewis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250590%22"}, {"id": "fda:K243781", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243781: HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243781", "people": [{"name": "Varad Raghuwanshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243781%22"}, {"id": "fda:K250280", "company": "Arum Dentistry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250280: SD TL Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250280", "people": [{"name": "Choi Won-Yi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250280%22"}, {"id": "fda:K242615", "company": "Xiamen Taotao Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242615: Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242615", "people": [{"name": "Chunshui Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242615%22"}, {"id": "fda:K243681", "company": "Olea Medical S.A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243681: Neuro Insight V1.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243681", "people": [{"name": "Nathalie Palumbo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243681%22"}, {"id": "fda:K251073", "company": "Innovasis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251073: Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251073", "people": [{"name": "Michael Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251073%22"}, {"id": "fda:K251280", "company": "Terrats Medical SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251280: DESS\u00ae Dental Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251280", "people": [{"name": "Roger Terrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251280%22"}, {"id": "fda:K251265", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251265: Resilience Fully Covered Esophageal Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251265", "people": [{"name": "David Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251265%22"}, {"id": "fda:K251213", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251213: Da Vinci Surgical System (IS5000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251213", "people": [{"name": "Jennifer Karafin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251213%22"}, {"id": "fda:K243373", "company": "Vitrolife Sweden AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243373: Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243373", "people": [{"name": "Ann-Cathrine Ericson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243373%22"}, {"id": "nih:1R43DA062307-01", "company": "Carina Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": 304215, "summary": "NIH award 1R43DA062307-01: Development of Validation of a Novel Software Platform for Decentralized Clinical Trial in Substance Use Disorder Incorporating Large Language Models ($304,215)", "source_url": "https://reporter.nih.gov/project-details/11056587", "people": [{"name": "Xue Feng", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41DC022811-01A1", "company": "Silicon Audio Rf Circulator, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": 292694, "summary": "NIH award 1R41DC022811-01A1: High Signal-to-Noise Ratio Miniature Microphones for Hearing Assistive Devices ($292,694)", "source_url": "https://reporter.nih.gov/project-details/11256306", "people": [{"name": "Neal Allen Hall", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EB034614-03", "company": "Base Pair Biotechnologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": 746175, "summary": "NIH award 5R44EB034614-03: Bench-top Reader and Aptamer-based Assay for Rapid, High-sensitivity Drug/Opiate Detection ($746,175)", "source_url": "https://reporter.nih.gov/project-details/11177780", "people": [{"name": "George W Jackson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DA063255-01", "company": "Rescue Biomedical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": 399715, "summary": "NIH award 1R43DA063255-01: User-Centric Development of a Detection Module for a Closed-Loop Solution to Opioid Overdose ($399,715)", "source_url": "https://reporter.nih.gov/project-details/11169417", "people": [{"name": "Vy Le", "role": "Principal Investigator"}, {"name": "Hyowon Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43HD115478-02", "company": "Bsolutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": 66700, "summary": "NIH award 5R43HD115478-02: Cribsy: A platform for home-based automated developmental risk screening ($66,700)", "source_url": "https://reporter.nih.gov/project-details/11132680", "people": [{"name": "BHARATH MODAYUR", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07078071", "company": "Huawei Device Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial for Evaluating the Effectiveness and Safety of the Pulse Wave-based Atrial Fibrillation and Premature Beat Alert Software", "source_url": "https://clinicaltrials.gov/study/NCT07078071"}, {"id": "trialreg:NCT07077070", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Investigating Electrical Categorical Loudness Scaling Using a Mobile Research App in Experienced Adult Cochlear Implant Participants", "source_url": "https://clinicaltrials.gov/study/NCT07077070"}, {"id": "trialreg:NCT07078331", "company": "Theradaptive, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge Augmentations", "source_url": "https://clinicaltrials.gov/study/NCT07078331"}, {"id": "trialreg:NCT07076160", "company": "Johnson & Johnson Vision Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses", "source_url": "https://clinicaltrials.gov/study/NCT07076160"}, {"id": "trialreg:NCT07078968", "company": "BioLab Holdings", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Real World Data Collection of Human Amniotic Membrane(s) on Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers and Post Operative Wounds.", "source_url": "https://clinicaltrials.gov/study/NCT07078968"}, {"id": "trialreg:NCT07078370", "company": "Vascudyne, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety Study of Acellular Tissue Engineered Vessel for Coronary Artery Bypass", "source_url": "https://clinicaltrials.gov/study/NCT07078370"}, {"id": "trialreg:NCT07079215", "company": "Nu Eyne Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Physical Device for Medical Use (ADTPM 1) for Opioid Withdrawal Symptoms", "source_url": "https://clinicaltrials.gov/study/NCT07079215"}, {"id": "trialreg:NCT07078383", "company": "Vascutek Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta", "source_url": "https://clinicaltrials.gov/study/NCT07078383"}, {"id": "trialreg:NCT07078422", "company": "Encora, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Home Use Study of Targeted Mechanical Stimulation for Tremor Relief", "source_url": "https://clinicaltrials.gov/study/NCT07078422"}, {"id": "fda:K251616", "company": "Ods Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251616: Clear Miracle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251616", "people": [{"name": "Kyung-Ran Back", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251616%22"}, {"id": "fda:K243566", "company": "Cardiosense, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243566: CardioTag\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243566", "people": [{"name": "Arezou Azar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243566%22"}, {"id": "fda:K244018", "company": "Zhejiang Curaway Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244018: Disposable Biopsy Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244018", "people": [{"name": "Tu Mengjing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244018%22"}, {"id": "fda:K251505", "company": "Alafair Biosciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251505: VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251505", "people": [{"name": "Sarah Mayes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251505%22"}, {"id": "fda:K251300", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251300: Plastic Surgical Kits", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251300", "people": [{"name": "Laura Sobrin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251300%22"}, {"id": "fda:K243367", "company": "Minnesota Medical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243367: Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243367", "people": [{"name": "Robert Anglin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243367%22"}, {"id": "fda:K251310", "company": "Ots Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251310: OTS 25-L (100-5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251310", "people": [{"name": "Dekel Assaf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251310%22"}, {"id": "fda:K243415", "company": "P.G.F. Industry Solutions GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243415: Granudacyn\u00ae Wound Irrigation Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243415", "people": [{"name": "Peter Fritz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243415%22"}, {"id": "fda:K251638", "company": "Suzhou Master Machinery Manufacturing Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251638: Mobility Scooter (MS160C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251638", "people": [{"name": "Siqi Shangguan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251638%22"}, {"id": "fda:K250686", "company": "Neurospectrum Insights Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250686: GyriCalc (Version 1.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250686", "people": [{"name": "Andrew Stewart", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250686%22"}, {"id": "fda:K250901", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250901: Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250901", "people": [{"name": "Orlando Tadeo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250901%22"}, {"id": "fda:K251255", "company": "Lymphatech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251255: LymphaTech Mobile 3D Measuring Tool", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251255", "people": [{"name": "Mike Weiler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251255%22"}, {"id": "fda:K243432", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243432: Vascular Navigation PAD 2.0; Navigation Software Vascular PAD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243432", "people": [{"name": "Sadwini Suresh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243432%22"}, {"id": "fda:K243425", "company": "Talladium Espa\u00f1a, SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243425: Guided DAS Surgical Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243425", "people": [{"name": "Xavier Soca Filella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243425%22"}, {"id": "fda:K250211", "company": "Innocare Optoelectronics Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250211: Yushan X-Ray Flat Panel Detector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250211", "people": [{"name": "Christy Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250211%22"}, {"id": "nih:3R44GM149106-03S1", "company": "Cellchorus Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-21", "observed": "2026-08-21", "amount_usd": 56415, "summary": "NIH award 3R44GM149106-03S1: Dynamic single-cell analysis instrument to evaluate immune cell function ($56,415)", "source_url": "https://reporter.nih.gov/project-details/11323428", "people": [{"name": "Laurence J.N. Cooper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44GM156127-02", "company": "Nirrin Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-21", "observed": "2026-08-21", "amount_usd": 780308, "summary": "NIH award 5R44GM156127-02: A tunable laser scanning system for rapid analysis of biopharmaceutical formulations ($780,308)", "source_url": "https://reporter.nih.gov/project-details/11181637", "people": [{"name": "Bryan Hassell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44HD111106-02", "company": "Venova Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-21", "observed": "2026-08-21", "amount_usd": 1125480, "summary": "NIH award 2R44HD111106-02: Development of a novel, non-hormonal female contraceptive device to submit IDE ($1,125,480)", "source_url": "https://reporter.nih.gov/project-details/11183494", "people": [{"name": "Emily Man", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K251564", "company": "Iline Microsystems, S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251564: microINR System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251564", "people": [{"name": "Miren Itsaso Hormaeche", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251564%22"}, {"id": "trialreg:NCT07073950", "company": "AstraZeneca", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation", "source_url": "https://clinicaltrials.gov/study/NCT07073950"}, {"id": "trialreg:NCT07074483", "company": "DigitalRehab", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Accuracy of AuReha for Measuring Upper Limb Movements", "source_url": "https://clinicaltrials.gov/study/NCT07074483"}, {"id": "trialreg:NCT07075198", "company": "Liberating Technologies, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Caesar Foot Take-Home Validation Testing", "source_url": "https://clinicaltrials.gov/study/NCT07075198"}, {"id": "trialreg:NCT07074769", "company": "Luxottica Group S.p.A.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of In-lab Benefit for Speech-in-noise Intelligibility With Device for Adults With Mild to Moderate Hearing Loss", "source_url": "https://clinicaltrials.gov/study/NCT07074769"}, {"id": "trialreg:NCT07075796", "company": "iGluco", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of the Performance of the GLUCUBE System in Patients With Type 2 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07075796"}, {"id": "fda:K250913", "company": "Jiangsu Tingsn Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250913: TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250913", "people": [{"name": "Jing Wan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250913%22"}, {"id": "nih:5R44GM148147-03", "company": "Cytequest, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": 983392, "summary": "NIH award 5R44GM148147-03: Adaptable and scalable electroporation for cellular therapy ($983,392)", "source_url": "https://reporter.nih.gov/project-details/11163425", "people": [{"name": "HAROLD G CRAIGHEAD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07072832", "company": "Replasia BV", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia", "source_url": "https://clinicaltrials.gov/study/NCT07072832"}, {"id": "fda:K252012", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K252012: SPY Cystoscope/Hysteroscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252012", "people": [{"name": "Irina Glazkova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252012%22"}, {"id": "fda:K243404", "company": "Takeda Pharmaceuticals", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243404: HyHub\u0099 and HyHub\u0099 Duo Vial Access Devices", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243404", "people": [{"name": "Louwanna Wilson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243404%22"}, {"id": "fda:K251655", "company": "Alafair Biosciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251655: VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251655", "people": [{"name": "Sarah Mayes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251655%22"}, {"id": "fda:K251809", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251809: Arthrex FiberTak Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251809", "people": [{"name": "Alex Underberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251809%22"}, {"id": "fda:K251906", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251906: Z1 Hip System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251906", "people": [{"name": "Erin Giffin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251906%22"}, {"id": "fda:K251542", "company": "Onepass Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251542: InstaFAN", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251542", "people": [{"name": "Jacob Ben Arie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251542%22"}, {"id": "fda:K252218", "company": "Micro Current Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K252218: MF SC GEN2 Facial Toning System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252218", "people": [{"name": "David Suzuki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K252218%22"}, {"id": "fda:K243775", "company": "Excite Medical of Tampa Bay, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243775: True Non-Surgical Spinal Decompression System (DRX9000-SL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243775", "people": [{"name": "Saleem Musallam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243775%22"}, {"id": "fda:K250999", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250999: V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250999", "people": [{"name": "Yujin Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250999%22"}, {"id": "fda:K250902", "company": "HeartFlow, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250902: HeartFlow Analysis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250902", "people": [{"name": "Kristen DeJeu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250902%22"}, {"id": "fda:K251585", "company": "CMT Health PTE., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251585: Profoject\u0099 Enteral Feeding Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251585", "people": [{"name": "Monica Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251585%22"}, {"id": "fda:K231562", "company": "Micro-Nx Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231562: ELEC ENGINE (Model: ISE-170L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231562", "people": [{"name": "Lee Jong Kun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231562%22"}, {"id": "fda:K250750", "company": "Dk Medical Systems Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250750: INNOVISION-P5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250750", "people": [{"name": "Sung-moon Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250750%22"}, {"id": "fda:K250553", "company": "Tomey Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250553: Tomey Cornea/Anterior Segment OCT (CASIA2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250553", "people": [{"name": "Yuko Matsushita", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250553%22"}, {"id": "fda:K250952", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250952: Baby Gorilla\u00ae/Gorilla\u00ae Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250952", "people": [{"name": "Edward Wells-Spicer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250952%22"}, {"id": "fda:K250084", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250084: MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250084", "people": [{"name": "Elaine Duncan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250084%22"}, {"id": "nih:3R43CA281429-02S1", "company": "Enclear Therapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": 150000, "summary": "NIH award 3R43CA281429-02S1: Smart CSF Delivery System for CNS Drug Therapy for Leptomeningeal Disease ($150,000)", "source_url": "https://reporter.nih.gov/project-details/11200364", "people": [{"name": "MARCIE A GLICKSMAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA291315-01A1", "company": "Darwin Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": 399998, "summary": "NIH award 1R43CA291315-01A1: Point-of-need screening device for lung cancer in low-resource settings ($399,998)", "source_url": "https://reporter.nih.gov/project-details/11065762", "people": [{"name": "Nicholas Ryan Meyerson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07070921", "company": "CytaCoat AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessing Safety and Performance of the Novel CytaCoat Foley Catheter", "source_url": "https://clinicaltrials.gov/study/NCT07070921"}, {"id": "trialreg:NCT07071584", "company": "Phantom Neuro Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Multi-electrode Prosthesis Control System for Real-world Tasks Performance in Individuals With Upper Limb Transradial Amputation", "source_url": "https://clinicaltrials.gov/study/NCT07071584"}, {"id": "trialreg:NCT07070115", "company": "Tela Bio Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Clinical Hiatal Hernia Outcomes Using OviTex\u00ae", "source_url": "https://clinicaltrials.gov/study/NCT07070115"}, {"id": "trialreg:NCT07070830", "company": "Insulet Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Simplified Onboarding in Adults With Type 2 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07070830"}, {"id": "trialreg:NCT07071480", "company": "Restorear Devices LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Noninvasive Therapy for Tinnitus", "source_url": "https://clinicaltrials.gov/study/NCT07071480"}, {"id": "trialreg:NCT07069920", "company": "BRPharm Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: To Evaluate the Efficacy and Safety of 'BRDE33-100' for the Temporary Correction of Moderate to Severe Nasolabial Folds", "source_url": "https://clinicaltrials.gov/study/NCT07069920"}, {"id": "trialreg:NCT07071740", "company": "Distalmotion SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Robotic Minimally Invasive Ventral Hernia Repair With DEXTER", "source_url": "https://clinicaltrials.gov/study/NCT07071740"}, {"id": "trialreg:NCT07070089", "company": "Sonorous NV, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus", "source_url": "https://clinicaltrials.gov/study/NCT07070089"}, {"id": "trialreg:NCT07069738", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07069738"}, {"id": "fda:K243324", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243324: Masimo O3 Regional Oximeter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243324", "people": [{"name": "Kertana Shankar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243324%22"}, {"id": "fda:K251016", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251016: MectaLIF 3D Metal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251016", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251016%22"}, {"id": "fda:K251839", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251839: uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251839", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251839%22"}, {"id": "fda:K243547", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243547: uMR Ultra", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243547", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243547%22"}, {"id": "fda:K243756", "company": "Arbor Endovascular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243756: 0.014\u0094 Willow Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243756", "people": [{"name": "Kim Otto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243756%22"}, {"id": "fda:K242505", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242505: Elecsys Cortisol III", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242505", "people": [{"name": "Chunhong (Emma) Tao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242505%22"}, {"id": "fda:K243420", "company": "Genoray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243420: HESTIA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243420", "people": [{"name": "Jiyeon Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243420%22"}, {"id": "fda:K243428", "company": "Dxtx Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243428: e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243428", "people": [{"name": "Paul Lawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243428%22"}, {"id": "fda:K250751", "company": "Terumo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250751: DualView Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250751", "people": [{"name": "Patrick McDonald", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250751%22"}, {"id": "fda:K251556", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251556: Device 300423 Granules", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251556", "people": [{"name": "Jan Van der Ploeg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251556%22"}, {"id": "fda:K251175", "company": "Alafair Biosciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251175: VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251175", "people": [{"name": "Sarah Mayes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251175%22"}, {"id": "fda:K251491", "company": "Osstem Implant Company., Ltd. Chair Business", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251491: K5 Cart, K5 Mount, K5 Swing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251491", "people": [{"name": "Jimin Hyun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251491%22"}, {"id": "nih:1R44HD117546-01", "company": "Little Room Innovations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-16", "observed": "2026-08-21", "amount_usd": 624165, "summary": "NIH award 1R44HD117546-01: A Novel Prosthetic Ankle Joint with Swing Phase Dorsiflexion and Terrain Adaptation ($624,165)", "source_url": "https://reporter.nih.gov/project-details/11068450", "people": [{"name": "Harrison Logan Bartlett", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07067372", "company": "Shanghai MicroPort EP MedTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study on the Safety and Efficacy of a New Magnetic Navigation Radiofrequency Ablation Catheter for Rapid Arrhythmia", "source_url": "https://clinicaltrials.gov/study/NCT07067372"}, {"id": "trialreg:NCT07067658", "company": "Heartfelt Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk", "source_url": "https://clinicaltrials.gov/study/NCT07067658"}, {"id": "trialreg:NCT07069556", "company": "Geneoscopy, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ColoSense Post-Approval Study", "source_url": "https://clinicaltrials.gov/study/NCT07069556"}, {"id": "trialreg:NCT07068061", "company": "21 Century Medical Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)", "source_url": "https://clinicaltrials.gov/study/NCT07068061"}, {"id": "trialreg:NCT07068438", "company": "Suzhou Hengruihongyuan Medical Technology Co. LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease", "source_url": "https://clinicaltrials.gov/study/NCT07068438"}, {"id": "trialreg:NCT07068204", "company": "Dr. Joachim Enax", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F)", "source_url": "https://clinicaltrials.gov/study/NCT07068204"}, {"id": "fda:K251198", "company": "Spectrawave, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251198: HyperVue\u0099 Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251198", "people": [{"name": "Ankit Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251198%22"}, {"id": "fda:K243412", "company": "Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243412: ARCHIMEDES Biodegradable Pancreatic Stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243412", "people": [{"name": "Eric Mangiardi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243412%22"}, {"id": "fda:K250949", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250949: Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250949", "people": [{"name": "Osamu Tamada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250949%22"}, {"id": "fda:K251202", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251202: da Vinci Surgical System (IS5000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251202", "people": [{"name": "Changxin Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251202%22"}, {"id": "fda:K251102", "company": "Cemho Medical Technology (Guangdong) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251102: Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251102", "people": [{"name": "Gang Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251102%22"}, {"id": "fda:K251151", "company": "Ischemaview", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251151: Rapid CTA 360", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251151", "people": [{"name": "James Rosa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251151%22"}, {"id": "fda:K251342", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251342: EchoPAC Software Only / EchoPAC Plug-in", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251342", "people": [{"name": "Lee Bush", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251342%22"}, {"id": "fda:K251845", "company": "Kerecis Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251845: Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251845", "people": [{"name": "Skuli Magnusson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251845%22"}, {"id": "fda:K243782", "company": "Bioventus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243782: StimTrial Neuromodulation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243782", "people": [{"name": "Sageev George", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243782%22"}, {"id": "fda:K243397", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243397: uMR 680", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243397", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243397%22"}, {"id": "nih:1R43DK142274-01", "company": "Endonavis, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": 226192, "summary": "NIH award 1R43DK142274-01: Novel Over-the-Scope Platform for Control of Variceal Bleeding ($226,192)", "source_url": "https://reporter.nih.gov/project-details/11065838", "people": [{"name": "Anthony Appling", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM149106-03", "company": "Cellchorus Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": 462781, "summary": "NIH award 5R44GM149106-03: Dynamic single-cell analysis instrument to evaluate immune cell function ($462,781)", "source_url": "https://reporter.nih.gov/project-details/11136848", "people": [{"name": "Laurence J.N. Cooper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R43CA281429-02", "company": "Enclear Therapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": 107649, "summary": "NIH award 5R43CA281429-02: Smart CSF Delivery System for CNS Drug Therapy for Leptomeningeal Disease ($107,649)", "source_url": "https://reporter.nih.gov/project-details/11120986", "people": [{"name": "MARCIE A GLICKSMAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:2R44HD105529-04", "company": "Autoivf, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": 997028, "summary": "NIH award 2R44HD105529-04: OvaReady: An automated microfluidic oocyte retrieval and denudation device ($997,028)", "source_url": "https://reporter.nih.gov/project-details/11067713", "people": [{"name": "Ismail Emre Ozkumur", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "trialreg:NCT07065331", "company": "AstraZeneca", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of Inhaled AZD8630 in Adolescents With Asthma", "source_url": "https://clinicaltrials.gov/study/NCT07065331"}, {"id": "trialreg:NCT07065214", "company": "Erbe Elektromedizin GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy", "source_url": "https://clinicaltrials.gov/study/NCT07065214"}, {"id": "trialreg:NCT07066761", "company": "A.M.I. Agency for Medical Innovations GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)", "source_url": "https://clinicaltrials.gov/study/NCT07066761"}, {"id": "fda:K242237", "company": "Xiros Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242237: Jewel Soft Tissue Reinforcement Device (102-6005)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242237", "people": [{"name": "Grannells Janet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242237%22"}, {"id": "fda:K250350", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250350: Thrive 2-in-1 Breast Pump (Model P3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250350", "people": [{"name": "Yang Xiaoyan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250350%22"}, {"id": "fda:K251053", "company": "Hangzhou AllTest Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251053: Shinetell PlusTM Digital Early Pregnancy Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251053", "people": [{"name": "Rosa Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251053%22"}, {"id": "fda:K251844", "company": "Kerecis Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251844: Kerecis SurgiBind (50241)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251844", "people": [{"name": "Skuli Magnusson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251844%22"}, {"id": "fda:K251045", "company": "Unimed Medical Supplies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251045: Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251045", "people": [{"name": "Huanyu Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251045%22"}, {"id": "fda:K242818", "company": "Isoaid, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242818: IsoSphere", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242818", "people": [{"name": "Timothy Bright", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242818%22"}, {"id": "fda:K250119", "company": "Tempus AI, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250119: Tempus ECG-Low EF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250119", "people": [{"name": "Alain Silk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250119%22"}, {"id": "fda:K250181", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250181: AV Viewer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250181", "people": [{"name": "Arbel Shezaf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250181%22"}, {"id": "trialreg:NCT07062575", "company": "ABLE Human Motion S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.", "source_url": "https://clinicaltrials.gov/study/NCT07062575"}, {"id": "trialreg:NCT07062471", "company": "Shockwave Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study)", "source_url": "https://clinicaltrials.gov/study/NCT07062471"}, {"id": "trialreg:NCT07062094", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of Orbera365\u2122 Intragastric Balloon System", "source_url": "https://clinicaltrials.gov/study/NCT07062094"}, {"id": "trialreg:NCT07061912", "company": "bioLytical Laboratories", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Performance of INSTI\u00ae HIV Self Test When Performed by Unobserved Intended Users in the US", "source_url": "https://clinicaltrials.gov/study/NCT07061912"}, {"id": "fda:K251096", "company": "Peek Health, S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251096: PeekMed web", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251096", "people": [{"name": "Sara Silva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251096%22"}, {"id": "fda:K250660", "company": "Siemens Medical Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250660: LUMINOS Q.namix T; LUMINOS Q.namix R", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250660", "people": [{"name": "Camila Rodriguez Valentin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250660%22"}, {"id": "fda:K251554", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251554: Materialise TKA Guide System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251554", "people": [{"name": "Giulia Girola", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251554%22"}, {"id": "fda:K251488", "company": "Expanse Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251488: FLOWRUNNER Aspiration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251488", "people": [{"name": "Shiva Ardakani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251488%22"}, {"id": "fda:K251173", "company": "Shenzhen Fansizhe Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251173: Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251173", "people": [{"name": "Endang Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251173%22"}, {"id": "fda:K243917", "company": "Fisher & Paykel Healthcare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243917: F&P Optiflow Air/Oxygen Flow Source", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243917", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243917%22"}, {"id": "fda:K251850", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251850: Phantom\u00ae Hindfoot TTC/TC Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251850", "people": [{"name": "Edward Wells-Spicer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251850%22"}, {"id": "fda:K251132", "company": "Acumed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251132: The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251132", "people": [{"name": "Marina Bull", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251132%22"}, {"id": "fda:K250185", "company": "Jiangxi Aicare Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250185: Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250185", "people": [{"name": "Xiao Lizhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250185%22"}, {"id": "fda:K250120", "company": "Narnar, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250120: GECHO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250120", "people": [{"name": "Jiri Sklenar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250120%22"}, {"id": "fda:K250504", "company": "Ceramoptec GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250504: Leonardo Duster", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250504", "people": [{"name": "Roland Dreschau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250504%22"}, {"id": "fda:K251378", "company": "Zimmer Medizinsysteme GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251378: CoolTone", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251378", "people": [{"name": "Ute Killet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251378%22"}, {"id": "sbir:DOD:W911-QY-25-CA-041", "company": "FireHUD, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-07-14", "observed": "2026-09-18", "amount_usd": 1315219, "summary": "DOD SBIR Phase II award $1,315,219: Real Time Physiological Status Monitor for MicroClimate Control", "source_url": "https://www.sbir.gov/awards?search=C2-0700"}, {"id": "fda:K243598", "company": "Welch Allyn, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243598: Welch Allyn Connex\u00ae 360 (Multiple)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243598", "people": [{"name": "Susan Schmidt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243598%22"}, {"id": "fda:K243199", "company": "Livassured BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243199: NightWatch+ US", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243199", "people": [{"name": "Jolanda Oorthuizen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243199%22"}, {"id": "nih:1R41HL178190-01", "company": "Cutcath LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": 395306, "summary": "NIH award 1R41HL178190-01: Aortic dissection flap division by novel electrosurgical catheter facilitates aortic endograft landing zones ($395,306)", "source_url": "https://reporter.nih.gov/project-details/11069448", "people": [{"name": "Ramon Berguer", "role": "Principal Investigator"}, {"name": "Jonathan Lee Eliason", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL178137-01A1", "company": "Pranions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": 1213182, "summary": "NIH award 1R44HL178137-01A1: High-flow portable oxygen concentrator for long-term oxygen therapy ($1,213,182)", "source_url": "https://reporter.nih.gov/project-details/11186192", "people": [{"name": "Benjamin Robert Dickerhoff", "role": "Principal Investigator"}, {"name": "Syed Mubeen", "role": "Principal Investigator"}, {"name": "MADHAVAN L RAGHAVAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07061769", "company": "FluxWear, INC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Helping Cancer Patients Manage Neuropathy Symptoms From Chemotherapy With a Low-Intensity, Low-Risk Cranial PEMF Device", "source_url": "https://clinicaltrials.gov/study/NCT07061769"}, {"id": "trialreg:NCT07061054", "company": "Shanghai Golden Leaf MedTec Co. Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Netrod-Pilot Study of Renal Denervation With NetrodTM Sixelectrode Radiofrequency RDN System", "source_url": "https://clinicaltrials.gov/study/NCT07061054"}, {"id": "trialreg:NCT07059793", "company": "Edwards Lifesciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MITRIS China Post Market Clinical Follow-up (PMCF) Study", "source_url": "https://clinicaltrials.gov/study/NCT07059793"}, {"id": "trialreg:NCT07059962", "company": "Bodyport Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)", "source_url": "https://clinicaltrials.gov/study/NCT07059962"}, {"id": "trialreg:NCT07059754", "company": "EyeCool Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study to Determine What Effect the EyeCool Treatment Has on the Eye's Surface Anatomy and Inflammation Response After Being Treated for Having Chronic Ocular Surface Pain (COSP)", "source_url": "https://clinicaltrials.gov/study/NCT07059754"}, {"id": "trialreg:NCT07060547", "company": "HepQuant, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease", "source_url": "https://clinicaltrials.gov/study/NCT07060547"}, {"id": "trialreg:NCT07060911", "company": "Neola Medical Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pivotal Study to Assess Safety and Performance of Neola\u00ae, a Novel Lung Monitoring Device for Neonates", "source_url": "https://clinicaltrials.gov/study/NCT07060911"}, {"id": "fda:K251472", "company": "Inion OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251472: Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251472", "people": [{"name": "Hanne Kankaanp\u00e4\u00e4", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251472%22"}, {"id": "fda:K250761", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250761: KALA Therapy Wand (Model: KALA-03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250761", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250761%22"}, {"id": "fda:K251352", "company": "Codonics.Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251352: Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251352", "people": [{"name": "Gary Enos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251352%22"}, {"id": "fda:K250820", "company": "Sinolinks Medical Innovation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250820: Disposable Trocars", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250820", "people": [{"name": "Juan Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250820%22"}, {"id": "fda:K243655", "company": "Spirair, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243655: TurbAlign", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243655", "people": [{"name": "Tracey Henry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243655%22"}, {"id": "fda:K250156", "company": "Bisco, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250156: Choice 2 DC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250156", "people": [{"name": "Jessica Bernstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250156%22"}, {"id": "fda:K251808", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251808: Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251808", "people": [{"name": "Mehmet Caner Cagdanlioglu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251808%22"}, {"id": "fda:K250034", "company": "Shaoguan Regenex Pharmaceuticals Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250034: Natural rubber latex male condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250034", "people": [{"name": "Kangwei Pan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250034%22"}, {"id": "fda:K243227", "company": "Accutome, Inc. Doing Business AS Keeler USA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243227: B-Scan", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243227", "people": [{"name": "Claudia Hill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243227%22"}, {"id": "fda:K251470", "company": "Shofu Dental Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251470: ResiCem EX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251470", "people": [{"name": "Mauro Malzyner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251470%22"}, {"id": "fda:K251436", "company": "Pioneer Surgical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251436: Resolve Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251436", "people": [{"name": "Jaclyn Holli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251436%22"}, {"id": "fda:K250671", "company": "Caire, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250671: FreeStyle Comfort (AS200 / FreeStyle Comfort)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250671", "people": [{"name": "Ted Vlahopoulos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250671%22"}, {"id": "fda:K250762", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250762: ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250762", "people": [{"name": "Toshio Nakamura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250762%22"}, {"id": "fda:K251149", "company": "Cutera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251149: AviClear Laser System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251149", "people": [{"name": "Julia Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251149%22"}, {"id": "fda:K251134", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251134: RipCord", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251134", "people": [{"name": "Divya Raghavi Nandakumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251134%22"}, {"id": "fda:K251482", "company": "Lexington Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251482: AEON\u0099 Endoscopic Powered Stapler", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251482", "people": [{"name": "Sharon Timberlake", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251482%22"}, {"id": "fda:K243296", "company": "Carbon (Shenzhen) Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243296: Disposable Biopsy Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243296", "people": [{"name": "Min Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243296%22"}, {"id": "fda:K250942", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250942: Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250942", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250942%22"}, {"id": "fda:K243274", "company": "Centers for Disease Control and Prevention", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243274: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243274", "people": [{"name": "Marie Kirby", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243274%22"}, {"id": "fda:K251786", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251786: Geistlich Bio-Oss\u00ae; Geistlich Bio-Oss Pen\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251786", "people": [{"name": "Erik Wirth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251786%22"}, {"id": "fda:K241179", "company": "VivaQuant, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241179: Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241179", "people": [{"name": "Brian Brockway", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241179%22"}, {"id": "fda:K251155", "company": "Becton Dickinson Infusion Therapy Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251155: BD Cathena\u0099 Safety IV Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251155", "people": [{"name": "Adrian Vidriales-Estrada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251155%22"}, {"id": "fda:K250266", "company": "Ceragem Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250266: Ceragem Automatic Thermal Massager (CGM MB-2401)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250266", "people": [{"name": "Seon Gyu Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250266%22"}, {"id": "fda:K250772", "company": "Surgical Instrument Service and Savings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250772: Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250772", "people": [{"name": "Kelsey LeMay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250772%22"}, {"id": "nih:1R41DC022812-01", "company": "Ao Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": 306311, "summary": "NIH award 1R41DC022812-01: Development of a high performance reduced cost OCT Otoscope ($306,311)", "source_url": "https://reporter.nih.gov/project-details/11183991", "people": [{"name": "Brian E. Applegate", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:6R44CA287803-02", "company": "Ne Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": 603206, "summary": "NIH award 6R44CA287803-02: Computer Guided Microwave Liver Ablation ($603,206)", "source_url": "https://reporter.nih.gov/project-details/11081744", "people": [{"name": "Andrea Borsic", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07058883", "company": "Nordberg Medical AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Jul\u00e4ine (TM) for the Treatment of Atrophic Facial Acne Scars", "source_url": "https://clinicaltrials.gov/study/NCT07058883"}, {"id": "trialreg:NCT07059065", "company": "DePuy Synthes Products, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FIBERGRAFT Aeridyan Posterolateral Fusion Study", "source_url": "https://clinicaltrials.gov/study/NCT07059065"}, {"id": "trialreg:NCT07058701", "company": "ChinaNorm", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Serum Instant Anti-Redness Efficacy Clinical Study", "source_url": "https://clinicaltrials.gov/study/NCT07058701"}, {"id": "trialreg:NCT07058610", "company": "Amplifi Vascular, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3", "source_url": "https://clinicaltrials.gov/study/NCT07058610"}, {"id": "trialreg:NCT07058909", "company": "Nipro Medical Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Premarket Clinical Safety Assessment of the ELISIO\u2122-HX", "source_url": "https://clinicaltrials.gov/study/NCT07058909"}, {"id": "fda:K251885", "company": "Providence Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251885: CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251885", "people": [{"name": "Edward Liou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251885%22"}, {"id": "fda:K250072", "company": "Avalign Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250072: CONDUIT\u0099 SYNFIX\u0099 Evolution Secured Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250072", "people": [{"name": "Jennifer Staunton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250072%22"}, {"id": "fda:K244004", "company": "Shenzhen Dachi Communication Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244004: Microcurrent Facial Device (CEC101, EE0101, EEI101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244004", "people": [{"name": "Chunhua Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244004%22"}, {"id": "fda:K251145", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251145: Arthrex PushLock Suture Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251145", "people": [{"name": "Rebecca Homan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251145%22"}, {"id": "fda:K251169", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251169: Vivid Pioneer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251169", "people": [{"name": "Lee Bush", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251169%22"}, {"id": "fda:K250283", "company": "LivaNova USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250283: RAP Femoral Venous Cannulae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250283", "people": [{"name": "Luigi Vecchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250283%22"}, {"id": "fda:K250063", "company": "Arum Dentistry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250063: ARENA Star, Galaxy Star", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250063", "people": [{"name": "Choi Won-Yi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250063%22"}, {"id": "fda:K251830", "company": "FUJIFILM Sonosite, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251830: Sonosite LX Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251830", "people": [{"name": "Anoush Frankian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251830%22"}, {"id": "fda:K243252", "company": "Zbeats, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243252: ZBPro Diagnostic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243252", "people": [{"name": "Bin Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243252%22"}, {"id": "fda:K250032", "company": "Bard Peripheral Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250032: Marquee\u0099 Disposable Core Biopsy Instrument and Instrument Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250032", "people": [{"name": "Rachel LaPoint", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250032%22"}, {"id": "fda:K251945", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251945: TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251945", "people": [{"name": "Blesson Abraham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251945%22"}, {"id": "pma:P240020", "company": "Keri Medical SA", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240020: TOUCH\u00ae CMC 1 Prosthesis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240020", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240020%22"}, {"id": "breakthrough:P240020", "company": "Keri Medical, Sa.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-07-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P240020: TOUCH CMC 1 PROSTHESIS", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43CA298267-01A1", "company": "Alelopharma Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-09", "observed": "2026-08-21", "amount_usd": 399153, "summary": "NIH award 1R43CA298267-01A1: Ultra-precision diagnostics for ALK+ non-small cell lung cancer ($399,153)", "source_url": "https://reporter.nih.gov/project-details/11183253", "people": [{"name": "David Randall Armant", "role": "Principal Investigator"}, {"name": "Rodrigo C Fernandez-Valdivia", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07056569", "company": "Biokosmes Srl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters", "source_url": "https://clinicaltrials.gov/study/NCT07056569"}, {"id": "trialreg:NCT07056036", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EXOMIND (BTL-699-2) for the Improvement in Willpower & Food Cravings", "source_url": "https://clinicaltrials.gov/study/NCT07056036"}, {"id": "fda:K250108", "company": "Mr Surgical Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250108: OptiVu\u0099 Shoulder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250108", "people": [{"name": "Brian Karpinski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250108%22"}, {"id": "fda:K250193", "company": "Basic Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250193: Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250193", "people": [{"name": "Zhao John", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250193%22"}, {"id": "fda:K243500", "company": "Abbott Laboratories", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243500: ARCHITECT iGentamicin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243500", "people": [{"name": "Weijie Jiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243500%22"}, {"id": "fda:K243731", "company": "P&a USA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243731: HEXIM Implant; Samwon General Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243731", "people": [{"name": "Jung Shin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243731%22"}, {"id": "fda:K250133", "company": "Nuvascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250133: HARBOR Occlusion Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250133", "people": [{"name": "Meadow Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250133%22"}, {"id": "fda:K251759", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251759: Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251759", "people": [{"name": "Galit Gershon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251759%22"}, {"id": "fda:K242562", "company": "Ge Medical Systems Information Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242562: Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242562", "people": [{"name": "Yanli Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242562%22"}, {"id": "fda:K250247", "company": "Wenzel Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250247: panaSIa SI Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250247", "people": [{"name": "William Wilson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250247%22"}, {"id": "fda:K250505", "company": "Phasor Health, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250505: EZ-FIDUCIALS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250505", "people": [{"name": "Ray King", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250505%22"}, {"id": "fda:K251520", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251520: Cios Alpha; Cios Flow", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251520", "people": [{"name": "Patricia Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251520%22"}, {"id": "nih:1R43DA060641-01A1", "company": "Ksana Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": 406451, "summary": "NIH award 1R43DA060641-01A1: Building a Contextually Triggered Just-in-Time Intervention for Opioid UseDisorder: Stakeholder Evaluation and User Centered Design ($406,451)", "source_url": "https://reporter.nih.gov/project-details/11035041", "people": [{"name": "NICHOLAS B ALLEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA063467-01", "company": "Taesun, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": 305369, "summary": "NIH award 1R43DA063467-01: A comprehensive device integrating fentanyl test strips with sample preparation features for convenient and discreet fentanyl testing in high-risk environments ($305,369)", "source_url": "https://reporter.nih.gov/project-details/11186576", "people": [{"name": "Jeanie Chung", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DA058470-02", "company": "Autonomous Healthcare, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": 1157858, "summary": "NIH award 2R44DA058470-02: Noncontact Monitoring for the Detection of Opioid-Induced Respiratory Depression ($1,157,858)", "source_url": "https://reporter.nih.gov/project-details/11169624", "people": [{"name": "Behnood Gholami", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH128076-04", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": 850143, "summary": "NIH award 5R44MH128076-04: Next generation axonal quantification and classification using AI ($850,143)", "source_url": "https://reporter.nih.gov/project-details/11093531", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44CA302033-01", "company": "Rivanna Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": 1073736, "summary": "NIH award 1R44CA302033-01: Reduced Traumatic Lumbar Puncture Rates in Pediatric Oncology Patients Through Development of an AI-Assisted, Ultrasound-Based Interventional Guidance Platform ($1,073,736)", "source_url": "https://reporter.nih.gov/project-details/11182396", "people": [{"name": "Frank William Mauldin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07054281", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: UNITY VCS Vitreoretinal Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07054281"}, {"id": "trialreg:NCT07053618", "company": "Suzhou Hengruihongyuan Medical Technology Co. LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Interventional Left Ventricular Assist System for PCI in CHIP Patients", "source_url": "https://clinicaltrials.gov/study/NCT07053618"}, {"id": "trialreg:NCT07054710", "company": "Therabody, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Efficacy of a Cosmetic Light Mask", "source_url": "https://clinicaltrials.gov/study/NCT07054710"}, {"id": "trialreg:NCT07054593", "company": "Envivo Bio Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effect of Proton Pump Inhibitors on Gut Microbiota Composition and Metabolites in Healthy Subjects Using CapScan", "source_url": "https://clinicaltrials.gov/study/NCT07054593"}, {"id": "fda:K241525", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241525: ExcelsiusXR\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241525", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241525%22"}, {"id": "fda:K250342", "company": "Encompass Industries Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250342: Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250342", "people": [{"name": "Atikah Muhyiddin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250342%22"}, {"id": "fda:K251766", "company": "SimBioSys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251766: TumorSight Viz", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251766", "people": [{"name": "Kimberly Oleson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251766%22"}, {"id": "fda:K250065", "company": "Jeisys Medical Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250065: DENSITY; DENZA; DENSITY Noir", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250065", "people": [{"name": "Jeongwook Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250065%22"}, {"id": "fda:K251776", "company": "Encore Medical L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251776: EMPOWR Revision Knee\u0099 (EMPOWR Revision VVC+, e+ Tibial Insert)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251776", "people": [{"name": "Morgan Paronish", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251776%22"}, {"id": "fda:K251761", "company": "Momentis Surgical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251761: Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251761", "people": [{"name": "Maya Leib Shlomo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251761%22"}, {"id": "fda:K240908", "company": "Spectrum Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240908: Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240908", "people": [{"name": "Asia Lukuc", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240908%22"}, {"id": "fda:K251447", "company": "Terumo Europe N.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251447: K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251447", "people": [{"name": "Liesbeth Decoster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251447%22"}, {"id": "fda:K250695", "company": "Shenzhen HugeMed Medical Technical Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250695: Single-use Ureteral Access Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250695", "people": [{"name": "Cathy Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250695%22"}, {"id": "fda:K251741", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251741: PathLoc Lumbar Interbody Fusion Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251741", "people": [{"name": "Kihayng Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251741%22"}, {"id": "fda:K251804", "company": "S.m.a.i.o", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251804: KHEIRON\u00ae Spinal Fixation System, including patient specific K-ROD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251804", "people": [{"name": "Jean-Charles Roussouly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251804%22"}, {"id": "nih:2R42GM145129-02", "company": "Odmr Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-07", "observed": "2026-08-21", "amount_usd": 1004525, "summary": "NIH award 2R42GM145129-02: Diamond NMR spectrometer for microfluidic metabolite profiling ($1,004,525)", "source_url": "https://reporter.nih.gov/project-details/11186779", "people": [{"name": "Victor Marcel Acosta", "role": "Principal Investigator"}, {"name": "Andrejs Jarmola", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41ES037566-01", "company": "Bioprinting Laboratories, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-07", "observed": "2026-08-21", "amount_usd": 306872, "summary": "NIH award 1R41ES037566-01: High-throughput DNT testing with engineered brain organoids ($306,872)", "source_url": "https://reporter.nih.gov/project-details/11169353", "people": [{"name": "Pranav Joshi", "role": "Principal Investigator"}, {"name": "MOO-YEAL LEE", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DE034651-01", "company": "Mobius Biotech LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-07", "observed": "2026-08-21", "amount_usd": 305320, "summary": "NIH award 1R43DE034651-01: Developing novel 3D printed grafts for nasal reconstruction ($305,320)", "source_url": "https://reporter.nih.gov/project-details/11068936", "people": [{"name": "Scott J Hollister", "role": "Principal Investigator"}, {"name": "Hansa Makhija", "role": "Principal Investigator"}, {"name": "DAVID Adam ZOPF", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL180216-01", "company": "Filamentech. Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-07", "observed": "2026-08-21", "amount_usd": 297720, "summary": "NIH award 1R43HL180216-01: MUSICO: An in silico platform for evaluating the effects of disease and drug effectiveness in HCM and DCM cardiomyopathies ($297,720)", "source_url": "https://reporter.nih.gov/project-details/11185186", "people": [{"name": "Srboljub M Mijailovich", "role": "Principal Investigator"}, {"name": "Farid Moussavi-Harami", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07052773", "company": "Genesis Medical AI", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of the Lung Cancer AI-based Decision Support Tool in Low-Dose Lung CT", "source_url": "https://clinicaltrials.gov/study/NCT07052773"}, {"id": "trialreg:NCT07052851", "company": "Lipo-Sphere", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial", "source_url": "https://clinicaltrials.gov/study/NCT07052851"}, {"id": "fda:K250496", "company": "Zibo Shengkun Chemical Industry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250496: Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250496", "people": [{"name": "Yanfeng Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250496%22"}, {"id": "fda:K251502", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251502: TruLift\u00ae Lateral Expandable Spacer & Lateral Buttress Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251502", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251502%22"}, {"id": "fda:K251863", "company": "Customsurg AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251863: CustomSurg OrthoPlanner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251863", "people": [{"name": "Thomas Zumbrunn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251863%22"}, {"id": "fda:K250827", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250827: aprevo\u00ae anterior lumbar interbody fusion device; aprevo\u00ae lateral lumbar interbody fusion device; aprevo\u00ae anterior lumbar interbody fusion device with interfixation; aprevo\u00ae transforaminal lumbar interbody fusion device; aprevo\u00ae TLIF-CA Articulating System; aprevo\u00ae Cervical ACDF; aprevo\u00ae Cervical ACDF-X; aprevo\u00ae Cervical ACDF-X No Cams", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250827", "people": [{"name": "Julie Lamothe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250827%22"}, {"id": "fda:K243884", "company": "Caranx Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243884: TAVIPILOT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243884", "people": [{"name": "Pierrre Berthet-Rayne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243884%22"}, {"id": "nih:5R44HL172325-02", "company": "Lazzaro Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-04", "observed": "2026-08-21", "amount_usd": 1104123, "summary": "NIH award 5R44HL172325-02: Lazzaro Medical Scaffold System for improved treatment of tracheobronchomalacia ($1,104,123)", "source_url": "https://reporter.nih.gov/project-details/11091573", "people": [{"name": "Dawn Dawn Bitz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL151147-04", "company": "DNA Medicine Institute", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-04", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44HL151147-04: Hemophilia Point-of-Care Monitoring Device and App ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11045006", "people": [{"name": "Eugene Yan-ho Chan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "trialreg:NCT07051707", "company": "Nuvaira, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD", "source_url": "https://clinicaltrials.gov/study/NCT07051707"}, {"id": "trialreg:NCT07052331", "company": "Vibwife AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The MOBY Study: Efficacy of Birth Mobility", "source_url": "https://clinicaltrials.gov/study/NCT07052331"}, {"id": "trialreg:NCT07051278", "company": "Radiometer Medical ApS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ABL90 FLEX PLUS Method Comparison Neonatal Capillary", "source_url": "https://clinicaltrials.gov/study/NCT07051278"}, {"id": "trialreg:NCT07052292", "company": "Novo Nordisk A/S", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: User Experience With DuraTouch\u00ae in Patients With Type 1 or Type 2 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07052292"}, {"id": "nih:5R44MH140096-03", "company": "Neurolux, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": 966320, "summary": "NIH award 5R44MH140096-03: Wireless Implantable Mechano-Acoustic Recording Device ($966,320)", "source_url": "https://reporter.nih.gov/project-details/11164739", "people": [{"name": "Cameron Good", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44MH134669-02", "company": "Pinnacle Technology, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": 1028331, "summary": "NIH award 2R44MH134669-02: Functionalized Multi-Modal Tetrode Arrays for Real-Time, Site-Specific Neurochemical Monitoring ($1,028,331)", "source_url": "https://reporter.nih.gov/project-details/11184003", "people": [{"name": "DAVID A JOHNSON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07049341", "company": "NeuroEM Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pilot Trial Evaluating Patient Experience With the MemorEM for Patients With Neurological Diseases", "source_url": "https://clinicaltrials.gov/study/NCT07049341"}, {"id": "trialreg:NCT07049913", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TBE Zone 2 PMS in Japan", "source_url": "https://clinicaltrials.gov/study/NCT07049913"}, {"id": "trialreg:NCT07050875", "company": "ABLE Human Motion S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Acquired Brain Injury in a Clinical Setting", "source_url": "https://clinicaltrials.gov/study/NCT07050875"}, {"id": "trialreg:NCT07050628", "company": "Rhaeos, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device", "source_url": "https://clinicaltrials.gov/study/NCT07050628"}, {"id": "trialreg:NCT07049744", "company": "XII Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea", "source_url": "https://clinicaltrials.gov/study/NCT07049744"}, {"id": "trialreg:NCT07050667", "company": "Terraplasma Medical GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Treatment of Chronic Wounds With Cold Plasma -Plasma Care\u00ae vs. Placebo", "source_url": "https://clinicaltrials.gov/study/NCT07050667"}, {"id": "trialreg:NCT07049120", "company": "Zhejiang Zylox Medical Device Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07049120"}, {"id": "trialreg:NCT07050784", "company": "Myant Medical Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Wearable Garment vs Gel Electrodes for Electrical Muscle Stimulation", "source_url": "https://clinicaltrials.gov/study/NCT07050784"}, {"id": "fda:K243207", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243207: BD Vacutainer\u00ae Eclipse\u0099 Blood Collection Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243207", "people": [{"name": "Sravan Rajamani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243207%22"}, {"id": "fda:K250838", "company": "Guangzhou Pinzhi Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250838: Denudation Pipettes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250838", "people": [{"name": "Hestia Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250838%22"}, {"id": "fda:K243255", "company": "Truabutment, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243255: URIS Long Implant & Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243255", "people": [{"name": "Ki Yoon Nam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243255%22"}, {"id": "fda:K250448", "company": "Shenzhen Trious Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250448: Disposable Percutaneous Nephrostomy Dilatation Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250448", "people": [{"name": "Yi Yingfang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250448%22"}, {"id": "fda:K251528", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251528: syngo.via MI Workflows; Scenium; syngo MBF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251528", "people": [{"name": "Clayton Ginn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251528%22"}, {"id": "fda:K251599", "company": "Hunan Vathin Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251599: Single-use Ureteral Access Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251599", "people": [{"name": "Ya Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251599%22"}, {"id": "fda:K243679", "company": "Therapixel", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243679: MammoScreen\u00ae (4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243679", "people": [{"name": "Pierre Fillard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243679%22"}, {"id": "fda:K243678", "company": "Bioventus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243678: TalisMann Neuromodulation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243678", "people": [{"name": "Sageev George", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243678%22"}, {"id": "fda:K250286", "company": "The Magstim Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250286: Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250286", "people": [{"name": "Daniel Gregory", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250286%22"}, {"id": "fda:K243826", "company": "Lima Corporate S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243826: SMR Reverse HP Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243826", "people": [{"name": "Marco Tallerico", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243826%22"}, {"id": "fda:K243123", "company": "Medusa (Guangxi)Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243123: IPL Treatment Device (MDSQMC-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243123", "people": [{"name": "Zhanai Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243123%22"}, {"id": "fda:K250733", "company": "Bimed Teknik Aletler Sanayi & Ticaret A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250733: 3DOSE 1ml Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250733", "people": [{"name": "Aysel Kilic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250733%22"}, {"id": "fda:K251291", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251291: Advanix\u0099 Pancreatic Stent and NaviFlex\u0099 Rapid Exchange (RX) Pancreatic Delivery System and Pushers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251291", "people": [{"name": "Yanine Garcia-Quezada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251291%22"}, {"id": "fda:K250165", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250165: Pastelle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250165", "people": [{"name": "Hyun Sik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250165%22"}, {"id": "fda:K251671", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251671: Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251671", "people": [{"name": "Clayton Ginn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251671%22"}, {"id": "fda:K243220", "company": "Onera B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243220: Onera STS 2 (ONERA STS 2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243220", "people": [{"name": "Pieter Ermers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243220%22"}, {"id": "fda:K250105", "company": "Aveera Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250105: Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250105", "people": [{"name": "Christopher Chapek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250105%22"}, {"id": "fda:K251390", "company": "Voco GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251390: MTA vpt", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251390", "people": [{"name": "Katrin Froehlich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251390%22"}, {"id": "fda:K250822", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250822: SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250822", "people": [{"name": "Kenny M Bello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250822%22"}, {"id": "fda:K243280", "company": "W&H Dentalwerk Buermoos GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243280: Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243280", "people": [{"name": "Gerhard Weidler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243280%22"}, {"id": "fda:K250398", "company": "Innovita (Tangshan) Biological Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250398: Innovita Flu A/B Antigen Rapid Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250398", "people": [{"name": "Yan Hua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250398%22"}, {"id": "fda:K251054", "company": "Teleflex Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251054: Hem-o-lok\u0099 PurplePlus\u0099 Large Polymer Ligating Clips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251054", "people": [{"name": "Hope West", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251054%22"}, {"id": "fda:K251080", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251080: IdentiTi II Cervical Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251080", "people": [{"name": "Unnati Bhuptani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251080%22"}, {"id": "nih:3R44ES036065-02S1", "company": "Lebrun Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44ES036065-02S1: An In Chemico Test to Identify Dermal Corrosives ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11326447", "people": [{"name": "Stewart Lebrun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA281709-02", "company": "Voxel Healthcare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": 665400, "summary": "NIH award 5R44CA281709-02: Long term radiation treatment planning in brain tumors in the pediatric population ($665,400)", "source_url": "https://reporter.nih.gov/project-details/11110298", "people": [{"name": "Niharika R Gajawelli", "role": "Principal Investigator"}, {"name": "Natasha Lepore", "role": "Principal Investigator"}, {"name": "Justin Low", "role": "Principal Investigator"}, {"name": "Benjamin Paul Ziemer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42CA275665-03", "company": "Digital Health Navigation Solutions, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": 1013300, "summary": "NIH award 5R42CA275665-03: A cloud-based digital health navigation program for colorectal cancer screening ($1,013,300)", "source_url": "https://reporter.nih.gov/project-details/11146650", "people": [{"name": "David P Miller", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07047638", "company": "Galderma R&D", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Effectiveness and Safety of Restylane Skinboosters Vital Lidocaine", "source_url": "https://clinicaltrials.gov/study/NCT07047638"}, {"id": "trialreg:NCT07047924", "company": "Menicon Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Trial Assessing the Safety and Effectiveness of Orthokeratology Lenses in Patients With Myopia and Myopic Astigmatism", "source_url": "https://clinicaltrials.gov/study/NCT07047924"}, {"id": "trialreg:NCT07048262", "company": "CSL Behring", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)", "source_url": "https://clinicaltrials.gov/study/NCT07048262"}, {"id": "trialreg:NCT07046832", "company": "MediView XR, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of an Augmented Reality Intraprocedural Needle Guidance Platform for Soft Tissue Biopsy", "source_url": "https://clinicaltrials.gov/study/NCT07046832"}, {"id": "trialreg:NCT07047196", "company": "Jiangsu Hansoh Pharmaceutical Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Efficacy and Safety of Intra-articular Injection of HS-20116 in Patients With Knee Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT07047196"}, {"id": "fda:K251720", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251720: OsteoFlo HydroFiber", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251720", "people": [{"name": "Luke Scrudato", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251720%22"}, {"id": "fda:K251049", "company": "Micro-Energy Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251049: SurgiLight 1470 Diode Laser System (Model:Halo)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251049", "people": [{"name": "Danning Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251049%22"}, {"id": "fda:K243468", "company": "Joytech Healthcare Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243468: Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243468", "people": [{"name": "Jing Cong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243468%22"}, {"id": "fda:K250729", "company": "Vive Health, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250729: Power Wheelchair (MOB1107)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250729", "people": [{"name": "Guy Savioli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250729%22"}, {"id": "fda:K250779", "company": "Curative Sound Therapeutics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250779: CS-Pro MED", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250779", "people": [{"name": "Les Bogdanowicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250779%22"}, {"id": "fda:K250587", "company": "Ziehm-Orthoscan, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250587: Orthoscan TAU Mini C-Arm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250587", "people": [{"name": "Kevin Bridgman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250587%22"}, {"id": "fda:K243701", "company": "Nanospectra Biosciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243701: AuroLase\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243701", "people": [{"name": "David Jorden", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243701%22"}, {"id": "fda:K250415", "company": "Aktiia SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250415: G0 Blood Pressure Monitoring System (G0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250415", "people": [{"name": "Neil Puri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250415%22"}, {"id": "fda:K250312", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250312: Hudson RCI\u00ae Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI\u00ae Comfort Flo Plus and Soft Plus Cannula Extra Small", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250312", "people": [{"name": "Sirisha Kommana", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250312%22"}, {"id": "fda:K251746", "company": "Sofwave Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251746: Pure Impact", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251746", "people": [{"name": "Ruthie Amir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251746%22"}, {"id": "fda:K251490", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251490: 8 mm Assist Cannula; 12 mm Assist Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251490", "people": [{"name": "Melissa Gonzalez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251490%22"}, {"id": "fda:K243868", "company": "Pegavision Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243868: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243868", "people": [{"name": "Oliver Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243868%22"}, {"id": "fda:K251241", "company": "Encore Medical L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251241: EMPOWR Revision Knee\u0099 (EMPOWR Revision Knee\u0099 Symmetric TT Cones)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251241", "people": [{"name": "Morgan Paronish", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251241%22"}, {"id": "fda:K250524", "company": "Mendaera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250524: Mendaera Guidance System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250524", "people": [{"name": "Josh DeFonzo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250524%22"}, {"id": "fda:K243399", "company": "Boehringer Laboratories, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243399: Boehringer Laboratories Liver Retractor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243399", "people": [{"name": "William Dackis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243399%22"}, {"id": "fda:K250848", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250848: Identity Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250848", "people": [{"name": "Deanna Strombeck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250848%22"}, {"id": "fda:K251285", "company": "Zhejiang Automwheel Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251285: Electric Wheelchair (HG-630)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251285", "people": [{"name": "Zhihao Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251285%22"}, {"id": "fda:K250684", "company": "Terumo Cardiovascular Systems Thi Plant", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250684: OPUSWAVE Dual Sensor Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250684", "people": [{"name": "Rahul Reddy Chinkeri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250684%22"}, {"id": "fda:K251031", "company": "Shanghai Apolo Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251031: Fiber Laser Treatment Systems (HS-232,HS-233)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251031", "people": [{"name": "Felix Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251031%22"}, {"id": "fda:K250279", "company": "Belport Company, Inc., Gingi-Pak", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250279: RC-SwiftPrep", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250279", "people": [{"name": "Peng Jingtian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250279%22"}, {"id": "fda:K250391", "company": "Elekta Solutions AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250391: Leksell Gamma Knife\u00ae (Elekta Esprit); Leksell Gamma Knife\u00ae (Icon\u0099); Leksell Gamma Knife\u00ae (Perfexion\u0099)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250391", "people": [{"name": "Simon Sj\u00f6hage", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250391%22"}, {"id": "pma:P240040", "company": "Life Technologies Corporation", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240040: Oncomine Dx Express Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240040", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240040%22"}, {"id": "nih:5R44CA228920-05", "company": "Leuko Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": 1802488, "summary": "NIH award 5R44CA228920-05: Reducing the incidence of febrile neutropenia in cancer patients treated with chemotherapy with PointCheck: a portable non-invasive neutropenia analyzer ($1,802,488)", "source_url": "https://reporter.nih.gov/project-details/11125802", "people": [{"name": "Carlos Castro-Gonzalez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44GM154507-02", "company": "Applied Biophysics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": 901192, "summary": "NIH award 5R44GM154507-02: Development of an impedance-based cell assurance monitor to aid in identifying and characterizing cells in tissue culture ($901,192)", "source_url": "https://reporter.nih.gov/project-details/11124210", "people": [{"name": "CHARLES R KEESE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44EY037603-01", "company": "Universal Adherence, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": 912573, "summary": "NIH award 1R44EY037603-01: The iD2: A Smart Eye Drop Cap Monitor for Eye Drop Adherence ($912,573)", "source_url": "https://reporter.nih.gov/project-details/11183998", "people": [{"name": "Robert Kinast", "role": "Principal Investigator"}, {"name": "Steven L Mansberger", "role": "Principal Investigator"}, {"name": "Vincent O'Malley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07046065", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Algorithm-assisted Subjective Refraction Program Dedicated to Children", "source_url": "https://clinicaltrials.gov/study/NCT07046065"}, {"id": "trialreg:NCT07045194", "company": "Orchestra BioMed, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Virtue\u00ae SAB in the Treatment of Coronary ISR Trial", "source_url": "https://clinicaltrials.gov/study/NCT07045194"}, {"id": "trialreg:NCT07044674", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Cataract Surgery Clinical Trial", "source_url": "https://clinicaltrials.gov/study/NCT07044674"}, {"id": "trialreg:NCT07046234", "company": "GE Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-07-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Point of Care Lung Ultrasound Examination in Patients With Shortness of Breath", "source_url": "https://clinicaltrials.gov/study/NCT07046234"}, {"id": "fda:K250096", "company": "Fasikl Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250096: Felix NeuroAI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250096", "people": [{"name": "Zhen Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250096%22"}, {"id": "fda:K251719", "company": "Ulrich Medical USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251719: Momentum\u00ae Posterior Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251719", "people": [{"name": "Eric Lucas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251719%22"}, {"id": "fda:K250699", "company": "Convatec", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250699: Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250699", "people": [{"name": "Cole Langham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250699%22"}, {"id": "fda:K243779", "company": "BunkerHill Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243779: Bunkerhill Abdominal Aortic Quantification (AAQ)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243779", "people": [{"name": "Nishith Khandwala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243779%22"}, {"id": "fda:K243485", "company": "Abbott Molecular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243485: Alinity m CMV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243485", "people": [{"name": "Stacy Ferguson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243485%22"}, {"id": "fda:K250016", "company": "Htl-Strefa S.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250016: droplet\u00ae personal lancets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250016", "people": [{"name": "Justyna Zemigala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250016%22"}, {"id": "fda:K250221", "company": "Circle Cardiovascular Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250221: StrokeSENS ASPECTS Software Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250221", "people": [{"name": "Kyle Mayr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250221%22"}, {"id": "fda:K243690", "company": "PAJUNK GmbH Medizintechnologie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243690: SonoMSK", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243690", "people": [{"name": "Christian Quass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243690%22"}, {"id": "fda:K251453", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251453: Arthrex iBalance Partial Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251453", "people": [{"name": "Tiffany Mentzel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251453%22"}, {"id": "fda:K251032", "company": "Medtronic Minimed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251032: MiniMed 780G insulin pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251032", "people": [{"name": "Hemang Kotecha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251032%22"}, {"id": "fda:K251212", "company": "Access Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251212: Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251212", "people": [{"name": "Scott Blood", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251212%22"}, {"id": "fda:K251933", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251933: SnugFit ASA Extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251933", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251933%22"}, {"id": "fda:K250204", "company": "Shenzhen Sophway Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250204: Endoscopic Camera System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250204", "people": [{"name": "Peter Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250204%22"}, {"id": "nih:1R43EY036763-01A1", "company": "Kineolabs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-30", "observed": "2026-08-21", "amount_usd": 300001, "summary": "NIH award 1R43EY036763-01A1: Line Scan Swept Source OCT (LS-SS-OCT) ($300,001)", "source_url": "https://reporter.nih.gov/project-details/11185712", "people": [{"name": "Walid Atia", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44HL172473-02", "company": "Cerulean Scientific Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-30", "observed": "2026-08-21", "amount_usd": 1394084, "summary": "NIH award 4R44HL172473-02: Slippery, Omniphobic Coating to Prevent Thrombosis and Biofilm Formation on Peripheral Vascular Grafts ($1,394,084)", "source_url": "https://reporter.nih.gov/project-details/11326089", "people": [{"name": "Todd McFarland", "role": "Principal Investigator"}, {"name": "Daniel Durant Myers", "role": "Principal Investigator"}, {"name": "Andrea Tara Obi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K250022", "company": "Voluntis", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250022: HeroTracker Sense", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250022", "people": [{"name": "Sana Charnine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250022%22"}, {"id": "fda:K250484", "company": "Piur Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250484: PIUR tUS inside", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250484", "people": [{"name": "Milos Stojanovic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250484%22"}, {"id": "fda:K251088", "company": "Otsuka America Pharmaceutical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251088: Otsuka Digital Feedback Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251088", "people": [{"name": "Nancy Teague", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251088%22"}, {"id": "fda:K250670", "company": "Mycardium AI Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250670: EchoConfidence (USA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250670", "people": [{"name": "Michael Walker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250670%22"}, {"id": "fda:K243647", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243647: Synapse PACS (7.5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243647", "people": [{"name": "Kulkarni Chaitrali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243647%22"}, {"id": "fda:K250987", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250987: aprevo\u00ae posterior/transforaminal lumbar interbody fusion device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250987", "people": [{"name": "Jesse Albright", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250987%22"}, {"id": "fda:K251000", "company": "Shenzhen Chuangtong Yigou Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251000: Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251000", "people": [{"name": "Kingway Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251000%22"}, {"id": "fda:K250990", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250990: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250990", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250990%22"}, {"id": "trialreg:NCT07044128", "company": "Lapsi Health Holding B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.", "source_url": "https://clinicaltrials.gov/study/NCT07044128"}, {"id": "trialreg:NCT07043036", "company": "Resilience", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Randomized Controlled Trial Comparing Remote Patient Monitoring vs Standard Care in IBD Patients Initiating or Changing Advanced Therapy", "source_url": "https://clinicaltrials.gov/study/NCT07043036"}, {"id": "trialreg:NCT07043075", "company": "Caranx Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: First-in-Human (FIH) Study on the Feasibility and Safety of the TaviPilot Augmented Reality Guidance Software", "source_url": "https://clinicaltrials.gov/study/NCT07043075"}, {"id": "trialreg:NCT07042620", "company": "SonoClear AS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07042620"}, {"id": "fda:K250972", "company": "Pendracare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250972: Primum Hydrophilic Guiding Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250972", "people": [{"name": "Erendira Rodriguez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250972%22"}, {"id": "nih:5R44AA030512-03", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": 1379360, "summary": "NIH award 5R44AA030512-03: Oscillated Insertion Tool for Minimally Invasive, Low-Damage, Accurate Placement of Delivery Cannula to Improve Efficacy for DREADDS Therapy in Alcohol Addiction Treatment ($1,379,360)", "source_url": "https://reporter.nih.gov/project-details/11093475", "people": [{"name": "Roger Brooks Bagwell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43CA302117-01", "company": "Calla Health Foundation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": 317420, "summary": "NIH award 1R43CA302117-01: Development and validation of patient-ready Callascope for cervical imaging ($317,420)", "source_url": "https://reporter.nih.gov/project-details/11183576", "people": [{"name": "Brian Crouch", "role": "Principal Investigator"}, {"name": "MARLEE KRIEGER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43TR005426-01", "company": "Analytical Diagnostic Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": 305352, "summary": "NIH award 1R43TR005426-01: A point-of-care device for the determination of homocysteine (Hcy), the Hcy Now ($305,352)", "source_url": "https://reporter.nih.gov/project-details/11068896", "people": [{"name": "Robert Harper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH136865-02", "company": "Spikegadgets, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": 1747812, "summary": "NIH award 5R44MH136865-02: A commercialized platform for diversified large-scale chronic electrophysiology ($1,747,812)", "source_url": "https://reporter.nih.gov/project-details/11139521", "people": [{"name": "Peter Denes", "role": "Principal Investigator"}, {"name": "Mattias Peter Karlsson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07041047", "company": "Swiss Footcare Laboratories - Poderm Professional", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Apaisant Serum - Ingrown Nails for Ingrown Toenails", "source_url": "https://clinicaltrials.gov/study/NCT07041047"}, {"id": "trialreg:NCT07040150", "company": "Nippon Sigmax co., ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis", "source_url": "https://clinicaltrials.gov/study/NCT07040150"}, {"id": "trialreg:NCT07042217", "company": "Soterix Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Transcranial Direct Current Stimulation for Depression", "source_url": "https://clinicaltrials.gov/study/NCT07042217"}, {"id": "trialreg:NCT07041918", "company": "Disera T\u0131bbi Cihazlar Lojistik Sanayi ve Ticaret A.\u015e", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Performance and Safety of VACUSERA\u00ae PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma", "source_url": "https://clinicaltrials.gov/study/NCT07041918"}, {"id": "fda:K243190", "company": "Ustomed Instrumente Ulrich Storz GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243190: USTOMED Bone Fixation/Bone Augmentation Systems - PIN", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243190", "people": [{"name": "Alexander Schwoy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243190%22"}, {"id": "fda:K251116", "company": "Coloplast Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251116: Luja Coud\u00e9", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251116", "people": [{"name": "Troy Thome", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251116%22"}, {"id": "fda:K250984", "company": "Moon Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250984: Maestro System (REF100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250984", "people": [{"name": "Anne Osdoit", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250984%22"}, {"id": "fda:K250648", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250648: Philips iCT CT system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250648", "people": [{"name": "Maya Tolchinsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250648%22"}, {"id": "fda:K250610", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250610: Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250610", "people": [{"name": "Luigi Vecchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250610%22"}, {"id": "fda:K251431", "company": "Jeil Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251431: FIX-C PEEK ACIF SA System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251431", "people": [{"name": "Jinwoo Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251431%22"}, {"id": "fda:K251660", "company": "Biomet 3i, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251660: T3 Pro Implants\u0096 ZimVie Packaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251660", "people": [{"name": "Ant\u00eda Fernandez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251660%22"}, {"id": "fda:K250522", "company": "Multi4 Medical AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250522: Multi4 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250522", "people": [{"name": "Miden Melle-Hannah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250522%22"}, {"id": "fda:K243187", "company": "Cork Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243187: Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243187", "people": [{"name": "Antonio Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243187%22"}, {"id": "fda:K243388", "company": "Micro-Tech (Nanjing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243388: Disposable Distal Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243388", "people": [{"name": "Sally He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243388%22"}, {"id": "fda:K243077", "company": "Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243077: Affirm 800", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243077", "people": [{"name": "Lu Ju", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243077%22"}, {"id": "fda:K250585", "company": "Cathegenix (Xiamen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250585: LumenaTM Ureteral Access Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250585", "people": [{"name": "Deyuan Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250585%22"}, {"id": "fda:K242988", "company": "Genostis AF", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242988: Genostis Osteosynthesis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242988", "people": [{"name": "Sabine S\u00f6hndel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242988%22"}, {"id": "fda:K243682", "company": "PAJUNK GmbH Medizintechnologie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243682: SonoPlex STIM; SonoPlex II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243682", "people": [{"name": "Christian Quass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243682%22"}, {"id": "fda:K251329", "company": "Risu Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251329: Diode laser device (RF3120-BI)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251329", "people": [{"name": "Tianqiang Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251329%22"}, {"id": "fda:K251654", "company": "Becton Dickinson Infusion Therapy Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251654: BD Insyte\u0099 Autoguard\u0099 Shielded IV Catheter, BD Insyte\u0099 Autoguard\u0099 BC Shielded IV Catheter and BD Insyte\u0099 Autoguard\u0099 BC Pro Shielded IV Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251654", "people": [{"name": "Laura Castelnoble", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251654%22"}, {"id": "fda:K250969", "company": "Dent4you AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250969: JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250969", "people": [{"name": "Oliver Ashe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250969%22"}, {"id": "fda:K243130", "company": "Guangdong Yadeng Medical Apparatus Co., Ltd.,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243130: Integral Dental Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243130", "people": [{"name": "Chang Ming Weng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243130%22"}, {"id": "fda:K250828", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250828: CPS Locator 3D Plus Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250828", "people": [{"name": "Conner Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250828%22"}, {"id": "fda:K243144", "company": "Scopio Labs , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243144: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243144", "people": [{"name": "Ifat Raved", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243144%22"}, {"id": "fda:K243816", "company": "Spine Wave, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243816: Testa TP Pivoting Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243816", "people": [{"name": "Smith Ronald", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243816%22"}, {"id": "fda:K243183", "company": "Rtm Vital Signs, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243183: RTMsense Respiratory Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243183", "people": [{"name": "Dicciani Nance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243183%22"}, {"id": "fda:K251642", "company": "Yian Medical Technology (Haining) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251642: Dental CBCT X-ray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251642", "people": [{"name": "Lili Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251642%22"}, {"id": "fda:K243900", "company": "Empnia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243900: eMotus Respiratory Motion Management System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243900", "people": [{"name": "Manojeet Bhattacharya", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243900%22"}, {"id": "fda:K250310", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250310: VIKING\u0099 Fixed Curve Diagnostic Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250310", "people": [{"name": "Oliver Buttleman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250310%22"}, {"id": "fda:K251210", "company": "Neuromodulatory Devices & Applications", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251210: Ampa One System (AMPA-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251210", "people": [{"name": "Don Vaughn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251210%22"}, {"id": "nih:1R43TR005330-01A1", "company": "Nanoengineering Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": 349909, "summary": "NIH award 1R43TR005330-01A1: Development of a Viral Vector Sizing Tool to Improve Gene Therapy Analytics and Reduce the Cost of Drug Development ($349,909)", "source_url": "https://reporter.nih.gov/project-details/11068858", "people": [{"name": "Luis Javier Perez Lorenzo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07039604", "company": "Pulnovo Medical (Wuxi) Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real-World Study of PADN for the Treatment of PAH", "source_url": "https://clinicaltrials.gov/study/NCT07039604"}, {"id": "trialreg:NCT07039357", "company": "Glyconics Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07039357"}, {"id": "trialreg:NCT07039981", "company": "Insulet Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07039981"}, {"id": "trialreg:NCT07039942", "company": "Insulet Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: French Prospective Multicentric Study in Real World", "source_url": "https://clinicaltrials.gov/study/NCT07039942"}, {"id": "trialreg:NCT07038395", "company": "LensAR Incorporated", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Retrospective Analysis of the Time Elements for Different Workflow Scenarios During Femtosecond Laser-assisted Cataract Surgery (FLACS) From the Surgeon, Staff, and Patient Perspectives.", "source_url": "https://clinicaltrials.gov/study/NCT07038395"}, {"id": "trialreg:NCT07039032", "company": "Shanghai MicroPort EP MedTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study on the Use of a Domestically Produced Three-dimensional Cardiac Electrophysiological Mapping System Combined With Pressure Monitoring Technology and Star Mapping Technology for the Treatment of Paroxysmal Atrial Fibrillation.", "source_url": "https://clinicaltrials.gov/study/NCT07039032"}, {"id": "trialreg:NCT07039461", "company": "Lumenis Be Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion", "source_url": "https://clinicaltrials.gov/study/NCT07039461"}, {"id": "fda:K251717", "company": "Maxx Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251717: Freedom\u00ae Total Knee System \u0096 Titanium Tibial Base Plate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251717", "people": [{"name": "Corey Perine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251717%22"}, {"id": "fda:K243636", "company": "Neuralytix, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243636: Neuralytix iD3 System (NTX-9001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243636", "people": [{"name": "Christopher Wybo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243636%22"}, {"id": "fda:K251613", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251613: SwissGraft X", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251613", "people": [{"name": "Erik Wirth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251613%22"}, {"id": "fda:K251632", "company": "InMode , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251632: Optimas MAX System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251632", "people": [{"name": "Suhair Francis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251632%22"}, {"id": "fda:K251728", "company": "Sonic Incytes Medical Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251728: Velacur One (LI-1100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251728", "people": [{"name": "Tinuade Orimalade", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251728%22"}, {"id": "fda:K251395", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251395: The Rialto\u0099 SI Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251395", "people": [{"name": "Rong Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251395%22"}, {"id": "fda:K243391", "company": "PathAI, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243391: AISight Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243391", "people": [{"name": "Hisani Madison", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243391%22"}, {"id": "fda:K242846", "company": "Shenzhen Bestman Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242846: Doppler FHR Detector (BF-500D+, BF-560)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242846", "people": [{"name": "Yong Bai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242846%22"}, {"id": "fda:K250956", "company": "Hardy Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250956: HardyDisk AST Gepotidacin 10\u00b5g (GEP10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250956", "people": [{"name": "Lauren Hamilton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250956%22"}, {"id": "fda:K250929", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250929: TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250929", "people": [{"name": "Divya Raghavi Nandakumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250929%22"}, {"id": "fda:K250519", "company": "ViOptix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250519: Lap.Ox\u0099 Laparoscopic Tissue Oximeter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250519", "people": [{"name": "Scott Coleridge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250519%22"}, {"id": "fda:K250940", "company": "Atmo Biosciences, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250940: Atmo Gas Capsule System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250940", "people": [{"name": "Ian Macfarlane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250940%22"}, {"id": "fda:K251694", "company": "Tianjin Huahong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251694: safety lancet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251694", "people": [{"name": "Ningning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251694%22"}, {"id": "fda:K243175", "company": "Chengdu Daxan Innovative Medical Tech. Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243175: Disposable Intermittent Catheter (TPU Catheter)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243175", "people": [{"name": "Zeng Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243175%22"}, {"id": "fda:K243275", "company": "Exactech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243275: Equinoxe\u00ae Scapula Fracture System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243275", "people": [{"name": "Valdimir Talley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243275%22"}, {"id": "fda:K250967", "company": "Open Implants, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250967: Sherlock", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250967", "people": [{"name": "Gregg Gellman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250967%22"}, {"id": "fda:K243079", "company": "Verity Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243079: NeuroTrac\u00ae MyoPlus Pro (MYO120U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243079", "people": [{"name": "Nigel Verity", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243079%22"}, {"id": "fda:K250548", "company": "Joytech Healthcare Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250548: Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250548", "people": [{"name": "Cong Jing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250548%22"}, {"id": "fda:K243179", "company": "Yichang Xinxin Paper Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243179: Sterilization Pouch and Roll", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243179", "people": [{"name": "Xiao Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243179%22"}, {"id": "nih:1R43GM161144-01", "company": "Edvotek, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": 304862, "summary": "NIH award 1R43GM161144-01: The STEMfluidics Platform: Inspiring STEM Learning and Career Exploration with Microfluidics ($304,862)", "source_url": "https://reporter.nih.gov/project-details/11250216", "people": [{"name": "Brian Ell", "role": "Principal Investigator"}, {"name": "DANIELLE SNOWFLACK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG077737-03", "company": "Hido Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": 1232957, "summary": "NIH award 5R44AG077737-03: Preventing Medication Mismanagement in People Living with Dementia through Automated Medication Dispensing with Facial Recognition and Video Observation ($1,232,957)", "source_url": "https://reporter.nih.gov/project-details/11196749", "people": [{"name": "NEELUM T. AGGARWAL", "role": "Principal Investigator"}, {"name": "Charles Gellman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL170779-02", "company": "Innovative Biotherapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": 1513922, "summary": "NIH award 5R44HL170779-02: Cell Directed Immunomodulation Therapy as a Bridge to Left Ventricular Device Implantation in Chronic Heart Failure Patients ($1,513,922)", "source_url": "https://reporter.nih.gov/project-details/11078730", "people": [{"name": "Kimberly Anne Johnston", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA210770-06", "company": "Civatech Oncology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": 1017318, "summary": "NIH award 5R44CA210770-06: Commercializing CivaSheet for Pancreatic Cancer Patients ($1,017,318)", "source_url": "https://reporter.nih.gov/project-details/11117056", "people": [{"name": "Kristy Perez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "trialreg:NCT07036965", "company": "Hangzhou Dinova EP Technology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07036965"}, {"id": "trialreg:NCT07037446", "company": "Occlutech International AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks", "source_url": "https://clinicaltrials.gov/study/NCT07037446"}, {"id": "trialreg:NCT07036510", "company": "EyeD Pharma", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07036510"}, {"id": "trialreg:NCT07035431", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area", "source_url": "https://clinicaltrials.gov/study/NCT07035431"}, {"id": "trialreg:NCT07036068", "company": "Shanghai MicroPort EP MedTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT07036068"}, {"id": "trialreg:NCT07036835", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation", "source_url": "https://clinicaltrials.gov/study/NCT07036835"}, {"id": "trialreg:NCT07035925", "company": "ECM Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas", "source_url": "https://clinicaltrials.gov/study/NCT07035925"}, {"id": "trialreg:NCT07036107", "company": "ABLE Human Motion S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System", "source_url": "https://clinicaltrials.gov/study/NCT07036107"}, {"id": "fda:K250943", "company": "Sysmex America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250943: Sysmex XR-Series (XR-10) Automated Hematology Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250943", "people": [{"name": "Yvonne Doswell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250943%22"}, {"id": "fda:K251003", "company": "Expanding Innovations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251003: X-PAC\u00ae LLIF Expandable Lateral Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251003", "people": [{"name": "Robert Jaramillo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251003%22"}, {"id": "fda:K250921", "company": "Blue Belt Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250921: CORIOGRAPH Pre-Op Planning and Modeling Services", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250921", "people": [{"name": "Corrine Herlinger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250921%22"}, {"id": "fda:K250774", "company": "PAJUNK GmbH Medizintechnologie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250774: SPROTTE\u00ae STANDARD (LUER/ NRFit\u00ae) Lumbar Puncture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250774", "people": [{"name": "Christian Quass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250774%22"}, {"id": "fda:K250329", "company": "Geniphys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250329: GeniPhys Collymer Self-Assembling Scaffold", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250329", "people": [{"name": "Sherry Harbin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250329%22"}, {"id": "fda:K251611", "company": "Fisher & Paykel Healthcare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251611: Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251611", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251611%22"}, {"id": "fda:K243184", "company": "Strait Access Technologies Holdings", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243184: SAT CenterFlow Molding Balloon Catheter (IN20-00313)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243184", "people": [{"name": "Malcolm Applewhite", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243184%22"}, {"id": "fda:K243112", "company": "Enraf-Nonius, B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243112: Curapuls 670", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243112", "people": [{"name": "Tom Doodkorte", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243112%22"}, {"id": "fda:K250747", "company": "Kardium, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250747: Globe\u00ae Pulsed Field System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250747", "people": [{"name": "Ricardo Romero", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250747%22"}, {"id": "fda:K242845", "company": "S&G Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242845: EGIS Biliary Double Bare Stent (BDB080405)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242845", "people": [{"name": "Yoo Young Ji", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242845%22"}, {"id": "fda:K250966", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250966: CurrentBody Skin\u0099 LED Light Therapy Mask Series 2 (MK-90H)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250966", "people": [{"name": "Dijkstra Alain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250966%22"}, {"id": "fda:K251371", "company": "Sysmex America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251371: Sysmex XR-Series (XR-20) Automated Hematology Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251371", "people": [{"name": "Yvonne Doswell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251371%22"}, {"id": "fda:K251606", "company": "Anhui Jbh Medical Apparatus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251606: Power Wheelchair (D26)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251606", "people": [{"name": "Yuanwei Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251606%22"}, {"id": "fda:K251725", "company": "Cg Medtech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251725: ANAX\u0099 OCT Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251725", "people": [{"name": "Jeongah Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251725%22"}, {"id": "fda:K250302", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250302: Flexible Partial Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250302", "people": [{"name": "Jiahe Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250302%22"}, {"id": "fda:K251627", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251627: BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251627", "people": [{"name": "Crystal Treadway", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251627%22"}, {"id": "nih:1R41DK139916-01A1", "company": "Katharos, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-24", "observed": "2026-08-21", "amount_usd": 350000, "summary": "NIH award 1R41DK139916-01A1: Novel Extracorporeal Technology for Kidney Disease ($350,000)", "source_url": "https://reporter.nih.gov/project-details/11065551", "people": [{"name": "MELANIE S JOY", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07034092", "company": "Pathfinder Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PATH-03 Paraguay Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07034092"}, {"id": "trialreg:NCT07033689", "company": "SONIRE Therapeutics Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study of Suizenji, in Patients With Unresectable Pancreatic Ductal Adenocarcinoma (SUNRISE-II)", "source_url": "https://clinicaltrials.gov/study/NCT07033689"}, {"id": "trialreg:NCT07033130", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Performance of Different Sound Paths in Adult NeuroZti CI-users", "source_url": "https://clinicaltrials.gov/study/NCT07033130"}, {"id": "trialreg:NCT07034924", "company": "LLC UkrMedGroup", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage", "source_url": "https://clinicaltrials.gov/study/NCT07034924"}, {"id": "trialreg:NCT07032597", "company": "AbbVie", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Assess Safety and Effectiveness of HArmonyCa Lidocaine Injectable Gel for Restoration and/or Creation of Mid-Face Volume in Adult Participants", "source_url": "https://clinicaltrials.gov/study/NCT07032597"}, {"id": "trialreg:NCT07033845", "company": "Applied Biology, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pharmacokinetic Study of Topical Phenylephrine", "source_url": "https://clinicaltrials.gov/study/NCT07033845"}, {"id": "trialreg:NCT07032428", "company": "Magnetic Tides", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy of kTMP, a Novel Non-invasive Brain Stimulation Method, for the Treatment of Anhedonia", "source_url": "https://clinicaltrials.gov/study/NCT07032428"}, {"id": "trialreg:NCT07033195", "company": "CognifiSense Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT)", "source_url": "https://clinicaltrials.gov/study/NCT07033195"}, {"id": "trialreg:NCT07032948", "company": "Shanghai MicroPort EP MedTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy Study of the First Domestically Produced FireMagic\u2122 PreciSense\u2122 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function", "source_url": "https://clinicaltrials.gov/study/NCT07032948"}, {"id": "trialreg:NCT07034014", "company": "Molnlycke Health Care AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices", "source_url": "https://clinicaltrials.gov/study/NCT07034014"}, {"id": "fda:K251362", "company": "OrthoPediatrics Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251362: PediFlex\u0099 Flexible Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251362", "people": [{"name": "Jessica Powers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251362%22"}, {"id": "fda:K251648", "company": "Prosidyan, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251648: GPS Advanced; GPS Advanced Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251648", "people": [{"name": "Tamala Wampler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251648%22"}, {"id": "fda:K251358", "company": "Philips Image Guided Therapy Devices", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251358: Bridge Plus Occlusion Balloon (590-002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251358", "people": [{"name": "Sondra Chandler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251358%22"}, {"id": "fda:K243009", "company": "Imagine Milling Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243009: MIST IC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243009", "people": [{"name": "Felix Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243009%22"}, {"id": "fda:K250268", "company": "Hypervision Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250268: HyperSnap Surgical System (HSS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250268", "people": [{"name": "Jaco Jacobs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250268%22"}, {"id": "fda:K250326", "company": "Spectrum Medical S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250326: Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250326", "people": [{"name": "Raffaella Tommasini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250326%22"}, {"id": "fda:K251644", "company": "Pro Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251644: ProAM ALIF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251644", "people": [{"name": "Jason Blain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251644%22"}, {"id": "nih:5R44HD094406-03", "company": "Dfusion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": 518297, "summary": "NIH award 5R44HD094406-03: Scaling Effective Behavioral Interventions with MPC Avatar-Based Virtual Training ($518,297)", "source_url": "https://reporter.nih.gov/project-details/11131087", "people": [{"name": "Mia Barrett", "role": "Principal Investigator"}, {"name": "Tamara J. Kuhn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AI192170-01", "company": "Mucommune, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": 1025000, "summary": "NIH award 1R44AI192170-01: IND-enabling development of MM-009, a reservoir-intravaginal ring for ultra-highrates of month-long lactic acid release to treat and prevent bacterial vaginosis ($1,025,000)", "source_url": "https://reporter.nih.gov/project-details/11186410", "people": [{"name": "Keiichiro Kushiro", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07032311", "company": "SIPPA Solutions INC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk", "source_url": "https://clinicaltrials.gov/study/NCT07032311"}, {"id": "fda:K243142", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243142: Cranial 4Pi Immobilization", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243142", "people": [{"name": "Sadwini Suresh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243142%22"}, {"id": "fda:K242924", "company": "Opxion Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242924: OPXION Optical Skin Viewer (OPXSV1-01F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242924", "people": [{"name": "Shao-Hua Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242924%22"}, {"id": "fda:K251271", "company": "Rizhao Huge Biomaterials Company, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251271: TempFIT Temporary Crown and Bridge Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251271", "people": [{"name": "Maggie Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251271%22"}, {"id": "fda:K250470", "company": "Shenzhen AOJ Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250470: Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250470", "people": [{"name": "Jack Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250470%22"}, {"id": "fda:K250862", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250862: EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250862", "people": [{"name": "Tamada Osamu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250862%22"}, {"id": "fda:K250885", "company": "Liofilchem, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250885: Ceftobiprole BPR 5 \u00b5g Disc", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250885", "people": [{"name": "Emily Hodgkins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250885%22"}, {"id": "fda:K243339", "company": "Idmed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243339: WiTOF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243339", "people": [{"name": "Aurelie Gruener", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243339%22"}, {"id": "fda:K250143", "company": "Apple, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250143: Digital Prism Correction Feature (DPCF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250143", "people": [{"name": "Ian Marcus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250143%22"}, {"id": "fda:K251570", "company": "Vipamat Sarl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251570: Hippocampe Marathon and Trail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251570", "people": [{"name": "Vincent Leroy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251570%22"}, {"id": "pma:P240029", "company": "InspireMD, Ltd.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-06-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240029: CGuard Prime Carotid Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240029", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240029%22"}, {"id": "trialreg:NCT07031882", "company": "Entia Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Liberty Analyzer WBC System: Reference Interval Study", "source_url": "https://clinicaltrials.gov/study/NCT07031882"}, {"id": "trialreg:NCT07032038", "company": "Rinri Therapeutics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant", "source_url": "https://clinicaltrials.gov/study/NCT07032038"}, {"id": "trialreg:NCT07031050", "company": "Distalmotion SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance", "source_url": "https://clinicaltrials.gov/study/NCT07031050"}, {"id": "trialreg:NCT07032155", "company": "eXRt Intelligent Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Virtual Reality in Occupational Therapy Upper Limb Stroke Rehabilitation", "source_url": "https://clinicaltrials.gov/study/NCT07032155"}, {"id": "trialreg:NCT07030322", "company": "Ekso Bionics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Health and Financial Impact on the Use of a Personal Exoskeleton in the Home and Community: a Case Study", "source_url": "https://clinicaltrials.gov/study/NCT07030322"}, {"id": "trialreg:NCT07032246", "company": "icometrix", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study", "source_url": "https://clinicaltrials.gov/study/NCT07032246"}, {"id": "nih:1R43CA302053-01", "company": "Imcare Biotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": 364763, "summary": "NIH award 1R43CA302053-01: A novel multi-analyte algorithmic assay diagnostic for hepatocellular carcinoma (HCC). ($364,763)", "source_url": "https://reporter.nih.gov/project-details/11181451", "people": [{"name": "Bobby Kumar Biswal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K243000", "company": "Shenzhen Medke Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243000: Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243000", "people": [{"name": "Wei Tao Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243000%22"}, {"id": "fda:K251560", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251560: FUBUKI XF-R Neurovascular Long Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251560", "people": [{"name": "Fujimura Katsuhiko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251560%22"}, {"id": "fda:K243062", "company": "Becton Dickinson", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243062: BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243062", "people": [{"name": "Tim Wade", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243062%22"}, {"id": "fda:K251248", "company": "Jinhua Qidian Vehicle Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251248: ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251248", "people": [{"name": "Qunbao Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251248%22"}, {"id": "fda:K250151", "company": "Eko.Ai Pte Ltd. D/B/A Us2.Ai", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250151: Us2.ca", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250151", "people": [{"name": "Hui Qun Tay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250151%22"}, {"id": "fda:K242981", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242981: Atellica IM Thyroglobulin (Tg)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242981", "people": [{"name": "Mey Vasquez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242981%22"}, {"id": "fda:K251567", "company": "Polynovo Biomaterials Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251567: NovoSorb BTM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251567", "people": [{"name": "Shruti Dave", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251567%22"}, {"id": "fda:K251240", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251240: Branchor X Balloon Guide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251240", "people": [{"name": "Fujimura Katsuhiko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251240%22"}, {"id": "fda:K242964", "company": "Hadleigh Health Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242964: Celsi Warmer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242964", "people": [{"name": "Molly McCabe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242964%22"}, {"id": "fda:K250037", "company": "Wright Medical Technology, Inc. (Stryker)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250037: Incompass Total Ankle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250037", "people": [{"name": "Antonio Ayala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250037%22"}, {"id": "fda:K243978", "company": "Shenzhen Sunsred Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243978: LED Facial Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243978", "people": [{"name": "Xiufeng Cai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243978%22"}, {"id": "fda:K250566", "company": "Spident Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250566: EsCem RMGI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250566", "people": [{"name": "Hyemin Kwon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250566%22"}, {"id": "fda:K242974", "company": "Sophysa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242974: External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242974", "people": [{"name": "Julie Lopez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242974%22"}, {"id": "fda:K242985", "company": "Ovigenex, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242985: CollOvine\u0099 Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242985", "people": [{"name": "Thomas Hyland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242985%22"}, {"id": "fda:K251258", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251258: MC2\u0099 Two-Stage Venous Cannula; MC2X\u0099 Three-Stage Venous Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251258", "people": [{"name": "Stephen Beier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251258%22"}, {"id": "fda:K250877", "company": "THINK Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250877: TMINI Miniature Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250877", "people": [{"name": "Denise Duchene", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250877%22"}, {"id": "fda:K243120", "company": "Erbe Elektromedizin GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243120: HybridAPC probe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243120", "people": [{"name": "Matthias Kollek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243120%22"}, {"id": "fda:K243168", "company": "Abbott Laboratories", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243168: Alinity i Rubella IgG", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243168", "people": [{"name": "Laura Fraczek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243168%22"}, {"id": "fda:K250732", "company": "Yangzhou Fartley Medical Instrument Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250732: Disposable Endoscopy Valve Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250732", "people": [{"name": "Xi Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250732%22"}, {"id": "fda:K242911", "company": "Shanghai Medconn Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242911: Medconn Glycated Hemoglobin Test system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242911", "people": [{"name": "Judan Guan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242911%22"}, {"id": "fda:K250968", "company": "Pathpresenter Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250968: PathPresenter Clinical Viewer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250968", "people": [{"name": "Brian Matcheski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250968%22"}, {"id": "fda:K243589", "company": "Microaire Surgical Instruments, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243589: PAL Sterilization Case", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243589", "people": [{"name": "Glenn Gerstenfeld", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243589%22"}, {"id": "fda:K250880", "company": "Foshan Guangyu Weilai Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250880: LED LIGHT MASK (A093)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250880", "people": [{"name": "Guang Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250880%22"}, {"id": "fda:K251224", "company": "Acera Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251224: Restrata Soft Tissue Reinforcement (STR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251224", "people": [{"name": "Tamas Kovacs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251224%22"}, {"id": "fda:K243053", "company": "Claronav", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243053: Navient Image Guided Navigation System (ENT) (955-NC-NC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243053", "people": [{"name": "Karen Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243053%22"}, {"id": "fda:K243398", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243398: CT Scanner TSX-501R/1 V11.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243398", "people": [{"name": "Orlando Tadeo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243398%22"}, {"id": "fda:K250583", "company": "Hcmed Innovations Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250583: AdheResp Smart Breath-actuated Mesh Nebulizer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250583", "people": [{"name": "Michelle Pieh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250583%22"}, {"id": "fda:K242843", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242843: The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242843", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242843%22"}, {"id": "fda:K251114", "company": "Flosonics Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251114: FloPatch FP120", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251114", "people": [{"name": "Caleb Chin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251114%22"}, {"id": "nih:1R43CA298410-01", "company": "Metastx LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-19", "observed": "2026-08-21", "amount_usd": 399954, "summary": "NIH award 1R43CA298410-01: Epithelial-Mesenchymal Transition Signature Markers (EMTsm) with Machine Learning-Based Analysis as a Predictor of Metastatic Prostate Cancer ($399,954)", "source_url": "https://reporter.nih.gov/project-details/11068839", "people": [{"name": "Harvey D Homan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA302286-01", "company": "Pumpkinseed Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-19", "observed": "2026-08-21", "amount_usd": 353204, "summary": "NIH award 1R43CA302286-01: Dynamic, live-cell monitoring of T-cell states against presented peptides ($353,204)", "source_url": "https://reporter.nih.gov/project-details/11186158", "people": [{"name": "Jack Hu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44DA056277-02", "company": "Rescue Biomedical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-19", "observed": "2026-08-21", "amount_usd": 874139, "summary": "NIH award 4R44DA056277-02: User-centric development of closed-loop therapy for opioid overdose ($874,139)", "source_url": "https://reporter.nih.gov/project-details/11306118", "people": [{"name": "Vy Le", "role": "Principal Investigator"}, {"name": "Hyowon Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07028541", "company": "Bioretec Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: RemeOs\u2122 DrillPin for Fixation of Distal Radius Fractures in Children", "source_url": "https://clinicaltrials.gov/study/NCT07028541"}, {"id": "trialreg:NCT07027878", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: JETi Lower Extremity Venous Thrombosis", "source_url": "https://clinicaltrials.gov/study/NCT07027878"}, {"id": "trialreg:NCT07028060", "company": "PulseNmore", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Detection of Lung Pathologies Among Dialysis Patients Using Pulsenmore MC\u2122 Device - Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT07028060"}, {"id": "trialreg:NCT07029997", "company": "AventaMed DAC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device", "source_url": "https://clinicaltrials.gov/study/NCT07029997"}, {"id": "trialreg:NCT07028619", "company": "Med-El Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Benefits of Bimodal Streaming With MED-EL Cochlear Implants and Starkey Hearing Aids", "source_url": "https://clinicaltrials.gov/study/NCT07028619"}, {"id": "trialreg:NCT07029438", "company": "Colgate Palmolive", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparative Efficacy of Floss and Essential Oil/CPC+Zn Mouthwashes in Reducing Dental Plaque and Gingivitis", "source_url": "https://clinicaltrials.gov/study/NCT07029438"}, {"id": "trialreg:NCT07028203", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Non-invasive Rejuvenation of the Periorbital Area and Lower Eyelid", "source_url": "https://clinicaltrials.gov/study/NCT07028203"}, {"id": "fda:K242944", "company": "Leone S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242944: Leone Orthodontic Implant TAD (Temporary Anchorage Device)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242944", "people": [{"name": "Martina Corsani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242944%22"}, {"id": "fda:K250515", "company": "Empatica S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250515: EpiMonitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250515", "people": [{"name": "Alberto Poli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250515%22"}, {"id": "fda:K251235", "company": "Baisheng Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251235: Electrosurgical Pads", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251235", "people": [{"name": "Haley Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251235%22"}, {"id": "nih:5R43CA287836-02", "company": "Embiosys Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": 188875, "summary": "NIH award 5R43CA287836-02: DEVELOPMENT OF A WEARABLE, NON-INVASIVE, TREATMENT DEVICE FOR METASTATIC TRIPLE-NEGATIVE BREAST CANCER (TNBC) ($188,875)", "source_url": "https://reporter.nih.gov/project-details/11086646", "people": [{"name": "Christopher Barron", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA302122-01", "company": "Surgivance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": 978154, "summary": "NIH award 1R44CA302122-01: Rapid 3D POC digital cancer pathology by unique confocal microscopy instrumentation and downstream AI: a simple, efficient, robust direct-to-digital approach to meet market demand ($978,154)", "source_url": "https://reporter.nih.gov/project-details/11185487", "people": [{"name": "Daniel Summer Gareau", "role": "Principal Investigator"}, {"name": "Adam LaPrad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG081111-02", "company": "Outlier Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": 1383492, "summary": "NIH award 2R44AG081111-02: NeuroSync: a data-driven, music-based augmented reality neurorehabilitation platform of games & puzzles to stimulate neuroplasticity and prolong functional independence in Alzheimer's Disease patients ($1,383,492)", "source_url": "https://reporter.nih.gov/project-details/11077657", "people": [{"name": "Peter Gray", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43ES037460-01", "company": "Softworthy LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": 100000, "summary": "NIH award 1R43ES037460-01: SoftWorthy's Interactive Virtual Environment Laboratory to support Health and Safety Training of Emergency Responders Exposed to Extreme Ambient Temperatures (SWIVEL-HASTE) ($100,000)", "source_url": "https://reporter.nih.gov/project-details/11126916", "people": [{"name": "GAURAV KEWLANI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07027267", "company": "Spirair, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness of TurbAlign\u2122 for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07027267"}, {"id": "trialreg:NCT07027150", "company": "Perin Health Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pulse Oximeter Validation Study for the Perin Health Patch", "source_url": "https://clinicaltrials.gov/study/NCT07027150"}, {"id": "trialreg:NCT07025837", "company": "Freedom Laser, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Effects of an LED Face Mask & Neck and Chest Mask On Skin Health", "source_url": "https://clinicaltrials.gov/study/NCT07025837"}, {"id": "trialreg:NCT07027358", "company": "Teranga Software", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation Evaluating the Use of NETSmart Solution , Incorporated to NETSoins Software, in the Care and Support of Elderly People Living in Nursing Homes", "source_url": "https://clinicaltrials.gov/study/NCT07027358"}, {"id": "trialreg:NCT07027657", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EXOMIND (BTL-699-2) for the Improvement of Sleep Quality and Reduction of Stress", "source_url": "https://clinicaltrials.gov/study/NCT07027657"}, {"id": "trialreg:NCT07026877", "company": "Bolton Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA", "source_url": "https://clinicaltrials.gov/study/NCT07026877"}, {"id": "fda:K250082", "company": "Winner Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250082: Procedure mask/Surgical mask/Face mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250082", "people": [{"name": "Jiali Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250082%22"}, {"id": "fda:K243672", "company": "GE Medical Systems SCS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243672: CardIQ Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243672", "people": [{"name": "Haddad Mireille", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243672%22"}, {"id": "fda:K242894", "company": "Shanghai Saints Sages Surgical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242894: SanAgile\u0099 Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile\u0099 Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile\u0099 Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile\u0099 Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile\u0099 Ultrasonic Surgery Advanced Dissector (SASD45)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242894", "people": [{"name": "Xue Ting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242894%22"}, {"id": "fda:K242922", "company": "Shenzhen Wikkon Precision Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242922: Extracorporeal Shock Wave Lithotripter (U200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242922", "people": [{"name": "Jack Kong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242922%22"}, {"id": "fda:K250492", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250492: FlexiGo 3D Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250492", "people": [{"name": "Conner Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250492%22"}, {"id": "fda:K250908", "company": "SeaSpine Orthopedics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250908: Virata Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250908", "people": [{"name": "Sali Gully", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250908%22"}, {"id": "fda:K243039", "company": "Alton (Shanghai) Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243039: Ureteral Stents (AF-D series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243039", "people": [{"name": "Vivian Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243039%22"}, {"id": "fda:K242224", "company": "Happy Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242224: Happy Health Home Sleep Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242224", "people": [{"name": "Dustin Freckleton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242224%22"}, {"id": "fda:K250872", "company": "Bioline Dental Implant Systems, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250872: Bioline Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250872", "people": [{"name": "Asher Ohayon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250872%22"}, {"id": "fda:K243014", "company": "Eyeq, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243014: EyeQ nanoECP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243014", "people": [{"name": "Gary Mocnik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243014%22"}, {"id": "fda:K242917", "company": "HMC Premedical S.p.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242917: Enteral Drainage System, Enteral Medicine straw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242917", "people": [{"name": "Danilo Bosetti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242917%22"}, {"id": "fda:K242933", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242933: SPINEART Navigation Instrument System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242933", "people": [{"name": "Estelle Lefeuvre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242933%22"}, {"id": "fda:K243253", "company": "Esaote, S.p.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243253: 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243253", "people": [{"name": "Piet De Jong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243253%22"}, {"id": "fda:K243366", "company": "Excite Medical of Tampa Bay, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243366: DRX9000C-SL Cervical Spinal Decompression System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243366", "people": [{"name": "Saleem Musallam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243366%22"}, {"id": "fda:K251253", "company": "Bard Access Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251253: PowerPort\u0099 isp Implantable Port; PowerPort\u0099 Slim Implantable Port; PowerPort\u0099 M.R.I. \u0099 Implantable Port; PowerPort\u0099 M.R.I.\u0099 isp Implantable Port", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251253", "people": [{"name": "Aaron Roessler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251253%22"}, {"id": "fda:K250886", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250886: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250886", "people": [{"name": "Deval Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250886%22"}, {"id": "fda:K251296", "company": "Acumed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251296: The Acumed Wrist Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251296", "people": [{"name": "Marina Bull", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251296%22"}, {"id": "fda:K243102", "company": "Jiangxi Jiangte Electric Vehicle Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243102: Mobility Scooter (JT10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243102", "people": [{"name": "Qi Ding", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243102%22"}, {"id": "fda:K243172", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243172: Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243172", "people": [{"name": "Caitlin Senter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243172%22"}, {"id": "fda:K243583", "company": "Fisher & Paykel Healthcare Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243583: F&P Nova Nasal Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243583", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243583%22"}, {"id": "fda:K251530", "company": "Conmed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251530: CONMED Argo Knotless\u00ae Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251530", "people": [{"name": "Mirela Gjini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251530%22"}, {"id": "fda:K250845", "company": "Curiteva, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250845: Curiteva Porous PEEK Standalone ALIF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250845", "people": [{"name": "Eric Linder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250845%22"}, {"id": "fda:K251634", "company": "Lin-Zhi International, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251634: LZI Fentanyl III Enzyme Immunoassay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251634", "people": [{"name": "Chris Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251634%22"}, {"id": "pma:P240001", "company": "Cerapedics, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240001: PearlMatrix\u0099 Bone Graft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240001", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240001%22"}, {"id": "breakthrough:P240001", "company": "Cerapedics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-06-18", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P240001: PEARLMATRIX BONE GRAFT", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43DK143795-01", "company": "Anova Biomedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": 298371, "summary": "NIH award 1R43DK143795-01: Biodegradable and Elastic Vascular Grafts for Hemodialysis ($298,371)", "source_url": "https://reporter.nih.gov/project-details/11182162", "people": [{"name": "Anthony D'Amato", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DC022211-01A1", "company": "Restorear Devices, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": 307962, "summary": "NIH award 1R43DC022211-01A1: Noninvasive therapeutic hypothermia for tinnitus ($307,962)", "source_url": "https://reporter.nih.gov/project-details/11184989", "people": [{"name": "Curtis Scott King", "role": "Principal Investigator"}, {"name": "Hillary Anne Snapp", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07024459", "company": "GE Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CARESCAPE Monitoring Systems ME Study", "source_url": "https://clinicaltrials.gov/study/NCT07024459"}, {"id": "trialreg:NCT07025304", "company": "Smith & Nephew, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China", "source_url": "https://clinicaltrials.gov/study/NCT07025304"}, {"id": "trialreg:NCT07024550", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Impact of the EXOMIND (BTL-699-2) on the Brain Reward Pathway", "source_url": "https://clinicaltrials.gov/study/NCT07024550"}, {"id": "fda:K243133", "company": "Kl-Kepong Rubber Products Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243133: Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243133", "people": [{"name": "Phooi Yann Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243133%22"}, {"id": "fda:K250665", "company": "Konica Minolta, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250665: SKR 3000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250665", "people": [{"name": "Makoto Sumi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250665%22"}, {"id": "fda:K243618", "company": "Bridge TO Life", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243618: EasiSlush\u00ae Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243618", "people": [{"name": "Mark Harper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243618%22"}, {"id": "fda:K250219", "company": "Bard Peripheral Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250219: Dorado\u0099 PTA Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250219", "people": [{"name": "Joan Bergstrom", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250219%22"}, {"id": "fda:K250440", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250440: RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250440", "people": [{"name": "Sadwini Suresh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250440%22"}, {"id": "fda:K243880", "company": "Wuxi Hisky Medical Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243880: Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243880", "people": [{"name": "Jinhua Shao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243880%22"}, {"id": "fda:K243003", "company": "VitalSigns Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243003: VitalSigns 1-Lead Holter (VSH101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243003", "people": [{"name": "Jih-liang Juang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243003%22"}, {"id": "fda:K250997", "company": "Anika Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250997: Integrity\u0099 Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250997", "people": [{"name": "Shajunath Nirupama", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250997%22"}, {"id": "fda:DEN240038", "company": "Fziomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240038: Oxiplex\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240038", "people": [{"name": "Lisa Gawehn", "role": "510(k) submission contact"}]}, {"id": "fda:K251017", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251017: CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251017", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251017%22"}, {"id": "fda:K243666", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243666: uOmniscan", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243666", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243666%22"}, {"id": "fda:K243561", "company": "Nano-Ditech Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243561: Nano-Check Influenza+COVID-19 Dual Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243561", "people": [{"name": "James B Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243561%22"}, {"id": "fda:DEN240066", "company": "Tissium SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240066: COAPTIUM Connect with TISSIUM LIGHT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240066", "people": [{"name": "Clara Defraye", "role": "510(k) submission contact"}]}, {"id": "pma:P240031", "company": "Neuspera Medical, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240031: Neuspera Sacral Neuromodulation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240031", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240031%22"}, {"id": "denovo:DEN240038", "company": "Fziomed, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-06-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240038 granted: Oxiplex\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240038"}, {"id": "denovo:DEN240066", "company": "Tissium SA", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-06-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240066 granted: COAPTIUM Connect with TISSIUM LIGHT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240066"}, {"id": "nih:1R43HD115423-01A1", "company": "Little Room Innovations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-16", "observed": "2026-08-21", "amount_usd": 304906, "summary": "NIH award 1R43HD115423-01A1: A Unique Body-Powered Terminal Device with Enhanced Grasping Capabilities for Individuals with Upper Limb Loss ($304,906)", "source_url": "https://reporter.nih.gov/project-details/11068131", "people": [{"name": "Harrison Logan Bartlett", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K250436", "company": "Siemens Shenzhen Magnetic Resonance , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250436: MAGNETOM Flow.Ace; MAGNETOM Flow.Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250436", "people": [{"name": "Li Hai Ting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250436%22"}, {"id": "fda:K243011", "company": "Guangdong Ecan Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243011: Silicone Urethral Catheter (Silicone Urethral Catheter)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243011", "people": [{"name": "Liuyuan Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243011%22"}, {"id": "fda:K242870", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242870: Access hsTnI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242870", "people": [{"name": "Mary Beth Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242870%22"}, {"id": "fda:K243872", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243872: BD Veritor System for SARS-CoV-2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243872", "people": [{"name": "Thi My Lan Dang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243872%22"}, {"id": "fda:K244012", "company": "Navier Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244012: Mosaic (V1.0.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244012", "people": [{"name": "Aastha Chaudhary", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244012%22"}, {"id": "fda:K250443", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250443: MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250443", "people": [{"name": "Friederike Hertle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250443%22"}, {"id": "fda:K250900", "company": "EvoEndo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250900: EvoEndo Single-Use Endoscopy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250900", "people": [{"name": "Paul Imaoka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250900%22"}, {"id": "fda:K242978", "company": "Geomedi Co,., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242978: Geo Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242978", "people": [{"name": "Jihyo Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242978%22"}, {"id": "fda:K250685", "company": "Methinks Software, S.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250685: Methinks NCCT Stroke", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250685", "people": [{"name": "Claudia Carbonell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250685%22"}, {"id": "fda:K251617", "company": "Expanding Innovations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251617: X-PAC\u00ae TLIF Expandable Posterior Cage System; X-PAC\u00ae LLIF Expandable Lateral Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251617", "people": [{"name": "Robert Jaramillo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251617%22"}, {"id": "nih:1R43HL177915-01A1", "company": "Link Medical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-15", "observed": "2026-08-21", "amount_usd": 298368, "summary": "NIH award 1R43HL177915-01A1: Novel Device for Treating Mitral Regurgitation ($298,368)", "source_url": "https://reporter.nih.gov/project-details/11181442", "people": [{"name": "Brian Biancucci", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07022314", "company": "FIZE Medical ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO\u00ae", "source_url": "https://clinicaltrials.gov/study/NCT07022314"}, {"id": "trialreg:NCT07021742", "company": "Signum Surgical USA Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BioHealx\u00ae Anal Fistula Device Post Market Surveillance Study", "source_url": "https://clinicaltrials.gov/study/NCT07021742"}, {"id": "trialreg:NCT07021833", "company": "Cryosa, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC_AUS)", "source_url": "https://clinicaltrials.gov/study/NCT07021833"}, {"id": "trialreg:NCT07022054", "company": "Icare Finland Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: iCare IC1000 Alignment Study", "source_url": "https://clinicaltrials.gov/study/NCT07022054"}, {"id": "trialreg:NCT07022249", "company": "Ton-Bridge Medical Tech. Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms", "source_url": "https://clinicaltrials.gov/study/NCT07022249"}, {"id": "trialreg:NCT07021560", "company": "ZEISS Vision Care", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Wearability of and Myopia Progression With ZEISS MyoCare Spectacle Lenses", "source_url": "https://clinicaltrials.gov/study/NCT07021560"}, {"id": "fda:K242863", "company": "Bioptimal International Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242863: Bioptimal Bipolar Pacing Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242863", "people": [{"name": "Ra Bpi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242863%22"}, {"id": "fda:K243036", "company": "Bestway Plastic and Metal Products , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243036: IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243036", "people": [{"name": "Jonah Ci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243036%22"}, {"id": "fda:K240795", "company": "Withings", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240795: Withings ECG App", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240795", "people": [{"name": "Khushboo Surendran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240795%22"}, {"id": "nih:1R41NS137850-01A1", "company": "Intrinsic Powers, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": 524243, "summary": "NIH award 1R41NS137850-01A1: Portable TMS-EEG device for bedside detection of covert consciousness ($524,243)", "source_url": "https://reporter.nih.gov/project-details/11068934", "people": [{"name": "Melanie Boly", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44GM145015-03S1", "company": "Wellsim Biomedical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": 122815, "summary": "NIH award 3R44GM145015-03S1: Multi-omics profiling of individual exosomes for origin-tracing, biomarker discovery, and biological function characterization ($122,815)", "source_url": "https://reporter.nih.gov/project-details/11309068", "people": [{"name": "Yuchao Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AG091857-01", "company": "Plans4care Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": 490262, "summary": "NIH award 1R44AG091857-01: Activites4Care: A Digital Platform to Enhance Caregiver Well-being by Providing Customized Activities that Improve Quality of Life for People Living with Dementia ($490,262)", "source_url": "https://reporter.nih.gov/project-details/11066629", "people": [{"name": "Laura N. Gitlin", "role": "Principal Investigator"}, {"name": "Sokha Koeuth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07020000", "company": "Retropsoas Technologies, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode", "source_url": "https://clinicaltrials.gov/study/NCT07020000"}, {"id": "trialreg:NCT07020611", "company": "Life Seal Vascular Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients", "source_url": "https://clinicaltrials.gov/study/NCT07020611"}, {"id": "trialreg:NCT07018882", "company": "Todoc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.", "source_url": "https://clinicaltrials.gov/study/NCT07018882"}, {"id": "trialreg:NCT07020520", "company": "Urotronic Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures", "source_url": "https://clinicaltrials.gov/study/NCT07020520"}, {"id": "fda:K250469", "company": "Rivanna Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250469: Accuro\u00ae 3S Needle Guide Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250469", "people": [{"name": "Will Mauldin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250469%22"}, {"id": "fda:K243237", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243237: 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243237", "people": [{"name": "Tara Kenney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243237%22"}, {"id": "fda:K250759", "company": "Changsha Anxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250759: 3 in 1 TENS UNIT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250759", "people": [{"name": "William Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250759%22"}, {"id": "fda:K250674", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250674: Vessel Sealer Curved (480522)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250674", "people": [{"name": "Meirav Harsat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250674%22"}, {"id": "fda:K250273", "company": "Abbott Diagnostics Scarborough, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250273: BinaxNOW COVID-19 Ag Card", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250273", "people": [{"name": "Kristen Cyr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250273%22"}, {"id": "fda:K250075", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250075: Medtronic Stedi Extra Support Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250075", "people": [{"name": "Hillary Barasa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250075%22"}, {"id": "fda:K243729", "company": "Lumos Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243729: Prismira", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243729", "people": [{"name": "Robert (Bob) Schafer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243729%22"}, {"id": "fda:K243638", "company": "Microvention", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243638: MV Flow Aspiration Pump (MVFLOWPMP01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243638", "people": [{"name": "Alick Tan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243638%22"}, {"id": "fda:K251189", "company": "Inquis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251189: Aventus Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251189", "people": [{"name": "Zachary Woodson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251189%22"}, {"id": "fda:K244017", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244017: FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244017", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244017%22"}, {"id": "fda:K242852", "company": "Inomed Medizintechnik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242852: ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242852", "people": [{"name": "Anja Moerchen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242852%22"}, {"id": "fda:K251166", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251166: Mfinity Femoral System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251166", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251166%22"}, {"id": "fda:K243633", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243633: Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243633", "people": [{"name": "Sadwini Suresh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243633%22"}, {"id": "fda:K251485", "company": "Contego Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251485: Excipio LV Prime Thrombectomy Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251485", "people": [{"name": "Nitin Mehta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251485%22"}, {"id": "fda:K250251", "company": "Dev4", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250251: Eleganz Fusion Screw System (Fusion Screw System)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250251", "people": [{"name": "Jeff Seavey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250251%22"}, {"id": "nih:5R44AI124871-06", "company": "Scanogen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI124871-06: Bloodstream infection detection directly on whole blood ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11140525", "people": [{"name": "Alfredo Andres Celedon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R43AI186556-02", "company": "Integral Molecular", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": 288515, "summary": "NIH award 5R43AI186556-02: Development of Safe and Rapid Reporter Viruses for Studying Pathogenic and Pandemic Viruses ($288,515)", "source_url": "https://reporter.nih.gov/project-details/11124869", "people": [{"name": "Benjamin J Doranz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:3R44NS127667-03S4", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": 49750, "summary": "NIH award 3R44NS127667-03S4: Exploring the Parameter Space of High Frequency Magnetic Perturbation in Manipulating Neural Excitability and Plasticity. ($49,750)", "source_url": "https://reporter.nih.gov/project-details/11176593", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07018180", "company": "Capteur Protect", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Interventional Clinical Trial Evaluating COVER PATCH CAPTEUR PROTECT Support Solutions for Continuous Glucose Monitoring Sensors in Patients With Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07018180"}, {"id": "trialreg:NCT07016698", "company": "C. R. Bard", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)", "source_url": "https://clinicaltrials.gov/study/NCT07016698"}, {"id": "trialreg:NCT07017907", "company": "Thyroscope Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating an AI Tool for Detecting Thyrotoxic States", "source_url": "https://clinicaltrials.gov/study/NCT07017907"}, {"id": "trialreg:NCT07017972", "company": "Fairtility", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Collection and Professional Simulated Use Study to Develop an Embryo Quality Artificial Intelligence (AI) Model", "source_url": "https://clinicaltrials.gov/study/NCT07017972"}, {"id": "trialreg:NCT07017634", "company": "CGBio Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease", "source_url": "https://clinicaltrials.gov/study/NCT07017634"}, {"id": "trialreg:NCT07018596", "company": "Pulse Biosciences, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System", "source_url": "https://clinicaltrials.gov/study/NCT07018596"}, {"id": "trialreg:NCT07018648", "company": "KARDI AI Technologies s.r.o.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System", "source_url": "https://clinicaltrials.gov/study/NCT07018648"}, {"id": "trialreg:NCT07017933", "company": "3ive Labs", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes", "source_url": "https://clinicaltrials.gov/study/NCT07017933"}, {"id": "trialreg:NCT07017998", "company": "Restorear Devices LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: External Therapy for Tinnitus Management", "source_url": "https://clinicaltrials.gov/study/NCT07017998"}, {"id": "fda:K250936", "company": "Beijing Sano Laser S&T Development Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250936: Q-Switched Nd:YAG Laser (SHE-LSP101-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250936", "people": [{"name": "Zhu Qi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250936%22"}, {"id": "fda:K251209", "company": "Lg Electronics.Inc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251209: Medical Monitor (32HS710S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251209", "people": [{"name": "Daseul An", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251209%22"}, {"id": "fda:K251154", "company": "Ht Medical D.B.A. Xenix Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251154: RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251154", "people": [{"name": "Tyler Holschlag", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251154%22"}, {"id": "fda:K251459", "company": "Novapproach Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251459: OneLIF\u0099 Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251459", "people": [{"name": "Ron Green", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251459%22"}, {"id": "fda:K250559", "company": "Gm Dos Reis Industria E Comercio", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250559: GMReis Fibula Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250559", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250559%22"}, {"id": "fda:K251279", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251279: Disposable Cytology Brush BC-202D/203D Series", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251279", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251279%22"}, {"id": "fda:K243683", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243683: Deka Bluebeam", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243683", "people": [{"name": "Paolo Peruzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243683%22"}, {"id": "fda:K243973", "company": "Jeil Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243973: FIX-L PEEK PLIF and T-PLIF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243973", "people": [{"name": "Dajung Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243973%22"}, {"id": "fda:K242872", "company": "Id-Fish Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242872: iDart Lyme IgM ImmunoBlot Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242872", "people": [{"name": "Jyotsna Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242872%22"}, {"id": "fda:K251557", "company": "Davol, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251557: Bard\u00ae Mesh; Bard\u00ae Mesh Pre-Shaped", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251557", "people": [{"name": "Becca DeFrancia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251557%22"}, {"id": "fda:K250826", "company": "Dmax Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250826: Multi M Series", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250826", "people": [{"name": "Priscilla Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250826%22"}, {"id": "fda:K243608", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243608: TRIGEN Stable Lock Nut & Washer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243608", "people": [{"name": "Jessica Roach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243608%22"}, {"id": "fda:K250856", "company": "Biom\u00e9rieux", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250856: ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250856", "people": [{"name": "St\u00e9phanie Millon-Serme", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250856%22"}, {"id": "fda:K251193", "company": "Medtronic Sofamor Danek, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251193: Grafton\u0099 DBM; Grafton Plus\u0099 DBM Paste; Magnifuse\u0099 Bone Graft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251193", "people": [{"name": "Ian Dunkley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251193%22"}, {"id": "fda:K251153", "company": "Ge Medical Systems Israel", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251153: Aurora", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251153", "people": [{"name": "Hanne Jubran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251153%22"}, {"id": "fda:K250789", "company": "Thermo Fisher Scientific (Oxoid Ltd.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250789: Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 \u00b5g) AZA50", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250789", "people": [{"name": "Sonali Karnik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250789%22"}, {"id": "fda:K250782", "company": "Zhengzhou PZ Laser Slim Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250782: Fractional CO2 Laser Machine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250782", "people": [{"name": "Hongwei Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250782%22"}, {"id": "fda:K242865", "company": "Biocomposites, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242865: Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242865", "people": [{"name": "Melisa Lamanna", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242865%22"}, {"id": "fda:K243234", "company": "Pearl, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243234: Second Opinion\u00ae CS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243234", "people": [{"name": "William Birdsall", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243234%22"}, {"id": "fda:DEN240032", "company": "Firalis SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240032: APO-Easy Genotyping kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240032", "people": [{"name": "Huseyin Firat", "role": "510(k) submission contact"}]}, {"id": "denovo:DEN240032", "company": "Firalis SA", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-06-12", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240032 granted: APO-Easy Genotyping kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240032"}, {"id": "nih:1R44NS137933-01A1", "company": "Pison Technology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": 459097, "summary": "NIH award 1R44NS137933-01A1: A Digital Biomarker for ALS - Pison Neural Biosensor ($459,097)", "source_url": "https://reporter.nih.gov/project-details/11069980", "people": [{"name": "Megan H. Blackwell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44EB035057-02", "company": "Cellia Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": 1074143, "summary": "NIH award 2R44EB035057-02: Deep-UV Microscopy for Real-Time Adequacy Analysis of Bone Marrow Aspirates ($1,074,143)", "source_url": "https://reporter.nih.gov/project-details/11069801", "people": [{"name": "Amy J Castleman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA285197-02", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44CA285197-02: A parallelized computational microscope platform for high-throughput live imaging of patient-derived organoids ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11110363", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT07015437", "company": "Cerus Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1", "source_url": "https://clinicaltrials.gov/study/NCT07015437"}, {"id": "trialreg:NCT07015424", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass", "source_url": "https://clinicaltrials.gov/study/NCT07015424"}, {"id": "trialreg:NCT07016568", "company": "LLC UkrMedGroup", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region", "source_url": "https://clinicaltrials.gov/study/NCT07016568"}, {"id": "trialreg:NCT07015125", "company": "Hinge Health, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Wearable Device for Acute Treatment of Migraines", "source_url": "https://clinicaltrials.gov/study/NCT07015125"}, {"id": "trialreg:NCT07016607", "company": "Embrace Medical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Vital Peripheral Intravenous Catheter Feasibility", "source_url": "https://clinicaltrials.gov/study/NCT07016607"}, {"id": "fda:K250584", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250584: Rezum System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250584", "people": [{"name": "Joseph Tabor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250584%22"}, {"id": "fda:K250933", "company": "Bonebridge AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250933: LORRAINE 2.5/3.5mm Distal Humerus System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250933", "people": [{"name": "Michelle Gumpelmayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250933%22"}, {"id": "fda:K243482", "company": "GI Windows, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243482: Self-Forming Magnet (Flexagon)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243482", "people": [{"name": "Yverre Bobay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243482%22"}, {"id": "fda:K240852", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240852: da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240852", "people": [{"name": "Mike Yramategui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240852%22"}, {"id": "fda:K242801", "company": "Carl Zeiss Meditec Cataract Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242801: MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242801", "people": [{"name": "Andrew Rybold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242801%22"}, {"id": "fda:K250787", "company": "Medtronic, Ireland", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250787: Liberant Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250787", "people": [{"name": "Barbara Zampedri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250787%22"}, {"id": "fda:K250646", "company": "Nvision Biomedical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250646: Impact PEEK Union Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250646", "people": [{"name": "Erin Lansdale", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250646%22"}, {"id": "fda:K250269", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250269: Ambu\u00ae aScope\u0099 5 Cysto HD (Standard Deflection); Ambu\u00ae aScope\u0099 5 Cysto HD (Reverse Deflection)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250269", "people": [{"name": "Martina Krautwald", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250269%22"}, {"id": "fda:K251499", "company": "William Cook Europe Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251499: Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251499", "people": [{"name": "Mie Dyrholm", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251499%22"}, {"id": "fda:K250710", "company": "Enpuno Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250710: Injectable Root Canal Bioceramic Sealer (nRoot SP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250710", "people": [{"name": "Chengfa Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250710%22"}, {"id": "breakthrough:K240852", "company": "Intuitive Surgical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-06-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K240852: DA VINCI X SURGICAL SYSTEM (IS4200); DA VINCI XI SURGICAL SYSTEM (IS4000)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44GM137688-03", "company": "Abterra Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-10", "observed": "2026-08-21", "amount_usd": 961244, "summary": "NIH award 5R44GM137688-03: REPTOR: accelerating antibody discovery and improving hits with machine learning ($961,244)", "source_url": "https://reporter.nih.gov/project-details/11194970", "people": [{"name": "Natalie Castellana", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41AG093459-01", "company": "Tensense LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-10", "observed": "2026-08-21", "amount_usd": 308927, "summary": "NIH award 1R41AG093459-01: Intraoperative Sensor to Comprehensively Measure Ligament Engagement During Knee Arthroplasty ($308,927)", "source_url": "https://reporter.nih.gov/project-details/11069479", "people": [{"name": "Lesley Lizalek", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07013929", "company": "Medtronic Vascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Spyral InSight Study", "source_url": "https://clinicaltrials.gov/study/NCT07013929"}, {"id": "trialreg:NCT07014163", "company": "Espad Pharmed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas", "source_url": "https://clinicaltrials.gov/study/NCT07014163"}, {"id": "trialreg:NCT07011966", "company": "ResMed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ASV Therapy for Insomnia", "source_url": "https://clinicaltrials.gov/study/NCT07011966"}, {"id": "trialreg:NCT07012291", "company": "Perosphere Technologies Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek\u2122", "source_url": "https://clinicaltrials.gov/study/NCT07012291"}, {"id": "trialreg:NCT07014007", "company": "Pierre Fabre Dermo Cosmetique", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Tolerance and Efficacy Open-label Study With RV4421B, in Various Populations With Atopic Dermatitis for 12 Weeks", "source_url": "https://clinicaltrials.gov/study/NCT07014007"}, {"id": "fda:K242921", "company": "Vitaltec Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242921: 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242921", "people": [{"name": "Joseph Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242921%22"}, {"id": "fda:K243956", "company": "Nihon Kohden Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243956: TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243956", "people": [{"name": "Sandra Gadeyne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243956%22"}, {"id": "fda:K250010", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250010: EXTRON 3; EXTRON 5; EXTRON 7", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250010", "people": [{"name": "Minjeong Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250010%22"}, {"id": "fda:K250354", "company": "Viz. Ai, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250354: Viz Subdural+, Viz SUBDURAL PLUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250354", "people": [{"name": "Gregory Ramina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250354%22"}, {"id": "fda:K250768", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250768: Elecsys Anti-SARS-CoV-2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250768", "people": [{"name": "Tammy Dean", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250768%22"}, {"id": "fda:K243512", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243512: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243512", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243512%22"}, {"id": "fda:K242996", "company": "Endymed Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242996: EndyMed PRO MAX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242996", "people": [{"name": "Ohad Fisher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242996%22"}, {"id": "fda:K250735", "company": "Fomed Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250735: Dental Barrier and Sleeves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250735", "people": [{"name": "Xing He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250735%22"}, {"id": "nih:3R44GM137688-02S1", "company": "Abterra Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-09", "observed": "2026-08-21", "amount_usd": 63564, "summary": "NIH award 3R44GM137688-02S1: REPTOR: accelerating antibody discovery and improving hits with machine learning ($63,564)", "source_url": "https://reporter.nih.gov/project-details/11322291", "people": [{"name": "Natalie Castellana", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM145015-03", "company": "Wellsim Biomedical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-09", "observed": "2026-08-21", "amount_usd": 738347, "summary": "NIH award 5R44GM145015-03: Multi-omics profiling of individual exosomes for origin-tracing, biomarker discovery, and biological function characterization ($738,347)", "source_url": "https://reporter.nih.gov/project-details/11144343", "people": [{"name": "Yuchao Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44CA254637-02", "company": "Media Rez, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-09", "observed": "2026-08-21", "amount_usd": 734690, "summary": "NIH award 2R44CA254637-02: Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors ($734,690)", "source_url": "https://reporter.nih.gov/project-details/11069198", "people": [{"name": "Daniel J Greenberg", "role": "Principal Investigator"}, {"name": "J. Hunter Groninger", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42GM140538-03", "company": "Durametrix LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-09", "observed": "2026-08-21", "amount_usd": 946480, "summary": "NIH award 5R42GM140538-03: Establishing the market-readiness of an in vivo technology for assessing drug toxicity-induced tissue damage ($946,480)", "source_url": "https://reporter.nih.gov/project-details/11099941", "people": [{"name": "Steven Edward Johnson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH134719-03", "company": "Friendi.fi Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-09", "observed": "2026-08-21", "amount_usd": 386118, "summary": "NIH award 5R44MH134719-03: Optimizing and testing the care.coach avatar as a personalized, engaging and adaptive virtual health assistant for maximizing functional and quality of life outcomes in autistic young adults. ($386,118)", "source_url": "https://reporter.nih.gov/project-details/11118981", "people": [{"name": "Chantal M Kerssens", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41GM157850-01", "company": "Nanoengineering Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-09", "observed": "2026-08-21", "amount_usd": 338843, "summary": "NIH award 1R41GM157850-01: Soft-Landing of Size-Separated Macromolecules for Structural Analysis by Cryo-TEM ($338,843)", "source_url": "https://reporter.nih.gov/project-details/11069565", "people": [{"name": "Luis Javier Perez Lorenzo", "role": "Principal Investigator"}, {"name": "Brandon T Ruotolo", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K251093", "company": "Oneness Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251093: Bonvadis\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251093", "people": [{"name": "Angel Hsieh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251093%22"}, {"id": "fda:K250465", "company": "Nanjing Bestview Laser S&T Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250465: CO2 Laser Machine (Lume)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250465", "people": [{"name": "Jing Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250465%22"}, {"id": "fda:K250830", "company": "Shenzhen Sungrow Led Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250830: LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250830", "people": [{"name": "Yafen Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250830%22"}, {"id": "fda:K251500", "company": "Biocorp Production", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251500: MallyaG Injection Pen Adapter (MallyaG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251500", "people": [{"name": "Alexia Garin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251500%22"}, {"id": "trialreg:NCT07009912", "company": "Zimmer Biomet", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ROSA\u00ae Knee System V1.5 Pilot Study", "source_url": "https://clinicaltrials.gov/study/NCT07009912"}, {"id": "trialreg:NCT07010094", "company": "BrosMed Medical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BM Shockwave Devices Clinical Study in Coronary Calcified Lesions", "source_url": "https://clinicaltrials.gov/study/NCT07010094"}, {"id": "trialreg:NCT07010965", "company": "magAssist, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SAVE-PCI: NyokAssist\u2122 Small-Bore VAD vs. IABP in Elective High-Risk PCI", "source_url": "https://clinicaltrials.gov/study/NCT07010965"}, {"id": "trialreg:NCT07010354", "company": "Bentley InnoMed GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow", "source_url": "https://clinicaltrials.gov/study/NCT07010354"}, {"id": "trialreg:NCT07010549", "company": "Phitogen Beauty Labs SRL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical and Instrumental Evaluation of the Face Biorevitalization Effect With the Medical Device Foliage Hydrofil", "source_url": "https://clinicaltrials.gov/study/NCT07010549"}, {"id": "trialreg:NCT07011537", "company": "Hinge Health, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Examining the Impact of a Digital Health Program and TENS Device for Patients With Chronic Low Back Pain", "source_url": "https://clinicaltrials.gov/study/NCT07011537"}, {"id": "trialreg:NCT07010562", "company": "Acorai AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Multi-site, Prospective, Non-interventional, Observational Data Collection Study in Patients Undergoing a Right Heart Catheterization", "source_url": "https://clinicaltrials.gov/study/NCT07010562"}, {"id": "trialreg:NCT07011420", "company": "Liberating Technologies, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control", "source_url": "https://clinicaltrials.gov/study/NCT07011420"}, {"id": "fda:K250746", "company": "Levita Magnetics International Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250746: Magnetic Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250746", "people": [{"name": "Donielle Baudin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250746%22"}, {"id": "trialreg:NCT07009236", "company": "iSTAR Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma", "source_url": "https://clinicaltrials.gov/study/NCT07009236"}, {"id": "trialreg:NCT07007897", "company": "Haag-Streit AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Observational Study - TA- 2025-1", "source_url": "https://clinicaltrials.gov/study/NCT07007897"}, {"id": "trialreg:NCT07008001", "company": "SightGlass Vision, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of DOT Spectacles in Chinese Children Extension", "source_url": "https://clinicaltrials.gov/study/NCT07008001"}, {"id": "trialreg:NCT07007702", "company": "Laboratoires Thea", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease", "source_url": "https://clinicaltrials.gov/study/NCT07007702"}, {"id": "trialreg:NCT07009132", "company": "HepQuant, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cholate Clearance in Fontan and Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT07009132"}, {"id": "trialreg:NCT07009405", "company": "Rhaeos, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During", "source_url": "https://clinicaltrials.gov/study/NCT07009405"}, {"id": "fda:K240983", "company": "Quanta System Spa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240983: Discovery Pico; Discovery Pico Plus; Discovery Pico Derm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240983", "people": [{"name": "Dario Bandiera", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240983%22"}, {"id": "fda:K243456", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243456: ONVOY\u0099 Acetabular System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243456", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243456%22"}, {"id": "fda:K251009", "company": "Sora Neuroscience, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251009: Cirrus Resting State fMRI Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251009", "people": [{"name": "Stephen Schaefer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251009%22"}, {"id": "fda:K251042", "company": "Guangzhou Ahead Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251042: Light Therapy System (M500, L6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251042", "people": [{"name": "Zheng Leo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251042%22"}, {"id": "fda:K251450", "company": "Shenzhen Desida Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251450: Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251450", "people": [{"name": "Shuangcheng Yuan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251450%22"}, {"id": "fda:K243994", "company": "Ningbo Ican Machines Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243994: Steam Sterilizer (2545D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243994", "people": [{"name": "Hui Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243994%22"}, {"id": "fda:K251452", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251452: Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251452", "people": [{"name": "Logan Persons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251452%22"}, {"id": "fda:K242759", "company": "Geister Medizin Technik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242759: Geister K-Rex rongeurs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242759", "people": [{"name": "Florian Herb", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242759%22"}, {"id": "fda:K242431", "company": "Omnia Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242431: Omnia Medical PsiF DNA\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242431", "people": [{"name": "Troy Schifano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242431%22"}, {"id": "fda:K242774", "company": "Creo Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242774: SpydrBlade Flex Instrument (PRD-RG1-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242774", "people": [{"name": "Diane Davis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242774%22"}, {"id": "fda:K250109", "company": "Tybr Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250109: TYBR Collagen Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250109", "people": [{"name": "Tim Keane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250109%22"}, {"id": "fda:K250591", "company": "Momentis Surgical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250591: Anovo Surgical System (6Ne)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250591", "people": [{"name": "Maya Leib Shlomo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250591%22"}, {"id": "fda:K243550", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243550: KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243550", "people": [{"name": "Emily Rhiel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243550%22"}, {"id": "fda:K251525", "company": "Si-Technology, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251525: SI-TECHNOLOGY\u00ae SI-DESIS\u00ae X\u0099 Sacroiliac Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251525", "people": [{"name": "Chris Donner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251525%22"}, {"id": "fda:K242907", "company": "CnS Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242907: DELPHI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242907", "people": [{"name": "Lee Jin Wook", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242907%22"}, {"id": "fda:K250321", "company": "George Courey, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250321: GCI Sterilization Wrappers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250321", "people": [{"name": "Naab Cort", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250321%22"}, {"id": "fda:K250722", "company": "Hebei JT Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250722: Nd: YAG Laser Therapy System (QN-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250722", "people": [{"name": "Ying Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250722%22"}, {"id": "fda:K243694", "company": "Mah Sing Healthcare Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243694: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243694", "people": [{"name": "Ivan Tan Chee Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243694%22"}, {"id": "fda:K251283", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251283: Once-Fil Flow", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251283", "people": [{"name": "Ku Da Hyeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251283%22"}, {"id": "fda:K242737", "company": "Empatica S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242737: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242737", "people": [{"name": "Alberto Poli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242737%22"}, {"id": "fda:K250891", "company": "Convatec Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250891: Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250891", "people": [{"name": "Alexandra Hyde", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250891%22"}, {"id": "fda:K251131", "company": "Spine Wave, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251131: Annex\u00ae 2 Adjacent Level System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251131", "people": [{"name": "Ronald Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251131%22"}, {"id": "fda:K243490", "company": "Luminex Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243490: LIAISON PLEX Gram-Positive Blood Culture Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243490", "people": [{"name": "Rocio Rueda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243490%22"}, {"id": "fda:K243002", "company": "MBA Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243002: MBA Biotech Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243002", "people": [{"name": "Sung Youn Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243002%22"}, {"id": "nih:5R44GM144007-03", "company": "Indelible Learning, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": 841530, "summary": "NIH award 5R44GM144007-03: Interactive Hand Hygiene Trainer for School-Age Children ($841,530)", "source_url": "https://reporter.nih.gov/project-details/11135545", "people": [{"name": "Jasminka Criley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT07005843", "company": "AMT Medical BV", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study Testing the Elana Device for Multi-Artery Heart Bypass Surgery", "source_url": "https://clinicaltrials.gov/study/NCT07005843"}, {"id": "trialreg:NCT07007351", "company": "Laboratoires FILLMED", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multicenter, Prospective Study to Determine the Performance and Safety of the New M-HA30 Architect Device on the Quality of the Skin: HEBE8 Study", "source_url": "https://clinicaltrials.gov/study/NCT07007351"}, {"id": "trialreg:NCT07006090", "company": "SamanTree Medical SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EU Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog Scanner.", "source_url": "https://clinicaltrials.gov/study/NCT07006090"}, {"id": "trialreg:NCT07006493", "company": "SuZhou Sinus Medical Technologies Co.,Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy", "source_url": "https://clinicaltrials.gov/study/NCT07006493"}, {"id": "trialreg:NCT07006467", "company": "Stentit", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery", "source_url": "https://clinicaltrials.gov/study/NCT07006467"}, {"id": "trialreg:NCT07005232", "company": "Medtronic", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Lead Evaluation for Defibrillation and Reliability Post Approval Study", "source_url": "https://clinicaltrials.gov/study/NCT07005232"}, {"id": "fda:K242736", "company": "Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242736: Portable Oxygen Concentrator (Spirit-3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242736", "people": [{"name": "Yan Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242736%22"}, {"id": "fda:K242704", "company": "Synapse Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242704: Synchrony (20-3000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242704", "people": [{"name": "Jason Fiest", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242704%22"}, {"id": "fda:K243703", "company": "DeepHealth, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243703: TechLive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243703", "people": [{"name": "B. Nathan Hunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243703%22"}, {"id": "fda:K242744", "company": "Corin U.S.A. Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242744: Trinity EVO Acetabular Shell", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242744", "people": [{"name": "Aaron Brunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242744%22"}, {"id": "fda:K250800", "company": "Philips DS North America, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250800: UroNav 4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250800", "people": [{"name": "Sagar Pimpalwar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250800%22"}, {"id": "fda:K250545", "company": "Surgical Instrument Service and Savings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250545: Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250545", "people": [{"name": "Stephanie Boyle Mays", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250545%22"}, {"id": "fda:K250701", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250701: Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250701", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250701%22"}, {"id": "fda:K242464", "company": "Medtronic Navigation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242464: Stealth\u0099 Spine Clamps; ModuLeX\u0099 Shank Mounts", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242464", "people": [{"name": "Victoria Baldock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242464%22"}, {"id": "fda:K250467", "company": "Shenzhen Idea Light Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250467: Red Light Hair Growth Cap (LP-RJVGRW-BLK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250467", "people": [{"name": "Nicole Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250467%22"}, {"id": "fda:K243639", "company": "Grumpy Innovation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243639: Portare System (FA-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243639", "people": [{"name": "Sam Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243639%22"}, {"id": "fda:K251456", "company": "Brightheart", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251456: BrightHeart View Classifier", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251456", "people": [{"name": "Christophe Gardella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251456%22"}, {"id": "fda:K251084", "company": "Estetic Ceram AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251084: zirkon; structure; LFU shades, stains and glazes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251084", "people": [{"name": "Micheal Reise", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251084%22"}, {"id": "fda:K243667", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243667: Sonic DL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243667", "people": [{"name": "Emily Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243667%22"}, {"id": "fda:K242750", "company": "Nihon Kohden Digital Health Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242750: Central Station", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242750", "people": [{"name": "Arthur Webb", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242750%22"}, {"id": "fda:K250616", "company": "Icu Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250616: Clave\u0099 Neutral-Displacement Needlefree Connectors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250616", "people": [{"name": "Nichelle Cato", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250616%22"}, {"id": "trialreg:NCT07005050", "company": "Verve Medical, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Renal Pelvic Denervation Pilot Trial", "source_url": "https://clinicaltrials.gov/study/NCT07005050"}, {"id": "trialreg:NCT07003841", "company": "SKIA Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients", "source_url": "https://clinicaltrials.gov/study/NCT07003841"}, {"id": "trialreg:NCT07004400", "company": "Implantica CE Reflux Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Blinded Randomized Clinical Study of RefluxStop\u2122 Compared With Nissen Fundoplication in the Treatment of GERD", "source_url": "https://clinicaltrials.gov/study/NCT07004400"}, {"id": "trialreg:NCT07004153", "company": "G2e Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT07004153"}, {"id": "trialreg:NCT07005063", "company": "ZuriMED Technologies AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation", "source_url": "https://clinicaltrials.gov/study/NCT07005063"}, {"id": "trialreg:NCT07004010", "company": "Espad Pharmed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Treatment of Flank Fat", "source_url": "https://clinicaltrials.gov/study/NCT07004010"}, {"id": "trialreg:NCT07004907", "company": "Fresenius Medical Care Deutschland GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Tolerability of the APD Treatment in PAED Patients", "source_url": "https://clinicaltrials.gov/study/NCT07004907"}, {"id": "trialreg:NCT07004439", "company": "Implantica CE Reflux Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Post-market Registry to Assess Safety and Performance of RefluxStop\u2122 in the Treatment of GERD in General Hospital Practice", "source_url": "https://clinicaltrials.gov/study/NCT07004439"}, {"id": "fda:K243368", "company": "Medifield Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243368: Montblanc Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243368", "people": [{"name": "Bonggu Ha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243368%22"}, {"id": "fda:K251433", "company": "Surgify Medical OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251433: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251433", "people": [{"name": "Jukka Kreander", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251433%22"}, {"id": "fda:K240788", "company": "Jkh Health Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240788: Ultrasound Stimulator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240788", "people": [{"name": "Pu Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240788%22"}, {"id": "fda:K243843", "company": "Kerecis Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243843: Tendon Protect (50242)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243843", "people": [{"name": "Skuli Magnusson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243843%22"}, {"id": "fda:K250879", "company": "Proprio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250879: Paradigm System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250879", "people": [{"name": "Shannon Eubanks", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250879%22"}, {"id": "fda:K242712", "company": "Sk Zen, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242712: LubriZenzs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242712", "people": [{"name": "Yasminka Jurisic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242712%22"}, {"id": "fda:K250961", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250961: Blood collection tube holders", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250961", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250961%22"}, {"id": "fda:K241433", "company": "Weero Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241433: EVE Synergy (EVE-20M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241433", "people": [{"name": "Moon young Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241433%22"}, {"id": "fda:K250749", "company": "Physcade, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250749: PhysCade System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250749", "people": [{"name": "Raphael Michel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250749%22"}, {"id": "fda:K243499", "company": "Ng Biotech", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243499: NG-Test\u00ae CTX-M MULTI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243499", "people": [{"name": "Milovan Stankov-Puges", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243499%22"}, {"id": "fda:K251397", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251397: Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251397", "people": [{"name": "Liselotte Kornmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251397%22"}, {"id": "fda:K250804", "company": "Id Korea Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250804: ID LIGHT CURE SYSTEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250804", "people": [{"name": "Eunhui Lim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250804%22"}, {"id": "fda:K243810", "company": "Brainlab , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243810: TraumaCad Neo (1.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243810", "people": [{"name": "Veronika Kravtsov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243810%22"}, {"id": "fda:K250118", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250118: Disposable Balloon Catheter B5-2C", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250118", "people": [{"name": "Eve Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250118%22"}, {"id": "fda:K250259", "company": "The ScottCare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250259: TeleRehab Aermos Cardiopulmonary Rehabilitation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250259", "people": [{"name": "Matthew Tarler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250259%22"}, {"id": "fda:K251216", "company": "Barbaras Development, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251216: 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251216", "people": [{"name": "Matthew Baile", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251216%22"}, {"id": "nih:1R43GM159820-01", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": 350000, "summary": "NIH award 1R43GM159820-01: Direct Proteolytic Machine Assessments for Unfolding and Sequencing Proteins ($350,000)", "source_url": "https://reporter.nih.gov/project-details/11179965", "people": [{"name": "Sean German", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT07001332", "company": "Magenta Medical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ELEVATE High-Risk PCI Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT07001332"}, {"id": "trialreg:NCT07001007", "company": "HJN Sverige AB/Neko Health", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-06-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment", "source_url": "https://clinicaltrials.gov/study/NCT07001007"}, {"id": "fda:K243948", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243948: Raptor Aspiration Catheter; Balt Aspiration Tubing Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243948", "people": [{"name": "Catherine Chiou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243948%22"}, {"id": "fda:K250657", "company": "Cintron Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250657: gi2000 Electrosurgical Generator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250657", "people": [{"name": "William Bowers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250657%22"}, {"id": "fda:K243796", "company": "Glove One, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243796: GLOVEONE\u0099 Powder-Free Nitrile Examination Gloves \u0096 Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243796", "people": [{"name": "Jason Palmer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243796%22"}, {"id": "fda:K243382", "company": "Rz Medizintechnik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243382: RZ Resectoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243382", "people": [{"name": "Daniela Lang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243382%22"}, {"id": "fda:K251035", "company": "Serim Research", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251035: DISINTEK\u0099 PA Test Strips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251035", "people": [{"name": "Jackie Nelson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251035%22"}, {"id": "fda:K250001", "company": "Spinal Simplicity, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250001: Patriot SI Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250001", "people": [{"name": "Adam Rogers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250001%22"}, {"id": "fda:K243205", "company": "Phasor Health, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243205: EVAC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243205", "people": [{"name": "Ray King", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243205%22"}, {"id": "fda:K251127", "company": "Pentax of America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251127: PENTAX Medical Video Processor (EPK-i8020c)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251127", "people": [{"name": "Gurvinder Singh Nanda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251127%22"}, {"id": "fda:K250598", "company": "Aroa Biosurgery , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250598: Endoform Reconstructive Template - PLGA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250598", "people": [{"name": "Stacy Spies", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250598%22"}, {"id": "fda:K242897", "company": "Clemde SA DE CV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242897: Partial Flex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242897", "people": [{"name": "Cabrera Francisco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242897%22"}, {"id": "fda:K250682", "company": "Becton Dickinson Infusion Therapy Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250682: BD Nexiva\u0099 Diffusics\u0099 Closed IV Catheter System and BD Nexiva\u0099 Diffusics\u0099 Closed IV Catheter System with BD MaxZero\u0099 Needle-free Connector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250682", "people": [{"name": "Vantana Krishnakumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250682%22"}, {"id": "fda:K250529", "company": "Kardium, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250529: Globe Introducer (601-01001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250529", "people": [{"name": "Ricardo Romero", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250529%22"}, {"id": "nih:2R44HD110306-03", "company": "Mother's Milk Is Best, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-06-02", "observed": "2026-08-21", "amount_usd": 1175845, "summary": "NIH award 2R44HD110306-03: Point of Care maternal milk concentration device optimizing neonatal growth with targeted nutrition support: Establishing clinical evidence of benefit as an alternative to milk sourced fortification ($1,175,845)", "source_url": "https://reporter.nih.gov/project-details/11068786", "people": [{"name": "Elizabeth Randall Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K251335", "company": "Acuity Surgical Devices, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251335: Tera Lumbar Interbody Fusion System (Various PNs)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251335", "people": [{"name": "Chuck Forton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251335%22"}, {"id": "fda:K250844", "company": "Science & Bio Materials (S.B.M.) Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250844: PULLUP\u00ae; PULLUP\u00ae CLIP; BT LOOP\u00ae; PULLUP\u00ae TEX CLIP; RIGIDLOOP\u0099 T; RIGIDLOOP\u0099 Clip; RIGIDLOOP\u0099 BTB; RIGIDLOOP\u0099 Suture Loop", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250844", "people": [{"name": "Anne Cospin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250844%22"}, {"id": "fda:K250452", "company": "MacroLux Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250452: CoralWell\u0099 Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250452", "people": [{"name": "Ye Linbin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250452%22"}, {"id": "fda:K250410", "company": "W. L. Gore & Associates, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250410: GORE\u00ae Tri-Lobe Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250410", "people": [{"name": "Erika Grecco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250410%22"}, {"id": "fda:K250965", "company": "Sysmex America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-06-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250965: Automated Blood Coagulation Analyzer CN-Series (CN-6000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250965", "people": [{"name": "Esther John-Olotu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250965%22"}, {"id": "trialreg:NCT06999408", "company": "Recens Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-31", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of TargetCool + Benev Exosomes in Patients With Hair Thinning", "source_url": "https://clinicaltrials.gov/study/NCT06999408"}, {"id": "fda:K251376", "company": "LimFlow, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251376: LimFlow ARC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251376", "people": [{"name": "Haley Ritchie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251376%22"}, {"id": "nih:1R44HG014445-01", "company": "Vellum Biotechnology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": 1020280, "summary": "NIH award 1R44HG014445-01: Developing a New Nucleic Acid Extraction Technology to Enable High Quality DNA Sequencing for Formalin Fixed Paraffin Embedded Tissue Samples ($1,020,280)", "source_url": "https://reporter.nih.gov/project-details/11186794", "people": [{"name": "Yann Astier", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44HL170817-01A1S1", "company": "DNA Medicine Institute", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44HL170817-01A1S1: 5-Minute Point-of-Care Anti-Factor Xa Test for Emergent Patient Management ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11252219", "people": [{"name": "Eugene Yan-ho Chan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH140731-01", "company": "Spatial Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": 1244076, "summary": "NIH award 1R44MH140731-01: Next generation spatial genomics tools for the human brain ($1,244,076)", "source_url": "https://reporter.nih.gov/project-details/11186828", "people": [{"name": "Kirsten Frieda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM139391-02A1", "company": "Cg Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": 833381, "summary": "NIH award 2R44GM139391-02A1: Low-Cost Platform Technology for Rapid Isolation of Peripheral Blood Mononuclear Cells ($833,381)", "source_url": "https://reporter.nih.gov/project-details/11077586", "people": [{"name": "Lotien Richard Huang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA268156-04", "company": "Opsiclear LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": 929497, "summary": "NIH award 5R44CA268156-04: 3D optical histopathology for head and neck intraoperative consultation. ($929,497)", "source_url": "https://reporter.nih.gov/project-details/11131182", "people": [{"name": "YEHE LIU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "trialreg:NCT06997003", "company": "Bausch & Lomb GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a New Laser Refractive Vision Correction Using the TENEO\u2122 317 Model 2", "source_url": "https://clinicaltrials.gov/study/NCT06997003"}, {"id": "trialreg:NCT06997380", "company": "Biovico Sp. z o.o.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel", "source_url": "https://clinicaltrials.gov/study/NCT06997380"}, {"id": "trialreg:NCT06996600", "company": "Rhaeos, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device", "source_url": "https://clinicaltrials.gov/study/NCT06996600"}, {"id": "fda:K250236", "company": "Hyperfine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250236: Swoop\u00ae Portable MR Imaging\u00ae System (V2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250236", "people": [{"name": "Christine Kupchick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250236%22"}, {"id": "fda:K250368", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250368: Wearable Breast Pump (Model S21)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250368", "people": [{"name": "Xiaoyan Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250368%22"}, {"id": "fda:K250365", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250365: Motif Aura Glow breast pump (Model Motif Aura Glow)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250365", "people": [{"name": "Xiaoyan Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250365%22"}, {"id": "fda:K250150", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250150: VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250150", "people": [{"name": "Martina Carlini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250150%22"}, {"id": "fda:K243654", "company": "Vapocoolshot, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243654: DentalJect", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243654", "people": [{"name": "Jacob Leibovici", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243654%22"}, {"id": "fda:K251238", "company": "Maquet Cardiovascular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251238: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251238", "people": [{"name": "Brad Sheals", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251238%22"}, {"id": "fda:K243505", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243505: 5008X Hemodialysis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243505", "people": [{"name": "Laura Reed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243505%22"}, {"id": "fda:K250078", "company": "Mindset Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250078: Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250078", "people": [{"name": "Jeremy Markovich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250078%22"}, {"id": "fda:K250024", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250024: TE Air Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250024", "people": [{"name": "Jufang Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250024%22"}, {"id": "fda:K243005", "company": "Audax D.O.O.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243005: AudaxCeph Cephalogram Analysis Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243005", "people": [{"name": "Peter Kobal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243005%22"}, {"id": "fda:K250195", "company": "Matelaser, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250195: MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250195", "people": [{"name": "Ruth Garcia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250195%22"}, {"id": "fda:K243010", "company": "Owens & Minor (O&M) Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243010: Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243010", "people": [{"name": "Angela Bunn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243010%22"}, {"id": "fda:K250957", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250957: Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250957", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250957%22"}, {"id": "fda:K251063", "company": "Theramicro", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251063: TekBrace Solo Soft Tissue Reinforcement Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251063", "people": [{"name": "Christine Scifert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251063%22"}, {"id": "fda:K242926", "company": "Xbody Hungary Kft.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242926: XBody Go USA, XBody Pro USA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242926", "people": [{"name": "Orsolya Balog", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242926%22"}, {"id": "fda:K242635", "company": "Alton (Shanghai) Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242635: Endoscopic Distal Attachment (AF-D series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242635", "people": [{"name": "Vivian Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242635%22"}, {"id": "fda:DEN240047", "company": "Clairity, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240047: Allix5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240047", "people": [{"name": "Kris Zeschin", "role": "510(k) submission contact"}]}, {"id": "fda:K243530", "company": "Talladium Espa\u00f1a, SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243530: Dynamic TiBase", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243530", "people": [{"name": "Xavier Soca Filella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243530%22"}, {"id": "fda:K251406", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251406: BriefCase-Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251406", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251406%22"}, {"id": "fda:K251383", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251383: Prestige Coil System (Prestige Packing Line Extension)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251383", "people": [{"name": "Kavita Chandrashekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251383%22"}, {"id": "fda:K250317", "company": "Spident Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250317: EsFlow PLUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250317", "people": [{"name": "Hyemin Kwon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250317%22"}, {"id": "fda:K250637", "company": "Amber Implants", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250637: VCFix Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250637", "people": [{"name": "Banafsheh Sajadi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250637%22"}, {"id": "fda:K250581", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250581: KALA Red Light Face Mask (KALA-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250581", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250581%22"}, {"id": "fda:K242830", "company": "Bonraybio Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242830: LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242830", "people": [{"name": "Clare Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242830%22"}, {"id": "fda:K243522", "company": "Thi Total Healthcare Innovation GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243522: ViVi\u00ae Toga Premium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243522", "people": [{"name": "Karl Hintermann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243522%22"}, {"id": "fda:K242640", "company": "Fertipro NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242640: FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242640", "people": [{"name": "Liesbeth Faes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242640%22"}, {"id": "fda:K242725", "company": "Ningbo Youhe Electrical Appliance Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242725: Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242725", "people": [{"name": "Yun Jun Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242725%22"}, {"id": "fda:K243863", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243863: Opulus\u0099 Lymphoma Precision", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243863", "people": [{"name": "Aarti Shukla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243863%22"}, {"id": "fda:K241313", "company": "Osang, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241313: OHC COVID-19 Antigen Self Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241313", "people": [{"name": "Seungyeob Dan Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241313%22"}, {"id": "fda:K242751", "company": "Jeil Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242751: ARIX Pectus Bar System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242751", "people": [{"name": "Hong Soomin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242751%22"}, {"id": "denovo:DEN240047", "company": "Clairity, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-05-30", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240047 granted: Allix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240047"}, {"id": "nih:1R43HD117457-01", "company": "Kate Allyn Prosthetic Research", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": 306869, "summary": "NIH award 1R43HD117457-01: A novel pediatric prosthetic foot for functional multi-axial mobility during active play ($306,869)", "source_url": "https://reporter.nih.gov/project-details/11065691", "people": [{"name": "Katheryn Jo Allyn", "role": "Principal Investigator"}, {"name": "Evandro Maicon Ficanha", "role": "Principal Investigator"}, {"name": "Murray E. Maitland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK141400-01A1", "company": "Lumina Medical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": 324678, "summary": "NIH award 1R43DK141400-01A1: Motorized Girth Adjustable Dilator with Dilation and Pressure Measurement for Anorectal Disorders, Designed to Improve Patient Adherence to Treatment via Static-Passive Stretching ($324,678)", "source_url": "https://reporter.nih.gov/project-details/11069996", "people": [{"name": "BENJAMIN JAYOL", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06994546", "company": "Maxigen Biotech Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ArtiBest for Knee Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT06994546"}, {"id": "trialreg:NCT06994819", "company": "Mane Biotech GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Niostem Headset for Hair Growth and Hair Quality", "source_url": "https://clinicaltrials.gov/study/NCT06994819"}, {"id": "fda:K251315", "company": "Remex Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251315: Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251315", "people": [{"name": "Cheng-Hsiung Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251315%22"}, {"id": "fda:K250307", "company": "Medtronic Navigation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250307: Visualase V2 MRI-guided Laser Ablation System (9736422)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250307", "people": [{"name": "Sharon McDermott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250307%22"}, {"id": "fda:K250606", "company": "Yueying Medical Instruments (Langfang) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250606: Dental Barrier and Sleeves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250606", "people": [{"name": "Xiaoliang Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250606%22"}, {"id": "fda:K251340", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251340: ProSeal\u0099 Bag Spike with Additive Port (423370ST, 423370)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251340", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251340%22"}, {"id": "fda:K243484", "company": "Piccolo Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243484: PM2+ System and SmartPICC Stylet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243484", "people": [{"name": "Augustus Shanahan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243484%22"}, {"id": "fda:K250673", "company": "Kuraray Noritake Dental, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250673: CERABIEN MiLai", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250673", "people": [{"name": "Yasujiro Ohara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250673%22"}, {"id": "fda:K250757", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250757: Radius VSM and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250757", "people": [{"name": "Jazmin Laidet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250757%22"}, {"id": "fda:K250215", "company": "Cochlear", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250215: Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250215", "people": [{"name": "Denis DiMartino", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250215%22"}, {"id": "fda:K243372", "company": "Gerium Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243372: BiliWrap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243372", "people": [{"name": "Noam Rubin Tal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243372%22"}, {"id": "fda:K243480", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243480: SuturePatch Tissue Reinforcement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243480", "people": [{"name": "Tiffany Mentzel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243480%22"}, {"id": "fda:K243497", "company": "Shanghai AnQing Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243497: Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243497", "people": [{"name": "Shuwen Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243497%22"}, {"id": "fda:K250543", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250543: Voluson\u0099 Performance 16; Voluson\u0099 Performance 18", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250543", "people": [{"name": "Bryan Behn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250543%22"}, {"id": "fda:K243309", "company": "Terumo Europe N.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243309: 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243309", "people": [{"name": "Liesbeth Decoster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243309%22"}, {"id": "fda:K250048", "company": "Neurent Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250048: NEUROMARK System (NMK00301)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250048", "people": [{"name": "Fay Dalton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250048%22"}, {"id": "fda:DEN240048", "company": "Reflow Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240048: Spur Peripheral Retrievable Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240048", "people": [{"name": "Lori Grace", "role": "510(k) submission contact"}]}, {"id": "fda:K251325", "company": "Baylis Medical Company, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251325: VersaCross Connect\u0099 Transseptal Dilator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251325", "people": [{"name": "Ezgi Tas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251325%22"}, {"id": "fda:K243856", "company": "Shenzhen Astec Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243856: TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243856", "people": [{"name": "Connie Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243856%22"}, {"id": "fda:K243469", "company": "Osteonic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243469: SIGNEX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243469", "people": [{"name": "Hye-Min Ahn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243469%22"}, {"id": "denovo:DEN240048", "company": "Reflow Medical, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-05-29", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240048 granted: Spur Peripheral Retrievable Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240048"}, {"id": "breakthrough:DEN240048", "company": "Reflow Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-05-29", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN240048: SPUR PERIPHERAL RETRIEVABLE STENT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44HD090811-06", "company": "Infinite Biomedical Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": 876333, "summary": "NIH award 5R44HD090811-06: Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses ($876,333)", "source_url": "https://reporter.nih.gov/project-details/11083081", "people": [{"name": "Rahul Reddy Kaliki", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "trialreg:NCT06991413", "company": "Endo Health GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Impact of an App on the Quality of Life and Symptoms in Individuals With Premenstrual Syndrome", "source_url": "https://clinicaltrials.gov/study/NCT06991413"}, {"id": "trialreg:NCT06992310", "company": "Sebastian Griepentrog", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Exploration of the Functional Effect of Different Hearing Aid Noise Reduction Algorithms in an Ecologically Valid Conversational Situation", "source_url": "https://clinicaltrials.gov/study/NCT06992310"}, {"id": "trialreg:NCT06992960", "company": "Primex ehf", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)", "source_url": "https://clinicaltrials.gov/study/NCT06992960"}, {"id": "trialreg:NCT06992596", "company": "Neuralink Corp", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices", "source_url": "https://clinicaltrials.gov/study/NCT06992596"}, {"id": "trialreg:NCT06993207", "company": "Bitbrain", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population", "source_url": "https://clinicaltrials.gov/study/NCT06993207"}, {"id": "fda:K250624", "company": "Resmed Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250624: myAir", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250624", "people": [{"name": "Rose Malonzo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250624%22"}, {"id": "fda:K243949", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243949: OsteoFlo HydroFiber", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243949", "people": [{"name": "Guilherme Pires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243949%22"}, {"id": "fda:K242752", "company": "Iradimed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242752: MRidium 3870 MRI Infusion Pump System (3870)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242752", "people": [{"name": "Steven Kachelmeyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242752%22"}, {"id": "fda:K242793", "company": "Shenzhen Insighters Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242793: Insighters\u0099 Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters\u0099 Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters\u0099 Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters\u0099 Insight Workstation iS-PF1.", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242793", "people": [{"name": "Baohong Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242793%22"}, {"id": "fda:K250427", "company": "Taiwan Medical Imaging Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250427: TAIMedImg DeepMets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250427", "people": [{"name": "Bo-Ru Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250427%22"}, {"id": "fda:K251344", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251344: OptiMap\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251344", "people": [{"name": "Derek Charchuk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251344%22"}, {"id": "fda:K240950", "company": "Pacific Care Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240950: Disposable Prophy Angle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240950", "people": [{"name": "Chris Kwong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240950%22"}, {"id": "fda:K243378", "company": "Ischemaview, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243378: Rapid MLS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243378", "people": [{"name": "James Rosa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243378%22"}, {"id": "fda:K242699", "company": "Opcom Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242699: Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242699", "people": [{"name": "ChingLin Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242699%22"}, {"id": "fda:K243716", "company": "Termosalud S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243716: Zionic Pro Max (Radiofrequency)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243716", "people": [{"name": "Cristina Cifuentes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243716%22"}, {"id": "fda:K243047", "company": "Imperative Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243047: Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243047", "people": [{"name": "Michael Wong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243047%22"}, {"id": "fda:K244049", "company": "Livermoretech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244049: Europa (Alternative: AiRTouch) portable X-ray system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244049", "people": [{"name": "Casey Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244049%22"}, {"id": "fda:K250367", "company": "Smart Soft Healthcare AD", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250367: CoLumboX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250367", "people": [{"name": "Nedelcho Georgiev", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250367%22"}, {"id": "nih:3R43DK141421-01S1", "company": "Flowpoint Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43DK141421-01S1: Self-sealing needle guide system for reliable hemodialysis ($55,000)", "source_url": "https://reporter.nih.gov/project-details/11237368", "people": [{"name": "Evren U. AZELOGLU", "role": "Principal Investigator"}, {"name": "Jason Bobe", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06991322", "company": "VahatiCor, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD) (SERRA-I Study)", "source_url": "https://clinicaltrials.gov/study/NCT06991322"}, {"id": "trialreg:NCT06991270", "company": "Sight Sciences, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma", "source_url": "https://clinicaltrials.gov/study/NCT06991270"}, {"id": "fda:K250614", "company": "Jjgc Ind\u00fastria E Com\u00e9rcia DE Materiais Dent\u00e1rios S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250614: Neodent Implant System - Custom Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250614", "people": [{"name": "Leticia Milani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250614%22"}, {"id": "fda:K242604", "company": "Preventamed Technologies, Inc. Dba Surfacide Manufacturing", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242604: Helios+ UV-C System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242604", "people": [{"name": "Jeffry Veenhuis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242604%22"}, {"id": "fda:K242611", "company": "Mipont Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242611: Integral Dental Units", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242611", "people": [{"name": "Chen Salon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242611%22"}, {"id": "fda:K250435", "company": "Distalmotion SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250435: Dexter L6 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250435", "people": [{"name": "Larry Carrier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250435%22"}, {"id": "fda:K242841", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242841: Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242841", "people": [{"name": "Elijah Canal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242841%22"}, {"id": "fda:K243777", "company": "Theodent, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243777: Rennou\u0099 Varnish (3% / Spearmint); Rennou\u0099 Varnish (3% / Strawberry); Rennou\u0099 Varnish (3% / Cherry); Rennou\u0099 Varnish (3% / Bubble Gum)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243777", "people": [{"name": "Joseph Fuselier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243777%22"}, {"id": "fda:K250475", "company": "Ningbo Baichen Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250475: Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250475", "people": [{"name": "Xiaolong Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250475%22"}, {"id": "fda:K250932", "company": "Medicalgorithmics S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250932: DeepRhythmAI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250932", "people": [{"name": "Agnieszka Romowicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250932%22"}, {"id": "fda:K251578", "company": "Shofu Dental Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251578: BEAUTIFIL II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251578", "people": [{"name": "Malzyner Mauro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251578%22"}, {"id": "fda:K250573", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250573: Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250573", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250573%22"}, {"id": "fda:K251309", "company": "OSSIO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251309: OSSIOfiber\u00ae Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251309", "people": [{"name": "Taly Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251309%22"}, {"id": "fda:K242820", "company": "Puritan Medical Products, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242820: Puritan PurSafe Plus Collection and Transport System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242820", "people": [{"name": "Mehdi Karamchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242820%22"}, {"id": "nih:5R44CA268678-03", "company": "Collinge And Associates", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-26", "observed": "2026-08-21", "amount_usd": 1030459, "summary": "NIH award 5R44CA268678-03: mHealth app for caregiver instruction in manual therapy for chemotherapy-induced peripheral neuropathy ($1,030,459)", "source_url": "https://reporter.nih.gov/project-details/11115814", "people": [{"name": "WILLIAM B. COLLINGE", "role": "Principal Investigator"}, {"name": "Cindy Tofthagen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44LM014736-01", "company": "Guided Clinical Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-26", "observed": "2026-08-21", "amount_usd": 313819, "summary": "NIH award 1R44LM014736-01: GuidedOR: A Real-Time Medication Safety Software Platform for the Operating Room ($313,819)", "source_url": "https://reporter.nih.gov/project-details/11068796", "people": [{"name": "Karen C Nanji", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06991127", "company": "Centervue SpA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection", "source_url": "https://clinicaltrials.gov/study/NCT06991127"}, {"id": "trialreg:NCT06989242", "company": "Ciatrix, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Yoga-based, Movement Therapy Device as Noninvasive Glymphatic Clearance Augmentation in Alzheimer's Disease.", "source_url": "https://clinicaltrials.gov/study/NCT06989242"}, {"id": "trialreg:NCT06990048", "company": "Endologix", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System", "source_url": "https://clinicaltrials.gov/study/NCT06990048"}, {"id": "trialreg:NCT06990412", "company": "Neuracle Medical Technology(Shanghai) Co.,Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface\uff08BCI\uff09System NEO in Patients With Tetraplegia", "source_url": "https://clinicaltrials.gov/study/NCT06990412"}, {"id": "trialreg:NCT06989580", "company": "Biotronik SE & Co. KG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software", "source_url": "https://clinicaltrials.gov/study/NCT06989580"}, {"id": "trialreg:NCT06990906", "company": "BAIBYS Fertility", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating the Safety and Clinical Efficacy of the BAIBYS\u2122 System in Intracytoplasmic Sperm Injection (ICSI)", "source_url": "https://clinicaltrials.gov/study/NCT06990906"}, {"id": "trialreg:NCT06989450", "company": "Sidekick Health", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Digital Patient Support Program for Self-efficacy and Medication Adherence in Women on Adjuvant Endocrine Treatment for Breast Cancer", "source_url": "https://clinicaltrials.gov/study/NCT06989450"}, {"id": "trialreg:NCT06989775", "company": "AtriCure, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BoxX-NoAF Clinical Trial", "source_url": "https://clinicaltrials.gov/study/NCT06989775"}, {"id": "trialreg:NCT06988800", "company": "Muvik Labs", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Musically-Guided Paced Breathing Improves Mental Health in War-Affected Adolescents", "source_url": "https://clinicaltrials.gov/study/NCT06988800"}, {"id": "trialreg:NCT06990074", "company": "Horizon Surgical Systems Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Early Feasibility, Prospective, Single-Arm Study of the Polaris System", "source_url": "https://clinicaltrials.gov/study/NCT06990074"}, {"id": "trialreg:NCT06991010", "company": "Transradial Technologies, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure", "source_url": "https://clinicaltrials.gov/study/NCT06991010"}, {"id": "trialreg:NCT06989931", "company": "MicroPort NeuroTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Intracranial Distal Access Catheter in Neurointerventional Therapy", "source_url": "https://clinicaltrials.gov/study/NCT06989931"}, {"id": "trialreg:NCT06990100", "company": "Sacimex", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Performance and Safety of ENDOPACK\u00ae DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery", "source_url": "https://clinicaltrials.gov/study/NCT06990100"}, {"id": "trialreg:NCT06987474", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Capella Scientia Development Study", "source_url": "https://clinicaltrials.gov/study/NCT06987474"}, {"id": "trialreg:NCT06987617", "company": "Endo Health GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Menopause", "source_url": "https://clinicaltrials.gov/study/NCT06987617"}, {"id": "trialreg:NCT06986954", "company": "Cook Research Incorporated", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study", "source_url": "https://clinicaltrials.gov/study/NCT06986954"}, {"id": "trialreg:NCT06986499", "company": "Wsaud A/s", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Standard Post Market Clinical Follow-up (PMCF) Study WSA 2025", "source_url": "https://clinicaltrials.gov/study/NCT06986499"}, {"id": "trialreg:NCT06987253", "company": "ENIKAM d.o.o.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of the Efficacy and Safety of OROXID\u00ae Oral Solution in Patients With Oral Cavity Surgery", "source_url": "https://clinicaltrials.gov/study/NCT06987253"}, {"id": "fda:K250384", "company": "El Global Trade, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250384: IPL400", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250384", "people": [{"name": "Stephanie Khoury", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250384%22"}, {"id": "fda:K243937", "company": "Rivanna Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243937: Accuro 3S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243937", "people": [{"name": "F. William Mauldin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243937%22"}, {"id": "fda:K250778", "company": "Dsi Dental Solutions, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250778: Sil-Flow", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250778", "people": [{"name": "Shlomi Krasner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250778%22"}, {"id": "fda:K251211", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251211: ViewFlex\u0099 Xtra ICE Catheter; ViewFlex\u0099 Eco Reprocessed ICE Catheter; Advisor\u0099 HD Grid Mapping Catheter, Sensor Enabled\u0099; Advisor\u0099 HD Grid X Mapping Catheter, Sensor Enabled\u0099; Agilis\u0099 NxT Steerable Introducer; Agilis\u0099 NxT Steerable Introducer Dual-Reach\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251211", "people": [{"name": "Adam Bakken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251211%22"}, {"id": "fda:K250005", "company": "Ewoosoft Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250005: Clever One", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250005", "people": [{"name": "Hyeonguk Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250005%22"}, {"id": "fda:K242594", "company": "Deepecho", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242594: DEEPECHO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242594", "people": [{"name": "Youssef Bouyakhf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242594%22"}, {"id": "fda:K243474", "company": "Kuros Biosciences B.V", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243474: MagnetOs MIS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243474", "people": [{"name": "Hen Baron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243474%22"}, {"id": "fda:K251292", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251292: RECLAIM Monobloc Revision Femoral Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251292", "people": [{"name": "Robin Layton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251292%22"}, {"id": "fda:K250938", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250938: Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250938", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250938%22"}, {"id": "fda:K244047", "company": "Venocare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244047: Navi\u0099 Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244047", "people": [{"name": "Raul Leyte-Vidal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244047%22"}, {"id": "fda:K243989", "company": "Pearl, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243989: Second Opinion\u00ae 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243989", "people": [{"name": "Ashley Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243989%22"}, {"id": "fda:K250239", "company": "LVIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250239: NeuroMatch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250239", "people": [{"name": "Sweta Srivastava", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250239%22"}, {"id": "fda:K243023", "company": "Wellell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243023: WiZARD 520 Full Face Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243023", "people": [{"name": "Chieh Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243023%22"}, {"id": "fda:K243261", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243261: FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243261", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243261%22"}, {"id": "fda:K251044", "company": "Piraeus Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251044: 93 NeuFlex Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251044", "people": [{"name": "Jared Hutar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251044%22"}, {"id": "fda:K250549", "company": "The Binding Site Group , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250549: Optilite\u00ae Freelite Mx Kappa Free Kit; Optilite\u00ae Freelite Mx Lambda Free Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250549", "people": [{"name": "Jolanta Wolff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250549%22"}, {"id": "fda:K250446", "company": "Spineup, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250446: Frida\u0099 Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250446", "people": [{"name": "Philippe Laurito", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250446%22"}, {"id": "fda:K242575", "company": "Brain Navi Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242575: Stereotaxic Guiding Surgical Devices, NaoTrac S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242575", "people": [{"name": "I-Ju Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242575%22"}, {"id": "fda:K250544", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250544: Knotilus+ Biocomposite Knotless Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250544", "people": [{"name": "Madison Mutchler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250544%22"}, {"id": "fda:K242545", "company": "Eizo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242545: RadiForce MX317W-PA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242545", "people": [{"name": "Hiroaki Hashimoto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242545%22"}, {"id": "fda:K250361", "company": "Geske Beauty Tech GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250361: SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250361", "people": [{"name": "Natalia Reshetnikova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250361%22"}, {"id": "pma:P240042", "company": "Abbott Medical", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240042: Tendyne Transcatheter Mitral Valve System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240042", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240042%22"}, {"id": "breakthrough:P240042", "company": "Abbott Medical", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-05-23", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P240042: TENDYNE TRANSCATHETER MITRAL VALVE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:FA8649-25-P-0367", "company": "Qore Health Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-05-23", "observed": "2026-09-18", "amount_usd": 1799987, "summary": "DOD STTR Phase II award $1,799,987: En Route Medical Monitoring and Air-to-Ground Triage", "source_url": "https://www.sbir.gov/awards?search=FX24D-PTCSO1-0373"}, {"id": "nih:5R44AI167330-04", "company": "Scanogen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI167330-04: Culture and amplification-free bacterial sepsis diagnosis ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11090450", "people": [{"name": "Alfredo Andres Celedon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43HD116639-01A1", "company": "Charles River Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": 399988, "summary": "NIH award 1R43HD116639-01A1: Social, Assistive Mobile Manipulator (SAMM) to enhance functional independence in persons with tetraplegia secondary to severe cervical spinal cord injury ($399,988)", "source_url": "https://reporter.nih.gov/project-details/11180646", "people": [{"name": "Ernest Vincent Cross", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44DA060643-01S1", "company": "Resilient Lifescience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": 54944, "summary": "NIH award 3R44DA060643-01S1: Developing a wearable medical device to detect opioid overdose ($54,944)", "source_url": "https://reporter.nih.gov/project-details/11268256", "people": [{"name": "Bradford A Holden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06984419", "company": "Institute Hyalual GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation of the Medical Device \"Alexa Volume\" for Correction of Midface Volume Loss", "source_url": "https://clinicaltrials.gov/study/NCT06984419"}, {"id": "trialreg:NCT06985888", "company": "Coloplast A/S", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: New Coating for Urinary Intermittent Catheters", "source_url": "https://clinicaltrials.gov/study/NCT06985888"}, {"id": "trialreg:NCT06985238", "company": "Stratagen Bio, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Stratagen Quantitative Prostate MRI Platform Pilot Study", "source_url": "https://clinicaltrials.gov/study/NCT06985238"}, {"id": "trialreg:NCT06985433", "company": "UVISA Health ApS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Light Treatment of Vaginal Infections in Reproductive Age Women", "source_url": "https://clinicaltrials.gov/study/NCT06985433"}, {"id": "trialreg:NCT06984432", "company": "Institute Hyalual GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of a Non-cross-linked Hyaluronic Acid Medical Device (\"Electri\" and \"XELA REDERM\") for Improving Facial Skin Appearance", "source_url": "https://clinicaltrials.gov/study/NCT06984432"}, {"id": "trialreg:NCT06984224", "company": "NeuFit - Neurological Fitness and Education", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pulsed Direct Current Electrical Stimulation for Treatment of Low Back Pain", "source_url": "https://clinicaltrials.gov/study/NCT06984224"}, {"id": "trialreg:NCT06985875", "company": "Avizor SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4%", "source_url": "https://clinicaltrials.gov/study/NCT06985875"}, {"id": "trialreg:NCT06984484", "company": "Devintec Sagl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance and Safety of Afluxin\u00ae in Patients With Gastroesophageal Reflux Disease", "source_url": "https://clinicaltrials.gov/study/NCT06984484"}, {"id": "trialreg:NCT06984744", "company": "Lactea Therapeutics, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: 4-day Plaque Accumulation Model Evaluating Compound Containing Gum", "source_url": "https://clinicaltrials.gov/study/NCT06984744"}, {"id": "fda:K250897", "company": "Clinical Innovations, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250897: Koala Intrauterine Pressure Catheter (IPC-5000E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250897", "people": [{"name": "Alex Garrett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250897%22"}, {"id": "fda:K250878", "company": "Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250878: YUWELL\u00ae Infrared Ear Thermometer (YHT100); YUWELL\u00ae Infrared Ear Thermometer (YHT107)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250878", "people": [{"name": "Fang (Fawn) Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250878%22"}, {"id": "fda:K250532", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250532: Solawave 2-in-1 Skincare Mini (Model: 61043)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250532", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250532%22"}, {"id": "fda:K251493", "company": "Cryoconcepts LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251493: Skin Clinic Freeze Point for Warts and Skin Tags", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251493", "people": [{"name": "Sam Niedbala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251493%22"}, {"id": "fda:K242684", "company": "Hua Yue Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242684: Harioculture TL-16 Time-lapse Incubator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242684", "people": [{"name": "Zhenzhi Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242684%22"}, {"id": "fda:K250910", "company": "Urotronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250910: Optilume\u00ae High Pressure Urological Balloon Dilation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250910", "people": [{"name": "Alex Zuniga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250910%22"}, {"id": "fda:K250935", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250935: TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250935", "people": [{"name": "Blesson Abraham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250935%22"}, {"id": "fda:K250630", "company": "Basic Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250630: Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250630", "people": [{"name": "Zhao John", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250630%22"}, {"id": "fda:K251052", "company": "Ortho Development Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251052: Trivicta\u00ae Hip Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251052", "people": [{"name": "Drew Weaver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251052%22"}, {"id": "fda:DEN240035", "company": "Randox Laboratories, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240035: ConcizuTrace\u0099 ELISA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240035", "people": [{"name": "Karena Shaw", "role": "510(k) submission contact"}]}, {"id": "fda:K250920", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250920: Arthrex Spine Compression FT Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250920", "people": [{"name": "Kristi Frisch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250920%22"}, {"id": "fda:K242659", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242659: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242659", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242659%22"}, {"id": "fda:K250639", "company": "Terrats Medical SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250639: DESS Dental Smart Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250639", "people": [{"name": "Roger Terrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250639%22"}, {"id": "fda:K250980", "company": "Lima Corporate S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250980: Physica System (Physica CR Porous Femoral components)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250980", "people": [{"name": "Simone De Marco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250980%22"}, {"id": "fda:K242586", "company": "Ovesco Endoscopy AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242586: ArgoCap (200.52)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242586", "people": [{"name": "Clara Thiemann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242586%22"}, {"id": "denovo:DEN240035", "company": "Randox Laboratories, Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-05-22", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240035 granted: ConcizuTrace\u2122 ELISA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240035"}, {"id": "breakthrough:DEN240035", "company": "Randox Laboratories Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-05-22", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN240035: CONCIZUTRACE ELISA", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "trialreg:NCT06982820", "company": "GrayMatters Health Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia", "source_url": "https://clinicaltrials.gov/study/NCT06982820"}, {"id": "trialreg:NCT06983041", "company": "Coologics, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)", "source_url": "https://clinicaltrials.gov/study/NCT06983041"}, {"id": "trialreg:NCT06982781", "company": "Microvention-Terumo, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FRED Retrospective Study of Intracranial Aneurysms Treatment", "source_url": "https://clinicaltrials.gov/study/NCT06982781"}, {"id": "trialreg:NCT06982235", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Stone and Laser Therapies Post-Market Study (SALT)", "source_url": "https://clinicaltrials.gov/study/NCT06982235"}, {"id": "fda:K243429", "company": "Hjy Smart Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243429: HJY VisualNext 3D Endoscopic Vision System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243429", "people": [{"name": "John Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243429%22"}, {"id": "fda:K243116", "company": "Integrity Implants Inc. Dba Accelus", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243116: FlareHawk Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243116", "people": [{"name": "Lauren Kamer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243116%22"}, {"id": "fda:K242857", "company": "Finemedix Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242857: ClearHemograsper", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242857", "people": [{"name": "Youn Jung Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242857%22"}, {"id": "fda:K242637", "company": "Mem Dental Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242637: MEM Clear Aligner System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242637", "people": [{"name": "Maggie Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242637%22"}, {"id": "fda:K250798", "company": "Tandem Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250798: Control-IQ+ technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250798", "people": [{"name": "Miriam Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250798%22"}, {"id": "fda:K242527", "company": "Spinal Elements, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242527: The Karma\u00ae Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242527", "people": [{"name": "Cheryl Allen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242527%22"}, {"id": "fda:K250493", "company": "Anx Robotica Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250493: MotiliCap GI Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250493", "people": [{"name": "Tim Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250493%22"}, {"id": "fda:K243793", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243793: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243793", "people": [{"name": "Deval Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243793%22"}, {"id": "fda:K243122", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243122: uMR Omega", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243122", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243122%22"}, {"id": "fda:K250528", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250528: Stryker AlphaVent\u0099 Knotless SP Biocomposite Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250528", "people": [{"name": "Matt Corbett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250528%22"}, {"id": "fda:K243762", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243762: Synapse 3D Base Tools (V7.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243762", "people": [{"name": "Kulkarni Chaitrali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243762%22"}, {"id": "fda:K243866", "company": "InVision Medical Technology Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243866: InVision Precision Cardiac Amyloid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243866", "people": [{"name": "David Ouyang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243866%22"}, {"id": "fda:K251276", "company": "Hyperfine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251276: Swoop\u00ae Portable MR Imaging\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251276", "people": [{"name": "Christine Kupchick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251276%22"}, {"id": "fda:K251230", "company": "Alma Lasers, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251230: The Alma Hybrid Laser System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251230", "people": [{"name": "Jessica Rivera-Montejo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251230%22"}, {"id": "fda:K251109", "company": "Ray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251109: SMARTDent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251109", "people": [{"name": "Soo Ji Huh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251109%22"}, {"id": "fda:K251239", "company": "Voco GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251239: GrandioSO Unlimited", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251239", "people": [{"name": "Katrin Froehlich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251239%22"}, {"id": "fda:K243302", "company": "Printbio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243302: 3DMatrix DynaFlex (DynaFlex)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243302", "people": [{"name": "Janet Vargo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243302%22"}, {"id": "breakthrough:K243866", "company": "Invision Medical Technology Corporation", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-05-21", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K243866: INVISION PRECISION CARDIAC AMYLOID", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R44CA298064-01", "company": "Rarecyte, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-20", "observed": "2026-08-21", "amount_usd": 658336, "summary": "NIH award 1R44CA298064-01: Adaptive imaging for pioneering multiplexed spatial profiling of tumors and tissues for cancer research and diagnosis ($658,336)", "source_url": "https://reporter.nih.gov/project-details/11066603", "people": [{"name": "Tad George", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH140643-01", "company": "Openmindxr LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-20", "observed": "2026-08-21", "amount_usd": 449729, "summary": "NIH award 1R43MH140643-01: Developing virtual reality programs to address social skills deficits in youth with ADHD ($449,729)", "source_url": "https://reporter.nih.gov/project-details/11186175", "people": [{"name": "Kevin Miller", "role": "Principal Investigator"}, {"name": "Zebulun Maxwell Wood", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06981481", "company": "Silimed Industria de Implantes Ltda", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction", "source_url": "https://clinicaltrials.gov/study/NCT06981481"}, {"id": "trialreg:NCT06979778", "company": "iamYiam Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Testing the Efficacy of the \"Syd\" App on Improving Quality of Life and Mental Health Among University Students in the Kingdom of Saudi Arabia", "source_url": "https://clinicaltrials.gov/study/NCT06979778"}, {"id": "trialreg:NCT06980766", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Philips Non-Invasive Blood Pressure Validation Study of VS30 Monitor", "source_url": "https://clinicaltrials.gov/study/NCT06980766"}, {"id": "fda:K250602", "company": "Expanding Innovations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250602: X-PAC\u00ae N-GAGE\u0099 Lumbar Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250602", "people": [{"name": "Robert Jaramillo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250602%22"}, {"id": "fda:K250199", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250199: VitalFlow Console", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250199", "people": [{"name": "Elizabeth Rose", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250199%22"}, {"id": "fda:K250866", "company": "Met One Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250866: Sovereign Posterior Cervical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250866", "people": [{"name": "Evan Carbonell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250866%22"}, {"id": "fda:K242485", "company": "Breas Medical AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242485: EveryWare", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242485", "people": [{"name": "Ivan Liljegren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242485%22"}, {"id": "fda:K250534", "company": "Aidite (Qinhuangdao) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250534: Biomic Color Opaque", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250534", "people": [{"name": "Zhanfu Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250534%22"}, {"id": "fda:K251231", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251231: ViewFlex\u0099 X ICE Catheter, Sensor Enabled\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251231", "people": [{"name": "Kyle Nevala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251231%22"}, {"id": "fda:K250370", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250370: SCENARIA View Phase 5.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250370", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250370%22"}, {"id": "fda:K250489", "company": "Keystone Industries", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250489: FP3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250489", "people": [{"name": "Autumn McClure", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250489%22"}, {"id": "fda:K250243", "company": "Flexicare Medical Limited.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250243: ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250243", "people": [{"name": "Rebecca Funston", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250243%22"}, {"id": "nih:5R41AI184218-02", "company": "L2 Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": 299862, "summary": "NIH award 5R41AI184218-02: Delivery of a candidate AgTRIOVx malaria vaccine by thermostable microneedle patches ($299,862)", "source_url": "https://reporter.nih.gov/project-details/11095978", "people": [{"name": "KAREN G. ANTHONY", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43ES037580-01", "company": "Framergy, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": 260993, "summary": "NIH award 1R43ES037580-01: A Novel Approach for the At Home Detection of PFAS in Drinking Water ($260,993)", "source_url": "https://reporter.nih.gov/project-details/11185206", "people": [{"name": "R. OSMAN K. OZDEMIR", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K242547", "company": "Resmed Pty , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242547: AirFit F20 Mask System; AirFit F20 NM Mask System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242547", "people": [{"name": "Lawrence Colin Kwan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242547%22"}, {"id": "fda:K243301", "company": "Vision Rt, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243301: MapRT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243301", "people": [{"name": "Watheq Al-Hakam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243301%22"}, {"id": "fda:K242755", "company": "Gigaalaser Company , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242755: Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242755", "people": [{"name": "Xinxing Nie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242755%22"}, {"id": "fda:K243643", "company": "Restor3D", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243643: restor3d Reverse Total Shoulder Arthroplasty System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243643", "people": [{"name": "Brianna Prindle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243643%22"}, {"id": "fda:K250390", "company": "Rowpar Pharmaceuticals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250390: CloSYS\u00ae Dry Mouth Sensitive Mouth Rinse", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250390", "people": [{"name": "Michael Tune", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250390%22"}, {"id": "fda:K243411", "company": "Nanjing Perlove Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243411: Diagnostic X-ray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243411", "people": [{"name": "Fengfang Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243411%22"}, {"id": "fda:K243601", "company": "Route 92 Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243601: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243601", "people": [{"name": "Kirsten Valley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243601%22"}, {"id": "fda:K250020", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250020: Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250020", "people": [{"name": "Wei Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250020%22"}, {"id": "fda:K250038", "company": "Zhengzhou PZ Laser Slim Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250038: Muscle Stimulator Device (PZ-100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250038", "people": [{"name": "Hongwei Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250038%22"}, {"id": "fda:K250456", "company": "Doc Brands, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250456: Dentemp Pro-Comfort Dental Guard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250456", "people": [{"name": "Sean Stubbs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250456%22"}, {"id": "fda:K250122", "company": "Splintek, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250122: SleepRight Snore Aid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250122", "people": [{"name": "Thomas Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250122%22"}, {"id": "fda:K250447", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250447: BD Phoenix\u0099 Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250447", "people": [{"name": "Kamisha Gray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250447%22"}, {"id": "sbir:DOD:FA2384-25-C-B034", "company": "Luna Labs USA LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-05-19", "observed": "2026-09-18", "amount_usd": 1699996, "summary": "DOD STTR Phase II award $1,699,996: ReadiPlex - Implantable Biosensor for Continuous Monitoring of Indicators of Human Performance", "source_url": "https://www.sbir.gov/awards?search=F23A-T002-0015"}, {"id": "sbir:DOD:FA2384-25-C-B035", "company": "Hedgefog Research Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-05-19", "observed": "2026-09-18", "amount_usd": 1699996, "summary": "DOD STTR Phase II award $1,699,996: Contact Lens Integrated Physiological Sensors", "source_url": "https://www.sbir.gov/awards?search=F23A-T003-0014"}, {"id": "trialreg:NCT06978842", "company": "Dux Healthcare Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Seizure Prediction Using Wearable EEG", "source_url": "https://clinicaltrials.gov/study/NCT06978842"}, {"id": "nih:3R44HL172444-01A1S1", "company": "Lasarrus Clinic And Research Center, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R44HL172444-01A1S1: Bilateral Acoustic Sensing and Automated Breathing Segmentation for Remote Monitoring of Patients with COPD: A Longitudinal Study ($55,000)", "source_url": "https://reporter.nih.gov/project-details/11269235", "people": [{"name": "Lloyd E Emokpae", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06974773", "company": "Samphire Group, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups", "source_url": "https://clinicaltrials.gov/study/NCT06974773"}, {"id": "trialreg:NCT06976723", "company": "Theranica", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Nerivio Efficacy by Time of Treatment Onset", "source_url": "https://clinicaltrials.gov/study/NCT06976723"}, {"id": "trialreg:NCT06975631", "company": "i+Med S.Coop.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-market Study on TrHCROSS\u00ae in Knee Osteoarthritis After a Single Injection", "source_url": "https://clinicaltrials.gov/study/NCT06975631"}, {"id": "trialreg:NCT06974760", "company": "Pulse Medical Imaging Technology (Shanghai) Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures", "source_url": "https://clinicaltrials.gov/study/NCT06974760"}, {"id": "trialreg:NCT06976697", "company": "Sooma Medical Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Home-Based tDCS Treatment Of Major Depressive Disorder", "source_url": "https://clinicaltrials.gov/study/NCT06976697"}, {"id": "trialreg:NCT06976086", "company": "Oticon Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pediatric Expansion Study of the Sentio System", "source_url": "https://clinicaltrials.gov/study/NCT06976086"}, {"id": "trialreg:NCT06975969", "company": "Liquet Medical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Single Center Post-Market Study of Thrombolytic Therapy Using the Versus\u2122 Catheter", "source_url": "https://clinicaltrials.gov/study/NCT06975969"}, {"id": "fda:K240554", "company": "Infervision Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240554: InferRead Lung CT.AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240554", "people": [{"name": "Matt Deng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240554%22"}, {"id": "fda:K250099", "company": "Varian Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250099: Mobius3D (4.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250099", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250099%22"}, {"id": "fda:K242706", "company": "Fujirebio Diagnostics,Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242706: Lumipulse G pTau217/\u00df-Amyloid 1-42 Plasma Ratio", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242706", "people": [{"name": "Stacey Dolan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242706%22"}, {"id": "fda:K244033", "company": "Shenzhen Desida Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244033: Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244033", "people": [{"name": "Shuangcheng Yuan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244033%22"}, {"id": "fda:K242731", "company": "Medicatech USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242731: MasteRad MiniX Mobile Digital Imaging System (Mini-X)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242731", "people": [{"name": "Theodor Gillebaard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242731%22"}, {"id": "fda:K241671", "company": "Esaote, S.p.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241671: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241671", "people": [{"name": "Alberto Carcagn\u00ec", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241671%22"}, {"id": "fda:K243602", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243602: Arthrex Spine Endoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243602", "people": [{"name": "Lai Saeteurn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243602%22"}, {"id": "fda:K250086", "company": "Ortoma AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250086: OTS Hip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250086", "people": [{"name": "Anders Hahn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250086%22"}, {"id": "fda:K243176", "company": "Cellah Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243176: BLESSING System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243176", "people": [{"name": "Priscilla Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243176%22"}, {"id": "fda:K242569", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242569: Mixed Reality Spine Navigation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242569", "people": [{"name": "Esther Moreno Garcia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242569%22"}, {"id": "fda:K243371", "company": "Byonyks Pvt, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243371: Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243371", "people": [{"name": "Eric Flachbart", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243371%22"}, {"id": "fda:K250141", "company": "Austin Medical Ventures, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250141: Synthecure Synthetic Calcium Sulfate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250141", "people": [{"name": "Austin Brian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250141%22"}, {"id": "fda:K243927", "company": "Waldemar Link GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243927: MobileLink Acetabular Cup System - inhouse coatings", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243927", "people": [{"name": "Stefanie Fuchs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243927%22"}, {"id": "fda:K243617", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243617: uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243617", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243617%22"}, {"id": "fda:K243837", "company": "Iorbit Digital Technologies Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243837: iBSM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243837", "people": [{"name": "Sandeep Zende", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243837%22"}, {"id": "fda:K250971", "company": "Biosphere Medical, S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250971: Embosphere Microspheres", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250971", "people": [{"name": "Rosene Amosse", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250971%22"}, {"id": "fda:K242585", "company": "SENTINEL CH. SpA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242585: Cystatin C", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242585", "people": [{"name": "Patricia Dup\u00e9", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242585%22"}, {"id": "fda:K242438", "company": "Breas Medical AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242438: Clearo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242438", "people": [{"name": "Ivan Liljegren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242438%22"}, {"id": "fda:K250110", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250110: Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250110", "people": [{"name": "Wei Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250110%22"}, {"id": "fda:K243105", "company": "Venocare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243105: Ruby Intravascular Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243105", "people": [{"name": "Raul Leyte-Vidal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243105%22"}, {"id": "fda:K244008", "company": "Philips Medical Systems Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244008: Spectral CT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244008", "people": [{"name": "Rachel Shalit", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244008%22"}, {"id": "fda:K251184", "company": "Encore Medical L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251184: AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251184", "people": [{"name": "Patricia Kontoudis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251184%22"}, {"id": "fda:K241581", "company": "Haolang Medical USA Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241581: Hemodialysis Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241581", "people": [{"name": "Lisa Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241581%22"}, {"id": "breakthrough:K242706", "company": "Fujirebio Diagnostics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-05-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K242706: LUMIPULSE G PTAU217/\u00df-AMYLOID 1-42 PLASMA RATIO", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R41AI186707-01A1", "company": "Priogen Corp", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": 314363, "summary": "NIH award 1R41AI186707-01A1: Microfluidic device for detection of infectious prion proteins ($314,363)", "source_url": "https://reporter.nih.gov/project-details/11180802", "people": [{"name": "Sang-Hyun Oh", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06972966", "company": "Artiria Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)", "source_url": "https://clinicaltrials.gov/study/NCT06972966"}, {"id": "trialreg:NCT06972953", "company": "Artiria Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I)", "source_url": "https://clinicaltrials.gov/study/NCT06972953"}, {"id": "trialreg:NCT06973031", "company": "Kardium Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe\u00ae Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT06973031"}, {"id": "trialreg:NCT06972589", "company": "Fisher and Paykel Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.", "source_url": "https://clinicaltrials.gov/study/NCT06972589"}, {"id": "fda:K242519", "company": "Philips Ultrasound", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242519: Lumify Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242519", "people": [{"name": "Sudipta Chakrabarti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242519%22"}, {"id": "fda:K243165", "company": "Eywa Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243165: Limfa Therapy System (Limfa Therapy)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243165", "people": [{"name": "Tommaso Faiella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243165%22"}, {"id": "fda:K250454", "company": "Hardy Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250454: HardyDisk Aztreonam/Avibactam 30/20\u00b5g (AZA50)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250454", "people": [{"name": "Lauren Hamilton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250454%22"}, {"id": "fda:K242518", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242518: Hypertension Prediction Index (HePI) Algorithm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242518", "people": [{"name": "Daphney Germain-Kolawole", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242518%22"}, {"id": "fda:K251186", "company": "C.R. Bard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251186: Bard\u00ae Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251186", "people": [{"name": "Caitlin Bowles", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251186%22"}, {"id": "fda:K242931", "company": "Mekics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242931: HFT750U", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242931", "people": [{"name": "Sang-Hag Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242931%22"}, {"id": "fda:K250276", "company": "Embolization, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250276: Nitinol Enhanced Device (NED)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250276", "people": [{"name": "James Kasic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250276%22"}, {"id": "fda:K242155", "company": "Nikkiso Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242155: DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242155", "people": [{"name": "Satoko Hina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242155%22"}, {"id": "fda:K251156", "company": "Guard Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251156: NPseal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251156", "people": [{"name": "Machiel van der Leest", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251156%22"}, {"id": "fda:K250432", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250432: Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250432", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250432%22"}, {"id": "fda:K250213", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250213: OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250213", "people": [{"name": "Dayana Manganese", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250213%22"}, {"id": "fda:K250444", "company": "Microport Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250444: NEXUS\u00ae Hip Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250444", "people": [{"name": "Hunter Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250444%22"}, {"id": "fda:K250451", "company": "Neuraxis", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250451: NeurAxis IB-Stim (01-1020)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250451", "people": [{"name": "Thomas Carrico", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250451%22"}, {"id": "fda:K242176", "company": "Nikkiso Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242176: BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242176", "people": [{"name": "Satoko Hina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242176%22"}, {"id": "fda:K240857", "company": "We Medical Technology (Wuxi) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240857: Youmagic FLM System (YM5-U1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240857", "people": [{"name": "Tianmin Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240857%22"}, {"id": "fda:K242479", "company": "Nikkiso Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242479: BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242479", "people": [{"name": "Satoko Hina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242479%22"}, {"id": "pma:P240004", "company": "Phraxis, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240004: EndoForce Connector for Endovascular Venous Anastomosis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240004", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240004%22"}, {"id": "nih:2R42NS112066-02", "company": "Microsurgical Innovations, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": 919846, "summary": "NIH award 2R42NS112066-02: Tacrolimus-eluting nerve guidance conduit for enhanced regeneration in critical-sized peripheral nerve injuries ($919,846)", "source_url": "https://reporter.nih.gov/project-details/11070031", "people": [{"name": "AZUR AZAPAGIC", "role": "Principal Investigator"}, {"name": "Jayant Prasad Agarwal", "role": "Principal Investigator"}, {"name": "Bruce Gale", "role": "Principal Investigator"}, {"name": "JILL E SHEA", "role": "Principal Investigator"}, {"name": "Himanshu Sant", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT06971796", "company": "Inspire Medical Systems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EURO-STIM Registry", "source_url": "https://clinicaltrials.gov/study/NCT06971796"}, {"id": "trialreg:NCT06970899", "company": "PATH EX, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Initial Feasibility Study of the CycloPE\u00ae Device", "source_url": "https://clinicaltrials.gov/study/NCT06970899"}, {"id": "trialreg:NCT06971835", "company": "Red Rock Regeneration Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: INDUCE: A Prospective 2-Year Spine Registry", "source_url": "https://clinicaltrials.gov/study/NCT06971835"}, {"id": "fda:K250712", "company": "Trax Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250712: Linkt Compression Staple System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250712", "people": [{"name": "Stephen Deane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250712%22"}, {"id": "fda:K250405", "company": "Theranica Bio-Electronics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250405: Nerivio; Nerivio Infinity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250405", "people": [{"name": "Alon Ironi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250405%22"}, {"id": "fda:K250533", "company": "Taizhou Reach Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250533: Magnesium alloy scooter (RS100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250533", "people": [{"name": "Rong Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250533%22"}, {"id": "fda:K250414", "company": "Tribun Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250414: CaloPix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250414", "people": [{"name": "Jean-Fran\u00e7ois Pomerol", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250414%22"}, {"id": "fda:K243830", "company": "Shenzhen Trious Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243830: Disposable ureteral stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243830", "people": [{"name": "Yingfang Yi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243830%22"}, {"id": "fda:K242437", "company": "Cube Click, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242437: Smile Dx\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242437", "people": [{"name": "Richard Ricci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242437%22"}, {"id": "fda:K250813", "company": "Ascensia Diabetes Care U.S., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250813: MICROLET\u00aeNEXT 2 Lancing Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250813", "people": [{"name": "Sangram Yadav", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250813%22"}, {"id": "fda:K250041", "company": "Zhengzhou PZ Laser Slim Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250041: Medical Picosecond ND: YAG Laser System (PZ-6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250041", "people": [{"name": "Junmei Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250041%22"}, {"id": "fda:K242624", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242624: Medical Image Post-processing Software (uOmnispace.CT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242624", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242624%22"}, {"id": "fda:K250420", "company": "Helios Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250420: Helios Dura Regeneration Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250420", "people": [{"name": "Yiannis Monovoukas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250420%22"}, {"id": "fda:K250835", "company": "Ethicon Endo-Surgery, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250835: ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250835", "people": [{"name": "Megan Westendorf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250835%22"}, {"id": "fda:K250775", "company": "Imperative Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250775: Symphony\u0099 Thrombectomy System; Symphony\u0099 16F 82cm Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250775", "people": [{"name": "Vida Sollanek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250775%22"}, {"id": "fda:K251288", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251288: Veincare", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251288", "people": [{"name": "Hyunsik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251288%22"}, {"id": "fda:K242072", "company": "Ceraroot SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242072: CeraRoot TL Implant System (TL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242072", "people": [{"name": "Josep Oliva-Ochoa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242072%22"}, {"id": "pma:P240037", "company": "Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240037: VENTANA MET (SP44) RxDx Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240037", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240037%22"}, {"id": "nih:5R44AR083316-02", "company": "Myolex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-13", "observed": "2026-08-21", "amount_usd": 963608, "summary": "NIH award 5R44AR083316-02: Convenient quantification of myopathic change in muscle via electrical impedance myography ($963,608)", "source_url": "https://reporter.nih.gov/project-details/11112443", "people": [{"name": "David P. Dickinson", "role": "Principal Investigator"}, {"name": "Pushpa Narayanaswami", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43DA054867-01A1S1", "company": "See Yourself Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-13", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43DA054867-01A1S1: The Chiron Project: ICORP PROGRAM ($55,000)", "source_url": "https://reporter.nih.gov/project-details/11269392", "people": [{"name": "Maxwell Lee Drascher", "role": "Principal Investigator"}, {"name": "Suzanne Mitchell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44AG087872-02", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-13", "observed": "2026-08-21", "amount_usd": 1245833, "summary": "NIH award 4R44AG087872-02: Developing an Integrated Brain State Monitor for Personalized Anesthesia Decision Support: Preventing Postoperative Delirium in Elderly and Patients At Risk for Alzheimer's or Related Dementias ($1,245,833)", "source_url": "https://reporter.nih.gov/project-details/11273457", "people": [{"name": "David Arney", "role": "Principal Investigator"}, {"name": "Tuan Le Mau", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42EY031628-03", "company": "Unar Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-13", "observed": "2026-08-21", "amount_usd": 775623, "summary": "NIH award 5R42EY031628-03: STTR Phase II - Development of a visual-to-tactile conversion system for automating the tactile graphic generation process ($775,623)", "source_url": "https://reporter.nih.gov/project-details/11062457", "people": [{"name": "Hari Prasath Palani", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06968845", "company": "Rein Therapeutics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis", "source_url": "https://clinicaltrials.gov/study/NCT06968845"}, {"id": "trialreg:NCT06968494", "company": "Comphya Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction", "source_url": "https://clinicaltrials.gov/study/NCT06968494"}, {"id": "trialreg:NCT06968221", "company": "Shanghai Cingularbio Co. Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Bovine Reinforcement in Stomach, Colorectal and Lung Operation", "source_url": "https://clinicaltrials.gov/study/NCT06968221"}, {"id": "trialreg:NCT06968364", "company": "Ultrasound-Innovation Medtech, S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FB-CT2 Includes Two Prospective, Multi-centre Studies With a Medical Device in Hospital Settings: a Randomized, Dual-arm, Open-label Pilot Study in Spain, Followed by a Single-arm, Non-randomized, Open-label International Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT06968364"}, {"id": "trialreg:NCT06968741", "company": "UroMems SAS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Assess the Safety and Effectiveness of the UrOActive\u00ae Artificial Urinary sPHincter (AUS)", "source_url": "https://clinicaltrials.gov/study/NCT06968741"}, {"id": "trialreg:NCT06967129", "company": "Johnson & Johnson Vision Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process", "source_url": "https://clinicaltrials.gov/study/NCT06967129"}, {"id": "trialreg:NCT06968026", "company": "Shenyang Jinghua Hospital", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Right Prefrontal Autonomic Mapping in Recurrent Pregnancy Loss With Comorbid Anxiety", "source_url": "https://clinicaltrials.gov/study/NCT06968026"}, {"id": "fda:K251138", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251138: Promisemed Safety Huber Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251138", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251138%22"}, {"id": "fda:K242762", "company": "Aesculap, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242762: Aesculap Aicon\u00ae Series Container System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242762", "people": [{"name": "Hamza Ahmed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242762%22"}, {"id": "fda:K250418", "company": "Ulthera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250418: Ulthera System (UC-1 Control Unit PRIME Model 2.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250418", "people": [{"name": "Christopher Lefancheck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250418%22"}, {"id": "fda:K242808", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242808: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242808", "people": [{"name": "Biggins Paul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242808%22"}, {"id": "fda:K242674", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242674: Freedom Posterior Cervical Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242674", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242674%22"}, {"id": "fda:K250786", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250786: SP Endoscope, 0\u00b0 (430600)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250786", "people": [{"name": "Kunal Gunjal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250786%22"}, {"id": "nih:2R44NS117294-04", "company": "Noctrix Health, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": 515503, "summary": "NIH award 2R44NS117294-04: Developing closed-loop tonic motor activation therapy for treatment of refractory restless legs syndrome ($515,503)", "source_url": "https://reporter.nih.gov/project-details/11064926", "people": [{"name": "Jonathan David Charlesworth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43HD117484-01", "company": "Noma AI Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": 305292, "summary": "NIH award 1R43HD117484-01: A Real-time, Automated Maternal Hemorrhage Risk Assessment Platform Using Artificial Intelligence ($305,292)", "source_url": "https://reporter.nih.gov/project-details/11067518", "people": [{"name": "Salim Malakouti", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K250393", "company": "United Zirconia", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250393: ZircaGlow & ZircaGlow HT Zirconia", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250393", "people": [{"name": "Kanal Ebeid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250393%22"}, {"id": "fda:K244050", "company": "Apyx Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244050: AYON Body Contouring System (AYON SYSTEM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244050", "people": [{"name": "Angela Huber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244050%22"}, {"id": "fda:K243632", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243632: uWS-Angio Basic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243632", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243632%22"}, {"id": "fda:K250763", "company": "C.E.I.B.Med", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250763: Reon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250763", "people": [{"name": "Hyo jeong Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250763%22"}, {"id": "fda:K250431", "company": "Shandong Moonlight Electronics Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250431: Medical Diode Laser Hair Removal System (MNLT-D1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250431", "people": [{"name": "Jvqiang Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250431%22"}, {"id": "fda:K242477", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242477: Shoulder Soft Tissue Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242477", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242477%22"}, {"id": "fda:K250592", "company": "Northeast Scientific, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250592: NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250592", "people": [{"name": "Matthew Farley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250592%22"}, {"id": "fda:K243509", "company": "3D-Side", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243509: Archer PSI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243509", "people": [{"name": "Florence All\u00e9", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243509%22"}, {"id": "fda:K242418", "company": "P-Cure, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242418: P-Cure Proton Therapy System (PPTS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242418", "people": [{"name": "Ori Lubin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242418%22"}, {"id": "fda:K250421", "company": "Inari Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250421: InThrill\u0099 Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250421", "people": [{"name": "Ellen Nguyen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250421%22"}, {"id": "fda:K250868", "company": "Heidelberg Engineering GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250868: SPECTRALIS HRA+OCT and variants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250868", "people": [{"name": "Arianna Schoess Vargas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250868%22"}, {"id": "trialreg:NCT06965140", "company": "Coloplast A/S", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CP376 OCT Exploratory Skin Study", "source_url": "https://clinicaltrials.gov/study/NCT06965140"}, {"id": "trialreg:NCT06965582", "company": "ALPFA Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System", "source_url": "https://clinicaltrials.gov/study/NCT06965582"}, {"id": "trialreg:NCT06965504", "company": "Abiomed Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery", "source_url": "https://clinicaltrials.gov/study/NCT06965504"}, {"id": "fda:K250360", "company": "Shenzhen Jiantuo Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250360: TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250360", "people": [{"name": "Jin Liang Zou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250360%22"}, {"id": "fda:K250377", "company": "ACON Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250377: Flowflex Plus COVID-19 + Flu A/B Home Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250377", "people": [{"name": "Catherine Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250377%22"}, {"id": "nih:2R44ES035657-02A1", "company": "Scitovation, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": 973277, "summary": "NIH award 2R44ES035657-02A1: Triage of Developmental and Reproductive Toxicants using an In vitro to In Vivo Extrapolation (IVIVE)-Toxicokinetic Computational modeling Application ($973,277)", "source_url": "https://reporter.nih.gov/project-details/11184606", "people": [{"name": "Todor Antonijevic", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41MH141906-01", "company": "Spike Neuro LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": 233825, "summary": "NIH award 1R41MH141906-01: The development of a flexible carbon fiber penetrating nerve cuff and cortical array for neural recording, stimulation, and neurochemical detection ($233,825)", "source_url": "https://reporter.nih.gov/project-details/11175132", "people": [{"name": "Aidan Boyer", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06964048", "company": "Plasana Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Cold Plasma in Chronic Wound Healing", "source_url": "https://clinicaltrials.gov/study/NCT06964048"}, {"id": "trialreg:NCT06963879", "company": "Braingaze", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation Study of a New Digital Diagnostic and Treatment Test Based on Interactive Video Games for Alzheimer's Disease", "source_url": "https://clinicaltrials.gov/study/NCT06963879"}, {"id": "trialreg:NCT06964685", "company": "Abiomed Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessment of Support With Impella\u00ae Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock", "source_url": "https://clinicaltrials.gov/study/NCT06964685"}, {"id": "fda:K251126", "company": "Iterative Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251126: SKOUT system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251126", "people": [{"name": "Caitlyn Seidl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251126%22"}, {"id": "fda:K243107", "company": "Dongguan Yanxuan Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243107: Water Solubility Human Body Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243107", "people": [{"name": "Wang Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243107%22"}, {"id": "fda:K242294", "company": "Diasys Diagnostic Systems GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242294: DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242294", "people": [{"name": "Jan Gorka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242294%22"}, {"id": "fda:K250053", "company": "Shenzhen Jiantuo Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250053: TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250053", "people": [{"name": "Jinliang Zou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250053%22"}, {"id": "fda:K241086", "company": "Avidhrt, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241086: Avidhrt Sense SpO2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241086", "people": [{"name": "Prabode Weebadde", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241086%22"}, {"id": "fda:K243230", "company": "Pearl, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243230: Second Opinion\u00ae BLE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243230", "people": [{"name": "William Birdsall", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243230%22"}, {"id": "fda:K243290", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243290: BTL-785MJ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243290", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243290%22"}, {"id": "fda:K250758", "company": "Changshu Pingfang Wheelchair Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250758: Electric Wheelchair (F309)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250758", "people": [{"name": "Jian Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250758%22"}, {"id": "fda:K251103", "company": "Philips Image Guided Therapy Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251103: VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251103", "people": [{"name": "Travis Pittman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251103%22"}, {"id": "fda:K242392", "company": "Crossroads Neurovascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242392: PATH BGC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242392", "people": [{"name": "Ryan Breckenridge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242392%22"}, {"id": "fda:K242732", "company": "Tristel Solutions , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242732: Tristel OPH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242732", "people": [{"name": "Julija Shabanova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242732%22"}, {"id": "fda:K242388", "company": "Bonraybio Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242388: LensHooke X12 PRO Semen Analysis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242388", "people": [{"name": "Clare Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242388%22"}, {"id": "fda:DEN240045", "company": "Teal Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240045: Teal Wand", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240045", "people": [{"name": "Trena Depel", "role": "510(k) submission contact"}]}, {"id": "fda:K251425", "company": "Mectron S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251425: turbodent touch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251425", "people": [{"name": "Chiara Acunzo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251425%22"}, {"id": "fda:K243812", "company": "Volta Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243812: Volta AF-Xplorer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243812", "people": [{"name": "Paola Milpied", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243812%22"}, {"id": "fda:K251110", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251110: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251110", "people": [{"name": "Vera Kong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251110%22"}, {"id": "fda:K250400", "company": "Vigeon Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250400: Vigeon Laparoscopic Universal Smoke Evacuator (VG003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250400", "people": [{"name": "Liang Tong Kuo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250400%22"}, {"id": "fda:K242692", "company": "Capillary Biomedical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242692: SteadiSet Infusion Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242692", "people": [{"name": "Kristina Nistler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242692%22"}, {"id": "fda:K243322", "company": "Altaviz, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243322: Altaviz Intravitreal Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243322", "people": [{"name": "James Lescoulie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243322%22"}, {"id": "fda:K250299", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250299: CT/ MR Tandem and Ovoid Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250299", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250299%22"}, {"id": "denovo:DEN240045", "company": "Teal Health, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-05-09", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240045 granted: Teal Wand", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240045"}, {"id": "breakthrough:DEN240045", "company": "Teal Health, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-05-09", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN240045: TEAL WAND", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44AI181347-02", "company": "Inhalon Biopharma, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": 1024879, "summary": "NIH award 5R44AI181347-02: IND-enabling development for IN-003, an inhaled mAb therapy against human metapneumovirus infection ($1,024,879)", "source_url": "https://reporter.nih.gov/project-details/11089428", "people": [{"name": "JEFF T HUTCHINS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41DE034646-01", "company": "Deep Reasoning AI Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": 350000, "summary": "NIH award 1R41DE034646-01: Deep Reasoning AI Virtual Anatomical Technology & Augmented Reasoning Platform: Application to Craniomaxillofacial Reconstruction ($350,000)", "source_url": "https://reporter.nih.gov/project-details/11069219", "people": [{"name": "Di Chen", "role": "Principal Investigator"}, {"name": "Jonathan M Morris", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06962345", "company": "Mucosa Innovations, S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.", "source_url": "https://clinicaltrials.gov/study/NCT06962345"}, {"id": "trialreg:NCT06962371", "company": "Transverse Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)", "source_url": "https://clinicaltrials.gov/study/NCT06962371"}, {"id": "trialreg:NCT06961448", "company": "Samyang Biopharmaceuticals Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study in Adults Evaluating Polycaprolactone Microsphere Filler for Treatment of Moderate to Severe Nasolabial Folds", "source_url": "https://clinicaltrials.gov/study/NCT06961448"}, {"id": "trialreg:NCT06963138", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparative Study and Validation of New Methodologies for Measuring Addition", "source_url": "https://clinicaltrials.gov/study/NCT06963138"}, {"id": "fda:K250582", "company": "CG Bio Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250582: COLONNADE Posterior Screw Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250582", "people": [{"name": "Suwon Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250582%22"}, {"id": "fda:K243110", "company": "Suntech UK , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243110: eFOLDi Navigator Powerchair (STPC-A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243110", "people": [{"name": "Jinfeng Ning", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243110%22"}, {"id": "fda:K243226", "company": "Leltek, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243226: Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243226", "people": [{"name": "Paul Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243226%22"}, {"id": "fda:K251133", "company": "Telesair, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251133: AVEA disposable expiratory filter/water trap (11790)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251133", "people": [{"name": "Don Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251133%22"}, {"id": "fda:K242670", "company": "Philips Ultrasound", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242670: Lumify Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242670", "people": [{"name": "Sudipta Chakrabarti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242670%22"}, {"id": "fda:K243824", "company": "Preat Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243824: Preat Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243824", "people": [{"name": "Nicholas Grassel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243824%22"}, {"id": "fda:K250226", "company": "Clarius Mobile Health Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250226: Clarius Median Nerve AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250226", "people": [{"name": "Agatha Szeliga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250226%22"}, {"id": "fda:K243419", "company": "Altus Partners, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243419: Altus Spine Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243419", "people": [{"name": "Rand Baker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243419%22"}, {"id": "fda:K243764", "company": "Wuhan Pioon Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243764: Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243764", "people": [{"name": "Feng Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243764%22"}, {"id": "fda:K233271", "company": "Synoross Dba Osseone", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233271: OsseOne Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233271", "people": [{"name": "Gennady Shapiro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233271%22"}, {"id": "fda:K250482", "company": "Fissiontech, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250482: Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250482", "people": [{"name": "Mike Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250482%22"}, {"id": "fda:K242410", "company": "Nextstep Arthropedix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242410: NextStep Arthropedix Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242410", "people": [{"name": "Garrett Spurgeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242410%22"}, {"id": "nih:1R44CA297977-01", "company": "5 Point App", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-07", "observed": "2026-08-21", "amount_usd": 1019587, "summary": "NIH award 1R44CA297977-01: Decentralized Clinical Trial of Effectiveness of EnergyPoints App to Guide Acupressure Use for Fatigue and Sleep Disturbances in Cancer Survivors ($1,019,587)", "source_url": "https://reporter.nih.gov/project-details/11062928", "people": [{"name": "SUSAN L BECK", "role": "Principal Investigator"}, {"name": "MELANIE Ariane GOLD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS129521-04", "company": "Turing Medical Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-07", "observed": "2026-08-21", "amount_usd": 1500000, "summary": "NIH award 5R44NS129521-04: Behavioral feedback and rewards for improving functional brain mapping in presurgical pediatric patients ($1,500,000)", "source_url": "https://reporter.nih.gov/project-details/11117053", "people": [{"name": "Damien A Fair", "role": "Principal Investigator"}, {"name": "Kevin King", "role": "Principal Investigator"}, {"name": "Jarod Roland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43GM157838-01", "company": "Virginia Diodes, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-07", "observed": "2026-08-21", "amount_usd": 299996, "summary": "NIH award 1R43GM157838-01: Solid-State Sources for DNP-NMR ($299,996)", "source_url": "https://reporter.nih.gov/project-details/11068673", "people": [{"name": "Alisa Leavesley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06961305", "company": "Institute Hyalual GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Post-Marketing Study of Alexa Medium for \u0421orrection of the Lips Volume Loss", "source_url": "https://clinicaltrials.gov/study/NCT06961305"}, {"id": "trialreg:NCT06960018", "company": "Aesculap AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate\u00ae Method for Pedicle Screw Placement", "source_url": "https://clinicaltrials.gov/study/NCT06960018"}, {"id": "trialreg:NCT06959862", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ACURATE Enhance Post Market Study", "source_url": "https://clinicaltrials.gov/study/NCT06959862"}, {"id": "trialreg:NCT06960239", "company": "ENTire Medical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of the Irreversible Electroporation (IRE) System for Adenotonsillar Hypertrophy in Children", "source_url": "https://clinicaltrials.gov/study/NCT06960239"}, {"id": "trialreg:NCT06959836", "company": "Braile Biomedica Ind. Com. e Repr. Ltda.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-market Safety and Performance Outcomes of the VIVERE\u00ae Bovine Pericardial Bioprosthetic Valve", "source_url": "https://clinicaltrials.gov/study/NCT06959836"}, {"id": "trialreg:NCT06960785", "company": "Carl Zeiss Meditec AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser", "source_url": "https://clinicaltrials.gov/study/NCT06960785"}, {"id": "fda:K242975", "company": "Wuyi Aichi Industry & Trade Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242975: Mobility Scooter (Model X-01, X-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242975", "people": [{"name": "Wei Lyu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242975%22"}, {"id": "fda:K251111", "company": "Excitus AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251111: Cary", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251111", "people": [{"name": "\u00d8ystein Refseth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251111%22"}, {"id": "fda:K250222", "company": "Belport Company, Inc., Gingi-Pak", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250222: SDF Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250222", "people": [{"name": "Peng Jingtian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250222%22"}, {"id": "fda:K243684", "company": "Brightheart", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243684: BrightHeart View Classifier", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243684", "people": [{"name": "Christophe Gardella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243684%22"}, {"id": "fda:K251128", "company": "Extremity Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251128: Extremity Medical External Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251128", "people": [{"name": "Mary Hoffman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251128%22"}, {"id": "fda:K243776", "company": "Zeus Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243776: Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243776", "people": [{"name": "Mark Kopnitsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243776%22"}, {"id": "nih:5R44AG082621-03", "company": "Evon Medics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-06", "observed": "2026-08-21", "amount_usd": 1249244, "summary": "NIH award 5R44AG082621-03: Development and Evaluation of Portable Compendium of Psychophysical and Physiological Tests for Alzheimer's Disease and Related Dementias (ADRD) ($1,249,244)", "source_url": "https://reporter.nih.gov/project-details/11143916", "people": [{"name": "Charles Chiedu Nwaokobia", "role": "Principal Investigator"}, {"name": "Evaristus A Nwulia", "role": "Principal Investigator"}, {"name": "Vamsi Reddy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06958237", "company": "Langsteiner sp. z o.o.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Salicylic Acid Wart Patch for the Treatment of Common Warts and Plantar Warts", "source_url": "https://clinicaltrials.gov/study/NCT06958237"}, {"id": "trialreg:NCT06959524", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions", "source_url": "https://clinicaltrials.gov/study/NCT06959524"}, {"id": "trialreg:NCT06959121", "company": "Pulse Biosciences, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CellFX\u00ae Nanosecond Pulsed Field Ablation (nsPFA)\u2122 Cardiac Surgery Clamp System to Treat Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT06959121"}, {"id": "trialreg:NCT06959277", "company": "RxFunction Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems", "source_url": "https://clinicaltrials.gov/study/NCT06959277"}, {"id": "fda:K250253", "company": "Dongguan Boyuan Intelligent Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250253: IPL Hair Removal Device (KCA511/KCA516/KCA522)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250253", "people": [{"name": "JinLong Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250253%22"}, {"id": "fda:K251094", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251094: Alma Veil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251094", "people": [{"name": "Hyun Sik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251094%22"}, {"id": "fda:K241980", "company": "Solutions For Tomorrow AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241980: !M1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241980", "people": [{"name": "Martin Yngvesson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241980%22"}, {"id": "fda:K250785", "company": "Hunan Vathin Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250785: Single-use Flexible Ureteroscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250785", "people": [{"name": "Charlene Du", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250785%22"}, {"id": "fda:K243017", "company": "Foshan Newface Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243017: IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243017", "people": [{"name": "Jiazhen Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243017%22"}, {"id": "fda:K250160", "company": "Mentice Spain S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250160: ANKYRAS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250160", "people": [{"name": "H\u00e9ctor Fern\u00e1ndez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250160%22"}, {"id": "trialreg:NCT06957847", "company": "Withings", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 (WIHYP-GP)", "source_url": "https://clinicaltrials.gov/study/NCT06957847"}, {"id": "fda:K242962", "company": "Philips Medizin Systeme B\u00f6blingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242962: Telemetry Monitor 5500 Release 4.0 (867232)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242962", "people": [{"name": "Mary Couch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242962%22"}, {"id": "fda:K240447", "company": "Thermasolutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240447: ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240447", "people": [{"name": "Rhea Johny", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240447%22"}, {"id": "fda:K243893", "company": "Pearl, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243893: Second Opinion\u00ae Pediatric", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243893", "people": [{"name": "Ashley Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243893%22"}, {"id": "fda:K243370", "company": "Asiga Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243370: DentaTOOTH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243370", "people": [{"name": "Justin Elsey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243370%22"}, {"id": "fda:K242754", "company": "Zamar Medical D.O.O.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242754: ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242754", "people": [{"name": "Gianmarco Zanotti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242754%22"}, {"id": "fda:K243603", "company": "Aevice Health Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243603: AeviceMD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243603", "people": [{"name": "Adrian Ang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243603%22"}, {"id": "fda:K242937", "company": "Dae Myung Chemical Co., Ltd. (Vietnam)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242937: Dream Medi Sterile Surgical Gown (SurgicalGownUL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242937", "people": [{"name": "Tri Do Minh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242937%22"}, {"id": "fda:K250728", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250728: Arthrex Synergy Vision Endoscopic Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250728", "people": [{"name": "Lai Saeteurn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250728%22"}, {"id": "fda:K242386", "company": "Genoss Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242386: Bluemoon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242386", "people": [{"name": "Jiyeon Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242386%22"}, {"id": "trialreg:NCT06957730", "company": "Sonova AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Comparison of Hearing Aid Noise Programs on Speech Intelligibility", "source_url": "https://clinicaltrials.gov/study/NCT06957730"}, {"id": "trialreg:NCT06956209", "company": "Iota Biosciences, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Akyva First In Human", "source_url": "https://clinicaltrials.gov/study/NCT06956209"}, {"id": "nih:4R44HL169034-02", "company": "3dt Holdings, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": 1065759, "summary": "NIH award 4R44HL169034-02: Software-guided Operative Planning of MitraClip Placement ($1,065,759)", "source_url": "https://reporter.nih.gov/project-details/11294378", "people": [{"name": "Julius Matteo Guccione", "role": "Principal Investigator"}, {"name": "GHASSAN S KASSAB", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43HL172397-01S1", "company": "Mosaic Engineering LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43HL172397-01S1: Programmable Microfluidic Perfusion Bioreactor for 3D Organoid Culture and Screening Applications ($55,000)", "source_url": "https://reporter.nih.gov/project-details/11270625", "people": [{"name": "Frank Myers", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06954766", "company": "Chong Kun Dang Pharmaceutical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981", "source_url": "https://clinicaltrials.gov/study/NCT06954766"}, {"id": "trialreg:NCT06955273", "company": "Corsano Health B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System", "source_url": "https://clinicaltrials.gov/study/NCT06955273"}, {"id": "trialreg:NCT06956105", "company": "Neurovalens Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety in Adolescents", "source_url": "https://clinicaltrials.gov/study/NCT06956105"}, {"id": "trialreg:NCT06955429", "company": "Septodont", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine\u2122 XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.", "source_url": "https://clinicaltrials.gov/study/NCT06955429"}, {"id": "trialreg:NCT06956118", "company": "Neurovalens Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients", "source_url": "https://clinicaltrials.gov/study/NCT06956118"}, {"id": "trialreg:NCT06955936", "company": "Efferon JSC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction", "source_url": "https://clinicaltrials.gov/study/NCT06955936"}, {"id": "trialreg:NCT06955793", "company": "Takeda", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Expanded Access to TAK-881 for People With Primary Immunodeficiency Diseases in the USA and Czech Republic", "source_url": "https://clinicaltrials.gov/study/NCT06955793"}, {"id": "fda:K242986", "company": "Beijing Rongrui-Century Science & Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242986: SpO2 Extension Cable", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242986", "people": [{"name": "Zhenghua Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242986%22"}, {"id": "fda:K251071", "company": "Brightheart", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251071: Fetal EchoScan (v1.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251071", "people": [{"name": "Christophe Gardella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251071%22"}, {"id": "fda:K244014", "company": "Abbott Point of Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244014: i-STAT CG4+ cartridge with the i-STAT 1 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244014", "people": [{"name": "Brian Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244014%22"}, {"id": "fda:K243069", "company": "Intradys", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243069: LUMYS (V1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243069", "people": [{"name": "Tiffany VAZ", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243069%22"}, {"id": "fda:K243894", "company": "Sg Endoscopy Pte, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243894: F88 URE-SD/RD Flexible Ureteroscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243894", "people": [{"name": "John Yeng Jie Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243894%22"}, {"id": "fda:K250629", "company": "Hathor Professional Skincare , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250629: Sutil Rich Personal Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250629", "people": [{"name": "Carolyn (Mellta) Swift", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250629%22"}, {"id": "fda:K242583", "company": "Atsens Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242583: AT-Patch (ATP-C130/ATP-C70)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242583", "people": [{"name": "KeonHoon Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242583%22"}, {"id": "fda:K243114", "company": "Medical Electronic Systems , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243114: SQA-iOw Sperm Quality Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243114", "people": [{"name": "Taly Vider Cohen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243114%22"}, {"id": "fda:K243828", "company": "Cionic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243828: CIONIC NEURAL SLEEVE (NS-200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243828", "people": [{"name": "Mihai Ionescu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243828%22"}, {"id": "fda:K243043", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243043: Origin\u0099 Cemented Hip Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243043", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243043%22"}, {"id": "fda:K251048", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251048: Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251048", "people": [{"name": "Steven Deline", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251048%22"}, {"id": "fda:K243457", "company": "Seriously Clean, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243457: Nixall Antimicrobial Solutions\u0099 Skin & Wound Hydrogel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243457", "people": [{"name": "Kip Glass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243457%22"}, {"id": "fda:K250161", "company": "Shenzhen AOJ Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250161: Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250161", "people": [{"name": "Jack Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250161%22"}, {"id": "fda:K242763", "company": "Pfm Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242763: JetCan\u00ae Pro Safety Huber Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242763", "people": [{"name": "Jessica Jho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242763%22"}, {"id": "fda:K251056", "company": "Momentis Surgical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251056: Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251056", "people": [{"name": "Maya Leib Shlomo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251056%22"}, {"id": "fda:K243757", "company": "Shockwave Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243757: Shockwave CS Guide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243757", "people": [{"name": "Renee Maack", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243757%22"}, {"id": "fda:K250292", "company": "Skydance Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250292: OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250292", "people": [{"name": "Scott Pease", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250292%22"}, {"id": "fda:K244001", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244001: KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244001", "people": [{"name": "Thomas Ostrowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244001%22"}, {"id": "nih:5R44HD097809-06", "company": "Reia, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": 995757, "summary": "NIH award 5R44HD097809-06: Non-surgical treatment option for pelvic organ prolapse ($995,757)", "source_url": "https://reporter.nih.gov/project-details/11084311", "people": [{"name": "Paul Hanissian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "trialreg:NCT06952894", "company": "Hutom Corp", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility of RUS Lung in MITS", "source_url": "https://clinicaltrials.gov/study/NCT06952894"}, {"id": "trialreg:NCT06952816", "company": "Aether Tech S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-05-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation Study of the EMILY AI Device in Acute and Chronic Respiratory Failure", "source_url": "https://clinicaltrials.gov/study/NCT06952816"}, {"id": "fda:K250641", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250641: APEX 3D Total Ankle Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250641", "people": [{"name": "Edward Wells-Spicer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250641%22"}, {"id": "fda:K250996", "company": "Cepheid\u00ae", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250996: Xpert Xpress CoV-2/Flu/RSV plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250996", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250996%22"}, {"id": "fda:K242315", "company": "United Orthopedic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242315: Resolve Modular Revision Hip Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242315", "people": [{"name": "Lois Ho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242315%22"}, {"id": "fda:K243521", "company": "BioHorizons Implant Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243521: Conical Ti Base abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243521", "people": [{"name": "Jared Cooper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243521%22"}, {"id": "fda:K250296", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250296: Disposable Distal Attachment D-201 Series", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250296", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250296%22"}, {"id": "fda:K250087", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250087: Vscan Air", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250087", "people": [{"name": "Lee Bush", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250087%22"}, {"id": "fda:K251014", "company": "Alembic, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251014: APRO 45 Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251014", "people": [{"name": "Stina Almaleh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251014%22"}, {"id": "fda:K251007", "company": "Circa Scientific, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251007: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251007", "people": [{"name": "Jennifer Willner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251007%22"}, {"id": "fda:K243870", "company": "Traferox Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243870: X\u00b0Port Lung Preservation System; X\u00b0Port Lung Preservation Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243870", "people": [{"name": "Anuradha Iyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243870%22"}, {"id": "fda:K244020", "company": "Shenzhen Qianyu Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244020: Wrinkle Treatment Device (JM1, JM2B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244020", "people": [{"name": "Guoyang Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244020%22"}, {"id": "fda:K250995", "company": "Cepheid\u00ae", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250995: Xpert Xpress CoV-2/Flu/RSV plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250995", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250995%22"}, {"id": "fda:K250029", "company": "Innovative Sterilization Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250029: ONE TRAY\u00ae Sealed Sterilization Container System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250029", "people": [{"name": "Walter Oko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250029%22"}, {"id": "nih:5R44NS125892-03", "company": "Axonova Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": 1099609, "summary": "NIH award 5R44NS125892-03: Development of Tissue Engineered Neuromuscular Interfaces from GalSafe Neurons ($1,099,609)", "source_url": "https://reporter.nih.gov/project-details/11077850", "people": [{"name": "Kritika Katiyar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06951685", "company": "Xeltis", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT06951685"}, {"id": "trialreg:NCT06951724", "company": "BrosMed Medical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Coronary Aspiration Catheter Clinical Trial", "source_url": "https://clinicaltrials.gov/study/NCT06951724"}, {"id": "trialreg:NCT06951672", "company": "Valcare Medical Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AMEND TS Early Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT06951672"}, {"id": "trialreg:NCT06952439", "company": "Origin Medical Systems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Performance Evaluation of the Artificial Intelligence (AI)/ Machine Learning (ML) Technologies Utilized by the Origin Medical EXAM ASSISTANT", "source_url": "https://clinicaltrials.gov/study/NCT06952439"}, {"id": "trialreg:NCT06951178", "company": "Materialise", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Long-term Safety and Performance of Materialise's Patient-specific TMJ System.", "source_url": "https://clinicaltrials.gov/study/NCT06951178"}, {"id": "fda:K250295", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250295: Dentsply Sirona Titanium Bases system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250295", "people": [{"name": "Laura Sobrin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250295%22"}, {"id": "fda:K250907", "company": "Sol-Millennium Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250907: Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250907", "people": [{"name": "Mike Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250907%22"}, {"id": "fda:K250328", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250328: UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250328", "people": [{"name": "Orlando Tadeo Jr.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250328%22"}, {"id": "fda:K251051", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251051: AuST Steerable Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251051", "people": [{"name": "Conner Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251051%22"}, {"id": "fda:K250497", "company": "Aidite (Qinhuangdao) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250497: Additive Manufacturing (Light Curing) Crown Bridge Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250497", "people": [{"name": "Zhanfu Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250497%22"}, {"id": "fda:K250274", "company": "Biomerieux S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250274: ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250274", "people": [{"name": "Sophie Quiblier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250274%22"}, {"id": "fda:K250683", "company": "Optain Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250683: Resolve Fundus Camera", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250683", "people": [{"name": "Emilia Gonzalez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250683%22"}, {"id": "fda:K243934", "company": "Nexus Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243934: Stable-L Lumbar Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243934", "people": [{"name": "Jared Crocker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243934%22"}, {"id": "fda:K243942", "company": "Medivance, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243942: Arctic Sun Stat Temperature Management System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243942", "people": [{"name": "Lauren Valdes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243942%22"}, {"id": "fda:K251015", "company": "Alembic, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251015: APRO 45 Catheter and Alembic Aspiration Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251015", "people": [{"name": "Stina Almaleh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251015%22"}, {"id": "fda:K244000", "company": "Shenzhen AOJ Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244000: Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244000", "people": [{"name": "Jack Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244000%22"}, {"id": "fda:K250282", "company": "A.T.S. Applicazione Tecnologie Speciali S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250282: Persona C HR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250282", "people": [{"name": "Francesca Pedretti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250282%22"}, {"id": "fda:K243541", "company": "Contra Healthcare Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243541: LumiRex Bronchoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243541", "people": [{"name": "John O'Conner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243541%22"}, {"id": "fda:K251024", "company": "Haemonetics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251024: TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251024", "people": [{"name": "Erica Molaro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251024%22"}, {"id": "pma:P230022", "company": "Element Science, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230022: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230022", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230022%22"}, {"id": "nih:5R44AG071409-04", "company": "Trace-ability, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": 1499998, "summary": "NIH award 5R44AG071409-04: Enabling nationwide AD PET imaging to support most efficient clinical trials by adoption of radically simplified and standardized quality control in commercial production of AD PET tracers. ($1,499,998)", "source_url": "https://reporter.nih.gov/project-details/11163546", "people": [{"name": "Arkadij Elizarov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43MD020239-01", "company": "See Yourself Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": 385816, "summary": "NIH award 1R43MD020239-01: Mirame Salud: Immersive Diabetes Self-Management Training for Latino Americans ($385,816)", "source_url": "https://reporter.nih.gov/project-details/11066046", "people": [{"name": "Ronald Irwin Harris", "role": "Principal Investigator"}, {"name": "Suzanne Mitchell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06949969", "company": "Photonica USA, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Alesis OSA-1 Obstructive Sleep Apnea Treatment", "source_url": "https://clinicaltrials.gov/study/NCT06949969"}, {"id": "trialreg:NCT06948773", "company": "Sight Sciences, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)", "source_url": "https://clinicaltrials.gov/study/NCT06948773"}, {"id": "trialreg:NCT06948591", "company": "CONMED Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BioBrace\u00ae Augmentation in Anterior Cruciate Ligament Reconstruction Procedures", "source_url": "https://clinicaltrials.gov/study/NCT06948591"}, {"id": "trialreg:NCT06950021", "company": "Sirius Medical Systems B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-29", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety & Performance of CANOpus PINtuition Surgical Marker Navigation", "source_url": "https://clinicaltrials.gov/study/NCT06950021"}, {"id": "fda:K250308", "company": "Dongguan Boyuan Intelligent Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250308: Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250308", "people": [{"name": "Jinlong Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250308%22"}, {"id": "fda:K250962", "company": "Alembic, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250962: APRO 55 Intermediate Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250962", "people": [{"name": "Lisa Yen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250962%22"}, {"id": "fda:K242354", "company": "Enchant Tek Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242354: AllNEB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242354", "people": [{"name": "Ling Leonard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242354%22"}, {"id": "fda:K242211", "company": "Coaptech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242211: PUMA-G Pediatric System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242211", "people": [{"name": "Jack Kent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242211%22"}, {"id": "fda:K250069", "company": "Comfort Rubber Gloves Industries Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250069: Powder Free Natural Rubber Latex Examination Gloves \u0096 Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250069", "people": [{"name": "Sumathi Saravana Sami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250069%22"}, {"id": "fda:K242495", "company": "Teleflex Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242495: LMA Fastrach ETT SU", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242495", "people": [{"name": "Irma Govea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242495%22"}, {"id": "fda:K250617", "company": "Sprintray, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250617: Apex Flex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250617", "people": [{"name": "Sara Moghtadernejad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250617%22"}, {"id": "fda:K243886", "company": "Inrad, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243886: ExpressCore Biopsy Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243886", "people": [{"name": "Heidi Halverson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243886%22"}, {"id": "fda:K242255", "company": "Medex", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242255: Qitexio\u00ae 4-Way Stopcock (QIT014)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242255", "people": [{"name": "Guylaine Casses", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242255%22"}, {"id": "fda:K243963", "company": "OrthoPediatrics Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243963: Pediatric Plating Platform Hip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243963", "people": [{"name": "Yan Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243963%22"}, {"id": "nih:4R44GM156142-02", "company": "Gmj Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": 1597901, "summary": "NIH award 4R44GM156142-02: High-Resolution Native Capillary Zone Electrophoresis with Inline UV and Native Mass Spectrometry for Characterizing Charge Variants in Biologics ($1,597,901)", "source_url": "https://reporter.nih.gov/project-details/11142793", "people": [{"name": "Oluwatosin Dada", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HD117450-01", "company": "Lumina Medical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": 384923, "summary": "NIH award 1R43HD117450-01: Innovative Vaginal Girth Adjustable Dilator with Precise Dilation Monitoring, designed to Significantly Improve Patient Pain Management in Pelvic Floor Disorder Treatment ($384,923)", "source_url": "https://reporter.nih.gov/project-details/11067421", "people": [{"name": "BENJAMIN JAYOL", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM160998-01", "company": "Kasa Bio, L.l.c.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": 345285, "summary": "NIH award 1R43GM160998-01: A probe-based higher order multiplex technology to expand the capacity of digital PCR systems ($345,285)", "source_url": "https://reporter.nih.gov/project-details/11183168", "people": [{"name": "Kiran Madanahally Divakar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K250958", "company": "Alembic, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250958: APRO 55 Swift Catheter and Alembic Aspiration Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250958", "people": [{"name": "Lisa Yen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250958%22"}, {"id": "fda:K243532", "company": "Contra Healthcare Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243532: LumiRex Ureteroscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243532", "people": [{"name": "John O'Conner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243532%22"}, {"id": "fda:K243896", "company": "Alcon Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243896: LenSx Laser System (8065998162)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243896", "people": [{"name": "Tammy Vu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243896%22"}, {"id": "fda:K250977", "company": "Suturion AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250977: Suture-TOOL System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250977", "people": [{"name": "Paan Hermansson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250977%22"}, {"id": "fda:K242951", "company": "Beijing Nubway S&T Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242951: Diode laser hair removal machine (QDTM-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242951", "people": [{"name": "Xiting Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242951%22"}, {"id": "fda:K243376", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243376: uAngio AVIVA CX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243376", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243376%22"}, {"id": "fda:K241663", "company": "Eminent Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241663: Eminent Spine 3D Titanium Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241663", "people": [{"name": "Stephen Courtney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241663%22"}, {"id": "fda:K250158", "company": "Zhe Jiang Cleisman Industry and Trade Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250158: Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250158", "people": [{"name": "Chongjie Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250158%22"}, {"id": "fda:K250256", "company": "Aventamed Dac", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250256: Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250256", "people": [{"name": "Keith Jansen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250256%22"}, {"id": "fda:K250030", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250030: Flash Ultrasound System 5100 Point of Care", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250030", "people": [{"name": "Irma Sandoval-Watt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250030%22"}, {"id": "trialreg:NCT06947447", "company": "Itamar-Medical, Israel", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: WatchPAT SpO2 Validation Study", "source_url": "https://clinicaltrials.gov/study/NCT06947447"}, {"id": "fda:K251101", "company": "Cro, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251101: AIRO Suction Unit (AIRO-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251101", "people": [{"name": "Jeffrey Boardman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251101%22"}, {"id": "nih:3R41HD113429-01A1S1", "company": "Neocare Innovations, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R41HD113429-01A1S1: Pedi-Sync: A Clinical Decision Support Tool to Improve Oral Feeding Outcomes in Preterm Infants ($55,000)", "source_url": "https://reporter.nih.gov/project-details/11260394", "people": [{"name": "Caryn Bradley", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MD019604-02", "company": "One Cow Standing, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": 985366, "summary": "NIH award 5R44MD019604-02: The HMP Next Gen digital health platform: accelerating research implementation, amplifying public health impact ($985,366)", "source_url": "https://reporter.nih.gov/project-details/11172639", "people": [{"name": "Nickie Buckner", "role": "Principal Investigator"}, {"name": "Lisa B Hightow-Weidman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R41AI181135-02", "company": "Luna Bioscience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": 299631, "summary": "NIH award 5R41AI181135-02: Leptospiral VM Protein Antigen Detection for Rapid Diagnosis of Leptospirosis ($299,631)", "source_url": "https://reporter.nih.gov/project-details/11085136", "people": [{"name": "Reetika Chaurasia", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI141283-05", "company": "Prothera Biologics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": 971267, "summary": "NIH award 5R44AI141283-05: Rapid Test to Assist Therapy in Neonatal Sepsis and Necrotizing Enterocolitis ($971,267)", "source_url": "https://reporter.nih.gov/project-details/11076833", "people": [{"name": "YOW-PIN LIM", "role": "Principal Investigator"}, {"name": "James F Padbury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "trialreg:NCT06945809", "company": "Hangzhou Endonom Medtech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)", "source_url": "https://clinicaltrials.gov/study/NCT06945809"}, {"id": "trialreg:NCT06944951", "company": "Biokosmes Srl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of PROCTOeze\u00ae PLUS", "source_url": "https://clinicaltrials.gov/study/NCT06944951"}, {"id": "trialreg:NCT06945640", "company": "Hutom Corp", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability", "source_url": "https://clinicaltrials.gov/study/NCT06945640"}, {"id": "trialreg:NCT06944509", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: RADIQAL Study (Radiation Dose and Image Quality Trial)", "source_url": "https://clinicaltrials.gov/study/NCT06944509"}, {"id": "trialreg:NCT06944405", "company": "Precordior Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Implementation for Heart Failure Therapies Post-discharge Followed by CardiOSIgnal at HOME", "source_url": "https://clinicaltrials.gov/study/NCT06944405"}, {"id": "trialreg:NCT06944834", "company": "Shanghai StairMed Technology Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation", "source_url": "https://clinicaltrials.gov/study/NCT06944834"}, {"id": "fda:K243264", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243264: DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243264", "people": [{"name": "Martina Carlini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243264%22"}, {"id": "fda:K243570", "company": "Siemens Healthcare Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243570: Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243570", "people": [{"name": "Yevgenia Sarkisian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243570%22"}, {"id": "fda:K243861", "company": "Compact Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243861: butterflyBVM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243861", "people": [{"name": "Jonathan Merrell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243861%22"}, {"id": "fda:K250554", "company": "Centinel Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250554: prodisc\u00ae L Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250554", "people": [{"name": "Jessica Staub", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250554%22"}, {"id": "fda:K250046", "company": "Shenzhen Urion Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250046: Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250046", "people": [{"name": "Janice Ou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250046%22"}, {"id": "fda:K250426", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250426: Amulet\u0099 Steerable Delivery Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250426", "people": [{"name": "Meghann Kayoum", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250426%22"}, {"id": "fda:K243721", "company": "Wellmed Dental Medical Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243721: Self Sealing Sterilization Pouches", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243721", "people": [{"name": "Renxian Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243721%22"}, {"id": "fda:K243821", "company": "A.M.I. Agency For Medical Innovations GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243821: i-Cut", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243821", "people": [{"name": "Anke Ristow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243821%22"}, {"id": "fda:K243082", "company": "Guangzhou Daxin Health Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243082: Infrared Thermometer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243082", "people": [{"name": "LuPeng Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243082%22"}, {"id": "fda:K250289", "company": "Varian Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250289: Intracavitary/Interstitial System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250289", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250289%22"}, {"id": "fda:K243855", "company": "Carefusion 303, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243855: BD Alaris Infusion System with Guardrails Suite MX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243855", "people": [{"name": "Darin Oppenheimer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243855%22"}, {"id": "fda:K242469", "company": "Agnes Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242469: RFMagik Lite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242469", "people": [{"name": "Heui Kyeong Pak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242469%22"}, {"id": "fda:K250909", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250909: Prelude Wave Hydrophilic Sheath Introducer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250909", "people": [{"name": "Niloufar Samimi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250909%22"}, {"id": "fda:K242321", "company": "EchoNous, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242321: Kosmos", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242321", "people": [{"name": "Joshua Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242321%22"}, {"id": "fda:K250723", "company": "Cardio Flow Inc.,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250723: FreedomFlow\u0099 Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250723", "people": [{"name": "Michael Kallok", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250723%22"}, {"id": "fda:K244026", "company": "Microaire Surgical Instruments, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244026: PAL 7020 Console", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244026", "people": [{"name": "Glenn Gerstenfeld", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244026%22"}, {"id": "fda:K243876", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243876: VERIFY STEAM Integrating Indicator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243876", "people": [{"name": "Logan Persons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243876%22"}, {"id": "fda:K251075", "company": "Promethean Restorative, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251075: DYNAMIS\u0099 Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251075", "people": [{"name": "Glenn Bowman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251075%22"}, {"id": "fda:K250153", "company": "Neuhealth Digital , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250153: Neu Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250153", "people": [{"name": "Giovanni Maggi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250153%22"}, {"id": "fda:K243998", "company": "Institut Geroges Lopez", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243998: DCX Disposable Cassette (DCX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243998", "people": [{"name": "Prouteau Matthieu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243998%22"}, {"id": "fda:K243406", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243406: cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243406", "people": [{"name": "Sumedha Sinha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243406%22"}, {"id": "fda:K250892", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250892: CastleLoc Pectus Bar System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250892", "people": [{"name": "Kihayng Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250892%22"}, {"id": "fda:K243400", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243400: cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243400", "people": [{"name": "Sumedha Sinha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243400%22"}, {"id": "fda:K250608", "company": "Mako Surgical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250608: Mako Total Knee Application (3.0); Hybrid Tip Pointer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250608", "people": [{"name": "Shikha Khandelwal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250608%22"}, {"id": "fda:K251117", "company": "4Web Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251117: Cervical Spine Truss System (CSTS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251117", "people": [{"name": "Jonathan Hires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251117%22"}, {"id": "fda:K243041", "company": "Bhm-Tech Produktionsgesellschaft Mbh", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243041: contact forte Alpha", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243041", "people": [{"name": "Markus Hirtzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243041%22"}, {"id": "nih:5R44AI109891-08", "company": "Dxdiscovery, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": 989461, "summary": "NIH award 5R44AI109891-08: Point-of-care lateral flow immunoassay for diagnosis of pertussis ($989,461)", "source_url": "https://reporter.nih.gov/project-details/11084549", "people": [{"name": "Amanda Burnham-Marusich", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 8, "new_award": false}, {"id": "nih:5R44CA250663-03", "company": "Crosslife Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": 994439, "summary": "NIH award 5R44CA250663-03: Point of Care HPV 16/18/45 DNA Test for Cervical Cancer ($994,439)", "source_url": "https://reporter.nih.gov/project-details/10930943", "people": [{"name": "HyunDae Cho", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DA057122-03", "company": "Evidence-based Practice Institute, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": 1181728, "summary": "NIH award 5R44DA057122-03: iKinnect Mobile Technology to Reduce Teen Substance Misuse and Health Disparities ($1,181,728)", "source_url": "https://reporter.nih.gov/project-details/11077888", "people": [{"name": "Linda A Dimeff", "role": "Principal Investigator"}, {"name": "Cindy M. Schaeffer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06941610", "company": "Erchonia Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity", "source_url": "https://clinicaltrials.gov/study/NCT06941610"}, {"id": "trialreg:NCT06942338", "company": "Corsano Health B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 287-2 in an Intensive Care Setting.", "source_url": "https://clinicaltrials.gov/study/NCT06942338"}, {"id": "trialreg:NCT06942325", "company": "HearX SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance and Effectiveness of a Self-fitting Over-the-counter Hearing Aid", "source_url": "https://clinicaltrials.gov/study/NCT06942325"}, {"id": "trialreg:NCT06942949", "company": "Avvio Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial", "source_url": "https://clinicaltrials.gov/study/NCT06942949"}, {"id": "fda:K243239", "company": "Exo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243239: Lung AI (LAI001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243239", "people": [{"name": "Murray Jacqueline", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243239%22"}, {"id": "fda:K243945", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243945: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243945", "people": [{"name": "Guilherme Pires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243945%22"}, {"id": "fda:K243954", "company": "Circa Scientific, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243954: PeriCross\u0099 Epicardial Access Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243954", "people": [{"name": "Alice Ouyang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243954%22"}, {"id": "fda:K242514", "company": "Shenzhen Rogin Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242514: Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242514", "people": [{"name": "Salon Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242514%22"}, {"id": "fda:K250116", "company": "Shenzhen AOJ Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250116: Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250116", "people": [{"name": "Jack Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250116%22"}, {"id": "fda:K242973", "company": "Canwell Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242973: CanMINI Hand and Foot System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242973", "people": [{"name": "Hui Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242973%22"}, {"id": "fda:K250206", "company": "Ivylaser (Beijing) Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250206: Diode laser system (Night Universe; Predator)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250206", "people": [{"name": "Yuan Xiujuan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250206%22"}, {"id": "fda:K250183", "company": "Zhuozhou Summer Star Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250183: CO2 Laser System (CO2 Laser SST-L23)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250183", "people": [{"name": "Lei Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250183%22"}, {"id": "fda:K250002", "company": "Life Spark Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250002: Smart Check O2 (MA0236)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250002", "people": [{"name": "Darryl Zitting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250002%22"}, {"id": "fda:K242214", "company": "Sound Health Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242214: Sonu", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242214", "people": [{"name": "Parameswaran Gopi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242214%22"}, {"id": "fda:K243714", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243714: da Vinci SP Surgical System (SP1098)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243714", "people": [{"name": "Mike Yramategui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243714%22"}, {"id": "fda:K250262", "company": "Go-Pen Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250262: GO-PEN\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250262", "people": [{"name": "Ole Nielsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250262%22"}, {"id": "fda:K242963", "company": "Mentor Worldwide, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242963: MENTOR\u0099 PliaForm\u0099 Breast Tissue Expander w/ Suture Tabs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242963", "people": [{"name": "Alicia Botham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242963%22"}, {"id": "fda:K233337", "company": "Freespira, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233337: Freespira Breathing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233337", "people": [{"name": "Thomas Simon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233337%22"}, {"id": "nih:5R44OD036187-02", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": 996377, "summary": "NIH award 5R44OD036187-02: High-content behavioral phenotyping of model organisms in three dimensions with a gigapixel microscope ($996,377)", "source_url": "https://reporter.nih.gov/project-details/11087562", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DC018760-03", "company": "Restorear Devices, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": 892211, "summary": "NIH award 5R44DC018760-03: Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss ($892,211)", "source_url": "https://reporter.nih.gov/project-details/11090523", "people": [{"name": "Curtis Scott King", "role": "Principal Investigator"}, {"name": "Suhrud M. Rajguru", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06939686", "company": "Reprise Biomedical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing", "source_url": "https://clinicaltrials.gov/study/NCT06939686"}, {"id": "trialreg:NCT06939946", "company": "Optosurgical, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)", "source_url": "https://clinicaltrials.gov/study/NCT06939946"}, {"id": "trialreg:NCT06940648", "company": "Virtuoso Surgical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Virtuoso Improving Anatomic Bladder Lesion Excision (VIABLE) Trial", "source_url": "https://clinicaltrials.gov/study/NCT06940648"}, {"id": "trialreg:NCT06939634", "company": "Wandercraft", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia", "source_url": "https://clinicaltrials.gov/study/NCT06939634"}, {"id": "trialreg:NCT06939907", "company": "Next Biomedical Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder\u2122 for Diverticular Bleeding in the Lower Gastrointestinal Tract", "source_url": "https://clinicaltrials.gov/study/NCT06939907"}, {"id": "trialreg:NCT06939673", "company": "Reprise Biomedical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care", "source_url": "https://clinicaltrials.gov/study/NCT06939673"}, {"id": "trialreg:NCT06940765", "company": "GID BIO, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-23", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Post COVID-19", "source_url": "https://clinicaltrials.gov/study/NCT06940765"}, {"id": "fda:K250697", "company": "Shenzhen Kingboom Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250697: Electric Nasal Aspirator (BC026, BC025, BC023)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250697", "people": [{"name": "Qiang Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250697%22"}, {"id": "fda:K250155", "company": "Newclip Technics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250155: Xpert Knee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250155", "people": [{"name": "Ga\u00eblle Gourbi\u00e8re", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250155%22"}, {"id": "fda:K243479", "company": "Sonavex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243479: EchoGuide (Version 1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243479", "people": [{"name": "Ralph Del Negro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243479%22"}, {"id": "fda:K250198", "company": "Laon Medi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250198: Laon Ortho", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250198", "people": [{"name": "Mina Yun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250198%22"}, {"id": "fda:K243697", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243697: MySpine WebPlanner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243697", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243697%22"}, {"id": "fda:K250944", "company": "Gmp Medicare Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250944: Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250944", "people": [{"name": "Ummi Salmah Othman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250944%22"}, {"id": "fda:K243326", "company": "LEM Surgical AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243326: Dynamis Robotic Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243326", "people": [{"name": "Yossi Bar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243326%22"}, {"id": "fda:K242531", "company": "Hycor Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242531: NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242531", "people": [{"name": "Aashrey Kaul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242531%22"}, {"id": "fda:K250228", "company": "Esonic Technology (Wuhan) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250228: eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250228", "people": [{"name": "Souquet Jacques", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250228%22"}, {"id": "fda:K250869", "company": "Sofradim Production", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250869: Parietene\u0099 Macroporous Mesh (PPM5050 )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250869", "people": [{"name": "Jhony Mallet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250869%22"}, {"id": "fda:K242232", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242232: Mpact 3D Metal Augments II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242232", "people": [{"name": "Baj Stefano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242232%22"}, {"id": "fda:K250831", "company": "Annalise-Ai", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250831: Annalise Enterprise", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250831", "people": [{"name": "Haylee Bosshard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250831%22"}, {"id": "trialreg:NCT06939491", "company": "Gymna Uniphy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparison of Ultrasound-guided Electrolysis Therapy vs. Sham Electrolysis in Patients With Patellar Tendinopathy: A Prospective Randomized Study Including MRI and Shear-wave Ultrasound Elastography Imaging", "source_url": "https://clinicaltrials.gov/study/NCT06939491"}, {"id": "trialreg:NCT06939374", "company": "Cryotherapeutics SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT06939374"}, {"id": "trialreg:NCT06938399", "company": "Motiva USA LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Motiva Implants\u00ae Post-Approval Study", "source_url": "https://clinicaltrials.gov/study/NCT06938399"}, {"id": "trialreg:NCT06937216", "company": "Baxter Healthcare Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production", "source_url": "https://clinicaltrials.gov/study/NCT06937216"}, {"id": "trialreg:NCT06937242", "company": "Hanger Institute for Clinical Research and Education, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators", "source_url": "https://clinicaltrials.gov/study/NCT06937242"}, {"id": "trialreg:NCT06938854", "company": "Shockwave Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-22", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal Arteries", "source_url": "https://clinicaltrials.gov/study/NCT06938854"}, {"id": "fda:K243343", "company": "Bd Integrated Diagnostic Solutions/Becton,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243343: BD CTGCTV2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243343", "people": [{"name": "Teresa Jennifer Sugumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243343%22"}, {"id": "fda:K243944", "company": "Goodman Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243944: Aperta NSE PTA Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243944", "people": [{"name": "Kanechika Aida", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243944%22"}, {"id": "fda:K242247", "company": "Jeil Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242247: ARIX Femur Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242247", "people": [{"name": "Dajung Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242247%22"}, {"id": "fda:K250669", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250669: Adaptix\u0099 Interbody System with Titan nanoLOCK\u0099 Surface Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250669", "people": [{"name": "Alicia Goins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250669%22"}, {"id": "fda:K243386", "company": "Acuity Surgical Devices, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243386: Ventris Intervertebral Body Fusion Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243386", "people": [{"name": "Chuck Forton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243386%22"}, {"id": "fda:K241931", "company": "Ocusciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241931: OcuMet Beacon (OCUB100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241931", "people": [{"name": "Kurt Riegger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241931%22"}, {"id": "fda:K242542", "company": "Medentika GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242542: Medentika CAD/CAM Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242542", "people": [{"name": "Tobias Ludwig", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242542%22"}, {"id": "fda:K243621", "company": "Evoden Ind\u00fastria Com\u00e9rcio Importa\u00e7\u00e3o E Exporta\u00e7\u00e3o", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243621: Evoblock, Perl\u00e9on", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243621", "people": [{"name": "J\u00e9ssica Augusto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243621%22"}, {"id": "pma:P240036", "company": "Medtronic, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240036: OmniaSecure\u0099 MRI SureScan\u0099 Lead Model 3930M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240036", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240036%22"}, {"id": "breakthrough:P240036", "company": "Medtronic, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-04-22", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P240036: OMNIASECURE MRI SURESCAN LEAD MODEL 3930M", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44GM143996-04", "company": "Infotech Soft, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-21", "observed": "2026-08-21", "amount_usd": 346252, "summary": "NIH award 5R44GM143996-04: Deep-CDS: Deep Learning Semantic Data Lake for Clinical Decision Support ($346,252)", "source_url": "https://reporter.nih.gov/project-details/11045748", "people": [{"name": "Mansur R. Kabuka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K251196", "company": "Ec Certification Service GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K251196: Composite Orthodontic Brackets and Buttons", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251196", "people": [{"name": "Elisabeth Moschik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K251196%22"}, {"id": "fda:K242254", "company": "Dk Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242254: D\u00b7Kutting\u0099 LL Peripheral Scoring Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242254", "people": [{"name": "Quan Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242254%22"}, {"id": "fda:K250176", "company": "D.A.N.D. Metal Industries North, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250176: DAND Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250176", "people": [{"name": "Yossi Nahon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250176%22"}, {"id": "fda:K243875", "company": "Spectrum Antimicrobials, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243875: Spectricept Skin and Wound Cleanser", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243875", "people": [{"name": "Hoji Alimi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243875%22"}, {"id": "fda:K243508", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243508: Wearable breast pump (model S12A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243508", "people": [{"name": "Peter Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243508%22"}, {"id": "fda:K243651", "company": "GE Medical Systems SCS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243651: VersaViewer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243651", "people": [{"name": "Peter Uhlir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243651%22"}, {"id": "fda:K243383", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243383: CHIKAI Nexus 014", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243383", "people": [{"name": "Katsuhiko Fujimura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243383%22"}, {"id": "trialreg:NCT06935383", "company": "CorFlow Therapeutics AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Randomised EValuation of Therapies for microvAscuLar Injury in STEACS", "source_url": "https://clinicaltrials.gov/study/NCT06935383"}, {"id": "trialreg:NCT06936176", "company": "Shanghai Bluesail Boyuan Medical Technology Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)", "source_url": "https://clinicaltrials.gov/study/NCT06936176"}, {"id": "trialreg:NCT06935591", "company": "Vektor Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study", "source_url": "https://clinicaltrials.gov/study/NCT06935591"}, {"id": "trialreg:NCT06936449", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array", "source_url": "https://clinicaltrials.gov/study/NCT06936449"}, {"id": "trialreg:NCT06935266", "company": "Takeda", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults", "source_url": "https://clinicaltrials.gov/study/NCT06935266"}, {"id": "nih:5R44HL142491-03", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": 1002895, "summary": "NIH award 5R44HL142491-03: A Novel, Low-Cost Mobile Metabolic Measurement (M3) System ($1,002,895)", "source_url": "https://reporter.nih.gov/project-details/11078330", "people": [{"name": "Brian R Clark", "role": "Principal Investigator"}, {"name": "B EUGENE PARKER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06934980", "company": "Incyte Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate Microneedle-based Collection of Dermal Interstitial Skin Fluid in Healthy Participants and Atopic Dermatitis Participants", "source_url": "https://clinicaltrials.gov/study/NCT06934980"}, {"id": "trialreg:NCT06934005", "company": "UNEEG Medical A/S", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II", "source_url": "https://clinicaltrials.gov/study/NCT06934005"}, {"id": "trialreg:NCT06934135", "company": "NeuroThera DE", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Trial of Transcranial Photobiomodulation for Depression With PET and EEG Outcomes", "source_url": "https://clinicaltrials.gov/study/NCT06934135"}, {"id": "trialreg:NCT06933420", "company": "Cern Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Protocol CERN Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT06933420"}, {"id": "trialreg:NCT06934486", "company": "C. R. Bard", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection", "source_url": "https://clinicaltrials.gov/study/NCT06934486"}, {"id": "fda:K242170", "company": "Kamiya Biomedical Company, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242170: K-ASSAY CRP (Ver.2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242170", "people": [{"name": "Shawn Kaplan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242170%22"}, {"id": "fda:K250146", "company": "Sofwave Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250146: SofWave System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250146", "people": [{"name": "Ruthie Amir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250146%22"}, {"id": "fda:K250224", "company": "iSMART Developments, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250224: handLITE (TN19S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250224", "people": [{"name": "Susan D'Arcy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250224%22"}, {"id": "fda:K250834", "company": "Zimmer Biomet", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250834: Zimmer Biomet Ceramic Heads (22.2mm diameter)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250834", "people": [{"name": "Sean Gleason", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250834%22"}, {"id": "fda:K243734", "company": "Allengers Medical Systems Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243734: Wireless/ Wired X-Ray Flat Panel Detectors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243734", "people": [{"name": "Sanjeev K. Marjara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243734%22"}, {"id": "fda:K250459", "company": "Technoflex Sas.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250459: DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250459", "people": [{"name": "Dominique Saint Ellier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250459%22"}, {"id": "fda:K250481", "company": "SKY Medical, a.s.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250481: Extension Feeding Set with ENFit\u0099 Connectors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250481", "people": [{"name": "Yulia Surinova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250481%22"}, {"id": "fda:K241188", "company": "SEKISUI Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241188: Acucy\u00ae Influenza A&B Test with the Acucy\u00ae 2 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241188", "people": [{"name": "Craig Jolicoeur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241188%22"}, {"id": "fda:K250842", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250842: PADLOCK CLIP EFTR Kit (00713229)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250842", "people": [{"name": "Jackie Oliver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250842%22"}, {"id": "fda:K243013", "company": "Luminex Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243013: LIAISON PLEX Gram-Negative Blood Culture Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243013", "people": [{"name": "Sheri Calderon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243013%22"}, {"id": "fda:K240355", "company": "Carrtech Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240355: FROG (Filter Removal of Glass)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240355", "people": [{"name": "Sue Carr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240355%22"}, {"id": "fda:K240775", "company": "Tamabio", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240775: PeriBeam\u00ae Pericardial Membrane", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240775", "people": [{"name": "Tetsuya Nagao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240775%22"}, {"id": "fda:K241996", "company": "Ecoray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241996: ULTRA 1040", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241996", "people": [{"name": "Haeri Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241996%22"}, {"id": "nih:2R44HD107718-02", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": 925658, "summary": "NIH award 2R44HD107718-02: Virtual Activities of Living for Occupational Rehabilitation ($925,658)", "source_url": "https://reporter.nih.gov/project-details/11066116", "people": [{"name": "Richard J. Adams", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R43AI181303-02", "company": "Orlance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 5R43AI181303-02: Gene Gun-delivered RNA vaccines. ($300,000)", "source_url": "https://reporter.nih.gov/project-details/11083760", "people": [{"name": "Hannah Frizzell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44DC022498-01", "company": "Estenda Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": 1372201, "summary": "NIH award 1R44DC022498-01: Hub4Smell: Advancing Human Olfactory Research through Digital Innovation and Community Engagement ($1,372,201)", "source_url": "https://reporter.nih.gov/project-details/11068524", "people": [{"name": "Richard Kedziora", "role": "Principal Investigator"}, {"name": "Patricia Lucas-Schnarre", "role": "Principal Investigator"}, {"name": "Valentina Parma", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:6R44DA056316-03", "company": "Lc Acquisition LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": 803562, "summary": "NIH award 6R44DA056316-03: Compact Liquid Chromatography for Routine Screening in Drug Treatment Centers ($803,562)", "source_url": "https://reporter.nih.gov/project-details/11293196", "people": [{"name": "MILTON L. LEE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K242056", "company": "Benq Materials Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242056: miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242056", "people": [{"name": "Eric Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242056%22"}, {"id": "fda:K250829", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250829: Lacevo Wearable Breast Pump (Model S70)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250829", "people": [{"name": "Xiaoyan Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250829%22"}, {"id": "fda:DEN240062", "company": "Epi-Minder Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240062: Minder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240062", "people": [{"name": "Tracy Cameron", "role": "510(k) submission contact"}]}, {"id": "fda:K243460", "company": "Brain Ultimate, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243460: Ultimate rTMS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243460", "people": [{"name": "Frank Ge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243460%22"}, {"id": "fda:K250499", "company": "Alcresta Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250499: RELiZORB (100300/100301)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250499", "people": [{"name": "Daniel Orlando", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250499%22"}, {"id": "fda:K242129", "company": "Vitalconnect, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242129: VitalRhythm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242129", "people": [{"name": "Gabriel Nallathambi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242129%22"}, {"id": "fda:K250270", "company": "Coloplast Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250270: Luja Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250270", "people": [{"name": "Vallabha Tantry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250270%22"}, {"id": "fda:K243750", "company": "Envision Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243750: SimpleStitch Suturing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243750", "people": [{"name": "Azadeh Khanicheh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243750%22"}, {"id": "fda:K250455", "company": "Fluoptics Sas (A Getinge Group Company}", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250455: FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250455", "people": [{"name": "Marion Boudet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250455%22"}, {"id": "fda:K242337", "company": "Imds Operations B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242337: FlowGuide (FG60F); GuidionShort (GS60F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242337", "people": [{"name": "Edwin Schulting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242337%22"}, {"id": "fda:K250889", "company": "Corentec Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250889: EXULT Knee Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250889", "people": [{"name": "Sanghee Seo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250889%22"}, {"id": "fda:K243878", "company": "Carl Zeiss Meditec, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243878: CLARUS (700)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243878", "people": [{"name": "Tanesha Bland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243878%22"}, {"id": "fda:K243337", "company": "Yofo Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243337: Dental Cone Beam Computed Tomography System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243337", "people": [{"name": "li Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243337%22"}, {"id": "fda:K243459", "company": "Brain Ultimate, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243459: Ultimate rTMS for OCD (M-series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243459", "people": [{"name": "Frank Ge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243459%22"}, {"id": "fda:K242992", "company": "RaySearch Laboratories AB (PUBL)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242992: RayCare (2024A SP1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242992", "people": [{"name": "Olympiada Lachana", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242992%22"}, {"id": "denovo:DEN240062", "company": "Epi-Minder Pty, Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-04-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240062 granted: Minder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240062"}, {"id": "breakthrough:DEN240062", "company": "Epi-minder Pty Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-04-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN240062: MINDER SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:4R44TR005137-02", "company": "Cellchorus Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": 984242, "summary": "NIH award 4R44TR005137-02: Integrated assays of single-cell dynamics and molecular phenotype for cell therapy manufacturing ($984,242)", "source_url": "https://reporter.nih.gov/project-details/11179716", "people": [{"name": "Rebecca L Berdeaux", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL178364-01", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": 413595, "summary": "NIH award 1R43HL178364-01: Magnetic Rotational Platform for Coronary Lesions ($413,595)", "source_url": "https://reporter.nih.gov/project-details/11077590", "people": [{"name": "Richard Gordon Bach", "role": "Principal Investigator"}, {"name": "Francis Milton Creighton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI162425-04", "company": "Vectech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": 970682, "summary": "NIH award 5R44AI162425-04: High accuracy automated tick classification using computer vision ($970,682)", "source_url": "https://reporter.nih.gov/project-details/11062363", "people": [{"name": "Autumn Goodwin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R41MH139194-01", "company": "Parc Innovations LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": 442074, "summary": "NIH award 1R41MH139194-01: Interactive E-Learning for Therapist Training in Exposure Therapy ($442,074)", "source_url": "https://reporter.nih.gov/project-details/11065966", "people": [{"name": "Kristen G Benito", "role": "Principal Investigator"}, {"name": "Joshua Kemp", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42HL167342-02", "company": "Sensydia Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": 1607970, "summary": "NIH award 4R42HL167342-02: A non-invasive, automated platform for hemodynamic assessment of patients at risk of heart failure or pulmonary hypertension ($1,607,970)", "source_url": "https://reporter.nih.gov/project-details/10953826", "people": [{"name": "Anthony Arnold", "role": "Principal Investigator"}, {"name": "Aman Mahajan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT06930833", "company": "Corsano Health B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study", "source_url": "https://clinicaltrials.gov/study/NCT06930833"}, {"id": "trialreg:NCT06929923", "company": "TecTraum Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pro-2-Cool Pivotal Trial II", "source_url": "https://clinicaltrials.gov/study/NCT06929923"}, {"id": "trialreg:NCT06930677", "company": "Next Biomedical Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study in Patients With Knee Osteoarthritis Treated by Embolization Using NBGM200", "source_url": "https://clinicaltrials.gov/study/NCT06930677"}, {"id": "trialreg:NCT06930339", "company": "Helius Medical Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis", "source_url": "https://clinicaltrials.gov/study/NCT06930339"}, {"id": "trialreg:NCT06930781", "company": "Oticon Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)", "source_url": "https://clinicaltrials.gov/study/NCT06930781"}, {"id": "trialreg:NCT06930209", "company": "Spiderwort Biotechnologies Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-16", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Histological Analysis of CelluJuve\u00ae Injections in the Brachium", "source_url": "https://clinicaltrials.gov/study/NCT06930209"}, {"id": "fda:K242806", "company": "Medyssey Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242806: Medyssey Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242806", "people": [{"name": "Taehyun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242806%22"}, {"id": "fda:K242500", "company": "Laralab GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242500: LARALAB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242500", "people": [{"name": "Julian Bernard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242500%22"}, {"id": "fda:K250850", "company": "Nano-X Imaging , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250850: Nanox.ARC X", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250850", "people": [{"name": "Ofir Koren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250850%22"}, {"id": "fda:K241733", "company": "Novasonix Technology S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241733: HEBE (NP0000763)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241733", "people": [{"name": "Carlos Navarro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241733%22"}, {"id": "fda:K250809", "company": "Lumenis Be, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250809: Stellar M22", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250809", "people": [{"name": "Shlomit Segman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250809%22"}, {"id": "fda:K243853", "company": "Clarius Mobile Health Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243853: Clarius Prostate AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243853", "people": [{"name": "Agatha Szeliga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243853%22"}, {"id": "fda:K242647", "company": "Mysegmenter Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242647: MySegmenter (v2.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242647", "people": [{"name": "Ketan Jajal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242647%22"}, {"id": "fda:K243513", "company": "Pneumowave, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243513: DCM (PW-DCM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243513", "people": [{"name": "Stuart Kelly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243513%22"}, {"id": "nih:1R41DC022504-01", "company": "Vdf Industries Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": 305197, "summary": "NIH award 1R41DC022504-01: Phonocath - An endovascular medical device to objectively evaluate Pulsatile Tinnitus ($305,197)", "source_url": "https://reporter.nih.gov/project-details/11070171", "people": [{"name": "Matthew Amans", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DE033934-01", "company": "Oraliva, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": 1178476, "summary": "NIH award 1R44DE033934-01: AI-linked cytomics-on-a-chip to enable near-real time identification and management of oral lichenoid lesions in primary care ($1,178,476)", "source_url": "https://reporter.nih.gov/project-details/10921587", "people": [{"name": "Nicolaos Joseph Christodoulides", "role": "Principal Investigator"}, {"name": "JOHN T MCDEVITT", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA298750-01", "company": "Sensewhy, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": 399891, "summary": "NIH award 1R43CA298750-01: ASHES: Assessing Smoking BeHavior with ThErmal Sensing to Prevent Relapse ($399,891)", "source_url": "https://reporter.nih.gov/project-details/11069872", "people": [{"name": "Nabil Alshurafa", "role": "Principal Investigator"}, {"name": "Harrison Dong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD118899-01", "company": "Nextgenjane, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": 759944, "summary": "NIH award 1R44HD118899-01: Performance evaluation of a non-invasive menstrual test for endometriosis in infertility patients ($759,944)", "source_url": "https://reporter.nih.gov/project-details/11185524", "people": [{"name": "Stephen Gire", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG078009-03", "company": "Potluck, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": 797288, "summary": "NIH award 5R44AG078009-03: Enhancing Social Engagement through Online Gameplay for Older Adults with and without Mild Cognitive Impairment ($797,288)", "source_url": "https://reporter.nih.gov/project-details/11064009", "people": [{"name": "Maribeth Gandy Coleman", "role": "Principal Investigator"}, {"name": "Dillon Myers", "role": "Principal Investigator"}, {"name": "Kayci Vickers", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06929052", "company": "Kashiv BioSciences, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects.", "source_url": "https://clinicaltrials.gov/study/NCT06929052"}, {"id": "trialreg:NCT06928545", "company": "GT Metabolic Solutions, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MagDI U.S. Registry", "source_url": "https://clinicaltrials.gov/study/NCT06928545"}, {"id": "trialreg:NCT06927752", "company": "A.M.I. Agency for Medical Innovations GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Retrospective Data Analysis PelviGYNious/EndoGYNious", "source_url": "https://clinicaltrials.gov/study/NCT06927752"}, {"id": "trialreg:NCT06928337", "company": "Fairtility", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-15", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Collection Protocol for the Development of CHLOE-OQ, an AI Model for Assessing Oocytes Quality.", "source_url": "https://clinicaltrials.gov/study/NCT06928337"}, {"id": "fda:K250833", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250833: SwissMembrane X; SwissMembrane X Socket", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250833", "people": [{"name": "Erik Wirth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250833%22"}, {"id": "fda:K243055", "company": "EMA Aesthetics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243055: Pr\u00e9ime DermaFacial Collagen+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243055", "people": [{"name": "Alice Daniels", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243055%22"}, {"id": "fda:K250824", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250824: Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250824", "people": [{"name": "Stephanie Anderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250824%22"}, {"id": "fda:K242786", "company": "Sight Sciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242786: TearCare MGX System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242786", "people": [{"name": "Rachel Franco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242786%22"}, {"id": "fda:K250650", "company": "Arineta , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250650: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250650", "people": [{"name": "Yaara Tirosh-Kamienchick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250650%22"}, {"id": "fda:K242658", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242658: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242658", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242658%22"}, {"id": "fda:K242773", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242773: Electro Lube NXT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242773", "people": [{"name": "Steve Elliott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242773%22"}, {"id": "fda:K242932", "company": "Cryoconcepts LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242932: Skin Clinic Nitro Clear Wart Remover", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242932", "people": [{"name": "Sam Niedbala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242932%22"}, {"id": "fda:K250327", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250327: OptaBlate Radiofrequency (RF) Generator System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250327", "people": [{"name": "Josh Measures", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250327%22"}, {"id": "fda:K250803", "company": "Anhui Deepblue Medical Technological Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250803: Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250803", "people": [{"name": "Fengling Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250803%22"}, {"id": "fda:K250212", "company": "Ark Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250212: LapBox Power Tissue Containment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250212", "people": [{"name": "Stav Tori", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250212%22"}, {"id": "nih:1R44MH136864-01A1", "company": "Groupware Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-14", "observed": "2026-08-21", "amount_usd": 1243071, "summary": "NIH award 1R44MH136864-01A1: A unified eligibility application and determination system to increase Ryan White linkage to care and retention in care by reducing structural barriers and facilitating client engagement ($1,243,071)", "source_url": "https://reporter.nih.gov/project-details/11063943", "people": [{"name": "Bob Harrison Hedgcock", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44NR021119-04", "company": "Handl Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-14", "observed": "2026-08-21", "amount_usd": 690531, "summary": "NIH award 5R44NR021119-04: A mobile application to offer upfront healthcare prices and automated medical billing for socioeconomically disadvantaged Americans ($690,531)", "source_url": "https://reporter.nih.gov/project-details/11070289", "people": [{"name": "Ahmed Marmoush", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K243852", "company": "Elfi-Tech , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243852: Elfor-L", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243852", "people": [{"name": "Orly Maor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243852%22"}, {"id": "fda:K250802", "company": "Advanced Sterilization Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250802: STERRAD\u00ae 100NX Sterilizer with ALLClear\u0099 Technology (10104)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250802", "people": [{"name": "Ayse Erkan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250802%22"}, {"id": "fda:K250094", "company": "Neuralynx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250094: Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250094", "people": [{"name": "Kelly Moeykens", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250094%22"}, {"id": "fda:K250823", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250823: Any-Com Flow", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250823", "people": [{"name": "Priscilla Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250823%22"}, {"id": "fda:K250402", "company": "AVAVA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250402: AVAVA\u0099 Skin Treatment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250402", "people": [{"name": "Richard Bankowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250402%22"}, {"id": "fda:K250301", "company": "Merge Healthcare Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250301: Merge Universal Viewer (MUV)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250301", "people": [{"name": "Sara Pesian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250301%22"}, {"id": "trialreg:NCT06925971", "company": "MicroPort NeuroTech Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Randomized Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease\uff08TARGET-DREAM\uff09", "source_url": "https://clinicaltrials.gov/study/NCT06925971"}, {"id": "trialreg:NCT06926400", "company": "JW Medical Systems Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter in the Pre-dilation of Coronary Artery Stenosis Lesions", "source_url": "https://clinicaltrials.gov/study/NCT06926400"}, {"id": "nih:5R44AI136172-05", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": 1015000, "summary": "NIH award 5R44AI136172-05: Point-of-care diagnostic test for T. cruzi (Chagas) infection ($1,015,000)", "source_url": "https://reporter.nih.gov/project-details/11061837", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "trialreg:NCT06924307", "company": "Koronis Biomedical Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Parent-Child EF Intervention", "source_url": "https://clinicaltrials.gov/study/NCT06924307"}, {"id": "trialreg:NCT06923774", "company": "Intuitive Surgical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: European Real-World Registry for Use of the Ion Endoluminal System", "source_url": "https://clinicaltrials.gov/study/NCT06923774"}, {"id": "trialreg:NCT06924736", "company": "Shanghai Bluesail Boyuan Medical Technology Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SONICURE\uff08SONICracker for the Treatment of UndeRExpansion\uff09", "source_url": "https://clinicaltrials.gov/study/NCT06924736"}, {"id": "fda:K250811", "company": "Aidite (Qinhuangdao) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250811: Dental Zirconia Ceramic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250811", "people": [{"name": "Jeffry Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250811%22"}, {"id": "fda:K242120", "company": "Cascination AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242120: OTOPLAN", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242120", "people": [{"name": "Gordana Salleles", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242120%22"}, {"id": "fda:K243346", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243346: cobas liat SARS-CoV-2 v2 nucleic acid test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243346", "people": [{"name": "Deborah Leu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243346%22"}, {"id": "fda:K243260", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243260: FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243260", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243260%22"}, {"id": "fda:K242646", "company": "Guilin Aesthedent Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242646: Dental Implant Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242646", "people": [{"name": "Chen Salon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242646%22"}, {"id": "fda:K243537", "company": "Xelite Biomed , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243537: XeliteMed VertehighFix High Viscosity Spinal Bone Cement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243537", "people": [{"name": "Wei Chun Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243537%22"}, {"id": "fda:DEN240064", "company": "Click Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240064: CT-132", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240064", "people": [{"name": "Dr. Shaheen Lakhan", "role": "510(k) submission contact"}]}, {"id": "fda:K243558", "company": "Cognoa, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243558: Canvas Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243558", "people": [{"name": "Sharief Taraman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243558%22"}, {"id": "fda:K243888", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243888: Medline UNITE\u00ae REFLEX\u00ae Hybrid Nitinol Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243888", "people": [{"name": "Jennifer Mason", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243888%22"}, {"id": "fda:K242748", "company": "Oncospace, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242748: Oncospace", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242748", "people": [{"name": "Sigrid Schoepel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242748%22"}, {"id": "fda:K242772", "company": "SmartsurgN, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242772: AirSurgN Insufflator (10030/AirSurgN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242772", "people": [{"name": "Jocelyn Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242772%22"}, {"id": "fda:K243710", "company": "Shenzhen Trious Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243710: Disposable ureteral access sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243710", "people": [{"name": "Yingfang Yi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243710%22"}, {"id": "fda:K243857", "company": "Shanghai AnQing Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243857: Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243857", "people": [{"name": "Shuwen Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243857%22"}, {"id": "fda:K250748", "company": "Klaxon-Mobility GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250748: KLAXON (TWIST); KLAXON (TWIST R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250748", "people": [{"name": "Riccardo Colomba", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250748%22"}, {"id": "fda:K250438", "company": "CooperSurgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250438: CooperSurgical Milex\u00ae Pessaries", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250438", "people": [{"name": "Drake Schaffer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250438%22"}, {"id": "fda:K242600", "company": "Pearl, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242600: Second Opinion Periapical Radiolucency Contours", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242600", "people": [{"name": "William Birdsall", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242600%22"}, {"id": "fda:K243044", "company": "Alma Lasers, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243044: Alma Harmony", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243044", "people": [{"name": "Jessica Rivera-Montejo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243044%22"}, {"id": "fda:K250081", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250081: Atlantis\u00ae Abutments in Titanium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250081", "people": [{"name": "Laura Sorbin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250081%22"}, {"id": "fda:K243921", "company": "Foshan Coxo Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243921: LED Curing Lights (DB686 HALO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243921", "people": [{"name": "Zhaorong Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243921%22"}, {"id": "fda:K242098", "company": "Shenzhen Vivolight Medical Device & Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242098: Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242098", "people": [{"name": "Gao Pengyang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242098%22"}, {"id": "fda:K250416", "company": "Galileo Cds, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250416: GBrain MRI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250416", "people": [{"name": "Abhijeet Pradhan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250416%22"}, {"id": "fda:K243898", "company": "Nelson Environmental Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243898: Chlorine Sentinel II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243898", "people": [{"name": "QuocHuy (Huy) Nguyen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243898%22"}, {"id": "fda:K243356", "company": "Asiga Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243356: Asiga DentaBASE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243356", "people": [{"name": "Justin Elsey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243356%22"}, {"id": "pma:P240028", "company": "EBR Systems, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240028: WiSE\u00ae (Wireless Stimulation of the Endocardium Technology) CRT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240028", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240028%22"}, {"id": "denovo:DEN240064", "company": "Click Therapeutics, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-04-11", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240064 granted: CT-", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240064"}, {"id": "breakthrough:DEN240064", "company": "Click Therapeutics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-04-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN240064: CT-132", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P240028", "company": "Ebr Systems, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-04-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P240028: WISE (WIRELESS STIMULATION OF THE ENDOCARDIUM TECHNOLOGY) CRT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R41DC022808-01", "company": "Intelligent Hearing Systems", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": 308712, "summary": "NIH award 1R41DC022808-01: Improving accessibility, accuracy, and efficiency of auditory evoked response testing using a telehealth and artificial intelligence approach ($308,712)", "source_url": "https://reporter.nih.gov/project-details/11181788", "people": [{"name": "Rafael E Delgado", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43DA061397-01S1", "company": "Labsys, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43DA061397-01S1: Wearable Continuous Drug Monitoring Device for Personal Medications in Opioid Use Disorders (CDM-MOUD) ($55,000)", "source_url": "https://reporter.nih.gov/project-details/11237209", "people": [{"name": "Yue Huang", "role": "Principal Investigator"}, {"name": "Zhe Wang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DC020684-03", "company": "Thrive Neuromedical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": 588466, "summary": "NIH award 5R44DC020684-03: Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants ($588,466)", "source_url": "https://reporter.nih.gov/project-details/11078358", "people": [{"name": "Dean R Koch", "role": "Principal Investigator"}, {"name": "Nathalie Maitre", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06922136", "company": "Fidia Farmaceutici s.p.a.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Performance and Safety of Hyalo Gyn\u00ae Gel Compared to Placebo in Postmenopausal Breast Cancer Survivors", "source_url": "https://clinicaltrials.gov/study/NCT06922136"}, {"id": "trialreg:NCT06921551", "company": "ABLE Human Motion S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis", "source_url": "https://clinicaltrials.gov/study/NCT06921551"}, {"id": "trialreg:NCT06921902", "company": "Abbott Diabetes Care", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Glycemic Metrics and Patterns in People With and Without Prediabetes", "source_url": "https://clinicaltrials.gov/study/NCT06921902"}, {"id": "trialreg:NCT06920745", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TriClip CED RWE Study", "source_url": "https://clinicaltrials.gov/study/NCT06920745"}, {"id": "fda:K250009", "company": "Premium Plus (Dongguan) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250009: LED Curing Light (C01-X, C02-X)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250009", "people": [{"name": "Jessica Mao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250009%22"}, {"id": "fda:K242928", "company": "Kyocera Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242928: Tesera-k SC System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242928", "people": [{"name": "Dennis Ty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242928%22"}, {"id": "fda:K243953", "company": "Vizionfocus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243953: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243953", "people": [{"name": "Angus Shih", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243953%22"}, {"id": "fda:K250486", "company": "Kyocera Medical Technologies Inc. (KMTI)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250486: Skyway Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250486", "people": [{"name": "Joey Thompson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250486%22"}, {"id": "fda:K242089", "company": "Jiangsu Ruifuda Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242089: Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242089", "people": [{"name": "Jingkai Shao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242089%22"}, {"id": "fda:K250389", "company": "Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250389: XNY Disposable Gastric Calibration Tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250389", "people": [{"name": "Hong Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250389%22"}, {"id": "fda:K243145", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243145: syngo.CT LVO Detection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243145", "people": [{"name": "Kenny M. Bello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243145%22"}, {"id": "fda:K250058", "company": "Brain Electrophysiology Laboratory Company, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250058: NEAT 001", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250058", "people": [{"name": "Phan Luu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250058%22"}, {"id": "fda:K250112", "company": "Orthofix Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250112: FitboneTM Trochanteric", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250112", "people": [{"name": "Elvira Taccarelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250112%22"}, {"id": "fda:K250371", "company": "AtriCure, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250371: cryoICE cryoXT cryoablation probe (cryoXT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250371", "people": [{"name": "Ronit Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250371%22"}, {"id": "fda:K250177", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250177: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250177", "people": [{"name": "Swetha Paritala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250177%22"}, {"id": "fda:K242045", "company": "Kyocera Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242045: Initia T3 Acetabular Hemispherical Shell System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242045", "people": [{"name": "Sumihiko Maeno", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242045%22"}, {"id": "fda:K243240", "company": "Canon Medical Informatics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243240: Vitrea CT VScore", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243240", "people": [{"name": "Jay Vaishnav", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243240%22"}, {"id": "fda:K250754", "company": "Curemetrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250754: cmAngio\u00ae (V1.6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250754", "people": [{"name": "Kevin Harris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250754%22"}, {"id": "fda:K242561", "company": "Donnevie Medical Technology (Shanghai) Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242561: Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242561", "people": [{"name": "Hannah Hang Yin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242561%22"}, {"id": "fda:K243943", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243943: TriMed\u00ae Compression Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243943", "people": [{"name": "Thomas Arnold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243943%22"}, {"id": "nih:7R44AG063683-05", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": 797710, "summary": "NIH award 7R44AG063683-05: A Mobile Informatics Solution to Assist Caregivers with Care Coordination and Social Engagement ($797,710)", "source_url": "https://reporter.nih.gov/project-details/11234410", "people": [{"name": "GARY D HAVEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44AI177199-02", "company": "Inhalon Biopharma, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": 1023875, "summary": "NIH award 5R44AI177199-02: SBIR: IND-enabling development of IN-007, an inhaled muco-trapping immunotherapy for COVID19 and other ACE2-targeted infections ($1,023,875)", "source_url": "https://reporter.nih.gov/project-details/11046650", "people": [{"name": "JEFF T HUTCHINS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT06920277", "company": "Smart Alfa Teknoloji San. ve Tic. A.S.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Ultrasound Image Collection for the Development of an AI Software", "source_url": "https://clinicaltrials.gov/study/NCT06920277"}, {"id": "trialreg:NCT06920290", "company": "Sight Intelligence Engineering Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Visual Field Analysis With Artificial Intelligence", "source_url": "https://clinicaltrials.gov/study/NCT06920290"}, {"id": "trialreg:NCT06920459", "company": "Zimmer Biomet", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Zimmer Biomet Shoulder Arthroplasty PMCF Study", "source_url": "https://clinicaltrials.gov/study/NCT06920459"}, {"id": "trialreg:NCT06919809", "company": "McGuire Institute", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Effectiveness and Safety of X A-DERM\u2122 Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery", "source_url": "https://clinicaltrials.gov/study/NCT06919809"}, {"id": "trialreg:NCT06918587", "company": "Kashiv BioSciences, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Comparative Evaluation of Pharmacokinetics and Immunogenicity.", "source_url": "https://clinicaltrials.gov/study/NCT06918587"}, {"id": "trialreg:NCT06920030", "company": "Berlin Heals GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead", "source_url": "https://clinicaltrials.gov/study/NCT06920030"}, {"id": "trialreg:NCT06918496", "company": "Grena Biomed Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery", "source_url": "https://clinicaltrials.gov/study/NCT06918496"}, {"id": "trialreg:NCT06918041", "company": "ZuriMED Technologies Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-09", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FiberLocker\u00ae System Augmentation of Rotator Cuff Repairs", "source_url": "https://clinicaltrials.gov/study/NCT06918041"}, {"id": "fda:K250098", "company": "Davol, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250098: Bard Soft Mesh; Bard Soft Mesh Pre-Shaped", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250098", "people": [{"name": "Becca DeFrancia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250098%22"}, {"id": "fda:K243966", "company": "Faceheart Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243966: FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243966", "people": [{"name": "Dr. Meng Liang Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243966%22"}, {"id": "fda:K243743", "company": "Holberg Eeg AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243743: autoSCORE (V 2.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243743", "people": [{"name": "Smriti Franklin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243743%22"}, {"id": "fda:K250373", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250373: ProLift Expandable Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250373", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250373%22"}, {"id": "fda:K242429", "company": "Becton Dickinson Inc. (Bd)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242429: CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242429", "people": [{"name": "Connor Dahl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242429%22"}, {"id": "fda:DEN240021", "company": "Active Protective Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240021: Tango\u00ae Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240021", "people": [{"name": "Wamis Singhatat", "role": "510(k) submission contact"}]}, {"id": "fda:K250752", "company": "Integra LifeSciences Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250752: AURORA\u00ae Surgiscope\u00ae System (ASX15/60); AURORA\u00ae Surgiscope\u00ae System (ASX15/80)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250752", "people": [{"name": "Rebecca Odulio", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250752%22"}, {"id": "fda:K243819", "company": "Luminopia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243819: Luminopia", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243819", "people": [{"name": "Scott Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243819%22"}, {"id": "fda:K243214", "company": "Dexcom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243214: Dexcom G7 15 Day Continuous Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243214", "people": [{"name": "Holly Drake", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243214%22"}, {"id": "fda:K241589", "company": "Ceribell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241589: Ceribell Seizure Detection Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241589", "people": [{"name": "Raymond Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241589%22"}, {"id": "fda:K243613", "company": "Transtimulation Research, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243613: Patch-TEA (Model TRI-21)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243613", "people": [{"name": "Victor Pikov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243613%22"}, {"id": "denovo:DEN240021", "company": "Active Protective Technologies, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-04-09", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240021 granted: Tango\u00ae Belt (Model SAS-001-01 (XS); Mode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240021"}, {"id": "breakthrough:DEN240021", "company": "Active Protective Technologies, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-04-09", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN240021: TANGO BELT (MODEL SAS-001-01 (XS); MODEL SAS-001-02 (S); MODEL SAS-001-03 (M); MODEL SAS-001-04 (L); MODEL SAS-001-05 (XL))", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "trialreg:NCT06916845", "company": "Capso Vision, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Data Collection for CV-3E AI Software Development", "source_url": "https://clinicaltrials.gov/study/NCT06916845"}, {"id": "trialreg:NCT06916728", "company": "Smith & Nephew, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee", "source_url": "https://clinicaltrials.gov/study/NCT06916728"}, {"id": "trialreg:NCT06915545", "company": "Lifetech Scientific (Shenzhen) Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study on the Aortic Arch Single Branch Stent Graft System", "source_url": "https://clinicaltrials.gov/study/NCT06915545"}, {"id": "trialreg:NCT06915818", "company": "GI Windows, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery", "source_url": "https://clinicaltrials.gov/study/NCT06915818"}, {"id": "trialreg:NCT06915402", "company": "Rose Pharma SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of \"LMW - CL - HA - FACE/BODY\" for the Augmentation of the Cheeks", "source_url": "https://clinicaltrials.gov/study/NCT06915402"}, {"id": "trialreg:NCT06917326", "company": "Neola Medical AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study to Assess Safety and Performance of Neola\u00ae, a Novel Lung Monitoring Device for Neonates", "source_url": "https://clinicaltrials.gov/study/NCT06917326"}, {"id": "trialreg:NCT06915337", "company": "GI Windows, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Magnet Anastomosis in Patients Undergoing Gastric Surgery", "source_url": "https://clinicaltrials.gov/study/NCT06915337"}, {"id": "trialreg:NCT06915363", "company": "BioPoly LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BioPoly\u00ae Partial Resurfacing Knee Implant IDE", "source_url": "https://clinicaltrials.gov/study/NCT06915363"}, {"id": "trialreg:NCT06916325", "company": "XVIVO Perfusion", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion", "source_url": "https://clinicaltrials.gov/study/NCT06916325"}, {"id": "trialreg:NCT06917352", "company": "Norbert Health", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-08", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Validation of the Norbert Health Device for Pulse Rate Measurement at Vigilant Clinical Testing", "source_url": "https://clinicaltrials.gov/study/NCT06917352"}, {"id": "fda:K242151", "company": "Shenzhen Nuon Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242151: Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242151", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242151%22"}, {"id": "fda:K243722", "company": "Selio Medical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243722: Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243722", "people": [{"name": "Colm McGarvey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243722%22"}, {"id": "fda:K243749", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243749: Jmoon Conductive Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243749", "people": [{"name": "Yang Blue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243749%22"}, {"id": "fda:K250948", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250948: TriMed Fusion Cup System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250948", "people": [{"name": "Blesson Abraham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250948%22"}, {"id": "fda:K250136", "company": "Globalcare Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250136: Globalcare Blood Pressure Monitor (GUS610)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250136", "people": [{"name": "Valentina Sassi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250136%22"}, {"id": "fda:K242552", "company": "Icat Solutions, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242552: Horos Mobile", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242552", "people": [{"name": "Georgios Michalopoulos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242552%22"}, {"id": "fda:K242295", "company": "BunkerHill Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242295: BunkerHill BMD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242295", "people": [{"name": "Nishith Khandwala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242295%22"}, {"id": "fda:K243027", "company": "Hangzhou Sightnovo Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243027: Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243027", "people": [{"name": "Eric Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243027%22"}, {"id": "fda:K243967", "company": "Global Protection Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243967: ONE Nitrile Condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243967", "people": [{"name": "Christina Cataldo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243967%22"}, {"id": "fda:K250366", "company": "Anhui Longway Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250366: Electric Wheelchair (LW01301A07)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250366", "people": [{"name": "Xie Alan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250366%22"}, {"id": "fda:K250708", "company": "Guard Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250708: NPseal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250708", "people": [{"name": "Machiel van der Leest", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250708%22"}, {"id": "fda:K250343", "company": "LuxCreo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250343: LuxCreo Clear Aligner System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250343", "people": [{"name": "Tao Feng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250343%22"}, {"id": "nih:4R44EY034758-02", "company": "Aesculatech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-07", "observed": "2026-08-21", "amount_usd": 1220683, "summary": "NIH award 4R44EY034758-02: Humidifeye Plug for Dry Eye Disease ($1,220,683)", "source_url": "https://reporter.nih.gov/project-details/11216481", "people": [{"name": "Niki Bayat", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL147771-05", "company": "Annoviant, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-07", "observed": "2026-08-21", "amount_usd": 1265524, "summary": "NIH award 5R44HL147771-05: Pulmonary Valved Graft with Regeneration Potential for Pediatric Patients ($1,265,524)", "source_url": "https://reporter.nih.gov/project-details/11060870", "people": [{"name": "Ajay Houde", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:2R44HL147734-04", "company": "Retham Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-07", "observed": "2026-08-21", "amount_usd": 1154002, "summary": "NIH award 2R44HL147734-04: An in vitro diagnostic assay for the early and accurate detection of platelet-activating antibodies associated with Heparin-inducedThrombocytopenia ($1,154,002)", "source_url": "https://reporter.nih.gov/project-details/11043284", "people": [{"name": "Curtis Jones", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43DC022823-01", "company": "Qualia Oto, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-07", "observed": "2026-08-21", "amount_usd": 304723, "summary": "NIH award 1R43DC022823-01: Robotic-Inserted, Shape-Conforming Cochlear Implant Electrode Arrays ($304,723)", "source_url": "https://reporter.nih.gov/project-details/11186545", "people": [{"name": "Jimin Maeng", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K250033", "company": "Guangzhou Pinzhi Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250033: Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250033", "people": [{"name": "XianQing Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250033%22"}, {"id": "fda:K243143", "company": "Bomtech Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243143: E-PEN (E-PEN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243143", "people": [{"name": "Lee Junseok", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243143%22"}, {"id": "fda:K243567", "company": "Tyto Care , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243567: Tyto Insights for Rhonchi Detection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243567", "people": [{"name": "Stella Raizelman Perry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243567%22"}, {"id": "fda:K250395", "company": "Conmed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250395: BioBrace \u00ae RC Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250395", "people": [{"name": "Dionne Sanders", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250395%22"}, {"id": "fda:K250521", "company": "Biocomposites, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250521: NanoBone\u00ae SBX Putty ; NanoBone\u00ae QD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250521", "people": [{"name": "Ciara Airey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250521%22"}, {"id": "fda:K242385", "company": "Shenzhen Borria Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242385: LED Therapy Mask (MN1, M226)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242385", "people": [{"name": "Chardy Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242385%22"}, {"id": "fda:K250425", "company": "APK Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250425: Ultraviolet Phototherapy Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250425", "people": [{"name": "Caifang Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250425%22"}, {"id": "trialreg:NCT06914583", "company": "IBSA Farmaceutici Italia Srl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy Evaluation of Sodium Hyaluronate 32mg/ml in Improving Facial Skin Dryness and Dullness", "source_url": "https://clinicaltrials.gov/study/NCT06914583"}, {"id": "trialreg:NCT06912594", "company": "Endo Health GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: App Impact on Quality of Life and Symptoms in PCOS", "source_url": "https://clinicaltrials.gov/study/NCT06912594"}, {"id": "trialreg:NCT06912646", "company": "Erchonia Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Efficacy of the Erchonia EVRL for Providing Temporary Relief of Idiopathic Peripheral Neuropathy Foot Pain", "source_url": "https://clinicaltrials.gov/study/NCT06912646"}, {"id": "trialreg:NCT06914596", "company": "McGuire Institute", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Trial Comparing 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP to a Control Group Post-SRP.", "source_url": "https://clinicaltrials.gov/study/NCT06914596"}, {"id": "nih:1R42DA062250-01", "company": "Mountainpass Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R42DA062250-01: MyTrials: An Integrated Tool to Support Remote Biomarker Capture within Decentralized Clinical Trials for Substance Use Disorders ($400,000)", "source_url": "https://reporter.nih.gov/project-details/11053714", "people": [{"name": "Jennifer Renee Dahne", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06911632", "company": "Tempus AI", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary Hypertension", "source_url": "https://clinicaltrials.gov/study/NCT06911632"}, {"id": "trialreg:NCT06910306", "company": "Alpha Tau Medical LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma", "source_url": "https://clinicaltrials.gov/study/NCT06910306"}, {"id": "trialreg:NCT06909838", "company": "Gymna Uniphy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Radial Shockwave for Spasticity in Children With CP or ABI", "source_url": "https://clinicaltrials.gov/study/NCT06909838"}, {"id": "trialreg:NCT06911541", "company": "Eupnea AS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Validation of a Novel, Accelerometer Based, Continuous Respiratory Rate Sensor", "source_url": "https://clinicaltrials.gov/study/NCT06911541"}, {"id": "trialreg:NCT06910111", "company": "Certmedica International GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)", "source_url": "https://clinicaltrials.gov/study/NCT06910111"}, {"id": "trialreg:NCT06910033", "company": "Materialise", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Long-term Safety and Performance of CMF Porous Titanium Implants", "source_url": "https://clinicaltrials.gov/study/NCT06910033"}, {"id": "trialreg:NCT06910592", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EXOMIND (BTL-995) for Reduction of Binge-eating", "source_url": "https://clinicaltrials.gov/study/NCT06910592"}, {"id": "fda:K250011", "company": "Turbett Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250011: Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250011", "people": [{"name": "Melissa Conley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250011%22"}, {"id": "fda:K242103", "company": "3Shape TRIOS A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242103: TRIOS Ready Tip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242103", "people": [{"name": "Klaus Rudbaek Hoj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242103%22"}, {"id": "fda:K243691", "company": "Seigla Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243691: LiquID .051 LP Guide Catheter Extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243691", "people": [{"name": "Chad Kugler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243691%22"}, {"id": "fda:K242576", "company": "Hangzhou AllTest Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242576: AllTest Viral Transport Medium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242576", "people": [{"name": "Rosa Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242576%22"}, {"id": "fda:K250656", "company": "Wuhan Pioon Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250656: Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250656", "people": [{"name": "Feng Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250656%22"}, {"id": "fda:K250332", "company": "Highridge Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250332: Virage\u00ae OCT Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250332", "people": [{"name": "Regan Ream", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250332%22"}, {"id": "fda:K243581", "company": "Terumo Europe N.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243581: K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243581", "people": [{"name": "Liesbeth Decoster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243581%22"}, {"id": "fda:K242068", "company": "Ningbo Dechang Electrical Machinery Made Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242068: LED Light Therapy Mask (RT01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242068", "people": [{"name": "Yinling Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242068%22"}, {"id": "fda:K243769", "company": "Qfr Solutions BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243769: QFR (3.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243769", "people": [{"name": "Bob Goedhart", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243769%22"}, {"id": "fda:K243074", "company": "Spectrum Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243074: Spectrum Spine Lumbar Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243074", "people": [{"name": "Scott Baltsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243074%22"}, {"id": "fda:K243549", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243549: JETi Hydrodynamic Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243549", "people": [{"name": "Fiona Pu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243549%22"}, {"id": "fda:DEN240031", "company": "Prapela, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240031: Prapela SVS hospital bassinet pad (model P01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240031", "people": [{"name": "John Konsin", "role": "510(k) submission contact"}]}, {"id": "fda:K242807", "company": "Deski", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242807: HeartFocus (V.1.1.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242807", "people": [{"name": "Saray Ugidos Seman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242807%22"}, {"id": "fda:K242001", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242001: Philips VSC-MEDlib", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242001", "people": [{"name": "David Boser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242001%22"}, {"id": "fda:K243786", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243786: Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243786", "people": [{"name": "Timothy Groves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243786%22"}, {"id": "fda:K250727", "company": "Hangzhou AllTest Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250727: AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250727", "people": [{"name": "Rosa Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250727%22"}, {"id": "fda:K241982", "company": "Foqus Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241982: DeepFoqus (DeepFoqus-Accelerate)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241982", "people": [{"name": "Sadegh Raeisi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241982%22"}, {"id": "fda:K250706", "company": "Biotronik, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250706: Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250706", "people": [{"name": "Jon Brumbaugh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250706%22"}, {"id": "fda:K242116", "company": "Oculogica, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242116: EyeBOX EBX-4.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242116", "people": [{"name": "Rosina Samadani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242116%22"}, {"id": "fda:K243236", "company": "Whoop., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243236: WHOOP ECG (electrocardiogram) Feature (1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243236", "people": [{"name": "Nikki Batista", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243236%22"}, {"id": "fda:K242209", "company": "Apex BioTechnology Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242209: UASure II Blood Uric Acid Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242209", "people": [{"name": "Lisa Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242209%22"}, {"id": "fda:K240398", "company": "RaySearch Laboratories AB (PUBL)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240398: RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240398", "people": [{"name": "Anders Wihlborg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240398%22"}, {"id": "fda:K242769", "company": "Draegerwerk AG & CO Kgaa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242769: VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242769", "people": [{"name": "Jan Upmeier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242769%22"}, {"id": "fda:K250667", "company": "Degen Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250667: DeGen Medical Patient Specific Implant (PSI) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250667", "people": [{"name": "Craig Black", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250667%22"}, {"id": "denovo:DEN240031", "company": "Prapela, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-04-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240031 granted: Prapela SVS hospital bassinet pad (model", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240031"}, {"id": "breakthrough:DEN240031", "company": "Prapela, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-04-04", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN240031: PRAPELA SVS HOSPITAL BASSINET PAD (MODEL P01)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R44AI188772-01", "company": "Biacure Therapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-03", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 1R44AI188772-01: Using Targeted, Controlled High Frequency Energy for Treatment of Onychomycosis ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11065825", "people": [{"name": "Laura King", "role": "Principal Investigator"}, {"name": "Richard William Schefelker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06908538", "company": "AtriCure, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain", "source_url": "https://clinicaltrials.gov/study/NCT06908538"}, {"id": "trialreg:NCT06908577", "company": "AstraZeneca", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab", "source_url": "https://clinicaltrials.gov/study/NCT06908577"}, {"id": "trialreg:NCT06909292", "company": "Nevro Corp", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1", "source_url": "https://clinicaltrials.gov/study/NCT06909292"}, {"id": "trialreg:NCT06909578", "company": "CorFlow Therapeutics AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Microvascular Obstruction Diagnosis Using the CoFI\u2122 System Assessment - II", "source_url": "https://clinicaltrials.gov/study/NCT06909578"}, {"id": "fda:K243514", "company": "Spine Wave, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243514: Salvo\u00ae Robotic Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243514", "people": [{"name": "Ronald Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243514%22"}, {"id": "fda:K243298", "company": "Carbon (Shenzhen) Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243298: Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243298", "people": [{"name": "Min Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243298%22"}, {"id": "fda:K250404", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250404: stay\u0095safe\u00ae catheter extension set with Safe- Lock, 12 inch; stay\u0095safe\u00ae catheter extension set with Luer-Lock, 6 inch; stay\u0095safe\u00ae catheter extension set with Luer-Lock, 12 inch; stay\u0095safe\u00ae catheter extension set with Luer-Lock, 18 inch; stay\u0095safe\u00ae to Luer-Lock Adapter, 4 inch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250404", "people": [{"name": "Caitlin Kalda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250404%22"}, {"id": "fda:K243936", "company": "Staclear, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243936: StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243936", "people": [{"name": "Jackson Thornton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243936%22"}, {"id": "fda:K250658", "company": "Shina Med Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250658: SureFine Pen Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250658", "people": [{"name": "Taejoo Ha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250658%22"}, {"id": "fda:K242358", "company": "Xsto Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242358: Powered wheelchair (mobility robot) (M4, M4U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242358", "people": [{"name": "Jingbu Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242358%22"}, {"id": "fda:K243305", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243305: Masimo W1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243305", "people": [{"name": "Sindura Penubarthi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243305%22"}, {"id": "fda:K242551", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242551: syngo Dynamics (Version VA41D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242551", "people": [{"name": "Jiayan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242551%22"}, {"id": "fda:K243760", "company": "OSSIO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243760: OSSIOfiber\u00ae Suture Anchor 2.5-3.5 mm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243760", "people": [{"name": "Taly Linder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243760%22"}, {"id": "fda:K240615", "company": "Beaver-Visitec International, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240615: Leos Laser and Endoscopy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240615", "people": [{"name": "Christopher Brady", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240615%22"}, {"id": "nih:5R44HD112264-03", "company": "Inherent Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": 804660, "summary": "NIH award 5R44HD112264-03: Novel Epigenetic Test for the Treatment and Improvement of Longitudinal Health-Outcomes for Men with Severe Infertility ($804,660)", "source_url": "https://reporter.nih.gov/project-details/11026097", "people": [{"name": "Kristin R Brogaard", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R42GM157918-01", "company": "Biosensing Instrument, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": 349566, "summary": "NIH award 1R42GM157918-01: Spotting-free Nano-Oscillator Array for Quantification of Virion Displayed Membrane Protein Binding Kinetics ($349,566)", "source_url": "https://reporter.nih.gov/project-details/11070131", "people": [{"name": "Nguyen Ly", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DC022201-01A1", "company": "Iotamotion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": 306073, "summary": "NIH award 1R43DC022201-01A1: Development of a Navigation-Based Insertion Tool for Trajectory Optimization during Cochlear Implantation ($306,073)", "source_url": "https://reporter.nih.gov/project-details/11184702", "people": [{"name": "CONSTANTINOS NIKOU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06906055", "company": "Summa Therapeutics, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters", "source_url": "https://clinicaltrials.gov/study/NCT06906055"}, {"id": "trialreg:NCT06906718", "company": "Teleon Surgical B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Long-term Visual Acuity Data After Bilateral Implantation of the Aspheric EDOF Lens ACUNEX\u00ae Vario", "source_url": "https://clinicaltrials.gov/study/NCT06906718"}, {"id": "trialreg:NCT06907017", "company": "CorWave", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CorWave LVAS FIH Study", "source_url": "https://clinicaltrials.gov/study/NCT06907017"}, {"id": "trialreg:NCT06907147", "company": "Medtronic Vascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SPYRAL GEMINI Pilot Study", "source_url": "https://clinicaltrials.gov/study/NCT06907147"}, {"id": "trialreg:NCT06907888", "company": "VivaQuant", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-02", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT06907888"}, {"id": "fda:K242117", "company": "Icu Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242117: LifeShield Infusion Safety Software Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242117", "people": [{"name": "Pernell Abrantes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242117%22"}, {"id": "fda:K242460", "company": "Progenix, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242460: Progenix Select Stim", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242460", "people": [{"name": "Christian Hunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242460%22"}, {"id": "fda:K250760", "company": "Osteoremedies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250760: SPECTRUM GV Bone Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250760", "people": [{"name": "Rachel Kennedy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250760%22"}, {"id": "fda:K250152", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250152: eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250152", "people": [{"name": "Xiaoyan Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250152%22"}, {"id": "fda:K241984", "company": "Hi-D Imaging AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241984: Hi-D Imaging 4TAVR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241984", "people": [{"name": "Utku Gulan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241984%22"}, {"id": "fda:K243659", "company": "SeaSpine Orthopedics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243659: FLASH\u0099 Facet Fusion Instruments, IsoTis\u00ae Facet Fusion Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243659", "people": [{"name": "Cindy Toyama", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243659%22"}, {"id": "fda:K250930", "company": "Deka Research & Development Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250930: twiist system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250930", "people": [{"name": "William Calhoun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250930%22"}, {"id": "fda:K243889", "company": "Orthocell, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243889: Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243889", "people": [{"name": "Kelly Hunter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243889%22"}, {"id": "fda:K250677", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250677: LEGION Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250677", "people": [{"name": "Dana Hartlein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250677%22"}, {"id": "fda:K242031", "company": "Stepone Fertility Ltd (T/A B\u00e9a Fertility)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242031: B\u00e9a Applicator (BAP-GB-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242031", "people": [{"name": "Tom Littleford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242031%22"}, {"id": "fda:K242114", "company": "Icu Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242114: Plum Solo\u0099 Precision IV Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242114", "people": [{"name": "Yuliya Matlin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242114%22"}, {"id": "fda:K243733", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243733: SION blue PLUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243733", "people": [{"name": "Katsuhiko Fujimura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243733%22"}, {"id": "fda:K242113", "company": "Biocircuit Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242113: Nerve Wrap (07-DW-001-TAB)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242113", "people": [{"name": "Jack Griffis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242113%22"}, {"id": "fda:K242067", "company": "Olympus Corporations of the Americas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242067: VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242067", "people": [{"name": "Elizabeth Greene", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242067%22"}, {"id": "fda:K242115", "company": "Icu Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242115: Plum Duo\u0099 Precision IV Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242115", "people": [{"name": "Yuliya Matlin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242115%22"}, {"id": "fda:K250613", "company": "Nvision Biomedical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250613: SnapHammer Hammertoe Correction System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250613", "people": [{"name": "Erin Lansdale", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250613%22"}, {"id": "fda:K250138", "company": "Prosum Medical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250138: Small Volume 0.2mL Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250138", "people": [{"name": "Yanshen Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250138%22"}, {"id": "fda:K250705", "company": "Gynesonics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250705: Sonata Transcervical Fibroid Ablation System 2.2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250705", "people": [{"name": "Christine Ehmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250705%22"}, {"id": "nih:1R44AI193415-01", "company": "Partillion Bioscience Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-04-01", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 1R44AI193415-01: Scaling function-first antibody discovery leveraging memory B cells ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11185382", "people": [{"name": "Joseph de Rutte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06903741", "company": "Laboratoires Thea", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye", "source_url": "https://clinicaltrials.gov/study/NCT06903741"}, {"id": "trialreg:NCT06905808", "company": "Laborie Medical Technologies Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: e-Sense\u00ae Normal Values of Urodynamic Pressures Using e-Sense\u00ae Catheters", "source_url": "https://clinicaltrials.gov/study/NCT06905808"}, {"id": "trialreg:NCT06904846", "company": "Sinocare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-04-01", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: To Evaluate the Change in Glucose Parameters in Adult Patients With Type 1 or Type 2 Diabetes From Europe Using the iCan o3 CGM System for 60 Days Period", "source_url": "https://clinicaltrials.gov/study/NCT06904846"}, {"id": "fda:K250189", "company": "Advalight Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250189: AdvaTx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250189", "people": [{"name": "Amogh Kothare", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250189%22"}, {"id": "fda:K250623", "company": "OrthoPediatrics Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250623: Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250623", "people": [{"name": "Yan Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250623%22"}, {"id": "fda:K242105", "company": "Essity Higiene Y Salud Mexico. S.A. DE C.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242105: SABA Tampons", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242105", "people": [{"name": "Sean Anderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242105%22"}, {"id": "fda:K242925", "company": "GE Healthcare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242925: MR Contour DL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242925", "people": [{"name": "Allena Holzworth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242925%22"}, {"id": "fda:K242041", "company": "Taiwan Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242041: STOPWET iontophoresis apparatus (SW01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242041", "people": [{"name": "Chi-Lin Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242041%22"}, {"id": "fda:K250578", "company": "Careglove Global Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250578: Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250578", "people": [{"name": "Lim Kwee Shyan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250578%22"}, {"id": "fda:K250018", "company": "Gigaalaser Company , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250018: Medical Diode Laser Systems (THEIA808)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250018", "people": [{"name": "Xinxing Nie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250018%22"}, {"id": "fda:K242427", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242427: da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242427", "people": [{"name": "Jennifer Karafin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242427%22"}, {"id": "fda:K243938", "company": "Scientia Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243938: Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243938", "people": [{"name": "Bret Draper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243938%22"}, {"id": "fda:K243072", "company": "EMA Aesthetics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243072: Pr\u00e9ime DermaFacial (MicroT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243072", "people": [{"name": "Alice Daniels", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243072%22"}, {"id": "fda:K250263", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250263: Disposable Grasping Forceps FG-52D/FG-54D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250263", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250263%22"}, {"id": "fda:K242166", "company": "Tribusmed Beheer BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242166: TribusConnect", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242166", "people": [{"name": "Johan Vogelaar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242166%22"}, {"id": "fda:K250946", "company": "Hangzhou SHINING3D Dental Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250946: Denture Base Resin DT20", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250946", "people": [{"name": "Yuzhuo Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250946%22"}, {"id": "fda:K243384", "company": "Bridge TO Life", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243384: Belzer UW\u00ae Cold Storage Solution (BTLBUW-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243384", "people": [{"name": "Mark Harper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243384%22"}, {"id": "fda:K250663", "company": "Taewoong Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250663: Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250663", "people": [{"name": "Yongjin \"Jeff\" Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250663%22"}, {"id": "fda:K243178", "company": "Shantou Institute of Ultrasonic Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243178: Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243178", "people": [{"name": "Zeqin Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243178%22"}, {"id": "trialreg:NCT06902584", "company": "CooperVision International Limited (CVIL)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: North American Comfilcon A Clinical Study", "source_url": "https://clinicaltrials.gov/study/NCT06902584"}, {"id": "trialreg:NCT06902610", "company": "Poppins", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-30", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Examining the Medium-term Effect on Non Inferiority of the Previous Training With the DMD Poppins Clinical for Cognitive, Musical Training in Addition to Bi-monthly Speech and Reading Therapy on Reading Writing Abilities of Pediatric Patients With SLD Reading VS Control Group", "source_url": "https://clinicaltrials.gov/study/NCT06902610"}, {"id": "fda:K242618", "company": "Precision Neuroscience, Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242618: Layer 7-T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618", "people": [{"name": "Shruti Jayakumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242618%22"}, {"id": "fda:K250601", "company": "Alpha Omega Engineering , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250601: Neuro Omega System; NeuroSmart System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250601", "people": [{"name": "Efrat Shamgar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250601%22"}, {"id": "nih:1R43DE034322-01", "company": "Ther-ai LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": 306633, "summary": "NIH award 1R43DE034322-01: CraniaMap: Joint Solution for Auto-Segmentation and Landmarking from CBCT Scans ($306,633)", "source_url": "https://reporter.nih.gov/project-details/11006192", "people": [{"name": "Wade Han", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06899919", "company": "Laboratoires URGO", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)", "source_url": "https://clinicaltrials.gov/study/NCT06899919"}, {"id": "trialreg:NCT06899659", "company": "Zimmer Biomet", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation on Safety and Effectiveness of the An All-inside, All-suture Meniscal Repair Device", "source_url": "https://clinicaltrials.gov/study/NCT06899659"}, {"id": "trialreg:NCT06899646", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EXOMIND (BTL-699-2) for Improvement of Mental Well-being", "source_url": "https://clinicaltrials.gov/study/NCT06899646"}, {"id": "fda:K250596", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250596: Arthrex FiberTak Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250596", "people": [{"name": "Ruth Segall", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250596%22"}, {"id": "fda:K244030", "company": "Wuxi Jiajian Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244030: Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244030", "people": [{"name": "Wenqing Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244030%22"}, {"id": "fda:DEN240020", "company": "Visby Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240020: Visby Medical Women's Sexual Health Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240020", "people": [{"name": "Jennifer Albrecht", "role": "510(k) submission contact"}]}, {"id": "fda:K250571", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250571: CATALYSTEM Femoral Stems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250571", "people": [{"name": "Chelsea Bagley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250571%22"}, {"id": "fda:K234067", "company": "Medphoton GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234067: ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234067", "people": [{"name": "Thomas Fessmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234067%22"}, {"id": "fda:K241927", "company": "Synthes GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241927: Synthes Graphic Case & Tray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241927", "people": [{"name": "Thomas Shea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241927%22"}, {"id": "fda:K243520", "company": "Turing Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243520: Bullsai Confirm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243520", "people": [{"name": "Christa Nova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243520%22"}, {"id": "fda:K243228", "company": "Convatec", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243228: Flexi-Seal AIR (with ENFit Connector)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243228", "people": [{"name": "Michael Chitiyo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243228%22"}, {"id": "fda:K242022", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242022: Access Toxo IgG", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242022", "people": [{"name": "Audree Demmers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242022%22"}, {"id": "fda:K244044", "company": "Selux Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244044: PBC Separator with Selux AST System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244044", "people": [{"name": "Carrene Plummer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244044%22"}, {"id": "fda:K242952", "company": "Siemens Healthcare Diagnostic Products GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242952: INNOVANCE Antithrombin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242952", "people": [{"name": "Martina Pfeiff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242952%22"}, {"id": "fda:K233953", "company": "Makani Science, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233953: Makani Science\u0099 Respiration Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233953", "people": [{"name": "Michael Chu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233953%22"}, {"id": "denovo:DEN240020", "company": "Visby Medical, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-03-28", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240020 granted: Visby Medical Women's Sexual Health Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240020"}, {"id": "breakthrough:K244044", "company": "Selux Diagnostics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-03-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K244044: PBC SEPARATOR WITH SELUX AST SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R43AI181482-02", "company": "Bioamp Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": 79309, "summary": "NIH award 5R43AI181482-02: Evolving the standard of care for carbapenem resistant infections, through the development of a phenotypic assay capable of DETECTing and classifying carbapenemases ($79,309)", "source_url": "https://reporter.nih.gov/project-details/11064781", "people": [{"name": "Nicole Jackson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43DE034324-01", "company": "Greenmark Biomedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": 294632, "summary": "NIH award 1R43DE034324-01: Improving Caries Diagnosis with Targeted Nanoparticle-Enhanced AI-Assisted Intraoral Imaging ($294,632)", "source_url": "https://reporter.nih.gov/project-details/11006908", "people": [{"name": "Nathan Andrew Jones", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43MH135674-02", "company": "Empathy Rocks Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": 223705, "summary": "NIH award 5R43MH135674-02: Empathy for Everyone: Generative AI that Improves Patient-Provider Cultural Attunement in Real Time ($223,705)", "source_url": "https://reporter.nih.gov/project-details/11082351", "people": [{"name": "Sarah Peregrine Lord", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT06898515", "company": "Reprieve Cardiovascular, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)", "source_url": "https://clinicaltrials.gov/study/NCT06898515"}, {"id": "trialreg:NCT06898411", "company": "Ivoclar Vivadent AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation on the Longevity of Glass Ceramic Based Single Tooth Restorations", "source_url": "https://clinicaltrials.gov/study/NCT06898411"}, {"id": "fda:K243426", "company": "Headsafe Mfg Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243426: Nurochek-Pro System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243426", "people": [{"name": "Dylan Mahony", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243426%22"}, {"id": "fda:K243768", "company": "Restor3D, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243768: iTotal\u00ae Identity\u0099 Cruciate Retaining 3DP Porous Knee Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243768", "people": [{"name": "Brianna Prindle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243768%22"}, {"id": "fda:K250555", "company": "Biocorp Production", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250555: MallyaD injection pen adapter (MallyaD)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250555", "people": [{"name": "Alexia Garin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250555%22"}, {"id": "fda:K242201", "company": "Threadstone, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242201: HyperSuture White/Green Extension Line", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242201", "people": [{"name": "Jeremy Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242201%22"}, {"id": "fda:K241785", "company": "Fotona D.O.O.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241785: StarFormer (M008-3T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241785", "people": [{"name": "Tina Bartolic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241785%22"}, {"id": "fda:K243038", "company": "Artrya Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243038: Salix Central", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243038", "people": [{"name": "Gabriela Quijada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243038%22"}, {"id": "fda:K244059", "company": "Access Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244059: HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244059", "people": [{"name": "Scott Blood", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244059%22"}, {"id": "fda:K250558", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250558: SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250558", "people": [{"name": "Samiksha Tiwari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250558%22"}, {"id": "fda:K241962", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241962: Crossloop", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241962", "people": [{"name": "Katsuhiko Fujimura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241962%22"}, {"id": "fda:K244046", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244046: Edwards eSheath Optima introducer set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244046", "people": [{"name": "Andrea Gasca", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244046%22"}, {"id": "fda:K241862", "company": "Zmi Electronics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241862: Levina Pelvic Floor Muscle Stimulator (RS-48)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241862", "people": [{"name": "Lawrence Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241862%22"}, {"id": "fda:K242745", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242745: AI-Rad Companion Organs RT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242745", "people": [{"name": "Kira Morales", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242745%22"}, {"id": "fda:K242919", "company": "V5med, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242919: V5med Lung AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242919", "people": [{"name": "Ining Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242919%22"}, {"id": "fda:K243708", "company": "Scivita Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243708: Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243708", "people": [{"name": "Ruqin Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243708%22"}, {"id": "fda:K250092", "company": "HC Biologics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250092: HC Biologics Osteopoint Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250092", "people": [{"name": "Onur Basol", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250092%22"}, {"id": "nih:6R44MH134719-02", "company": "Friendi.fi Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": 614157, "summary": "NIH award 6R44MH134719-02: Optimizing and testing the care.coach avatar as a personalized, engaging and adaptive virtual health assistant for maximizing functional and quality of life outcomes in autistic young adults. ($614,157)", "source_url": "https://reporter.nih.gov/project-details/11163722", "people": [{"name": "Chantal M Kerssens", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT06895070", "company": "XVIVO Perfusion", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)", "source_url": "https://clinicaltrials.gov/study/NCT06895070"}, {"id": "trialreg:NCT06897280", "company": "Nevro Corp", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial of MED HF10\u2122 Spinal Cord Stimulation for the Treatment of Chronic Pain", "source_url": "https://clinicaltrials.gov/study/NCT06897280"}, {"id": "trialreg:NCT06895967", "company": "Takeda", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of TAK-881 and HyQvia in Healthy Adults", "source_url": "https://clinicaltrials.gov/study/NCT06895967"}, {"id": "trialreg:NCT06896734", "company": "Seers Technology Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: mobiCARE\u2122 ECG Monitoring System", "source_url": "https://clinicaltrials.gov/study/NCT06896734"}, {"id": "trialreg:NCT06895889", "company": "Epibone, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EB-OC for the Treatment of Focal Chondral/Osteochondral Defects in the Knee", "source_url": "https://clinicaltrials.gov/study/NCT06895889"}, {"id": "trialreg:NCT06895590", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial", "source_url": "https://clinicaltrials.gov/study/NCT06895590"}, {"id": "trialreg:NCT06895603", "company": "Philips Clinical & Medical Affairs Global", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)", "source_url": "https://clinicaltrials.gov/study/NCT06895603"}, {"id": "trialreg:NCT06895187", "company": "LUMA Vision Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Catheter Ablation Using a Novel Navigation and Imaging System", "source_url": "https://clinicaltrials.gov/study/NCT06895187"}, {"id": "trialreg:NCT06897163", "company": "Ampa Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A New Method for Ileostomy Output Collection Using an Intestinal Tampon", "source_url": "https://clinicaltrials.gov/study/NCT06897163"}, {"id": "fda:K243840", "company": "Bridge TO Life", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243840: Belzer MPS\u00ae (UW Machine Perfusion Solution) (BMPS-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243840", "people": [{"name": "Mark Harper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243840%22"}, {"id": "fda:K240189", "company": "Mde Orvosbiol\u00f3giai Kutat\u00f3, Fejleszto,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240189: NM-01/CPT neurometer (NM-01/CPT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240189", "people": [{"name": "Aba Tomjanovich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240189%22"}, {"id": "fda:K250542", "company": "Arrow International, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250542: AC3\u0099 Range\u0099 Intra-Aortic Balloon Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250542", "people": [{"name": "Apurva Gokhale", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250542%22"}, {"id": "fda:K243831", "company": "AZmed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243831: Rayvolve LN", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243831", "people": [{"name": "Christelle Baille", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243831%22"}, {"id": "fda:K242669", "company": "Kent Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242669: SnapshotGLO (KB100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242669", "people": [{"name": "Hitalo Arume", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242669%22"}, {"id": "fda:K243995", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243995: Arthrex Humeral Plating System and Cerclage Button", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243995", "people": [{"name": "Ivette Galmez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243995%22"}, {"id": "fda:K243891", "company": "Earlitec Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243891: EarliPoint System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243891", "people": [{"name": "Ryan Bormann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243891%22"}, {"id": "fda:K250134", "company": "Ningbo Youhuan Automation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250134: Power Wheelchair (YH-E6011,YH-E6013A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250134", "people": [{"name": "Francis Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250134%22"}, {"id": "fda:K241855", "company": "Sb-Kawasumi Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241855: SB Knife Jr2 (MD-47702 and MD-47702L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241855", "people": [{"name": "Kenichi Inamura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241855%22"}, {"id": "fda:K250194", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250194: Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250194", "people": [{"name": "Yang Blue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250194%22"}, {"id": "fda:K244003", "company": "Kunshan Hi-Fortune Health Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244003: Electrically powered wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244003", "people": [{"name": "Zhanli Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244003%22"}, {"id": "nih:5R43HL176331-02", "company": "Ventsafe, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-25", "observed": "2026-08-21", "amount_usd": 288855, "summary": "NIH award 5R43HL176331-02: VENTSAFE\u2122 Life Saving Ventilation for the Treatment of ARDS ($288,855)", "source_url": "https://reporter.nih.gov/project-details/11175442", "people": [{"name": "Dean Antony Barker", "role": "Principal Investigator"}, {"name": "Sean Degmetich", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44AR085500-01", "company": "Peer Technologies, PLLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-25", "observed": "2026-08-21", "amount_usd": 830712, "summary": "NIH award 1R44AR085500-01: Smart Cavity Creator Drill for Lumbar Interbody Fusion: Direct to Phase II ($830,712)", "source_url": "https://reporter.nih.gov/project-details/11076616", "people": [{"name": "Sohail K Mirza", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06894615", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EXOMIND (BTL-995) for the Reduction of Binge-eating", "source_url": "https://clinicaltrials.gov/study/NCT06894615"}, {"id": "trialreg:NCT06894303", "company": "Advanced Bionics AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up", "source_url": "https://clinicaltrials.gov/study/NCT06894303"}, {"id": "trialreg:NCT06893952", "company": "Vascutek Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Technical Evaluation and Results of the Use of TREO\u00ae Modular Aortic Endografts for the Treatment of Abdominal Aortic Aneurysms", "source_url": "https://clinicaltrials.gov/study/NCT06893952"}, {"id": "trialreg:NCT06894407", "company": "Sona Nanotech Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Intratumoral Targeted Hyperthermia Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma", "source_url": "https://clinicaltrials.gov/study/NCT06894407"}, {"id": "trialreg:NCT06894160", "company": "MarsiBionics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases", "source_url": "https://clinicaltrials.gov/study/NCT06894160"}, {"id": "trialreg:NCT06893588", "company": "Vesalio", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts", "source_url": "https://clinicaltrials.gov/study/NCT06893588"}, {"id": "fda:K250668", "company": "Inquis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250668: Aventus Thrombectomy System (IM-2100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250668", "people": [{"name": "Zachary Woodson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250668%22"}, {"id": "fda:K250225", "company": "Bolt Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250225: Bolt Intravascular Lithotripsy (IVL) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250225", "people": [{"name": "Stephanie Onstot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250225%22"}, {"id": "nih:5R44GM145194-03", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": 1235487, "summary": "NIH award 5R44GM145194-03: System for unitary automation of library preparation ($1,235,487)", "source_url": "https://reporter.nih.gov/project-details/11092107", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DA056259-03", "company": "Sonara Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": 865116, "summary": "NIH award 5R44DA056259-03: Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care ($865,116)", "source_url": "https://reporter.nih.gov/project-details/11084433", "people": [{"name": "MICHAEL L. DENNIS", "role": "Principal Investigator"}, {"name": "Michael Giles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06892028", "company": "Wave Neuroscience", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EEG-based Personalized Transcranial Magnetic Stimulation (eTMS) to Treat Post-Traumatic Stress Disorder", "source_url": "https://clinicaltrials.gov/study/NCT06892028"}, {"id": "trialreg:NCT06891898", "company": "Beta Bionics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The iLet Experience Study", "source_url": "https://clinicaltrials.gov/study/NCT06891898"}, {"id": "trialreg:NCT06891755", "company": "Apreo Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3", "source_url": "https://clinicaltrials.gov/study/NCT06891755"}, {"id": "trialreg:NCT06891729", "company": "Next Life Sciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Plan A Novel Delivery Device Study", "source_url": "https://clinicaltrials.gov/study/NCT06891729"}, {"id": "trialreg:NCT06891781", "company": "Newronika", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Investigating Adaptive Deep Brain Stimulation in Parkinson's Disease Management", "source_url": "https://clinicaltrials.gov/study/NCT06891781"}, {"id": "fda:K243865", "company": "Aurora Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243865: AERO MIS Facet Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243865", "people": [{"name": "Laszlo Garamszegi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243865%22"}, {"id": "fda:K250603", "company": "Innovasis", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250603: AxTiHA\u00ae Stand-Alone ALIF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250603", "people": [{"name": "Mr. Mike Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250603%22"}, {"id": "fda:K250125", "company": "Xplr , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250125: LMNT O2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250125", "people": [{"name": "Izhaki Meital", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250125%22"}, {"id": "fda:K243930", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243930: Sonopet iQ Ultrasonic Aspirator System (5500-050-000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243930", "people": [{"name": "Louise Keane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243930%22"}, {"id": "fda:K242356", "company": "Restor3D, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242356: TIDAL Fusion Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242356", "people": [{"name": "Brianna Prindle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242356%22"}, {"id": "fda:K243525", "company": "PAJUNK GmbH Medizintechnologie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243525: SonoTAP and SonoTAP II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243525", "people": [{"name": "Christian Quass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243525%22"}, {"id": "fda:K250182", "company": "Innovasis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250182: Innovasis Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250182", "people": [{"name": "Michael Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250182%22"}, {"id": "fda:K243991", "company": "Total Joint Othopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243991: Klassic Knee System - Revision Tibial Baseplate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243991", "people": [{"name": "Bobbi Siddoway", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243991%22"}, {"id": "fda:K243642", "company": "Bard Peripheral Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243642: UltraCor\u0099 Twirl\u0099 Breast Tissue Marker", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243642", "people": [{"name": "Meghan McKelvey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243642%22"}, {"id": "fda:K241921", "company": "Abbott Molecular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241921: Alinity m BKV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241921", "people": [{"name": "Gina Sammarco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241921%22"}, {"id": "fda:K250013", "company": "Control Medical Technology, Inc. / Dba Ventiv Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250013: VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250013", "people": [{"name": "Shawn Fojtik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250013%22"}, {"id": "fda:K243052", "company": "Bright Uro, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243052: Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243052", "people": [{"name": "Dr. Roychowdhury Suranjan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243052%22"}, {"id": "fda:K242893", "company": "Luma Vision Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242893: VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242893", "people": [{"name": "Marta Walker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242893%22"}, {"id": "breakthrough:K242356", "company": "Restor3d, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-03-24", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K242356: TIDAL FUSION CAGE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44DC019586-05", "company": "Restorear Devices, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": 329169, "summary": "NIH award 5R44DC019586-05: Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation ($329,169)", "source_url": "https://reporter.nih.gov/project-details/11052557", "people": [{"name": "Curtis Scott King", "role": "Principal Investigator"}, {"name": "Suhrud M. Rajguru", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "trialreg:NCT06889298", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EXOMIND (BTL-699) for the Reduction of Food Cravings", "source_url": "https://clinicaltrials.gov/study/NCT06889298"}, {"id": "trialreg:NCT06888934", "company": "Novastep", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes With Lync", "source_url": "https://clinicaltrials.gov/study/NCT06888934"}, {"id": "fda:K242107", "company": "Casebioscience, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242107: CaseMONO\u0099 Culture (CMON); CaseMONO\u0099 w/HEPES (WHMO); CaseBioscience\u00ae HTF (HTFC); CaseBioscience\u00ae HTF w/HEPES (HHTF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242107", "people": [{"name": "Monica Mezezi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242107%22"}, {"id": "fda:K243808", "company": "AZmed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243808: Rayvolve PTX-PE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243808", "people": [{"name": "Anthony Joseph", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243808%22"}, {"id": "fda:K242909", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242909: FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242909", "people": [{"name": "Aeree Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242909%22"}, {"id": "fda:K242564", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242564: Autoclavable Cassette (Glidewell HT\u0099 Implant Guided Surgical Kit, Glidewell HT\u0099 Implant Surgical Kit, Glidewell\u0099 Prosthetic Kit)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242564", "people": [{"name": "Haiyan Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242564%22"}, {"id": "fda:K243185", "company": "Epitel", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243185: REMI Remote EEG Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243185", "people": [{"name": "Christopher Phillips", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243185%22"}, {"id": "fda:K243649", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243649: BD Vacutainer\u00ae Multiple Sample Luer Adapter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243649", "people": [{"name": "Eva Zapletal Sawyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243649%22"}, {"id": "fda:K241833", "company": "Vitromed GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241833: V-GRAD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241833", "people": [{"name": "Greg Holland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241833%22"}, {"id": "fda:K250517", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250517: Navigator\u0099 HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator\u0099 HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator\u0099 HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator\u0099 HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator\u0099 HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator\u0099 HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator\u0099 HD Ureteral Access Sheath Set 13/15 F x 28cm (M006", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250517", "people": [{"name": "Timilehin Adenekan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250517%22"}, {"id": "fda:K250106", "company": "Signos, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250106: Signos Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250106", "people": [{"name": "Trevor Denbo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250106%22"}, {"id": "fda:K243451", "company": "Erbe Elektromedizin GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243451: FiAPC plus probes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243451", "people": [{"name": "Matthias Kollek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243451%22"}, {"id": "fda:K250561", "company": "Natural Cycles Nordic AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250561: Natural Cycles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250561", "people": [{"name": "Megan Callanan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250561%22"}, {"id": "fda:K250186", "company": "Getset Surgical, SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250186: GoLIF! Lumbar Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250186", "people": [{"name": "Jowita Sokalska", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250186%22"}, {"id": "fda:K241890", "company": "Philips Medizin Systeme B\u00f6blingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241890: Philips Holter Analysis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241890", "people": [{"name": "Cathy Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241890%22"}, {"id": "fda:K243958", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243958: Consolidated Operating Room Equipment (CORE) 2 Console", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243958", "people": [{"name": "Leandra Burke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243958%22"}, {"id": "fda:K243630", "company": "Solar LS Cjsc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243630: Medical Laser System Incanto / Evoline Platinum /Evoline", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243630", "people": [{"name": "Dmitry Kiselevich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243630%22"}, {"id": "fda:K240761", "company": "Yukon Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240761: Arisure\u00ae Closed Male Luer with Spike Adapter (YM060)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240761", "people": [{"name": "Todd Korogi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240761%22"}, {"id": "fda:K250556", "company": "Ventris Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250556: Porous Biologic Scaffold", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250556", "people": [{"name": "John Brunelle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250556%22"}, {"id": "fda:K243980", "company": "Kico Knee Innovation Company Pty Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243980: ARVIS Surgical Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243980", "people": [{"name": "Ryan Matthew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243980%22"}, {"id": "fda:K250513", "company": "Cytovale, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250513: IntelliSep Test (CV-ICG-048)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250513", "people": [{"name": "Sarah Esterquest", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250513%22"}, {"id": "fda:K242289", "company": "Stryker Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242289: Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242289", "people": [{"name": "Manmeet Chawla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242289%22"}, {"id": "fda:K243032", "company": "Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243032: EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243032", "people": [{"name": "Zhengzhou Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243032%22"}, {"id": "fda:K242888", "company": "Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242888: Electrohydraulic Lithotriptor (TCS-B3-II)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242888", "people": [{"name": "Zhengzhou Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242888%22"}, {"id": "fda:K241065", "company": "Dentis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241065: ChecQ (AC100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241065", "people": [{"name": "Gyeong-Seob Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241065%22"}, {"id": "fda:K242053", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242053: FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242053", "people": [{"name": "Timothy Groves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242053%22"}, {"id": "fda:K250403", "company": "Tenon Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250403: Catamaran SI Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250403", "people": [{"name": "Richard Ginn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250403%22"}, {"id": "nih:5R44ES032369-03", "company": "Zebra Analytix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": 919218, "summary": "NIH award 5R44ES032369-03: Autonomous Monitor for Toxic Gas Exposure ($919,218)", "source_url": "https://reporter.nih.gov/project-details/11075331", "people": [{"name": "John Anthony Michalek", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06885073", "company": "Compremium AG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Non-invasive Central Venous Pressure Estimation in Pediatric Patients", "source_url": "https://clinicaltrials.gov/study/NCT06885073"}, {"id": "trialreg:NCT06885099", "company": "FemPulse Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Ease of Use Study of the FemPulse System", "source_url": "https://clinicaltrials.gov/study/NCT06885099"}, {"id": "trialreg:NCT06885502", "company": "Eodyne Systems SL", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)", "source_url": "https://clinicaltrials.gov/study/NCT06885502"}, {"id": "trialreg:NCT06885177", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: TECTONIC CAD IVL IDE Study", "source_url": "https://clinicaltrials.gov/study/NCT06885177"}, {"id": "trialreg:NCT06885931", "company": "Amber Therapeutics Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)", "source_url": "https://clinicaltrials.gov/study/NCT06885931"}, {"id": "trialreg:NCT06887465", "company": "Vena Vitals", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Non-invasive and Continuous Blood Pressure Monitoring", "source_url": "https://clinicaltrials.gov/study/NCT06887465"}, {"id": "trialreg:NCT06885112", "company": "Lumenis Be Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Study to Evaluate the Improvement in Hair Loss in Skin of Color Treated With Fractional Non-Ablative Laser", "source_url": "https://clinicaltrials.gov/study/NCT06885112"}, {"id": "trialreg:NCT06886113", "company": "Shenzhen Core Medical Technology CO.,LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial", "source_url": "https://clinicaltrials.gov/study/NCT06886113"}, {"id": "trialreg:NCT06885775", "company": "Dexlevo", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-20", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Purpose of This Study is the Demonstration of Safety and Efficacy of the Dermal Fillers DXP01 Temporary Improvement of Moderate to Severe Nasolabial Folds", "source_url": "https://clinicaltrials.gov/study/NCT06885775"}, {"id": "fda:K243292", "company": "Avatar Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243292: brAIn\u0099 Shoulder Positioning", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243292", "people": [{"name": "Adeline Francois", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243292%22"}, {"id": "fda:K241884", "company": "Hunan Haipuming Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241884: HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241884", "people": [{"name": "Mingxuan Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241884%22"}, {"id": "fda:K243922", "company": "Meridian Bioscience, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243922: Revogene", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243922", "people": [{"name": "Whitney Rooker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243922%22"}, {"id": "fda:K241961", "company": "Vent Creativity", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241961: Vent Creativity Knee v1.0 (Hermes)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241961", "people": [{"name": "Craig Vittorio", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241961%22"}, {"id": "fda:K242958", "company": "Joylux, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242958: Joylux Intimacy Gel (PG3100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242958", "people": [{"name": "Colette Courtion", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242958%22"}, {"id": "fda:K243988", "company": "Riverpoint Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243988: RootMend MRR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243988", "people": [{"name": "Jacquelyn Pinnel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243988%22"}, {"id": "fda:K241704", "company": "Hangzhou AGS MedTech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241704: Endoscopic Water Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241704", "people": [{"name": "Yanping Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241704%22"}, {"id": "fda:K242770", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242770: EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242770", "people": [{"name": "YeongSuk An", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242770%22"}, {"id": "fda:K243016", "company": "Spectrawave, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243016: Starlight Imaging Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243016", "people": [{"name": "Ankit Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243016%22"}, {"id": "fda:K242771", "company": "Kyocera Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242771: Tesera-k PL System and Tesera-k XL System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242771", "people": [{"name": "Dennis Ty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242771%22"}, {"id": "fda:K243975", "company": "Pixee Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243975: Knee+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243975", "people": [{"name": "Fran\u00e7ois Beaumont", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243975%22"}, {"id": "fda:K250463", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250463: Ameda GLO Wearable Breast Pump (Model W8S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250463", "people": [{"name": "Yang Xiaoyan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250463%22"}, {"id": "fda:K250468", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250468: iSLEEVE Introducer Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250468", "people": [{"name": "Elizabeth LaDriere", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250468%22"}, {"id": "fda:K243928", "company": "Cardiovia , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243928: ViaOne Epicardial Access System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243928", "people": [{"name": "Orly Maor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243928%22"}, {"id": "breakthrough:K243928", "company": "Cardiovia, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-03-20", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K243928: VIAONE EPICARDIAL ACCESS SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43DA063260-01", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": 386452, "summary": "NIH award 1R43DA063260-01: Rapid Fingerstick Diagnostics for Opioid and Stimulant Use Disorders ($386,452)", "source_url": "https://reporter.nih.gov/project-details/11169097", "people": [{"name": "Eric Ervin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI157508-03", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": 996914, "summary": "NIH award 5R44AI157508-03: Rapid point-of-care molecular test for HCV VL ($996,914)", "source_url": "https://reporter.nih.gov/project-details/11064785", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44HD104539-03", "company": "Zsx Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 2R44HD104539-03: Zip-stitch for Laparoscopic Hysterectomy - Clinical Validation ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11068352", "people": [{"name": "Dan C Mazzucco", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06884202", "company": "Alcon Research", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Delefilcon A Contact Lenses", "source_url": "https://clinicaltrials.gov/study/NCT06884202"}, {"id": "trialreg:NCT06883617", "company": "Lunair Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Neurostimulation for Sleep Disordered Breathing", "source_url": "https://clinicaltrials.gov/study/NCT06883617"}, {"id": "fda:K243689", "company": "Coreline Soft Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243689: AVIEW", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243689", "people": [{"name": "Park Hyeyi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243689%22"}, {"id": "fda:K243092", "company": "Acurable Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243092: AcuPebble Ox (200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243092", "people": [{"name": "Esther Rodriguez Villegas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243092%22"}, {"id": "fda:K241791", "company": "Gigaalaser Company , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241791: Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241791", "people": [{"name": "Xinxing Nie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241791%22"}, {"id": "fda:DEN240018", "company": "Nanosonics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240018: CORIS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240018", "people": [{"name": "Nancy Kaiser", "role": "510(k) submission contact"}]}, {"id": "fda:K250131", "company": "Mustech Electronics Co., Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250131: IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250131", "people": [{"name": "Kevin Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250131%22"}, {"id": "fda:K250210", "company": "Scivita Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250210: Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250210", "people": [{"name": "Wu Ruqin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250210%22"}, {"id": "fda:K250042", "company": "Peek Health, S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250042: PeekMed web", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250042", "people": [{"name": "Sara Silva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250042%22"}, {"id": "fda:K250429", "company": "Macromedics BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250429: DSPS-Prominent\u00ae baseplate, MR (113820); DSPS-Prominent\u00ae baseplate (113120); DSPS-Prominent\u00ae Cradle-I (113140); DSPS-Prominent\u00ae Cradle-II (113150); DSPS-Prominent\u00ae Cradle-III (113160); DSPS-Prominent\u00ae Cradle-IV (113170); DSPS-Prominent\u00ae Cradle-VI (113180); DSPS-Prominent\u00ae Cradle-VII (113260); Mask DSPS\u00ae-PROSCVRL set/5 (113760); Mask DSPS\u00ae-PROSC set/5 (113770); Mask DSPS\u00ae-PROSCVR set/5 (113780); Mask DSPS\u00ae-PROSCL set/5 (113790); Mask DSPS\u00ae-PROSHVRL set/5 (113890); Mask DSPS\u00ae-PROSH set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250429", "people": [{"name": "Elizabeth Hajos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250429%22"}, {"id": "fda:K243472", "company": "Campomats S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243472: 1NEED Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243472", "people": [{"name": "Mats Erik Andreasson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243472%22"}, {"id": "fda:K250171", "company": "Shenzhen Yang WO Electronic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250171: IPL Hair Removal Device (BE965A, BE965B, BE965C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250171", "people": [{"name": "Ken Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250171%22"}, {"id": "fda:K241842", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241842: Luer-Split MAJ-2092", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241842", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241842%22"}, {"id": "fda:K243999", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243999: TriMed Ankle Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243999", "people": [{"name": "Divya Raghavi Nandakumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243999%22"}, {"id": "fda:K250502", "company": "Safesource Direct, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250502: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250502", "people": [{"name": "Courtney Cormier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250502%22"}, {"id": "fda:K242241", "company": "ShenB Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242241: Sunny", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242241", "people": [{"name": "Sunny Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242241%22"}, {"id": "fda:K242486", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242486: Tyber Medical Anatomical Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242486", "people": [{"name": "Chelsea Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242486%22"}, {"id": "fda:K243987", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243987: TriMed Elbow and Forearm System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243987", "people": [{"name": "Mikayla German", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243987%22"}, {"id": "fda:K243443", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243443: EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243443", "people": [{"name": "Juhee Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243443%22"}, {"id": "denovo:DEN240018", "company": "Nanosonics Limited", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-03-19", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240018 granted: CORIS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240018"}, {"id": "trialreg:NCT06881394", "company": "Miller Biosciences LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Polymer Film Device to Treat Excessive Palmar Sweating", "source_url": "https://clinicaltrials.gov/study/NCT06881394"}, {"id": "trialreg:NCT06882395", "company": "Neodent", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Impact of Aligner Replacement Protocols on Predictability of Planned Dental Movements: Evaluation of Double Aligner", "source_url": "https://clinicaltrials.gov/study/NCT06882395"}, {"id": "trialreg:NCT06881667", "company": "Onera BV", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: US Development and Evaluation Study of a Patch-Based PSG System", "source_url": "https://clinicaltrials.gov/study/NCT06881667"}, {"id": "trialreg:NCT06882408", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Objective of This Study is to Evaluate the Perfomance of a Photorefraction Device for Screening Ametropia in Children. Eligible Participants Will Undergo Multiple Refractive Error Measurements, Visual Acuity and Strabismus Assessments During a Single Evaluation Visit.", "source_url": "https://clinicaltrials.gov/study/NCT06882408"}, {"id": "fda:K240287", "company": "Hangzhou Laihe Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240287: LYHER\u00ae Oral fluid Multi-Drug Test Kit (Cube)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240287", "people": [{"name": "Chen Yaohua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240287%22"}, {"id": "fda:K242533", "company": "Better Care Plastic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242533: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242533", "people": [{"name": "Chunyan Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242533%22"}, {"id": "fda:K243807", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243807: Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243807", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243807%22"}, {"id": "fda:K241783", "company": "Vy Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241783: FortiVy\u0099 OsteoVy\u0099 Lumbar IBF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241783", "people": [{"name": "Jordan Hendrickson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241783%22"}, {"id": "fda:K243556", "company": "Iray Imaging Technology (Haining) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243556: Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243556", "people": [{"name": "Junjie Qian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243556%22"}, {"id": "fda:K250413", "company": "Shenzhen Perfect Idea Technology Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250413: Aglaia LED Beauty Device (BP-D2309)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250413", "people": [{"name": "Zhuo Zhan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250413%22"}, {"id": "fda:K242161", "company": "Radlink, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242161: Radlink GPS Pro Imaging", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242161", "people": [{"name": "Victoria Nadershahi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242161%22"}, {"id": "fda:K242683", "company": "Quibim S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242683: QP-Prostate\u00ae CAD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242683", "people": [{"name": "Angel Alberich Bayarri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242683%22"}, {"id": "fda:K240933", "company": "Global Healthcare SG Sdn. Bhd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240933: CarbonCool\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240933", "people": [{"name": "Keng Liang Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240933%22"}, {"id": "fda:K243553", "company": "Teleflex Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243553: QuikClot Control+ Hemostatic Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243553", "people": [{"name": "Jane Doll", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243553%22"}, {"id": "fda:K250494", "company": "OsteoCentric Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250494: The OsteoCentric Bone Plate and Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250494", "people": [{"name": "Todd Evans", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250494%22"}, {"id": "fda:K241937", "company": "Klarity Medical & Equipment (GZ) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241937: Klarity SGRT System (ARSG-E1A, ARSG-E3A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241937", "people": [{"name": "Guohuang Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241937%22"}, {"id": "fda:K241729", "company": "Whip Mix Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241729: Hard Splint & Thermo-Adaptive Splint", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241729", "people": [{"name": "Meena Muniaswamy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241729%22"}, {"id": "trialreg:NCT06880133", "company": "Heart Force Medical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Expansion of SCG/GCG-Based CAD Sceering: Inclusion of Healthy Controls and CCTA Patients", "source_url": "https://clinicaltrials.gov/study/NCT06880133"}, {"id": "trialreg:NCT06878508", "company": "Shenzhen Core Medical Technology CO.,LTD.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: DuoCor Ventricular Assist System Early Feasibility Study", "source_url": "https://clinicaltrials.gov/study/NCT06878508"}, {"id": "trialreg:NCT06878911", "company": "Smart Alfa Teknoloji San. ve Tic. A.S.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Validation of Nerveblox, an Artificial Intelligence Software to Support Ultrasound-Guided Regional Anesthesia Procedures", "source_url": "https://clinicaltrials.gov/study/NCT06878911"}, {"id": "trialreg:NCT06880120", "company": "Heart Force Medical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Diagnostic Accuracy Of Seismocardiography for Coronary Artery Disease", "source_url": "https://clinicaltrials.gov/study/NCT06880120"}, {"id": "fda:K241975", "company": "Serv Medical Pte., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241975: SERV MEDICAL CDSS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241975", "people": [{"name": "Jing Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241975%22"}, {"id": "fda:K250514", "company": "Specialty Water Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250514: UPT Series Medical RO Water Treatment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250514", "people": [{"name": "Alex Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250514%22"}, {"id": "fda:K242140", "company": "Jiale Health Technology Shenzhen Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242140: Air Compression Leg Massager (K-705)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242140", "people": [{"name": "Lixun Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242140%22"}, {"id": "fda:K243867", "company": "Lagis Enterprise Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243867: LAGIS Suction Irrigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243867", "people": [{"name": "Lynn Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243867%22"}, {"id": "fda:K243504", "company": "Centervue S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243504: MAIA (AHMACME001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243504", "people": [{"name": "Luca Scienza", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243504%22"}, {"id": "fda:K244056", "company": "Cranial Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244056: DOC Band 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244056", "people": [{"name": "Jeff Riggs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244056%22"}, {"id": "fda:K243862", "company": "Dia Imaging Analysis, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243862: LVivo Software Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243862", "people": [{"name": "Michal Yaacobi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243862%22"}, {"id": "fda:K243646", "company": "Ziehm Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243646: Ziehm Solo FD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243646", "people": [{"name": "Cornelia Schildbach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243646%22"}, {"id": "fda:K250498", "company": "Orthonovis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250498: BPS Wrist Fracture System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250498", "people": [{"name": "Ken West", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250498%22"}, {"id": "fda:K243802", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243802: aprevo\u00ae anterior and lateral lumbar interbody fusion device, aprevo\u00ae anterior lumbar interbody fusion device with interfixation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243802", "people": [{"name": "Karen Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243802%22"}, {"id": "fda:K243869", "company": "The Magstim Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243869: Horizon\u00ae 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon\u00ae 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon\u00ae 3.0 TMS Therapy System (Horizon 3.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243869", "people": [{"name": "Alan Yik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243869%22"}, {"id": "fda:K250379", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250379: SIGNA Prime Elite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250379", "people": [{"name": "Glen Sabin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250379%22"}, {"id": "fda:K250439", "company": "Contract Medical International, GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250439: Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250439", "people": [{"name": "Jan Kubicek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250439%22"}, {"id": "nih:4R44HG013294-02", "company": "Survey Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": 1091941, "summary": "NIH award 4R44HG013294-02: Pioneering assays for spatially-resolved single-cell multiomics ($1,091,941)", "source_url": "https://reporter.nih.gov/project-details/11241688", "people": [{"name": "George Christopher Hartoularos", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT06876311", "company": "Silony Medical GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Observational Study to Evaluate the STALIF\u00ae C FLX, STALIF\u00ae M FLX, STALIF\u00ae L FLX Cages and FORTOS-C\u00ae", "source_url": "https://clinicaltrials.gov/study/NCT06876311"}, {"id": "trialreg:NCT06878300", "company": "HearX SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Assessing Functional Outcomes and User Experience of the Lexie B3 Pro Powered by Bose Over-the-counter Self-Fitting Hearing Aid", "source_url": "https://clinicaltrials.gov/study/NCT06878300"}, {"id": "trialreg:NCT06877546", "company": "Koite Health Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Photodynamic Treatment as Part of Oral Healthcare on Persons With Sj\u00f6gren's Syndrome", "source_url": "https://clinicaltrials.gov/study/NCT06877546"}, {"id": "trialreg:NCT06877520", "company": "Tau-MEDICAL Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment", "source_url": "https://clinicaltrials.gov/study/NCT06877520"}, {"id": "trialreg:NCT06877026", "company": "Echosens", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: FibroScan-Reproducibility and Repeatability Study", "source_url": "https://clinicaltrials.gov/study/NCT06877026"}, {"id": "fda:K242323", "company": "Moon Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242323: Maestro System (REF100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242323", "people": [{"name": "Anne Osdoit", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242323%22"}, {"id": "fda:K250267", "company": "Kettenbach GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250267: Visalys\u00ae Bulk Fill 1 x 4 g Syringe (15060); Visalys\u00ae Bulk Fill 15 x 0.25 g Caps (15062); Visalys\u00ae Bulk Flow 1 x 2 g Syringe (15064); Visalys\u00ae Bulk Flow 15 x 0.25 g Caps (15066); Visalys\u00ae Bulk Flow Intro pack (15067); Visalys\u00ae Bulk Intro pack (15068)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250267", "people": [{"name": "Marleen Steger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250267%22"}, {"id": "fda:K250526", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250526: Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250526", "people": [{"name": "Ruth Segall", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250526%22"}, {"id": "fda:K243332", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243332: Promisemed Safety Huber Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243332", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243332%22"}, {"id": "fda:K234012", "company": "bioMerieux, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234012: VITEK COMPACT PRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234012", "people": [{"name": "Craig Buehler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234012%22"}, {"id": "fda:K243353", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243353: One-Fil Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243353", "people": [{"name": "Da Hyeon Ku", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243353%22"}, {"id": "fda:K242010", "company": "Shenzhen Sanping Image Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242010: Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242010", "people": [{"name": "Pan Vincent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242010%22"}, {"id": "fda:K242811", "company": "Neurologica Corporation, A Subsidiary of Samsung", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242811: BodyTom 64", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242811", "people": [{"name": "Ninad Gujar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242811%22"}, {"id": "fda:K250091", "company": "Korot Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250091: KOROT Blood Pressure Monitor (KOROT P3 Accurate)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250091", "people": [{"name": "Muyeol Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250091%22"}, {"id": "fda:K241816", "company": "OrthoPediatrics Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241816: VerteGlide Spinal Growth Guidance System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241816", "people": [{"name": "Yan Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241816%22"}, {"id": "fda:K243599", "company": "Arrow International, LLC (A subsidiary of Teleflex, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243599: Arrow\u0099 Endurance\u0099 Extended Dwell Peripheral Catheter System (EDC-00818)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243599", "people": [{"name": "Kim Pennington", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243599%22"}, {"id": "fda:K241765", "company": "Dosisoft SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241765: PLANET Onco Dose (3.2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241765", "people": [{"name": "Marc Uszynski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241765%22"}, {"id": "fda:K242244", "company": "Lumea, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242244: Viewer+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242244", "people": [{"name": "Emre Gulturk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242244%22"}, {"id": "fda:K243838", "company": "Nexxt Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243838: NEXXT MATRIXX\u00ae SI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243838", "people": [{"name": "Andy Elsbury", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243838%22"}, {"id": "fda:K243931", "company": "Centers for Disease Control and Prevention", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243931: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243931", "people": [{"name": "Marie Kirby", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243931%22"}, {"id": "fda:K250079", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250079: Ruby XL System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250079", "people": [{"name": "Samyukta Rangachari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250079%22"}, {"id": "fda:K242121", "company": "Monogram Orthopaedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242121: mB\u00f4s (Monogram mB\u00f4s TKA System)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242121", "people": [{"name": "Patel Nisha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242121%22"}, {"id": "fda:K243529", "company": "Baxter Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243529: Solution Administration Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243529", "people": [{"name": "Meaghan Bonn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243529%22"}, {"id": "fda:K250401", "company": "Aion Biosystems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250401: AION TempShield\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250401", "people": [{"name": "Samara Barend", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250401%22"}, {"id": "fda:K241960", "company": "Nox Medical Ehf", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241960: DeepRESP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241960", "people": [{"name": "Kolbr\u00fan E Ott\u00f3sd\u00f3ttir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241960%22"}, {"id": "fda:K250025", "company": "Aidite (Qinhuangdao) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250025: Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250025", "people": [{"name": "Zhanfu Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250025%22"}, {"id": "trialreg:NCT06874361", "company": "Mi-Helper, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cooling to Alleviate Migraine #3", "source_url": "https://clinicaltrials.gov/study/NCT06874361"}, {"id": "trialreg:NCT06874101", "company": "Barron Associates, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients", "source_url": "https://clinicaltrials.gov/study/NCT06874101"}, {"id": "trialreg:NCT06873932", "company": "Neodent", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners", "source_url": "https://clinicaltrials.gov/study/NCT06873932"}, {"id": "trialreg:NCT06874504", "company": "Norbert Health", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Validation of the Norbert Health Device for Pulse Rate Measurement", "source_url": "https://clinicaltrials.gov/study/NCT06874504"}, {"id": "trialreg:NCT06874374", "company": "Pulvinar Neuro, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Individualized Non-invasive Brain Stimulation for the Treatment of Major Depressive Disorder", "source_url": "https://clinicaltrials.gov/study/NCT06874374"}, {"id": "fda:K250113", "company": "G.N.S Neolaser , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250113: neoLaser Laser Surgery Fibers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250113", "people": [{"name": "Gil Shapira", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250113%22"}, {"id": "fda:K241811", "company": "Medcad", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241811: MedCAD\u00ae AccuStride\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241811", "people": [{"name": "Brian Buss", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241811%22"}, {"id": "fda:K250380", "company": "Surgify Medical OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250380: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250380", "people": [{"name": "Jukka Kreander", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250380%22"}, {"id": "fda:K250255", "company": "Augmedics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250255: xvision Spine system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250255", "people": [{"name": "Tami Harel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250255%22"}, {"id": "fda:K242406", "company": "Sioxmed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242406: SiOxC Cream", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242406", "people": [{"name": "Adam Jorgensen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242406%22"}, {"id": "fda:K244022", "company": "Boston Aesthetics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244022: 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244022", "people": [{"name": "Cao Hongmei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244022%22"}, {"id": "fda:K243735", "company": "Ziehm Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243735: Ziehm Vision FD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243735", "people": [{"name": "Cornelia Schildbach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243735%22"}, {"id": "fda:K250385", "company": "Spectranetics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250385: Turbo-Elite Laser Atherectomy Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250385", "people": [{"name": "Katie Adamski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250385%22"}, {"id": "fda:K250382", "company": "Maxx Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250382: Freedom Total Knee System (All-poly Tibial Plate)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250382", "people": [{"name": "Donald Guthner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250382%22"}, {"id": "fda:K243487", "company": "Cryosurgery, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243487: CryoFreeze Wart and Skin Tag Remover", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243487", "people": [{"name": "Ronald McDow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243487%22"}, {"id": "fda:K250088", "company": "Inari Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250088: FlowTriever2 Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250088", "people": [{"name": "Rayee Patil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250088%22"}, {"id": "fda:K242997", "company": "MY01, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242997: MY01 Continuous Compartmental Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242997", "people": [{"name": "Olivier Bataille", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242997%22"}, {"id": "fda:K243788", "company": "Bioserenity Medical Devices Group", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243788: IceCap product line", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243788", "people": [{"name": "Melanie Renaud-Samiri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243788%22"}, {"id": "fda:K243993", "company": "Xemis Medical Technology (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243993: Photon Therapy Apparatus (BL-10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243993", "people": [{"name": "Yongfen Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243993%22"}, {"id": "breakthrough:K242997", "company": "My01, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-03-13", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K242997: MY01 CONTINUOUS COMPARTMENTAL PRESSURE MONITOR", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R44DA062284-01", "company": "Evidation Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-12", "observed": "2026-08-21", "amount_usd": 304023, "summary": "NIH award 1R44DA062284-01: Research and Engagement on Substance use Harnessing Awareness and Personalized Education (RESHAPE) ($304,023)", "source_url": "https://reporter.nih.gov/project-details/11055951", "people": [{"name": "Christian Jules Cerrada", "role": "Principal Investigator"}, {"name": "Monika Jain", "role": "Principal Investigator"}, {"name": "Joyce Nortey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06872905", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Real-World Data Collection of the GORE\u00ae VIABAHN\u00ae VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease", "source_url": "https://clinicaltrials.gov/study/NCT06872905"}, {"id": "trialreg:NCT06871683", "company": "Inari Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ClotTriever\u00ae Thrombectomy System Use-Result Survey in Japan", "source_url": "https://clinicaltrials.gov/study/NCT06871683"}, {"id": "trialreg:NCT06872684", "company": "Stryker Neurovascular", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)", "source_url": "https://clinicaltrials.gov/study/NCT06872684"}, {"id": "trialreg:NCT06873581", "company": "Levee Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pivotal Study of Voro Urologic Scaffold", "source_url": "https://clinicaltrials.gov/study/NCT06873581"}, {"id": "trialreg:NCT06872359", "company": "Kiomed Pharma", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling", "source_url": "https://clinicaltrials.gov/study/NCT06872359"}, {"id": "trialreg:NCT06872619", "company": "Wren Laboratories LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: RegisterPROS - a Registry for Prostate Cancers", "source_url": "https://clinicaltrials.gov/study/NCT06872619"}, {"id": "trialreg:NCT06872866", "company": "Aspargo Labs, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo\u00ae (ASP-001.1, Sildenafil) Under Fed Versus 100 mg of Hezkue Turbo\u00ae (ASP-001.1, Sildenafil) Under Fasted Conditions in Healthy Adult Male Subjects", "source_url": "https://clinicaltrials.gov/study/NCT06872866"}, {"id": "trialreg:NCT06873048", "company": "CooperVision International Limited (CVIL)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Short-term Study of Two Soft Contact Lenses in Wearers With Low Astigmatism", "source_url": "https://clinicaltrials.gov/study/NCT06873048"}, {"id": "fda:K241822", "company": "Rewalk Robotics Ltd. Dba Lifeward", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241822: ReWalk\u00ae 7 Personal Exoskeleton (50-20-0005)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241822", "people": [{"name": "Pariente Miri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241822%22"}, {"id": "fda:K243822", "company": "Biofire Defense, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243822: BioFire Warrior Panel; BioFire Warrior Panel Control Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243822", "people": [{"name": "David Rabiger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243822%22"}, {"id": "fda:K243849", "company": "Rayence Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243849: 2430TCA with Xmaru W", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243849", "people": [{"name": "Dong Hyeon Oh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243849%22"}, {"id": "fda:K250605", "company": "Cutting Edge Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250605: EVOL\u00ae ha \u0096 Hyper C Cervical Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250605", "people": [{"name": "Kyle Kuntz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250605%22"}, {"id": "fda:K243763", "company": "Changsha Anxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243763: Wireless TENS & EMS Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243763", "people": [{"name": "William Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243763%22"}, {"id": "fda:K243746", "company": "Quantalx Neroscience", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243746: Delphi Amplifier", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243746", "people": [{"name": "Iftach Dolev", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243746%22"}, {"id": "fda:K250411", "company": "Dannik, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250411: DANNIK\u00ae Laparoscopic Single-Use Poly Specimen Retrieval System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250411", "people": [{"name": "Olga Haberland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250411%22"}, {"id": "fda:K243903", "company": "Ray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243903: RCT600", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243903", "people": [{"name": "Soo Ji Huh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243903%22"}, {"id": "fda:K243783", "company": "Shenzhen Zuowei Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243783: Walking rehabilitation training electric wheelchair (ZW518)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243783", "people": [{"name": "Xingping Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243783%22"}, {"id": "fda:K243957", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243957: PICOALEX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243957", "people": [{"name": "Hyunsik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243957%22"}, {"id": "nih:1R44TR005339-01A1", "company": "Captis Diagnostics", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-11", "observed": "2026-08-21", "amount_usd": 1077369, "summary": "NIH award 1R44TR005339-01A1: Magnetic Lipid Nanoprobe Platform for Rapid, Highly-Efficient, and Cost-Effective Isolation of Extracellular Vesicles from Non-Invasive Bodily Fluids ($1,077,369)", "source_url": "https://reporter.nih.gov/project-details/11077464", "people": [{"name": "Hongzhang He", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06869200", "company": "Guangdong Hongzhi Health Technology", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study on the Use of a Concentrated Growth Factor Preparation Kit for the Treatment of Knee Osteoarthritis", "source_url": "https://clinicaltrials.gov/study/NCT06869200"}, {"id": "trialreg:NCT06870175", "company": "Myant Medical Corp.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Smart Textile ECG Monitoring", "source_url": "https://clinicaltrials.gov/study/NCT06870175"}, {"id": "trialreg:NCT06870123", "company": "Limacorporate S.p.a", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MINIMA Stem With DELTA TT or DELTA ST-C Study", "source_url": "https://clinicaltrials.gov/study/NCT06870123"}, {"id": "trialreg:NCT06870110", "company": "Neurotype Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Brain Training for Substance Use Disorders", "source_url": "https://clinicaltrials.gov/study/NCT06870110"}, {"id": "trialreg:NCT06870994", "company": "Sona Nanotech Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Intratumoral Targeted Hyperthermia Therapy (THT) for Cutaneous Metastatic Melanoma", "source_url": "https://clinicaltrials.gov/study/NCT06870994"}, {"id": "trialreg:NCT06869122", "company": "Creo Medical Limited", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK", "source_url": "https://clinicaltrials.gov/study/NCT06869122"}, {"id": "trialreg:NCT06870591", "company": "Sensydia Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pivotal Study for the Cardiac Performance System (CPS)", "source_url": "https://clinicaltrials.gov/study/NCT06870591"}, {"id": "trialreg:NCT06868615", "company": "AVAVA, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AVAVA MIRIA General Use", "source_url": "https://clinicaltrials.gov/study/NCT06868615"}, {"id": "trialreg:NCT06869044", "company": "CooperVision International Limited (CVIL)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Comparison of Proclear\u00ae 1 Day Multifocal and Clariti\u00ae 1 Day Multifocal 3 Add", "source_url": "https://clinicaltrials.gov/study/NCT06869044"}, {"id": "trialreg:NCT06868446", "company": "Oui Therapeutics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)", "source_url": "https://clinicaltrials.gov/study/NCT06868446"}, {"id": "fda:K250357", "company": "Deka Research & Development Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250357: RemunityPRO\u0099 Pump for Remodulin\u00ae (treprostinil) Injection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250357", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250357%22"}, {"id": "fda:K242610", "company": "Iconocare Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242610: 8mm Monopolar Curved Scissors (470179)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242610", "people": [{"name": "Rick Ferreira", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242610%22"}, {"id": "fda:K250424", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250424: Arthrex TightRope Soft Button, RT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250424", "people": [{"name": "Erikka Edwardsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250424%22"}, {"id": "fda:K241562", "company": "Disa Medinotec", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241562: OutFlo Aortic Valve Dilatation Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241562", "people": [{"name": "Lyndon Oldfield", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241562%22"}, {"id": "fda:K243029", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243029: Origin\u0099 TT Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243029", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243029%22"}, {"id": "fda:K241725", "company": "Better Diagnostics AI Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241725: Better Diagnostics Caries Assist (BDCA) Version 1.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241725", "people": [{"name": "Rajeev Nohria", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241725%22"}, {"id": "fda:K250374", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250374: iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250374", "people": [{"name": "Alison Garrad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250374%22"}, {"id": "nih:5R44AI162202-03", "company": "Trace-ability, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-10", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI162202-03: Improving availability of ImmunoPET via automation of radio-synthesis and quality control of antibody-based HIV imaging PET tracers on a single platform. ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11010813", "people": [{"name": "Arkadij Elizarov", "role": "Principal Investigator"}, {"name": "Henry F. VanBrocklin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06866197", "company": "MMI (Medical Microinstruments, Inc.)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CONNECT: A Multi-Cohort, Prospective Investigation of the Symani\u00ae Surgical System", "source_url": "https://clinicaltrials.gov/study/NCT06866197"}, {"id": "trialreg:NCT06868186", "company": "Hutom Corp", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Multicenter Study of RUS NE", "source_url": "https://clinicaltrials.gov/study/NCT06868186"}, {"id": "trialreg:NCT06865989", "company": "Insulet Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Omnipod\u00ae SmartAdjust 2.0 System Compared to the Omnipod\u00ae 5 System in Individuals With Type 1 or Type 2 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT06865989"}, {"id": "trialreg:NCT06866418", "company": "Phagenesis Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Phagenyx\u00ae Registry Study", "source_url": "https://clinicaltrials.gov/study/NCT06866418"}, {"id": "trialreg:NCT06867705", "company": "Resilience", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only", "source_url": "https://clinicaltrials.gov/study/NCT06867705"}, {"id": "trialreg:NCT06867185", "company": "Checkpoint Surgical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries", "source_url": "https://clinicaltrials.gov/study/NCT06867185"}, {"id": "trialreg:NCT06868108", "company": "Integrity Orthopaedics, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Trial on the Effect of the Flexible Suturing System With Anchors (FSSA) in Full-thickness Rotator Cuff Tendon Tears", "source_url": "https://clinicaltrials.gov/study/NCT06868108"}, {"id": "trialreg:NCT06868043", "company": "EyeSense GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Investigate a Transdermal Continuous Glucose Monitoring System in Diabetic Patients for a Period of 28 Days", "source_url": "https://clinicaltrials.gov/study/NCT06868043"}, {"id": "trialreg:NCT06867965", "company": "EyeSense GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Feasibility Study of a Novel Subcutaneous Continuous Glucose Monitoring System in Diabetics", "source_url": "https://clinicaltrials.gov/study/NCT06867965"}, {"id": "trialreg:NCT06867978", "company": "VPIX Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.", "source_url": "https://clinicaltrials.gov/study/NCT06867978"}, {"id": "trialreg:NCT06867380", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients", "source_url": "https://clinicaltrials.gov/study/NCT06867380"}, {"id": "trialreg:NCT06866132", "company": "Noctrix Health, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Response to an Investigational Device in Patients With Restless Legs Syndrome", "source_url": "https://clinicaltrials.gov/study/NCT06866132"}, {"id": "fda:K241944", "company": "Implantcast GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241944: AGILON\u00ae XO Shoulder Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241944", "people": [{"name": "Juliane H\u00f6ppner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241944%22"}, {"id": "fda:K243839", "company": "Exactech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243839: Alteon\u00ae HA Femoral Stems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243839", "people": [{"name": "Pedro Ravelo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243839%22"}, {"id": "fda:K243596", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243596: da Vinci SP SureForm 45 Staplers and Reloads (SP1098)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243596", "people": [{"name": "Alifiya Jagmag", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243596%22"}, {"id": "fda:K243101", "company": "Surgical Instrument Service and Savings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243101: Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243101", "people": [{"name": "Stephanie Boyle Mays", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243101%22"}, {"id": "fda:K250188", "company": "Vaporox, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250188: Wound Treatment System (VHT-200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250188", "people": [{"name": "Alan Sage", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250188%22"}, {"id": "fda:K243676", "company": "Medtronic Neurosurgery", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243676: Duet External Drainage and Monitoring System (EDMS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243676", "people": [{"name": "Foram Shukla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243676%22"}, {"id": "trialreg:NCT06864858", "company": "Johnson & Johnson Vision Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Evaluation of Two Cosmetic Contact Lenses", "source_url": "https://clinicaltrials.gov/study/NCT06864858"}, {"id": "fda:K242914", "company": "Ecential Robotics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242914: Op.n(TM) Navigation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242914", "people": [{"name": "Elodie Bouillet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242914%22"}, {"id": "fda:K242207", "company": "Daeju Meditech Engineering Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242207: NOABLE LASER", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242207", "people": [{"name": "Kim Seongun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242207%22"}, {"id": "fda:K243970", "company": "Intradin (Shanghai) Machinery Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243970: Portable Wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243970", "people": [{"name": "Mark Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243970%22"}, {"id": "fda:K242383", "company": "Shenzhen Rogin Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242383: Apex Locator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242383", "people": [{"name": "Salon Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242383%22"}, {"id": "fda:K243798", "company": "OrthoPediatrics Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243798: Orthex External Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243798", "people": [{"name": "Jessica Powers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243798%22"}, {"id": "fda:K242338", "company": "Cleerly, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242338: Cleerly LABS (v2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242338", "people": [{"name": "Kristen DeJeu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242338%22"}, {"id": "fda:K242510", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242510: Geistlich Bio-Flow\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242510", "people": [{"name": "Marco Steiner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242510%22"}, {"id": "fda:K241799", "company": "Atmos Medizintechnik GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241799: ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241799", "people": [{"name": "Abdulaziz Abdunasimov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241799%22"}, {"id": "fda:K243515", "company": "Epiwatch, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243515: EpiWatch Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243515", "people": [{"name": "Teresa Prego", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243515%22"}, {"id": "fda:K241159", "company": "Batec Mobility, S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241159: Handbike Batec Electric", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241159", "people": [{"name": "Jordi Clap\u00e9s Donadeu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241159%22"}, {"id": "fda:K242890", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242890: SPINEART Navigation Instrument System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242890", "people": [{"name": "Estelle Lefeuvre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242890%22"}, {"id": "fda:K243801", "company": "Fort Defiance Industries, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243801: FRONT-LINE Field Sterilizer (FL135)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243801", "people": [{"name": "Chris Coleman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243801%22"}, {"id": "fda:K242642", "company": "Shanghai Longmann Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242642: CuffTrek", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242642", "people": [{"name": "Yexue Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242642%22"}, {"id": "fda:K243421", "company": "Lelo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243421: Lelo Hex Lubricated Natural Rubber Latex Condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243421", "people": [{"name": "Pavle Sedic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243421%22"}, {"id": "fda:K243535", "company": "Shanghai SeeGen Photoelectric Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243535: Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243535", "people": [{"name": "Die Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243535%22"}, {"id": "fda:K243610", "company": "Medartis AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243610: APTUS Hand System; APTUS Elbow Dorsal Olecranon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243610", "people": [{"name": "Zurbuchen-De Santis Claudia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243610%22"}, {"id": "nih:5R44NS125745-03", "company": "Evon Medics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-06", "observed": "2026-08-21", "amount_usd": 1280870, "summary": "NIH award 5R44NS125745-03: Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P) ($1,280,870)", "source_url": "https://reporter.nih.gov/project-details/11053642", "people": [{"name": "Charles Chiedu Nwaokobia", "role": "Principal Investigator"}, {"name": "Evaristus A Nwulia", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06862557", "company": "Herrick Medical LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pulsed Electromagnetic Field Treatment With Dementia Patients", "source_url": "https://clinicaltrials.gov/study/NCT06862557"}, {"id": "trialreg:NCT06861361", "company": "Ceric S\u00e0rl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients", "source_url": "https://clinicaltrials.gov/study/NCT06861361"}, {"id": "trialreg:NCT06862440", "company": "Lady Technologies Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Kegg Fertility Study", "source_url": "https://clinicaltrials.gov/study/NCT06862440"}, {"id": "trialreg:NCT06861907", "company": "Charles River Analytics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: IMPRINT VR Trainer Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT06861907"}, {"id": "trialreg:NCT06860321", "company": "Koite Health Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Photodynamic Treatment in the Management of Residual Biofilm - a Crossover Study", "source_url": "https://clinicaltrials.gov/study/NCT06860321"}, {"id": "trialreg:NCT06862648", "company": "Acoustic Wave Cell Therapy, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluating SUI-100\u2122, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence", "source_url": "https://clinicaltrials.gov/study/NCT06862648"}, {"id": "trialreg:NCT06860555", "company": "Optina Diagnostics Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Hyperspectral Drusen Classification", "source_url": "https://clinicaltrials.gov/study/NCT06860555"}, {"id": "trialreg:NCT06861673", "company": "Asklepios proresearch", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: COCONUT Study Concomitant PVI and LAAC", "source_url": "https://clinicaltrials.gov/study/NCT06861673"}, {"id": "trialreg:NCT06860867", "company": "Spinal Stabilization Technologies", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PerQdisc Traditional Feasibility Trial.", "source_url": "https://clinicaltrials.gov/study/NCT06860867"}, {"id": "fda:K243724", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243724: Persona\u00ae Revision Knee System (Persona Revision SoluTion\u0099 Femoral Components)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243724", "people": [{"name": "Gregory Foster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243724%22"}, {"id": "fda:K243001", "company": "Laboratorios Biogalenic S.A. DE C.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243001: Sterile Water USP and Sterile 0.9% Normal Saline USP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243001", "people": [{"name": "Roberto Qui\u00f1onez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243001%22"}, {"id": "fda:K241790", "company": "Dermaroller GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241790: XCELLARISPRO TWIST microneedling device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241790", "people": [{"name": "Anna Lena Kaufholz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241790%22"}, {"id": "fda:K243578", "company": "Miach Orthopaedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243578: BEAR\u00ae (Bridge-Enhanced ACL Restoration) Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243578", "people": [{"name": "Rita Paparazzo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243578%22"}, {"id": "fda:K243871", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243871: Philips IntelliSite Pathology Solution 5.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243871", "people": [{"name": "Donna Peled", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243871%22"}, {"id": "fda:K243331", "company": "Dia Imaging Analysis, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243331: LVivo Seamless", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243331", "people": [{"name": "Michal Yaacobi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243331%22"}, {"id": "fda:K250344", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250344: BD Phoenix\u0099 Automated Microbiology System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250344", "people": [{"name": "Katherine Cicala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250344%22"}, {"id": "fda:K241767", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241767: Versacem Acetabular Shell and Double Mobility HC Liners", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241767", "people": [{"name": "Baj Stefano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241767%22"}, {"id": "fda:K243587", "company": "Xtreem Pulse, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243587: PureLift GLOW", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243587", "people": [{"name": "Andrew Barile", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243587%22"}, {"id": "fda:K243842", "company": "Centerline Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243842: Intra-Operative Positioning System (IOPS\u00ae)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243842", "people": [{"name": "Amanda Shade", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243842%22"}, {"id": "nih:5R44DK131766-03", "company": "Fistula Solution Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-05", "observed": "2026-08-21", "amount_usd": 483306, "summary": "NIH award 5R44DK131766-03: Novel Post-surgical Incision Management Device to Prevent Ostomy Complications ($483,306)", "source_url": "https://reporter.nih.gov/project-details/11047676", "people": [{"name": "Andrew T Obst", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "trialreg:NCT06859866", "company": "Koite Health Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis", "source_url": "https://clinicaltrials.gov/study/NCT06859866"}, {"id": "trialreg:NCT06858306", "company": "Medtronic Cardiac Ablation Solutions", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SPHERE Per-AF Post-Approval Study", "source_url": "https://clinicaltrials.gov/study/NCT06858306"}, {"id": "trialreg:NCT06858007", "company": "Quantum Beauty Kozmetik", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS\u00ae M in Lip Augmentation", "source_url": "https://clinicaltrials.gov/study/NCT06858007"}, {"id": "trialreg:NCT06858111", "company": "Gameto, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Fertilo In Vitro Research Study and Trial", "source_url": "https://clinicaltrials.gov/study/NCT06858111"}, {"id": "trialreg:NCT06860230", "company": "Medtronic - MITG", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Philips FAST Evaluation", "source_url": "https://clinicaltrials.gov/study/NCT06860230"}, {"id": "trialreg:NCT06859970", "company": "InterShunt Technologies, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT06859970"}, {"id": "fda:K241734", "company": "Well Lead Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241734: Wellead\u00ae Hydrophilic Intermittent Catheter Ready to Use; Wellead\u00ae Hydrophilic Intermittent Catheter Compact", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241734", "people": [{"name": "Jenny Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241734%22"}, {"id": "fda:K242190", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242190: Access Cortisol; DxC 500i Clinical Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242190", "people": [{"name": "Mary Beth Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242190%22"}, {"id": "fda:K243751", "company": "Mako Surgical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243751: Mako Total Hip Application 5.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243751", "people": [{"name": "Rita Koremblum", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243751%22"}, {"id": "fda:K242149", "company": "Polynovo Biomaterials Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242149: NovoSorb\u00ae MTX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242149", "people": [{"name": "Tarun Nekkenti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242149%22"}, {"id": "fda:K241770", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241770: Prostate MR AI (VA10A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241770", "people": [{"name": "Abhineet Johri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241770%22"}, {"id": "fda:K242597", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242597: CROSSLEAD 0.018inch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242597", "people": [{"name": "Katsuhiko Fujimura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242597%22"}, {"id": "fda:K250304", "company": "Vilex, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250304: TITANEX Screw Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250304", "people": [{"name": "Scott Armacost", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250304%22"}, {"id": "nih:4R44ES036065-02", "company": "Lebrun Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-04", "observed": "2026-08-21", "amount_usd": 618652, "summary": "NIH award 4R44ES036065-02: An In Chemico Test to Identify Dermal Corrosives ($618,652)", "source_url": "https://reporter.nih.gov/project-details/11268301", "people": [{"name": "Stewart Lebrun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT06857058", "company": "Sino Medical Sciences Technology Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis", "source_url": "https://clinicaltrials.gov/study/NCT06857058"}, {"id": "trialreg:NCT06857045", "company": "Sino Medical Sciences Technology Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparison Three vs Six Months of Dual Anti-platelet Therapy After Sirolimus-eluting Stent Implantation", "source_url": "https://clinicaltrials.gov/study/NCT06857045"}, {"id": "trialreg:NCT06857864", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Exploratory Study on the Effectiveness of Myopia Control Lenses in Slowing Myopia Progression in Young Children", "source_url": "https://clinicaltrials.gov/study/NCT06857864"}, {"id": "trialreg:NCT06856707", "company": "Virtual Incision Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MIRA Registry Study", "source_url": "https://clinicaltrials.gov/study/NCT06856707"}, {"id": "trialreg:NCT06856655", "company": "Argon Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Achieving Portal Access With Scorpion Post-Approval Study 2", "source_url": "https://clinicaltrials.gov/study/NCT06856655"}, {"id": "trialreg:NCT06857084", "company": "Smith & Nephew, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant", "source_url": "https://clinicaltrials.gov/study/NCT06857084"}, {"id": "fda:K243809", "company": "Limacorporate", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243809: Biolox\u00ae Delta Revision heads", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243809", "people": [{"name": "Alessia Collarini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243809%22"}, {"id": "fda:K243933", "company": "Ceevra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243933: Ceevra Reveal 3+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243933", "people": [{"name": "Ken Koster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243933%22"}, {"id": "fda:K241679", "company": "Alton (Shanghai) Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241679: Disposable Cytology Brush (AF series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241679", "people": [{"name": "Vivian Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241679%22"}, {"id": "fda:K243461", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243461: Calibrate Interbody Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243461", "people": [{"name": "Andrew Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243461%22"}, {"id": "fda:K232383", "company": "Euroteknika", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232383: iPhysio\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232383", "people": [{"name": "Yoann Delatre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232383%22"}, {"id": "nih:3R44CA287829-01A1S1", "company": "Precision Epigenomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-03-03", "observed": "2026-08-21", "amount_usd": 70000, "summary": "NIH award 3R44CA287829-01A1S1: Development of a Molecular Assay to Diagnose Malignant Pleural Effusions ($70,000)", "source_url": "https://reporter.nih.gov/project-details/11196648", "people": [{"name": "Mark Anthony Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06853418", "company": "Overture Life", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System (\"DaVitri\") to Standard Manual Process for Clinical Pregnancy Outcomes", "source_url": "https://clinicaltrials.gov/study/NCT06853418"}, {"id": "trialreg:NCT06854328", "company": "GrayMatters Health Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents", "source_url": "https://clinicaltrials.gov/study/NCT06854328"}, {"id": "trialreg:NCT06854263", "company": "Laboratoires BIOTIC Phocea", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: CLARITY Study - PMCF Study", "source_url": "https://clinicaltrials.gov/study/NCT06854263"}, {"id": "trialreg:NCT06854016", "company": "DJO UK Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Performance and Safety of LightForce\u00ae Therapy Lasers on Lateral Ankle Sprain", "source_url": "https://clinicaltrials.gov/study/NCT06854016"}, {"id": "trialreg:NCT06854796", "company": "Shaanxi Giant Biotechnology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles", "source_url": "https://clinicaltrials.gov/study/NCT06854796"}, {"id": "trialreg:NCT06853470", "company": "ForQaly Medical (Shanghai) Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prospective Evaluation for Receiving SynFlow 3.0 Interventional Circulatory Support in High-risk PCI: A Randomized Controlled Trial", "source_url": "https://clinicaltrials.gov/study/NCT06853470"}, {"id": "trialreg:NCT06855420", "company": "Walk With Path", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Smart Insoles for Improving Sensation, Balance and Mobility in People With Diabetic Peripheral Neuropathy.", "source_url": "https://clinicaltrials.gov/study/NCT06855420"}, {"id": "trialreg:NCT06853990", "company": "Deka Research and Development", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-03-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Innovative Automated Insulin Delivery System for Type 2 Diabetes", "source_url": "https://clinicaltrials.gov/study/NCT06853990"}, {"id": "fda:K241947", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241947: EnergyLounger (TY-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241947", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241947%22"}, {"id": "fda:K243380", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243380: VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243380", "people": [{"name": "Toshio Nakamura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243380%22"}, {"id": "fda:K243881", "company": "Bracco Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243881: HeartSee\u0099 Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243881", "people": [{"name": "Elyssa Murray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243881%22"}, {"id": "fda:K243235", "company": "Dia Imaging Analysis, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243235: LVivo Software Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243235", "people": [{"name": "Michal Yaacobi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243235%22"}, {"id": "fda:K243611", "company": "JLK, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243611: JLK-SDH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243611", "people": [{"name": "Dongmin Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243611%22"}, {"id": "fda:K243939", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243939: Titanium Flexible Geometry FSD Applicator Set (GM11013400)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243939", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243939%22"}, {"id": "fda:K242943", "company": "Beijing Nubway S&T Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-03-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242943: Q Switched Nd:YAG Laser machine (QNHF-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242943", "people": [{"name": "Xiting Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242943%22"}, {"id": "nih:2R44HL129577-04A1", "company": "Polyvascular Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": 815391, "summary": "NIH award 2R44HL129577-04A1: Development of a Polymeric Percutaneous Pulmonary Valve for Use in Young Children ($815,391)", "source_url": "https://reporter.nih.gov/project-details/11044614", "people": [{"name": "Daniel A Harrington", "role": "Principal Investigator"}, {"name": "Vivian Fikry Khalil", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:4R44HG013591-02", "company": "Lase Innovation Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": 900298, "summary": "NIH award 4R44HG013591-02: DNA-optical barcoding technology for spatiotemporal single-cell analysis ($900,298)", "source_url": "https://reporter.nih.gov/project-details/11251484", "people": [{"name": "Sheldon J.J. Kwok", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44DK141289-01A1", "company": "Sonomotion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": 278224, "summary": "NIH award 1R44DK141289-01A1: Break Wave lithotripsy to fragment large kidney stones ($278,224)", "source_url": "https://reporter.nih.gov/project-details/11066949", "people": [{"name": "Oren Levy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06851494", "company": "Lebon Produtos Quimicos E Farmaceuticos Ltda.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Efficacy of Linnea Safe PMMA 30% Use for Gluteal Augmentation.", "source_url": "https://clinicaltrials.gov/study/NCT06851494"}, {"id": "trialreg:NCT06851481", "company": "Ladera Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Ladera Suture-Mediated Large Bore Closure Study", "source_url": "https://clinicaltrials.gov/study/NCT06851481"}, {"id": "trialreg:NCT06851949", "company": "Cardiac Success", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Vsling\u2122 I: Clinical Evaluation of the Vsling\u2122 Device for Ventricular Repair in Patients With Heart Failure", "source_url": "https://clinicaltrials.gov/study/NCT06851949"}, {"id": "trialreg:NCT06852924", "company": "Novlead Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)", "source_url": "https://clinicaltrials.gov/study/NCT06852924"}, {"id": "trialreg:NCT06851338", "company": "Inspire Medical Systems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-28", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pediatric Down Syndrome Post-Approval Study", "source_url": "https://clinicaltrials.gov/study/NCT06851338"}, {"id": "fda:K243582", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243582: da Vinci SP Advanced Access Port Kit (432701)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243582", "people": [{"name": "Manjunath Ramappa Bisalehalli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243582%22"}, {"id": "fda:K244054", "company": "Quality Electrodynamics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244054: 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244054", "people": [{"name": "JoVanna Boudreaux", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244054%22"}, {"id": "fda:K241041", "company": "Young Dental Manufacturing Co. 1, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241041: Silver Fluoride Hypersensitivity Varnish", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241041", "people": [{"name": "Brian Prange", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241041%22"}, {"id": "fda:K241717", "company": "Shandon Diagnostics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241717: E1000 Dx Digital Pathology Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241717", "people": [{"name": "Naveen Kaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241717%22"}, {"id": "fda:K242676", "company": "Phenox Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242676: pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242676", "people": [{"name": "Rachel McDaid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242676%22"}, {"id": "fda:K242718", "company": "Qingdao Kingon Medical Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242718: Portable Oxygen Concentrator (P2-TOC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242718", "people": [{"name": "Benrong Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242718%22"}, {"id": "fda:K241374", "company": "Anhui Jbh Medical Apparatus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241374: Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241374", "people": [{"name": "Yuanwei Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241374%22"}, {"id": "fda:K242798", "company": "Heroic Faith International , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242798: Airmod", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242798", "people": [{"name": "Cheng Yuan-ren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242798%22"}, {"id": "fda:K243730", "company": "Cepheid\u00ae", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243730: Xpert C. difficile/Epi", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243730", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243730%22"}, {"id": "fda:K242179", "company": "W&H Dentalwerk B\u00fcrmoos GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242179: Synea Fusion Handpieces (Intensiv & Profin)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242179", "people": [{"name": "Gerhard Weidler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242179%22"}, {"id": "fda:K242876", "company": "Shenzhen Viatom Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242876: Pulse Oximeter ( PO2, PO2A, PO2B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242876", "people": [{"name": "Lynne Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242876%22"}, {"id": "fda:K244039", "company": "Suzhou Microport Orthorecon Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244039: MedalOne Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244039", "people": [{"name": "Qingling Bao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244039%22"}, {"id": "fda:K241922", "company": "Phantomics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241922: Myomics", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241922", "people": [{"name": "Soeun Baek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241922%22"}, {"id": "fda:K242339", "company": "Baxter Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242339: Intravascular Extension Sets and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242339", "people": [{"name": "Bernhard Bartmer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242339%22"}, {"id": "fda:K250324", "company": "QIAGEN GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250324: QIAstat-Dx GI Panel 2 Mini B", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250324", "people": [{"name": "Kristen Kanack", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250324%22"}, {"id": "fda:K243359", "company": "Gt Metabolic Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243359: MagDI System (MAG-02, DS-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243359", "people": [{"name": "Lisa Griffin Vincent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243359%22"}, {"id": "fda:K243436", "company": "Basis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243436: Seclusion Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243436", "people": [{"name": "David Martin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243436%22"}, {"id": "fda:K243874", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243874: FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243874", "people": [{"name": "Timothy Groves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243874%22"}, {"id": "fda:K241617", "company": "Rb Health (Us), LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241617: Durex Polyisoprene Condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241617", "people": [{"name": "Matthew Pleus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241617%22"}, {"id": "fda:K243565", "company": "Promethean Restorative, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243565: DYNAMIS\u0099 SI Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243565", "people": [{"name": "Glenn Bowman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243565%22"}, {"id": "nih:1R43HL178239-01", "company": "Spinhance, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": 306530, "summary": "NIH award 1R43HL178239-01: Free-Breathing Dynamic Cardiopulmonary Function Imaging System to use with Xenon MRI ($306,530)", "source_url": "https://reporter.nih.gov/project-details/11070224", "people": [{"name": "Kiarash Emami", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06850259", "company": "C. R. Bard", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.", "source_url": "https://clinicaltrials.gov/study/NCT06850259"}, {"id": "trialreg:NCT06850363", "company": "Niche Biomedical, Inc. dba ANEUVO", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ExaStim Upper Limb Home Use Clinical Validation Study", "source_url": "https://clinicaltrials.gov/study/NCT06850363"}, {"id": "trialreg:NCT06849258", "company": "Rivermark Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms", "source_url": "https://clinicaltrials.gov/study/NCT06849258"}, {"id": "trialreg:NCT06850389", "company": "Primex ehf", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PMCF Investigation of Medical Device ChitoCare\u00ae Medical", "source_url": "https://clinicaltrials.gov/study/NCT06850389"}, {"id": "trialreg:NCT06850168", "company": "Essilor International", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-27", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression", "source_url": "https://clinicaltrials.gov/study/NCT06850168"}, {"id": "fda:K241620", "company": "Gleamer Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241620: ChestView US", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241620", "people": [{"name": "Antoine Tournier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241620%22"}, {"id": "fda:K242175", "company": "Xod, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242175: XOD Diathermia Radiofrequency Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242175", "people": [{"name": "Ron Gardi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242175%22"}, {"id": "fda:K243704", "company": "Brosmed Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243704: Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243704", "people": [{"name": "Crystal Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243704%22"}, {"id": "fda:K242900", "company": "Icotec AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242900: VADER\u00ae Pedicle System and VADER\u00aeone Pedicle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242900", "people": [{"name": "Vanessa Faessler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242900%22"}, {"id": "fda:K242128", "company": "Xaga Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242128: Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242128", "people": [{"name": "Anders Grim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242128%22"}, {"id": "fda:K243543", "company": "Iline Microsystems, S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243543: microINR System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243543", "people": [{"name": "Miren Itsaso Hormaeche", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243543%22"}, {"id": "fda:K243738", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243738: The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 \u00b5g/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243738", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243738%22"}, {"id": "fda:K243357", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243357: CastleLoc Pectus Bar System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243357", "people": [{"name": "Kihyang Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243357%22"}, {"id": "fda:K241550", "company": "Vascutek, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241550: Gelweave\u0099 Vascular Prostheses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241550", "people": [{"name": "Ryan King", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241550%22"}, {"id": "fda:K241586", "company": "Becton Dickinson Infusion Therapy Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241586: PIVO\u0099 Pro Needle-free Blood Collection Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241586", "people": [{"name": "Amy Moore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241586%22"}, {"id": "fda:K241595", "company": "Veol Medical Technologies Pvt , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241595: EzVu Visual Vasopressor injector (EV-19)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241595", "people": [{"name": "Sneha Pandit", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241595%22"}, {"id": "fda:K250021", "company": "Nanofiber Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250021: Rotium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250021", "people": [{"name": "Jason Chakroff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250021%22"}, {"id": "fda:K244043", "company": "Hangzhou AllTest Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244043: AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244043", "people": [{"name": "Rosa Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244043%22"}, {"id": "nih:2R44TR003744-02A1", "company": "Biomesense, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": 1117161, "summary": "NIH award 2R44TR003744-02A1: Development of a Novel Biosensor to Accelerate Investigations of the Gut Microbiome ($1,117,161)", "source_url": "https://reporter.nih.gov/project-details/11067898", "people": [{"name": "Dylan Nichols", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "trialreg:NCT06846216", "company": "BTL Industries Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Combination of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness", "source_url": "https://clinicaltrials.gov/study/NCT06846216"}, {"id": "trialreg:NCT06847542", "company": "Hoffmann-La Roche", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD", "source_url": "https://clinicaltrials.gov/study/NCT06847542"}, {"id": "trialreg:NCT06847789", "company": "Stimuli Technology", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of the Tensi+ Device for the Treatment of Overactive Bladder", "source_url": "https://clinicaltrials.gov/study/NCT06847789"}, {"id": "trialreg:NCT06846593", "company": "Incrediwear Holdings, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-26", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Comparison of Semiconductor Embedded Therapeutic Arm Sleeves for the Treatment of ECRB Tendinopathy", "source_url": "https://clinicaltrials.gov/study/NCT06846593"}, {"id": "fda:K250202", "company": "Inquis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250202: Aventus Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250202", "people": [{"name": "Zachary Woodson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250202%22"}, {"id": "fda:K241222", "company": "Ventripoint Diagnostics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241222: Ventripoint Medical System Plus (VMS+) 4.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241222", "people": [{"name": "Zhang Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241222%22"}, {"id": "fda:K242844", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242844: Medline Level 4 Surgical Gown with Breathable Sleeves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242844", "people": [{"name": "Kelsey Closen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242844%22"}, {"id": "fda:K250346", "company": "Elute, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250346: BonVie+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250346", "people": [{"name": "Ashok Khandkar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250346%22"}, {"id": "fda:K243918", "company": "Maquet Cardiovascular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243918: Vasoview Hemopro 3 Power Supply", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243918", "people": [{"name": "Brad Sheals, MS", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243918%22"}, {"id": "fda:K244031", "company": "SteriLance Medical (Suzhou), Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244031: Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244031", "people": [{"name": "Susan Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244031%22"}, {"id": "fda:K241576", "company": "Infraredx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241576: Makoto Intravascular Imaging System\u0099 (VC-MC10 / TVC-MC10i); Dualpro\u0099 IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241576", "people": [{"name": "Stephen Sum", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241576%22"}, {"id": "fda:K250281", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250281: DEKA LOTUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250281", "people": [{"name": "Peruzzi Paolo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250281%22"}, {"id": "fda:K241587", "company": "Vygon Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241587: pilot TLS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241587", "people": [{"name": "Chris Steinke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241587%22"}, {"id": "fda:K241546", "company": "Fovia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241546: aiCockpit AI Viewer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241546", "people": [{"name": "Paula Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241546%22"}, {"id": "fda:K244036", "company": "SteriLance Medical (Suzhou), Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244036: Heel Incision Safety Lancet (SteriHeel 2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244036", "people": [{"name": "Susan Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244036%22"}, {"id": "fda:K250012", "company": "Perfuze, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250012: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250012", "people": [{"name": "Anne-Marie Gannon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250012%22"}, {"id": "nih:1R43MH139259-01", "company": "Neuronexus Technologies", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-25", "observed": "2026-08-21", "amount_usd": 449228, "summary": "NIH award 1R43MH139259-01: Advanced culture and recording system for long-term electrophysiological profiling in human brain organoids ($449,228)", "source_url": "https://reporter.nih.gov/project-details/11069575", "people": [{"name": "DARYL R KIPKE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06845917", "company": "Epoca U&i", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Personalized Digital Remote Monitoring for Elderly Patients", "source_url": "https://clinicaltrials.gov/study/NCT06845917"}, {"id": "trialreg:NCT06843980", "company": "Moximed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MOTION Clinical Trial", "source_url": "https://clinicaltrials.gov/study/NCT06843980"}, {"id": "trialreg:NCT06845631", "company": "Curonix LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Retrospective-Prospective PNS Study", "source_url": "https://clinicaltrials.gov/study/NCT06845631"}, {"id": "trialreg:NCT06846151", "company": "Optos, PLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Retinal Investigation Using Optos OCT Device", "source_url": "https://clinicaltrials.gov/study/NCT06846151"}, {"id": "trialreg:NCT06844760", "company": "Espad Pharmed", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Neck Area", "source_url": "https://clinicaltrials.gov/study/NCT06844760"}, {"id": "trialreg:NCT06843577", "company": "Zona Health, Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects", "source_url": "https://clinicaltrials.gov/study/NCT06843577"}, {"id": "trialreg:NCT06846047", "company": "Neursantys Inc", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-25", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Therapeutic Effects of Electrical Vestibular Stimulation (EVS) on Balance and Gait", "source_url": "https://clinicaltrials.gov/study/NCT06846047"}, {"id": "fda:K250223", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250223: BruxZir\u00ae Esthetic NOW", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250223", "people": [{"name": "So Hyun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250223%22"}, {"id": "fda:K233963", "company": "Taiwan Aulisa Medical Devices Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233963: Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233963", "people": [{"name": "Ming Hsiu Hsiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233963%22"}, {"id": "fda:K242967", "company": "Fitbit", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242967: Loss of Pulse Detection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242967", "people": [{"name": "Dinesh Puppala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242967%22"}, {"id": "fda:K250348", "company": "JLK, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250348: JLK-AILink", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250348", "people": [{"name": "Dongmin Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250348%22"}, {"id": "fda:K243276", "company": "Ethicon Endo-Surgery, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243276: ECHELON LINEAR\u0099 Stapler 30mm Stapler (GTX30); ECHELON LINEAR\u0099 Stapler 60mm Stapler (GTX60); ECHELON LINEAR\u0099 Stapler 90mm Stapler (GTX90); ECHELON LINEAR\u0099 Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR\u0099 Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR\u0099 Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR\u0099 Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR\u0099 Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR\u0099 Stapler 3D 90mm Green Reload (GTXR90G)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243276", "people": [{"name": "Aysenur Huseyinoglu Erucman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243276%22"}, {"id": "fda:K241601", "company": "Cpmt Laser (Canadian Pioneer Medical Technology Corporation)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241601: EMS (FlexPulse, MagnaCore, Magnetika)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241601", "people": [{"name": "Rashid Reza Mir Sayah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241601%22"}, {"id": "fda:K250238", "company": "Abanza Tecnomed S.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250238: WasherCap\u0099 Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250238", "people": [{"name": "Ander Menaut", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250238%22"}, {"id": "fda:K243446", "company": "GE Medical Systems SCS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243446: 3DXR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243446", "people": [{"name": "Ning WEN", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243446%22"}, {"id": "fda:K242822", "company": "Therapanacea Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242822: ART-Plan+ (v.3.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242822", "people": [{"name": "Bhairavi Ajachandra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242822%22"}, {"id": "trialreg:NCT06841276", "company": "Novesia", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-24", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Impact of QoLibri Medical Device on the Consequences of Chronic Pain: a Randomized Controlled Trial", "source_url": "https://clinicaltrials.gov/study/NCT06841276"}, {"id": "fda:K243287", "company": "Alembic, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243287: APRO 70 Swift Catheter and Alembic Aspiration Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243287", "people": [{"name": "Lisa Yen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243287%22"}, {"id": "fda:K241703", "company": "Arum Dentistry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241703: SD Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241703", "people": [{"name": "Choi Won-Yi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241703%22"}, {"id": "fda:K244010", "company": "Jpi Healthcare Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244010: ExamVue Apex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244010", "people": [{"name": "Jeongjoon Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244010%22"}, {"id": "fda:K241565", "company": "Anqing Clean Dental Instrument Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241565: Sterilization Package/Reel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241565", "people": [{"name": "Wu Yiming", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241565%22"}, {"id": "fda:K243823", "company": "Tandem Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243823: Control-IQ+ technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243823", "people": [{"name": "Christin Dunn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243823%22"}, {"id": "fda:K242994", "company": "Oncosoft. Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242994: OncoStudio (OS-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242994", "people": [{"name": "Boram Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242994%22"}, {"id": "fda:K243959", "company": "Lingshi Hongruida Health Protection Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243959: Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243959", "people": [{"name": "Chai Tinglong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243959%22"}, {"id": "fda:K243035", "company": "Ulthera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243035: Ulthera\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243035", "people": [{"name": "Scott Jewett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243035%22"}, {"id": "nih:1R44HL177945-01", "company": "Corvion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": 1024635, "summary": "NIH award 1R44HL177945-01: Development of a Totally Implanted Left Ventricular Assist Device ($1,024,635)", "source_url": "https://reporter.nih.gov/project-details/11067361", "people": [{"name": "Greg Aber", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI181154-02", "company": "Nanopathdx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": 964943, "summary": "NIH award 5R44AI181154-02: Multiplexed Assay for Point-of-Care UTI Diagnosis (ID/AMR) ($964,943)", "source_url": "https://reporter.nih.gov/project-details/11043387", "people": [{"name": "Alison Burklund", "role": "Principal Investigator"}, {"name": "Amogha Tadimety", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43HL172316-01S1", "company": "Scientific Horizons Consulting LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43HL172316-01S1: A Novel Aerosolization and Inhalation Platform for the Pulmonary Delivery of Anti-inflammatory Agents to Distal Airways for the Enhanced Pain Management in Chronic Obstructive Pulmonary Disease (COPD) ($55,000)", "source_url": "https://reporter.nih.gov/project-details/11237357", "people": [{"name": "Xiang Gao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R41HL176288-01S1", "company": "Circulatech LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": 6500, "summary": "NIH award 3R41HL176288-01S1: TABA: Proactive Dual-Irrigation Cardiac Chest Tube to Maintain Postoperative Patency ($6,500)", "source_url": "https://reporter.nih.gov/project-details/11251843", "people": [{"name": "Jake Pistiner", "role": "Principal Investigator"}, {"name": "Cory Michael Tschabrunn", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "trialreg:NCT06839222", "company": "Allegro NV/SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Knee OsteoArthritis Long-term Assessment", "source_url": "https://clinicaltrials.gov/study/NCT06839222"}, {"id": "trialreg:NCT06840509", "company": "Biotronik Australia Pty Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family", "source_url": "https://clinicaltrials.gov/study/NCT06840509"}, {"id": "trialreg:NCT06839209", "company": "ABResearch S.r.l.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea", "source_url": "https://clinicaltrials.gov/study/NCT06839209"}, {"id": "trialreg:NCT06840990", "company": "D&V FARMA srl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Cross-linked CMC and Silk Proteins in Corneal Re-epithelization", "source_url": "https://clinicaltrials.gov/study/NCT06840990"}, {"id": "trialreg:NCT06839898", "company": "Biotech Healthcare Holding Gmbh", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-21", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses", "source_url": "https://clinicaltrials.gov/study/NCT06839898"}, {"id": "fda:K243614", "company": "Sonio", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243614: Sonio Suspect", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243614", "people": [{"name": "Florian Akpakpa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243614%22"}, {"id": "fda:K241555", "company": "Rti Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241555: Moldable Bone Void Filler and Moldable Bone Void Filler + CCC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241555", "people": [{"name": "Ellen Rounds", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241555%22"}, {"id": "fda:K241186", "company": "Shenzhen Dazhou Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241186: Synthetic Bone Graft Particulate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241186", "people": [{"name": "Jingzhou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241186%22"}, {"id": "fda:K243088", "company": "VATECH Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243088: Green X 12 SE (PHT-40CHS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243088", "people": [{"name": "Daniel Lim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243088%22"}, {"id": "fda:K243115", "company": "Shenzhen Urion Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243115: Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243115", "people": [{"name": "Janice Ou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243115%22"}, {"id": "fda:K242607", "company": "Scandiags AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242607: ScanDiags Ortho L-Spine MR-Q", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242607", "people": [{"name": "Stefan Voser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242607%22"}, {"id": "fda:K243916", "company": "Spinal Elements, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243916: Primus Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243916", "people": [{"name": "Cheryl Allen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243916%22"}, {"id": "fda:K243330", "company": "Lyma Life , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243330: LYMA Laser PRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243330", "people": [{"name": "Lucy Goff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243330%22"}, {"id": "fda:K242850", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242850: Wearable breast pump (model W8)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242850", "people": [{"name": "Peter Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242850%22"}, {"id": "fda:K250218", "company": "Cepheid", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250218: Xpert\u00ae FII & FV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250218", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250218%22"}, {"id": "fda:K250027", "company": "Intradin (Shanghai) Machinery Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250027: Powered Mobility Scooter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250027", "people": [{"name": "Mark Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250027%22"}, {"id": "fda:K243940", "company": "Vita Zahnfabrik H.Rauter GmbH & Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243940: VITA YZ Multi Translucent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243940", "people": [{"name": "Lindsay Tilton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243940%22"}, {"id": "fda:K243431", "company": "Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243431: Medicom Sterilization Pouch and Reel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243431", "people": [{"name": "Kristy Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243431%22"}, {"id": "fda:K242838", "company": "Aikenist Technologies Pvt, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242838: QuickRad", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242838", "people": [{"name": "Ashwin Amarapuram Chandramouly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242838%22"}, {"id": "fda:K243637", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243637: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243637", "people": [{"name": "Polliane Carvalho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243637%22"}, {"id": "fda:K242898", "company": "Shanghai Jianzhong Medical Packaging Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242898: Sterilization Pouches and Reels", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242898", "people": [{"name": "Xinhua Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242898%22"}, {"id": "fda:K241983", "company": "Orthopediatrics Canada Ulc Dba Pega Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241983: Fassier-Duval Telescoping IM System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241983", "people": [{"name": "Enrique Garcia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241983%22"}, {"id": "fda:K243278", "company": "Institut Straumann AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243278: Custom Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243278", "people": [{"name": "Jennifer Jackson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243278%22"}, {"id": "fda:K243951", "company": "Taiwan Dental Materials Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243951: TEMP MASTER, PMMA-based dental resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243951", "people": [{"name": "Pey-Fen Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243951%22"}, {"id": "fda:K241563", "company": "Extremity Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241563: Extremity Medical External Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241563", "people": [{"name": "Mary Hoffman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241563%22"}, {"id": "fda:K243258", "company": "Proprio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243258: Paradigm System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243258", "people": [{"name": "Shannon Eubanks", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243258%22"}, {"id": "fda:K243640", "company": "Church & Dwight Co., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243640: Trojan\u0099 Ultra Ribbed Ecstasy latex condom with lubricant (Trojan\u0099 Ultra Ribbed Ecstasy)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243640", "people": [{"name": "Lori Kordyban", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243640%22"}, {"id": "fda:K241626", "company": "Ipreg Incorporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241626: SperSort\u0099 Sperm Sorting Chip (IPG02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241626", "people": [{"name": "Ching-Wen Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241626%22"}, {"id": "fda:K241470", "company": "LinkBio Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241470: CORE Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241470", "people": [{"name": "Deniz Kortan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241470%22"}, {"id": "fda:K242240", "company": "Caristo Diagnostics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242240: CaRi-Plaque", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242240", "people": [{"name": "Frank Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242240%22"}, {"id": "fda:K243283", "company": "Abbott Laboratories", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243283: Alinity h-series System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243283", "people": [{"name": "Saloni Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243283%22"}, {"id": "fda:K243086", "company": "Unimed Medical Supplies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243086: Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243086", "people": [{"name": "Huanyu Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243086%22"}, {"id": "fda:K250214", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250214: Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250214", "people": [{"name": "Tracy Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250214%22"}, {"id": "fda:K250172", "company": "Steritec Products, Inc. (A Getinge Company)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250172: Green Card Bowie-Dick Test (BD115)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250172", "people": [{"name": "Chris Muha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250172%22"}, {"id": "fda:K242447", "company": "Compumedics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242447: Falcon HST", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242447", "people": [{"name": "John Joseph", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242447%22"}, {"id": "fda:K243312", "company": "Cardiocalm Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243312: CER-S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243312", "people": [{"name": "Fabio Badilini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243312%22"}, {"id": "fda:K242821", "company": "Ever Fortune.Ai, Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242821: EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242821", "people": [{"name": "Chang Joseph", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242821%22"}, {"id": "fda:K243344", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243344: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243344", "people": [{"name": "Emmarie Halteman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243344%22"}, {"id": "fda:K250140", "company": "Steris Corparation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250140: Defendo Fujifilm 700 Single Use Cleaning Adapter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250140", "people": [{"name": "Gregory Land", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250140%22"}, {"id": "fda:K234004", "company": "Reveal Lasers , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234004: Medical diode laser systems (CHARISMA, REGAL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234004", "people": [{"name": "Mike Collette", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234004%22"}, {"id": "fda:K250487", "company": "Ormco Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250487: SparkTM Clear Aligner System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250487", "people": [{"name": "Jessica Pomares", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250487%22"}, {"id": "fda:K242681", "company": "Nurodata, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242681: NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242681", "people": [{"name": "Hsien-chen Chiou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242681%22"}, {"id": "fda:K250067", "company": "Guangzhou Decheng Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250067: Dochek\u00ae Multi-Drug Urine Test Cup; Dochek\u00ae Multi-Drug Urine Test Cup Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250067", "people": [{"name": "Mango Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250067%22"}, {"id": "nih:2R44MH126793-03", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": 866289, "summary": "NIH award 2R44MH126793-03: A Mobile Text Approach to Measurement and Feedback for Wraparound Care Coordination ($866,289)", "source_url": "https://reporter.nih.gov/project-details/11068805", "people": [{"name": "ERIC J. BRUNS", "role": "Principal Investigator"}, {"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL142440-05", "company": "Alleviant Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": 992964, "summary": "NIH award 5R44HL142440-05: Transcatheter Device for Congestive Heart Failure Treatment Through Left Atrial Decompression ($992,964)", "source_url": "https://reporter.nih.gov/project-details/11011326", "people": [{"name": "Thomas Diffley Pate", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "trialreg:NCT06834880", "company": "Radiometer Medical ApS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study", "source_url": "https://clinicaltrials.gov/study/NCT06834880"}, {"id": "trialreg:NCT06833879", "company": "Merck Sharp & Dohme LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Activity Tracking Study in Healthy Volunteers (MK-0000-419)", "source_url": "https://clinicaltrials.gov/study/NCT06833879"}, {"id": "trialreg:NCT06833684", "company": "usMIMA S.L.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: MowOot and Trans-anal Irrigation fOr coNstipation", "source_url": "https://clinicaltrials.gov/study/NCT06833684"}, {"id": "trialreg:NCT06835647", "company": "GE Healthcare", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Maternal Fetal Device Performance Twins", "source_url": "https://clinicaltrials.gov/study/NCT06835647"}, {"id": "trialreg:NCT06834516", "company": "Edwards Lifesciences", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ClearSight Baby Cuff", "source_url": "https://clinicaltrials.gov/study/NCT06834516"}, {"id": "trialreg:NCT06834568", "company": "Tandem Diabetes Care, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-19", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Tandem Freedom - Feasibility Trial 2", "source_url": "https://clinicaltrials.gov/study/NCT06834568"}, {"id": "fda:K243241", "company": "Davol, Inc., A Subsidiary of C.R. Bard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243241: Phasix ST Umbilical Hernia Patch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243241", "people": [{"name": "Shannon Green", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243241%22"}, {"id": "fda:K242526", "company": "Visby Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242526: Visby Medical Respiratory Health Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242526", "people": [{"name": "Jennifer Albrecht", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242526%22"}, {"id": "fda:K250473", "company": "Dci International, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250473: Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250473", "people": [{"name": "Dana Shusterman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250473%22"}, {"id": "fda:K244015", "company": "Arcuro Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244015: SuperBall-RC\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244015", "people": [{"name": "Lee Ranon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244015%22"}, {"id": "fda:K241578", "company": "Shenzhen Bsx Technology Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241578: Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241578", "people": [{"name": "XiYu Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241578%22"}, {"id": "fda:K242411", "company": "Brainomix Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242411: Brainomix 360 e-Lung", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242411", "people": [{"name": "Thais Sala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242411%22"}, {"id": "fda:K243206", "company": "Sichuan Qianli-Beoka Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243206: Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243206", "people": [{"name": "Qiuju Cai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243206%22"}, {"id": "fda:K243761", "company": "Biomet Orthopedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243761: A.L.P.S. Small Fragment Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243761", "people": [{"name": "Tracy Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243761%22"}, {"id": "fda:K242455", "company": "Avita Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242455: AViTA Pulse Oximeter (SP62B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242455", "people": [{"name": "Maggie Chao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242455%22"}, {"id": "fda:K241666", "company": "Smith & Nephew", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241666: EVOS Pelvic and Acetabular System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241666", "people": [{"name": "Mandy Coe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241666%22"}, {"id": "fda:K243588", "company": "Quanta System Spa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243588: Single Use CO2 Laser Fiber (HAF005001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243588", "people": [{"name": "Dario Bandiera", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243588%22"}, {"id": "fda:K242023", "company": "Implant Microdent System S.L.U.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242023: Microdent Sterilization Cassette", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242023", "people": [{"name": "Joan Mu\u00f1oz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242023%22"}, {"id": "fda:K243478", "company": "Institut Straumann AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243478: Straumann InLab Validated Workflow", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243478", "people": [{"name": "Olivier Russo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243478%22"}, {"id": "fda:K243591", "company": "Optosurgical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243591: OPTOVISION Endoscopic Light Source Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243591", "people": [{"name": "Yoseph Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243591%22"}, {"id": "trialreg:NCT06832631", "company": "OrbusNeich", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: VITUS Post-Market Registry", "source_url": "https://clinicaltrials.gov/study/NCT06832631"}, {"id": "trialreg:NCT06833060", "company": "Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Transscleral Selective Laser Trabeculoplasty Project", "source_url": "https://clinicaltrials.gov/study/NCT06833060"}, {"id": "trialreg:NCT06831448", "company": "Smith & Nephew, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Human Participant Study of a Prototype Multilayer Foam Dressing on Intact Skin.", "source_url": "https://clinicaltrials.gov/study/NCT06831448"}, {"id": "trialreg:NCT06832306", "company": "Lungpacer Medical Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: STimulation to Activate RespIration", "source_url": "https://clinicaltrials.gov/study/NCT06832306"}, {"id": "trialreg:NCT06832449", "company": "Curonix LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-18", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Retrospective PNS Study", "source_url": "https://clinicaltrials.gov/study/NCT06832449"}, {"id": "fda:K243593", "company": "Stryker Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243593: AXS Lift Intracranial Base Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243593", "people": [{"name": "Natalie Allen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243593%22"}, {"id": "fda:K243915", "company": "Jeil Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243915: FIX-C 3D Ti ACIF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243915", "people": [{"name": "Jinwoo Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243915%22"}, {"id": "fda:K243576", "company": "Smith & Nephew Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243576: RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243576", "people": [{"name": "Ruby Uttley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243576%22"}, {"id": "fda:K243584", "company": "Okamoto USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243584: 0.04 ZERO ZERO FOUR Male Latex Condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243584", "people": [{"name": "Kenji Komatsu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243584%22"}, {"id": "fda:K243574", "company": "Microport Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243574: Evolution\u00ae Total Knee Systems - Kinematic Alignment Instrumentation and Technique", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243574", "people": [{"name": "Ryan Ross", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243574%22"}, {"id": "fda:K243792", "company": "Basic Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243792: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243792", "people": [{"name": "John Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243792%22"}, {"id": "trialreg:NCT06830746", "company": "Abbott Medical Devices", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ASCEND CSP IDE Study", "source_url": "https://clinicaltrials.gov/study/NCT06830746"}, {"id": "trialreg:NCT06830265", "company": "Uro-1 Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis", "source_url": "https://clinicaltrials.gov/study/NCT06830265"}, {"id": "trialreg:NCT06829615", "company": "SHEN.AI sp\u00f3\u0142ka z ograniczon\u0105 odpowiedzialno\u015bci\u0105 oddzia\u0142 w Polsce", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Contactless Measurement of Heart Rate, Heart Rate Variability, Breathing Rate and Blood Pressure Using Remote Photoplethysmography", "source_url": "https://clinicaltrials.gov/study/NCT06829615"}, {"id": "trialreg:NCT06828939", "company": "CardioFocus", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF", "source_url": "https://clinicaltrials.gov/study/NCT06828939"}, {"id": "trialreg:NCT06829212", "company": "Shanghai StairMed Technology Co., Ltd.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Research on Wireless Brain Implant System for General Control of External Devices", "source_url": "https://clinicaltrials.gov/study/NCT06829212"}, {"id": "trialreg:NCT06829667", "company": "Stryker Trauma and Extremities", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability", "source_url": "https://clinicaltrials.gov/study/NCT06829667"}, {"id": "trialreg:NCT06830876", "company": "Sara Peterson-Snyder", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-17", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA", "source_url": "https://clinicaltrials.gov/study/NCT06830876"}, {"id": "fda:K241737", "company": "Sway Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241737: Sway System Sports Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241737", "people": [{"name": "Alex Pettigrew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241737%22"}, {"id": "nih:5R44MH128484-04", "company": "Ksana Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": 794102, "summary": "NIH award 5R44MH128484-04: Development and testing of a digitally assisted risk reduction platform for youth at high risk for suicide ($794,102)", "source_url": "https://reporter.nih.gov/project-details/11064882", "people": [{"name": "NICHOLAS B ALLEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "trialreg:NCT06828770", "company": "Renata Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Minima Stent System Post- Approval Study (PAS)", "source_url": "https://clinicaltrials.gov/study/NCT06828770"}, {"id": "trialreg:NCT06827795", "company": "Surgify Medical Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)", "source_url": "https://clinicaltrials.gov/study/NCT06827795"}, {"id": "trialreg:NCT06827990", "company": "W.L.Gore & Associates", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: GORE\u00ae Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections", "source_url": "https://clinicaltrials.gov/study/NCT06827990"}, {"id": "trialreg:NCT06828224", "company": "Quantum Beauty Kozmetik", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS\u00ae L in Correcting Moderate or Severe Nasolabial Folds", "source_url": "https://clinicaltrials.gov/study/NCT06828224"}, {"id": "trialreg:NCT06828237", "company": "Quantum Beauty Kozmetik", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS\u00ae S in the Correction of Moderate or Severe Infraorbital Hollowing", "source_url": "https://clinicaltrials.gov/study/NCT06828237"}, {"id": "trialreg:NCT06828198", "company": "Quantum Beauty Kozmetik", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS\u00ae XL for the Restoration and/or Augmentation of Facial Volume", "source_url": "https://clinicaltrials.gov/study/NCT06828198"}, {"id": "trialreg:NCT06826599", "company": "Cylite Pty Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Agreement and Precision Study of UNITY\u00ae DX and a Comparator Biometer", "source_url": "https://clinicaltrials.gov/study/NCT06826599"}, {"id": "trialreg:NCT06828107", "company": "Sense Diagnostics, LLC", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the SENSE Device's Ability to Detect TBI", "source_url": "https://clinicaltrials.gov/study/NCT06828107"}, {"id": "trialreg:NCT06827262", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-14", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain", "source_url": "https://clinicaltrials.gov/study/NCT06827262"}, {"id": "fda:K243212", "company": "Terrats Medical SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243212: DESS Dental Smart Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243212", "people": [{"name": "Roger Terrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243212%22"}, {"id": "fda:K241527", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241527: Pastelle Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241527", "people": [{"name": "Hyun Sik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241527%22"}, {"id": "fda:K250248", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250248: BriefCase-Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250248", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250248%22"}, {"id": "fda:K242776", "company": "LimFlow, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242776: LimFlow V-Ceiver", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242776", "people": [{"name": "Tosan Eweka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242776%22"}, {"id": "fda:K241958", "company": "Ward 24/7 Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241958: WARD-CSS (v1.2.x)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241958", "people": [{"name": "Madolina Christian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241958%22"}, {"id": "fda:K241643", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241643: WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241643", "people": [{"name": "Hyun Sik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241643%22"}, {"id": "fda:K241573", "company": "Abbott Molecular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241573: Alinity m Resp-4-Plex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241573", "people": [{"name": "Stacy Ferguson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241573%22"}, {"id": "fda:K242198", "company": "Natus Medical Denmark Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242198: ICS Dizcovery (1091)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242198", "people": [{"name": "Therese Coffey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242198%22"}, {"id": "fda:K243503", "company": "New World Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243503: VIA360\u0099 Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243503", "people": [{"name": "Sartaj (Taj) Kaur-Hurrle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243503%22"}, {"id": "fda:K243136", "company": "Shenzhen Finicare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243136: Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243136", "people": [{"name": "Li Chao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243136%22"}, {"id": "fda:K243696", "company": "Coreline Soft Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243696: AVIEW CAC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243696", "people": [{"name": "Hyeyi Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243696%22"}, {"id": "fda:K243294", "company": "Brainomix Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243294: Brainomix 360 e-ASPECTS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243294", "people": [{"name": "Delanyo Mensah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243294%22"}, {"id": "fda:K243081", "company": "VATECH Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243081: Green X 21 (PHT-90CHO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243081", "people": [{"name": "Daniel Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243081%22"}, {"id": "fda:K242593", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242593: CurrentBody\u0099 LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242593", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242593%22"}, {"id": "pma:P240027", "company": "Pramand, LLC", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240027: SpineSeal Spine Sealant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240027", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240027%22"}, {"id": "nih:5R44MH125238-05", "company": "Istovisr", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": 1196536, "summary": "NIH award 5R44MH125238-05: Scaling Volumetric Imaging, Analysis and Science Communication Using Immersive Virtual Reality ($1,196,536)", "source_url": "https://reporter.nih.gov/project-details/11017717", "people": [{"name": "Gianfranco Doretto", "role": "Principal Investigator"}, {"name": "Michael David Morehead", "role": "Principal Investigator"}, {"name": "GEORGE A SPIROU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "trialreg:NCT06824987", "company": "AstraZeneca", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease", "source_url": "https://clinicaltrials.gov/study/NCT06824987"}, {"id": "trialreg:NCT06825104", "company": "Volta Medical", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-13", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT06825104"}, {"id": "fda:K241832", "company": "Boston Aesthetics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241832: Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241832", "people": [{"name": "Hongmei Cao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241832%22"}, {"id": "fda:K243319", "company": "Neuromodulatory Devices & Applications", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243319: Ampa One System (AMPA-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243319", "people": [{"name": "Don Vaughn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243319%22"}, {"id": "fda:K243912", "company": "Newclip Technics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243912: Newclip Patient-matched instrumentation non sterile PSI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243912", "people": [{"name": "Ga\u00eblle Gourbiere", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243912%22"}, {"id": "fda:K241410", "company": "Jmt Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241410: EDEN ControlCath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241410", "people": [{"name": "Sang-Ok Nam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241410%22"}, {"id": "fda:K242317", "company": "Denjoy Dental Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242317: Integrated Endo System (Meet Endo-II)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242317", "people": [{"name": "Chengfa Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242317%22"}, {"id": "fda:K250117", "company": "Assure Tech., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250117: FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250117", "people": [{"name": "Shisheng Ling", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250117%22"}, {"id": "fda:K243778", "company": "Fitbit, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243778: Body Temperature Software (BTS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243778", "people": [{"name": "Nathan Austin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243778%22"}, {"id": "fda:K243396", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243396: Aptima SARS-CoV-2 Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243396", "people": [{"name": "Katerina Capkova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243396%22"}, {"id": "fda:K242104", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242104: Penumbra System (Reperfusion Catheter RED 72)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242104", "people": [{"name": "Sindokht (Sisi) Soltanzadeh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242104%22"}, {"id": "fda:K243546", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243546: AH Plus Endodontic Sealer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243546", "people": [{"name": "Rebecca Sporer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243546%22"}, {"id": "fda:K241597", "company": "Maxx Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241597: Freedom\u00ae Total Knee System - Porous Tibial Base Plate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241597", "people": [{"name": "Corey Perine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241597%22"}, {"id": "pma:P240022", "company": "Symatese", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240022: EVOLYSSE\u0099 SMOOTH and EVOLYSSE\u0099 FORM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240022", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240022%22"}, {"id": "trialreg:NCT06821854", "company": "Mastelli S.r.l", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of PN20 (Plinest) for the Improvement of Skin Hydration", "source_url": "https://clinicaltrials.gov/study/NCT06821854"}, {"id": "trialreg:NCT06821412", "company": "Liberating Technologies, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Wireless Prosthetic Control Effectiveness Study", "source_url": "https://clinicaltrials.gov/study/NCT06821412"}, {"id": "trialreg:NCT06823700", "company": "Shanghai Shenqi Medical Technology Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU", "source_url": "https://clinicaltrials.gov/study/NCT06823700"}, {"id": "trialreg:NCT06821867", "company": "Mastelli S.r.l", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of PN+HA (NEWEST) for the Improvement of Skin Hydration", "source_url": "https://clinicaltrials.gov/study/NCT06821867"}, {"id": "trialreg:NCT06822738", "company": "AbbVie", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma", "source_url": "https://clinicaltrials.gov/study/NCT06822738"}, {"id": "trialreg:NCT06822322", "company": "Ceric S\u00e0rl", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations", "source_url": "https://clinicaltrials.gov/study/NCT06822322"}, {"id": "trialreg:NCT06822712", "company": "BrosMed Medical Co., Ltd", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions", "source_url": "https://clinicaltrials.gov/study/NCT06822712"}, {"id": "trialreg:NCT06823648", "company": "Radiometer Medical ApS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-12", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Precision and In-use Analyte Stability Study for 19 Parameters in Adult Arterial Whole Blood for PICO70 and SafePICO", "source_url": "https://clinicaltrials.gov/study/NCT06823648"}, {"id": "fda:K243961", "company": "Kunshan Hi-Fortune Health Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243961: Electrically Powered Wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243961", "people": [{"name": "Zhanli Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243961%22"}, {"id": "fda:K243523", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243523: NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243523", "people": [{"name": "Tabitha Estes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243523%22"}, {"id": "fda:K243907", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243907: Affixus Tibial Nailing System - 4mm screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243907", "people": [{"name": "Akash Savalia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243907%22"}, {"id": "fda:K241418", "company": "Opsens, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241418: OptoMonitor 3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241418", "people": [{"name": "Marc Chaunet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241418%22"}, {"id": "fda:K243575", "company": "Biokit, S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243575: ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243575", "people": [{"name": "Janna Puig", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243575%22"}, {"id": "fda:K242006", "company": "Quality Electrodynamics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242006: SureWave Elastography (Q7000225)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242006", "people": [{"name": "Eric Yeh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242006%22"}, {"id": "fda:K243250", "company": "Subtle Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243250: SubtleHD (1.x)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243250", "people": [{"name": "Ronny Elor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243250%22"}, {"id": "fda:K241479", "company": "Etiometry, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241479: Etiometry Platform (DAV 5.4 RAE 9.2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241479", "people": [{"name": "Tim Hanson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241479%22"}, {"id": "fda:K241425", "company": "Aspen Imaging Healthcare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241425: AspenView", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241425", "people": [{"name": "Casey Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241425%22"}, {"id": "fda:K243962", "company": "Kunshan Hi-Fortune Health Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243962: Electrically Powered Wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243962", "people": [{"name": "Zhanli Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243962%22"}, {"id": "fda:K242666", "company": "Gi Bionics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242666: Fecobionics Anorectal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242666", "people": [{"name": "Ricardo Villanueva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242666%22"}, {"id": "fda:K243702", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243702: V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243702", "people": [{"name": "Yujin Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243702%22"}, {"id": "sbir:DOD:HT9425-25-C-0006", "company": "Nirsense, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-02-12", "observed": "2026-09-18", "amount_usd": 1300000, "summary": "DOD SBIR Phase II award $1,300,000: Ultra-thin Helmet-Compatible NIRS/EEG-Based Cerebrovascular Monitoring Sensor System for Future Vertical Lift Operator State Monitoring Integration", "source_url": "https://www.sbir.gov/awards?search=H2-0806"}, {"id": "trialreg:NCT06819865", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism", "source_url": "https://clinicaltrials.gov/study/NCT06819865"}, {"id": "trialreg:NCT06819306", "company": "Hedia ApS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-11", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: The Effect of Hedia Diabetes Assistant on TiMe-in-range in People With Type 1 Diabetes and Sub-Optimal Glycemic Control in France - A Randomised Controlled Trial.", "source_url": "https://clinicaltrials.gov/study/NCT06819306"}, {"id": "fda:K243518", "company": "Abbott Diagnostics Scarborough, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243518: BinaxNOW\u0099 COVID-19 Antigen Self Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243518", "people": [{"name": "Kristen Cyr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243518%22"}, {"id": "fda:K243620", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243620: Vivid iq", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243620", "people": [{"name": "Bush Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243620%22"}, {"id": "fda:K241897", "company": "Morari, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241897: MOR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241897", "people": [{"name": "Jeff Bennett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241897%22"}, {"id": "fda:K243188", "company": "Signus Medizintechnik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243188: CYLOX\u00ae ST", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243188", "people": [{"name": "Antje Schmidt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243188%22"}, {"id": "fda:K243317", "company": "Infinitum Eta, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243317: NUVENTUS NV.C\u0099 Surgical Cassette and Tray", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243317", "people": [{"name": "Avital Barlev", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243317%22"}, {"id": "fda:K250200", "company": "Inbella Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250200: InbellaBody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250200", "people": [{"name": "Michael Kreindel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250200%22"}, {"id": "fda:K241634", "company": "Guangdong Xinyu Electronic and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241634: Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241634", "people": [{"name": "Rita Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241634%22"}, {"id": "fda:K241451", "company": "Teleflex Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241451: Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241451", "people": [{"name": "Bouse Angela", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241451%22"}, {"id": "fda:K241462", "company": "Noris Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241462: LONGY Implant and LONGY-N Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241462", "people": [{"name": "Noa Mor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241462%22"}, {"id": "fda:K243628", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243628: Vivid T9/Vivid T8", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243628", "people": [{"name": "Bush Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243628%22"}, {"id": "fda:K243155", "company": "Dongguan Zsr Biomedical Technology Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243155: Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243155", "people": [{"name": "Wen Sharon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243155%22"}, {"id": "fda:K240867", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240867: cobas\u00ae SARS-CoV-2 Qualitative for use on the cobas\u00ae 5800/6800/8800 Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240867", "people": [{"name": "Mounika Kommineni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240867%22"}, {"id": "fda:K241817", "company": "Shoulder Innovations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241817: InSet Total Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241817", "people": [{"name": "Mark Hanes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241817%22"}, {"id": "trialreg:NCT06818448", "company": "BAAT Medical Products B.V.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: SINEFIX-2022 Comparative Phase", "source_url": "https://clinicaltrials.gov/study/NCT06818448"}, {"id": "trialreg:NCT06816069", "company": "CLASSYS Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Study on Safety and Efficacy of Monopolar Radio Frequency Device for Facial Skin Tightening", "source_url": "https://clinicaltrials.gov/study/NCT06816069"}, {"id": "trialreg:NCT06816446", "company": "Rodenstock GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Influence of Rodenstock Spectacle Lenses on Myopia Progression.", "source_url": "https://clinicaltrials.gov/study/NCT06816446"}, {"id": "trialreg:NCT06817967", "company": "Pharma Nordic AS", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study Comparing Proponent Solution - Nasal Spray (PSNS) With Salt Water for Treating Nasal Congestion Symptoms in Adults With Rebound Nasal Congestion While Weaning From Nasal Decongestant Sprays", "source_url": "https://clinicaltrials.gov/study/NCT06817967"}, {"id": "trialreg:NCT06816485", "company": "Biosensors Europe SA", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis", "source_url": "https://clinicaltrials.gov/study/NCT06816485"}, {"id": "trialreg:NCT06817785", "company": "CooperVision, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere", "source_url": "https://clinicaltrials.gov/study/NCT06817785"}, {"id": "trialreg:NCT06815939", "company": "DL Analytics", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-10", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer", "source_url": "https://clinicaltrials.gov/study/NCT06815939"}, {"id": "fda:K241659", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241659: Ultrasound Workspace (UWS 6.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241659", "people": [{"name": "Petra Galgoczy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241659%22"}, {"id": "fda:K243201", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243201: The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243201", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243201%22"}, {"id": "fda:K240958", "company": "Hebei Ruihe Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240958: Locking Plates and Screws Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240958", "people": [{"name": "Mengjia Chi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240958%22"}, {"id": "fda:K244042", "company": "Abbott Ireland", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244042: Calcium2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244042", "people": [{"name": "Cherie Lipowsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244042%22"}, {"id": "fda:K242905", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242905: The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242905", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242905%22"}, {"id": "fda:K241516", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241516: BTL-398", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241516", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241516%22"}, {"id": "fda:K243516", "company": "Grindguard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243516: Remi Custom Night Guard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243516", "people": [{"name": "Oscar Adelman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243516%22"}, {"id": "fda:K243063", "company": "Raja Trading Company, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243063: Myolight Microcurrent Handpiece", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243063", "people": [{"name": "Robert J. Adipietro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243063%22"}, {"id": "fda:K243453", "company": "Philips Consumer Lifestyle B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243453: Philips Lumea IPL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243453", "people": [{"name": "Martijn Halbesma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243453%22"}, {"id": "fda:K243511", "company": "Changsha Anxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243511: OTC TENS & EMS Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243511", "people": [{"name": "William Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243511%22"}, {"id": "sbir:DOD:FA8649-25-P-0184", "company": "Autonomus Medical Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-02-10", "observed": "2026-09-18", "amount_usd": 108186, "summary": "DOD STTR Phase I award $108,186: Handheld Robotic Medical Device for Semi-automated Nerve Block Administration in Austere Environments", "source_url": "https://www.sbir.gov/awards?search=FX24E-TPCSO1-0393"}, {"id": "trialreg:NCT06815354", "company": "AIQ Solutions", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Comprehensive Assessment of Cancer Theranostic Response", "source_url": "https://clinicaltrials.gov/study/NCT06815354"}, {"id": "trialreg:NCT06813820", "company": "BioVentrix", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial", "source_url": "https://clinicaltrials.gov/study/NCT06813820"}, {"id": "trialreg:NCT06814028", "company": "Spark Biomedical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial", "source_url": "https://clinicaltrials.gov/study/NCT06814028"}, {"id": "trialreg:NCT06815614", "company": "Taiwan Biophotonic Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: This Study Aims to Assess the Performances of Optical Blood Pressure Monitoring Device, tBPC Product With Reference to ISO 81060-3:2022", "source_url": "https://clinicaltrials.gov/study/NCT06815614"}, {"id": "trialreg:NCT06814015", "company": "Wandercraft", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-07", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Self-balancing Personal Exoskeleton for SCI (Site 2)", "source_url": "https://clinicaltrials.gov/study/NCT06814015"}, {"id": "fda:K242713", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242713: Any-Com Bulk", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242713", "people": [{"name": "Da Hyeon Ku", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242713%22"}, {"id": "fda:K242368", "company": "Medical Microinstruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242368: Symani Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242368", "people": [{"name": "Zainab Amini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242368%22"}, {"id": "fda:K243996", "company": "Assure Tech., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243996: AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243996", "people": [{"name": "Allen Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243996%22"}, {"id": "fda:K243661", "company": "Hetaida Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243661: Electronic Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243661", "people": [{"name": "Tom Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243661%22"}, {"id": "fda:K242483", "company": "Genesys Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242483: Genesys Spine AIS-C II Cervical Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242483", "people": [{"name": "Derek Southard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242483%22"}, {"id": "fda:K243321", "company": "Guangzhou Red Pine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243321: Endoscopic Video Image Processor (RP-IPD-V1000F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243321", "people": [{"name": "Weihua Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243321%22"}, {"id": "fda:K241453", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241453: Elecsys sFlt-1 and Elecsys PlGF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241453", "people": [{"name": "Jane Phillips", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241453%22"}, {"id": "fda:K241483", "company": "Encore Medical L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241483: ceramys\u0099 femoral head system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241483", "people": [{"name": "Katrina Dombovari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241483%22"}, {"id": "fda:K243780", "company": "Laseroptek Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243780: HELIOS 785 Pico (1754V2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243780", "people": [{"name": "Chu Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243780%22"}, {"id": "fda:K242404", "company": "Bdc Dental Corporation , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242404: BDC Dental Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242404", "people": [{"name": "Yanfei Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242404%22"}, {"id": "fda:K242957", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242957: Identify (4.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242957", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242957%22"}, {"id": "breakthrough:K241453", "company": "Roche Diagnostics", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-02-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K241453: ELECSYS SFLT-1 AND ELECSYS PLGF", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "trialreg:NCT06812533", "company": "Alleviant Medical, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Alleviant ALLAY-HFrEF Study", "source_url": "https://clinicaltrials.gov/study/NCT06812533"}, {"id": "trialreg:NCT06811805", "company": "CardioRenal Systems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Post-Marketing Study to Assess the Safety & Efficacy of RenalGuard\u00ae Therapy for Prevention CSA-AKI", "source_url": "https://clinicaltrials.gov/study/NCT06811805"}, {"id": "trialreg:NCT06810856", "company": "Repolar Pharmaceuticals Oy", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: HRIPT Study to Evaluate the Irritation and Allergenic Potential of Medical-grade Norway Spruce (Picea Abies) Resin Salve (Abilar)", "source_url": "https://clinicaltrials.gov/study/NCT06810856"}, {"id": "trialreg:NCT06810726", "company": "Estar Medical dba Medical Technologies, LTD", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.", "source_url": "https://clinicaltrials.gov/study/NCT06810726"}, {"id": "trialreg:NCT06812572", "company": "Visibly", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-06", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Clinical Study to Evaluate the Repeatability of the Visibly Vision Test", "source_url": "https://clinicaltrials.gov/study/NCT06812572"}, {"id": "fda:K242428", "company": "Guangzhou Decheng Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242428: Dochek\u00ae Fentanyl Urine Test Strip, Dochek\u00ae Fentanyl Urine Test Strip Plus, Dochek\u00ae Fentanyl Urine Test Card, Dochek\u00ae Fentanyl Urine Test Card Plus, Dochek\u00ae Fentanyl Urine Test Cup and Dochek\u00ae Fentanyl Urine Test Cup Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242428", "people": [{"name": "Jenny Mao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242428%22"}, {"id": "fda:K243243", "company": "Quantalx Neuroscience, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243243: Delphi MCS Electrode Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243243", "people": [{"name": "Hlila Fogel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243243%22"}, {"id": "fda:K242111", "company": "Unimom.Co", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242111: VIVACE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242111", "people": [{"name": "Yeong-Bin Chon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242111%22"}, {"id": "fda:K242324", "company": "Novatech SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242324: DUTAU-NOVATECH\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242324", "people": [{"name": "Stuart K. Montgomery", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242324%22"}, {"id": "fda:K241599", "company": "Signature Orthopaedic Pty , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241599: Signature Osteosynthesis Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241599", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241599%22"}, {"id": "fda:K241702", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241702: CROSSLEAD 0.014inch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241702", "people": [{"name": "Katsuhiko Fujimura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241702%22"}, {"id": "fda:K242192", "company": "Beijing Zksk Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242192: Disposable Sphincterotome", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242192", "people": [{"name": "Li Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242192%22"}, {"id": "fda:K243784", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243784: Stryker Orthopaedics Hip Devices Labeling Update", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243784", "people": [{"name": "Julia Bally", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243784%22"}, {"id": "fda:K242977", "company": "Xuzhou Kernel Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242977: 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242977", "people": [{"name": "Che Gang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242977%22"}, {"id": "fda:K244034", "company": "Ever Global (Vietnam) Enterprise Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244034: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244034", "people": [{"name": "Elizabeth Deng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244034%22"}, {"id": "fda:K242580", "company": "Unimed Medical Supplies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242580: Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242580", "people": [{"name": "Huanyu Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242580%22"}, {"id": "fda:K250044", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250044: Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250044", "people": [{"name": "Logan Persons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250044%22"}, {"id": "fda:K250066", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250066: Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250066", "people": [{"name": "Kyra McNamara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250066%22"}, {"id": "fda:K243488", "company": "Termosalud", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243488: VMAT PRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243488", "people": [{"name": "Christina Cifuentes Pantoja", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243488%22"}, {"id": "fda:K243817", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243817: Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert \u0096 Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert \u0096 Posteriorly Stabilized Insert", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243817", "people": [{"name": "Tara Rudrapatna", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243817%22"}, {"id": "fda:K250055", "company": "Orthonovis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250055: BPS - Bone Fragment Fixation Plates, Screws and Washers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250055", "people": [{"name": "Ken West", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250055%22"}, {"id": "fda:K250061", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250061: Celerity Incubator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250061", "people": [{"name": "Karly Eitzman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250061%22"}, {"id": "fda:K243794", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243794: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243794", "people": [{"name": "Deval Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243794%22"}, {"id": "fda:K243465", "company": "Guangzhou Chuang Zao Mei Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243465: Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243465", "people": [{"name": "Sergei Slashchilin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243465%22"}, {"id": "trialreg:NCT06809543", "company": "Mastelli S.r.l", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy", "source_url": "https://clinicaltrials.gov/study/NCT06809543"}, {"id": "trialreg:NCT06810219", "company": "Cognixion", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS", "source_url": "https://clinicaltrials.gov/study/NCT06810219"}, {"id": "trialreg:NCT06809907", "company": "Kintsugi Mindful Wellness, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Kintsugi Voice Device Pivotal Study", "source_url": "https://clinicaltrials.gov/study/NCT06809907"}, {"id": "trialreg:NCT06808880", "company": "Natera, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: EXpanding Prenatal Cell Free DNA Screening Across moNogenic Disorders (EXPAND)", "source_url": "https://clinicaltrials.gov/study/NCT06808880"}, {"id": "trialreg:NCT06808217", "company": "Boston Scientific Corporation", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation", "source_url": "https://clinicaltrials.gov/study/NCT06808217"}, {"id": "trialreg:NCT06809647", "company": "PLU Ophthalmic", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Prospective Interventional Cohort Study to Evaluate the Efficacy and Safety of the AquaLumen, a Novel Filtration Procedure for the Treatment of Open Angle Glaucoma", "source_url": "https://clinicaltrials.gov/study/NCT06809647"}, {"id": "trialreg:NCT06810518", "company": "American Laboratory Products Company", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-05", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool", "source_url": "https://clinicaltrials.gov/study/NCT06810518"}, {"id": "fda:K242896", "company": "Nvision Biomedical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242896: Caliber Intramedullary Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242896", "people": [{"name": "Erin Lansdale", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242896%22"}, {"id": "fda:K243580", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243580: GraftGun Universal Graft Delivery System (GDS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243580", "people": [{"name": "Jason Hershman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243580%22"}, {"id": "fda:K241327", "company": "Claronav", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241327: Navient Image Guide Navigation System (955-NC-NC), Cranial", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241327", "people": [{"name": "Karen Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241327%22"}, {"id": "fda:K243790", "company": "Depuy Mitek", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243790: GRYPHON\u0099 X Anchor; HEALIX TRANSTEND\u0099 Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243790", "people": [{"name": "Ashley Aromando", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243790%22"}, {"id": "fda:K242352", "company": "Accurate Meditech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242352: Accurate Mini Non-invasive blood pressure monitor (AMB-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242352", "people": [{"name": "Kuan-Jen Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242352%22"}, {"id": "fda:K241488", "company": "Trainfes", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241488: TrainFES Advance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241488", "people": [{"name": "Matias Hosiasson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241488%22"}, {"id": "fda:K241593", "company": "Gleamer Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241593: BoneMetrics (US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241593", "people": [{"name": "Antoine Tournier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241593%22"}, {"id": "fda:K242983", "company": "Creo Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242983: CROMA Electrosurgical Generator (PRD-EMR-050)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242983", "people": [{"name": "Diane Davis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242983%22"}, {"id": "fda:K243555", "company": "Shenzhen Eyco Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243555: LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243555", "people": [{"name": "Ding Martin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243555%22"}, {"id": "sbir:DOD:HT9425-25-C-0007", "company": "Quantum Applied Science & Research Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-02-05", "observed": "2026-09-18", "amount_usd": 1299999, "summary": "DOD SBIR Phase II award $1,299,999: Cognitive Health Impact and Physiological Sensors (CHIPS) Helmet, Phase II", "source_url": "https://www.sbir.gov/awards?search=H2-0798"}, {"id": "trialreg:NCT06807099", "company": "Merit Medical Systems, Inc.", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: WRAP North America", "source_url": "https://clinicaltrials.gov/study/NCT06807099"}, {"id": "trialreg:NCT06807359", "company": "SpectraCure AB", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System", "source_url": "https://clinicaltrials.gov/study/NCT06807359"}, {"id": "trialreg:NCT06807502", "company": "ScreenCell", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-04", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device", "source_url": "https://clinicaltrials.gov/study/NCT06807502"}, {"id": "fda:K250068", "company": "Venclose, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250068: Venclose digiRF Generator (VCRFG1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250068", "people": [{"name": "Kulveen Dhatt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250068%22"}, {"id": "fda:K243333", "company": "Roclub GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243333: rTOP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243333", "people": [{"name": "Mario Schrenk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243333%22"}, {"id": "fda:K243138", "company": "Geon Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243138: Geon (S2) Nasal Aspirator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243138", "people": [{"name": "Henry Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243138%22"}, {"id": "fda:K242916", "company": "Largan Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242916: Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242916", "people": [{"name": "Shih-min Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242916%22"}, {"id": "trialreg:NCT06805175", "company": "Cochlear", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration", "source_url": "https://clinicaltrials.gov/study/NCT06805175"}, {"id": "trialreg:NCT06805006", "company": "A.M.I. Agency for Medical Innovations GmbH", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)", "source_url": "https://clinicaltrials.gov/study/NCT06805006"}, {"id": "trialreg:NCT06805461", "company": "RenovoRx", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: PumaRx Registry Trial", "source_url": "https://clinicaltrials.gov/study/NCT06805461"}, {"id": "trialreg:NCT06805838", "company": "SafeBVM", "kind": "trial_registration", "kind_label": "ClinicalTrials.gov device trial registration", "date": "2025-02-03", "observed": "2026-08-18", "amount_usd": null, "summary": "New device trial registered: Prolonged Manual Ventilation Simulation", "source_url": "https://clinicaltrials.gov/study/NCT06805838"}, {"id": "fda:K243908", "company": "Zavation Medical Products, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243908: Tiger 2 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243908", "people": [{"name": "Frankie Cummins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243908%22"}, {"id": "fda:K241454", "company": "Guangzhou Hehong Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241454: Minvitro\u00ae Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241454", "people": [{"name": "Yu Feng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241454%22"}, {"id": "fda:K241368", "company": "Huntleigh Healthcare , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241368: Sonicaid Team3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241368", "people": [{"name": "Steve Monks", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241368%22"}, {"id": "fda:K243182", "company": "Momentis Surgical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243182: Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243182", "people": [{"name": "Maya Leib Shlomo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243182%22"}, {"id": "fda:K243393", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243393: JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243393", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243393%22"}, {"id": "fda:K243268", "company": "Pranaq Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243268: TipTraQ (TTQ001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243268", "people": [{"name": "Jerry Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243268%22"}, {"id": "fda:K250035", "company": "Mim Software, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250035: Contour Prot\u00e9g\u00e9AI+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250035", "people": [{"name": "Sydney Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250035%22"}, {"id": "fda:K241375", "company": "Alphatec Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241375: IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241375", "people": [{"name": "Alanna Joshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241375%22"}, {"id": "fda:K240402", "company": "Cytochip, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240402: Cito CBC System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240402", "people": [{"name": "Wendian Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240402%22"}, {"id": "fda:K243146", "company": "Ihealth Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243146: iCare APP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243146", "people": [{"name": "Tianyang Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243146%22"}, {"id": "fda:K241590", "company": "Guangdong Xinyu Electronic and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-02-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241590: Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241590", "people": [{"name": "Rita Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241590%22"}, {"id": "fda:K241334", "company": "C.R. Bard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241334: Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH\u0099 Temporary Pacing Electrode Catheter,", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241334", "people": [{"name": "Caitlin Bowles", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241334%22"}, {"id": "fda:K242135", "company": "Nanjing Synthgene Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242135: Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242135", "people": [{"name": "Alvin Qian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242135%22"}, {"id": "fda:K243441", "company": "Basic Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243441: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243441", "people": [{"name": "Zhao John", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243441%22"}, {"id": "fda:K242982", "company": "Suzhou Master Machinery Manufacturing Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242982: Mobility Scooter (MS160A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242982", "people": [{"name": "Siqi Shangguan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242982%22"}, {"id": "fda:K243150", "company": "Luxottica Group S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243150: Nuance Audio Hearing Aid Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243150", "people": [{"name": "Giulia Cuccato", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243150%22"}, {"id": "fda:K241193", "company": "Marzzan Lucas Jorge", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241193: AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241193", "people": [{"name": "Lucas Jorge Marzzan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241193%22"}, {"id": "fda:K242966", "company": "Gentuity, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242966: Gentuity\u00ae HF-OCT Imaging System with Vis-Rx Prime\u00ae Micro-Imaging Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242966", "people": [{"name": "Edwin Rule", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242966%22"}, {"id": "fda:K241348", "company": "Motilitycount Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241348: SwimCount\u00ae Harvester (1 mL); SwimCount\u00ae Harvester (3 mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241348", "people": [{"name": "Jacob M\u00f8llenbach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241348%22"}, {"id": "fda:K242442", "company": "Innovate Orthopaedics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242442: Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242442", "people": [{"name": "Mike Bilson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242442%22"}, {"id": "fda:K243665", "company": "ZheJiang Decans Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243665: Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243665", "people": [{"name": "Haifeng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243665%22"}, {"id": "fda:K243572", "company": "Avanos Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243572: Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243572", "people": [{"name": "Dana Goussev", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243572%22"}, {"id": "fda:K241694", "company": "Tae Young Soft Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241694: ZeTTA PACS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241694", "people": [{"name": "Hong Hyeon An", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241694%22"}, {"id": "fda:K243742", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243742: Arthrex DynaNite Nitinol Staples", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243742", "people": [{"name": "Kelsey Roberts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243742%22"}, {"id": "fda:K243820", "company": "Dornier Medtech America", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243820: Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243820", "people": [{"name": "John Hoffer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243820%22"}, {"id": "fda:K241292", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241292: MyShoulder Planner (5.3SSWPL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241292", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241292%22"}, {"id": "fda:K241270", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241270: BTL-754", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241270", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241270%22"}, {"id": "fda:K243410", "company": "Abbott Molecular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243410: simpli-COLLECT STI Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243410", "people": [{"name": "Stacy Ferguson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243410%22"}, {"id": "fda:K243442", "company": "Mobius Mobility", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243442: iBOT\u00ae PMD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243442", "people": [{"name": "Joseph Sullivan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243442%22"}, {"id": "fda:K242717", "company": "Laboratorios Biogalenic S.A. DE C.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242717: Laboratorios Biogalenic Sterile Water for Inhalation, USP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242717", "people": [{"name": "Roberto Qui\u00f1onez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242717%22"}, {"id": "fda:K243025", "company": "Seplou (Zhuhai) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243025: Ureteral Access Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243025", "people": [{"name": "Vince Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243025%22"}, {"id": "fda:K243726", "company": "Responsive Arthroscopy, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243726: Osprey Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243726", "people": [{"name": "Gretchen Hinchley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243726%22"}, {"id": "fda:K242757", "company": "Bard Peripheral Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242757: Rotarex Atherectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242757", "people": [{"name": "Aaron Conovaloff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242757%22"}, {"id": "fda:K243060", "company": "Guangdong Transtek Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243060: TeleRPM Gen2 Blood Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243060", "people": [{"name": "Qian Mark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243060%22"}, {"id": "fda:K242568", "company": "Shenzhen Zhongkemingwang Telecommunications Software Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242568: Wrist Blood Pressure Monitor (OHMS11, OHMS12)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242568", "people": [{"name": "Queena Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242568%22"}, {"id": "fda:K233956", "company": "Taiwan Aulisa Medical Devices Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233956: Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233956", "people": [{"name": "Ming Hsiu Hsiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233956%22"}, {"id": "fda:K243202", "company": "Liofilchem s.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243202: MTS Ceftobiprole 0.002-32 \u00b5g/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243202", "people": [{"name": "Fabio Rocco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243202%22"}, {"id": "fda:K243712", "company": "Abanza Tecnomed S.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243712: WasherCap\u0099 Mini Fixation System (Model 45)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243712", "people": [{"name": "Ander Menaut", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243712%22"}, {"id": "fda:K242217", "company": "Surcam Medical Devices and Developments, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242217: Surcam Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242217", "people": [{"name": "Shay Shabat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242217%22"}, {"id": "fda:K241915", "company": "Access Bio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241915: CareSuperb\u0099 COVID-19 Antigen Home Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241915", "people": [{"name": "Sung Jang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241915%22"}, {"id": "fda:K243042", "company": "Hygea Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243042: Co-Ablation System with Sterile Co-Ablation Probe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243042", "people": [{"name": "Xingtong Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243042%22"}, {"id": "fda:K243673", "company": "Xenco Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243673: Xenco Medical CancelleX Cervical Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243673", "people": [{"name": "Jason Haider", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243673%22"}, {"id": "fda:K243117", "company": "Hunan Vathin Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243117: Digital Video Processor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243117", "people": [{"name": "Jing Du", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243117%22"}, {"id": "fda:K243740", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243740: Versalock Upper Limb Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243740", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243740%22"}, {"id": "fda:K243213", "company": "GI Windows, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243213: Self-Forming Magnet (FLEX SFM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243213", "people": [{"name": "Yverre Bobay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243213%22"}, {"id": "fda:K243387", "company": "Gyder Surgical Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243387: GYDER\u00ae Hip System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243387", "people": [{"name": "Sujit Dike", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243387%22"}, {"id": "nih:1R43DA062420-01", "company": "Mobile Health Interventions LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-28", "observed": "2026-08-21", "amount_usd": 280207, "summary": "NIH award 1R43DA062420-01: A Digital Intervention to Reduce Youth Cannabis Use ($280,207)", "source_url": "https://reporter.nih.gov/project-details/11067951", "people": [{"name": "Frederick John Muench", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K244025", "company": "Conmed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244025: Argo Knotless GENESYS Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244025", "people": [{"name": "Dionne Sanders", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244025%22"}, {"id": "fda:K243698", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243698: Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243698", "people": [{"name": "Esther Moreno Garcia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243698%22"}, {"id": "fda:K243501", "company": "3M Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243501: 3M\u0099 Attest\u0099 Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M\u0099 Attest\u0099 Auto-reader 490; 3M\u0099 Attest\u0099 Auto-reader 490H; 3M\u0099 Attest\u0099 Mini Auto-reader 490M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243501", "people": [{"name": "Michelle Larsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243501%22"}, {"id": "fda:K243374", "company": "Instrumentation Laboratory (IL) Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243374: HemosIL CL HIT-IgG(PF4-H)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243374", "people": [{"name": "Nikita Malladi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243374%22"}, {"id": "fda:K243423", "company": "Shenzhen Rainbow Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243423: LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243423", "people": [{"name": "Layla Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243423%22"}, {"id": "fda:K243439", "company": "Lg Electronics.Inc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243439: Medical Monitor (27HS714S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243439", "people": [{"name": "Hanseul Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243439%22"}, {"id": "fda:K244027", "company": "Huxley Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244027: SANSA HSAT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244027", "people": [{"name": "Daniel Burnham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244027%22"}, {"id": "fda:K242941", "company": "Beijing Sano Laser S&T Development Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242941: CO2 Laser Therapy Systems (SHE-LSP003-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242941", "people": [{"name": "Li Zhengrong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242941%22"}, {"id": "fda:K243229", "company": "BunkerHill Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243229: Bunkerhill AVC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243229", "people": [{"name": "Nishith Khandwala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243229%22"}, {"id": "fda:K231297", "company": "Firstar Dental Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231297: Firstar Dental Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231297", "people": [{"name": "Kang N Lei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231297%22"}, {"id": "fda:K241266", "company": "Raysolution Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241266: Imaging system of positron emission and X-ray computed tomography (DigitMI 930)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241266", "people": [{"name": "Feng Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241266%22"}, {"id": "fda:K250014", "company": "Medical Microinstruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250014: Symani Surgical System (820-03830)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250014", "people": [{"name": "Zainab Amini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250014%22"}, {"id": "nih:4R44HD112248-02", "company": "Spirit Fit & Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": 919209, "summary": "NIH award 4R44HD112248-02: SPIRIT Club CBI Pathway: A novel streaming platform for physical activity and wellness promotion for chronic brain injury survivors ($919,209)", "source_url": "https://reporter.nih.gov/project-details/11256946", "people": [{"name": "Jared Phillip Ciner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG047722-09", "company": "Posit Science Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": 826900, "summary": "NIH award 5R44AG047722-09: Phase IIB Plasticity-based Adaptive Cognitive Remediation for Alzheimers Disease ($826,900)", "source_url": "https://reporter.nih.gov/project-details/11019846", "people": [{"name": "Hyun Kyu Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 9, "new_award": false}, {"id": "fda:K241220", "company": "Roche Diagnostics Operations", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241220: Tina-quant Lipoprotein(a) Gen.2 Molarity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241220", "people": [{"name": "Leslie Patterson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241220%22"}, {"id": "fda:K241232", "company": "Ibex Medical Analytics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241232: Galen\u0099 Second Read\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241232", "people": [{"name": "Yael Liebes Peer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241232%22"}, {"id": "fda:K243657", "company": "ClearPoint Neuro, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243657: ClearPoint System (Software Version 3.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243657", "people": [{"name": "Brennan Sullivan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243657%22"}, {"id": "fda:K241107", "company": "Indiba S. A. U.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241107: Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241107", "people": [{"name": "Amit Goren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241107%22"}, {"id": "fda:K241239", "company": "Bridge TO Life, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241239: OrganProtex HTK Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241239", "people": [{"name": "Mark Harper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241239%22"}, {"id": "fda:K244023", "company": "Magentiq Eye, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244023: MAGENTIQ-COLO (ME-APDS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244023", "people": [{"name": "Dror Zur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244023%22"}, {"id": "fda:K242322", "company": "Zhejiang Curaway Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242322: Bone Marrow Biopsy Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242322", "people": [{"name": "Caili Cao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242322%22"}, {"id": "fda:K241793", "company": "Zhejiang Curaway Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241793: Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241793", "people": [{"name": "Li Yin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241793%22"}, {"id": "fda:K241057", "company": "Wuhan Guangdun Technology Co.,Ltd..", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241057: Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241057", "people": [{"name": "Suzy Pan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241057%22"}, {"id": "fda:K243739", "company": "Elliquence, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243739: AxCess\u00ae Expandable Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243739", "people": [{"name": "Paul Buhrke, IV", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243739%22"}, {"id": "breakthrough:K241232", "company": "Ibex Medical Analytics, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-01-24", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K241232: GALEN SECOND READ", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K243219", "company": "Auris Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243219: MONARCH\u0099 Platform (MON-000008)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243219", "people": [{"name": "Amy Clendening-Wheeler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243219%22"}, {"id": "fda:K243158", "company": "Terarecon,Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243158: TeraRecon Aorta.CT (1.1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243158", "people": [{"name": "Michael Sosebee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243158%22"}, {"id": "fda:K241199", "company": "Shenzhen Launch Electrical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241199: Rotatable Connector (5944RL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241199", "people": [{"name": "Christina Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241199%22"}, {"id": "fda:K241367", "company": "Shanghai Samedical & Plastic Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241367: RF Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241367", "people": [{"name": "Louis Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241367%22"}, {"id": "fda:K243624", "company": "Acumed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243624: Acu-Sinch Knotless Mini", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243624", "people": [{"name": "Marina Bull", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243624%22"}, {"id": "fda:K242714", "company": "Zhejiang Seedream Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242714: Mobility Scooter (S-01); Mobility Scooter (S-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242714", "people": [{"name": "Jinxiang Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242714%22"}, {"id": "fda:K241234", "company": "Ots Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241234: OTS 25-L (100-5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241234", "people": [{"name": "Assaf Dekel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241234%22"}, {"id": "fda:K241819", "company": "Cyncronus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241819: CephNinja", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241819", "people": [{"name": "Rohit Madan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241819%22"}, {"id": "fda:K243668", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243668: ProLift Pivot Expandable Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243668", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243668%22"}, {"id": "fda:K241728", "company": "Murata Vios, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241728: Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241728", "people": [{"name": "Amit Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241728%22"}, {"id": "fda:K243350", "company": "Ischemaview, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243350: Rapid Neuro3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243350", "people": [{"name": "Patricia Setti-LaPerch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243350%22"}, {"id": "fda:K243139", "company": "Indiba S. A. U.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243139: Reverso Pro System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243139", "people": [{"name": "Amit Goren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243139%22"}, {"id": "fda:K243982", "company": "Natus Neurology Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243982: Nicolet EDX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243982", "people": [{"name": "Judy Samson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243982%22"}, {"id": "fda:K243976", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243976: ZeroClear\u0099 Bag Access (423100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243976", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243976%22"}, {"id": "fda:K240311", "company": "Compex, Spol, S.R.O.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240311: JETT Medical II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240311", "people": [{"name": "Radek Nespor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240311%22"}, {"id": "fda:K243008", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243008: Arthrex NanoScope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243008", "people": [{"name": "Lai Saeteurn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243008%22"}, {"id": "fda:K243985", "company": "Icu Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243985: Rio\u0099 Drug Reconstitution Transfer Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243985", "people": [{"name": "Michelle Doherty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243985%22"}, {"id": "fda:K241956", "company": "Hunan Endoso Life Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241956: Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241956", "people": [{"name": "Fu Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241956%22"}, {"id": "fda:K242446", "company": "Persyst Development Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242446: Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242446", "people": [{"name": "Dari Darabbeigi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242446%22"}, {"id": "fda:K242835", "company": "Suturion AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242835: Suture-TOOL System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242835", "people": [{"name": "Paan Hermansson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242835%22"}, {"id": "fda:K241357", "company": "Biodynamik, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241357: XT3 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241357", "people": [{"name": "Johnny Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241357%22"}, {"id": "fda:K243977", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243977: EMPHASYS Acetabular System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243977", "people": [{"name": "Amy Joyce", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243977%22"}, {"id": "fda:K242288", "company": "Medical Brands Laboratories B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242288: Advanced Cryo Wart Remover", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242288", "people": [{"name": "Pieternella Bouter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242288%22"}, {"id": "fda:K243929", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243929: Oligio X", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243929", "people": [{"name": "Hyun Sik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243929%22"}, {"id": "fda:K241443", "company": "Hathor Professional Skincare , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241443: Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241443", "people": [{"name": "Carolyn (Mellta) Swift", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241443%22"}, {"id": "fda:K243955", "company": "Precision AI Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243955: Precision AI Surgical Planning System (PAI-SPS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243955", "people": [{"name": "Sara Baniadam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243955%22"}, {"id": "fda:K241444", "company": "Shenzhen HugeMed Medical Technical Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241444: Biliary Pancreaticobiliary Scope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241444", "people": [{"name": "Cathy Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241444%22"}, {"id": "fda:K243303", "company": "Ziehm Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243303: Ziehm Vision RFD 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243303", "people": [{"name": "Tsvetelina Milanova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243303%22"}, {"id": "nih:1R44HL178134-01", "company": "Ension, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-20", "observed": "2026-08-21", "amount_usd": 870467, "summary": "NIH award 1R44HL178134-01: Bearingless flux reversal motor for neonatal and pediatric extracorporeal life support applications ($870,467)", "source_url": "https://reporter.nih.gov/project-details/11069156", "people": [{"name": "Patrick Thomas Cahalan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K241910", "company": "Navi Medical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241910: Neonav ECG Tip Location System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241910", "people": [{"name": "Zorana Mayooran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241910%22"}, {"id": "nih:5R44HL152835-05", "company": "Vantis Vascular Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": 990619, "summary": "NIH award 5R44HL152835-05: Catheter for Complex Percutaneous Coronary Intervention ($990,619)", "source_url": "https://reporter.nih.gov/project-details/11011323", "people": [{"name": "Tim Alexander Fischell", "role": "Principal Investigator"}, {"name": "Michael Mirizzi", "role": "Principal Investigator"}, {"name": "Frank S Saltiel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44CA291419-01A1", "company": "Radiopharmaceutical Imaging And Dosimetry, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": 1003173, "summary": "NIH award 1R44CA291419-01A1: Cloud/Web-Based Platform for Quantitative SPECT Reconstruction of Therapeutic Radionuclides ($1,003,173)", "source_url": "https://reporter.nih.gov/project-details/11069459", "people": [{"name": "ERIC C. FREY", "role": "Principal Investigator"}, {"name": "Michael Ghaly", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA298754-01", "company": "Argosmd, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R41CA298754-01: Mini-reflectance confocal microscope (Mini-RCM) for aiding skin cancer diagnosis and treatment ($400,000)", "source_url": "https://reporter.nih.gov/project-details/11077184", "people": [{"name": "Dongkyun Kang", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K243941", "company": "Access Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243941: HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243941", "people": [{"name": "Brian Hanley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243941%22"}, {"id": "fda:K242705", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242705: Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242705", "people": [{"name": "Debra Taitague", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242705%22"}, {"id": "fda:K243218", "company": "Medimaps Group SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243218: TBS iNsight (V4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243218", "people": [{"name": "Giorgio Zoia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243218%22"}, {"id": "fda:K241261", "company": "MED-EL Elektromedizinische Ger\u00e4te GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241261: mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241261", "people": [{"name": "In\u00e9s Rom\u00e1n Santiago", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241261%22"}, {"id": "fda:K242825", "company": "Prenuvo", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242825: Prenuvo Body Composition", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242825", "people": [{"name": "Sam Hashemi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242825%22"}, {"id": "fda:K242608", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242608: Embozene Color-Advanced Microspheres", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242608", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242608%22"}, {"id": "fda:K241333", "company": "Koh Young Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241333: Geniant Cranial (Navigated Neurosurgical Positioning Robot)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241333", "people": [{"name": "Sooji Shin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241333%22"}, {"id": "fda:K241949", "company": "Sonoscape Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241949: Digital Color Doppler Ultrasound System (P60 Series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241949", "people": [{"name": "Toki Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241949%22"}, {"id": "fda:K243315", "company": "Sofradim Production", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243315: ProGrip\u0099 Self-Gripping Polypropylene Mesh", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243315", "people": [{"name": "Nicolas Micka\u00ebl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243315%22"}, {"id": "fda:K242064", "company": "Smart Denture Conversions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242064: Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut\u0099)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242064", "people": [{"name": "Derrik Conrad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242064%22"}, {"id": "fda:K243606", "company": "Draeger Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243606: Babyroo TN300", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243606", "people": [{"name": "Karl Nittinger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243606%22"}, {"id": "fda:K242374", "company": "Airgas Therapeutics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242374: ULSPIRA TS\u0099 Nitric Oxide Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242374", "people": [{"name": "Timothy Warren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242374%22"}, {"id": "fda:K243545", "company": "Philips Medizin Systeme B\u00f6blingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243545: Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243545", "people": [{"name": "Namita Nandurkar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243545%22"}, {"id": "fda:K241142", "company": "MED-EL Elektromedizinische Ger\u00e4te GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241142: mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241142", "people": [{"name": "In\u00e9s Rom\u00e1n Santiago", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241142%22"}, {"id": "fda:K243706", "company": "Medtronic Sofamor Danek, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243706: Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243706", "people": [{"name": "Ian Dunkley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243706%22"}, {"id": "fda:K242765", "company": "Shenzhen Superline Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242765: Electronic Apex Locator (Alpha Apex I)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242765", "people": [{"name": "Jinsong Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242765%22"}, {"id": "fda:K243502", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243502: EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243502", "people": [{"name": "Toshio Nakamura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243502%22"}, {"id": "fda:K243568", "company": "Wilson-Cook Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243568: Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243568", "people": [{"name": "Lindsey Ebke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243568%22"}, {"id": "fda:K243291", "company": "Neoventa Medical AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243291: Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243291", "people": [{"name": "Johan Sundberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243291%22"}, {"id": "fda:K243605", "company": "Ge Medical Systems Israel, Functional Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243605: Aurora", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243605", "people": [{"name": "Hanne Jubran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243605%22"}, {"id": "fda:K242860", "company": "True Indicating, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242860: Type 5 Integrating Indicator for Steam (CSPN-15)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242860", "people": [{"name": "Thomas Riha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242860%22"}, {"id": "fda:K243935", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243935: Aptima CMV Quant Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243935", "people": [{"name": "Maria Jose Cortes-Mateos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243935%22"}, {"id": "fda:DEN230051", "company": "Myocene", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230051: Myocene", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230051", "people": [{"name": "Jean-Yves Mignolet", "role": "510(k) submission contact"}]}, {"id": "fda:K243249", "company": "Medos International SARL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243249: TriALTIS\u0099 Spine System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243249", "people": [{"name": "Jeanette Gardner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243249%22"}, {"id": "fda:K242171", "company": "Milvue", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242171: TechCare Trauma", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242171", "people": [{"name": "Mathieu Quintin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242171%22"}, {"id": "fda:K242051", "company": "Unity Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242051: VersaD Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242051", "people": [{"name": "Matthew Ogle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242051%22"}, {"id": "fda:K241269", "company": "MED-EL Elektromedizinische Ger\u00e4te GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241269: mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241269", "people": [{"name": "In\u00e9s Rom\u00e1n Santiago", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241269%22"}, {"id": "fda:K240217", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240217: cobas\u00ae liat CT/NG nucleic acid test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240217", "people": [{"name": "Deborah Leu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240217%22"}, {"id": "fda:K242336", "company": "Amb Medtec", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242336: hygh-tec Drainage II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242336", "people": [{"name": "Frank Gehres", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242336%22"}, {"id": "fda:K243067", "company": "Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243067: The ETHICON\u0099 Total Energy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243067", "people": [{"name": "Lovelene Bangalon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243067%22"}, {"id": "fda:K243892", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243892: Affera Integrated Mapping System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243892", "people": [{"name": "Matthew Lobeck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243892%22"}, {"id": "pma:P230019", "company": "Medibeacon, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230019: MediBeacon\u00ae Transdermal GFR Measurement System (TGFR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230019", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230019%22"}, {"id": "pma:P210016", "company": "Enovis", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2025-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P210016: ManaFuse", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210016", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P210016%22"}, {"id": "denovo:DEN230051", "company": "Myocene", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2025-01-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230051 granted: Myocene", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230051"}, {"id": "sbir:DOD:FA8649-25-P-0024", "company": "MonuMedical LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-01-17", "observed": "2026-09-18", "amount_usd": 74836, "summary": "DOD SBIR Phase I award $74,836: Prolonged Field Care with the MiniFuser Infusion Device", "source_url": "https://www.sbir.gov/awards?search=FX247-PCSO1-0206"}, {"id": "nih:3R44HL166003-03S1", "company": "Prolocor Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44HL166003-03S1: Validation of Platelet Expression of Fc\u0263RIIa as a Precision Tool ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11238227", "people": [{"name": "Jeanne Ohrnberger", "role": "Principal Investigator"}, {"name": "David J Schneider", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K241176", "company": "Axis-Shield Diagnostics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241176: Alere NT-proBNP for Alinity i Reagent Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241176", "people": [{"name": "Claire Dora", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241176%22"}, {"id": "fda:K242416", "company": "Hunan Vathin Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242416: Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242416", "people": [{"name": "Charlene Du", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242416%22"}, {"id": "fda:K241736", "company": "Deka Research and Development Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241736: Remunity 2.0 Pump for Remodulin (treprostinil) Injection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241736", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241736%22"}, {"id": "fda:K243289", "company": "Nu Eyne Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243289: ADDNOX (BPSPM1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243289", "people": [{"name": "Dahee Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243289%22"}, {"id": "fda:K242522", "company": "Pearl, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242522: Second Opinion CC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242522", "people": [{"name": "William Birdsall", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242522%22"}, {"id": "fda:K242834", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242834: System 9 Sterile Battery Container", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242834", "people": [{"name": "Megan Guilbault", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242834%22"}, {"id": "fda:K244048", "company": "Ya-Man, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K244048: Medi Lift Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244048", "people": [{"name": "Jun Takada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K244048%22"}, {"id": "fda:K240197", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240197: cobas\u00ae liat CT/NG/MG nucleic acid test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240197", "people": [{"name": "Deborah Leu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240197%22"}, {"id": "fda:K242715", "company": "Pearl Digital, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242715: Pearl Clear Aligner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242715", "people": [{"name": "Henry Cao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242715%22"}, {"id": "fda:K243848", "company": "Cala Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243848: Cala kIQ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243848", "people": [{"name": "Alexander Kent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243848%22"}, {"id": "fda:K243256", "company": "Wondfo USA Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243256: WELLlife\u0099 COVID-19 / Influenza A&B Home Test; WELLlife\u0099 COVID-19 / Influenza A&B AntigenTest", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243256", "people": [{"name": "Kaiyu Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243256%22"}, {"id": "fda:K241113", "company": "Vieworks Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241113: VIVIX-M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241113", "people": [{"name": "Kevin Oh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241113%22"}, {"id": "fda:K241217", "company": "Inmedix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241217: CloudHRV\u0099 System (100-01-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241217", "people": [{"name": "Andrew Holman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241217%22"}, {"id": "fda:K233770", "company": "Pepper Interactive, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233770: Pepper EMS Training System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233770", "people": [{"name": "Emilia von Keyserlingk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233770%22"}, {"id": "fda:K243885", "company": "Biofire Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243885: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243885", "people": [{"name": "Karli Plenert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243885%22"}, {"id": "nih:5R44GM139468-04", "company": "Doty Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": 791121, "summary": "NIH award 5R44GM139468-04: A Novel Waveguide to Enable MAS-DNP-NMR in Standard-bore High-field Magnets ($791,121)", "source_url": "https://reporter.nih.gov/project-details/11013865", "people": [{"name": "Francis DAVID Doty", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K243569", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243569: TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243569", "people": [{"name": "Divya Raghavi Nandakumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243569%22"}, {"id": "fda:K242541", "company": "Synovis Micro Companies Alliance A Subsidiary of Baxter Int", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242541: GEM ZIPCLIP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242541", "people": [{"name": "Julie Carlston", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242541%22"}, {"id": "fda:K241096", "company": "Suzhou Minhua Medical Apparatus Supplies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241096: Venera 608 Deep Vein Thrombosis (DVT) Prevention System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241096", "people": [{"name": "Alex Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241096%22"}, {"id": "fda:K243328", "company": "Ziehm Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243328: Ziehm Vision RFD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243328", "people": [{"name": "Tsvetelina Milanova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243328%22"}, {"id": "fda:K242667", "company": "Trudell Medical International", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242667: AeroChamber2go Anti-Static Valved Holding Chamber", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242667", "people": [{"name": "Marianne Tanton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242667%22"}, {"id": "fda:K242935", "company": "BMC Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242935: Respiration Data Management Software (PAP Link PC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242935", "people": [{"name": "Amy Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242935%22"}, {"id": "fda:K242936", "company": "Sunray Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242936: Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242936", "people": [{"name": "Youyou Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242936%22"}, {"id": "fda:K242873", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242873: Ventrax\u0099 Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242873", "people": [{"name": "Jenny Soderquist", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242873%22"}, {"id": "fda:K242109", "company": "Cepheid\u00ae", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242109: Xpert\u00ae Xpress CoV-2 plus (XPRS-COV2-10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242109", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242109%22"}, {"id": "fda:K241512", "company": "Shenzhen Deliduo Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241512: Electrode Pad", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241512", "people": [{"name": "Andy Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241512%22"}, {"id": "fda:K243573", "company": "Assure Tech., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243573: FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243573", "people": [{"name": "Allen Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243573%22"}, {"id": "fda:K243065", "company": "Caption Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243065: Cardiac Guidance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243065", "people": [{"name": "Tahir Rizvi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243065%22"}, {"id": "fda:K242229", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242229: Micro Ace Gold Advanced Micro Access System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242229", "people": [{"name": "Niloufar Samimi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242229%22"}, {"id": "fda:K242634", "company": "3-D Matrix Europe SAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242634: PuraStat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242634", "people": [{"name": "Audrey Vion", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242634%22"}, {"id": "fda:K243946", "company": "Effortmed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243946: EffortMed Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243946", "people": [{"name": "Steven Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243946%22"}, {"id": "fda:K243860", "company": "AtriCure, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243860: AtriClip PRO-Mini LAA Exclusion System (PROM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243860", "people": [{"name": "Diane Sung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243860%22"}, {"id": "fda:K243284", "company": "Alcresta Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243284: RELiZORB (100300/ 100301)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243284", "people": [{"name": "Daniel Orlando", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243284%22"}, {"id": "fda:K243858", "company": "Haemonetics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243858: TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243858", "people": [{"name": "Erica Molaro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243858%22"}, {"id": "fda:K241066", "company": "Biobeat Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241066: BB-613-BPM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241066", "people": [{"name": "Johanan May", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241066%22"}, {"id": "fda:K241166", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241166: uCT 550", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241166", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241166%22"}, {"id": "fda:K242672", "company": "Imperative Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242672: Zoom System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242672", "people": [{"name": "Teri Nguyen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242672%22"}, {"id": "fda:K242205", "company": "Specto Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242205: SpectoMed (v1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242205", "people": [{"name": "Charly Leprince", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242205%22"}, {"id": "fda:K241037", "company": "Radiometer Medicals Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241037: ABL90 FLEX PLUS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241037", "people": [{"name": "Andrea Swingle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241037%22"}, {"id": "fda:K241180", "company": "Shalby Advanced Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241180: Consensus Knee System with TiNbN", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241180", "people": [{"name": "Christopher J Devine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241180%22"}, {"id": "fda:K243452", "company": "Ziehm-Orthoscan, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243452: Orthoscan VERSA Mini C-Arm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243452", "people": [{"name": "Kevin Bridgman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243452%22"}, {"id": "fda:K241278", "company": "Pfm Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241278: ASEPT\u00ae Glide Peritoneal Drainage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241278", "people": [{"name": "Madison Reid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241278%22"}, {"id": "fda:K243272", "company": "Zest Anchors, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243272: LOCATOR Angled Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243272", "people": [{"name": "David Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243272%22"}, {"id": "fda:K243577", "company": "Maduro Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243577: Radical the Dude 8F Guide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243577", "people": [{"name": "Janice Kemp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243577%22"}, {"id": "fda:K243297", "company": "Alembic, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243297: APRO 70 Swift Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243297", "people": [{"name": "Lisa Yen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243297%22"}, {"id": "fda:K243904", "company": "Clariance", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243904: Elegance\u00ae Anterior Cervical plate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243904", "people": [{"name": "Quang Tran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243904%22"}, {"id": "fda:K243950", "company": "Kico Knee Innovation Company Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243950: ARVIS\u00ae Shoulder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243950", "people": [{"name": "Ryan Matthew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243950%22"}, {"id": "fda:K241431", "company": "Joytech Healthcare Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241431: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241431", "people": [{"name": "Cong Jing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241431%22"}, {"id": "fda:K243271", "company": "Mentor Worldwide, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243271: MENTOR\u0099 MemoryShape\u0099 Resterilizable Gel Breast Implant Sizer; MENTOR\u0099 MemoryGel\u0099 Resterilizable Gel Breast Implant Sizer; MENTOR\u0099 MemoryGel\u0099 Enhance Single Use Gel Sizer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243271", "people": [{"name": "Saakshi Arora-Tice", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243271%22"}, {"id": "fda:K242689", "company": "Azac Group", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242689: AAMI Level 4 Protective; Gown", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242689", "people": [{"name": "Yen Ping Shan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242689%22"}, {"id": "fda:K242030", "company": "Megagen Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242030: MegaGen Dental Implant Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242030", "people": [{"name": "Back Kyung-Hee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242030%22"}, {"id": "fda:K241200", "company": "Arineta , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241200: SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241200", "people": [{"name": "Shira Alchanati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241200%22"}, {"id": "fda:K243791", "company": "Xiamen Weiyou Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243791: Air Pressure Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243791", "people": [{"name": "Guo Kelly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243791%22"}, {"id": "fda:K243527", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243527: High Flow Insufflation Unit (UHI-4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243527", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243527%22"}, {"id": "fda:K241059", "company": "Adler Ortho S.P.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241059: Pantheon Proximal Femur Reconstruction (PFR) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241059", "people": [{"name": "Davide Cremascoli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241059%22"}, {"id": "fda:K242680", "company": "Privapath Diagnostics Ltd (Dba Letsgetchecked)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242680: LetsGetChecked Impress", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242680", "people": [{"name": "Karen Walsh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242680%22"}, {"id": "fda:K243262", "company": "Osang, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243262: QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243262", "people": [{"name": "Seungyeob (Dan) Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243262%22"}, {"id": "fda:K233452", "company": "Breas Medical AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233452: Vivo 45 LS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233452", "people": [{"name": "Ivan Liljegren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233452%22"}, {"id": "fda:K243533", "company": "Hlb Co., Ltd. Healthcare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243533: Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243533", "people": [{"name": "Seung-won Baek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243533%22"}, {"id": "fda:K243295", "company": "Kyocera Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243295: Initia Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243295", "people": [{"name": "DeBenedictis Anthony", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243295%22"}, {"id": "fda:K243890", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243890: Arthrex Intramedullary Nails", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243890", "people": [{"name": "Stacy Valdez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243890%22"}, {"id": "fda:K243909", "company": "Alcon Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243909: Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243909", "people": [{"name": "Andreas Friese", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243909%22"}, {"id": "fda:K243836", "company": "Mentor Worldwide, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243836: Mentor\u0099 CPX \u0099 4 PLUS Enhance Breast Tissue Expander", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243836", "people": [{"name": "Catherine Carvalho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243836%22"}, {"id": "fda:K241641", "company": "Shenzhen Yattll Industry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241641: Electric Wheelchair (YE200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241641", "people": [{"name": "Kevin Shih", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241641%22"}, {"id": "fda:K241009", "company": "Perigen, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241009: PeriCALM Patterns 3.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241009", "people": [{"name": "Alva Candace", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241009%22"}, {"id": "fda:K242767", "company": "Safecare Biotech (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242767: Safecare Urinary Tract Infection Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242767", "people": [{"name": "Selina Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242767%22"}, {"id": "fda:K241781", "company": "Solo Pace, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241781: Solo Pace Control", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241781", "people": [{"name": "David Daniels", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241781%22"}, {"id": "fda:K241891", "company": "Imvaria, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241891: ScreenDx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241891", "people": [{"name": "Joshua Reicher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241891%22"}, {"id": "fda:K242901", "company": "Tools For Surgery, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242901: ZZIREN\u0099 Orogastric Tube; ZZIREN\u0099 SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN\u0099 SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN\u0099 SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN\u0099 GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN\u0099 GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN\u0099 GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242901", "people": [{"name": "Arnold Leiboff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242901%22"}, {"id": "fda:K243111", "company": "Bowhead Design Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243111: Bowhead ERA Wheelchairs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243111", "people": [{"name": "Tatiana Place", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243111%22"}, {"id": "fda:K242877", "company": "Applied BioCode, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242877: BioCode Gastrointestinal Pathogen Panel (GPP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242877", "people": [{"name": "Alex Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242877%22"}, {"id": "fda:K243477", "company": "Askorn Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243477: Universal Tendon Spacer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243477", "people": [{"name": "Denis Pichon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243477%22"}, {"id": "fda:K241764", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241764: Mould Probe MR Safe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241764", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241764%22"}, {"id": "fda:K242528", "company": "Shenzhen Ruiankang Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242528: Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242528", "people": [{"name": "Xinhua Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242528%22"}, {"id": "fda:K241174", "company": "Carl Zeiss Meditec, AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241174: INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241174", "people": [{"name": "Anke Seitz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241174%22"}, {"id": "fda:K242366", "company": "Overfibers S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242366: OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242366", "people": [{"name": "Castrenze Genovese", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242366%22"}, {"id": "fda:K243814", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243814: NuVasive Pulse System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243814", "people": [{"name": "Prem Kumar Pisupati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243814%22"}, {"id": "fda:K242228", "company": "Triopsy Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242228: Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242228", "people": [{"name": "David Bostwick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242228%22"}, {"id": "fda:K241064", "company": "Shandong Intco Hygiene Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241064: Unscented Tampon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241064", "people": [{"name": "Max Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241064%22"}, {"id": "fda:K240267", "company": "Klaxon Mobility GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240267: Klaxon (Twist); Klaxon (Twist R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240267", "people": [{"name": "Riccardo Colomba", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240267%22"}, {"id": "fda:K242071", "company": "Cepheid", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242071: Xpert Xpress CoV-2/Flu/RSV plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242071", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242071%22"}, {"id": "fda:K243195", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243195: Arthrex SS VAL and VAL KreuLock\u0099 Compression Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243195", "people": [{"name": "Konrad Wolfmeyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243195%22"}, {"id": "fda:K243492", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243492: Ulike Reglow Light Therapy Device (UM10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243492", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243492%22"}, {"id": "fda:K241676", "company": "Inflammatix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241676: TriVerity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241676", "people": [{"name": "Diana Lane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241676%22"}, {"id": "fda:K243806", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243806: Safety Winged Blood Collection Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243806", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243806%22"}, {"id": "fda:K243811", "company": "Erchonia Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243811: Erchonia Zerona\u00ae VZ8", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243811", "people": [{"name": "Travis Sammons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243811%22"}, {"id": "breakthrough:K241676", "company": "Inflammatix, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2025-01-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K241676: TRIVERITY", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:FA8649-25-P-0092", "company": "Marion Surgical Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2025-01-10", "observed": "2026-09-18", "amount_usd": 74507, "summary": "DOD SBIR Phase I award $74,507: PORTABLE HIGH- FIDELITY MICROSCOPE-Guided surgical simulator For hand and microvascular Surgery in Tactical Combat Casualty Care (TCCC) Training", "source_url": "https://www.sbir.gov/awards?search=FX247-PCSO1-1124"}, {"id": "nih:4R44DA058952-02", "company": "Mmj Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-09", "observed": "2026-08-21", "amount_usd": 455972, "summary": "NIH award 4R44DA058952-02: Creation and Validation of the Dose-Opioid-Source Evaluation tool (DOSE) - a Robust Opioid Use Clinical Outcome Assessment for Qualification as an FDA Medical Device Development Tool (MDDT) ($455,972)", "source_url": "https://reporter.nih.gov/project-details/11240717", "people": [{"name": "Amy Lynn Baxter", "role": "Principal Investigator"}, {"name": "Traci J Speed", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K242805", "company": "Changzhou Finno Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242805: Dental Cone-beam Computed Tomography (FinScan F350)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242805", "people": [{"name": "Jie Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242805%22"}, {"id": "fda:K241273", "company": "Paige.Ai, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241273: FullFocus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241273", "people": [{"name": "Mufaddal Jafferji", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241273%22"}, {"id": "nih:5R44MH129023-04", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": 995876, "summary": "NIH award 5R44MH129023-04: Microscope system for large scale optical imaging of neuronal activity using kilohertz frame rates ($995,876)", "source_url": "https://reporter.nih.gov/project-details/11003971", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K242043", "company": "Gimbo Medical Technology Shenzhen Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242043: Sperm Freezing Medium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242043", "people": [{"name": "Leo Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242043%22"}, {"id": "fda:K242290", "company": "Dormotech Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242290: DormoTech NLab", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242290", "people": [{"name": "Abed Nassir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242290%22"}, {"id": "fda:K242661", "company": "Tri Dental Implants Int. AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242661: TRI-matrix\u00ae X-Force Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242661", "people": [{"name": "Sandro Venanzoni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242661%22"}, {"id": "fda:K241806", "company": "Life Technologies Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241806: Applied Biosystems\u0099 TaqPath\u0099 COVID-19, Flu A, Flu B, RSV Select Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241806", "people": [{"name": "Stacey Moltchanoff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241806%22"}, {"id": "fda:K242741", "company": "Ace Medical Industry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242741: ACE Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242741", "people": [{"name": "Won-Bae Cho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242741%22"}, {"id": "fda:K243813", "company": "QIAGEN GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243813: QIAstat-Dx GI Panel 2 Mini B&V", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243813", "people": [{"name": "Autumn Collasius", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243813%22"}, {"id": "fda:K240590", "company": "W'U'S Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240590: Electrical Scooter, WT-T4SU", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240590", "people": [{"name": "Jen Ke-Min", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240590%22"}, {"id": "fda:K241003", "company": "Hiossen, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241003: HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241003", "people": [{"name": "Peter Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241003%22"}, {"id": "fda:K241489", "company": "Inter-Med, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241489: ReminGel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241489", "people": [{"name": "Alex Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241489%22"}, {"id": "fda:K243818", "company": "Hartalega NGC Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243818: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243818", "people": [{"name": "Kuan Mun Leong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243818%22"}, {"id": "fda:K243644", "company": "Ceragem Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243644: Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243644", "people": [{"name": "Sangmin Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243644%22"}, {"id": "fda:K242842", "company": "Sibel Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242842: ANNE View, Central Hub", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242842", "people": [{"name": "Sarah Coughlin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242842%22"}, {"id": "fda:K241456", "company": "Targeted Genomics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241456: GlutenID Celiac Genetic Health Risk Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241456", "people": [{"name": "Shelly Gunn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241456%22"}, {"id": "fda:K241079", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241079: uCT 780", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241079", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241079%22"}, {"id": "fda:K242588", "company": "OrbusNeich Medical (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242588: COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242588", "people": [{"name": "Dora Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242588%22"}, {"id": "fda:K243335", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243335: Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243335", "people": [{"name": "Orlando Tadeo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243335%22"}, {"id": "fda:K241808", "company": "Corin U.S.A. Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241808: ApolloHipX (THR.SS.0001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241808", "people": [{"name": "Aaron Brunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241808%22"}, {"id": "fda:K242019", "company": "DRGEM Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242019: GXR-Series Diagnostic X-Ray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242019", "people": [{"name": "Jongseon Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242019%22"}, {"id": "fda:K243259", "company": "Astura Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243259: MASADA Modular Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243259", "people": [{"name": "Parker Kelch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243259%22"}, {"id": "nih:1R41AI189162-01", "company": "Datirium, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-06", "observed": "2026-08-21", "amount_usd": 306500, "summary": "NIH award 1R41AI189162-01: Bioinformatics pipeline for personalized diagnostics of transplant rejection ($306,500)", "source_url": "https://reporter.nih.gov/project-details/11069619", "people": [{"name": "Artem Barski", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K242488", "company": "Omega Medical Imaging, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242488: Soteria E-View", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242488", "people": [{"name": "Matthew Anderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242488%22"}, {"id": "fda:K242499", "company": "Shenzhen Sontu Medical Imaging Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242499: Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242499", "people": [{"name": "Xiaomei Lao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242499%22"}, {"id": "fda:K243466", "company": "United Orthopedic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243466: Conformity Stem Extension Line, #0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243466", "people": [{"name": "Lois Ho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243466%22"}, {"id": "fda:K242139", "company": "Yongkang Yile Vehicle Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242139: Mobility Scooter (YL-09B, YL-07)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242139", "people": [{"name": "David Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242139%22"}, {"id": "fda:K242753", "company": "Arum Dentistry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242753: SD TL Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242753", "people": [{"name": "Choi Won-Yi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242753%22"}, {"id": "fda:K242123", "company": "Brainomix Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242123: Brainomix 360 e-CTA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242123", "people": [{"name": "Thais Sala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242123%22"}, {"id": "fda:K243481", "company": "THINK Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243481: TMINI Miniature Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243481", "people": [{"name": "Denise Duchene", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243481%22"}, {"id": "fda:K242760", "company": "Whill, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242760: WHILL Model R", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242760", "people": [{"name": "Tsuyoshi Iriyama", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242760%22"}, {"id": "fda:K241904", "company": "Fesariustherapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241904: DermiSphere Dermal Template", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241904", "people": [{"name": "Yulia Sapir-Lekhovitser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241904%22"}, {"id": "fda:K242119", "company": "Dk Medical System", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242119: INNOVISION-EXII", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242119", "people": [{"name": "Sung-moon Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242119%22"}, {"id": "fda:K241283", "company": "Zinkh NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241283: Elemental Granulate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241283", "people": [{"name": "Emiel Lippens", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241283%22"}, {"id": "fda:K241350", "company": "Ge Medical Systems Israel, Functional Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241350: Clarify DL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241350", "people": [{"name": "Mousa Elias Maysana", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241350%22"}, {"id": "fda:K241757", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241757: syngo.CT Dual Energy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241757", "people": [{"name": "Kenny M Bello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241757%22"}, {"id": "fda:K242578", "company": "Mallinckrodt Manufacturing, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242578: EVOLVE Nitric Oxide Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242578", "people": [{"name": "Jennifer Brett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242578%22"}, {"id": "fda:K242726", "company": "Inventis S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242726: Synapsys VHIT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242726", "people": [{"name": "Elena Tormen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242726%22"}, {"id": "fda:K243737", "company": "Inbella Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243737: Inbella RF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243737", "people": [{"name": "Michael Kreindel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243737%22"}, {"id": "fda:K240346", "company": "Nobel Biocare AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240346: NobelProcera Zirconia Implant Bridge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240346", "people": [{"name": "Bernice Jim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240346%22"}, {"id": "fda:K240984", "company": "Abbott Point of Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240984: i-STAT hs-TnI cartridge with the i-STAT 1 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240984", "people": [{"name": "Jacquelyn Gesumaria", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240984%22"}, {"id": "fda:K250015", "company": "Ormco Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K250015: Ormco\u0099 EtchFree Bonding System, Ormco\u0099 EtchFree Bonding Primer, Ormco\u0099 EtchFree Adhesive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250015", "people": [{"name": "Tara Bonny", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K250015%22"}, {"id": "fda:K233118", "company": "Eunsung Global Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233118: DUET-V (Model: ESK-3261DV)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233118", "people": [{"name": "MyeongSoo Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233118%22"}, {"id": "fda:K243363", "company": "JLK, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243363: JLK-ICH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243363", "people": [{"name": "Dongmin Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243363%22"}, {"id": "fda:K233419", "company": "Proimtech Saglik Urunleri Anonim Sirketi", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233419: GBR System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233419", "people": [{"name": "Hakan Cevik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233419%22"}, {"id": "fda:K242110", "company": "Pentax of America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242110: PENTAX Medical Video Colonoscope (EC38-i20cWL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242110", "people": [{"name": "Gurvinder Singh Nanda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242110%22"}, {"id": "fda:K242789", "company": "Dongguan Laiguang Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242789: Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242789", "people": [{"name": "Jiangxiang Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242789%22"}, {"id": "fda:K242326", "company": "Bionit Labs Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242326: Wave Electrode (AE02-60); Wave Electrode (AE02-50)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242326", "people": [{"name": "Aventaggiato Matteo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242326%22"}, {"id": "fda:K243049", "company": "Hunan Accurate Bio-Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243049: Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243049", "people": [{"name": "Li Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243049%22"}, {"id": "fda:K242448", "company": "Anhui Jbh Medical Apparatus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242448: Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242448", "people": [{"name": "Yuanwei Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242448%22"}, {"id": "fda:K241388", "company": "Micro Therapeutics, Inc. d/b/a ev3 Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241388: Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241388", "people": [{"name": "Vesselina Clayton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241388%22"}, {"id": "fda:K241005", "company": "Jiangxi Zhuoruihua Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241005: Haemostasis Clips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241005", "people": [{"name": "Qin Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241005%22"}, {"id": "fda:K241568", "company": "GreenMark Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241568: CrystLCare\u0099 PRO Biorestorative, Fluoride-Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241568", "people": [{"name": "Steven Bloembergen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241568%22"}, {"id": "fda:K241696", "company": "Ortho Ai, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241696: Ortho AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241696", "people": [{"name": "Jonathan Vigdorchik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241696%22"}, {"id": "fda:K242334", "company": "Ezra Ai, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2025-01-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242334: Ezra Flash", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242334", "people": [{"name": "David Girard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242334%22"}, {"id": "nih:4R44NS135792-02", "company": "Enclear Therapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2025-01-01", "observed": "2026-08-21", "amount_usd": 2977025, "summary": "NIH award 4R44NS135792-02: Targeted Cerebral Spinal Fluid (CSF) Drug Delivery - Enclear Precision System ($2,977,025)", "source_url": "https://reporter.nih.gov/project-details/11204746", "people": [{"name": "MARCIE A GLICKSMAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44GM148105-02", "company": "Ligo Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-12-31", "observed": "2026-08-21", "amount_usd": 762936, "summary": "NIH award 2R44GM148105-02: Dynamical Diffraction Analysis for 3D Electron Crystallography ($762,936)", "source_url": "https://reporter.nih.gov/project-details/11069541", "people": [{"name": "Raquel Bromberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241852", "company": "Avita Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241852: Nasal Aspirator (NS 13)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241852", "people": [{"name": "Maggie Chao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241852%22"}, {"id": "fda:K242468", "company": "Anhui Jbh Medical Apparatus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242468: Power Wheelchair (D10, D12, D15, D17, D20, D37)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242468", "people": [{"name": "Yuanwei Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242468%22"}, {"id": "fda:K243225", "company": "Genadyne Biotechnologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243225: Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243225", "people": [{"name": "Chien Ming Goh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243225%22"}, {"id": "fda:K243224", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243224: MitraClip\u0099 G5 Steerable Guide Catheter (SGC0801); TriClip\u0099 G5 Steerable Guide Catheter (TSGC0801)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243224", "people": [{"name": "Vidya Thyagarajan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243224%22"}, {"id": "fda:K241338", "company": "Chongqing Moffy Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241338: Peak Flow Meter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241338", "people": [{"name": "Yongxu Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241338%22"}, {"id": "fda:K242989", "company": "Nanjing E-Take Medical Apparatus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242989: Electric Wheelchair (MODEL H)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242989", "people": [{"name": "Owen Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242989%22"}, {"id": "fda:K243670", "company": "Clariance", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243670: Idys\u00ae LIF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243670", "people": [{"name": "Quang Tran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243670%22"}, {"id": "nih:1R43CA298055-01", "company": "Data Driven Bioscience Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-12-30", "observed": "2026-08-21", "amount_usd": 300682, "summary": "NIH award 1R43CA298055-01: Clinical validation of Duoseq, a Swiss army knife genomic approach to diagnosis of blood cancers ($300,682)", "source_url": "https://reporter.nih.gov/project-details/11066761", "people": [{"name": "Sandeep Dave", "role": "Principal Investigator"}, {"name": "Lanie Elizabeth Happ", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K243445", "company": "Bios S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243445: Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243445", "people": [{"name": "Martina De Iturbe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243445%22"}, {"id": "fda:K242376", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242376: Next Generation Access Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242376", "people": [{"name": "Alicia Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242376%22"}, {"id": "fda:K243394", "company": "Respironics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243394: AF531 Oro-Nasal SE Face Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243394", "people": [{"name": "Gary LeMere", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243394%22"}, {"id": "fda:K242804", "company": "Microaire Surgical Instruments, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242804: PAL Aspiration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242804", "people": [{"name": "Glenn Gerstenfeld", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242804%22"}, {"id": "fda:K233119", "company": "Shenzhen Beacon Display Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233119: 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233119", "people": [{"name": "Li Yafei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233119%22"}, {"id": "nih:2R44GM148111-02", "company": "Doty Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-12-27", "observed": "2026-08-21", "amount_usd": 982970, "summary": "NIH award 2R44GM148111-02: Ultra-low-temperature (6 K) static NMR-DNP for metalloproteins, proteins in cells, and materials ($982,970)", "source_url": "https://reporter.nih.gov/project-details/11068462", "people": [{"name": "Francis DAVID Doty", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43MH139287-01", "company": "3 I", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-12-27", "observed": "2026-08-21", "amount_usd": 505311, "summary": "NIH award 1R43MH139287-01: High bandwidth all-optical electrophysiology ($505,311)", "source_url": "https://reporter.nih.gov/project-details/11069680", "people": [{"name": "Karl Kilborn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241127", "company": "Cowellmedi Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241127: INNO SLA Mini Plus\u00ae Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241127", "people": [{"name": "Donghyung Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241127%22"}, {"id": "fda:K243084", "company": "Techsomed Medical Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243084: BioTraceIO Precision (2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243084", "people": [{"name": "Dalia Dickman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243084%22"}, {"id": "fda:K240828", "company": "Ge Hualun Medical Systems Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240828: OEC One ASD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240828", "people": [{"name": "Lifeng Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240828%22"}, {"id": "fda:K241924", "company": "Beijing Okvd Biological Technology , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241924: Elastic Impression Material", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241924", "people": [{"name": "Zhang Xianghao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241924%22"}, {"id": "fda:K242252", "company": "Anhui Jbh Medical Apparatus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242252: Power Wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242252", "people": [{"name": "Yuanwei Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242252%22"}, {"id": "fda:K243835", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243835: TiLink-P SI Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243835", "people": [{"name": "Berny Villejeune", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243835%22"}, {"id": "fda:K242480", "company": "7D Surgical ULC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242480: FLASH EVD System (10-0002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242480", "people": [{"name": "Elena Marenny", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242480%22"}, {"id": "fda:K241972", "company": "Megagen Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241972: BLUEDIAMOND IMPLANT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241972", "people": [{"name": "Hyo-Eun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241972%22"}, {"id": "hde:H240001", "company": "Stryker", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2024-12-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H240001: 4WEB Medical Talar Replacement Device", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "fda:K240517", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240517: ProSeal\u0099 Vented Universal Vial Adaptor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240517", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240517%22"}, {"id": "fda:K243677", "company": "Pacira Biosciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243677: iovera\u00b0 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243677", "people": [{"name": "Niloufa Insanally", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243677%22"}, {"id": "fda:K243037", "company": "Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243037: Diode Laser System model Dawn-S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243037", "people": [{"name": "Lily Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243037%22"}, {"id": "fda:K233252", "company": "Institut Straumann AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233252: Straumann CARES Visual and Nova Dental CAD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233252", "people": [{"name": "Gordon Dodds", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233252%22"}, {"id": "fda:K243141", "company": "Jiangxi Medex Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243141: Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243141", "people": [{"name": "Zhang Kaixia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243141%22"}, {"id": "fda:K232966", "company": "Golden Star Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232966: FISIOWARM 7.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232966", "people": [{"name": "Tiziaria Borrelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232966%22"}, {"id": "fda:K243658", "company": "Treace Medical Concepts", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243658: TMC Compression Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243658", "people": [{"name": "Brittany Grochala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243658%22"}, {"id": "fda:K243097", "company": "Bomtech Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243097: RM STAR EX with RMS Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243097", "people": [{"name": "Lee Junseok", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243097%22"}, {"id": "fda:K243623", "company": "Surgical Theater, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243623: SpineAR SNAP (SyncAR Spine)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243623", "people": [{"name": "Kevin Murrock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243623%22"}, {"id": "fda:K242434", "company": "Chirana T. Injecta", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242434: Insulin Syringes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242434", "people": [{"name": "Rastislav Broska", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242434%22"}, {"id": "fda:K242939", "company": "Artfx Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242939: ARTFX Trauma Bone Plate and Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242939", "people": [{"name": "Ozgen Ozfidan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242939%22"}, {"id": "fda:K243177", "company": "Elastimed , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243177: SACS PRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243177", "people": [{"name": "Zelka Omer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243177%22"}, {"id": "fda:K242782", "company": "Noraker", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242782: GlassBone Granules", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242782", "people": [{"name": "Catherine Flacard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242782%22"}, {"id": "fda:K242573", "company": "Jiangsu Lici Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242573: NIDO Baby Magnetic Resonance Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242573", "people": [{"name": "Bing Keong Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242573%22"}, {"id": "fda:K243248", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243248: INHANCE INTACT\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243248", "people": [{"name": "Sanjay Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243248%22"}, {"id": "fda:K242948", "company": "Nrt X-Ray A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242948: Adora DRFi (04550010)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242948", "people": [{"name": "Mogens Ravn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242948%22"}, {"id": "fda:K243693", "company": "Neo Medical SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243693: NEO Pedicle Screw System\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243693", "people": [{"name": "Larsson Jonas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243693%22"}, {"id": "fda:K242797", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242797: OsteoFlo HydroFiber", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242797", "people": [{"name": "Travis Greenhalgh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242797%22"}, {"id": "fda:K242735", "company": "Belmont Medical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242735: Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242735", "people": [{"name": "Lida Reed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242735%22"}, {"id": "fda:K240975", "company": "Beijing Taktvoll Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240975: Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240975", "people": [{"name": "Fan Dan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240975%22"}, {"id": "fda:K241091", "company": "Inogen, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241091: SIMEOX 200 Airway Clearance Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241091", "people": [{"name": "Carole Harris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241091%22"}, {"id": "fda:K242143", "company": "Shandong Int Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242143: Angiography Injector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242143", "people": [{"name": "Wei Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242143%22"}, {"id": "fda:K243103", "company": "Riton 3D Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243103: Denture Base", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243103", "people": [{"name": "Zhou BinBin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243103%22"}, {"id": "fda:K233614", "company": "Genadyne Biotechnologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233614: Genadyne DUO NPWT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233614", "people": [{"name": "Andrew Goh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233614%22"}, {"id": "fda:K240890", "company": "PanopticAI technologies Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240890: PanopticAI Vital Signs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240890", "people": [{"name": "Tsz Tai Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240890%22"}, {"id": "fda:K242403", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242403: Aquilion ONE (TSX-308A/3) V1.5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242403", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242403%22"}, {"id": "fda:K241288", "company": "Nox Medical Ehf", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241288: Noxturnal Web", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241288", "people": [{"name": "Kolbr\u00fan Ott\u00f3sd\u00f3ttir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241288%22"}, {"id": "fda:K242091", "company": "Fusion Orthopedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242091: Bolo Button System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242091", "people": [{"name": "Catalina Pardo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242091%22"}, {"id": "fda:K241856", "company": "Hlb Lifescience Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241856: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241856", "people": [{"name": "JiWon Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241856%22"}, {"id": "fda:K243121", "company": "Jiangxi Medex Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243121: SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5;", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243121", "people": [{"name": "Zhang Kaixia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243121%22"}, {"id": "fda:K243147", "company": "Light Guide Optics International , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243147: LGO-Surgical Laser Fibers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243147", "people": [{"name": "Santa Vucina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243147%22"}, {"id": "fda:K243085", "company": "Zhuzhou Goldenhot Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243085: IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243085", "people": [{"name": "Xianwu Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243085%22"}, {"id": "fda:K233639", "company": "Elucent Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233639: SmartClip Secure Soft Tissue Marker", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233639", "people": [{"name": "Judson Guericke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233639%22"}, {"id": "fda:K242953", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242953: KIDS Arterial Filters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242953", "people": [{"name": "Martina Carlini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242953%22"}, {"id": "fda:K242168", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242168: Voluson Expert 18; Voluson Expert 20; Voluson Expert 22", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242168", "people": [{"name": "Behn Bryan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242168%22"}, {"id": "fda:K243024", "company": "United Orthopedic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243024: Cellbrick Knee Spacer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243024", "people": [{"name": "Lois Ho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243024%22"}, {"id": "fda:K242530", "company": "Rizhao Huge Biomaterials Company, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242530: HF-Etchant Hydrofluoric Acid Etching Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242530", "people": [{"name": "Maggie Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242530%22"}, {"id": "fda:K243671", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243671: ExcelsiusGPS\u00ae Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243671", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243671%22"}, {"id": "fda:K241670", "company": "Beijing Adss Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241670: Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241670", "people": [{"name": "Jijuan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241670%22"}, {"id": "fda:K241652", "company": "Nuclein, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241652: DASH\u00ae SARS-CoV-2 & Flu A/B Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241652", "people": [{"name": "Ben Treece", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241652%22"}, {"id": "fda:K242929", "company": "Xplora 3D Europe S.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242929: Fas Aligner System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242929", "people": [{"name": "Esther Aznar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242929%22"}, {"id": "fda:K242628", "company": "Lichtmega Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242628: Scooter (PS30)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242628", "people": [{"name": "Hyman Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242628%22"}, {"id": "fda:K243759", "company": "Biofire Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243759: BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243759", "people": [{"name": "Karli Plenert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243759%22"}, {"id": "fda:K241167", "company": "Synergy Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241167: BioSphere Putty; BioSphere MIS Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241167", "people": [{"name": "Kevin Booth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241167%22"}, {"id": "fda:K241888", "company": "Leo Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241888: Single-use Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241888", "people": [{"name": "Guojun Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241888%22"}, {"id": "fda:K243308", "company": "Bonebridge AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243308: Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243308", "people": [{"name": "Michelle Gumpelmayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243308%22"}, {"id": "fda:K241411", "company": "Welch Allyn, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241411: Welch Allyn Connex\u00ae Spot Monitor; 901058 Vital Signs Monitor Core (CSM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241411", "people": [{"name": "Beth Rice", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241411%22"}, {"id": "fda:K242281", "company": "Arrow International, LLC (A subsidiary of Teleflex, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242281: Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242281", "people": [{"name": "Kim Pennington", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242281%22"}, {"id": "fda:K242599", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242599: aprevo\u00ae Digital Planning", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242599", "people": [{"name": "Aly Alvarez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242599%22"}, {"id": "fda:K242688", "company": "Skingrab Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242688: Finiff System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242688", "people": [{"name": "Oskar Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242688%22"}, {"id": "fda:K242572", "company": "Rizhao Huge Biomaterials Company, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242572: TopCEM-Try in Veneer Try-in Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242572", "people": [{"name": "Maggie Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242572%22"}, {"id": "fda:K242923", "company": "Envision Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242923: SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242923", "people": [{"name": "Azadeh Khanicheh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242923%22"}, {"id": "fda:K243911", "company": "Handpiece Headquarters", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243911: HPR Cordless Hygiene Handpiece", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243911", "people": [{"name": "Frederick Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243911%22"}, {"id": "fda:K242644", "company": "Okami Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242644: SENDERO MAX Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242644", "people": [{"name": "Jill Delsman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242644%22"}, {"id": "fda:K243629", "company": "Shenzhen Root Innovation Technology Co., , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243629: Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243629", "people": [{"name": "Amy Dong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243629%22"}, {"id": "fda:K243149", "company": "Congruence Medical Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243149: Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243149", "people": [{"name": "Gautam Shetty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243149%22"}, {"id": "fda:K243293", "company": "Zimmer Biomet", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243293: Zimmer\u00ae Persona\u00ae Personalized Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243293", "people": [{"name": "Adam Haas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243293%22"}, {"id": "fda:K243607", "company": "Diality, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243607: Moda-flx Hemodialysis System\u0099 Cartridge (102121-001 )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243607", "people": [{"name": "Clayton Poppe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243607%22"}, {"id": "fda:K242362", "company": "Nexsys Electronics Inc. Dba Medweb", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242362: Lightning Viewer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242362", "people": [{"name": "Brian Bandy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242362%22"}, {"id": "fda:K242534", "company": "Vydence Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242534: HandPICO Fractional Laser Handpiece Tip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242534", "people": [{"name": "Antonio Olivatto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242534%22"}, {"id": "fda:K243675", "company": "Inkspace Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243675: InkSpace Imaging Small Body Array", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243675", "people": [{"name": "Peter Fischer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243675%22"}, {"id": "fda:K243040", "company": "Shenzhen Siken 3D Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243040: LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243040", "people": [{"name": "Liu Jing Quan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243040%22"}, {"id": "fda:K242529", "company": "Tigon Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242529: Tigon Medical All-Suture Anchors (ASA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242529", "people": [{"name": "Jeremy Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242529%22"}, {"id": "fda:K241680", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241680: Momcozy Wearable Breast Pump (BP311)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241680", "people": [{"name": "Audrey Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241680%22"}, {"id": "fda:K241394", "company": "Andon Health Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241394: iHealth\u00ae Early Pregnancy Test; iHealth\u00ae Early Pregnancy Test Strip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241394", "people": [{"name": "Liu Yi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241394%22"}, {"id": "fda:K240435", "company": "Alpha Dent Implants GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240435: Alpha Dent Implants Dental Implants System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240435", "people": [{"name": "Simha Sibony", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240435%22"}, {"id": "pma:P230044", "company": "Sequana Medical NV", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230044: alfapump System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230044", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230044%22"}, {"id": "breakthrough:P230044", "company": "Sequana Medical Nv", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-12-20", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230044: ALFAPUMP SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K243361", "company": "Vygon USA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243361: Nutrifit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243361", "people": [{"name": "Chris Steinke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243361%22"}, {"id": "fda:K241768", "company": "Stryker Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241768: Broadway 8 Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241768", "people": [{"name": "Shazia Hakim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241768%22"}, {"id": "fda:K243595", "company": "TELA Bio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243595: OviTex PRS (Long-Term Resorbable)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243595", "people": [{"name": "John Urtz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243595%22"}, {"id": "fda:K243094", "company": "Quickdent Devices Private , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243094: Quickdent Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243094", "people": [{"name": "Mayur Khairnar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243094%22"}, {"id": "fda:K242270", "company": "Orthofix Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242270: OrthoNext Platform System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242270", "people": [{"name": "Elvira Taccarelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242270%22"}, {"id": "fda:DEN240014", "company": "Onward Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240014: ARC-EX System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240014", "people": [{"name": "Nathalie Gilat", "role": "510(k) submission contact"}]}, {"id": "fda:K243071", "company": "Collagen Matrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243071: Bovine Dermis Collagen Dermal Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243071", "people": [{"name": "Devin Dragon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243071%22"}, {"id": "fda:K243171", "company": "Innocare Optoelectronics Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243171: Yushan X-Ray Flat Panel Detector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243171", "people": [{"name": "April Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243171%22"}, {"id": "fda:K243725", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243725: BD Vaginal Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243725", "people": [{"name": "Joseph Basore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243725%22"}, {"id": "fda:K242908", "company": "Shanghai Sigma High-Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242908: UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242908", "people": [{"name": "Xing Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242908%22"}, {"id": "fda:K241637", "company": "Stryker Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241637: Echo Intracranial Base Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241637", "people": [{"name": "Shameena Segui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241637%22"}, {"id": "fda:K243430", "company": "Shenzhen Aozemei Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243430: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243430", "people": [{"name": "Zemin Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243430%22"}, {"id": "fda:K242700", "company": "Shenzhen Nuon Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242700", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242700%22"}, {"id": "fda:K242819", "company": "Implant Protesis Dental 2004, S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242819: IPD Dental Implant Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242819", "people": [{"name": "Francesc Fumanal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242819%22"}, {"id": "fda:K242370", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242370: Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242370", "people": [{"name": "Jin Ok", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242370%22"}, {"id": "fda:K242892", "company": "Cristaline Aligners GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242892: Cristaline Aligners Z FLX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242892", "people": [{"name": "Boris Simnovski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242892%22"}, {"id": "fda:K242954", "company": "Vivosonic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242954: Integrity V500 (Integrity, Integrity with VEMP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242954", "people": [{"name": "Trevor Rocheleau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242954%22"}, {"id": "fda:K243440", "company": "Yongkang Hengyi Vehicle Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243440: Electric Wheelchair (HC820N)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243440", "people": [{"name": "Kathyrn Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243440%22"}, {"id": "fda:K232813", "company": "Dmc Importacao E Exportacao DE Equipamentos Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232813: Therapy EC, Therapy XT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232813", "people": [{"name": "Renata Beninca Pereira", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232813%22"}, {"id": "fda:K242063", "company": "Synchrony Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242063: LibAirty Airway Clearance System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242063", "people": [{"name": "Anat Shani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242063%22"}, {"id": "fda:K243169", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243169: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243169", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243169%22"}, {"id": "fda:K241322", "company": "Joytech Healthcare Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241322: Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241322", "people": [{"name": "Yanyan Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241322%22"}, {"id": "fda:K242467", "company": "Imbio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242467: IQ-UIP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242467", "people": [{"name": "William McLain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242467%22"}, {"id": "fda:K243705", "company": "DeepHealth, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243705: Saige-Density (2.5.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243705", "people": [{"name": "B. Nathan Hunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243705%22"}, {"id": "fda:K240885", "company": "Simpson Interventions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240885: Shadow Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240885", "people": [{"name": "Chan Kin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240885%22"}, {"id": "fda:K241778", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241778: Hudson RCI Comfort Flo\u00ae CubCannula\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241778", "people": [{"name": "Nicole Schaffer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241778%22"}, {"id": "fda:K241168", "company": "Wassenburg Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241168: System 83 Revolve Endoscope Washer/Disinfector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241168", "people": [{"name": "Mario Infanti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241168%22"}, {"id": "fda:K240348", "company": "Quantumtx Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240348: Quantum Mitohormesis (QMT) (M2101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240348", "people": [{"name": "Ivan Goh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240348%22"}, {"id": "fda:K243652", "company": "Cardinalhealth", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243652: Monoject\u0099 Enteral Syringe with ENFit Connector (401SE); Monoject\u0099 Enteral Syringe with ENFit Connector (403SE); Monoject\u0099 Enteral Syringe with ENFit Connector (406SE); Monoject\u0099 Enteral Syringe with ENFit Connector (412SE); Monoject\u0099 Enteral Syringe with ENFit Connector (435SE); Monoject\u0099 Enteral Syringe with ENFit Connector (460SE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243652", "people": [{"name": "Kathleen Di Leo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243652%22"}, {"id": "fda:K243688", "company": "DeepHealth, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243688: Saige-Dx (3.1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243688", "people": [{"name": "B. Nathan Hunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243688%22"}, {"id": "pma:P240023", "company": "Merit Medical Systems, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240023: WRAPSODY\u00ae Cell-Impermeable Endoprosthesis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240023", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240023%22"}, {"id": "denovo:DEN240014", "company": "Onward Medical, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-12-19", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240014 granted: ARC-EX System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240014"}, {"id": "breakthrough:K242467", "company": "Imbio, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-12-19", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K242467: IQ-UIP", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:DEN240014", "company": "Onward Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-12-19", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN240014: ARC-EX SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P240023", "company": "Merit Medical Systems, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-12-19", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P240023: WRAPSODY CELL-IMPERMEABLE ENDOPROSTHESIS", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K241395", "company": "Caerus Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241395: Active System; Avenue8", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241395", "people": [{"name": "Kai Kroll", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241395%22"}, {"id": "fda:K242424", "company": "Cadwell Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242424: Bluebird Single-Use Respiratory Effort Belt", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242424", "people": [{"name": "Jason Ford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242424%22"}, {"id": "fda:K240763", "company": "Freudenberg Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240763: FirstFit Surgical Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240763", "people": [{"name": "Oliver Krause-Huckelberry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240763%22"}, {"id": "fda:K242216", "company": "Teknimed Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242216: GENTAFIX\u00ae (1, 3, 3MV)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242216", "people": [{"name": "Claudine Lavergne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242216%22"}, {"id": "fda:K241058", "company": "Quest Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241058: Lyka\u00ae PORT Needle Free Access Device (4170Y)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241058", "people": [{"name": "Stephanie Edugie Ajayi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241058%22"}, {"id": "fda:K240959", "company": "Chongqing Moffy Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240959: Respiratory Muscle Trainer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240959", "people": [{"name": "Yongxu Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240959%22"}, {"id": "fda:K242535", "company": "Hunan Vathin Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242535: Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242535", "people": [{"name": "Charlene Du", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242535%22"}, {"id": "fda:K243609", "company": "Etex Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243609: EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243609", "people": [{"name": "Priti Dhabekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243609%22"}, {"id": "fda:K243615", "company": "Lima Corporate S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243615: Physica Porous Femoral Components", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243615", "people": [{"name": "Massimo Rosso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243615%22"}, {"id": "fda:K241132", "company": "Artsmedia Denmark Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241132: ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241132", "people": [{"name": "Tina Andersen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241132%22"}, {"id": "fda:K242662", "company": "Viasonix , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242662: Falcon/Xpress (Falcon/Xpress)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242662", "people": [{"name": "Dan Manor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242662%22"}, {"id": "fda:K241040", "company": "Natec Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241040: Amethyst HP PTA OTW 0.035 Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241040", "people": [{"name": "Roy Devassy Pallippatt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241040%22"}, {"id": "fda:K243625", "company": "Cepheid\u00ae", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243625: Xpert MRSA/SA SSTI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243625", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243625%22"}, {"id": "fda:K241095", "company": "Artsmedia Denmark Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241095: ARTSMedia Semen Wash Medium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241095", "people": [{"name": "Tina Andersen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241095%22"}, {"id": "fda:K242787", "company": "Changsha Anxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242787: Tens & Ems Device (TU1080)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242787", "people": [{"name": "William Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242787%22"}, {"id": "fda:K243128", "company": "Soadco, S.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243128: Klockner Kits", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243128", "people": [{"name": "Mercedes Roldan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243128%22"}, {"id": "fda:K243720", "company": "Deltamed GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243720: 3Delta UNlimited", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243720", "people": [{"name": "Michael Zimmermann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243720%22"}, {"id": "fda:K240765", "company": "Ventris Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240765: Porous Biologic Scaffold", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240765", "people": [{"name": "John Brunelle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240765%22"}, {"id": "nih:1R44AI188680-01", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R44AI188680-01: A Rapid, Point-of-Care Diagnostic to Identify Viable Sexually Transmitted Infections, Reduce Overtreatment, and Prevent Emerging Antibiotic Resistance ($300,000)", "source_url": "https://reporter.nih.gov/project-details/11066649", "people": [{"name": "Rainer Ng", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K243664", "company": "Ai Optics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243664: Sentinel Camera", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243664", "people": [{"name": "Andrew DiGiore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243664%22"}, {"id": "fda:K241036", "company": "Jiangmen New Era External Use Drug Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241036: Autoclave Indicator Tape; EO Indicator Tape", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241036", "people": [{"name": "Yingxuan Mu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241036%22"}, {"id": "fda:K243365", "company": "Healgen Scientific,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243365: Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243365", "people": [{"name": "Jianqiu Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243365%22"}, {"id": "fda:K242869", "company": "Centinel Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242869: prodisc\u00ae L Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242869", "people": [{"name": "Jessica Staub", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242869%22"}, {"id": "fda:K242297", "company": "Precision Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242297: Reform Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242297", "people": [{"name": "Dawson Michael", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242297%22"}, {"id": "fda:K242816", "company": "Bisco, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242816: Quantium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242816", "people": [{"name": "Jessica Berstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242816%22"}, {"id": "fda:K242558", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242558: Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242558", "people": [{"name": "Caitlin Senter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242558%22"}, {"id": "fda:K242987", "company": "Allengers Global Healthcare Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242987: Thulium Fiber Laser (FiberLAZE+, FiberLAZE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242987", "people": [{"name": "Harpreet Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242987%22"}, {"id": "fda:K242146", "company": "Smith & Nephew Medical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242146: BIOBRANE Temporary Wound Dressing; BIOBRANE Glove", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242146", "people": [{"name": "Andrew Daglish", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242146%22"}, {"id": "fda:K242815", "company": "Hivox Biotek, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242815: POCKET TENS (EP-300)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242815", "people": [{"name": "Leslie Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242815%22"}, {"id": "fda:K241556", "company": "Philips Medizin Systeme B\u00f6blingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241556: Cardiac Workstation (5000); Cardiac Workstation (7000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241556", "people": [{"name": "Angel Ya", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241556%22"}, {"id": "fda:K243336", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243336: Lucitone Digital Print Denture\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243336", "people": [{"name": "Melanie Avila", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243336%22"}, {"id": "fda:K241801", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241801: Tornus ES", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241801", "people": [{"name": "Katsuhiko Fujimura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241801%22"}, {"id": "fda:K240798", "company": "Cntrl+, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240798: Cntrl+ Bladder Support Pessary", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240798", "people": [{"name": "Karen Brunet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240798%22"}, {"id": "fda:K242783", "company": "Ventana Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242783: Roche Digital Pathology Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242783", "people": [{"name": "Cameron Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242783%22"}, {"id": "fda:K241616", "company": "Allonus Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241616: ALLONUS Tech Prosthetics", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241616", "people": [{"name": "Daniel Kwon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241616%22"}, {"id": "fda:K242413", "company": "Vizionfocus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242413: VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242413", "people": [{"name": "Angus Shih", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242413%22"}, {"id": "fda:K223093", "company": "Inova Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223093: Aptiva APS IgG Reagent; Aptiva APS IgM Reagent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223093", "people": [{"name": "Andrea Seaman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223093%22"}, {"id": "fda:K240793", "company": "Mskai", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240793: MSKai", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240793", "people": [{"name": "Wade Lloyd", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240793%22"}, {"id": "fda:K240937", "company": "Inventeur, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240937: AIM (N/A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240937", "people": [{"name": "Tariq Chaudhry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240937%22"}, {"id": "fda:K232839", "company": "Yung Sheng Optical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232839: Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232839", "people": [{"name": "Wen-Han Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232839%22"}, {"id": "fda:K242015", "company": "DRGEM Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242015: TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242015", "people": [{"name": "Arim Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242015%22"}, {"id": "fda:K240809", "company": "Huizhou Foryou Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240809: LUOFUCON\u00ae Silver Collagen Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240809", "people": [{"name": "Zhaotong Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240809%22"}, {"id": "fda:K242307", "company": "Ignite Orthomotion", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242307: ACHIEVE Partial Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242307", "people": [{"name": "Russell Parrott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242307%22"}, {"id": "fda:K243641", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243641: da Vinci Surgical System (IS5000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243641", "people": [{"name": "Jennifer Karafin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243641%22"}, {"id": "fda:K242003", "company": "Aesculap, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242003: XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242003", "people": [{"name": "Kathy Racosky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242003%22"}, {"id": "fda:K243471", "company": "Micro-Tech (Nanjing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243471: Extraction Basket", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243471", "people": [{"name": "He Sally", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243471%22"}, {"id": "fda:K243066", "company": "Ditron Dental, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243066: Dental Implants and Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243066", "people": [{"name": "Ariel Zuhovitzky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243066%22"}, {"id": "fda:K240676", "company": "Vinno Technology (Suzhou) Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240676: ULTIMUS Series Ultrasound Diagnostic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240676", "people": [{"name": "Jeff Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240676%22"}, {"id": "fda:K240873", "company": "Instylla, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240873: TEMBO Embolic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240873", "people": [{"name": "Jennifer Greer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240873%22"}, {"id": "nih:7R43MD018218-02", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-12-15", "observed": "2026-08-21", "amount_usd": 287580, "summary": "NIH award 7R43MD018218-02: Ring wearable sensor use for diagnosis and monitoring of Parkinson's disease in underserved rural populations ($287,580)", "source_url": "https://reporter.nih.gov/project-details/11231422", "people": [{"name": "GARY D HAVEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "fda:K242124", "company": "Sim&Cure", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242124: Sim&Size", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242124", "people": [{"name": "Colette Maurin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242124%22"}, {"id": "nih:3R44HL167294-01A1S1", "company": "Safebeat Rx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": 47689, "summary": "NIH award 3R44HL167294-01A1S1: Novel, automated mobile heart rhythm analysis technology to start antiarrhythmic medications safely at home ($47,689)", "source_url": "https://reporter.nih.gov/project-details/11191222", "people": [{"name": "Edward Paul Gerstenfeld", "role": "Principal Investigator"}, {"name": "Rachita Navara", "role": "Principal Investigator"}, {"name": "Kunj G. Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K243635", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243635: aprevo\u00ae anterior lumbar interbody fusion device with interfixation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243635", "people": [{"name": "Liu Karen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243635%22"}, {"id": "fda:K242487", "company": "Laminar Digital Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242487: Laminar P1 (LDH-HW-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242487", "people": [{"name": "Jess Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242487%22"}, {"id": "fda:K243196", "company": "Uroviu Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243196: Uro-G HD Cystoscope (1520)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243196", "people": [{"name": "Thomas Lawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243196%22"}, {"id": "fda:K243493", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243493: Agilis NxT Steerable Introducer Dual-Reach", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243493", "people": [{"name": "Juan Ordonez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243493%22"}, {"id": "fda:K233001", "company": "Biosys Biyomedikal Muhendislik San. VE Tic. A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233001: Bioscope Neuromonitor Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233001", "people": [{"name": "Cemal Erdogan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233001%22"}, {"id": "fda:K241998", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241998: Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241998", "people": [{"name": "Yang Blue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241998%22"}, {"id": "fda:K241160", "company": "Brainu Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241160: CAIs Sensor (CAIs-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241160", "people": [{"name": "Sangwoo Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241160%22"}, {"id": "fda:K243281", "company": "Lock-In USA Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243281: LOCK-IN Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243281", "people": [{"name": "Lacaze Guillaume", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243281%22"}, {"id": "fda:K243307", "company": "Barco N.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243307: LCD Monitor (MDEC-2523)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243307", "people": [{"name": "Julie Vandecandelaere", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243307%22"}, {"id": "fda:K240779", "company": "Breas Medical AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240779: Vivo 3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240779", "people": [{"name": "Ivan Liljegren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240779%22"}, {"id": "fda:K243560", "company": "Remex Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243560: Remex Spine Surgery Navigation Instrument", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243560", "people": [{"name": "Cheng-Hsiung Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243560%22"}, {"id": "fda:K242532", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242532: BTL-785BNF-E", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242532", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242532%22"}, {"id": "fda:K240924", "company": "Heidelberg Engineering GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240924: Anterion", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240924", "people": [{"name": "Arianna Schoess Vargas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240924%22"}, {"id": "fda:K240778", "company": "Breas Medical AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240778: Vivo 1, Vivo 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240778", "people": [{"name": "Ivan Liljegren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240778%22"}, {"id": "fda:K240998", "company": "Radiometer Medicals Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240998: ABL90 FLEX PLUS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240998", "people": [{"name": "Andrea Swingle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240998%22"}, {"id": "fda:K233486", "company": "ZOLL Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233486: 731 Series Ventilator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233486", "people": [{"name": "Jeffrey Churchill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233486%22"}, {"id": "fda:K242668", "company": "Gastro Concepts, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242668: Gastro Concepts Air Assist", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242668", "people": [{"name": "Rick Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242668%22"}, {"id": "fda:K242463", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242463: ARIA Radiation Therapy Management System (18.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242463", "people": [{"name": "Dr. Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242463%22"}, {"id": "fda:K231424", "company": "Heartbeam, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231424: HeartBeam AIMIGo(TM) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231424", "people": [{"name": "Ken Persen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231424%22"}, {"id": "fda:K243495", "company": "Natus Neurology Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243495: Natus Ultrapro S100 (982A0594)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243495", "people": [{"name": "Aniket Deshpande", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243495%22"}, {"id": "fda:K242453", "company": "Terragene S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242453: Terragene\u00ae Bionova\u00ae Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene\u00ae Bionova\u00ae Photon Process Challenge Device with moving-front integrator (PCD225-C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242453", "people": [{"name": "Hernando Carrizo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242453%22"}, {"id": "fda:K242832", "company": "Eb Neuro S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242832: NExT Station; NExT Station Advanced", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242832", "people": [{"name": "Marco Rossi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242832%22"}, {"id": "fda:K241253", "company": "Cmf Medicon Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241253: Medicon Epiplating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241253", "people": [{"name": "Matthias Alber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241253%22"}, {"id": "fda:K241271", "company": "Aqua Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241271: Aqua Medical RF Vapor Ablation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241271", "people": [{"name": "Scott McGill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241271%22"}, {"id": "fda:K240735", "company": "Bredent GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240735: visio.lign color, visio.lign shield", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240735", "people": [{"name": "Christine Pakebusch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240735%22"}, {"id": "fda:K241389", "company": "Infrascan, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241389: Infrascanner Model 2500 (Model 2500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241389", "people": [{"name": "Baruch Ben Dor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241389%22"}, {"id": "fda:K242020", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242020: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242020", "people": [{"name": "Chanrasmey White", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242020%22"}, {"id": "fda:K243540", "company": "Ge Medical Systems Information Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243540: Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243540", "people": [{"name": "James Turner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243540%22"}, {"id": "fda:K233152", "company": "Geniova Technologies Sociedad Limitada", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233152: GENIOVA aligners", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233152", "people": [{"name": "Antonio Baselga de la Vega", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233152%22"}, {"id": "fda:K242934", "company": "Longly Biotechnology (Wuhan) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242934: Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242934", "people": [{"name": "Liang Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242934%22"}, {"id": "fda:K243538", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243538: uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243538", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243538%22"}, {"id": "nih:5R44DC021123-02", "company": "Creare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": 1174451, "summary": "NIH award 5R44DC021123-02: Open Source Hearing Assessment System for Open Science ($1,174,451)", "source_url": "https://reporter.nih.gov/project-details/11004965", "people": [{"name": "ODILE H CLAVIER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K242263", "company": "Techfit Digital Surgery, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242263: TECHFIT DISRP\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242263", "people": [{"name": "Susana Munoz Cuartas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242263%22"}, {"id": "fda:K242417", "company": "Rafael Medical Devices, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242417: VECTR \u0096 Video Endoscopic Carpal Tunnel Release System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242417", "people": [{"name": "Gavriel Feuer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242417%22"}, {"id": "fda:K241088", "company": "Monarch Medical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241088: EndoTool IV (3.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241088", "people": [{"name": "Tara Burnett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241088%22"}, {"id": "fda:K243498", "company": "Microgenics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243498: Alinity c Benzodiazepines Reagent Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243498", "people": [{"name": "Nikhita Tandon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243498%22"}, {"id": "fda:K241219", "company": "ZuriMED Technologies AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241219: FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241219", "people": [{"name": "Elias Bachman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241219%22"}, {"id": "fda:K242033", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242033: Access25\u0099 Delivery Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242033", "people": [{"name": "Akshay Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242033%22"}, {"id": "fda:K240758", "company": "Zhejiang Curaway Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240758: Radiofrequency Generator System, Cura RF Electrode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240758", "people": [{"name": "Ruiran Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240758%22"}, {"id": "fda:K242378", "company": "Varian Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242378: Eclipse Treatment Planning System (18.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242378", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242378%22"}, {"id": "fda:K242747", "company": "Foreo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242747: FAQ\u0099 (302)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242747", "people": [{"name": "Evan Feldstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242747%22"}, {"id": "fda:K243491", "company": "Stryker Leibinger GmbH & Co KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243491: SternalPlate Expansion", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243491", "people": [{"name": "Amelia Kesti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243491%22"}, {"id": "fda:K243548", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243548: BriefCase-Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243548", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243548%22"}, {"id": "fda:K241045", "company": "Technomed Europe", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241045: Disposable Subdermal Needle Electrode, Corkscrew", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241045", "people": [{"name": "Sanne Habets", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241045%22"}, {"id": "fda:K241873", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241873: OsseoFit Stemless Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241873", "people": [{"name": "Alexandria Irwin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241873%22"}, {"id": "fda:K243369", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243369: Cervical Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243369", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243369%22"}, {"id": "fda:K241505", "company": "Carestream Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241505: DRX-Revolution Mobile X-ray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241505", "people": [{"name": "Gina Maiolo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241505%22"}, {"id": "fda:K243132", "company": "Shantou Institute of Ultrasonic Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243132: Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243132", "people": [{"name": "Zeqin Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243132%22"}, {"id": "fda:K241521", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241521: Prelude Small O.D. Introducer Guide Wire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241521", "people": [{"name": "James Kenny", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241521%22"}, {"id": "fda:K242025", "company": "Elos Medtech Pinol A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242025: Elos Accurate\u00ae Hybrid Base\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242025", "people": [{"name": "Lise Terkelsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242025%22"}, {"id": "fda:K242327", "company": "Concourse Assistive Technology Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242327: Empulse M90", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242327", "people": [{"name": "David Mackay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242327%22"}, {"id": "fda:K231216", "company": "Jeisys Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231216: POTENZA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231216", "people": [{"name": "Bora Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231216%22"}, {"id": "fda:K243216", "company": "Analog Devices", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243216: Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243216", "people": [{"name": "Phani Puppala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243216%22"}, {"id": "fda:K242461", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242461: IRISeg", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242461", "people": [{"name": "Jyh-Shyan (Jesse) Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242461%22"}, {"id": "fda:K242630", "company": "Aerin Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242630: Aerin Console", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242630", "people": [{"name": "Teri Feeley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242630%22"}, {"id": "fda:K241391", "company": "Institut Straumann AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241391: Straumann\u00ae PURE Ceramic Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241391", "people": [{"name": "Corinne Arimatea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241391%22"}, {"id": "fda:K242511", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242511: V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242511", "people": [{"name": "Jee Young Ju", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242511%22"}, {"id": "fda:K242848", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242848: Philips IntelliSite Pathology Solution 5.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242848", "people": [{"name": "Donna Peled", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242848%22"}, {"id": "nih:3R44MH134706-02S1", "company": "Caring Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-12-09", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44MH134706-02S1: Transforming Hospitalizations of Autistic Adolescents via a Novel ABA Telehealth Platform ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11193418", "people": [{"name": "Ronald Oberleitner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K242729", "company": "Radformation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242729: AutoContour (Model RADAC V4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242729", "people": [{"name": "Jennifer Wampler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242729%22"}, {"id": "fda:K242508", "company": "Verily Life Sciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242508: Verily Numetric Retinal Camera", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242508", "people": [{"name": "Shah Pooja", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242508%22"}, {"id": "fda:K242451", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242451: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242451", "people": [{"name": "Varad Raghuwanshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242451%22"}, {"id": "fda:K240706", "company": "Ganshorn Medizin Electronic GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240706: PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240706", "people": [{"name": "Stefan Ponto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240706%22"}, {"id": "fda:K240841", "company": "Shenzhen Browiner Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240841: Digital Radiography System (ManntiX B, ManntiX K)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240841", "people": [{"name": "Li Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240841%22"}, {"id": "fda:K242758", "company": "Hartmann USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242758: Atrauman\u00ae Ag", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242758", "people": [{"name": "Xiong Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242758%22"}, {"id": "fda:K243364", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243364: TRIGEN META-TAN Trochanteric Antegrade Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243364", "people": [{"name": "Jessica Roach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243364%22"}, {"id": "fda:K240700", "company": "Somnomedics GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240700: HomeSleepTest (HST, HST REM+)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240700", "people": [{"name": "Cherita James", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240700%22"}, {"id": "fda:K243486", "company": "Yukon Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243486: SmartSiteTM Vented Vial Access Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243486", "people": [{"name": "Todd Korogi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243486%22"}, {"id": "fda:K241580", "company": "Abbott Molecular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241580: Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241580", "people": [{"name": "Stacy Ferguson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241580%22"}, {"id": "fda:K242824", "company": "Lake Region Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242824: PTFE Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242824", "people": [{"name": "Clara Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242824%22"}, {"id": "fda:K241567", "company": "Oxos Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241567: MC2 Portable X-ray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241567", "people": [{"name": "Dhruv Vishwakarma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241567%22"}, {"id": "fda:K241878", "company": "Stryker Corporation (Tornier, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241878: Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241878", "people": [{"name": "Stefanie Tarara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241878%22"}, {"id": "fda:K243073", "company": "GS Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243073: AnyPlus Navigated Instruments System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243073", "people": [{"name": "Kimberley Fountain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243073%22"}, {"id": "fda:K241989", "company": "Cercare Medical A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241989: Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241989", "people": [{"name": "Mikkel Bo Hansen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241989%22"}, {"id": "fda:K242687", "company": "AngioDynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242687: NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242687", "people": [{"name": "Brandon Brackett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242687%22"}, {"id": "fda:K242304", "company": "Neuraxis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242304: RED", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242304", "people": [{"name": "Thomas Carrico", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242304%22"}, {"id": "fda:K242645", "company": "Project Chemistry, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242645: INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242645", "people": [{"name": "Jessica Graham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242645%22"}, {"id": "fda:K242710", "company": "Shenzhen Jianchao Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242710: Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242710", "people": [{"name": "Fred Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242710%22"}, {"id": "fda:K241923", "company": "Ever Fortune.Ai, Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241923: EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241923", "people": [{"name": "Chang Joseph", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241923%22"}, {"id": "fda:K240680", "company": "Oxford Brain Diagnostics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240680: CDM Insights", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240680", "people": [{"name": "Terry Pollard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240680%22"}, {"id": "fda:K241073", "company": "Shenzhen Dazhou Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241073: DZ-Tabone Intervertebral Body Fusion Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241073", "people": [{"name": "Jingzhou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241073%22"}, {"id": "fda:K242524", "company": "Syntheticmr AB (Publ.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242524: SyMRI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242524", "people": [{"name": "Madeleine Enstr\u00f6m", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242524%22"}, {"id": "fda:K240561", "company": "Molecular Products , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240561: Rugged Oxygen Generator (ROG) (RO01-00001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240561", "people": [{"name": "Joe Atkinson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240561%22"}, {"id": "fda:K240461", "company": "Ames Medical Prosthetic Solutions, S.A.U.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240461: OsteoSinter\u00ae EVANS and COTTON wedges and related accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240461", "people": [{"name": "Emili Tarrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240461%22"}, {"id": "fda:K240971", "company": "Piraeus Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240971: 87 NeuGlide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240971", "people": [{"name": "Jared Hutar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240971%22"}, {"id": "fda:K241946", "company": "Bard Peripheral Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241946: PeritX\u0099 1L Drainage Kit (90-1010); PeritX\u0099 2L Drainage Kit (90-2010); PeritX\u0099 Peritoneal Catheter Kit (50-9000C); PeritX\u0099 Peritoneal Catheter and Starter Kit (50-9900C); PeritX\u0099 Peritoneal Catheter Mini Kit (50-9050A); PleurX\u0099 Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX\u0099 Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX\u0099 Supplemental Insertion Kit (50-7262); Procedure Pack (50-", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241946", "people": [{"name": "Gabrielle Wipper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241946%22"}, {"id": "fda:K241260", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241260: ACTIFY\u0099 Unicondylar Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241260", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241260%22"}, {"id": "fda:K240840", "company": "Foshan Care Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240840: Oxygen Concentrator (ZY-10AB/115)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240840", "people": [{"name": "Leona Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240840%22"}, {"id": "fda:K240926", "company": "Peek Health, S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240926: PeekMed web", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240926", "people": [{"name": "Sara Silva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240926%22"}, {"id": "fda:K242950", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242950: WallFlex Biliary PLUS RX Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242950", "people": [{"name": "Alexis Erazo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242950%22"}, {"id": "fda:K241213", "company": "Pentax of America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241213: PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241213", "people": [{"name": "Gurvinder Singh Nanda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241213%22"}, {"id": "fda:K241543", "company": "Vinbrain Joint Stock Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241543: DrAid\u0099 for Liver Segmentation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241543", "people": [{"name": "Steven Quoc Hung Truong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241543%22"}, {"id": "fda:K243463", "company": "Biofire Diagnostics, LLC (Biomerieux)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243463: BIOFIRE FILMARRAY Tropical Fever Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243463", "people": [{"name": "Karli Plenert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243463%22"}, {"id": "fda:K242740", "company": "Liaoning Rachcera Material Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242740: Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242740", "people": [{"name": "Liang Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242740%22"}, {"id": "fda:K241674", "company": "Heraeus Medical GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241674: OSTEOPAL\u00ae V", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241674", "people": [{"name": "Sarah Kopischke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241674%22"}, {"id": "fda:K243435", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243435: Magnetic Localization Patch Kit (AFR-00021)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243435", "people": [{"name": "Matthew Lobeck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243435%22"}, {"id": "fda:K243447", "company": "Navbit Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243447: Rapid Surgical Plan (RSP-SW-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243447", "people": [{"name": "David Thomson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243447%22"}, {"id": "fda:DEN240025", "company": "Ventana Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240025: VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240025", "people": [{"name": "Patricia Wade", "role": "510(k) submission contact"}]}, {"id": "fda:K242525", "company": "Nerbio Medical Software Platforms, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242525: iTOF\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242525", "people": [{"name": "Lloyd Leonard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242525%22"}, {"id": "fda:K241128", "company": "Tdm Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241128: TDM Plate and Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241128", "people": [{"name": "Jungwook Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241128%22"}, {"id": "fda:K243526", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243526: MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243526", "people": [{"name": "Aniq Darr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243526%22"}, {"id": "fda:K242653", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242653: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242653", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242653%22"}, {"id": "fda:K242703", "company": "Ossvis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242703: LW Pre-milled Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242703", "people": [{"name": "Woo Jin Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242703%22"}, {"id": "fda:K243444", "company": "Kyocera Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243444: BIOCERAM AZUL\u00ae HEAD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243444", "people": [{"name": "Yoshimi Amano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243444%22"}, {"id": "denovo:DEN240025", "company": "Ventana Medical Systems, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-12-05", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240025 granted: VENTANA Kappa and Lambda Dual ISH mRNA P", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240025"}, {"id": "fda:K242831", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242831: Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242831", "people": [{"name": "Connor Tighe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242831%22"}, {"id": "fda:K242643", "company": "CapsoVision, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242643: CapsoCam Plus (SV-3) Capsule Endoscopy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242643", "people": [{"name": "Azimun Jamal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242643%22"}, {"id": "fda:K241197", "company": "Medicalgorithmics S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241197: DeepRhythmAI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241197", "people": [{"name": "Joanna Dabala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241197%22"}, {"id": "fda:K243417", "company": "Appliedvr", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243417: RelieVRx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243417", "people": [{"name": "Michael Chibbaro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243417%22"}, {"id": "fda:K242686", "company": "Jjgc Ind\u00fastria E Com\u00e9rcia DE Materiais Dent\u00e1rios S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242686: Neodent Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242686", "people": [{"name": "Leticia Milani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242686%22"}, {"id": "fda:K242348", "company": "Double Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242348: Locking Screw,CoCrMo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242348", "people": [{"name": "Joy Zuo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242348%22"}, {"id": "fda:K243180", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243180: SSPC NXT Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243180", "people": [{"name": "Conner Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243180%22"}, {"id": "fda:K240671", "company": "Xstrahl, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240671: XBeam (v2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240671", "people": [{"name": "Gupta Vineet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240671%22"}, {"id": "fda:K242184", "company": "Alcon Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242184: Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242184", "people": [{"name": "Ganesh Balachandar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242184%22"}, {"id": "fda:K242185", "company": "Raypia Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242185: Rextar Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242185", "people": [{"name": "Yolanda Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242185%22"}, {"id": "fda:K243475", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243475: Chemical Indicator for enspire CLCSPS (LCC015)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243475", "people": [{"name": "Gregory Land", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243475%22"}, {"id": "fda:K242685", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242685: Atellica\u00ae CH Creatinine_3 (Crea3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242685", "people": [{"name": "Elisha Caban", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242685%22"}, {"id": "fda:K242395", "company": "Nano-X Imaging , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242395: Nanox.ARC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242395", "people": [{"name": "Erez Meltzer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242395%22"}, {"id": "fda:K243265", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243265: Ion 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243265", "people": [{"name": "Richard Sharp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243265%22"}, {"id": "fda:K242301", "company": "Scientia Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242301: Socrates 38 Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242301", "people": [{"name": "Thomas Lippert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242301%22"}, {"id": "pma:P240012", "company": "Lungpacer Medical USA, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240012: AeroPace\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240012", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240012%22"}, {"id": "breakthrough:P240012", "company": "Lungpacer Medical USA, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-12-04", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P240012: AEROPACE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "hde:H230007", "company": "Artivion, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2024-12-04", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H230007: AMDS Hybrid Prosthesis", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "nih:4R44DA055161-02", "company": "Rissana, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-12-03", "observed": "2026-08-21", "amount_usd": 917927, "summary": "NIH award 4R44DA055161-02: A digital intervention to decrease self-stigma among pregnant and postpartum women with opioid use disorder ($917,927)", "source_url": "https://reporter.nih.gov/project-details/11224099", "people": [{"name": "Patricia A Cavazos-Rehg", "role": "Principal Investigator"}, {"name": "Micah Goodman", "role": "Principal Investigator"}, {"name": "Alex Taylor Ramsey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K243470", "company": "Osteonic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243470: Fix2Lock (PEEK Self Punching)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243470", "people": [{"name": "Kim Da Hee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243470%22"}, {"id": "fda:K242861", "company": "Orthofix Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242861: TrueLok Elevate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242861", "people": [{"name": "Elvira Taccarelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242861%22"}, {"id": "fda:K243454", "company": "Cryosurgery, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243454: Verruca-Freeze H", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243454", "people": [{"name": "Ronald McDow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243454%22"}, {"id": "fda:K243467", "company": "Osteonic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243467: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243467", "people": [{"name": "Kim Da Hee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243467%22"}, {"id": "fda:K242188", "company": "Riverain Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242188: ClearRead CT CAC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242188", "people": [{"name": "Jonathan Jackson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242188%22"}, {"id": "fda:K241486", "company": "Covidien", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241486: Sofsilk\u0099 Coated Braided Silk Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241486", "people": [{"name": "Nicole Boroumand", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241486%22"}, {"id": "fda:K243020", "company": "Intravu, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243020: MIDASVu", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243020", "people": [{"name": "Jenna Rapoport", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243020%22"}, {"id": "fda:K243433", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243433: enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243433", "people": [{"name": "Jennifer Nalepka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243433%22"}, {"id": "fda:K242619", "company": "Apira Science, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242619: GroWell BT Hair Growth System (GW10042)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242619", "people": [{"name": "Ray Pizinger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242619%22"}, {"id": "fda:K223120", "company": "Flight Medical Innovations , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223120: Ventoux VC2; Ventoux VC3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223120", "people": [{"name": "Ken Raichman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223120%22"}, {"id": "fda:K243418", "company": "Micro Therapeutics, Inc. d/b/a ev3 Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243418: Riptide\u0099 Aspiration Pump; Riptide\u0099 Collection Canister with Intermediate Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243418", "people": [{"name": "Tony Rizzardi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243418%22"}, {"id": "fda:K241871", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241871: Philips IntelliSite Pathology Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241871", "people": [{"name": "Donna Peled", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241871%22"}, {"id": "fda:K243232", "company": "Synthon Hispania S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243232: GripMate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243232", "people": [{"name": "Ana Miralles", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243232%22"}, {"id": "fda:K240475", "company": "Vilex, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-12-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240475: Hintermann Series H2 Total Ankle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240475", "people": [{"name": "Jessica Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240475%22"}, {"id": "fda:K241628", "company": "Medical Electronic Systems , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241628: YO Home Sperm Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241628", "people": [{"name": "Taly Vider Cohen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241628%22"}, {"id": "fda:K243375", "company": "Ruthless, LLC Dba Ruthless Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243375: Ruthless Spine RJB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243375", "people": [{"name": "Renita Howard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243375%22"}, {"id": "fda:K241090", "company": "Movano Inc. Dba Movano Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241090: Evie Med Ring", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241090", "people": [{"name": "Kim Tompkins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241090%22"}, {"id": "fda:K242225", "company": "Surgical Instrument Service and Savings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242225: Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242225", "people": [{"name": "Stephanie Boyle Mays", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242225%22"}, {"id": "fda:K240645", "company": "Ontact Health Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240645: Sonix Health", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240645", "people": [{"name": "Seungah Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240645%22"}, {"id": "fda:K241835", "company": "Cellmyx", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241835: AirSculpt Body Contouring System (AIRS-1-SYS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241835", "people": [{"name": "Greg Miles", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241835%22"}, {"id": "fda:K233273", "company": "Prevest Denpro Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233273: C&B Ceramic; C&B Permanent; C&B Interim", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233273", "people": [{"name": "Atul Modi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233273%22"}, {"id": "fda:K243355", "company": "Ceragem Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243355: Ceragem Automatic Thermal Massager (CGM-MB-1902)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243355", "people": [{"name": "Choongwoo Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243355%22"}, {"id": "fda:K242638", "company": "Shenzhen Walton Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242638: LED Light Therapy Machine (G1, G3, G4, G6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242638", "people": [{"name": "Zhou Ling", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242638%22"}, {"id": "fda:K243221", "company": "Eizo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243221: RadiForce RX570; RadiForce RX570-AR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243221", "people": [{"name": "Hiroaki Hashimoto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243221%22"}, {"id": "fda:K242444", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242444: HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242444", "people": [{"name": "So-Yeon Jang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242444%22"}, {"id": "fda:K241899", "company": "Easymed Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241899: Pelvic Floor Stimulator (Intrelief PFE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241899", "people": [{"name": "Tingjie Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241899%22"}, {"id": "fda:K243409", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243409: KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243409", "people": [{"name": "Thomas Ostrowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243409%22"}, {"id": "fda:K242187", "company": "Conmed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242187: BioBrace\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242187", "people": [{"name": "Dionne Sanders", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242187%22"}, {"id": "fda:K242308", "company": "Zhejiang Zhonglei Medical Technology Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242308: Power wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242308", "people": [{"name": "Chengwei Ying", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242308%22"}, {"id": "fda:K243408", "company": "Vilex, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243408: TACTIX Vector Syndesmosis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243408", "people": [{"name": "Brock Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243408%22"}, {"id": "fda:K243362", "company": "Cyden Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243362: SmoothSkin Pure Switch (SSC1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243362", "people": [{"name": "Adam Stephens", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243362%22"}, {"id": "fda:K242796", "company": "Sharkninja Operating, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242796: CryoGlow (FW3XXXX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242796", "people": [{"name": "Alyssa Aquino", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242796%22"}, {"id": "fda:K241115", "company": "Spectrum Vascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241115: SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241115", "people": [{"name": "Sharon Klugewicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241115%22"}, {"id": "fda:K240994", "company": "Nextbiomedical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240994: Nexpowder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240994", "people": [{"name": "Kim Suji", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240994%22"}, {"id": "fda:K243354", "company": "Deka Research & Development Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243354: Remunity System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243354", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243354%22"}, {"id": "fda:K241353", "company": "Bard Access Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241353: PowerLoc\u0099 Max Power Injectable Infusion Set; SafeStep\u0099 Huber Needle Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241353", "people": [{"name": "Catherine Langford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241353%22"}, {"id": "fda:K240818", "company": "Terumo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240818: R2P Radifocus Glidewire Advantage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240818", "people": [{"name": "Qing Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240818%22"}, {"id": "fda:K242657", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242657: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242657", "people": [{"name": "Joel Matthew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242657%22"}, {"id": "fda:K242631", "company": "Smith & Nephew Inc., Endoscopy Div.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242631: REGENETEN\u0099 Bioinductive Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242631", "people": [{"name": "Lacey Klungseth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242631%22"}, {"id": "fda:K242318", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242318: da Vinci SP Surgical System (SP1098)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242318", "people": [{"name": "Mike Yramategui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242318%22"}, {"id": "fda:K241995", "company": "Footbridge Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241995: HyperFlex\u0099 Bunion Correction System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241995", "people": [{"name": "Robert Peterhans", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241995%22"}, {"id": "fda:K242961", "company": "Varian Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242961: Intraluminal Applicator Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242961", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242961%22"}, {"id": "fda:K243118", "company": "Shenzhen Imdk Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243118: Arm Blood Pressure Monitor (model: BPM-A7VL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243118", "people": [{"name": "Yuan Xia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243118%22"}, {"id": "fda:K241390", "company": "LVIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241390: NeuroMatch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241390", "people": [{"name": "Sweta Srivastava", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241390%22"}, {"id": "fda:K242810", "company": "Radunity Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242810: RadUnity (Version 1.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242810", "people": [{"name": "Timothy Szczykutowicz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242810%22"}, {"id": "fda:K231655", "company": "Solco Biomedical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231655: 4CIS\u00ae Chiron Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231655", "people": [{"name": "Seo-Hee Koo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231655%22"}, {"id": "fda:K243193", "company": "Circa Scientific, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243193: Cross Wise\u0099 Multi-Use RF Adapter Cable", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243193", "people": [{"name": "Jennifer Willner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243193%22"}, {"id": "fda:K243050", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243050: TriMed Posterior Malleolus Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243050", "people": [{"name": "Divya Raghavi Nandakumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243050%22"}, {"id": "fda:K240897", "company": "VIOL Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240897: Cellinew", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240897", "people": [{"name": "Sugun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240897%22"}, {"id": "fda:K243191", "company": "Atlas Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243191: Atlas Spine Lateral Expandable Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243191", "people": [{"name": "Thomas Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243191%22"}, {"id": "fda:K231859", "company": "Dentscare Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231859: PrimmaArt", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231859", "people": [{"name": "Roberta Uyara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231859%22"}, {"id": "fda:K242559", "company": "Sprintray, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242559: Digital Temp", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242559", "people": [{"name": "Sara Moghtadernejad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242559%22"}, {"id": "fda:K242258", "company": "Asg Superconductors S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242258: MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242258", "people": [{"name": "Leonardo Bertora", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242258%22"}, {"id": "fda:K242494", "company": "Riverpoint Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242494: OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242494", "people": [{"name": "Becca DeFrancia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242494%22"}, {"id": "fda:K242049", "company": "Coloplast Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242049: SureCath Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242049", "people": [{"name": "Vallabha Tantry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242049%22"}, {"id": "fda:K240650", "company": "Traferox Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240650: LungProtect", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240650", "people": [{"name": "Nicole Baker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240650%22"}, {"id": "nih:3R42ES034684-03S1", "company": "Spectree Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": 76776, "summary": "NIH award 3R42ES034684-03S1: Multispectral Sensor for Chemical Composition Analysis of Ultrafine Aerosols in Air Quality Assessment ($76,776)", "source_url": "https://reporter.nih.gov/project-details/11191101", "people": [{"name": "ALEXANDER V MAMISHEV", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K243345", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243345: Aptima BV Assay; Aptima CV/TV Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243345", "people": [{"name": "Gabriela McCoole", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243345%22"}, {"id": "fda:K241588", "company": "Zhejiang Kairui Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241588: Electric Wheelchair (KR8803)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241588", "people": [{"name": "Jinfeng Ning", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241588%22"}, {"id": "fda:K242245", "company": "Arum Dentistry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242245: Customized Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242245", "people": [{"name": "Choi Won-Yi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242245%22"}, {"id": "fda:K242253", "company": "FH Industrie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242253: JARVIS Glenoid Reverse Shoulder Prosthesis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242253", "people": [{"name": "Naoual Rahimi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242253%22"}, {"id": "fda:K241831", "company": "Screenpoint Medical B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241831: Transpara (2.1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241831", "people": [{"name": "Robin Barwegen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241831%22"}, {"id": "fda:K243162", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243162: World Liner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243162", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243162%22"}, {"id": "fda:K232588", "company": "Knox Medical Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232588: Aluna 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232588", "people": [{"name": "Michael Raftery", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232588%22"}, {"id": "fda:K242971", "company": "Heroic Faith International , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242971: AccurSound Electronic Stethoscope (AS101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242971", "people": [{"name": "Cheng Yuan-Ren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242971%22"}, {"id": "fda:K242538", "company": "3M Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242538: 3M\u0099 Attest\u0099 Super Rapid Readout Biological Indicator 1493; 3M\u0099 Attest\u0099 Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M\u0099 Attest\u0099 Auto-reader 490; 3M\u0099 Attest\u0099 Auto-reader 490H; 3M\u0099 Attest\u0099 Mini Auto-reader 490M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242538", "people": [{"name": "Michelle Larsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242538%22"}, {"id": "fda:K240575", "company": "Eemagine Medical Imaging Solutions GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240575: WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240575", "people": [{"name": "Maarten van de Velde", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240575%22"}, {"id": "fda:K232982", "company": "Shandong Huamei Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232982: EMS Sculpt Machine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232982", "people": [{"name": "Dong Yugui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232982%22"}, {"id": "fda:K241851", "company": "Liquet Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241851: Versus\u0099 Catheter (VS110-8B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241851", "people": [{"name": "John Schindler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241851%22"}, {"id": "fda:K241692", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241692: MIS LYNX Conical Connection Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241692", "people": [{"name": "Laura Sobrin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241692%22"}, {"id": "nih:4R44DA059491-02", "company": "Rtm Vital Signs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": 1276940, "summary": "NIH award 4R44DA059491-02: Wearable Wireless Respiratory Monitoring System that Detects and Predicts Opioid Induced Respiratory Depression ($1,276,940)", "source_url": "https://reporter.nih.gov/project-details/11146916", "people": [{"name": "Nance Katherine Dicciani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241953", "company": "PAJUNK GmbH Medizintechnologie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241953: SPROTTE\u00ae STANDARD (LUER/ NRFit\u00ae) Anesthesiology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241953", "people": [{"name": "Christian Quass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241953%22"}, {"id": "fda:K242203", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242203: BriefCase-Quantification", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242203", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242203%22"}, {"id": "fda:K241169", "company": "Gravitas Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241169: Entarik NI Feeding Tube System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241169", "people": [{"name": "Saheel Sutaria", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241169%22"}, {"id": "fda:K242927", "company": "Advamedix, GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242927: Suction Irrigation Tubing Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242927", "people": [{"name": "Dr. Islam Abed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242927%22"}, {"id": "fda:K241529", "company": "Zhejiang Nysin Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241529: Powered Wheelchair (NXN20-209)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241529", "people": [{"name": "Zhang Xiaoying", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241529%22"}, {"id": "fda:K221326", "company": "Nova Biomedical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221326: Nova Allegro HbA1c Assay, Nova Allegro Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221326", "people": [{"name": "Cesidio Tempesta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221326%22"}, {"id": "fda:K242002", "company": "Femasys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242002: FemVue MINI Saline-Air Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242002", "people": [{"name": "Carrie Engleman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242002%22"}, {"id": "fda:K242913", "company": "Jasberry Healthcare Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242913: Jasmate\u00ae Toothpaste", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242913", "people": [{"name": "Balwant Rai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242913%22"}, {"id": "fda:K242722", "company": "Sichuan Ast Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242722: Manual Wheelchair (MASY23)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242722", "people": [{"name": "Mae Tse", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242722%22"}, {"id": "fda:K242094", "company": "Beacon Biosignals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242094: Dreem 3S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242094", "people": [{"name": "Alexander Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242094%22"}, {"id": "fda:K233567", "company": "Flower Orthopedics Corporation Dba Conventus Flower Ortho", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233567: OsteoCoil\u0099 Nitinol Compression System (Multiple Component PNs)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233567", "people": [{"name": "Christina Rovaldi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233567%22"}, {"id": "fda:K243334", "company": "Xf Agencija Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243334: Nooro Body & Foot Stimulator (SM9141, SM9142)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243334", "people": [{"name": "John Londergan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243334%22"}, {"id": "fda:K242968", "company": "Gimbo Medical Technology Shenzhen Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242968: Giftlife\u00ae Single-Step Medium Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242968", "people": [{"name": "Leo Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242968%22"}, {"id": "fda:K242543", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242543: Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242543", "people": [{"name": "Gregory Foster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242543%22"}, {"id": "fda:K240632", "company": "Neuvotion, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240632: Neuvotion NeuStim NN-01", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240632", "people": [{"name": "Chad Bouton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240632%22"}, {"id": "fda:K242884", "company": "Aidite (Qinhuangdao) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242884: Additively Manufactured Denture Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242884", "people": [{"name": "Qianqian Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242884%22"}, {"id": "fda:K242259", "company": "Cala Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242259: Cala kIQ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242259", "people": [{"name": "Alexander Kent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242259%22"}, {"id": "breakthrough:K241169", "company": "Gravitas Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-11-22", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K241169: ENTARIK NI FEEDING TUBE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K232520", "company": "Shenzhen Smallsignal Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232520: Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232520", "people": [{"name": "Qingliang Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232520%22"}, {"id": "fda:K241495", "company": "Jazz Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241495: Jazz Classic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241495", "people": [{"name": "W. Edward Johansen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241495%22"}, {"id": "fda:K242998", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242998: GMReis Ankle Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242998", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242998%22"}, {"id": "fda:K242596", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242596: Versalock Mini and Micro Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242596", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242596%22"}, {"id": "fda:K242553", "company": "General Vibronics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242553: MIRARI\u00ae Cold Plasma System ( GV-M2-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242553", "people": [{"name": "Huan Truong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242553%22"}, {"id": "fda:K243405", "company": "Cepheid\u00ae", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243405: Xpert vanA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243405", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243405%22"}, {"id": "fda:K242874", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242874: Gating Reflector Block", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242874", "people": [{"name": "Allman Lynn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242874%22"}, {"id": "fda:K242799", "company": "Lifenet Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242799: PliaFX Flo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242799", "people": [{"name": "Brittany Beasley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242799%22"}, {"id": "fda:K241210", "company": "Coloplast Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241210: Luja Coude", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241210", "people": [{"name": "Troy Thome", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241210%22"}, {"id": "fda:K240569", "company": "Fink Engineering Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240569: FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240569", "people": [{"name": "Eric Fink", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240569%22"}, {"id": "fda:K242414", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242414: TiLink-P Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242414", "people": [{"name": "Gui Pires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242414%22"}, {"id": "fda:K241319", "company": "Konica Minolta, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241319: SKR 3000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241319", "people": [{"name": "Makoto Sumi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241319%22"}, {"id": "fda:K242871", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242871: ATTUNE\u0099 Revision Hinge Knee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242871", "people": [{"name": "Paige Myers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242871%22"}, {"id": "fda:K241157", "company": "Ilooda Co,., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241157: Secret MAX Multi-platform RF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241157", "people": [{"name": "Ha Yunjung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241157%22"}, {"id": "fda:K241603", "company": "Zhejiang Nysin Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241603: Powered Wheelchair (NXN20-208, NXN20-211)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241603", "people": [{"name": "Zhang Xiaoying", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241603%22"}, {"id": "fda:K232965", "company": "Shenzhen Ruiyi Business Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232965: Leg Massager (Models:RP-ALM070H, RP-ALM071H)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232965", "people": [{"name": "Derric Bai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232965%22"}, {"id": "fda:K242520", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242520: Element Vascular Access System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242520", "people": [{"name": "Soltanzadeh Sindokht (Sisi)", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242520%22"}, {"id": "fda:K242291", "company": "Sol-Millennium Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242291: SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242291", "people": [{"name": "Kalia Manu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242291%22"}, {"id": "fda:K241843", "company": "Gostar Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241843: TD-7301 Spirometer (TD-7301)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241843", "people": [{"name": "Pei-Fen Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241843%22"}, {"id": "fda:K243164", "company": "Indiba S. A. U.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243164: INDIBA COMPACT devices", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243164", "people": [{"name": "Nieves Arias Badia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243164%22"}, {"id": "fda:K240746", "company": "Q'Apel Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240746: Neurovascular Access System Family", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240746", "people": [{"name": "Jim Talbot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240746%22"}, {"id": "fda:K242359", "company": "Exo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242359: Strain AI (SAI001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242359", "people": [{"name": "Murray Jacqueline", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242359%22"}, {"id": "fda:K240716", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240716: AETOS Shoulder System Stemless Humeral Prosthesis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240716", "people": [{"name": "Cassidy Whipple", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240716%22"}, {"id": "fda:K242517", "company": "Pro Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242517: ProAM ACDF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242517", "people": [{"name": "Jason Blain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242517%22"}, {"id": "fda:K242521", "company": "Osstem Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242521: Estar-ZE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242521", "people": [{"name": "Seungju Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242521%22"}, {"id": "fda:K240856", "company": "Osartis GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240856: Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240856", "people": [{"name": "Volker Stirnal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240856%22"}, {"id": "fda:K243064", "company": "Eterbio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243064: ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243064", "people": [{"name": "Celine Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243064%22"}, {"id": "fda:K242363", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242363: HIGHERDOSE Red Light Hat (HG-120K)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242363", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242363%22"}, {"id": "pma:P210030", "company": "MicroVention, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P210030: Roadsaver/CASPER Carotid Stent Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210030", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P210030%22"}, {"id": "nih:5R44AG079777-03", "company": "Bmseed, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": 779587, "summary": "NIH award 5R44AG079777-03: A physiologically relevant pre-clinical drug screening platform for Alzheimer's Disease and Traumatic Brain Injury with integrated stretchable microelectrodes ($779,587)", "source_url": "https://reporter.nih.gov/project-details/10997391", "people": [{"name": "Oliver Graudejus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K242102", "company": "Cerrozone, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242102: CerroZone Mini", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242102", "people": [{"name": "Marlon Robinson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242102%22"}, {"id": "fda:K243323", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243323: Iconix Knotless Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243323", "people": [{"name": "Bianca Silva de Sousa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243323%22"}, {"id": "fda:K243277", "company": "Maxx Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243277: Freedom\u00ae Medial Congruent Liner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243277", "people": [{"name": "Donald Guthner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243277%22"}, {"id": "fda:K243045", "company": "Braxx Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243045: \u0093BRAXX\u0094 Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243045", "people": [{"name": "Wilson Lai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243045%22"}, {"id": "fda:K221349", "company": "Taidoc Technology Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221349: XPER Technology PREMIUM Pro Blood Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221349", "people": [{"name": "Jacky Chou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221349%22"}, {"id": "fda:K242293", "company": "Rhein Laser Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242293: Medical Thulium Fiber Laser Systems (UroFiber 60Q)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242293", "people": [{"name": "Na Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242293%22"}, {"id": "fda:K242516", "company": "MiRus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242516: EUROPA\u0099 Posterior Cervical Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242516", "people": [{"name": "Anuradha Nagulapati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242516%22"}, {"id": "fda:K243316", "company": "Polarean, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243316: XENOVIEW 3.0T Chest Coil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243316", "people": [{"name": "Neil Wadehra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243316%22"}, {"id": "fda:K242496", "company": "Eieling Technology (Shenzhen) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242496: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242496", "people": [{"name": "Salon Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242496%22"}, {"id": "fda:K242930", "company": "Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242930: Natus BrainWatch System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242930", "people": [{"name": "Behsa Khoshnevis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242930%22"}, {"id": "fda:K242523", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242523: ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242523", "people": [{"name": "Sulgue Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242523%22"}, {"id": "fda:K221813", "company": "Nova Biomedical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221813: Nova Allegro UACR Assay, Nova Allegro Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221813", "people": [{"name": "Cesidio Tempesta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221813%22"}, {"id": "fda:K242028", "company": "Dongguanshi Yiyingmei Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242028: Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242028", "people": [{"name": "Junbing Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242028%22"}, {"id": "breakthrough:K242516", "company": "Mirus, LLC.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-11-19", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K242516: EUROPA POSTERIOR CERVICAL FUSION SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:4R44MH135605-02", "company": "Ksana Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": 1071401, "summary": "NIH award 4R44MH135605-02: BRITE 2.0: A just-in-time adaptive intervention for suicide safety planning in adolescents ($1,071,401)", "source_url": "https://reporter.nih.gov/project-details/11212130", "people": [{"name": "NICHOLAS B ALLEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241700", "company": "Trice Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241700: Tenex 2nd Generation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241700", "people": [{"name": "David Vancelette", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241700%22"}, {"id": "fda:K241633", "company": "Mindset Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241633: Informed Vital Core Application (IVC App)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241633", "people": [{"name": "Chris Joslin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241633%22"}, {"id": "fda:K242092", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242092: MICRO Arterial Filters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242092", "people": [{"name": "Luigi Vecchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242092%22"}, {"id": "fda:K241498", "company": "Hebei Keylaser Sci-Tech Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241498: Diode laser Treatment System (K18)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241498", "people": [{"name": "Zhen Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241498%22"}, {"id": "fda:K242402", "company": "Zhejiang Zhonglei Medical Technology Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242402: Power wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242402", "people": [{"name": "Chengwei Ying", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242402%22"}, {"id": "fda:K242329", "company": "Philips Healthcare (Suzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242329: CT Collaboration Live", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242329", "people": [{"name": "Yael Curtz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242329%22"}, {"id": "fda:K241814", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241814: da Vinci SP Instruments (SP1098)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241814", "people": [{"name": "Kunal Gunjal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241814%22"}, {"id": "fda:K243506", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243506: Montage-XT Settable Bone Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243506", "people": [{"name": "Aniq Darr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243506%22"}, {"id": "fda:K242471", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242471: Power Wheelchair (W5538)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242471", "people": [{"name": "Shuangshuang Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242471%22"}, {"id": "fda:K241747", "company": "DeepHealth, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241747: Saige-Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241747", "people": [{"name": "B. Nathan Hunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241747%22"}, {"id": "fda:K240871", "company": "Enlight Medical Technologies (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240871: Synxess Neurovascular Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240871", "people": [{"name": "Gui Kason", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240871%22"}, {"id": "fda:K243320", "company": "Xiamen Weiyou Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243320: Air Pressure Therapy System (VU-IPC04B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243320", "people": [{"name": "Guo Kelly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243320%22"}, {"id": "fda:K242130", "company": "Koios Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242130: Koios DS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242130", "people": [{"name": "Michael Bocchinfuso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242130%22"}, {"id": "fda:K241138", "company": "Livsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241138: ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241138", "people": [{"name": "Eunyeong Hwang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241138%22"}, {"id": "fda:K243299", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243299: ACUSON Redwood Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243299", "people": [{"name": "Rapaka Shilpa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243299%22"}, {"id": "fda:K242419", "company": "Creagh Medical Ltd. Dba Surmodics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242419: 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242419", "people": [{"name": "Brendan McCormack", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242419%22"}, {"id": "fda:K242260", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242260: aprevo\u00ae Cervical ACDF; aprevo\u00ae Cervical ACDF-X; aprevo\u00ae Cervical ACDF-X NO CAM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242260", "people": [{"name": "Karen Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242260%22"}, {"id": "fda:K240528", "company": "B-One Ortho, Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240528: b-ONE\u00ae Total Hip System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240528", "people": [{"name": "Allison Gecik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240528%22"}, {"id": "fda:K242062", "company": "Mycardium AI Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242062: 1CMR Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242062", "people": [{"name": "Michael Walker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242062%22"}, {"id": "fda:K241439", "company": "Vuno, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241439: VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241439", "people": [{"name": "Jiwon Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241439%22"}, {"id": "fda:K242465", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242465: Panther Fusion SARS-CoV-2/Flu A/B/RSV assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242465", "people": [{"name": "Vlada Rudenko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242465%22"}, {"id": "fda:K233081", "company": "Infinitum Eta, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233081: NUVENTUS NV.C\u0099 Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233081", "people": [{"name": "Kobi Shakarchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233081%22"}, {"id": "fda:K242272", "company": "Blue Belt Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242272: CORIOGRAPH Pre-Op Planning and Modeling Services", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242272", "people": [{"name": "Chandler Caufield", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242272%22"}, {"id": "fda:K243285", "company": "THINK Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243285: TMINI Miniature Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243285", "people": [{"name": "Anand Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243285%22"}, {"id": "fda:K241070", "company": "Vascutek, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241070: Gelsoft\u0099 Plus Vascular Prostheses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241070", "people": [{"name": "Ryan King", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241070%22"}, {"id": "fda:K240523", "company": "Shenzhen Vitavitro Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240523: VitaVitro\u00ae Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro\u00ae Double Lumen Oocyte Retrieval Needle (ORND-17G)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240523", "people": [{"name": "Donghai Pan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240523%22"}, {"id": "fda:K243306", "company": "Tianjin Huahong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243306: Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243306", "people": [{"name": "Ningning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243306%22"}, {"id": "fda:K240860", "company": "Ultromics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240860: EchoGo Amyloidosis (1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240860", "people": [{"name": "Jaco Jacobs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240860%22"}, {"id": "fda:K242800", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242800: The 5000 Compact Series Ultrasound Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242800", "people": [{"name": "Suresh Kumar Alagarsamy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242800%22"}, {"id": "fda:K242960", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242960: AdVance\u0099 XP Male Sling System (720163-03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242960", "people": [{"name": "Natalie Asprey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242960%22"}, {"id": "fda:K241125", "company": "Vieworks Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241125: VIVIX-S 1751S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241125", "people": [{"name": "Oh Kevin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241125%22"}, {"id": "fda:K242360", "company": "Dent4you AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242360: Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242360", "people": [{"name": "Oliver Ashe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242360%22"}, {"id": "fda:K241224", "company": "Surgical Instrument Service and Savings Inc.(Dba Medline Ren", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241224: Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241224", "people": [{"name": "Stephanie Boyle Mays", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241224%22"}, {"id": "breakthrough:K240860", "company": "Ultromics, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-11-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K240860: ECHOGO AMYLOIDOSIS (1.0)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K242260", "company": "Carlsmed, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-11-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K242260: APREVO CERVICAL ACDF; APREVO CERVICAL ACDF-X; APREVO\u00ae CERVICAL ACDF-X NO CAM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K242342", "company": "Brightheart", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242342: Fetal EchoScan", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242342", "people": [{"name": "Christophe Gardella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242342%22"}, {"id": "fda:K242940", "company": "Shenzhen Xinrun Electric Appliances Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242940: Xrecovery (XR-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242940", "people": [{"name": "Chong Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242940%22"}, {"id": "fda:K242436", "company": "Skeletal Dynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242436: Proximal Humerus Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242436", "people": [{"name": "Alexandra Rodriguez Rojas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242436%22"}, {"id": "fda:K242598", "company": "InMode , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242598: DEFINE System (AG612444A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242598", "people": [{"name": "Ahava Stein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242598%22"}, {"id": "fda:K241930", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241930: Veincare", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241930", "people": [{"name": "Hyunsik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241930%22"}, {"id": "fda:K242814", "company": "Microware Precision Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242814: Tandry Q-Locking Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242814", "people": [{"name": "Harrison Du", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242814%22"}, {"id": "fda:K241397", "company": "Hinlab Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241397: Hinscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241397", "people": [{"name": "Denys-Michel De Larouzi\u00e8re", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241397%22"}, {"id": "fda:K242079", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242079: Arthrex Elbow Fracture Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242079", "people": [{"name": "Stacy Valdez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242079%22"}, {"id": "fda:K242440", "company": "Nanjing Bestview Laser S&T Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242440: Intense Pulsed Light Treatment System (LK-PT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242440", "people": [{"name": "Jing Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242440%22"}, {"id": "fda:K241339", "company": "Besmed Health Business Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241339: Besmed Bacterial Filter and HMEF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241339", "people": [{"name": "Sarah Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241339%22"}, {"id": "nih:5R44TR003956-03", "company": "Immersive Tech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-11-13", "observed": "2026-08-21", "amount_usd": 846089, "summary": "NIH award 5R44TR003956-03: Advancing emergency medicine training with remote stereoscopic livestream technology ($846,089)", "source_url": "https://reporter.nih.gov/project-details/11001563", "people": [{"name": "Shannon Kyle Tedder Bailey", "role": "Principal Investigator"}, {"name": "Micheal Burns", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K243273", "company": "Cequr SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243273: CeQur Simplicity\u0099 On-Demand Insulin Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243273", "people": [{"name": "Michael Simpson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243273%22"}, {"id": "fda:K211498", "company": "Nonin Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K211498: Nonin OTC Pulse Oximeter Model 3250", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211498", "people": [{"name": "Lisa Pray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K211498%22"}, {"id": "fda:K242764", "company": "Cmf Medicon Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242764: MediRod Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242764", "people": [{"name": "Matthias Alber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242764%22"}, {"id": "fda:K242407", "company": "Hunan Vsmile Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242407: Dental Glass Ceramics Blocks (HT, LT, MT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242407", "people": [{"name": "Xiaomi Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242407%22"}, {"id": "fda:K240337", "company": "Guangdong Jinme Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240337: Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240337", "people": [{"name": "Ying Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240337%22"}, {"id": "fda:K241135", "company": "Corvent Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241135: RESPOND(R) Ventilator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241135", "people": [{"name": "Richard Walsh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241135%22"}, {"id": "fda:K242856", "company": "Huizhou Foryou Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242856: LUOFUCON\u00ae Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON\u00ae Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242856", "people": [{"name": "Guosheng Tan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242856%22"}, {"id": "fda:DEN240023", "company": "ClearPoint Neuro, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240023: SmartFlow Neuro Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240023", "people": [{"name": "Brennan Sullivan", "role": "510(k) submission contact"}]}, {"id": "denovo:DEN240023", "company": "ClearPoint Neuro, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-11-13", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240023 granted: SmartFlow Neuro Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240023"}, {"id": "fda:K242173", "company": "Coloplast Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242173: Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242173", "people": [{"name": "Jennifer Tvrdik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242173%22"}, {"id": "fda:K242791", "company": "Zhejiang Kairui Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242791: Electric wheelchair (KR-8807)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242791", "people": [{"name": "Kevin Ni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242791%22"}, {"id": "fda:K242420", "company": "Phenox, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242420: pNOVUS 21 Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242420", "people": [{"name": "Rachel McDaid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242420%22"}, {"id": "fda:K242775", "company": "Medtronic Minimed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242775: InPen System App (MMT-8060 (iOS), MMT-8061 (Android))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242775", "people": [{"name": "Ty Cowart", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242775%22"}, {"id": "fda:K242502", "company": "Supermax Healthcare Canada \u0096 Supermax Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242502: Aurelia Surgical Mask ASTM Level-3 (2130)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242502", "people": [{"name": "Chiew Yi Tay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242502%22"}, {"id": "fda:K240771", "company": "Prognosys Medical Systems Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240771: PRORAD X-Ray Flat Panel Detector with DROC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240771", "people": [{"name": "Krishna Prasad Vajapeyam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240771%22"}, {"id": "fda:DEN230085", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230085: VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230085", "people": [{"name": "Anthony Piotrkowski", "role": "510(k) submission contact"}]}, {"id": "fda:K230915", "company": "Vyaire Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230915: AirLife\u0099 Open Et Oxygen Mask, AirLife\u0099 Open Et+ Oxygen Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230915", "people": [{"name": "Naila Bukhari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230915%22"}, {"id": "fda:K242430", "company": "Soul Mobility", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242430: Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242430", "people": [{"name": "Troy Tesmer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242430%22"}, {"id": "fda:K241074", "company": "Foshan Soco Precision Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241074: High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241074", "people": [{"name": "Gou Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241074%22"}, {"id": "fda:K242018", "company": "Lifesignals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242018: UbiqVue\u0099 2A Multi-parameter System (UX2550)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242018", "people": [{"name": "Saravanan Balasubramanian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242018%22"}, {"id": "fda:K241981", "company": "Change Healthcare Canada Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241981: Change Healthcare Stratus Imaging PACS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241981", "people": [{"name": "Alona Golik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241981%22"}, {"id": "denovo:DEN230085", "company": "Steris", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-11-12", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230085 granted: VERIFY RESI-TEST SLIDE-THRU Cleaning Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230085"}, {"id": "fda:K241575", "company": "Straumann USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241575: Straumann\u00ae Anatomic Healing Abutments XC (AHA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241575", "people": [{"name": "Laura Bleyendaal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241575%22"}, {"id": "fda:K243233", "company": "S4 Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243233: esolution\u00ae Esophageal Retractor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243233", "people": [{"name": "William Fuller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243233%22"}, {"id": "nih:5R43MH133521-02", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": 475002, "summary": "NIH award 5R43MH133521-02: A parallelized imaging platform for accurate and efficient long-term assessment of brain organoid development ($475,002)", "source_url": "https://reporter.nih.gov/project-details/11001572", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "fda:K241364", "company": "Hermes Medical Solutions AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241364: Hybrid Viewer (00859873006189)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241364", "people": [{"name": "Hanne Grinaker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241364%22"}, {"id": "fda:K242286", "company": "Guangzhou Aimira Innovation Technology Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242286: Superflow Prime Treatment System (ASP-1M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242286", "people": [{"name": "Wenyang Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242286%22"}, {"id": "fda:K240510", "company": "Sonoma Pharmaceuticals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240510: Microdacyn Hydrogel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240510", "people": [{"name": "Everardo Garibay Ramirez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240510%22"}, {"id": "fda:K242802", "company": "Hangzhou Clongene Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242802: CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242802", "people": [{"name": "Frank Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242802%22"}, {"id": "fda:K241636", "company": "Waldemar Link GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241636: MobileLink Acetabular Cup System - Line Extension (Multiple)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241636", "people": [{"name": "Stefanie Fuchs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241636%22"}, {"id": "fda:K242382", "company": "iSMART Developments, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242382: d\u00e9coLITE LED Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242382", "people": [{"name": "Susan D'Arcy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242382%22"}, {"id": "fda:K240417", "company": "Icad, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240417: ProFound Detection (V4.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240417", "people": [{"name": "Spence Hartwell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240417%22"}, {"id": "fda:K242749", "company": "Rizhao Huge Biomaterials Company, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242749: TopCEM Ceramic Primer Ceramic Coupling Agent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242749", "people": [{"name": "Maggie Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242749%22"}, {"id": "fda:K243004", "company": "Jeil Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243004: Xpine Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243004", "people": [{"name": "Jinwoo Kim Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243004%22"}, {"id": "fda:K242231", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242231: Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242231", "people": [{"name": "Jiahong Jin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242231%22"}, {"id": "fda:K243075", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243075: Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243075", "people": [{"name": "Disha Kabrawala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243075%22"}, {"id": "fda:K241342", "company": "Shenzhen Nuon Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241342: Hair Growth Comb (SZ-23,SZ-23A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241342", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241342%22"}, {"id": "fda:K243231", "company": "Nvision Biomedical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243231: Trigon PEEK HA Wedges", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243231", "people": [{"name": "Natalia Reyes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243231%22"}, {"id": "fda:K241099", "company": "Hironic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241099: Plasonic (Plasonic)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241099", "people": [{"name": "Hosung Ji", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241099%22"}, {"id": "fda:K241802", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241802: Device 300397 Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241802", "people": [{"name": "Marco Steiner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241802%22"}, {"id": "fda:K242756", "company": "Pulnovo Medical (Wuxi) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242756: Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242756", "people": [{"name": "Wen Gu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242756%22"}, {"id": "fda:K240794", "company": "Fourth Frontier Technologies Pvt, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240794: Frontier X Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240794", "people": [{"name": "Manav Bhushan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240794%22"}, {"id": "fda:K242595", "company": "Shenzhen Greatro Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242595: Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242595", "people": [{"name": "Xinhua Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242595%22"}, {"id": "fda:K242373", "company": "Mako Surgical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242373: Mako Shoulder Application (1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242373", "people": [{"name": "Anne Edwards", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242373%22"}, {"id": "fda:K242367", "company": "Biofire Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242367: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242367", "people": [{"name": "Karli Plenert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242367%22"}, {"id": "fda:K242734", "company": "Zsfab", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242734: ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242734", "people": [{"name": "Yuanqiao Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242734%22"}, {"id": "fda:K241872", "company": "Rebotix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241872: Remanufactured EndoWrist ProGrasp Forceps (420093)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241872", "people": [{"name": "Chris Gibson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241872%22"}, {"id": "fda:K212425", "company": "Exostat Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K212425: MicroTrend System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212425", "people": [{"name": "Irvin Pierskalla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K212425%22"}, {"id": "fda:K242361", "company": "Stryker Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242361: OZARK Cervical Plate System; PYRENEES\u00ae Cervical Plate System; EVEREST\u00ae Spinal System; MESA\u00ae Spinal System; MESA\u00ae Small Stature Spinal System; CASPIAN\u00ae Spinal System; DENALI\u00ae Spinal System; DENALI\u00ae MI Spinal System; YUKON OCT Spinal System; Xia\u00ae 3 Spinal System; K2M Patient Specific; CASCADIA\u0099 Interbody System; CAYMAN\u00ae Plate System; CAYMAN\u00ae Plate System-MI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242361", "people": [{"name": "Isabel Garza", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242361%22"}, {"id": "fda:K241346", "company": "Aspen Imaging Healthcare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241346: IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241346", "people": [{"name": "Casey Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241346%22"}, {"id": "fda:K241719", "company": "Neurocareai, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241719: NeuroICH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241719", "people": [{"name": "Junaid Saddiq Kalia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241719%22"}, {"id": "fda:K241853", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241853: Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241853", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241853%22"}, {"id": "fda:K242702", "company": "Spident Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242702: VioSeal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242702", "people": [{"name": "Eunok Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242702%22"}, {"id": "fda:K242379", "company": "Ossvis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242379: LL Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242379", "people": [{"name": "Woojin Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242379%22"}, {"id": "fda:K241468", "company": "Foundation Surgical Group, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241468: Vertiwedge\u00ae Intraosseous System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241468", "people": [{"name": "Asher Breverman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241468%22"}, {"id": "fda:K240712", "company": "Icometrix NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240712: icobrain aria", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240712", "people": [{"name": "Dirk Smeets", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240712%22"}, {"id": "fda:K240415", "company": "Newclip Technics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240415: Newclip Patient-matched instrumentation non sterile PSI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240415", "people": [{"name": "Robert Poggie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240415%22"}, {"id": "fda:K240429", "company": "Inrad, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240429: Trilogy Tissue Marker", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240429", "people": [{"name": "Heidi Halverson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240429%22"}, {"id": "fda:K240997", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240997: Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240997", "people": [{"name": "Angeline Chooi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240997%22"}, {"id": "fda:K240450", "company": "Acuitive Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240450: Citrepore\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240450", "people": [{"name": "Matthew Poggie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240450%22"}, {"id": "fda:K242039", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242039: Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242039", "people": [{"name": "Yang Blue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242039%22"}, {"id": "fda:K243222", "company": "Biofire Diagnostics, LLC (Biomerieux)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243222: BIOFIRE\u00ae FILMARRAY\u00ae Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE\u00ae FILMARRAY\u00ae Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243222", "people": [{"name": "Karli Plenert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243222%22"}, {"id": "fda:K242803", "company": "Medtech Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242803: Compound W Skin Tag Remover", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242803", "people": [{"name": "Vincent Argiro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242803%22"}, {"id": "fda:K242719", "company": "Nu Eyne Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242719: ELEXIR 2.0 (ALLIVE3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242719", "people": [{"name": "Dahee Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242719%22"}, {"id": "fda:K242412", "company": "Medisurge, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242412: Agility Symmetric\u0099 Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242412", "people": [{"name": "Megan Morrissey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242412%22"}, {"id": "fda:K240831", "company": "Asclepion Laser Technologies GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240831: MultiCut Solo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240831", "people": [{"name": "Tom Gruender", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240831%22"}, {"id": "fda:K242261", "company": "Biotech Dental, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242261: Accelx Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242261", "people": [{"name": "David Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242261%22"}, {"id": "pma:P240006", "company": "Biosense Webster, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240006: VARIPULSE\u0099 Platform (VARIPULSE\u0099 Catheter; TRUPULSE\u0099 Generator; Sterile Interface Cable; nGEN\u0099 Pump)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240006", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240006%22"}, {"id": "fda:K243106", "company": "CarboFix Orthopedics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243106: CarboClear\u00ae Hybrid Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243106", "people": [{"name": "Hila Wachsler-Avrahami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243106%22"}, {"id": "fda:K242345", "company": "Quantalx Neuroscience", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242345: Delphi Stimulator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242345", "people": [{"name": "Iftach Dolev", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242345%22"}, {"id": "fda:K231287", "company": "Jeisys Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231287: POTENZA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231287", "people": [{"name": "Bora Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231287%22"}, {"id": "fda:K241484", "company": "Orthopedic Designs North America, Inc. (Odi-Na)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241484: Atlas\u0099 Humeral Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241484", "people": [{"name": "Robin Wilson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241484%22"}, {"id": "fda:K241849", "company": "Imaxeon Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241849: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241849", "people": [{"name": "Anhua Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241849%22"}, {"id": "fda:K242332", "company": "Shenzhen Kentro Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242332: Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242332", "people": [{"name": "Zewu Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242332%22"}, {"id": "fda:K240624", "company": "First Medical Source, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240624: InfuLife", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240624", "people": [{"name": "Mark Shal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240624%22"}, {"id": "fda:K242947", "company": "Cardio Flow Inc.,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242947: FreedomFlow\u0099 Orbital Circumferential Atherectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242947", "people": [{"name": "Michael Kallok", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242947%22"}, {"id": "fda:K241312", "company": "Terarecon,Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241312: TeraRecon Cardiac.Chambers.MR (1.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241312", "people": [{"name": "Alexis Ferrier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241312%22"}, {"id": "fda:K242340", "company": "Terrats Medical SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242340: DESS Dental Smart Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242340", "people": [{"name": "Roger Terrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242340%22"}, {"id": "fda:K242664", "company": "Gri-Alleset, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242664: gentleheel\u00ae Adult Incision Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242664", "people": [{"name": "Marty Paugh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242664%22"}, {"id": "fda:K243015", "company": "Kyocera Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243015: Skyway Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243015", "people": [{"name": "Joey Thompson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243015%22"}, {"id": "pma:P240010", "company": "Caris Life Sciences", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-11-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240010: MI Cancer Seek", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240010", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240010%22"}, {"id": "fda:K242567", "company": "Changsha Anxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242567: Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242567", "people": [{"name": "William Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242567%22"}, {"id": "fda:K242709", "company": "JLK, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242709: JLK-PWI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242709", "people": [{"name": "Dongmin Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242709%22"}, {"id": "fda:K243061", "company": "Sonostik, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243061: SonoStik Guide Wire Introducer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243061", "people": [{"name": "Gary Wakeford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243061%22"}, {"id": "fda:K240512", "company": "Novoxel , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240512: Tixel i (TXLI0001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240512", "people": [{"name": "Daniela Dov Elmaz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240512%22"}, {"id": "fda:DEN230083", "company": "Lumithera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230083: Valeda Light Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230083", "people": [{"name": "Lori Holder", "role": "510(k) submission contact"}]}, {"id": "fda:K240438", "company": "Comercializadora Brever", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240438: CDB Hospital \u00ae Sterilization Wrap (70 gsm); CDB Hospital \u00ae Sterilization Wrap (44 gsm)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240438", "people": [{"name": "Clarisbeth Flores Lara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240438%22"}, {"id": "fda:K240637", "company": "Bionime Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240637: RIGHTEST Blood Glucose Monitoring System Max Tel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240637", "people": [{"name": "Kay Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240637%22"}, {"id": "fda:K242195", "company": "ZheJiang Decans Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242195: Gemini Cervical Fusion Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242195", "people": [{"name": "Chen Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242195%22"}, {"id": "denovo:DEN230083", "company": "Lumithera, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-11-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230083 granted: Valeda Light Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230083"}, {"id": "fda:K242269", "company": "Quanta Dialysis Technologies, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242269: SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242269", "people": [{"name": "Sam Drew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242269%22"}, {"id": "fda:K240881", "company": "Covidien (Part of Medtronic)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240881: Signia\u0099 Circular Adapter (Standard Length) (SIGCIRSTND); Signia\u0099 Circular Adapter XL Length (SIGCIRXL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240881", "people": [{"name": "Carolina Cabezas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240881%22"}, {"id": "fda:K240388", "company": "4Web Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240388: Osteotomy Truss System (OTS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240388", "people": [{"name": "Jonathan Hires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240388%22"}, {"id": "fda:K243091", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243091: Over-tube (TR-1108A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243091", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243091%22"}, {"id": "fda:K242311", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242311: EXPERT - Flexible Joint Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242311", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242311%22"}, {"id": "fda:K240366", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240366: EP\u0095XT\u0099 Unidirectional Steerable Diagnostic Catheter; Dynamic Tip\u0099 Unidirectional Steerable Diagnostic Catheter; Dynamic XT\u0099 Unidirectional Steerable Diagnostic Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240366", "people": [{"name": "Melissa Schneider", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240366%22"}, {"id": "fda:K240514", "company": "Applied Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240514: AMT Low-Profile Suprapubic Catheter & Drainage Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240514", "people": [{"name": "Jennifer Hazou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240514%22"}, {"id": "fda:K242076", "company": "Baylis Medical Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242076: VersaCross\u0099 RF Wire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242076", "people": [{"name": "Neethi Murali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242076%22"}, {"id": "fda:K242665", "company": "Depuy Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242665: DePuy ATTUNE\u0099 Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242665", "people": [{"name": "Christina Kaucic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242665%22"}, {"id": "fda:K241068", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241068: uDR 780i", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241068", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241068%22"}, {"id": "fda:K242620", "company": "Shenzhen Breo Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242620: Breo Laser Hair Growth Comb (Scalp 3L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242620", "people": [{"name": "Yong Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242620%22"}, {"id": "fda:K242591", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242591: XERO-alpha", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242591", "people": [{"name": "Yeongsuk An", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242591%22"}, {"id": "fda:K241999", "company": "Wright Medical Technology, Inc. (Stryker)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241999: Prophecy Surgical Planning System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241999", "people": [{"name": "Jonathan DiMotta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241999%22"}, {"id": "fda:K242320", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242320: BD Vacutainer\u00ae One Use Holder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242320", "people": [{"name": "Sravan Rajamani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242320%22"}, {"id": "fda:K242393", "company": "Acuity Polymers, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242393: Acuity 181\u0099 (tisilfocon A) and Acuity 181\u0099 (tisilfocon A) with Tangible\u0099 Hydra-PEG\u00ae Rigid Gas Permeable Contact Lenses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242393", "people": [{"name": "Jose Chavez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242393%22"}, {"id": "fda:K243381", "company": "Skeletal Dynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243381: Total Wrist Arthroplasty System (TWA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243381", "people": [{"name": "Alexandra Rodriguez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243381%22"}, {"id": "fda:K241646", "company": "Mvitro Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241646: ORTIV (ORTIV-BL, ORTIV-WH)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241646", "people": [{"name": "Jeong Seob Nam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241646%22"}, {"id": "fda:K242452", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242452: Monkey Bars Pin to Bar External Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242452", "people": [{"name": "Edward Wells-Spicer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242452%22"}, {"id": "fda:K243217", "company": "Pollogen, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243217: Legend X Desktop System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243217", "people": [{"name": "Karen Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243217%22"}, {"id": "fda:K241828", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241828: Affera Integrated Mapping System; Impedance Localization Patch Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241828", "people": [{"name": "Matthew Lobeck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241828%22"}, {"id": "fda:K242675", "company": "Spident Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242675: FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242675", "people": [{"name": "Eunok Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242675%22"}, {"id": "fda:K242328", "company": "Bard Access Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242328: PowerPort\u0099 ClearVUE\u0099 Slim Implantable Ports and PowerPort\u0099 ClearVUE\u0099 Slim Implantable Ports", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242328", "people": [{"name": "Roessler Aaron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242328%22"}, {"id": "fda:K243181", "company": "Bionova Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243181: Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243181", "people": [{"name": "Alex Greene", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243181%22"}, {"id": "fda:K240653", "company": "Smartcardia SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240653: SmartCardia 7L Platform (MCT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240653", "people": [{"name": "Srinivasan Murali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240653%22"}, {"id": "fda:K242623", "company": "Shenzhen Medke Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242623: Disposable Blood Pressure cuff; Reusable Blood Pressure cuff", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242623", "people": [{"name": "Wei Tao Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242623%22"}, {"id": "fda:K240455", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240455: BD Vacutainer\u00ae Citrate Blood Collection Tubes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240455", "people": [{"name": "Joseph Basore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240455%22"}, {"id": "fda:K240375", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240375: V80 Anesthetic Vaporizer (V80)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240375", "people": [{"name": "Yanhong Bai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240375%22"}, {"id": "fda:K242399", "company": "Bonebridge AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242399: Bonebridge Osteosynthesis Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242399", "people": [{"name": "Michelle Gumpelmayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242399%22"}, {"id": "fda:K240383", "company": "Highness Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240383: Highness Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240383", "people": [{"name": "Ji-yun Jeong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240383%22"}, {"id": "fda:K241223", "company": "Erad, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241223: eRAD PACS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241223", "people": [{"name": "Jaye Marotta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241223%22"}, {"id": "nih:1R41MD019586-01", "company": "Mhealth Systems, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": 296519, "summary": "NIH award 1R41MD019586-01: MiREA, a mHealth intervention to Reduce Health Disparities by Improving Access to Mandated College Students with Problematic Alcohol and Marijuana Use ($296,519)", "source_url": "https://reporter.nih.gov/project-details/10923432", "people": [{"name": "Donna Marie Kazemi", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:DEN230082", "company": "Sonomotion, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230082: Stone Clear (SC-LP9-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230082", "people": [{"name": "Oren Levy", "role": "510(k) submission contact"}]}, {"id": "fda:K242627", "company": "Ningbo Medsun Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242627: Safety Lancet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242627", "people": [{"name": "Liu Ping", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242627%22"}, {"id": "fda:K243186", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243186: Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243186", "people": [{"name": "Joseph Howell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243186%22"}, {"id": "fda:K240333", "company": "Guangdong Genial Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240333: Wearable Digital Thermometer (T31)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240333", "people": [{"name": "Jun Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240333%22"}, {"id": "fda:K241108", "company": "Remedy Logic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241108: RemedyLogic AI MRI Lumbar Spine Reader", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241108", "people": [{"name": "Andrej Rusakov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241108%22"}, {"id": "fda:K240177", "company": "iRhythm Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240177: Zio AT\u00ae device (A100A1001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240177", "people": [{"name": "Soyini Hamit", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240177%22"}, {"id": "fda:K240847", "company": "Ide Vision, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240847: MedicCO2LON (MedicCO2LON)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240847", "people": [{"name": "Nicholas See", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240847%22"}, {"id": "fda:K240670", "company": "Microgenics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240670: DRI Ecstasy Plus Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240670", "people": [{"name": "Amrit Takhar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240670%22"}, {"id": "fda:K242711", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242711: JOURNEY II Unicompartmental Knee System (JOURNEY II UK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242711", "people": [{"name": "Anne Remington", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242711%22"}, {"id": "fda:K241533", "company": "Neuraxis", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241533: NeurAxis IB-Stim (01-1020)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241533", "people": [{"name": "Thomas Carrico", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241533%22"}, {"id": "fda:K242271", "company": "Taiwan Main Orthopaedic Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242271: Caduceus S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242271", "people": [{"name": "Jacky Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242271%22"}, {"id": "fda:K240334", "company": "Lagis Enterprise Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240334: LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240334", "people": [{"name": "Lynn Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240334%22"}, {"id": "fda:K241902", "company": "HistoSonics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241902: Edison System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241902", "people": [{"name": "LeeAnne Swiridow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241902%22"}, {"id": "fda:K240560", "company": "Izenimplant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240560: ZENEX Implant System_Long", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240560", "people": [{"name": "Ji-Hwan Jeong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240560%22"}, {"id": "denovo:DEN230082", "company": "Sonomotion, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-10-30", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230082 granted: Stone Clear (SC-LP9-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230082"}, {"id": "fda:K243247", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243247: Persona the Personalized Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243247", "people": [{"name": "Gregory Foster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243247%22"}, {"id": "fda:K240175", "company": "Tigon Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240175: Tigon Medical Fractures, Instability, and Reconstruction (FIRE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240175", "people": [{"name": "Jeremy Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240175%22"}, {"id": "fda:K241612", "company": "Hunan Vathin Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241612: Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241612", "people": [{"name": "Charlene Du", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241612%22"}, {"id": "fda:K241077", "company": "Degen Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241077: DeGen Medical Patient Specific Implant (PSI) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241077", "people": [{"name": "Black Craig", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241077%22"}, {"id": "fda:K243080", "company": "Micro Therapeutics, Inc. d/b/a ev3 Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243080: Riptide Aspiration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243080", "people": [{"name": "Tony Rizzardi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243080%22"}, {"id": "fda:K242256", "company": "QIAGEN GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242256: QIAstat-Dx Meningitis/Encephalitis (ME) Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242256", "people": [{"name": "Autumn Collasius", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242256%22"}, {"id": "fda:K243126", "company": "Novatech SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243126: TRACHEOBRONXANE\u0099 DUMON\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243126", "people": [{"name": "Montgomery Stuart K.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243126%22"}, {"id": "fda:K241366", "company": "Dehas Medical Systems GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241366: QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241366", "people": [{"name": "Jens Mittendorf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241366%22"}, {"id": "fda:K243095", "company": "Devicor Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243095: Mammotome AutoCore\u0099 Single Insertion Core Biopsy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243095", "people": [{"name": "Edenborg Jamie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243095%22"}, {"id": "fda:K241965", "company": "Varian Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241965: Catheter Surface Flap Applicator Set (GM11011830)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241965", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241965%22"}, {"id": "fda:K241189", "company": "Jiaxing Xiaoxiang Medical Equipment Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241189: Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241189", "people": [{"name": "Jun Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241189%22"}, {"id": "fda:K243203", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243203: OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243203", "people": [{"name": "Paul Vagts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243203%22"}, {"id": "fda:K243157", "company": "AtriCure, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243157: AtriCure cryoICE BOX (ACM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243157", "people": [{"name": "Ronit Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243157%22"}, {"id": "fda:K242622", "company": "Ningbo Caremed Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242622: Sterile Lancets for Single Use", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242622", "people": [{"name": "Cen Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242622%22"}, {"id": "fda:K243137", "company": "Curiteva, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243137: Curiteva Porous PEEK Laminoplasty System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243137", "people": [{"name": "Eric Linder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243137%22"}, {"id": "fda:K241992", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241992: Catalyft\u0099 LS Expandable Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241992", "people": [{"name": "Rose Merlin Jose", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241992%22"}, {"id": "fda:K242350", "company": "Spinal Alignment Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242350: Spinal Alignment Solutions Pelvic Incidence (PI) Rod System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242350", "people": [{"name": "Bassel Diebo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242350%22"}, {"id": "fda:K241718", "company": "Shenzhen Aozemei Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241718: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241718", "people": [{"name": "Zemin Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241718%22"}, {"id": "fda:K240303", "company": "Jellox Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240303: MetaLite DX Digital Pathology Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240303", "people": [{"name": "Fan Tzu-Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240303%22"}, {"id": "fda:K241630", "company": "Ethicon Endo-Surgery, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241630: ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241630", "people": [{"name": "Megan Westendorf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241630%22"}, {"id": "fda:K242397", "company": "Norlase Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242397: LYNX Photocoagulator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242397", "people": [{"name": "Jan Forstberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242397%22"}, {"id": "fda:K243030", "company": "Ulike Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243030: Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243030", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243030%22"}, {"id": "fda:K241185", "company": "Avanos Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241185: CORGRIP* SR NG/NI Tube Retention System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241185", "people": [{"name": "Lauren Prock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241185%22"}, {"id": "fda:K242969", "company": "Biotronik, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242969: Pantera Pro; Pantera LEO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242969", "people": [{"name": "Jon Brumbaugh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242969%22"}, {"id": "fda:K243173", "company": "3D Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243173: Salto Talaris Ankle PSI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243173", "people": [{"name": "Ashley Dawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243173%22"}, {"id": "fda:K243031", "company": "Shenzhen Beacon Display Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243031: LCD Monitors C310S, G310S, C316S, G316S, C616W", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243031", "people": [{"name": "Li Yafei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243031%22"}, {"id": "fda:K242215", "company": "Neurophet., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242215: Neurophet AQUA (V3.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242215", "people": [{"name": "Kim Byeolei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242215%22"}, {"id": "fda:K242984", "company": "Ortho Development Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242984: BKS Revision System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242984", "people": [{"name": "Drew Weaver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242984%22"}, {"id": "fda:K240092", "company": "Shenzhen Yimi Life Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240092: Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240092", "people": [{"name": "Peng Shande", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240092%22"}, {"id": "fda:K242353", "company": "QIAGEN GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242353: QIAstat-Dx Respiratory Panel Mini", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242353", "people": [{"name": "Autumn Collasius", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242353%22"}, {"id": "fda:K240223", "company": "Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240223: FMT Disposable and Autoclavable Temperature Probes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240223", "people": [{"name": "Metehan Firat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240223%22"}, {"id": "fda:K243070", "company": "Cepheid\u00ae", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243070: Xpert\u00ae SA Nasal Complete", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243070", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243070%22"}, {"id": "fda:DEN230084", "company": "Distalmotion SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230084: Dexter L6 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230084", "people": [{"name": "Larry Carrier", "role": "510(k) submission contact"}]}, {"id": "fda:K240269", "company": "Comfort Rubber Gloves Industries Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240269: Nitrile Powder Free Examination Gloves Biodegradable (Green)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240269", "people": [{"name": "Sumanthi d/o Saravana Sami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240269%22"}, {"id": "fda:K243174", "company": "3D Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243174: Cadence Ankle PSI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243174", "people": [{"name": "Ashley Dawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243174%22"}, {"id": "fda:K240040", "company": "VATECH Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240040: VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240040", "people": [{"name": "Daniel Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240040%22"}, {"id": "fda:K242625", "company": "Cryoconcepts LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242625: Freeze Point & Private Label Versions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242625", "people": [{"name": "Sam Niedbala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242625%22"}, {"id": "fda:K242956", "company": "Ocuject, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242956: LDS Needle; OcuSafe\u00ae LDS Needle; SteriCap\u00ae LDS Safety Needle; VitreJect\u00ae LDS Safety Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242956", "people": [{"name": "Leonid Lerner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242956%22"}, {"id": "fda:K240918", "company": "Bruno Vision Care, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240918: Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240918", "people": [{"name": "Eddie Catalfamo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240918%22"}, {"id": "fda:K243189", "company": "SimBioSys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243189: TumorSight Viz", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243189", "people": [{"name": "Kimberly Oleson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243189%22"}, {"id": "denovo:DEN230084", "company": "Distalmotion SA", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-10-25", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230084 granted: Dexter L6 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230084"}, {"id": "fda:K242512", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242512: ROCC Console", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242512", "people": [{"name": "Rob Vingerhoed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242512%22"}, {"id": "fda:K241554", "company": "Telefield Medical Imaging (Shenzhen) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241554: Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241554", "people": [{"name": "Dolly Xiong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241554%22"}, {"id": "fda:K242560", "company": "Foshan Shunkangda Medical Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242560: Manual Wheelchair (SYIV100-CA9221)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242560", "people": [{"name": "Ruizhuo Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242560%22"}, {"id": "fda:K242458", "company": "Argen Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242458: ArgenZ MTZ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242458", "people": [{"name": "Paul Cascone", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242458%22"}, {"id": "fda:K242034", "company": "Medtronic Neurosurgery", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242034: Duet External Drainage and Monitoring System (EDMS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242034", "people": [{"name": "Foram Shukla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242034%22"}, {"id": "fda:K242086", "company": "Gt Metabolic Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242086: MagDI System (MAG-01, DS-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242086", "people": [{"name": "Lisa Griffin Vincent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242086%22"}, {"id": "fda:K241007", "company": "Shenzhen Urion Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241007: Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241007", "people": [{"name": "Zhu Changming", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241007%22"}, {"id": "fda:K241089", "company": "Keystone Industries", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241089: KeyPrint KeyDenture Base", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241089", "people": [{"name": "Caleb Barylski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241089%22"}, {"id": "fda:K240543", "company": "Medency S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240543: Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240543", "people": [{"name": "Alessandro Zorgati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240543%22"}, {"id": "fda:K240391", "company": "Implantcast GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240391: MUTARS\u00ae femoral stem cemented 160 mm and 200 mm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240391", "people": [{"name": "Juliane H\u00f6ppner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240391%22"}, {"id": "fda:K242462", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242462: CEREC Cercon 4D CAD/CAM Blocks", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242462", "people": [{"name": "Rebecca Sporer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242462%22"}, {"id": "pma:P240013", "company": "Medtronic, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240013: Sphere-9 Catheter and Affera Ablation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240013", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240013%22"}, {"id": "fda:K241324", "company": "Affinity Biosensors, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241324: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241324", "people": [{"name": "Ken Babcock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241324%22"}, {"id": "fda:K242183", "company": "Weifang Mingliang Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242183: Fractional CO2 Laser Therapy System (EXFU CO2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242183", "people": [{"name": "Lv Alisa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242183%22"}, {"id": "fda:K242829", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242829: BluEX Lumbar Expandable Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242829", "people": [{"name": "Kihyang Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242829%22"}, {"id": "fda:K242073", "company": "Tsk Laboratory International Japan KK", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242073: STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242073", "people": [{"name": "Seika Shiba", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242073%22"}, {"id": "fda:K242847", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242847: EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242847", "people": [{"name": "Hanbyul Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242847%22"}, {"id": "fda:K242513", "company": "Guangdong Optomedic Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242513: FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242513", "people": [{"name": "Weijuan Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242513%22"}, {"id": "fda:K243007", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243007: CD Horizon\u0099 Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243007", "people": [{"name": "Wafa Mustafa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243007%22"}, {"id": "fda:K234060", "company": "Paragonix Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234060: KIDNEYvault Portable Renal Perfusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234060", "people": [{"name": "Lucas Churchill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234060%22"}, {"id": "fda:K241988", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241988: ProSeal\u0099 Closed System Bag Access", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241988", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241988%22"}, {"id": "fda:K242589", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242589: Scarlet\u00ae AL-T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242589", "people": [{"name": "Estelle Lefeuvre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242589%22"}, {"id": "fda:K243012", "company": "Mim Software, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243012: MIM \u0096 Symphony HDR Fusion", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243012", "people": [{"name": "Sydney Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243012%22"}, {"id": "fda:K241876", "company": "Varian Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241876: Vitesse (5.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241876", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241876%22"}, {"id": "fda:K240289", "company": "Scivita Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240289: Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240289", "people": [{"name": "Wu Ruqin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240289%22"}, {"id": "fda:K243057", "company": "Adaptiiv Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243057: TrueFit Bolus; TrueFlex Bolus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243057", "people": [{"name": "Olga Zhuk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243057%22"}, {"id": "fda:K240865", "company": "Immunodiagnostic Systems Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240865: IDS-iSYS Free Testosterone", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240865", "people": [{"name": "Mick Henderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240865%22"}, {"id": "fda:K242995", "company": "The Orthopaedic Implant Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242995: OIC Small / Mini Fragment Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242995", "people": [{"name": "Douglas Fulton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242995%22"}, {"id": "fda:K241753", "company": "Biomet 3i, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241753: Immediate Molar Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241753", "people": [{"name": "Krupal Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241753%22"}, {"id": "fda:K242193", "company": "Avita Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242193: Arm Type Blood Pressure Monitor (BPM82)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242193", "people": [{"name": "Maggie Chao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242193%22"}, {"id": "fda:K241572", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241572: ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241572", "people": [{"name": "Patricia Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241572%22"}, {"id": "fda:K242250", "company": "3-D Matrix Europe SAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242250: PuraStat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242250", "people": [{"name": "Audrey Vion", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242250%22"}, {"id": "fda:K241398", "company": "Tianjin Mastervision Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241398: SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241398", "people": [{"name": "Delia Ke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241398%22"}, {"id": "fda:K241532", "company": "Shanghai SeeGen Photoelectric Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241532: Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241532", "people": [{"name": "Yihua Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241532%22"}, {"id": "fda:K241478", "company": "Brosmed Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241478: Tri-Wedge PTA Scoring Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241478", "people": [{"name": "Crystal Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241478%22"}, {"id": "fda:K240506", "company": "Karl Storz Endoscopy America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240506: KARL STORZ Holders", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240506", "people": [{"name": "Mario Trujillo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240506%22"}, {"id": "fda:K243209", "company": "Nordicneurolab AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243209: nordicMEDiVA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243209", "people": [{"name": "Chandana Gurung Bhandari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243209%22"}, {"id": "fda:K241758", "company": "Stryker Sustainability Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241758: Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241758", "people": [{"name": "Mia Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241758%22"}, {"id": "fda:K242099", "company": "Sol-Millennium Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242099: Sol-M\u0099 Slip Tip Syringe without Needle, Sol-M\u0099 Eccentric Tip Syringe without Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242099", "people": [{"name": "Kalia Manu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242099%22"}, {"id": "fda:K242058", "company": "Apple, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242058: Digital Prism Correction Feature (DPCF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242058", "people": [{"name": "Ian Marcus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242058%22"}, {"id": "fda:K242266", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242266: PhotonBlade 3; PhotonBlade 3 Smoke Evacuation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242266", "people": [{"name": "Miriam Giltinan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242266%22"}, {"id": "fda:K241170", "company": "Talladium Espa\u00f1a, SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241170: Dynamic TiBase; TRI Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241170", "people": [{"name": "Xavier Soca Filella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241170%22"}, {"id": "fda:K240783", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240783: Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240783", "people": [{"name": "Laurel Arrigona", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240783%22"}, {"id": "fda:K242554", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242554: Arthrex VAL and VAL KreuLock\u0099 Compression Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242554", "people": [{"name": "Konrad Wolfmeyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242554%22"}, {"id": "fda:K242157", "company": "Momentis Surgical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242157: Anovo Surgical System (Model 6Ne)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242157", "people": [{"name": "Maya Leib Shlomo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242157%22"}, {"id": "fda:K222740", "company": "Speciality Fibres and Materials, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222740: Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222740", "people": [{"name": "Nyerngoor Korda Hewitt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222740%22"}, {"id": "fda:K240029", "company": "iRhythm Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240029: Zio AT\u00ae device (A100A1001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240029", "people": [{"name": "Vishal Kanani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240029%22"}, {"id": "fda:K242828", "company": "Stimlabs, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242828: Corplex P/ Theracor P/ Allacor P", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242828", "people": [{"name": "Melissa O'Connor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242828%22"}, {"id": "fda:K241830", "company": "Sleepnet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241830: Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241830", "people": [{"name": "Jennifer Kennedy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241830%22"}, {"id": "fda:K240226", "company": "Oystershell NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240226: Pixie Skin Tag", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240226", "people": [{"name": "Laurens De Schepper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240226%22"}, {"id": "fda:K240916", "company": "Xiantao Daoqi Plastic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240916: Surgical Face Mask (Tie on/ Ear loops)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240916", "people": [{"name": "Honghong Bie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240916%22"}, {"id": "fda:K242473", "company": "Coloplast Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242473: Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242473", "people": [{"name": "Jennifer Mrkvicka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242473%22"}, {"id": "fda:K240725", "company": "Eclectic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240725: PreXolid CAD/CAM abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240725", "people": [{"name": "Injin Hwang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240725%22"}, {"id": "fda:K240844", "company": "Philips Medical Systems Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240844: Spectral CT 7500 RT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240844", "people": [{"name": "Siwar Assi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240844%22"}, {"id": "fda:K243033", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243033: dS Wrist coil 8ch 1.5T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243033", "people": [{"name": "Sherry Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243033%22"}, {"id": "fda:K242813", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242813: Materialise Shoulder System\u0099, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242813", "people": [{"name": "Lisa Barbara Parolari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242813%22"}, {"id": "fda:K233054", "company": "Well-Life Healthcare Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233054: Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233054", "people": [{"name": "Jenny Hsieh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233054%22"}, {"id": "fda:K242132", "company": "Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242132: FREDDO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242132", "people": [{"name": "Gianmaria Cominato Filho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242132%22"}, {"id": "fda:K222944", "company": "Safepath Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222944: SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222944", "people": [{"name": "Joseph Lane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222944%22"}, {"id": "fda:K241131", "company": "Edelweiss Dentistry Products GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241131: edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241131", "people": [{"name": "Jakob Unterweger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241131%22"}, {"id": "fda:K242435", "company": "Wellmed Dental Medical Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242435: Dental Barrier and Sleeves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242435", "people": [{"name": "Renxian Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242435%22"}, {"id": "fda:K242837", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242837: BriefCase-Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242837", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242837%22"}, {"id": "fda:K242864", "company": "Orthosoft Inc. (d/b/a) Zimmer CAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242864: ROSA\u00ae Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242864", "people": [{"name": "Nilam Dave", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242864%22"}, {"id": "fda:K232994", "company": "Dentscare Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232994: Vittra APS Unique Flow", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232994", "people": [{"name": "Paula Cristine de Oliveira", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232994%22"}, {"id": "fda:K242372", "company": "Bone Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242372: Mg OSTEOREVIVE\u0099, Mg OSTEOCRETE\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242372", "people": [{"name": "Drew Diaz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242372%22"}, {"id": "fda:K243245", "company": "Boston Scientific Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K243245: IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243245", "people": [{"name": "Dana Borris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K243245%22"}, {"id": "fda:K242868", "company": "Restor3D", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242868: Kinos Total Ankle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242868", "people": [{"name": "Brianna Prindle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242868%22"}, {"id": "fda:K241959", "company": "3M Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241959: 3M\u0099 Attest\u0099 Super Rapid Steam Clear Challenge Pack (1492PCD); 3M\u0099 Attest\u0099 Auto-reader (490); 3M\u0099 Attest\u0099 Auto-reader (490H); 3M\u0099 Attest\u0099 Mini Auto-reader (490M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241959", "people": [{"name": "Michelle Larsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241959%22"}, {"id": "fda:K233378", "company": "Acro Biomedical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233378: ABCcolla\u00ae Collagen ADM Scaffold", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233378", "people": [{"name": "Dar-Jen Hsieh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233378%22"}, {"id": "fda:K241490", "company": "Mvision AI OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241490: Contour+ (MVision AI Segmentation)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241490", "people": [{"name": "Kalpana Jha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241490%22"}, {"id": "fda:K242879", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242879: dS Knee Coil 8ch 1.5T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242879", "people": [{"name": "Asha Jacob", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242879%22"}, {"id": "pma:P230018", "company": "Ventana Medical Systems, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230018: VENTANA CLDN18 (43-14A) RxDx Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230018", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230018%22"}, {"id": "fda:K241337", "company": "Kunshan Hi-Fortune Health Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241337: Electrically powered wheelchair (HP202)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241337", "people": [{"name": "Lewis Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241337%22"}, {"id": "fda:K241267", "company": "Hidroxa Medical AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241267: Hidroxa SE30", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241267", "people": [{"name": "Sandra Eriksson Mirkovic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241267%22"}, {"id": "fda:K240408", "company": "Epitel, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240408: REMI-AI Rapid Detection Module (REMI-AI RDM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240408", "people": [{"name": "Randy Parry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240408%22"}, {"id": "fda:K240711", "company": "Perfuze, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240711: Zipline Access Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240711", "people": [{"name": "Anne-Marie Gannon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240711%22"}, {"id": "fda:K211943", "company": "Imbed Biosciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K211943: Microlyte Ag/Lidocaine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211943", "people": [{"name": "Ankit Agarwal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K211943%22"}, {"id": "fda:K242809", "company": "Medical Graphics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242809: Ascent Cardiorespiratory Diagnostic Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242809", "people": [{"name": "James McGurran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242809%22"}, {"id": "fda:K242197", "company": "Shenzhen Huaruibo Electric Appliances Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242197: IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242197", "people": [{"name": "Xinhua Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242197%22"}, {"id": "fda:K240321", "company": "Hager& Meisinger GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240321: MP Pin flat without thread (36BMP000020/MP20)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240321", "people": [{"name": "Melanie Otto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240321%22"}, {"id": "fda:K242899", "company": "Baui Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242899: NOVA Minimally Invasive System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242899", "people": [{"name": "Herman Jhan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242899%22"}, {"id": "fda:K240218", "company": "Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240218: Electric Breast Pump (F5055)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240218", "people": [{"name": "Jason Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240218%22"}, {"id": "fda:K241242", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241242: SIGNA MAGNUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241242", "people": [{"name": "Brian Zielski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241242%22"}, {"id": "fda:K240160", "company": "Astura Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240160: EGPS Navigated Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240160", "people": [{"name": "Parker Kelch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240160%22"}, {"id": "fda:K242839", "company": "Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242839: Safe Secure Sterilization Pouches and Rolls", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242839", "people": [{"name": "Parker Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242839%22"}, {"id": "fda:K240596", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240596: Cerebral Autoregulation Index (CAI) Algorithm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240596", "people": [{"name": "Daphney Germain-Kolawole", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240596%22"}, {"id": "fda:K241481", "company": "Augmedics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241481: xvision Spine System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241481", "people": [{"name": "Tami Harel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241481%22"}, {"id": "fda:DEN230087", "company": "Peytant Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230087: AMStent\u00ae Tracheobronchial Covered Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230087", "people": [{"name": "John Schorgl", "role": "510(k) submission contact"}]}, {"id": "fda:K241632", "company": "Kunshan Hi-Fortune Health Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241632: Electrically powered wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241632", "people": [{"name": "Zhanli Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241632%22"}, {"id": "fda:K240468", "company": "Abbott Laboratories Diagnostics Division", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240468: Alkaline Phosphatase", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240468", "people": [{"name": "Bryant Tate", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240468%22"}, {"id": "fda:K242556", "company": "JLK, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242556: JLK-CTP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242556", "people": [{"name": "Dongmin Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242556%22"}, {"id": "fda:K240114", "company": "Dualams, Inc., Dba Airkor", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240114: UltraEzAir\u00ae (UEA1A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240114", "people": [{"name": "John Reid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240114%22"}, {"id": "fda:K241221", "company": "Cerenovus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241221: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241221", "people": [{"name": "Cara Feely", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241221%22"}, {"id": "fda:K242784", "company": "Vy Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242784: Vy Spine\u0099 VyLam\u0099 Laminoplasty System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242784", "people": [{"name": "Jordan Hendrickson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242784%22"}, {"id": "fda:K241244", "company": "Cerenovus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241244: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241244", "people": [{"name": "Cara Feely", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241244%22"}, {"id": "fda:K240364", "company": "Li Medical Corporation , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240364: RELIEEV Uterine Manipulator Injector (CUMI 5.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240364", "people": [{"name": "Chen Jago", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240364%22"}, {"id": "fda:K241613", "company": "Shenzhen Hbcare Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241613: Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241613", "people": [{"name": "XuYu Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241613%22"}, {"id": "fda:K242794", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242794: ONCOZENE Microspheres", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242794", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242794%22"}, {"id": "fda:K240849", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240849: Ambu\u00ae aScope\u0099 5 Cysto HD (Standard Deflection); Ambu\u00ae aScope\u0099 5 Cysto HD (Reverse Deflection); Ambu\u00ae aBox\u0099 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240849", "people": [{"name": "Gurpreet Kaur Rehal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240849%22"}, {"id": "fda:K241272", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241272: Stryker Steri-Shield 8 Surgical Hoods and Togas", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241272", "people": [{"name": "Jordan Hackert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241272%22"}, {"id": "denovo:DEN230087", "company": "Peytant Solutions, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-10-16", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230087 granted: AMStent\u00ae Tracheobronchial Covered Stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230087"}, {"id": "fda:K242097", "company": "Den-Mat Holdings, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242097: DenMat Bulk Fill Composite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242097", "people": [{"name": "Kim Maynes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242097%22"}, {"id": "fda:K240385", "company": "Mediimg Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240385: VINT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240385", "people": [{"name": "Byeon-Uk Jeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240385%22"}, {"id": "fda:K241673", "company": "Shenzhen Piocreat 3D Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241673: Denture Base Resin (PN-Denture (Red, White))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241673", "people": [{"name": "Jason Cai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241673%22"}, {"id": "fda:K241894", "company": "Inari Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241894: Artix\u0099 MT; Artix\u0099 Thin-Walled Thrombectomy Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241894", "people": [{"name": "Ellen Nguyen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241894%22"}, {"id": "fda:K231997", "company": "Cure Point Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231997: SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231997", "people": [{"name": "Harold Kraft", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231997%22"}, {"id": "fda:K240192", "company": "Scivita Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240192: Single-use Extraction Baskets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240192", "people": [{"name": "Wu Ruqin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240192%22"}, {"id": "fda:K242536", "company": "Tautona Group", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242536: TauTona Pneumoperitoneum Assist Device (TPAD)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242536", "people": [{"name": "Mike Blanchette", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242536%22"}, {"id": "fda:K242795", "company": "Steritec Products Mfg. (A Getinge Group Company)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242795: Getinge Assured MI Steam Migrating Integrator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242795", "people": [{"name": "Muha Chris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242795%22"}, {"id": "fda:K242781", "company": "Circle Cardiovascular Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242781: cvi42 Software Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242781", "people": [{"name": "Omar Naimi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242781%22"}, {"id": "pma:P230042", "company": "Novocure, GmbH", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-10-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230042: Optune Lua", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230042", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230042%22"}, {"id": "fda:K242812", "company": "Nb Medical Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242812: NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242812", "people": [{"name": "Thi Vinh Vu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242812%22"}, {"id": "fda:K242387", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242387: Mobility Scooter (N3473)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242387", "people": [{"name": "Shuangshuang Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242387%22"}, {"id": "fda:K241163", "company": "Heidelberg Engineering GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241163: SPECTRALIS with Flex Module", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241163", "people": [{"name": "Arianna Schoess Vargas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241163%22"}, {"id": "fda:K241569", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241569: syngo Application Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241569", "people": [{"name": "Patricia Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241569%22"}, {"id": "fda:K242778", "company": "Qpix Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242778: X Sensor (Model: IOS-A15IF, HDI-15DGF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242778", "people": [{"name": "Seungman Yun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242778%22"}, {"id": "fda:K240499", "company": "Airos Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240499: ARTAIRA Arterial Compression Device (AACD01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240499", "people": [{"name": "Darren Behuniak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240499%22"}, {"id": "fda:K242779", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242779: Hood (DH-083ST)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242779", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242779%22"}, {"id": "fda:K242133", "company": "Centerline Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242133: Intra-Operative Positioning System (IOPS\u00ae) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS\u00ae) (Guidewire Handle)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242133", "people": [{"name": "Amanda Shade", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242133%22"}, {"id": "fda:K241857", "company": "Dongguan Boyuan Intelligent Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241857", "people": [{"name": "Le Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241857%22"}, {"id": "fda:K242095", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242095: Access Toxo IgM II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242095", "people": [{"name": "Stefanie K Berg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242095%22"}, {"id": "fda:K240501", "company": "Ormco Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240501: Spark\u0099 Clear Aligner System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240501", "people": [{"name": "Samantha Britt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240501%22"}, {"id": "fda:DEN230078", "company": "Cmr Surgical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230078: Versius Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230078", "people": [{"name": "Chris Weatherall", "role": "510(k) submission contact"}]}, {"id": "fda:K242035", "company": "Accure Acne, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242035: Accure Laser System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242035", "people": [{"name": "Alfred Intintoli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242035%22"}, {"id": "fda:K234110", "company": "Belun Technology Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234110: Belun Ring BLR-200 (BLR-200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234110", "people": [{"name": "Lap Wai Lydia Leung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234110%22"}, {"id": "fda:K240797", "company": "Permantis Public Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240797: PPH Saliva Collection Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240797", "people": [{"name": "Robert Darnell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240797%22"}, {"id": "fda:K241971", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241971: HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241971", "people": [{"name": "Ju Jee Young", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241971%22"}, {"id": "fda:K240242", "company": "Anhui Deepblue Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240242: HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240242", "people": [{"name": "Fengling Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240242%22"}, {"id": "fda:K240143", "company": "Jdentalcare Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240143: JDZygoma dental implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240143", "people": [{"name": "Grandi Antonio", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240143%22"}, {"id": "fda:K242742", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242742: DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242742", "people": [{"name": "Jackie Oliver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242742%22"}, {"id": "fda:K242833", "company": "Ortho Development Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242833: Legend\u00ae Acetabular Shell", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242833", "people": [{"name": "Drew Weaver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242833%22"}, {"id": "fda:K241153", "company": "Progressive Aligners, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241153: Progressive Orthodontics App", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241153", "people": [{"name": "Fouad Alaeddin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241153%22"}, {"id": "fda:K233265", "company": "Peters Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233265: Monotime and Optime R", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233265", "people": [{"name": "Ellen Henke Knupp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233265%22"}, {"id": "fda:K240472", "company": "Dongguan Tutamen Metalwork Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240472: PBM Hair Therapy Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240472", "people": [{"name": "Stephen Prior", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240472%22"}, {"id": "fda:K240826", "company": "Sterilmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240826: Reprocessed DECANAV\u0099 Electrophysiology Catheter; Reprocessed WEBSTER\u00ae Duo-Decapolar Electrophysiology Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240826", "people": [{"name": "Carrie Berge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240826%22"}, {"id": "fda:K232565", "company": "Copan Italia Spa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232565: UriSponge\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232565", "people": [{"name": "Silvia Caprini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232565%22"}, {"id": "fda:K232779", "company": "Qx World, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232779: QUEX ED; QUEX S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232779", "people": [{"name": "Lilla Strobel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232779%22"}, {"id": "pma:P240009", "company": "Contego Medical, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240009: Neuroguard IEP\u00ae 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240009", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240009%22"}, {"id": "denovo:DEN230078", "company": "Cmr Surgical Limited", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-10-11", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230078 granted: Versius Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230078"}, {"id": "fda:K241735", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241735: ProSeal\u0099 In Line Pump Set (423850)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241735", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241735%22"}, {"id": "fda:K242515", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242515: uDR 380i Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242515", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242515%22"}, {"id": "fda:K240992", "company": "Weero Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240992: eMVFit (MVF-10M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240992", "people": [{"name": "Moon young Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240992%22"}, {"id": "fda:K240848", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240848: Ambu\u00ae aScope\u0099 5 Cysto HD (Standard Deflection); Ambu\u00ae aScope\u0099 5 Cysto HD (Reverse Deflection); Ambu\u00ae aView\u0099 2 Advance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240848", "people": [{"name": "Gurpreet Kaur Rehal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240848%22"}, {"id": "fda:K242389", "company": "Bausch & Lomb, Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242389: EyeGility\u0099 Inserter for Preloaded enVista IOLs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242389", "people": [{"name": "Renee Stoffel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242389%22"}, {"id": "fda:K241092", "company": "Quanta System Spa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241092: Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241092", "people": [{"name": "Dario Bandiera", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241092%22"}, {"id": "fda:K241491", "company": "Stryker Corporation (Tornier, S.A.S.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241491: Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241491", "people": [{"name": "Aymen Azaiez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241491%22"}, {"id": "fda:K242400", "company": "Yilink (Tianjin) Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242400: Dental porcelain powder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242400", "people": [{"name": "Yaqiong Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242400%22"}, {"id": "fda:K230325", "company": "Greens Surgicals Pvt. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230325: GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230325", "people": [{"name": "Vinay Kumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230325%22"}, {"id": "fda:K241430", "company": "Icardio.Ai", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241430: EchoMeasure", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241430", "people": [{"name": "Roman Sandler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241430%22"}, {"id": "fda:K240786", "company": "HeartLung Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240786: AutoChamber", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240786", "people": [{"name": "Mark Scott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240786%22"}, {"id": "fda:K241951", "company": "BLUECORE COMPANY Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241951: Lasya-Trinity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241951", "people": [{"name": "Sang Mi Oh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241951%22"}, {"id": "fda:K240262", "company": "B.T.I. Biotechnology Institute, Sl.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240262: BTI Interna 3.0 Dental Implant System UnicCa\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240262", "people": [{"name": "Jos\u00e9 Ram\u00f3n Rivero", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240262%22"}, {"id": "fda:K233947", "company": "Ctl Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233947: KLIMT\u0099 Expandable Lumbar Interbody Fusion (LIF) Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233947", "people": [{"name": "Sean Suh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233947%22"}, {"id": "fda:K240315", "company": "Siemens Healthcare Diagnostics Products GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240315: INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240315", "people": [{"name": "Anja Wilhelm", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240315%22"}, {"id": "pma:P240005", "company": "Bausch & Lomb, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240005: enVista Envy\u0099 hydrophobic acrylic intraocular lens (IOL), enVista Envy\u0099 toric hydrophobic acrylic intraocular lens (IOL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240005%22"}, {"id": "fda:K241477", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241477: aprevo\u00ae anterior lumbar interbody fusion device with interfixation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241477", "people": [{"name": "Karen Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241477%22"}, {"id": "fda:K242029", "company": "H.S Hospital Service S.P.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242029: TRAP EASY", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242029", "people": [{"name": "Massimiliano Improta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242029%22"}, {"id": "fda:K242691", "company": "OsteoCentric Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242691: OsteoCentric Technologies Cannulated Fasteners and Nuts", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242691", "people": [{"name": "Todd Evan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242691%22"}, {"id": "fda:K241837", "company": "Limbus Ai, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241837: Limbus Contour", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241837", "people": [{"name": "Jonathan Giambattista", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241837%22"}, {"id": "fda:K241485", "company": "Truabutment, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241485: TruAbutment DS; TruBase", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241485", "people": [{"name": "Ki Yoon Nam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241485%22"}, {"id": "fda:K242021", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242021: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242021", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242021%22"}, {"id": "fda:K240095", "company": "Shanghai Care US Medical Product Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240095: CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240095", "people": [{"name": "Charles Shen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240095%22"}, {"id": "fda:K240991", "company": "Weero Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240991: eMVFit (MVF-10M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240991", "people": [{"name": "Moon young Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240991%22"}, {"id": "fda:K241355", "company": "Su-Ko Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241355: SER Pen Carain MicroSystem (MP1209SP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241355", "people": [{"name": "Yuan Yuan \"Susie\" Su Korrodi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241355%22"}, {"id": "fda:K231948", "company": "Medicreations, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231948: MEDIYAG", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231948", "people": [{"name": "Anthony Hardy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231948%22"}, {"id": "fda:K240181", "company": "Auxein Medical Pvt., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240181: Clavicle and Scapula System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240181", "people": [{"name": "Gaurav Luthra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240181%22"}, {"id": "fda:K240379", "company": "Church & Dwight Co., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240379: TROJAN SIS Synthetic Latex Condom with Silicone Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240379", "people": [{"name": "Lori Barr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240379%22"}, {"id": "fda:K242014", "company": "Meta Biomed Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242014: Jet Flow Bulk", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242014", "people": [{"name": "Suk Song Oh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242014%22"}, {"id": "fda:K240563", "company": "ZheJiang J&J Mobility Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240563: Power Wheelchair (JJW-6001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240563", "people": [{"name": "Cheng Linda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240563%22"}, {"id": "fda:K242267", "company": "ZheJiang Decans Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242267: Gemini Medical Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242267", "people": [{"name": "Haifeng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242267%22"}, {"id": "fda:K241446", "company": "Sichuan Qianii-Beoka Medical Technoiogy Lnc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241446: Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241446", "people": [{"name": "Zeng Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241446%22"}, {"id": "fda:K240640", "company": "Sejoy Biomedical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240640: Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240640", "people": [{"name": "Yinting Lan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240640%22"}, {"id": "fda:DEN230076", "company": "Omron Healthcare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230076: Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230076", "people": [{"name": "Terri Ingalls", "role": "510(k) submission contact"}]}, {"id": "fda:K242826", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242826: ProLift Wedge Expandable Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242826", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242826%22"}, {"id": "fda:K241756", "company": "Theranica Bio-Electronics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241756: Nerivio; NerivioInfinity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241756", "people": [{"name": "Alon Ironi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241756%22"}, {"id": "fda:K240167", "company": "Hunan Vathin Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240167: Single-use Ureteral Access Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240167", "people": [{"name": "Jing Du", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240167%22"}, {"id": "fda:K242391", "company": "Lucens Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242391: Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242391", "people": [{"name": "Kari Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242391%22"}, {"id": "denovo:DEN230076", "company": "Omron Healthcare, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-10-08", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230076 granted: Omron Blood Pressure Monitor with Atrial", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230076"}, {"id": "fda:K240980", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240980: EPIQ Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240980", "people": [{"name": "Michael Chambers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240980%22"}, {"id": "fda:K241029", "company": "Verdure Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241029: SpineUs\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241029", "people": [{"name": "Christopher Schlenger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241029%22"}, {"id": "fda:DEN240029", "company": "Healgen", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240029: Healgen Rapid Check COVID-19/Flu A&B Antigen Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240029", "people": [{"name": "Bingliang Fang", "role": "510(k) submission contact"}]}, {"id": "fda:K242084", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242084: EMPHASYS Acetabular Shell with RapiTite HA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242084", "people": [{"name": "Elaine Pears", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242084%22"}, {"id": "fda:K242357", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242357: Water Container (MAJ-901); Water Container (MAJ-902)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242357", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242357%22"}, {"id": "fda:K240843", "company": "Climbing Steps, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240843: GENESIS (MS-P02-GEN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240843", "people": [{"name": "Barry Fink", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240843%22"}, {"id": "fda:K242457", "company": "Retropsoas Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242457: EARP Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242457", "people": [{"name": "Nicholas Poulos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242457%22"}, {"id": "fda:K242746", "company": "Overture Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242746: OvertureTi Knee Resurfacing SystemTM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242746", "people": [{"name": "Jonathan Nielsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242746%22"}, {"id": "fda:K242208", "company": "Primed Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242208: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242208", "people": [{"name": "Mitra Fard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242208%22"}, {"id": "fda:K242375", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242375: OR3O Dual Mobility System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242375", "people": [{"name": "Dana Hartlein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242375%22"}, {"id": "fda:K242152", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242152: SMARTeZ\u0099 Elastomeric Infusion Pump (498111, 498121, 498131, 498141)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242152", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242152%22"}, {"id": "fda:K240485", "company": "Huizhou Foryou Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240485: LUOFUCON\u00ae Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON\u00ae Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240485", "people": [{"name": "Li Jiaqi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240485%22"}, {"id": "fda:K242693", "company": "Deka Research and Development Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242693: DEKA Infusion System, DEKA Administration Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242693", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242693%22"}, {"id": "denovo:DEN240029", "company": "Healgen", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-10-07", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240029 granted: Healgen Rapid Check COVID-19/Flu A&B Ant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240029"}, {"id": "fda:K242445", "company": "Stryker GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242445: Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242445", "people": [{"name": "Ashley Allison", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242445%22"}, {"id": "fda:K242343", "company": "Orthonovis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242343: BPS Wrist Fracture System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242343", "people": [{"name": "Kenneth West", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242343%22"}, {"id": "fda:K242364", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242364: IdentiTi\u0099 II Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242364", "people": [{"name": "Sandy Gill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242364%22"}, {"id": "fda:K241052", "company": "Advamedix, GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241052: Bladeless Trocar; Bladed Trocar; Hasson Trocar", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241052", "people": [{"name": "Islam Abed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241052%22"}, {"id": "fda:K242351", "company": "Zeta Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242351: Zeta Cranial Navigation System (ZNS131-US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242351", "people": [{"name": "Raahil Sha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242351%22"}, {"id": "fda:K241245", "company": "Echo IQ, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241245: EchoSolv AS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241245", "people": [{"name": "Dane Brescacin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241245%22"}, {"id": "fda:K242106", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242106: AuST Steerable Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242106", "people": [{"name": "Conner Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242106%22"}, {"id": "fda:K241854", "company": "Anhui Jbh Medical Apparatus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241854: Power Wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241854", "people": [{"name": "Yuanwei Wei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241854%22"}, {"id": "fda:K240553", "company": "Dia Imaging Analysis, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240553: LVivo Software Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240553", "people": [{"name": "Michal Yaacobi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240553%22"}, {"id": "fda:K240376", "company": "Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240376: Electroporation System (N3000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240376", "people": [{"name": "Guofang Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240376%22"}, {"id": "fda:K242671", "company": "Treace Medical Concepts, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242671: Treace Medical Concepts (TMC) Screw Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242671", "people": [{"name": "Melissa Coloroso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242671%22"}, {"id": "fda:K242721", "company": "Shenzhen Finicare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242721: Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242721", "people": [{"name": "Li Chao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242721%22"}, {"id": "fda:K241746", "company": "United Medical Resources, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241746: UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241746", "people": [{"name": "Chase Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241746%22"}, {"id": "fda:K241434", "company": "Hunan Vathin Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241434: Video Ureteroscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241434", "people": [{"name": "Jing Du", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241434%22"}, {"id": "fda:K242652", "company": "Lunit, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242652: Lunit INSIGHT DBT v1.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242652", "people": [{"name": "Suhyoung Bahk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242652%22"}, {"id": "fda:K242679", "company": "Fengh Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242679: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242679", "people": [{"name": "Jiao Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242679%22"}, {"id": "fda:K242325", "company": "Actuated Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242325: GripTract-GI Endoscopic Tissue Manipulator Lower GI Models", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242325", "people": [{"name": "Douglas Dillon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242325%22"}, {"id": "fda:K240675", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240675: Endoscopic Injection Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240675", "people": [{"name": "Yang Zearou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240675%22"}, {"id": "fda:K241869", "company": "Vivachek Biotech (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241869: BioSieve\u0099 Fentanyl FIA Home Test Kit; BioSieve\u0099 Fentanyl FIA Pro Test Kit; BioSieve\u0099 Toxismart Reader", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241869", "people": [{"name": "Max Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241869%22"}, {"id": "fda:K240074", "company": "Shenzhen Besdata Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240074: Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240074", "people": [{"name": "Xiaohong Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240074%22"}, {"id": "fda:K241796", "company": "TroCare, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241796: TroCare TroKit Laparoscope Lens Wiper (CP000626)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241796", "people": [{"name": "Kenneth Kleinhenz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241796%22"}, {"id": "fda:K241298", "company": "Eventum Orthopaedics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241298: QUADSENSE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241298", "people": [{"name": "John Naybour", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241298%22"}, {"id": "sbir:DOD:HT9425-25-P-0008", "company": "Corvid Technologies, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-10-04", "observed": "2026-09-18", "amount_usd": 249996, "summary": "DOD SBIR Phase I award $249,996: Robotic End-Effector for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H242-002-0039"}, {"id": "fda:K242660", "company": "Zevex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242660: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242660", "people": [{"name": "Santosh Bhagat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242660%22"}, {"id": "fda:K240393", "company": "Exactech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240393: Exactech\u00ae TRULIANT\u00ae Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240393", "people": [{"name": "Liz Howell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240393%22"}, {"id": "fda:K242507", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242507: OBSIDIO\u0099 Conformable Embolic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242507", "people": [{"name": "Heidi Shearer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242507%22"}, {"id": "fda:K241977", "company": "Longly Biotechnology (Wuhan) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241977: Injectable Root Canal Bioceramic Sealer (i-MTA SP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241977", "people": [{"name": "Liang Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241977%22"}, {"id": "fda:K240586", "company": "Hangzhou Thales Medtech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240586: Additive Manufacturing Zirconia Customized Restoration", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240586", "people": [{"name": "Wang Shuo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240586%22"}, {"id": "fda:K240808", "company": "Hunan Accurate Bio-Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240808: Pulse Oximeter (WS20A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240808", "people": [{"name": "Li Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240808%22"}, {"id": "fda:K241472", "company": "Corin U.S.A. Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241472: Icona Hip Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241472", "people": [{"name": "Aaron Brunt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241472%22"}, {"id": "fda:K242616", "company": "Orthalign, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242616: Lantern\u00ae Hip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242616", "people": [{"name": "Karyl Haskell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242616%22"}, {"id": "fda:K233497", "company": "Somnomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233497: Rest Assure System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233497", "people": [{"name": "Ty Cowart", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233497%22"}, {"id": "pma:P230043", "company": "Exact Sciences Corporation", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230043: Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230043", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230043%22"}, {"id": "fda:K241925", "company": "Perspectum, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241925: VitruvianScan (v1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241925", "people": [{"name": "Bhaskar Chikkanna", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241925%22"}, {"id": "fda:K241561", "company": "Therapixel", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241561: MammoScreen BD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241561", "people": [{"name": "Quentin De Snoeck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241561%22"}, {"id": "fda:K242302", "company": "Collagen Matrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242302: RejuvaKnee\u0099 Collagen Meniscus Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242302", "people": [{"name": "Devin Dragon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242302%22"}, {"id": "fda:K242005", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242005: Versana Premier; Versana Premier Lotus; LOGIQ F", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242005", "people": [{"name": "Lee Bush", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242005%22"}, {"id": "fda:K241487", "company": "Foundation Surgical Group, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241487: Interwedge\u00ae Standalone Lateral", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241487", "people": [{"name": "Asher Breverman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241487%22"}, {"id": "fda:K240529", "company": "Route 92 Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240529: 8F Modified Sheath System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240529", "people": [{"name": "Kirsten Valley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240529%22"}, {"id": "fda:K241907", "company": "Momentis Surgical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241907: Anovo Surgical System (model 6N)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241907", "people": [{"name": "Maya Leib Shlomo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241907%22"}, {"id": "fda:K240889", "company": "Artfx Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240889: ARTFX Lumbar PEEK Cages", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240889", "people": [{"name": "Ozgen Ozfidan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240889%22"}, {"id": "fda:K240153", "company": "Liaoning Upcera Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240153: Ceramic Etchant (HF-5 and HF-9)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240153", "people": [{"name": "Li Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240153%22"}, {"id": "fda:K242377", "company": "Osteoremedies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242377: REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242377", "people": [{"name": "Eric Stookey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242377%22"}, {"id": "fda:K242613", "company": "Luminex Molecular Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242613: NxTAG\u00ae Respiratory Pathogen Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242613", "people": [{"name": "Tara Vivian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242613%22"}, {"id": "fda:K241097", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241097: Arthrex Virtual Implant Positioning (VIP) System Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241097", "people": [{"name": "Troy Brooks", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241097%22"}, {"id": "fda:K241331", "company": "Springbok, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241331: MuscleView", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241331", "people": [{"name": "Scott Magargee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241331%22"}, {"id": "fda:K242277", "company": "Sprintray, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242277: Crown HT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242277", "people": [{"name": "Sara Moghtadernejad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242277%22"}, {"id": "fda:K240917", "company": "Wallaby Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240917: Esperance 3+ Aspiration Catheter System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240917", "people": [{"name": "Rachel McDaid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240917%22"}, {"id": "fda:K242498", "company": "Aicheck Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242498: Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242498", "people": [{"name": "Lisa Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242498%22"}, {"id": "fda:K240943", "company": "Bodyvision Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240943: LungVision", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240943", "people": [{"name": "Benny Krauz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240943%22"}, {"id": "fda:K240331", "company": "Yongkang Youha Electric Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240331: Electric wheelchair (YHWL002, YHWL003)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240331", "people": [{"name": "Yongbo Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240331%22"}, {"id": "fda:K241285", "company": "Alton (Shanghai) Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241285: Disposable Endoscope Valves Set (AF series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241285", "people": [{"name": "Johnny Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241285%22"}, {"id": "fda:K242651", "company": "Samsung Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242651: GM85", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242651", "people": [{"name": "Jaesang Noh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242651%22"}, {"id": "fda:K241967", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241967: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241967", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241967%22"}, {"id": "fda:K242678", "company": "Ge Hualun Medical Systems Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-10-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242678: Definium Pace Select ET", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242678", "people": [{"name": "Kenny Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242678%22"}, {"id": "fda:K241151", "company": "Dentalmax Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241151: LUXEN 5G", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241151", "people": [{"name": "Eunju Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241151%22"}, {"id": "fda:K241836", "company": "Kem Medical Products Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241836: Kem Medical Lead-free Chemical Indicators for Steam Sterilization", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241836", "people": [{"name": "Lisa Kruger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241836%22"}, {"id": "fda:K241317", "company": "Guangzhou Wondfo Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241317: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241317", "people": [{"name": "Xiao Kaiyu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241317%22"}, {"id": "fda:K241657", "company": "Mikron Makina Sanayi VE Ticaret Ltd. Sti.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241657: MSFX MIKRON SPINAL FIXATION SYSTEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241657", "people": [{"name": "Mustafa Ekiz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241657%22"}, {"id": "fda:K241952", "company": "Procept Biorobotics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241952: AQUABEAM Robotic System (AB2000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241952", "people": [{"name": "Sara Muddell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241952%22"}, {"id": "fda:DEN230011", "company": "Recensmedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230011: OcuCool", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230011", "people": [{"name": "Gun-Ho Kim", "role": "510(k) submission contact"}]}, {"id": "fda:K242154", "company": "MicroPort NeuroTech (Shanghai) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242154: Numen\u0099 Coil Embolization System; NumenFR\u0099 Detachment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242154", "people": [{"name": "Yuying Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242154%22"}, {"id": "fda:K242276", "company": "Vantis Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242276: CrossFAST\u0099 Integrated Microcatheter Guide Extension System (CFM55)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242276", "people": [{"name": "Angela Thompson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242276%22"}, {"id": "fda:K210933", "company": "Ysi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K210933: YSI 2900C Biochemistry Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210933", "people": [{"name": "Eric Lute", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K210933%22"}, {"id": "denovo:DEN230011", "company": "Recensmedical, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-09-30", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230011 granted: OcuCool", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230011"}, {"id": "fda:K241939", "company": "Resmed Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241939: EasyCare Tx 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241939", "people": [{"name": "Prerana Gurubasavaraj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241939%22"}, {"id": "fda:K233446", "company": "Amc Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233446: AMC Health CareConsole", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233446", "people": [{"name": "Hernani Castro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233446%22"}, {"id": "fda:K242213", "company": "Shockwave Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242213: Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242213", "people": [{"name": "Shira Stone", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242213%22"}, {"id": "fda:K242582", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242582: Optima Coil System (OptiBlock Line Extension)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242582", "people": [{"name": "Kavita Chandrashekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242582%22"}, {"id": "fda:DEN240017", "company": "Pi-Cardia, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240017: ShortCut", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240017", "people": [{"name": "Hadas Givon", "role": "510(k) submission contact"}]}, {"id": "fda:K242206", "company": "Daeju Meditech Engineering Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242206: ACTIVO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242206", "people": [{"name": "Kim Seongun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242206%22"}, {"id": "fda:K242125", "company": "Chiaro Technology, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242125: Elvie Stride 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242125", "people": [{"name": "Amelia Ortiz Rios", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242125%22"}, {"id": "fda:K241513", "company": "Brain Electrophysiology Laboratory Company, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241513: Sourcerer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241513", "people": [{"name": "Phan Luu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241513%22"}, {"id": "fda:K240993", "company": "Ait Austrian Institute of Technology GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240993: encevis (2.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240993", "people": [{"name": "Tilmann Kluge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240993%22"}, {"id": "fda:K241933", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241933: HIGHERDOSE Red and Infrared Light Mask (MK66-L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241933", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241933%22"}, {"id": "fda:K242557", "company": "Inari Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242557: ClotTriever XL Catheter (41-102)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242557", "people": [{"name": "Kaitlyn Weinkauf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242557%22"}, {"id": "fda:K240369", "company": "BunkerHill Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240369: CAC (gated) Algorithm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240369", "people": [{"name": "Nishith Khandwala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240369%22"}, {"id": "fda:K240220", "company": "Taiwan Aulisa Medical Devices Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240220: Aulisa Temperature Module (TM0002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240220", "people": [{"name": "Jou An Hsu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240220%22"}, {"id": "fda:K241909", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241909: Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241909", "people": [{"name": "Caitlin Senter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241909%22"}, {"id": "fda:K241480", "company": "JLK, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241480: JBS-LVO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241480", "people": [{"name": "Kim Dongmin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241480%22"}, {"id": "fda:K241447", "company": "Icare Finland OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241447: iCare ST500 (TA04)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241447", "people": [{"name": "Hannes Hyv\u00f6nen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241447%22"}, {"id": "fda:K240163", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240163: Hudson RCI\u00ae Comfort Flo Nasal Cannula; Hudson RCI\u00ae Comfort Flo Plus Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240163", "people": [{"name": "Sirisha Kommana", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240163%22"}, {"id": "fda:K242540", "company": "Hangzhou AllTest Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242540: AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242540", "people": [{"name": "Rosa Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242540%22"}, {"id": "fda:K241536", "company": "Nanosonics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241536: trophon Wireless Ultrasound Probe Holder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241536", "people": [{"name": "Nancy Kaiser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241536%22"}, {"id": "fda:K242571", "company": "Hyundae Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242571: Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242571", "people": [{"name": "Oh Ju-in", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242571%22"}, {"id": "fda:K241916", "company": "Optmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241916: TearRepair Liquid Skin Protectant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241916", "people": [{"name": "Nitasha Yajnik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241916%22"}, {"id": "fda:K240745", "company": "Westridge Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240745: ID Free Personal Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240745", "people": [{"name": "Gregg Haskell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240745%22"}, {"id": "denovo:DEN240017", "company": "Pi-Cardia, Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-09-27", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240017 granted: ShortCut", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240017"}, {"id": "breakthrough:DEN240017", "company": "Pi-cardia, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-09-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN240017: SHORTCUT", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44FD007584-03", "company": "Triple Ring Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": 750000, "summary": "NIH award 5R44FD007584-03: Virtual dose mapping for radiation sterilization ($750,000)", "source_url": "https://reporter.nih.gov/project-details/10938614", "people": [{"name": "TOBIAS FUNK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL166025-03", "company": "Eko Devices, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": 1108862, "summary": "NIH award 5R44HL166025-03: Deep learning for algorithmic detection of pulmonary hypertension using a combined digital stethoscope and single-lead electrocardiogram ($1,108,862)", "source_url": "https://reporter.nih.gov/project-details/10930932", "people": [{"name": "Gaurav Choudhary", "role": "Principal Investigator"}, {"name": "George Mathew", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44FD007588-03", "company": "Sonata Scientific, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": 919218, "summary": "NIH award 5R44FD007588-03: Reduced EtO emissions to safeguard biomedical supply chains ($919,218)", "source_url": "https://reporter.nih.gov/project-details/10930699", "people": [{"name": "Melissa A Petruska", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K241341", "company": "Fujifilm Irvine Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241341: cryo-GO Vitrification Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241341", "people": [{"name": "Cindy Kha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241341%22"}, {"id": "fda:K241895", "company": "Spineguard", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241895: Cannulated PsiFGuard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241895", "people": [{"name": "Stephane Bette", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241895%22"}, {"id": "fda:K241815", "company": "Skeletal Dynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241815: Protean Fragment Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241815", "people": [{"name": "Alexandra Rodriguez Rojas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241815%22"}, {"id": "fda:K241414", "company": "Circa Scientific, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241414: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241414", "people": [{"name": "Jennifer Willner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241414%22"}, {"id": "fda:K241101", "company": "Biointellisense, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241101: BioButton System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241101", "people": [{"name": "Yusi Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241101%22"}, {"id": "fda:K241147", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241147: Any-Com", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241147", "people": [{"name": "Priscilla Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241147%22"}, {"id": "fda:K241651", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241651: Affixus Tibial and Antegrade Femoral Nailing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241651", "people": [{"name": "Akash Savalia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241651%22"}, {"id": "fda:K241027", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241027: Permatage Settable Bone Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241027", "people": [{"name": "Schrayer Howard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241027%22"}, {"id": "fda:K241216", "company": "Resmed Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241216: myAir", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241216", "people": [{"name": "Rose Malonzo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241216%22"}, {"id": "fda:K241827", "company": "Canyon Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241827: Microwave Ablation Generator (KY-2000A, KY-2100A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241827", "people": [{"name": "Huiqi Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241827%22"}, {"id": "fda:K242632", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242632: Verifine\u00ae Pen Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242632", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242632%22"}, {"id": "fda:K240854", "company": "Accelerate Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240854: Accelerate Arc System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240854", "people": [{"name": "Jack Phillips", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240854%22"}, {"id": "fda:K234149", "company": "Molli Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234149: MOLLI 2 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234149", "people": [{"name": "Joseph De Croos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234149%22"}, {"id": "pma:P230005", "company": "Motiva USA, LLC", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230005: Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230005", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230005%22"}, {"id": "nih:1R43GM153742-01", "company": "Zeteo Tech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": 271495, "summary": "NIH award 1R43GM153742-01: High Mass MALDI TOF Employing a Novel High-Tc Superconducting Ion Detector ($271,495)", "source_url": "https://reporter.nih.gov/project-details/10822274", "people": [{"name": "VADYM D BERKOUT", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG084385-01A1", "company": "Clear Session, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": 499796, "summary": "NIH award 1R43AG084385-01A1: Personalized visualization tool to improve communication between clinicians, Latinos with ADRD, and their care partners ($499,796)", "source_url": "https://reporter.nih.gov/project-details/10918538", "people": [{"name": "Carl Haacke", "role": "Principal Investigator"}, {"name": "Rafael Samper-Ternent", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HG013911-01", "company": "Xgenomes Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": 384418, "summary": "NIH award 1R43HG013911-01: Super-resolution single-molecule sequencing by observing the dynamic hybridization of a repertoire of oligonucleotides to DNA targets ($384,418)", "source_url": "https://reporter.nih.gov/project-details/11008187", "people": [{"name": "Kalim Ullah Mir", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K242273", "company": "SeaSpine Orthopedics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242273: Cove Putty, OsteoCove Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242273", "people": [{"name": "Patrick Hughes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242273%22"}, {"id": "fda:K241535", "company": "ShenB Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241535: Vybe RF II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241535", "people": [{"name": "Sunny Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241535%22"}, {"id": "fda:K242299", "company": "Novabone Products, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242299: NovaBone Putty - Synthetic Bioactive Bone Graft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242299", "people": [{"name": "Ed Horton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242299%22"}, {"id": "fda:K242075", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242075: Indigo\u00ae Aspiration System \u0096 Lightning Bolt Aspiration Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242075", "people": [{"name": "Nikita Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242075%22"}, {"id": "fda:K242204", "company": "Dongguan Quanding Medical Supplies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242204: Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242204", "people": [{"name": "Grace Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242204%22"}, {"id": "fda:K241860", "company": "Beijing Winkonlaser Technology Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241860: Diode Laser Hair Removal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241860", "people": [{"name": "Jingya Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241860%22"}, {"id": "fda:K240041", "company": "Abionic SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240041: IVD CAPSULE PSP; abioSCOPE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240041", "people": [{"name": "Iwan M\u00e4rki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240041%22"}, {"id": "fda:K240434", "company": "Li Medical Corporation , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240434: RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240434", "people": [{"name": "Jago Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240434%22"}, {"id": "fda:K240042", "company": "Molli Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240042: MOLLI 2 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240042", "people": [{"name": "Joseph De Croos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240042%22"}, {"id": "nih:2R44TR003071-02A1", "company": "Insightfil", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": 677228, "summary": "NIH award 2R44TR003071-02A1: Personalized multi-medication packaging with integrated real-time instrumentation to improve adherence ($677,228)", "source_url": "https://reporter.nih.gov/project-details/11006411", "people": [{"name": "Edward Acworth", "role": "Principal Investigator"}, {"name": "Kimberly Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44AG071034-03A1", "company": "Active Life Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": 1716342, "summary": "NIH award 2R44AG071034-03A1: Measuring Whole and Tissue Level Bone Strength in men ($1,716,342)", "source_url": "https://reporter.nih.gov/project-details/10822362", "people": [{"name": "Peter Burks", "role": "Principal Investigator"}, {"name": "Simon Yue-Cheong Tang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AG084395-01A1", "company": "Vest Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": 947810, "summary": "NIH award 1R44AG084395-01A1: Mobius Accessibility Mounting System and Assistive Technology Product Line to Support Independence and Safety for Older Adults and Persons with Disabilities ($947,810)", "source_url": "https://reporter.nih.gov/project-details/11007733", "people": [{"name": "Chris Chovan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG072981-02A1", "company": "Amissa, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": 1419714, "summary": "NIH award 2R44AG072981-02A1: Empowering Advanced Alzheimers Disease and Dementia Research Through Remote Patient Monitoring and Cloud-Connected Wearable Devices ($1,419,714)", "source_url": "https://reporter.nih.gov/project-details/10922009", "people": [{"name": "Jon Andrew Corkey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44AG077737-02", "company": "Hido Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": 1243618, "summary": "NIH award 2R44AG077737-02: Preventing Medication Mismanagement in People Living with Dementia through Automated Medication Dispensing with Facial Recognition and Video Observation ($1,243,618)", "source_url": "https://reporter.nih.gov/project-details/11003943", "people": [{"name": "NEELUM T. AGGARWAL", "role": "Principal Investigator"}, {"name": "Charles Gellman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44AR080507-02", "company": "Apex Orthopaedic Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": 1238710, "summary": "NIH award 2R44AR080507-02: R-FIX (Rib-FIXation) Spinal Growth System for Early-onset Spinal Deformity ($1,238,710)", "source_url": "https://reporter.nih.gov/project-details/11013594", "people": [{"name": "Daniel James Bonthius", "role": "Principal Investigator"}, {"name": "Richard H. Gross", "role": "Principal Investigator"}, {"name": "Hai Yao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG084379-01A1", "company": "Synaptic Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": 499386, "summary": "NIH award 1R43AG084379-01A1: A novel closed-loop feedback neuromodulation system for improving slow wave sleep in Alzheimer's disease patients ($499,386)", "source_url": "https://reporter.nih.gov/project-details/10913009", "people": [{"name": "Brian Krohn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG082596-01A1", "company": "B A Maze, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": 405614, "summary": "NIH award 1R43AG082596-01A1: Connection, Independence, and Circular Support: Prompted Health Awareness Enabled by the At-Home Health Station ($405,614)", "source_url": "https://reporter.nih.gov/project-details/10922026", "people": [{"name": "Robert Mazur", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL174376-01", "company": "Heartlung Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": 294023, "summary": "NIH award 1R43HL174376-01: AutoChamber: an FDA-Designated Breakthrough AI Add-on to Coronary Artery Calcium and Lung Cancer Screening CT Scans to Flag Patients at High Risk of Atrial Fibrillation, Stroke and Heart Failure ($294,023)", "source_url": "https://reporter.nih.gov/project-details/10922647", "people": [{"name": "MORTEZA NAGHAVI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG087866-01", "company": "3D Bioanalytix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": 472695, "summary": "NIH award 1R41AG087866-01: Development of a blood-based test for neurodegenerative diseases ($472,695)", "source_url": "https://reporter.nih.gov/project-details/10922630", "people": [{"name": "Sandra Pankow", "role": "Principal Investigator"}, {"name": "John R Yates III", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG085838-01A1", "company": "Weinberg Medical Physics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": 100000, "summary": "NIH award 1R41AG085838-01A1: Treating Balance Impairment of the Elderly with TMS-induced Brain Connectivity ($100,000)", "source_url": "https://reporter.nih.gov/project-details/10919977", "people": [{"name": "Pranav J Parikh", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240776", "company": "Endocision Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240776: Celsio Flexible Cryocatheter System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240776", "people": [{"name": "Anthony Sirgi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240776%22"}, {"id": "fda:K234134", "company": "Resmed Pty Ltd (Registration Number: 3004604967)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234134: AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234134", "people": [{"name": "Shu-Ying Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234134%22"}, {"id": "fda:K240236", "company": "Happy Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240236: Happy Ring Health Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240236", "people": [{"name": "Dustin Freckleton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240236%22"}, {"id": "fda:K233807", "company": "Vy Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233807: LumiVy\u0099 Lumbar IBF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233807", "people": [{"name": "Jordan Hendrickson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233807%22"}, {"id": "fda:K242070", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242070: Ion Endoluminal System (IF 1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242070", "people": [{"name": "Farzin Bolourchian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242070%22"}, {"id": "fda:K242292", "company": "Shanghai United Imaging Intelligence Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242292: uAI Easy Triage ICH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242292", "people": [{"name": "Zhao Xiaojing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242292%22"}, {"id": "fda:K241874", "company": "Hobbs Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241874: Aspiration Catheter (2189)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241874", "people": [{"name": "John M. Kirwan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241874%22"}, {"id": "nih:1R44CA291336-01A1", "company": "Teal Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-23", "observed": "2026-08-21", "amount_usd": 1114893, "summary": "NIH award 1R44CA291336-01A1: Evaluation of the Teal self-collect device for cervical cancer screening ($1,114,893)", "source_url": "https://reporter.nih.gov/project-details/11008315", "people": [{"name": "Trena Depel", "role": "Principal Investigator"}, {"name": "Megan Fitzpatrick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K240243", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240243: EConsole2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240243", "people": [{"name": "An Yeong-suk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240243%22"}, {"id": "fda:K241570", "company": "Corin U.S.A. Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241570: Unity Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241570", "people": [{"name": "De Paoli Marine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241570%22"}, {"id": "fda:K240013", "company": "Ultromics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240013: EchoGo Heart Failure (2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240013", "people": [{"name": "Elena Traistaru", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240013%22"}, {"id": "fda:K241834", "company": "Shenzhen Yang WO Electronic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241834: IPL Hair Removal Device (BE932C, BE932D, BE932E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241834", "people": [{"name": "Ken Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241834%22"}, {"id": "nih:1R43MD020015-01", "company": "Renalis Health Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-22", "observed": "2026-08-21", "amount_usd": 306968, "summary": "NIH award 1R43MD020015-01: Cultural Adaptation of a Digital Overactive Bladder Behavioral Therapy for the U.S. Latina Population ($306,968)", "source_url": "https://reporter.nih.gov/project-details/11008437", "people": [{"name": "Yufan Brandon Chen", "role": "Principal Investigator"}, {"name": "Jesse Nodora", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MD019611-01", "company": "Pavmed Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-22", "observed": "2026-08-21", "amount_usd": 892112, "summary": "NIH award 1R44MD019611-01: Bridging the Gap: Enhancing Cancer Care for Underserved Populations with the Veris Health Cancer Care Platform ($892,112)", "source_url": "https://reporter.nih.gov/project-details/10919645", "people": [{"name": "Brian deGuzman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD018218-01A1", "company": "Advanced Medical Electronics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-21", "observed": "2026-08-21", "amount_usd": 5080, "summary": "NIH award 1R43MD018218-01A1: Ring wearable sensor use for diagnosis and monitoring of Parkinson's disease in underserved rural populations ($5,080)", "source_url": "https://reporter.nih.gov/project-details/10813912", "people": [{"name": "GARY D HAVEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD018950-01A1", "company": "Million Marker Wellness Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-21", "observed": "2026-08-21", "amount_usd": 272365, "summary": "NIH award 1R43MD018950-01A1: Development of an Environmental Health Literacy Mobile Application to Reduce Toxic Environmental Exposures in Black Communities ($272,365)", "source_url": "https://reporter.nih.gov/project-details/10921362", "people": [{"name": "Jenna Hua", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL176288-01", "company": "Circulatech LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-21", "observed": "2026-08-21", "amount_usd": 392119, "summary": "NIH award 1R41HL176288-01: Proactive Dual-Irrigation Cardiac Chest Tube to Maintain Postoperative Patency ($392,119)", "source_url": "https://reporter.nih.gov/project-details/11007859", "people": [{"name": "Jake Pistiner", "role": "Principal Investigator"}, {"name": "Cory Michael Tschabrunn", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA287615-01A1", "company": "Averto Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": 838162, "summary": "NIH award 1R44CA287615-01A1: Safety and Efficacy Trial of the ColoSeal ICD System for the Treatment of Rectal Cancer Patients ($838,162)", "source_url": "https://reporter.nih.gov/project-details/11007069", "people": [{"name": "Kenton Dodyan Fong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL169034-01A1", "company": "3dt Holdings, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": 480989, "summary": "NIH award 1R44HL169034-01A1: Software-guided Operative Planning of MitraClip Placement ($480,989)", "source_url": "https://reporter.nih.gov/project-details/10820659", "people": [{"name": "Julius Matteo Guccione", "role": "Principal Investigator"}, {"name": "GHASSAN S KASSAB", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41NS134425-01A1", "company": "Von Medical, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": 693385, "summary": "NIH award 1R41NS134425-01A1: Development of a Novel Aspiration Pump for Neurointerventional Procedures ($693,385)", "source_url": "https://reporter.nih.gov/project-details/10915784", "people": [{"name": "Manning Hanser", "role": "Principal Investigator"}, {"name": "Robert Michael Starke", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42CA295106-01", "company": "Xanthoshealth, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": 954983, "summary": "NIH award 1R42CA295106-01: ConnectedNest: a digital platform connecting individuals with cancer to social care ($954,983)", "source_url": "https://reporter.nih.gov/project-details/11003527", "people": [{"name": "David A Haynes", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG063589-02", "company": "Tymora Analytical Operations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": 815028, "summary": "NIH award 2R44AG063589-02: Validation and clinicaldevelopment of plasma EV protein biomarkers for minimally-invasive detection of Alzheimersdisease ($815,028)", "source_url": "https://reporter.nih.gov/project-details/10819738", "people": [{"name": "Anton Iliuk", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44EY034410-02", "company": "Praevium Research, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": 774486, "summary": "NIH award 4R44EY034410-02: Swept source retinal visible optical coherence tomography using broadly tunable frequency doubling of NIR MEMS-VCSELs ($774,486)", "source_url": "https://reporter.nih.gov/project-details/11130993", "people": [{"name": "Vijaysekhar Jayaraman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R42CA261376-02A1", "company": "Capsulomics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": 885000, "summary": "NIH award 2R42CA261376-02A1: An accurate, affordable, and transferable assay for minimally invasive detection of esophageal squamous cell carcinoma (ESCC) in Africa and the United States ($885,000)", "source_url": "https://reporter.nih.gov/project-details/10921933", "people": [{"name": "Sarah Laun", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA291290-01", "company": "Early Is Good Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": 821797, "summary": "NIH award 1R44CA291290-01: Multiplex and multi-omic diagnostic test for bladder cancer recurrence ($821,797)", "source_url": "https://reporter.nih.gov/project-details/10918479", "people": [{"name": "Thakshila Liyanage", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL172473-01", "company": "Cerulean Scientific Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": 297732, "summary": "NIH award 1R44HL172473-01: Slippery, Omniphobic Coating to Prevent Thrombosis and Biofilm Formation on Peripheral Vascular Grafts ($297,732)", "source_url": "https://reporter.nih.gov/project-details/10822370", "people": [{"name": "Todd McFarland", "role": "Principal Investigator"}, {"name": "Daniel Durant Myers", "role": "Principal Investigator"}, {"name": "Andrea Tara Obi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K241880", "company": "Nakanishi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241880: Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241880", "people": [{"name": "Kikuchi Masaaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241880%22"}, {"id": "fda:K240604", "company": "M&t S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240604: MTONE EVO (MTONE EVO)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240604", "people": [{"name": "Fiorenzo Rossi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240604%22"}, {"id": "fda:K242504", "company": "Perfuze, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242504: Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242504", "people": [{"name": "Anne-Marie Gannon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242504%22"}, {"id": "fda:K234129", "company": "Ecomed Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234129: Ecomed Disposable Administration Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234129", "people": [{"name": "David Yurek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234129%22"}, {"id": "fda:K242223", "company": "Supersonic Imagine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242223: SuperSonic HepaVu", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242223", "people": [{"name": "Charlotte Turc", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242223%22"}, {"id": "fda:K241332", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241332: aprevo\u00ae anterior and lateral lumbar interbody fusion device; aprevo\u00ae anterior lumbar interbody fusion devices with interfixation; aprevo\u00ae transforaminal lumbar interbody fusion device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241332", "people": [{"name": "Karen Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241332%22"}, {"id": "fda:K233153", "company": "Saeshin Precision Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233153: Traus SSG10 Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233153", "people": [{"name": "Gung San Nam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233153%22"}, {"id": "fda:K241821", "company": "Sol-Millennium Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241821: Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241821", "people": [{"name": "Manu Kalia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241821%22"}, {"id": "fda:K240420", "company": "Neurofield, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240420: NeuroField Analysis Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240420", "people": [{"name": "Nicholas Dogris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240420%22"}, {"id": "fda:K242650", "company": "Zygofix , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242650: zLOCK Lumbar Facet Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242650", "people": [{"name": "Levy Ofer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242650%22"}, {"id": "fda:K232670", "company": "MEZOO Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232670: HiCardi+ H100", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232670", "people": [{"name": "Junghwan Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232670%22"}, {"id": "fda:K242147", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242147: Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242147", "people": [{"name": "Unnati Bhuptani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242147%22"}, {"id": "fda:K241825", "company": "Canyon Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241825: Microwave Ablation Antennas", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241825", "people": [{"name": "Huiqi Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241825%22"}, {"id": "fda:K234108", "company": "Energy Resources International Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234108: ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234108", "people": [{"name": "Pearl Tsai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234108%22"}, {"id": "fda:K240061", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240061: TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240061", "people": [{"name": "Kayla Franklin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240061%22"}, {"id": "fda:K240722", "company": "Raya Pharmaceuticals, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240722: Derma-R Cream (Derma-R Cream)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240722", "people": [{"name": "Parikh Ankur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240722%22"}, {"id": "fda:K240036", "company": "Piur Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240036: PIUR tUS Infinity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240036", "people": [{"name": "Milos Stojanovic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240036%22"}, {"id": "nih:2R44GM137688-02", "company": "Abterra Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": 856396, "summary": "NIH award 2R44GM137688-02: REPTOR: accelerating antibody discovery and improving hits with machine learning ($856,396)", "source_url": "https://reporter.nih.gov/project-details/10822485", "people": [{"name": "Natalie Castellana", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA291564-01", "company": "Voximetry, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": 1003632, "summary": "NIH award 1R44CA291564-01: Torch Recon: An Innovative Reconstruction Software for Increased Throughput and Improved Low-Count Quantitative SPECT Imaging ($1,003,632)", "source_url": "https://reporter.nih.gov/project-details/10922106", "people": [{"name": "Joseph Grudzinski", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41NR021628-01", "company": "Inovcares Connected Comprehensive Healthcare Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": 360358, "summary": "NIH award 1R41NR021628-01: Efficacy of a culturally-sensitive telehealth platform in fostering community-based care coordination for respectful maternal mental health ($360,358)", "source_url": "https://reporter.nih.gov/project-details/10821967", "people": [{"name": "Mohamed A Kamara", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK139895-01A1", "company": "Biomedinnovations, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": 1870135, "summary": "NIH award 1R44DK139895-01A1: Platform for Extended Kidney Preservation Via Subnormothermic Perfusion ($1,870,135)", "source_url": "https://reporter.nih.gov/project-details/11013667", "people": [{"name": "Andrew Serghios Barbas", "role": "Principal Investigator"}, {"name": "ROBERT NEUSNER", "role": "Principal Investigator"}, {"name": "PRABIR ROY-CHAUDHURY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HG013294-01A1", "company": "Survey Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": 397995, "summary": "NIH award 1R44HG013294-01A1: Pioneering assays for spatially-resolved single-cell multiomics ($397,995)", "source_url": "https://reporter.nih.gov/project-details/11008791", "people": [{"name": "Lin Pham", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K241709", "company": "Biomet Microfixation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241709: Pectus Blu Support Bar System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241709", "people": [{"name": "Smeet Doshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241709%22"}, {"id": "fda:K234096", "company": "Medicaltek Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234096: MonoStereo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234096", "people": [{"name": "Shen Ching (James) Yeh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234096%22"}, {"id": "fda:K241465", "company": "Parker Hannifin Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241465: Midas Flowmeter; eAVS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241465", "people": [{"name": "Deanna Perry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241465%22"}, {"id": "fda:K242167", "company": "Anhui Deepblue Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242167: Sterile and Non-Sterile Ultrasonic Coupling Agent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242167", "people": [{"name": "Fengling Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242167%22"}, {"id": "fda:K240183", "company": "Dentalez, Inc., Stardental Division", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240183: Star E900 Handpiece Series", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240183", "people": [{"name": "Robert Young", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240183%22"}, {"id": "fda:K242162", "company": "Good Clean Love, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242162: Coconut Hybrid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242162", "people": [{"name": "Wendy Strgar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242162%22"}, {"id": "fda:K240901", "company": "Sparrow Acoustics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240901: Stethophone", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240901", "people": [{"name": "Nadia Ivanova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240901%22"}, {"id": "fda:K242509", "company": "Next Orthosurgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242509: HAnano InterFuse(R) Modular Interbody", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242509", "people": [{"name": "Misty Calkins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242509%22"}, {"id": "fda:K242478", "company": "Samsung Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242478: GF85 (models GF85-3P, GF85-SP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242478", "people": [{"name": "Jaesang Noh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242478%22"}, {"id": "nih:1R43HL174218-01", "company": "Elimu Informatics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 353403, "summary": "NIH award 1R43HL174218-01: TIBSA: A tailored interoperable guideline-based clinical decision-support system for asthma ($353,403)", "source_url": "https://reporter.nih.gov/project-details/10919374", "people": [{"name": "Aziz A Boxwala", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA059490-01", "company": "Charles River Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 319988, "summary": "NIH award 1R43DA059490-01: Stimulant Use Recovery Via Immersive Virtual Environments (SURVIVE) ($319,988)", "source_url": "https://reporter.nih.gov/project-details/10785027", "people": [{"name": "Bethany K Bracken", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG074825-02", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 1075644, "summary": "NIH award 2R44AG074825-02: A Novel Instrument to Address Freezing of Gait in Parkinson's Patients ($1,075,644)", "source_url": "https://reporter.nih.gov/project-details/10920027", "people": [{"name": "Brian R Clark", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41HL176259-01", "company": "Mira Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 306643, "summary": "NIH award 1R41HL176259-01: Efficient low flow pump for pediatric extracorporeal membrane oxygenation ($306,643)", "source_url": "https://reporter.nih.gov/project-details/11005336", "people": [{"name": "Kevin R. Cleary", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL172444-01A1", "company": "Lasarrus Clinic And Research Center, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 498638, "summary": "NIH award 1R44HL172444-01A1: Bilateral Acoustic Sensing and Automated Breathing Segmentation for Remote Monitoring of Patients with COPD: A Longitudinal Study ($498,638)", "source_url": "https://reporter.nih.gov/project-details/10917640", "people": [{"name": "Lloyd E Emokpae", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA291262-01A1", "company": "Orbit Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 999554, "summary": "NIH award 1R44CA291262-01A1: Development of a lung cancer subtyping diagnostic ($999,554)", "source_url": "https://reporter.nih.gov/project-details/11007304", "people": [{"name": "HAROLD R GARNER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41EB036383-01", "company": "Oncoblaze LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 374095, "summary": "NIH award 1R41EB036383-01: Laser-guided drug delivery to prevent tumor recurrences ($374,095)", "source_url": "https://reporter.nih.gov/project-details/11006909", "people": [{"name": "Dieter Haemmerich", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG063683-04", "company": "Advanced Medical Electronics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 114957, "summary": "NIH award 2R44AG063683-04: A Mobile Informatics Solution to Assist Caregivers with Care Coordination and Social Engagement ($114,957)", "source_url": "https://reporter.nih.gov/project-details/11007475", "people": [{"name": "GARY D HAVEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43GM156112-01", "company": "Sagespectra Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 349869, "summary": "NIH award 1R43GM156112-01: Development and validation of a wireless patch for post-surgical monitoring and electrotherapy of surgical flaps ($349,869)", "source_url": "https://reporter.nih.gov/project-details/11004044", "people": [{"name": "Madison Heck", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL174366-01A1", "company": "Inspire Rx LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 842408, "summary": "NIH award 1R44HL174366-01A1: Personal Respiratory Isolation System for Safe Transport and Treatment of Patients with Highly Transmissible Infectious Diseases ($842,408)", "source_url": "https://reporter.nih.gov/project-details/10921430", "people": [{"name": "Sridhar Kota", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG090247-01", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 399269, "summary": "NIH award 1R44AG090247-01: Developing an Elderly Patient-Specific, Accurate, Intuitive and Highly Interpretable System for Unconsciousness Management in General Anesthesia Using PASCALL FDA-Cleared Intraoperative EEG Monitor ($399,269)", "source_url": "https://reporter.nih.gov/project-details/11008566", "people": [{"name": "EMERY N BROWN", "role": "Principal Investigator"}, {"name": "Tuan Le Mau", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG061985-06", "company": "Zetroz Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 2196474, "summary": "NIH award 2R44AG061985-06: Daily & Localized NSAID Sonophoresis for Symptomatic Treatment of Knee Osteoarthritis ($2,196,474)", "source_url": "https://reporter.nih.gov/project-details/10919305", "people": [{"name": "George Kenneth Lewis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R44HG014126-01", "company": "Cantata Bio LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": 1247028, "summary": "NIH award 1R44HG014126-01: Commercialization of a rapid, automated Hi-C platform for sensitive genomic profiling of multiple cancer sample types ($1,247,028)", "source_url": "https://reporter.nih.gov/project-details/10921113", "people": [{"name": "Elizabeth Munding", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41AA031429-01", "company": "Echelon Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "NIH award 1R41AA031429-01: Innovative Point-of-Care Solutions for Long-term Alcohol Biomarkers ($1)", "source_url": "https://reporter.nih.gov/project-details/10823508", "people": [{"name": "PAUL O NEILSEN", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241424", "company": "Innocare Urologics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241424: InnoCare Specialty Foley Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241424", "people": [{"name": "Patrick McCain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241424%22"}, {"id": "fda:K241775", "company": "Xelite Biomed , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241775: XeliteMed VertehighFix High Viscosity Spinal Bone Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241775", "people": [{"name": "Wei Chun Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241775%22"}, {"id": "fda:K231383", "company": "Terragene S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231383: Terragene\u00ae Bionova\u00ae Self-Contained Biological Indicator (BT95), Terragene\u00ae Bionova\u00ae Self-Contained Biological Indicator (BT96), Terragene\u00ae Chemdye\u00ae Chemical Process Indicator (CD42), Terragene\u00ae Cintape\u00ae Chemical Process Indicator Tape (CT40)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231383", "people": [{"name": "Hernando Carrizo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231383%22"}, {"id": "fda:K231893", "company": "Lowtem Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231893: LOWTEM Crystal 120", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231893", "people": [{"name": "Suyeon Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231893%22"}, {"id": "fda:K241769", "company": "Response Ortho Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241769: Response Ortho Metaphyseal Hinge Fixator System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241769", "people": [{"name": "Sehmuz Isin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241769%22"}, {"id": "fda:K233064", "company": "Whitepeaks Dental Solutions GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233064: Copra Supreme", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233064", "people": [{"name": "Oliver Puckert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233064%22"}, {"id": "fda:K234142", "company": "Megagen Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234142: TiGEN Abutment, PMMA Abutment and Scan Healing Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234142", "people": [{"name": "Hyo-Eun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234142%22"}, {"id": "fda:K241123", "company": "Km Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241123: Perpak\u0099 Sterilization Tyvek Pouch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241123", "people": [{"name": "Shin Byung Soon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241123%22"}, {"id": "fda:K241784", "company": "Teleflex Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241784: Arrow\u00ae Nitinol Wire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241784", "people": [{"name": "Madison Snyder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241784%22"}, {"id": "fda:K234153", "company": "Edgelife Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234153: EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234153", "people": [{"name": "Quinn Place", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234153%22"}, {"id": "nih:1R42DA060644-01", "company": "Photopharmics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 319278, "summary": "NIH award 1R42DA060644-01: Amelioration of opioid use disorder with heterodyned whole body vibration ($319,278)", "source_url": "https://reporter.nih.gov/project-details/10908038", "people": [{"name": "Daniel Nathan Adams", "role": "Principal Investigator"}, {"name": "Scott C Steffensen", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41AT012854-01", "company": "Livotion LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 294312, "summary": "NIH award 1R41AT012854-01: A scalable intervention for stress management practices ($294,312)", "source_url": "https://reporter.nih.gov/project-details/10922374", "people": [{"name": "Milton Aguirre", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA285041-02", "company": "Binary Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 990771, "summary": "NIH award 2R44CA285041-02: Monitoring Immunotherapy Response via Gene Silencing Landscapes in Cell-Free DNA ($990,771)", "source_url": "https://reporter.nih.gov/project-details/10922080", "people": [{"name": "Michael T Barrett", "role": "Principal Investigator"}, {"name": "Abhijit Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK141421-01", "company": "Flowpoint Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 324836, "summary": "NIH award 1R43DK141421-01: Self-sealing needle guide system for reliable hemodialysis ($324,836)", "source_url": "https://reporter.nih.gov/project-details/11013179", "people": [{"name": "Evren U. AZELOGLU", "role": "Principal Investigator"}, {"name": "Jason Bobe", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42HL170864-01A1", "company": "Biomembretics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 294063, "summary": "NIH award 1R42HL170864-01A1: Manufacturable Biomimetic Microfluidic Oxygenator for Safer, Simpler Treatment of Respiratory Failure ($294,063)", "source_url": "https://reporter.nih.gov/project-details/10922050", "people": [{"name": "Todd Astor", "role": "Principal Investigator"}, {"name": "Jeffrey T. Borenstein", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R42HD116627-01", "company": "Klein Buendel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 346573, "summary": "NIH award 1R42HD116627-01: Hybrid Delivery to Increase Access and Sustainability: Evaluating ezParent Implementation ($346,573)", "source_url": "https://reporter.nih.gov/project-details/11005130", "people": [{"name": "Susan M Breitenstein", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL174221-01", "company": "Pgxl Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 301224, "summary": "NIH award 1R44HL174221-01: UroMarker Test Panel for Obstructive Sleep Apnea ($301,224)", "source_url": "https://reporter.nih.gov/project-details/10919156", "people": [{"name": "Christopher Thomas Burns", "role": "Principal Investigator"}, {"name": "Roland Valdes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL174172-01", "company": "Canairy LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 324770, "summary": "NIH award 1R41HL174172-01: A Stand Alone Wearable for Tracking Environmental Exposure and Evaluating Respiratory Response ($324,770)", "source_url": "https://reporter.nih.gov/project-details/10914353", "people": [{"name": "Terry Chapman", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44NS097113-06A1", "company": "Biocircuit Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 1188158, "summary": "NIH award 2R44NS097113-06A1: Line extension and expanded preclinical evidence for Nerve Tape, a sutureless nerve repair coaptation device ($1,188,158)", "source_url": "https://reporter.nih.gov/project-details/10921921", "people": [{"name": "Ryan S Clement", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R43HL176260-01", "company": "3dt Holdings, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 437461, "summary": "NIH award 1R43HL176260-01: Novel Stabilization Catheter for His Pacing Lead Implant ($437,461)", "source_url": "https://reporter.nih.gov/project-details/11005190", "people": [{"name": "William Combs", "role": "Principal Investigator"}, {"name": "GHASSAN S KASSAB", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL174365-01A1", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R43HL174365-01A1: Next-Generation Cardiovascular Risk Assessments Via State-Of-The-Art Lipoprotein Characterization ($400,000)", "source_url": "https://reporter.nih.gov/project-details/11007709", "people": [{"name": "Sean German", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL174177-01", "company": "3dt Holdings, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 293653, "summary": "NIH award 1R43HL174177-01: Software Tool for Optimization of CRT ($293,653)", "source_url": "https://reporter.nih.gov/project-details/10915234", "people": [{"name": "Julius Matteo Guccione", "role": "Principal Investigator"}, {"name": "GHASSAN S KASSAB", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL172384-01", "company": "Functional Fluidics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 265347, "summary": "NIH award 1R43HL172384-01: Development of POC system for patient condition and treatment monitoring in Sickle Cell Disease through hypoxia-induced sickling ($265,347)", "source_url": "https://reporter.nih.gov/project-details/10820097", "people": [{"name": "Patrick Hines", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD116620-01", "company": "Cx Therapeutics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 1141527, "summary": "NIH award 1R44HD116620-01: A Novel Device for Cervical Insufficiency in Pregnant Women ($1,141,527)", "source_url": "https://reporter.nih.gov/project-details/11006391", "people": [{"name": "Michael Douglas House", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44EY036778-01", "company": "Siloam Vision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 881796, "summary": "NIH award 1R44EY036778-01: Ultrawide field non-mydriatic portable pediatric retinal imaging ($881,796)", "source_url": "https://reporter.nih.gov/project-details/11007994", "people": [{"name": "Yifan Jian", "role": "Principal Investigator"}, {"name": "Karyn Jonas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44DK131644-03", "company": "Sonavex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 1000001, "summary": "NIH award 2R44DK131644-03: Clinical Trial to Demonstrate Impact of an AI-enabled 3D Ultrasound-based Guidance System in Reducing Arteriovenous Fistula Cannulation Injury and Improving Patient Quality of Life ($1,000,001)", "source_url": "https://reporter.nih.gov/project-details/10922007", "people": [{"name": "Randy Cooper", "role": "Principal Investigator"}, {"name": "Xin Kang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL174336-01", "company": "Aquillius Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 431664, "summary": "NIH award 1R43HL174336-01: Wearable Graphene Respiratory Sensor for Early Detection and Monitoring of Asthma ($431,664)", "source_url": "https://reporter.nih.gov/project-details/10922558", "people": [{"name": "MyPhuong T Le", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42HL176325-01", "company": "Powell Mansfield, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 615621, "summary": "NIH award 1R42HL176325-01: BREATH: Breakthrough Research in Electromyography for the Assessment of Sleep-disordered BreaTHing ($615,621)", "source_url": "https://reporter.nih.gov/project-details/11008902", "people": [{"name": "Jejo David Koola", "role": "Principal Investigator"}, {"name": "Ross Mandeville", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL174305-01", "company": "Safebeat Rx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": 295153, "summary": "NIH award 1R43HL174305-01: A novel, smartwatch-enabled, automated mobile heart rhythm analysis technology to start antiarrhythmic medications safely at home ($295,153)", "source_url": "https://reporter.nih.gov/project-details/10921676", "people": [{"name": "Rachita Navara", "role": "Principal Investigator"}, {"name": "Kunj G. Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240250", "company": "Nvision Biomedical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240250: 3D Printed PEEK Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240250", "people": [{"name": "Diana Langham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240250%22"}, {"id": "fda:K240660", "company": "Kulzer, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240660: Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240660", "people": [{"name": "Harmon Lucas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240660%22"}, {"id": "fda:K234132", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234132: Medline Reusable Sterilization Wrappers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234132", "people": [{"name": "Closen Kelsey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234132%22"}, {"id": "fda:K233721", "company": "KLS-Martin L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233721: KLS Martin Drill-Free MMF Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233721", "people": [{"name": "Melissa Bachorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233721%22"}, {"id": "fda:K242186", "company": "Ofan Intelligent Technology (Guangzhou) Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242186: Neo Sculptor (OF-NEO001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242186", "people": [{"name": "Tequila Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242186%22"}, {"id": "fda:K240274", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240274: PADLOCK CLIP EFTR Kit (00713229)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240274", "people": [{"name": "Jackie Oliver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240274%22"}, {"id": "fda:K240293", "company": "Techbopulm, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240293: STS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240293", "people": [{"name": "Shabtay Negry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240293%22"}, {"id": "fda:K241942", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241942: TriMed Bridge Plates", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241942", "people": [{"name": "Divya Raghavi Nandakumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241942%22"}, {"id": "fda:K241230", "company": "Togo Medikit Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241230: Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241230", "people": [{"name": "Daisuke Nagamizu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241230%22"}, {"id": "fda:K240689", "company": "Telebrands Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240689: Robin's Egg", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240689", "people": [{"name": "Shepard Bentley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240689%22"}, {"id": "fda:K240373", "company": "Zhangzhou Easepal Medical Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240373: Air compression Leg Massager (MM0520, MM0521, MM0522)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240373", "people": [{"name": "Yuehua Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240373%22"}, {"id": "nih:1R42HL174259-01A1", "company": "Third Coast Dynamics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": 656751, "summary": "NIH award 1R42HL174259-01A1: Anatomic Imaging Derived 4D Hemodynamics using Deep Learning ($656,751)", "source_url": "https://reporter.nih.gov/project-details/11006873", "people": [{"name": "Bradley David Allen", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41MH138179-01", "company": "Spotted Tech LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": 449093, "summary": "NIH award 1R41MH138179-01: CD4-LINK: Improving access to HIV care in underserves areas with a home-based, mail-in CD4 count test ($449,093)", "source_url": "https://reporter.nih.gov/project-details/11008514", "people": [{"name": "Marissa Fahlberg", "role": "Principal Investigator"}, {"name": "Monica Vaccari", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241335", "company": "Senseonics, Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241335: Eversense 365 Continuous Glucose Monitoring (CGM) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241335", "people": [{"name": "Mukul Jain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241335%22"}, {"id": "fda:K241771", "company": "Medical San Ind\u00fastria DE Equipamentos M\u00e9dicos Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241771: Liftendo; Liftendo 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241771", "people": [{"name": "Francis Laion de Padua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241771%22"}, {"id": "fda:K234050", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234050: HALYARD\u00ae ONE-STEP\u00ae Sterilization Wrap, HALYARD\u00ae QUICK CHECK\u00ae Sterilization Wrap, HALYARD\u00ae SEQUENTIAL Sterilization Wrap and HALYARD\u00ae SMART-FOLD\u00ae Sterilization Wrap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234050", "people": [{"name": "Anureet Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234050%22"}, {"id": "fda:K241201", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241201: TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241201", "people": [{"name": "Zhang Yuxi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241201%22"}, {"id": "fda:K241893", "company": "Medos International SARL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241893: CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241893", "people": [{"name": "Marina Minnock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241893%22"}, {"id": "fda:K232938", "company": "Saeshin Precision Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232938: Traus SSG30 Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232938", "people": [{"name": "Gung San Nam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232938%22"}, {"id": "fda:K241762", "company": "View Point Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241762: OneMark", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241762", "people": [{"name": "Tom Kane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241762%22"}, {"id": "fda:K240638", "company": "Ningbo Youhuan Automation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240638: Power Wheelchair (YH-E7007)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240638", "people": [{"name": "Francis Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240638%22"}, {"id": "fda:K241379", "company": "Zhejiang Nysin Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241379: Powered Wheelchair (NXN20-205, NXN20-205M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241379", "people": [{"name": "Xiaoying Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241379%22"}, {"id": "fda:K234089", "company": "Vivos Therapeutics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234089: DNA Appliance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234089", "people": [{"name": "Kimberly Griffith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234089%22"}, {"id": "nih:1R43HL170857-01A1", "company": "Convergent Engineering, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-15", "observed": "2026-08-21", "amount_usd": 295924, "summary": "NIH award 1R43HL170857-01A1: Decision Support System for Personalized Care of Ventilated Patients using Esophageal Pressure ($295,924)", "source_url": "https://reporter.nih.gov/project-details/10921410", "people": [{"name": "Neil R. Euliano", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241156", "company": "Surgical Instrument Service and Savings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241156: Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241156", "people": [{"name": "Stephanie Boyle Mays", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241156%22"}, {"id": "nih:1R44CA291456-01A1", "company": "Onc.ai, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": 1625000, "summary": "NIH award 1R44CA291456-01A1: Prospective validation of a radiomics-based multi-modal predictive model for metastatic non-small cell lung cancer patients treated with PD-1 immunotherapy ($1,625,000)", "source_url": "https://reporter.nih.gov/project-details/11007396", "people": [{"name": "Petr Jordan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD116640-01", "company": "Venova Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": 383114, "summary": "NIH award 1R43HD116640-01: A novel, non-hormonal, long-acting female contraceptive device ($383,114)", "source_url": "https://reporter.nih.gov/project-details/11006653", "people": [{"name": "Emily Man", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM156259-01", "company": "Laser Bioanalytics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": 304196, "summary": "NIH award 1R43GM156259-01: Photochemical Tissue Modification for MALDI Mass Spectrometry Imaging ($304,196)", "source_url": "https://reporter.nih.gov/project-details/11005360", "people": [{"name": "Kermit King Murray", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42HD115517-01", "company": "Takeoff41, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": 291523, "summary": "NIH award 1R42HD115517-01: An AI-driven total parenteral nutrition platform for cost-effective and scientifically personalized nutrition for premature newborns ($291,523)", "source_url": "https://reporter.nih.gov/project-details/10922569", "people": [{"name": "Nima Aghaeepour", "role": "Principal Investigator"}, {"name": "Thanaphong Phongpreecha", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K240977", "company": "Denq", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240977: DenQ Sub SLA Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240977", "people": [{"name": "Taehoon Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240977%22"}, {"id": "fda:K240544", "company": "Epitomee Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240544: Epitomee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240544", "people": [{"name": "Ruthie Amir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240544%22"}, {"id": "fda:K242441", "company": "Revian, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242441: Revian Lyte (10011)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242441", "people": [{"name": "Tammy Carrea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242441%22"}, {"id": "fda:K240087", "company": "Ivy Biomedical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240087: RT Carbon ECG Leads", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240087", "people": [{"name": "Nathan Middeleer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240087%22"}, {"id": "fda:K241875", "company": "Nextstep Arthropedix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241875: TheRay Collared and Collarless Femoral Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241875", "people": [{"name": "Garrett Spurgeon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241875%22"}, {"id": "fda:K240188", "company": "Black & Black Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240188: Vitruvian Liposaber", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240188", "people": [{"name": "Cynthia Rees", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240188%22"}, {"id": "fda:K234063", "company": "T2biosystems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234063: T2Candida 1.1 Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234063", "people": [{"name": "Rachel Gilbert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234063%22"}, {"id": "fda:K233399", "company": "Sonoma Pharmaceuticals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233399: Microdacyn Wound Care Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233399", "people": [{"name": "Everardo Garibay Ramirez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233399%22"}, {"id": "fda:K240176", "company": "Vitromed GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240176: V-VITFREEZE and V-VITWARM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240176", "people": [{"name": "Holland Greg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240176%22"}, {"id": "fda:K240232", "company": "Hiossen, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240232: EK D3.3 and Ultra Wide Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240232", "people": [{"name": "Peter Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240232%22"}, {"id": "fda:K241722", "company": "Elos Medtech Pinol A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241722: Elos Accurate\u00ae Hybrid Base\u0099; Elos Accurate\u00ae Customized Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241722", "people": [{"name": "Lise Terkelsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241722%22"}, {"id": "fda:K240929", "company": "Apple, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240929: Sleep Apnea Notification Feature (SANF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240929", "people": [{"name": "Lynda Ikejimba", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240929%22"}, {"id": "nih:1R43GM154584-01A1", "company": "Narwhal Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": 349816, "summary": "NIH award 1R43GM154584-01A1: A Universal Tool for Unravelling the Requirements for Clinically Relevant Cell-Cell Interactions via In Situ Phenotyping and Tagging of Live Cells ($349,816)", "source_url": "https://reporter.nih.gov/project-details/11007110", "people": [{"name": "Behrad Azimi", "role": "Principal Investigator"}, {"name": "John M Beierle", "role": "Principal Investigator"}, {"name": "Kenneth Hsueh-heng Hu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG063679-02", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": 705763, "summary": "NIH award 2R44AG063679-02: A Gait and Path Tortuosity System for Monitoring Cognitive Decline in Individuals at Risk for Alzheimer's Disease and/or Alzheimer's Disease Related Dementias (AD/ADRD) ($705,763)", "source_url": "https://reporter.nih.gov/project-details/11008106", "people": [{"name": "John Paul Condon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43GM156167-01", "company": "Doty Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": 306675, "summary": "NIH award 1R43GM156167-01: Low-loss Bi-directional THz Couplers to Enable Affordable MAS-DNP-NMR ($306,675)", "source_url": "https://reporter.nih.gov/project-details/11007872", "people": [{"name": "Francis DAVID Doty", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG085917-01A1", "company": "Illuminant Surgical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": 294992, "summary": "NIH award 1R43AG085917-01A1: Software Development and Cadaveric Testing of Deformable Registration Pipeline in Novel Camera-Projector Surgical Navigation Device ($294,992)", "source_url": "https://reporter.nih.gov/project-details/10922438", "people": [{"name": "James Hu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL172682-01", "company": "General Engineering And Research, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": 275765, "summary": "NIH award 1R41HL172682-01: Personal Cooling Garments to Protect at-Risk Patients from Extreme Heat Waves ($275,765)", "source_url": "https://reporter.nih.gov/project-details/10822850", "people": [{"name": "robin ihnfeldt", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA291369-01A1", "company": "Exai Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": 1280908, "summary": "NIH award 1R44CA291369-01A1: Orphan Non-coding RNA-based Test for Detecting Minimal Residual Disease in Resectable Non-small Cell Lung Cancer ($1,280,908)", "source_url": "https://reporter.nih.gov/project-details/11008417", "people": [{"name": "Babak Behsaz", "role": "Principal Investigator"}, {"name": "Jeremy Ku", "role": "Principal Investigator"}, {"name": "Sandip Pravin Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R42EY033266-02", "company": "Chromologic, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": 803560, "summary": "NIH award 2R42EY033266-02: NGS based metagenomic screening of ocular infections ($803,560)", "source_url": "https://reporter.nih.gov/project-details/11008714", "people": [{"name": "Espoir Kyubwa", "role": "Principal Investigator"}, {"name": "Russell N. Van Gelder", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44CA287952-02", "company": "Xilis, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": 1239153, "summary": "NIH award 4R44CA287952-02: An integrated microfluidic device for patient-derived micro-organospheres ($1,239,153)", "source_url": "https://reporter.nih.gov/project-details/11174023", "people": [{"name": "Daniel Aaron Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241249", "company": "Palodex Group OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241249: Orthopantomograph\u0099 OP 3D LX (PAN 3D); Orthopantomograph\u0099 OP 3D LX (PAN CEPH 3D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241249", "people": [{"name": "Riika Sarviaho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241249%22"}, {"id": "fda:K241432", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241432: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241432", "people": [{"name": "Tang Jing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241432%22"}, {"id": "fda:K241280", "company": "Q Bio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241280: Constellation (CON-001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241280", "people": [{"name": "Clarissa Shen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241280%22"}, {"id": "fda:K241582", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241582: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241582", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241582%22"}, {"id": "fda:K240803", "company": "Surgikor, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240803: Surgikor Fixation One, Abutment Blanks and Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240803", "people": [{"name": "Jeremy Barbanell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240803%22"}, {"id": "fda:K240168", "company": "Nuga Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240168: N7-S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240168", "people": [{"name": "Jun Woo Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240168%22"}, {"id": "fda:K233732", "company": "Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233732: CoolSculpting Elite System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233732", "people": [{"name": "Victoria Montemayor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233732%22"}, {"id": "fda:K242401", "company": "Corentec Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242401: EXULT Knee Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242401", "people": [{"name": "Seo Sanghee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242401%22"}, {"id": "fda:K220999", "company": "Shijiazhuang Hipro Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220999: Hipro Glycosylated Hemoglobin (HbA1c) Test System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220999", "people": [{"name": "Emily No Last Name Provided", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220999%22"}, {"id": "fda:K241710", "company": "3M Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241710: 3M\u0099 Attest\u0099 Super Rapid Readout Biological Indicator 1492V; 3M\u0099 Attest\u0099 Auto-reader 490; 3M\u0099 Attest\u0099 Auto-reader 490H; 3M\u0099 Attest\u0099 Mini Auto-reader 490M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241710", "people": [{"name": "Michelle Larsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241710%22"}, {"id": "fda:DEN230081", "company": "Apple, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230081: Hearing Aid Feature (HAF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230081", "people": [{"name": "Kevin Go", "role": "510(k) submission contact"}]}, {"id": "fda:K240942", "company": "Avicenna.Ai", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240942: CINA-CSpine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240942", "people": [{"name": "Stephane Berger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240942%22"}, {"id": "fda:K241493", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241493: Glidewell\u0099 3DP Denture Base Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241493", "people": [{"name": "Li Jiahe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241493%22"}, {"id": "fda:K242136", "company": "Zhejiang Hfizer Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242136: Electric wheelchair (C001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242136", "people": [{"name": "Ken Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242136%22"}, {"id": "fda:K241695", "company": "Field Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241695: Extremity All Suture System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241695", "people": [{"name": "Jillianne McKenzie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241695%22"}, {"id": "fda:K241524", "company": "Elucid Bioimaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241524: Elucid PlaqueIQ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241524", "people": [{"name": "Hiral Vora", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241524%22"}, {"id": "fda:K231982", "company": "Qura S.R.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231982: Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231982", "people": [{"name": "Raffaella Tommasini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231982%22"}, {"id": "fda:K240880", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240880: VitalFlow Set with Balance Biosurface", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240880", "people": [{"name": "Anna Wetherille", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240880%22"}, {"id": "fda:K240787", "company": "Biotronik, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240787: Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240787", "people": [{"name": "Jon Brumbaugh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240787%22"}, {"id": "denovo:DEN230081", "company": "Apple, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-09-12", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230081 granted: Hearing Aid Feature (HAF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230081"}, {"id": "fda:K240271", "company": "Linshom Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240271: Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240271", "people": [{"name": "William Stoll", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240271%22"}, {"id": "fda:K241745", "company": "Ksg Medicare Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241745: Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241745", "people": [{"name": "Jennifer Yow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241745%22"}, {"id": "fda:K241380", "company": "Diagnoly", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241380: FETOLY-HEART", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241380", "people": [{"name": "Ivan Voznyuk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241380%22"}, {"id": "fda:K241438", "company": "Signus Medizintechnik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241438: Signus Tetris\u0099 St; Signus Tetris\u0099 R St", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241438", "people": [{"name": "Antje Schmidt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241438%22"}, {"id": "fda:K240683", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240683: Rx Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240683", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240683%22"}, {"id": "fda:K241004", "company": "Huizhou Lvb Maternal and Infant Supplies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241004: Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241004", "people": [{"name": "Dongan Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241004%22"}, {"id": "fda:K232559", "company": "Arum Dentistry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232559: C&B NFH Hybrid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232559", "people": [{"name": "Boyeon Lim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232559%22"}, {"id": "fda:K241954", "company": "PAJUNK GmbH Medizintechnologie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241954: SonoBlock; SonoBlock II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241954", "people": [{"name": "Christian Quass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241954%22"}, {"id": "fda:K241161", "company": "Leltek, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241161: Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241161", "people": [{"name": "Paul Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241161%22"}, {"id": "fda:K241010", "company": "Depuy Mitek", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241010: HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241010", "people": [{"name": "Lidia Moses", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241010%22"}, {"id": "fda:K241362", "company": "Surmodics,Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241362: Pounce XL Thrombectomy System (PTS-1011-7F135)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241362", "people": [{"name": "Holly Ramirez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241362%22"}, {"id": "nih:1R41ES036480-01", "company": "Skyway Biosciences", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": 295923, "summary": "NIH award 1R41ES036480-01: Optimization and Validation of Minimally-Invasive and Low-Cost Blood Collection Device for Lead Testing ($295,923)", "source_url": "https://reporter.nih.gov/project-details/10920930", "people": [{"name": "Punkaj Ahuja", "role": "Principal Investigator"}, {"name": "William E Funk", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH138162-01", "company": "Adaptive Testing Technologies", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": 427986, "summary": "NIH award 1R44MH138162-01: Modifying and validating the K-CAT mental health scales for children and adolescents on the autism spectrum ($427,986)", "source_url": "https://reporter.nih.gov/project-details/11005450", "people": [{"name": "Paige Elizabeth Cervantes", "role": "Principal Investigator"}, {"name": "Yehuda Cohen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44OD035392-01A1", "company": "Cryocrate, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": 940821, "summary": "NIH award 1R44OD035392-01A1: Establishment of a First-in-Class Biocompatible and Efficient Cryopreservation Technology Platform for the Next Generation of Cell-Based Therapeutics in Regenerative Medicine and Drug Discovery ($940,821)", "source_url": "https://reporter.nih.gov/project-details/10823211", "people": [{"name": "Xu Han", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43LM014655-01", "company": "Nested Knowledge, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": 304971, "summary": "NIH award 1R43LM014655-01: Automating Tabular Data Extraction to Accelerate Evidence Synthesis and Systematic Literature Review ($304,971)", "source_url": "https://reporter.nih.gov/project-details/11008123", "people": [{"name": "Kevin Kallmes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44MH128999-02", "company": "Panluminate Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": 1219907, "summary": "NIH award 2R44MH128999-02: A 3D super-resolved platform for rapid and highly multiplexed proteomics ($1,219,907)", "source_url": "https://reporter.nih.gov/project-details/11008498", "people": [{"name": "Ons M'Saad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44CA285039-02", "company": "Exvade Bioscience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": 999360, "summary": "NIH award 4R44CA285039-02: Tumor Monorail Device for Serial Glioblastoma Biopsy ($999,360)", "source_url": "https://reporter.nih.gov/project-details/11174633", "people": [{"name": "Sean Meehan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K234064", "company": "Surgical Instrument Service and Savings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234064: Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234064", "people": [{"name": "Stephanie Boyle Mays", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234064%22"}, {"id": "fda:K240094", "company": "Augmedit B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240094: LumiNE US; Lumi", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240094", "people": [{"name": "Claartje Ypma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240094%22"}, {"id": "fda:K241609", "company": "Stryker Corporation (Tornier, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241609: Tornier Humeral Reconstruction System (Tornier HRS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241609", "people": [{"name": "Jang Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241609%22"}, {"id": "fda:K241214", "company": "Standard Textile Co., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241214: ProPel SG3\u0099 Surgical Gown", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241214", "people": [{"name": "Richard Holbert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241214%22"}, {"id": "fda:K242612", "company": "Argon Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242612: Option ELITE Vena Cava Filter System (352506070E 352506100E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242612", "people": [{"name": "Scott Bishop", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242612%22"}, {"id": "fda:K240990", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240990: Mobility Scooter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240990", "people": [{"name": "Grace Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240990%22"}, {"id": "fda:K241638", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241638: 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241638", "people": [{"name": "Kristy Ann Darling", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241638%22"}, {"id": "nih:1R41DA060000-01", "company": "Oprems LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": 295876, "summary": "NIH award 1R41DA060000-01: Feasibility of Electronic Screening to Identify Risk of Opioid Misuse and Overdose ($295,876)", "source_url": "https://reporter.nih.gov/project-details/10822394", "people": [{"name": "Nick Ferrarese", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41NS137832-01", "company": "Neuralenz, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": 498995, "summary": "NIH award 1R41NS137832-01: Development of Highly Parallelized Interferometric Near-Infrared Spectroscopy for the Real-Time Non-Invasive Measurement of Cerebral Blood Flow ($498,995)", "source_url": "https://reporter.nih.gov/project-details/10920028", "people": [{"name": "Oybek Kholiqov", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS137871-01", "company": "Microstructure Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": 353942, "summary": "NIH award 1R43NS137871-01: Reporting Quantitative Microstructural MRI Metrics to Stage and Monitor Multiple Sclerosis ($353,942)", "source_url": "https://reporter.nih.gov/project-details/10920523", "people": [{"name": "Grigoriy Lemberskiy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240697", "company": "See-Mode Technologies Pte, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240697: See-Mode Augmented Reporting Tool, Thyroid (SMART-T)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240697", "people": [{"name": "Sadaf Monajemi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240697%22"}, {"id": "fda:K241681", "company": "Overjet, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241681: Overjet Image Enhancement Assist", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241681", "people": [{"name": "Deepthi Paknikar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241681%22"}, {"id": "fda:K241678", "company": "Shenzhen Minghuangda Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241678: TENS & EMS Stimulator (MHD-1083)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241678", "people": [{"name": "Guixiang Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241678%22"}, {"id": "fda:K240791", "company": "Adas3D Medical S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240791: ADAS 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240791", "people": [{"name": "Antoni Riu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240791%22"}, {"id": "fda:K240233", "company": "S.H.Pitkar Orthotools Pvt. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240233: Pitkar Spinal Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240233", "people": [{"name": "Vivek Mangalwedhekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240233%22"}, {"id": "fda:K241205", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241205: Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241205", "people": [{"name": "Yang Blue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241205%22"}, {"id": "fda:K242042", "company": "Medos International SARL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242042: TriALTIS\u0099 Spine System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242042", "people": [{"name": "Denielle Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242042%22"}, {"id": "fda:K242349", "company": "Lumenis Be, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242349: FoLix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242349", "people": [{"name": "Shlomit Segman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242349%22"}, {"id": "fda:K242394", "company": "Rayence Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242394: Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242394", "people": [{"name": "Brianna Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242394%22"}, {"id": "fda:K240266", "company": "Sri Trang Gloves (Thailand) Public Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240266: Latex Examination Glove Powder Free (Ocean Blue and Natural White)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240266", "people": [{"name": "M. Jordan Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240266%22"}, {"id": "fda:K240486", "company": "Piccolo Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240486: PM2 System and ECGuide Connector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240486", "people": [{"name": "Augustus Shanahan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240486%22"}, {"id": "nih:1R41MH138146-01", "company": "Virtually Better, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": 386266, "summary": "NIH award 1R41MH138146-01: Clutter-GO: Facilitating Delivery and Adherence in Evidence-Based Treatment for Hoarding Disorder via a Patient-Provider Digital Health Tool ($386,266)", "source_url": "https://reporter.nih.gov/project-details/11003955", "people": [{"name": "Margo Adams Larsen", "role": "Principal Investigator"}, {"name": "Michael Grady Wheaton", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DA060643-01", "company": "Resilient Lifescience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": 399589, "summary": "NIH award 1R44DA060643-01: Developing a wearable medical device to detect opioid overdose ($399,589)", "source_url": "https://reporter.nih.gov/project-details/10908083", "people": [{"name": "Bradford A Holden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43EY036781-01", "company": "Ifocus Imaging LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": 306462, "summary": "NIH award 1R43EY036781-01: A diagnostic platform for diabetic retinopathy based on OCT angiography and artificial intelligence ($306,462)", "source_url": "https://reporter.nih.gov/project-details/11011245", "people": [{"name": "Tristan Hormel", "role": "Principal Investigator"}, {"name": "Yali Jia", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS127696-03", "company": "Cnd Life Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": 954862, "summary": "NIH award 5R44NS127696-03: Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies ($954,862)", "source_url": "https://reporter.nih.gov/project-details/10912671", "people": [{"name": "Todd Levine", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K233900", "company": "Synaptic Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233900: Nordica PV Cryo Mapping Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233900", "people": [{"name": "Jake Harandi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233900%22"}, {"id": "fda:K234044", "company": "Implantcast GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234044: ACS\u00ae LD FB Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234044", "people": [{"name": "Juliane H\u00f6ppner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234044%22"}, {"id": "fda:K232543", "company": "Yocon Biology Technology Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232543: MSC SFM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232543", "people": [{"name": "Haifeng Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232543%22"}, {"id": "fda:K241693", "company": "Femasys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241693: FemChec Controlled Saline-Air Device (FCD-250)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241693", "people": [{"name": "Christine Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241693%22"}, {"id": "fda:K240600", "company": "East End Medical I, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240600: SafeCross Vascular Introducer System (4001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240600", "people": [{"name": "David Neugaard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240600%22"}, {"id": "fda:K241164", "company": "Medicrea International S.A.S. (Medtronic)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241164: IB3D\u0099 PL Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241164", "people": [{"name": "Cecile Humbert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241164%22"}, {"id": "fda:K232996", "company": "Shanghai Iatrical-Ti Technologies CO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232996: Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232996", "people": [{"name": "Haozhang Zhong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232996%22"}, {"id": "fda:K240411", "company": "Shanghai United Imaging Intelligence Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240411: uAI Portal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240411", "people": [{"name": "Xiaojing Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240411%22"}, {"id": "fda:K233806", "company": "Osstem Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233806: T2 Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233806", "people": [{"name": "Jinsan Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233806%22"}, {"id": "fda:K233911", "company": "Carl Zeiss Meditec, AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233911: VISULAS combi", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233911", "people": [{"name": "Ling Ren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233911%22"}, {"id": "fda:K241427", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241427: Access Syphilis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241427", "people": [{"name": "Brenda Eifert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241427%22"}, {"id": "fda:K231667", "company": "Withings", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231667: Withings Sleep Rx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231667", "people": [{"name": "Khushboo Surendran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231667%22"}, {"id": "fda:K241976", "company": "Sfm Medical Devices GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241976: nextaro\u00ae va, 15mm, 5\u00b5m", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241976", "people": [{"name": "Dr. Olaf Broemsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241976%22"}, {"id": "fda:K233974", "company": "Alandra Medical Sapi DE CV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233974: Mucosal Impedance Measurement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233974", "people": [{"name": "Montserrat Godinez Garcia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233974%22"}, {"id": "fda:K241552", "company": "Mentor Worldwide, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241552: MENTOR\u0099 MemoryGel\u0099 Enhance Single Use Gel Sizer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241552", "people": [{"name": "Alicia Botham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241552%22"}, {"id": "fda:K241672", "company": "Amt Engineering Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241672: COPRO 3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241672", "people": [{"name": "Seung Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241672%22"}, {"id": "fda:K241415", "company": "Linear Health Sciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241415: Orchid Safety Release Valve\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241415", "people": [{"name": "Jessica Czamanski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241415%22"}, {"id": "fda:K242415", "company": "Treace Medical Concepts", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242415: TMC Compression Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242415", "people": [{"name": "Brittany Grochala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242415%22"}, {"id": "fda:K234035", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234035: COSINE\u0099 Spacer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234035", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234035%22"}, {"id": "fda:K241579", "company": "Dental Direkt GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241579: DD Hybridlayer (multicolored zirconia)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241579", "people": [{"name": "Patrick Berz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241579%22"}, {"id": "fda:K233921", "company": "Dentis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233921: Luvis Chair (LC700C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233921", "people": [{"name": "Kim Kaon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233921%22"}, {"id": "nih:1R44HL170817-01A1", "company": "DNA Medicine Institute", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": 1022908, "summary": "NIH award 1R44HL170817-01A1: 5-Minute Point-of-Care Anti-Factor Xa Test for Emergent Patient Management ($1,022,908)", "source_url": "https://reporter.nih.gov/project-details/11005242", "people": [{"name": "Eugene Yan-ho Chan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44DA059519-01", "company": "Dynamicare Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": 1076018, "summary": "NIH award 1R44DA059519-01: Decentralized clinical trial of contingency management digital therapeutic to treat stimulant use disorder ($1,076,018)", "source_url": "https://reporter.nih.gov/project-details/10786828", "people": [{"name": "David R Gastfriend", "role": "Principal Investigator"}, {"name": "Carla J Rash", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44EB034645-02", "company": "Quadridox, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": 923685, "summary": "NIH award 5R44EB034645-02: Development and evaluation of a combined X-ray transmission and diffraction imaging system for pathology ($923,685)", "source_url": "https://reporter.nih.gov/project-details/10925188", "people": [{"name": "Joel Greenberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44MH130305-02", "company": "Dimagi, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": 1014530, "summary": "NIH award 2R44MH130305-02: A novel digital platform for measurement-based peer supervision of non-specialist providers conducting brief psychological interventions ($1,014,530)", "source_url": "https://reporter.nih.gov/project-details/11007951", "people": [{"name": "Y. Xian Ho", "role": "Principal Investigator"}, {"name": "Neal Lesh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R42AG080886-02", "company": "Tritonx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": 864100, "summary": "NIH award 4R42AG080886-02: Clinical effectiveness of a wearable hydration device ($864,100)", "source_url": "https://reporter.nih.gov/project-details/11143961", "people": [{"name": "Eamon Johnson", "role": "Principal Investigator"}, {"name": "Joseph Piktel", "role": "Principal Investigator"}, {"name": "MARY Joan ROACH", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44AG084365-02", "company": "Plans4care Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": 1279400, "summary": "NIH award 4R44AG084365-02: Plans4Care: Personalized Dementia Care On-Demand ($1,279,400)", "source_url": "https://reporter.nih.gov/project-details/11143964", "people": [{"name": "Eric Jutkowitz", "role": "Principal Investigator"}, {"name": "Sokha Koeuth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44NS127667-03S3", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": 99011, "summary": "NIH award 3R44NS127667-03S3: Exploring the Parameter Space of High Frequency Magnetic Perturbation in Manipulating Neural Excitability and Plasticity. ($99,011)", "source_url": "https://reporter.nih.gov/project-details/11090181", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K232692", "company": "Intradin (Shanghai) Machinery Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232692: Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232692", "people": [{"name": "Mark Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232692%22"}, {"id": "fda:K241155", "company": "Shenzhen Nuon Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241155: Cold Sore Device (QPZ-03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241155", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241155%22"}, {"id": "fda:K231566", "company": "Medentis Medical GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231566: ICX-Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231566", "people": [{"name": "Alexander Scholz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231566%22"}, {"id": "fda:K242390", "company": "Baxter Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242390: Novum IQ Syringe Pump (40800BAXUS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242390", "people": [{"name": "Dhiraj Bizzul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242390%22"}, {"id": "fda:K241356", "company": "Bodycad Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241356: Fine Osteotomy\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241356", "people": [{"name": "Nadine Adia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241356%22"}, {"id": "fda:K241605", "company": "Nanovis, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241605: Adaptix\u0099 PEEK Interbody System with Nanotechnology; Capstone Control\u0099 PEEK Spinal System with Nanotechnology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241605", "people": [{"name": "Brian More", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241605%22"}, {"id": "fda:K233998", "company": "Aiq Global, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233998: TRAQinform IQ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233998", "people": [{"name": "Dona Alberti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233998%22"}, {"id": "fda:K241723", "company": "Zhejiang Richall Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241723: Electric wheelchair (W3902)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241723", "people": [{"name": "Dragon Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241723%22"}, {"id": "fda:K231741", "company": "Prestige Ameritech", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231741: ProGear\u00ae Surgical Mask with Oxafence\u00ae, Model AV82030", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231741", "people": [{"name": "Hofheinz Danica", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231741%22"}, {"id": "fda:K241721", "company": "Zhejiang Richall Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241721: Electric wheelchair (N3901)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241721", "people": [{"name": "Dragon Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241721%22"}, {"id": "fda:K240203", "company": "Dyne Medical Group, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240203: URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240203", "people": [{"name": "Moon Young-Hoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240203%22"}, {"id": "nih:1R43NS139780-01", "company": "Sage Cerebrovascular Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": 307538, "summary": "NIH award 1R43NS139780-01: Development and Validation of a Quantitative Diagnostic Biomarker for Silent Brain Injury ($307,538)", "source_url": "https://reporter.nih.gov/project-details/11007524", "people": [{"name": "Sadaf Ebrahimzadeh Pustchi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44HL164222-03S1", "company": "Linshom Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": 167476, "summary": "NIH award 3R44HL164222-03S1: Advanced Prediction of Emerging Respiratory Decline with the Linshom Continuous Predictive Respiratory Sensor (CPRS) ($167,476)", "source_url": "https://reporter.nih.gov/project-details/11006628", "people": [{"name": "Ronen Feldman", "role": "Principal Investigator"}, {"name": "James Richard Hughen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DA060729-01", "company": "Square2 Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": 295516, "summary": "NIH award 1R43DA060729-01: Cogito: A turnkey solution for rapidly developing, evaluating, deploying, and scaling digital therapeutics ($295,516)", "source_url": "https://reporter.nih.gov/project-details/10918866", "people": [{"name": "Michael John Grabinski", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44EB033725-02", "company": "Health Discovery Labs LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": 874061, "summary": "NIH award 2R44EB033725-02: Closed Loop Electrical Muscle Stimulation System (CL-EMS) with improved safety for ICU environment to mitigate ICU Acquired Weakness ($874,061)", "source_url": "https://reporter.nih.gov/project-details/10920531", "people": [{"name": "Oussama Hassan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44NS127667-03S2", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": 103750, "summary": "NIH award 3R44NS127667-03S2: Exploring the Parameter Space of High Frequency Magnetic Perturbation in Manipulating Neural Excitability and Plasticity. ($103,750)", "source_url": "https://reporter.nih.gov/project-details/11182116", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:9R44MH140338-02A1", "company": "Nalu Scientific, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": 1022870, "summary": "NIH award 9R44MH140338-02A1: Design and Development of SyMPET: System on chip Modular readout for high-resolution TOF-PET ($1,022,870)", "source_url": "https://reporter.nih.gov/project-details/11008896", "people": [{"name": "Luca Macchiarulo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K231095", "company": "International Medical Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231095: Tamper Evident Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231095", "people": [{"name": "David Meily", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231095%22"}, {"id": "fda:K242305", "company": "Eb Neuro S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242305: BE Plus PRO, Neurotravel LIGHT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242305", "people": [{"name": "Marco Rossi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242305%22"}, {"id": "fda:K240158", "company": "Modular Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240158: Modular Medical MODD1 Insulin Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240158", "people": [{"name": "Kelsie DiPerna", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240158%22"}, {"id": "fda:K233977", "company": "Sonic Incytes", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233977: Velacur", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233977", "people": [{"name": "Tinuade Orimalade", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233977%22"}, {"id": "fda:K241071", "company": "Vertex-Dental B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241071: NextDent Jet Denture Base; NextDent Jet Denture Teeth", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241071", "people": [{"name": "Bart Romanus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241071%22"}, {"id": "fda:K221275", "company": "AIOBIO Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221275: Qraycam PRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221275", "people": [{"name": "HongCheol Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221275%22"}, {"id": "fda:K240646", "company": "Somnomed Technologies Inc., Doing Business AS Remware", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240646: DreamClear", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240646", "people": [{"name": "Arun Ramabadran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240646%22"}, {"id": "fda:K231502", "company": "Proimtech Saglik Urunleri Anonim Sirketi", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231502: Mini Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231502", "people": [{"name": "Hakan Cevik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231502%22"}, {"id": "fda:K240142", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240142: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240142", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240142%22"}, {"id": "fda:K242306", "company": "Forest Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242306: SignalNED System (Model RE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242306", "people": [{"name": "Carmelo Montalvo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242306%22"}, {"id": "nih:1R44GM156127-01", "company": "Nirrin Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-03", "observed": "2026-08-21", "amount_usd": 1219222, "summary": "NIH award 1R44GM156127-01: A tunable laser scanning system for rapid analysis of biopharmaceutical formulations ($1,219,222)", "source_url": "https://reporter.nih.gov/project-details/11007369", "people": [{"name": "Bryan Hassell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA285033-01A1", "company": "O2m Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-03", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R43CA285033-01A1: Multifunctional EPRI Instrument to Advance Therapies in Biomedical Sciences ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10919608", "people": [{"name": "Mrignayani Kotecha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DA051289-04", "company": "Emitech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-03", "observed": "2026-08-21", "amount_usd": 953511, "summary": "NIH award 5R44DA051289-04: Wearable sensor for opioids detection based on electrochemical sensor arrayintegrated with Bluetooth device ($953,511)", "source_url": "https://reporter.nih.gov/project-details/10898019", "people": [{"name": "Igor A Levitsky", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K242251", "company": "Quanta System Spa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242251: Litho 60; Litho 100; Litho 150", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242251", "people": [{"name": "Bandiera Dario", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242251%22"}, {"id": "fda:K242319", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242319: Indigo\u00ae Aspiration System \u0096 Aspiration Catheter 6X", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242319", "people": [{"name": "Samyukta Rangachari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242319%22"}, {"id": "fda:K240487", "company": "Smith & Nephew", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240487: EVOS Patella Plates", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240487", "people": [{"name": "Mandy Coe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240487%22"}, {"id": "fda:K242069", "company": "Eminent Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242069: Eminent Spine Scoliosis Deformity Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242069", "people": [{"name": "Stephen Courtney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242069%22"}, {"id": "fda:K241295", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241295: SOMATOM On.site", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241295", "people": [{"name": "Kenny M Bello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241295%22"}, {"id": "fda:K241611", "company": "Imds Operations B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241611: ShapeIT (SI014135)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241611", "people": [{"name": "Edwin Schulting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241611%22"}, {"id": "fda:K233805", "company": "Osstem Implant Co., Ltd. Chair Business", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-09-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233805: K5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233805", "people": [{"name": "Sangyong Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233805%22"}, {"id": "nih:1R43EB035958-01", "company": "Akna Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-02", "observed": "2026-08-21", "amount_usd": 351600, "summary": "NIH award 1R43EB035958-01: Point-of-care testing for perinatal risks in early pregnancy ($351,600)", "source_url": "https://reporter.nih.gov/project-details/10920240", "people": [{"name": "Sascha Drewlo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM151918-02", "company": "Qatch Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-02", "observed": "2026-08-21", "amount_usd": 886907, "summary": "NIH award 5R44GM151918-02: High-throughput injectability screening of high concentration protein formulations by microfluidic quartz resonators ($886,907)", "source_url": "https://reporter.nih.gov/project-details/10916434", "people": [{"name": "Zehra Parlak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44ES035679-01A1", "company": "Ondavia, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-02", "observed": "2026-08-21", "amount_usd": 586190, "summary": "NIH award 1R44ES035679-01A1: Automated, in-line hexavalent chromium analyzer ($586,190)", "source_url": "https://reporter.nih.gov/project-details/10922498", "people": [{"name": "Mark C Peterman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK139864-01A1", "company": "Pupil Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-02", "observed": "2026-08-21", "amount_usd": 250464, "summary": "NIH award 1R44DK139864-01A1: Development of an early detection test for Type 1 Diabetes via NGS-based analysis of \u03b2 cells-specific methylation patterns in cfDNA ($250,464)", "source_url": "https://reporter.nih.gov/project-details/11007320", "people": [{"name": "Alessandro Pinto", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM144000-03", "company": "Partillion Bioscience Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-09-01", "observed": "2026-08-21", "amount_usd": 731568, "summary": "NIH award 5R44GM144000-03: Linking antibody sequences to function at the single-cell level using nanovial technology ($731,568)", "source_url": "https://reporter.nih.gov/project-details/10928715", "people": [{"name": "Joseph de Rutte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K241592", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241592: Arthrex VAL and VAL KreuLock\u0099 Compression Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241592", "people": [{"name": "Konrad Wolfmeyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241592%22"}, {"id": "nih:5R42AG058336-04", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 256151, "summary": "NIH award 5R42AG058336-04: Care Assistant for Family Caregivers of Persons with Dementia During Out of the Home Activities ($256,151)", "source_url": "https://reporter.nih.gov/project-details/10899735", "people": [{"name": "Shane M. Anderson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44NS120394-02", "company": "Soterya, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 1244175, "summary": "NIH award 2R44NS120394-02: A Device to Prevent Sudden Unexpected Death in Epilepsy (SUDEP) ($1,244,175)", "source_url": "https://reporter.nih.gov/project-details/11007633", "people": [{"name": "Pranav Bansal", "role": "Principal Investigator"}, {"name": "Jong Woo Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA254586-03", "company": "Pensievision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 1041955, "summary": "NIH award 5R44CA254586-03: A Novel, Low-Cost, Handheld, 3D Imaging System for Improved Screening of Cervical Neoplasia in Resource Limited Settings ($1,041,955)", "source_url": "https://reporter.nih.gov/project-details/10931557", "people": [{"name": "Joseph Carson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43MH138155-01", "company": "Square2 Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 306392, "summary": "NIH award 1R43MH138155-01: Transforming mental health care via science-based, personalizable and scalable digital therapeutics ($306,392)", "source_url": "https://reporter.nih.gov/project-details/11005366", "people": [{"name": "Michael John Grabinski", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44CA275590-02", "company": "Collagen Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 885123, "summary": "NIH award 4R44CA275590-02: Theranostic for gastric cancer ($885,123)", "source_url": "https://reporter.nih.gov/project-details/11141271", "people": [{"name": "Valerie Humblet", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44EY035596-02", "company": "Siloam Vision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 52865, "summary": "NIH award 5R44EY035596-02: Validation of artificial intelligence (AI) based software as medical device (SaMD) for retinopathy of prematurity (ROP) ($52,865)", "source_url": "https://reporter.nih.gov/project-details/10931442", "people": [{"name": "John Peter Campbell", "role": "Principal Investigator"}, {"name": "Karyn Jonas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44NS127667-03S1", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 103750, "summary": "NIH award 3R44NS127667-03S1: Exploring the Parameter Space of High Frequency Magnetic Perturbation in Manipulating Neural Excitability and Plasticity. ($103,750)", "source_url": "https://reporter.nih.gov/project-details/11084210", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R41NS132700-02", "company": "Popneuron LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 259788, "summary": "NIH award 5R41NS132700-02: Live spike sorting for multichannel and high-channel recordings ($259,788)", "source_url": "https://reporter.nih.gov/project-details/10932262", "people": [{"name": "Achim Klug", "role": "Principal Investigator"}, {"name": "Tim Chifong Lei", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43JG000002-01", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 303250, "summary": "NIH award 1R43JG000002-01: MiCRIA: Two-minute rapid assay platform for point-of-care diagnosis ($303,250)", "source_url": "https://reporter.nih.gov/project-details/11069126", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AR083337-02", "company": "Rivanna Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 1005539, "summary": "NIH award 5R44AR083337-02: Development of a regional anesthesia guidance system to increase patient access to opioid-sparing analgesia for hip fracture pain ($1,005,539)", "source_url": "https://reporter.nih.gov/project-details/10927446", "people": [{"name": "Frank William Mauldin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CE003634-01A1", "company": "Kinima, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 397205, "summary": "NIH award 1R43CE003634-01A1: SBIR, Augmented Reality Personalized Motion Tracking, Assessment, and Improvement Technology for Fall Prevention With Seniors Living in Subsidized Housing Using a Mobile Phone ($397,205)", "source_url": "https://reporter.nih.gov/project-details/10920581", "people": [{"name": "Renee Migdal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL166003-03", "company": "Prolocor Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 693288, "summary": "NIH award 5R44HL166003-03: Validation of Platelet Expression of Fc\u0263RIIa as a Precision Tool ($693,288)", "source_url": "https://reporter.nih.gov/project-details/10897855", "people": [{"name": "Jeanne Ohrnberger", "role": "Principal Investigator"}, {"name": "David J Schneider", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL154960-03", "company": "Bridgesource Medical Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": 875246, "summary": "NIH award 5R44HL154960-03: Novel Device to Optimize Aerosol Drug Delivery for Pulmonary Hypertension Treatment ($875,246)", "source_url": "https://reporter.nih.gov/project-details/10912642", "people": [{"name": "John E Porterfield", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K241393", "company": "Odi Medical AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241393: ODI-Tech", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241393", "people": [{"name": "Wenche Groennvold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241393%22"}, {"id": "fda:K241256", "company": "Therabody, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241256: JetBoots PRO Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241256", "people": [{"name": "CJ Frederick, III", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241256%22"}, {"id": "fda:K241662", "company": "Vitrolife Sweden AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241662: Ultrasound Transducer Cover", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241662", "people": [{"name": "Lin Huldeberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241662%22"}, {"id": "fda:K241957", "company": "Invent Medical USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241957: Talee, Talee PostOp", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241957", "people": [{"name": "Jiri Rosicky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241957%22"}, {"id": "fda:K241051", "company": "Vave Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241051: Vave Wireless Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241051", "people": [{"name": "Sandhya Mitnala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241051%22"}, {"id": "fda:K231969", "company": "Dongguanshi Yiyingmei Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231969: BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231969", "people": [{"name": "Chen Jian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231969%22"}, {"id": "fda:K241602", "company": "Hunan Qinghao Puzhong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241602: Kingcera Dental Zirconia Blank", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241602", "people": [{"name": "Zhiquan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241602%22"}, {"id": "fda:K241318", "company": "Adaptiiv Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241318: Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241318", "people": [{"name": "Olga Zhuk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241318%22"}, {"id": "fda:K242249", "company": "United Orthopedic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242249: Conformity Stem Extension Line", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242249", "people": [{"name": "Lois Ho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242249%22"}, {"id": "fda:K240003", "company": "Velmeni, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240003: Velmeni for Dentists (V4D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240003", "people": [{"name": "Mini Suri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240003%22"}, {"id": "fda:K234027", "company": "Embecta Medical I, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234027: embecta Insulin Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234027", "people": [{"name": "Andrew Harrell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234027%22"}, {"id": "fda:K242275", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242275: syngo.via MI Workflows; Scenium; syngo MBF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242275", "people": [{"name": "Clayton Ginn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242275%22"}, {"id": "fda:K241847", "company": "Imbio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241847: Imbio PHA (4.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241847", "people": [{"name": "Lauren Keith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241847%22"}, {"id": "fda:K241148", "company": "3D Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241148: Salto Talaris Ankle PSI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241148", "people": [{"name": "Ashley Dawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241148%22"}, {"id": "fda:K241326", "company": "3D Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241326: Cadence Ankle PSI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241326", "people": [{"name": "Ashley Dawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241326%22"}, {"id": "fda:K241585", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241585: uMI Panorama", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241585", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241585%22"}, {"id": "fda:K233872", "company": "Big Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233872: Daylight", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233872", "people": [{"name": "Reuben Lawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233872%22"}, {"id": "fda:K233932", "company": "Abbott Laboratories", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233932: Alinity i Toxo IgM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233932", "people": [{"name": "Laura Fraczek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233932%22"}, {"id": "fda:K241583", "company": "Remington Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241583: VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241583", "people": [{"name": "Dorothy Frieser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241583%22"}, {"id": "fda:K242300", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242300: MI View&GO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242300", "people": [{"name": "Brian Wui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242300%22"}, {"id": "fda:K233107", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233107: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233107", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233107%22"}, {"id": "fda:K241823", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241823: ToxiSeal\u0099 Vial Adaptor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241823", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241823%22"}, {"id": "fda:K241386", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241386: Heyman Packing Applicator Set (GM11004580)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241386", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241386%22"}, {"id": "fda:K241518", "company": "The Magstim Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241518: Horizon\u00ae 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon\u00ae 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon\u00ae 3.0 TMS Therapy System (Horizon 3.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241518", "people": [{"name": "Daniel Gregory", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241518%22"}, {"id": "fda:K232441", "company": "Tenscare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232441: Unipro (K-UNIPRO-US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232441", "people": [{"name": "Saskia Eldridge-Hinmers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232441%22"}, {"id": "fda:K240180", "company": "Orthopeasia Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240180: Orthopeasia Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240180", "people": [{"name": "Phunyawee Ritshima", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240180%22"}, {"id": "fda:K240464", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240464: WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240464", "people": [{"name": "Katherine Swanson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240464%22"}, {"id": "nih:5R44HL164222-03", "company": "Linshom Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": 666125, "summary": "NIH award 5R44HL164222-03: Advanced Prediction of Emerging Respiratory Decline with the Linshom Continuous Predictive Respiratory Sensor (CPRS) ($666,125)", "source_url": "https://reporter.nih.gov/project-details/10930979", "people": [{"name": "Ronen Feldman", "role": "Principal Investigator"}, {"name": "Richard D. Urman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DK137730-02", "company": "Gel4med, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": 1529428, "summary": "NIH award 5R44DK137730-02: Antimicrobial dermal matrices to promote infection free wound closure in DTU-DFUs. ($1,529,428)", "source_url": "https://reporter.nih.gov/project-details/10918299", "people": [{"name": "Manav Mehta", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241881", "company": "Shenzhen Junmei Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241881: IPL Hair Removal Device (JM-843, JM-865, JM-638)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241881", "people": [{"name": "Zenghui Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241881%22"}, {"id": "fda:K241400", "company": "Crown Aesthetics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241400: SkinPen Precision Elite System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241400", "people": [{"name": "Marie Fogartie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241400%22"}, {"id": "fda:K241227", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241227: RHYTHMIA HDx\u0099 Mapping System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241227", "people": [{"name": "Liliana Omar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241227%22"}, {"id": "fda:K242280", "company": "Stryker Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242280: Vitoss\u00ae BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss\u00ae BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma\u00ae Bioactive Bone Graft Substitute,Vitoss\u00ae BA2X Bioactive Bone Graft Substitute, Vitoss\u00ae Bioactive Bone Graft Substitute Pack,Vitoss\u00ae Bioactive Bone Graft Substitute, Vitoss\u00ae Foam Bone Graft Substitute, Vitoss\u00ae Bone Graft Substitute Filled Canister, Vitoss\u00ae Bone Graft Substitute, Vitoss\u00ae Bone Graft Substitute - Synthetic Cancellous Chips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242280", "people": [{"name": "Fiorella Lopardo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242280%22"}, {"id": "fda:K242243", "company": "Stryker Neurovscular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242243: Target Detachable Coils", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242243", "people": [{"name": "Lorraine Mazzeo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242243%22"}, {"id": "fda:K242296", "company": "Ortho-Design (Pty), Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242296: VersaTap\u0099 Suture Anchor (ADP050); VersaPEEK\u0099 Suture Anchor (APP002); MicroTi\u0099 Suture Anchor (ATP003-M); VersaLat\u0099 Ti Suture Anchor (ADP021-TI); VersaLat\u0099 Suture Anchor (ADP021-PK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242296", "people": [{"name": "Dian Peach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242296%22"}, {"id": "fda:K220908", "company": "Ensol Biosciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220908: Ensol EnTM Specimen Collection and Transport System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220908", "people": [{"name": "Cheol-Min Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220908%22"}, {"id": "fda:K240105", "company": "Forcemech International, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240105: Navigator (FMNVG15); Navigator XL (FMNVX06)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240105", "people": [{"name": "David Ou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240105%22"}, {"id": "fda:K242346", "company": "Natus Manufacturing Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242346: Grass\u00ae MR Conditional/CT Cup Electrodes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242346", "people": [{"name": "Sanjay Mehta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242346%22"}, {"id": "fda:K233826", "company": "EchoNous, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233826: Kosmos", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233826", "people": [{"name": "Joshua Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233826%22"}, {"id": "nih:1R43HD115467-01", "company": "Bold Type LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": 384973, "summary": "NIH award 1R43HD115467-01: An intravaginal, wearable device for treating women with pelvic floor myofascial pain ($384,973)", "source_url": "https://reporter.nih.gov/project-details/10921289", "people": [{"name": "Jose Luis Bohorquez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44NS132605-02S1", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": 116130, "summary": "NIH award 3R44NS132605-02S1: Low-Dose Magneto-Thrombolysis to Expand Stroke Care ($116,130)", "source_url": "https://reporter.nih.gov/project-details/11054715", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "COLIN Pieter DERDEYN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43OH012720-01A1", "company": "Applied Design Technologies", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": 295924, "summary": "NIH award 1R43OH012720-01A1: ClearWorks Particulate Respirator ($295,924)", "source_url": "https://reporter.nih.gov/project-details/11008868", "people": [{"name": "Christopher Estkowski", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R42HD104409-02", "company": "Frd Accel, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": 1039456, "summary": "NIH award 2R42HD104409-02: BabyStrong II (Stimulating the Tragus for Neural Growth): A Randomized Controlled Trial of taVNS-Paired Bottle Feeding to Improve Oral Feeding ($1,039,456)", "source_url": "https://reporter.nih.gov/project-details/11008650", "people": [{"name": "DOROTHEA DENISE JENKINS", "role": "Principal Investigator"}, {"name": "Joe Ruscito", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43OH012719-01", "company": "Inspire Rx LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": 295924, "summary": "NIH award 1R43OH012719-01: Protecting Healthcare Workers Using a Patient-Worn Negative Pressure System to Prevent the Spread of Highly Transmissible Infectious Diseases ($295,924)", "source_url": "https://reporter.nih.gov/project-details/10921441", "people": [{"name": "Sridhar Kota", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43AG084374-02", "company": "Minnesota Healthsolutions Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": 155491, "summary": "NIH award 5R43AG084374-02: A novel driving coach app for older adults with cognitive impairment ($155,491)", "source_url": "https://reporter.nih.gov/project-details/10914273", "people": [{"name": "Pouya Johnathon Ehsani", "role": "Principal Investigator"}, {"name": "Kevin M. Kramer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:2R44OH012421-02", "company": "Creare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": 643238, "summary": "NIH award 2R44OH012421-02: Refinement of Very Low Leakage Non-Invasive Ventilation Mask for Infectious Patients ($643,238)", "source_url": "https://reporter.nih.gov/project-details/11007800", "people": [{"name": "Daniel Micka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44EB034605-02", "company": "Axioforce Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": 941866, "summary": "NIH award 4R44EB034605-02: 3D force sensing insoles for wearable, AI empowered, high-fidelity gait monitoring ($941,866)", "source_url": "https://reporter.nih.gov/project-details/11144679", "people": [{"name": "Jonathan Daniel Miller", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DK117813-08", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": 804004, "summary": "NIH award 5R44DK117813-08: Active Disposable Cap for Endoscope Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps ($804,004)", "source_url": "https://reporter.nih.gov/project-details/10922840", "people": [{"name": "Maureen L. Mulvihill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 8, "new_award": false}, {"id": "fda:K241943", "company": "Sleepnet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241943: Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241943", "people": [{"name": "Jennifer Kennedy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241943%22"}, {"id": "fda:K240078", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240078: Fogarty Thru-Lumen Embolectomy Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240078", "people": [{"name": "Carmen Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240078%22"}, {"id": "fda:K232991", "company": "Bistos Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232991: BT-1000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232991", "people": [{"name": "Goeun Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232991%22"}, {"id": "fda:K241534", "company": "Ortho Clinical Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241534: VITROS Immunodiagnostic Products Syphilis Reagent Pack", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241534", "people": [{"name": "Rebecca Lewis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241534%22"}, {"id": "fda:K241557", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241557: Cercon\u00ae yo ML", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241557", "people": [{"name": "Rebecca Sporer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241557%22"}, {"id": "fda:K233827", "company": "Oxiwear, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233827: OxiWear", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233827", "people": [{"name": "Shavini Fernando", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233827%22"}, {"id": "fda:K233816", "company": "Vilex, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233816: REDEMPTION Charcot Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233816", "people": [{"name": "Brock Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233816%22"}, {"id": "fda:K240545", "company": "Genabio Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240545: GenaCheck\u0099 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240545", "people": [{"name": "Vincent Cai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240545%22"}, {"id": "fda:DEN230067", "company": "Germitec", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230067: Chronos\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230067", "people": [{"name": "Vincent Gardes", "role": "510(k) submission contact"}]}, {"id": "fda:K242316", "company": "Ningbo Medsun Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242316: Safety Lancet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242316", "people": [{"name": "Ping Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242316%22"}, {"id": "fda:K241457", "company": "Inter-Med, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241457: Vista BC Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241457", "people": [{"name": "Alex Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241457%22"}, {"id": "fda:K241932", "company": "OSSIO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241932: OSSIOfiber\u00ae Compression Staple", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241932", "people": [{"name": "Taly Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241932%22"}, {"id": "fda:K241913", "company": "Intuitive Surgical Operations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241913: da Vinci Handheld Camera", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241913", "people": [{"name": "Heena Khandelwal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241913%22"}, {"id": "pma:P240003", "company": "Renata Medical, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P240003: Minima Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240003", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P240003%22"}, {"id": "denovo:DEN230067", "company": "Germitec", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-08-28", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230067 granted: Chronos\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230067"}, {"id": "breakthrough:P240003", "company": "Renata Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-08-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P240003: MINIMA STENT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44GM152985-02", "company": "Potentiometric Probes, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 929918, "summary": "NIH award 5R44GM152985-02: Optimized Ratiometric Voltage-Sensitive Dyes for Cardiac Research, Safety Pharmacology ($929,918)", "source_url": "https://reporter.nih.gov/project-details/10925298", "people": [{"name": "Corey Acker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG058312-05", "company": "Osteodx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 827361, "summary": "NIH award 5R44AG058312-05: Development of Cortical Bone Mechanics Technology for Enhancing the Diagnosis of Osteoporosis ($827,361)", "source_url": "https://reporter.nih.gov/project-details/10876493", "people": [{"name": "Brian C Clark", "role": "Principal Investigator"}, {"name": "Andrew Dick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44AG076093-03", "company": "Proactive Memory Services, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 1203762, "summary": "NIH award 5R44AG076093-03: CUSTOMIZABLE TRAINING SOFTWARE FOR PROFESSIONAL ALZHEIMER DIRECT CARE PROVIDERS ($1,203,762)", "source_url": "https://reporter.nih.gov/project-details/10899632", "people": [{"name": "NORMAN LOUIS FOSTER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG066263-03", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 916985, "summary": "NIH award 5R44AG066263-03: Using Structured Light Sensing with Machine Learning to Detect Unwitnessed In-Home Falls ($916,985)", "source_url": "https://reporter.nih.gov/project-details/10934599", "people": [{"name": "Paul Gibson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44EB034614-02", "company": "Base Pair Biotechnologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 751525, "summary": "NIH award 4R44EB034614-02: Bench-top Reader and Aptamer-based Assay for Rapid, High-sensitivity Drug/Opiate Detection ($751,525)", "source_url": "https://reporter.nih.gov/project-details/11002781", "people": [{"name": "George W Jackson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG058339-03", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 1249991, "summary": "NIH award 5R44AG058339-03: Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals with Alzheimer Disease ($1,249,991)", "source_url": "https://reporter.nih.gov/project-details/10700137", "people": [{"name": "John Kablan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42NS125895-03", "company": "Navinetics Neuromodulation, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 795327, "summary": "NIH award 4R42NS125895-03: An Integrated Neurochemical/Electrophysiological Recording and Neuromodulation System for Basic and Clinical Research ($795,327)", "source_url": "https://reporter.nih.gov/project-details/11082538", "people": [{"name": "Kevin Elliott Bennet", "role": "Principal Investigator"}, {"name": "Kendall Lee", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R42GM154550-01A1", "company": "Biosensing Instrument, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 295561, "summary": "NIH award 1R42GM154550-01A1: Plasmonic Scattering Microscopy for high-throughput in-situ quantification of molecular binding kinetics on single cells ($295,561)", "source_url": "https://reporter.nih.gov/project-details/11008269", "people": [{"name": "Nguyen Ly", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44EB035459-01A1", "company": "Qscint Imaging Solutions, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 811503, "summary": "NIH award 1R44EB035459-01A1: Novel Isotopic Spectroscopy Imaging Tools for Advancing Targeted Alpha Cancer Therapies ($811,503)", "source_url": "https://reporter.nih.gov/project-details/10922240", "people": [{"name": "Jared William Moore", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R42CA287798-01", "company": "Trifoil Imaging", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 399491, "summary": "NIH award 1R42CA287798-01: Multi-Modality Optical Molecular Imaging System for Preclinical Cancer Models ($399,491)", "source_url": "https://reporter.nih.gov/project-details/10823044", "people": [{"name": "GULTEKIN GULSEN", "role": "Principal Investigator"}, {"name": "Austin Moy", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG082637-02", "company": "Moai Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 808635, "summary": "NIH award 5R44AG082637-02: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in at-risk Older Adults ($808,635)", "source_url": "https://reporter.nih.gov/project-details/10934547", "people": [{"name": "Olu Olofinboba", "role": "Principal Investigator"}, {"name": "Dereck L Salisbury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42AG078721-03", "company": "Gateway Biotechnology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": 482587, "summary": "NIH award 5R42AG078721-03: Developing a clinical diagnostic tool for age-related cochlear synaptopathy. ($482,587)", "source_url": "https://reporter.nih.gov/project-details/10929509", "people": [{"name": "Joseph Pinkl", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K242212", "company": "Nemoto Kyorindo Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242212: Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242212", "people": [{"name": "Jim Knipfer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242212%22"}, {"id": "fda:K241228", "company": "Zynex Medical Officer", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241228: TENSWave", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241228", "people": [{"name": "Sandgaard Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241228%22"}, {"id": "fda:K241354", "company": "Inter-Med, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241354: Sealer Solvent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241354", "people": [{"name": "Brett Arand", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241354%22"}, {"id": "fda:K240270", "company": "Guangdong Prestige Technology Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240270: Electric wheelchair (S7018)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240270", "people": [{"name": "Zhang Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240270%22"}, {"id": "fda:K233846", "company": "Ecmpc, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233846: Vitrification Solution Set and Warming Solution Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233846", "people": [{"name": "Jose Gaytan Melicoff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233846%22"}, {"id": "fda:K241787", "company": "Ascensia Diabetes Care U.S., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241787: CONTOUR\u00ae PLUS BLUE Blood Glucose Monitoring System; CONTOUR\u00ae NEXT GEN Blood Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241787", "people": [{"name": "Divya Munjpara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241787%22"}, {"id": "fda:K241684", "company": "Overjet, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241684: Overjet Charting Assist", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241684", "people": [{"name": "Deepthi Paknikar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241684%22"}, {"id": "fda:K241523", "company": "Laborie Medical Technologies, Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241523: injeTAK Adjustable Tip Needle (DIS199; DIS201)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241523", "people": [{"name": "Thomas Hirte", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241523%22"}, {"id": "fda:K234151", "company": "AtriCure, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234151: Isolator Synergy EnCapture Ablation System (EMH)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234151", "people": [{"name": "Dominique Neisz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234151%22"}, {"id": "fda:K242537", "company": "American Orthodontics Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242537: BracePaste Fluoride Sealant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242537", "people": [{"name": "Luke Hetue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242537%22"}, {"id": "fda:K241517", "company": "Stryker Leibinger GmbH & Co KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241517: Q Guidance System; Mako Spine System;", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241517", "people": [{"name": "Dipan Lad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241517%22"}, {"id": "fda:K241241", "company": "Orchard Medical Development, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241241: Z1 Cemented Hip System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241241", "people": [{"name": "Brett Zarda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241241%22"}, {"id": "nih:1R44CA295197-01", "company": "Creosalus, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": 857315, "summary": "NIH award 1R44CA295197-01: Comparison of convection enhanced delivery systems in a randomized controlled clinical study of recurrent Grade 3-4 glioma patients ($857,315)", "source_url": "https://reporter.nih.gov/project-details/11006772", "people": [{"name": "Vasiliy Abramov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM136046-03", "company": "Proteinaceous, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": 960667, "summary": "NIH award 5R44GM136046-03: Data-Driven Software to Automate Top-Down Mass Spectrometry of Large Molecules ($960,667)", "source_url": "https://reporter.nih.gov/project-details/10912761", "people": [{"name": "Kenneth Durbin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42NS129395-02", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": 1208662, "summary": "NIH award 4R42NS129395-02: Developing Active Stimulation and Monitoring Technologies to Optimize Pain and Nociception Management During Regional Anesthesia, General Anesthesia, and Post-Operative Care ($1,208,662)", "source_url": "https://reporter.nih.gov/project-details/11160369", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R42HL174371-01A1", "company": "Pip Care, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": 302049, "summary": "NIH award 1R42HL174371-01A1: Novel Digital Health Platform with Virtual Health Coach for Improving Perioperative Patient Outcomes and Care Coordination ($302,049)", "source_url": "https://reporter.nih.gov/project-details/11013554", "people": [{"name": "Jennifer Holder-Murray", "role": "Principal Investigator"}, {"name": "Kathy Kaluhiokalani", "role": "Principal Investigator"}, {"name": "Aman Mahajan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R43AG082615-02", "company": "Neurocomp Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": 231834, "summary": "NIH award 5R43AG082615-02: Assessment Validation ($231,834)", "source_url": "https://reporter.nih.gov/project-details/10933515", "people": [{"name": "JAMES P O'HALLORAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43EB034623-01A1", "company": "Imggyd LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": 349545, "summary": "NIH award 1R43EB034623-01A1: Saf-T-Drape: Sterile Drapery Shielding for Radiological Scanners ($349,545)", "source_url": "https://reporter.nih.gov/project-details/10918010", "people": [{"name": "TERRENCE R OAKES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241607", "company": "Myocardial Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241607: MyoStrain (6.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241607", "people": [{"name": "Linda Home", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241607%22"}, {"id": "fda:K241850", "company": "Ulrich GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241850: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241850", "people": [{"name": "Sven Erdmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241850%22"}, {"id": "fda:K242044", "company": "Erbe Elektromedizin GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242044: FiAPC plus probes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242044", "people": [{"name": "Matthias Kollek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242044%22"}, {"id": "fda:K241777", "company": "Insulet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241777: SmartAdjust\u0099 Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241777", "people": [{"name": "Alexander Hamad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241777%22"}, {"id": "fda:K241858", "company": "Ovesco Endoscopy AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241858: BARS Set (100.60)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241858", "people": [{"name": "Antonio Caputo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241858%22"}, {"id": "fda:K241538", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241538: TriClip Steerable Guide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241538", "people": [{"name": "Irma Barr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241538%22"}, {"id": "fda:K240286", "company": "Primed Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240286: PRIMED Surgical Masks and PRIMED Procedure Masks", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240286", "people": [{"name": "Mitra Fard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240286%22"}, {"id": "fda:K240982", "company": "Terrats Medical SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240982: DESS Dental Smart Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240982", "people": [{"name": "Roger Terrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240982%22"}, {"id": "pma:P230020", "company": "Neuros Medical, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230020: Altius\u00ae Direct Electrical Nerve Stimulation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230020", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230020%22"}, {"id": "pma:P230012", "company": "Alcon Research, LLC", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-08-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230012: UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230012", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230012%22"}, {"id": "breakthrough:P230020", "company": "Neuros Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-08-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230020: ALTIUS DIRECT ELECTRICAL NERVE STIMULATION SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43OD037625-01A1", "company": "Objective Biotechnology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": 294543, "summary": "NIH award 1R43OD037625-01A1: Machine vision guided robotics for automated microinjections into fruit fly embryos ($294,543)", "source_url": "https://reporter.nih.gov/project-details/11013464", "people": [{"name": "Andrew D Alegria", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA278186-02A1", "company": "Ananya Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": 1172978, "summary": "NIH award 2R44CA278186-02A1: Portable, low-cost cryotherapy system that does not require consumable cryogen gas for the treatment of cervical precancerous lesions ($1,172,978)", "source_url": "https://reporter.nih.gov/project-details/11008761", "people": [{"name": "Wei-Hsiang Chang", "role": "Principal Investigator"}, {"name": "Anubhuti Parvatiyar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG087803-01A1", "company": "Amissa, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": 505516, "summary": "NIH award 1R43AG087803-01A1: Augmented Preclinical Alzheimer's Disease Detection Through Wearable Health and Driving Behavior Data. ($505,516)", "source_url": "https://reporter.nih.gov/project-details/11008460", "people": [{"name": "Jon Andrew Corkey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH131510-03", "company": "Experiad, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": 685030, "summary": "NIH award 5R44MH131510-03: Acuity - A Clinical Decision Support System for Applied Behavior Analysis ($685,030)", "source_url": "https://reporter.nih.gov/project-details/10914301", "people": [{"name": "REX M JAKOBOVITS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43OH012650-01A1", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": 302409, "summary": "NIH award 1R43OH012650-01A1: Active Arm-Support Industrial Exoskeleton to Reduce Work-Related Musculoskeletal Disorders (WRMSDs) ($302,409)", "source_url": "https://reporter.nih.gov/project-details/10919980", "people": [{"name": "John Kablan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43MH132180-02", "company": "Habitaware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": 399278, "summary": "NIH award 5R43MH132180-02: Technology Assisted Treatment for Binge Eating Behavior ($399,278)", "source_url": "https://reporter.nih.gov/project-details/10895597", "people": [{"name": "Sameer Kumar", "role": "Principal Investigator"}, {"name": "CAROL B. PETERSON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA295373-01", "company": "Wild Dog Physics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": 1063155, "summary": "NIH award 1R44CA295373-01: Improving allocation of scarce medical physics resources through a novel, comprehensive quality assurance device. ($1,063,155)", "source_url": "https://reporter.nih.gov/project-details/11007744", "people": [{"name": "Janelle Arlene Molloy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K240896", "company": "Global Protection Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240896: ONE Nitrile Condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240896", "people": [{"name": "Christina Cataldo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240896%22"}, {"id": "fda:K242169", "company": "Biocardia", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242169: Morph DNA Steerable Introducer Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242169", "people": [{"name": "Ed Gillis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242169%22"}, {"id": "fda:K233358", "company": "InBios International, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233358: SCoV-2 Ag Detect Rapid Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233358", "people": [{"name": "Annabel Tsai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233358%22"}, {"id": "fda:K241302", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241302: SonoSync", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241302", "people": [{"name": "Jee Young Ju", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241302%22"}, {"id": "fda:K242264", "company": "THINK Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242264: TMINI Miniature Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242264", "people": [{"name": "Anand Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242264%22"}, {"id": "fda:K241492", "company": "JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241492: Guided Surgery Kit Cases", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241492", "people": [{"name": "Leticia Milani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241492%22"}, {"id": "fda:K233829", "company": "Fisher and Paykel Healthcare Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233829: Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233829", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233829%22"}, {"id": "fda:K231100", "company": "Proimtech Saglik Urunleri Anonim Sirketi", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231100: Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231100", "people": [{"name": "Hakan Cevik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231100%22"}, {"id": "fda:K242191", "company": "Olympus Surgical Technologies America", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242191: SOLTIVE\u0099 Laser System (SOLTIVE\u0099 Pro SuperPulsed Laser, SOLTIVE\u0099 Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242191", "people": [{"name": "Apurva Joshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242191%22"}, {"id": "fda:K241780", "company": "Cardinal Health200, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241780: Cardinal Health Nitrile Exam Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241780", "people": [{"name": "Vani Bala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241780%22"}, {"id": "fda:K240318", "company": "Bonebridge AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240318: SITTER 3.5mm Versatile System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240318", "people": [{"name": "Michelle Gumpelmayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240318%22"}, {"id": "fda:K240790", "company": "Suzhou Colour-Way New Material Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240790: Polyisoprene Surgical gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240790", "people": [{"name": "Yingfang Qian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240790%22"}, {"id": "fda:K242202", "company": "Fotona D.O.O.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242202: LightWalker Laser System Family", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242202", "people": [{"name": "Tina Bartolic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242202%22"}, {"id": "fda:K240593", "company": "NeuroServo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240593: VEEGix EEG System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240593", "people": [{"name": "Nicolas Tremblay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240593%22"}, {"id": "fda:K233801", "company": "Boston Scientific Neuromodulation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233801: Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233801", "people": [{"name": "Kaoru Lee Adair", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233801%22"}, {"id": "nih:1R43HL176331-01", "company": "Ventsafe, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": 290434, "summary": "NIH award 1R43HL176331-01: VENTSAFE\u2122 Life Saving Ventilation for the Treatment of ARDS ($290,434)", "source_url": "https://reporter.nih.gov/project-details/11007305", "people": [{"name": "Dean Antony Barker", "role": "Principal Investigator"}, {"name": "Sean Degmetich", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD115425-01", "company": "Theranova, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": 343510, "summary": "NIH award 1R43HD115425-01: SoleStim Neuromodulation System, a home-use device for the treatment of dysmenorrhea ($343,510)", "source_url": "https://reporter.nih.gov/project-details/10916979", "people": [{"name": "Daniel Rogers Burnett", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL169112-02", "company": "Thermedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": 1210431, "summary": "NIH award 5R44HL169112-02: Eliminating Ventricular Tachycardia: Pivotal Clinical Trial using the Durablate\u00ae Catheter ($1,210,431)", "source_url": "https://reporter.nih.gov/project-details/10928202", "people": [{"name": "MICHAEL G CURLEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM149102-02", "company": "Partillion Bioscience Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": 741926, "summary": "NIH award 5R44GM149102-02: Hydrogel microparticle technology for high-throughout screening of chimeric antigen receptor-T cells based on single cell effector function ($741,926)", "source_url": "https://reporter.nih.gov/project-details/10922670", "people": [{"name": "Joseph de Rutte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DK127835-04", "company": "Urogenie LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": 879432, "summary": "NIH award 5R44DK127835-04: Digital Uroflowmetry for Office and Home ($879,432)", "source_url": "https://reporter.nih.gov/project-details/10930136", "people": [{"name": "Roman Fedorovsky", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AT012302-02", "company": "Brightoutcome Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": 1201885, "summary": "NIH award 5R44AT012302-02: GEMINI: Virtual Integrative Medical Group Visits for Managing Chronic Pain ($1,201,885)", "source_url": "https://reporter.nih.gov/project-details/10930853", "people": [{"name": "Paula Marie Gardiner", "role": "Principal Investigator"}, {"name": "Niina M. Haas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44EB035063-02", "company": "Virtuoso Surgical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": 908121, "summary": "NIH award 5R44EB035063-02: A Robotic System to Remove Bladder Tumors Intact: The Key to Making Lifesaving Treatment Decisions ($908,121)", "source_url": "https://reporter.nih.gov/project-details/10925417", "people": [{"name": "Richard Joseph Hendrick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43OH012683-01", "company": "Minnesota Healthsolutions Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": 357231, "summary": "NIH award 1R43OH012683-01: Voice Amplifier to Enhance Occupational Safety and Critical Care among Masked Providers ($357,231)", "source_url": "https://reporter.nih.gov/project-details/10822861", "people": [{"name": "Matthew G Hilden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R42HD104305-02", "company": "Nuborn Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": 859275, "summary": "NIH award 2R42HD104305-02: A Novel Non-Invasive Method of Dysphagia Detection in Preterm Infants: Bottle Finalization & Validation ($859,275)", "source_url": "https://reporter.nih.gov/project-details/11008443", "people": [{"name": "Katlyn Elizabeth McGrattan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43GM154541-01", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": 302417, "summary": "NIH award 1R43GM154541-01: Virtual chromatographic cytometry for in-line biomanufacturing process analysis ($302,417)", "source_url": "https://reporter.nih.gov/project-details/10918821", "people": [{"name": "Jesung Park", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241803", "company": "Insulcloud S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241803: INSULCLOCK\u00ae v2.0 PRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241803", "people": [{"name": "Pilar Aranda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241803%22"}, {"id": "fda:K240227", "company": "Lina Medical Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240227: LiNA CystoVu\u0099 HD (CYV-100-5; CYV-101-5); LiNA ScopeVu\u0099 (SCP-100-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240227", "people": [{"name": "Barczak Katarzyna", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240227%22"}, {"id": "fda:K241098", "company": "Cortechs Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241098: NeuroQuant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241098", "people": [{"name": "Kora Marinkovic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241098%22"}, {"id": "fda:K241979", "company": "Beijing Konted Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241979: Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241979", "people": [{"name": "Deyi Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241979%22"}, {"id": "fda:K234128", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234128: Phantom Fibula Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234128", "people": [{"name": "Haylie Fast", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234128%22"}, {"id": "fda:K242248", "company": "Beijing Demax Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242248: Introducer Sheath Kits", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242248", "people": [{"name": "Nicole Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242248%22"}, {"id": "fda:K242126", "company": "Bq Plus Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242126: I.V. Administration Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242126", "people": [{"name": "Jin Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242126%22"}, {"id": "fda:K230071", "company": "Tdm Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230071: Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230071", "people": [{"name": "Jung Wook Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230071%22"}, {"id": "fda:K241369", "company": "Lijia, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241369: LIJIA Night Guard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241369", "people": [{"name": "Benjamin Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241369%22"}, {"id": "fda:K234076", "company": "Centervue S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234076: iCare ALTIUS CW", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234076", "people": [{"name": "Luca Scienza", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234076%22"}, {"id": "fda:K241109", "company": "Shenzhen Boon Medical Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241109: Single-use Sterile High-pressure Angiographic Syringes and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241109", "people": [{"name": "Shengyu Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241109%22"}, {"id": "fda:K241804", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241804: TRIGEN INTERTAN 10S Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241804", "people": [{"name": "Hiral Rathod", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241804%22"}, {"id": "nih:5R42AG069629-03", "company": "Rip Road, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R42AG069629-03: The Assessment of Smart Phone Everyday Tasks (ASSET): A new IADL test for early AD ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10932404", "people": [{"name": "Eric Leven Eric Leven Eric Leven", "role": "Principal Investigator"}, {"name": "GAD ASHER MARSHALL", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL172316-01", "company": "Scientific Horizons Consulting LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": 274875, "summary": "NIH award 1R43HL172316-01: A Novel Aerosolization and Inhalation Platform for the Pulmonary Delivery of Anti-inflammatory Agents to Distal Airways for the Enhanced Pain Management in Chronic Obstructive Pulmonary Disease (COPD) ($274,875)", "source_url": "https://reporter.nih.gov/project-details/10819739", "people": [{"name": "Xiang Gao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG050366-05", "company": "Parabon Nanolabs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": 648343, "summary": "NIH award 5R44AG050366-05: Novel whole-genome analysis methods for Alzheimer's risk prediction ($648,343)", "source_url": "https://reporter.nih.gov/project-details/10914867", "people": [{"name": "Ellen McRae Greytak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44AG079734-03", "company": "Einsenca Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": 1336772, "summary": "NIH award 5R44AG079734-03: PET Imaging of Damaging Neuroinflammation in Alzheimer's Disease ($1,336,772)", "source_url": "https://reporter.nih.gov/project-details/10912830", "people": [{"name": "Andrew Christian Larson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43MH135599-01A1", "company": "Neurotrainer Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": 489314, "summary": "NIH award 1R43MH135599-01A1: A Feasibility and Efficacy Study of NeuroTrainer Cognitive Training in Students With and Without Attention-Related Difficulties ($489,314)", "source_url": "https://reporter.nih.gov/project-details/11006829", "people": [{"name": "Jeff Nyquist", "role": "Principal Investigator"}, {"name": "JULIE B. SCHWEITZER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K242066", "company": "Amalgam Rx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242066: iSage Rx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242066", "people": [{"name": "Miller Andy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242066%22"}, {"id": "fda:K240859", "company": "Terumo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240859: Glidewire GT-R", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240859", "people": [{"name": "Qing Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240859%22"}, {"id": "fda:K241080", "company": "Kerecis Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241080: Kerecis Parvus (50207)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241080", "people": [{"name": "William Kabitz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241080%22"}, {"id": "fda:K241061", "company": "Cork Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241061: VERSA Negative Pressure Wound Therapy System (VCMPP-100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241061", "people": [{"name": "Antonio Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241061%22"}, {"id": "fda:K242142", "company": "Solta Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242142: Fraxel\u00ae FTX Laser System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242142", "people": [{"name": "Sophie Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242142%22"}, {"id": "fda:K240298", "company": "Bionova Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240298: Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240298", "people": [{"name": "Alex Greene", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240298%22"}, {"id": "fda:K241351", "company": "Guangdong Transtek Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241351: Blood Pressure Monitor (TMB-2092-G)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241351", "people": [{"name": "Fan Jerry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241351%22"}, {"id": "fda:K240290", "company": "Subtle Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240290: AiMIFY (1.x)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240290", "people": [{"name": "Ronny Elor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240290%22"}, {"id": "fda:K233391", "company": "VPIX Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233391: cCeLL - In vivo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233391", "people": [{"name": "Kyungmin Hwang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233391%22"}, {"id": "fda:K242141", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242141: TiLink-P SI Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242141", "people": [{"name": "Berny Villejeune", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242141%22"}, {"id": "fda:K232415", "company": "Boston Scientific Neuromodulation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232415: Nalu Neurostimulation System for Peripheral Nerve Stimulation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232415", "people": [{"name": "Kaoru Lee Adair", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232415%22"}, {"id": "fda:K240314", "company": "Guangzhou Ciellulu Photoelectric Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240314: MULA (K2-A1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240314", "people": [{"name": "Jackie Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240314%22"}, {"id": "fda:K233566", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233566: Montage-XT Settable, Resorbable Bone Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233566", "people": [{"name": "Howard Schrayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233566%22"}, {"id": "pma:P230011", "company": "Illumina, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-08-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230011: TruSight Oncology Comprehensive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230011", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230011%22"}, {"id": "nih:5R44EY032825-03", "company": "F Square Medical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": 1093927, "summary": "NIH award 5R44EY032825-03: Development of the First-ever Safe and Effective Anterior Chamber Paracentesis Instrument to Treat and Diagnose Ocular Diseases ($1,093,927)", "source_url": "https://reporter.nih.gov/project-details/10915425", "people": [{"name": "samer farah", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DA061397-01", "company": "Labsys, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": 294474, "summary": "NIH award 1R43DA061397-01: Wearable Continuous Drug Monitoring Device for Personal Medications in Opioid Use Disorders (CDM-MOUD) ($294,474)", "source_url": "https://reporter.nih.gov/project-details/10984292", "people": [{"name": "Yue Huang", "role": "Principal Investigator"}, {"name": "Zhe Wang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41EB035980-01", "company": "Pharynvac Surgical Technology Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": 285705, "summary": "NIH award 1R41EB035980-01: Development of a novel kit for reduction of aerosolized particles during endonasal surgeries: the PharynVac Device ($285,705)", "source_url": "https://reporter.nih.gov/project-details/10922180", "people": [{"name": "Alfred-Marc Iloreta", "role": "Principal Investigator"}, {"name": "Benjamin Isaac Rapoport", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH124562-05", "company": "Experiad, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": 839726, "summary": "NIH award 5R44MH124562-05: Goalspace: A Platform for Parent-Assisted Behavioral Interventions ($839,726)", "source_url": "https://reporter.nih.gov/project-details/10917249", "people": [{"name": "REX M JAKOBOVITS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44DK138688-02", "company": "Nephropathology Associates", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": 950283, "summary": "NIH award 5R44DK138688-02: A proprietary digital platform for precision patient identification and enrollment of clinical trials for rare kidney diseases ($950,283)", "source_url": "https://reporter.nih.gov/project-details/10930152", "people": [{"name": "Christopher P Larsen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43GM155903-01A1S1", "company": "Kasa Bio, L.l.c.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": 13000, "summary": "NIH award 3R43GM155903-01A1S1: A multiplex platform for quantitative analysis of clinically important gene expression signatures ($13,000)", "source_url": "https://reporter.nih.gov/project-details/11137159", "people": [{"name": "Kiran Madanahally Divakar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:9R44GM159290-02", "company": "Alida Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": 1082339, "summary": "NIH award 9R44GM159290-02: Engineered RNA Modification Recognition ($1,082,339)", "source_url": "https://reporter.nih.gov/project-details/10920516", "people": [{"name": "Zachary Miles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241738", "company": "GS Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241738: PYXIS 3D Titanium Cervical Cage system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241738", "people": [{"name": "Seon Yeon Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241738%22"}, {"id": "fda:K242134", "company": "Finemedix Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242134: ClearCap Distal Attachment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242134", "people": [{"name": "Seok-Jun Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242134%22"}, {"id": "fda:K240200", "company": "Procept Biorobotics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240200: HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240200", "people": [{"name": "Sara Muddell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240200%22"}, {"id": "fda:K241848", "company": "Ningbo Caremed Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241848: MedtFine Safety Lancet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241848", "people": [{"name": "Wei Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241848%22"}, {"id": "fda:K241458", "company": "Borvo Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241458: Borvo EVAC System (Ergo); Borvo EVAC System (Classic)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241458", "people": [{"name": "Soren Thompson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241458%22"}, {"id": "fda:K241102", "company": "Foreo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241102: Luna 4 plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241102", "people": [{"name": "Evan Feldstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241102%22"}, {"id": "fda:K231932", "company": "Techwin Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231932: TDS (TECHWIN DENTAL SYSTEM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231932", "people": [{"name": "Min-Jae Jo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231932%22"}, {"id": "fda:K234114", "company": "Okapi Medical, LLC Dba Resivant Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234114: CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234114", "people": [{"name": "Tom Stephens", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234114%22"}, {"id": "fda:K240077", "company": "Covidien", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240077: Mon-a-Therm\u0099 General Purpose Temperature Probe 400TM (90050, 90044)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240077", "people": [{"name": "Angelica Medina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240077%22"}, {"id": "fda:K242189", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242189: CELERITY HP Indicator Tape (PCC077)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242189", "people": [{"name": "Anthony Piotrkowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242189%22"}, {"id": "fda:K241496", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241496: Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241496", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241496%22"}, {"id": "sbir:DOD:HT9425-24-C-0065", "company": "Advanced Respiratory Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-08-20", "observed": "2026-09-18", "amount_usd": 1299976, "summary": "DOD SBIR Phase II award $1,299,976: Continued Development of the Coaxial Femoral Cannula (CFC) for Far Forward Extracoporeal Life Support Initiation, Prolonged Field Care, and Transport", "source_url": "https://www.sbir.gov/awards?search=H2-0774"}, {"id": "nih:1R43AR083322-01A1", "company": "Inprint Bio LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": 295481, "summary": "NIH award 1R43AR083322-01A1: MuscleInk: A multifunctional colloidal scaffold for the treatment of muscle loss ($295,481)", "source_url": "https://reporter.nih.gov/project-details/10920960", "people": [{"name": "Lindsay C Barnum", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MD019604-01", "company": "One Cow Standing, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": 987455, "summary": "NIH award 1R44MD019604-01: The HMP Next Gen digital health platform: accelerating research implementation, amplifying public health impact ($987,455)", "source_url": "https://reporter.nih.gov/project-details/10919984", "people": [{"name": "Nickie Buckner", "role": "Principal Investigator"}, {"name": "Lisa B Hightow-Weidman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44NS137901-01A1", "company": "Neurodex Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": 2147016, "summary": "NIH award 1R44NS137901-01A1: Blood-based Biomarker for Characterizing Progression and Therapeutic Response in Amyotrophic Lateral Sclerosis ($2,147,016)", "source_url": "https://reporter.nih.gov/project-details/11005933", "people": [{"name": "Erez Eitan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS135863-01A1", "company": "Backstop Neural, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": 485026, "summary": "NIH award 1R43NS135863-01A1: Thin, Softening Epidural Leads for Chronic Arm and Neck Pain ($485,026)", "source_url": "https://reporter.nih.gov/project-details/11006736", "people": [{"name": "Connie Manz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241870", "company": "Onpoint Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241870: OnPoint Augmented Reality Spine System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241870", "people": [{"name": "Amy O'Donnell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241870%22"}, {"id": "fda:K241023", "company": "Med Way, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241023: Negative Pressure Wound Therapy Device (V-Move, V-Grand)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241023", "people": [{"name": "Ahmed Alawad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241023%22"}, {"id": "fda:K241504", "company": "SI-BONE, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241504: iFuse TORQ TNT\u0099 Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241504", "people": [{"name": "Jayasri Prabakaran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241504%22"}, {"id": "fda:K241275", "company": "Samantree Medical SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241275: Histolog\u00ae Scanner (Hardware 2.4, Software 3.3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241275", "people": [{"name": "Olivier Delporte", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241275%22"}, {"id": "fda:K240235", "company": "Shenzhen Dakewe Bio-Engineering Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240235: OmniTrans Transport System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240235", "people": [{"name": "Wei Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240235%22"}, {"id": "fda:K242432", "company": "Mectron S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242432: MT-Bone", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242432", "people": [{"name": "Chiara Acunzo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242432%22"}, {"id": "fda:K241440", "company": "Nano-X AI , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241440: HealthCCSng", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241440", "people": [{"name": "Neta Sherman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241440%22"}, {"id": "fda:K241282", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241282: RibFix Titan\u0099 Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241282", "people": [{"name": "Paul Vagts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241282%22"}, {"id": "breakthrough:K241504", "company": "Si-bone, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-08-19", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K241504: IFUSE TORQ TNT IMPLANT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44GM152152-02", "company": "Advaita Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-17", "observed": "2026-08-21", "amount_usd": 896814, "summary": "NIH award 5R44GM152152-02: A web-based platform for robust single-cell analysis, bulk data deconvolution and system-level analysis ($896,814)", "source_url": "https://reporter.nih.gov/project-details/10915555", "people": [{"name": "Olivia Pifer Alge", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K240234", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240234: BTL-899MS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240234", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240234%22"}, {"id": "nih:5R44HD114305-02", "company": "Luna Labs USA, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": 857868, "summary": "NIH award 5R44HD114305-02: Improving Maternal Outcomes of Cesarean Delivery with the Prevention of Postoperative Adhesions ($857,868)", "source_url": "https://reporter.nih.gov/project-details/10931679", "people": [{"name": "Lauren Costella", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44HD090793-04", "company": "Advanced Tactile Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": 934714, "summary": "NIH award 2R44HD090793-04: Cervix monitor for risk assessment of spontaneous preterm delivery ($934,714)", "source_url": "https://reporter.nih.gov/project-details/11006927", "people": [{"name": "Vladimir Egorov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44DA050218-03", "company": "Dimagi, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": 874937, "summary": "NIH award 5R44DA050218-03: A conversational agent to support remote care for individuals with substance use disorder ($874,937)", "source_url": "https://reporter.nih.gov/project-details/10928274", "people": [{"name": "Y. Xian Ho", "role": "Principal Investigator"}, {"name": "Jonathan Lee Jackson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K242239", "company": "Gentuity, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242239: HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242239", "people": [{"name": "Edwin Rule", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242239%22"}, {"id": "fda:K240307", "company": "Shenzhen Vitavitro Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240307: VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240307", "people": [{"name": "Donghai Pan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240307%22"}, {"id": "fda:K241314", "company": "KLS-Martin L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241314: KLS Martin Oral-Max Implants MR Conditional (bundled)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241314", "people": [{"name": "Melissa Bachorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241314%22"}, {"id": "fda:K233755", "company": "B-Secur Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233755: HeartKey\u00ae Rhythm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233755", "people": [{"name": "Cameron Moore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233755%22"}, {"id": "fda:K242108", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242108: Ambu\u00ae aScope\u0099 5 Uretero (Standard Deflection); Ambu\u00ae aScope\u0099 5 Uretero (Reverse Deflection); Ambu\u00ae aView\u0099 2 Advance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242108", "people": [{"name": "Gamze Yilan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242108%22"}, {"id": "fda:K233700", "company": "Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233700: Avicenna Roboflex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233700", "people": [{"name": "Ahmet Sinan Kabakci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233700%22"}, {"id": "fda:K233499", "company": "OrbusNeich Medical (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233499: Sapphire NC ULTRA Coronary Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233499", "people": [{"name": "Jerry Cheung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233499%22"}, {"id": "fda:K242127", "company": "Instrumentation Laboratory (IL) Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242127: ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242127", "people": [{"name": "Sneh Pingle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242127%22"}, {"id": "fda:K240978", "company": "MacroLux Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240978: SeleneView\u00ae Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240978", "people": [{"name": "Linbin Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240978%22"}, {"id": "fda:K240740", "company": "Qure.Ai Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240740: qCT LN Quant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240740", "people": [{"name": "Abishamala Kingsly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240740%22"}, {"id": "fda:K240573", "company": "Align Technology , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240573: iTero Lumina\u0099 Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240573", "people": [{"name": "Aviva Touati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240573%22"}, {"id": "fda:K223700", "company": "Intelon Optics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223700: BOSS\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223700", "people": [{"name": "Pavana Mysore Ganesh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223700%22"}, {"id": "fda:K231979", "company": "Shenzhen Mecun Medical Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231979: Mecun SpO2 sensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231979", "people": [{"name": "Zheng Bo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231979%22"}, {"id": "fda:K222126", "company": "Vivachek Biotech (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222126: VivaChek\u0099 Fad Blood Glucose Monitoring System, VivaChek\u0099 Fad Smart Blood Glucose Monitoring System, VivaChek\u0099 Fad Sync Blood Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222126", "people": [{"name": "Mark Qian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222126%22"}, {"id": "fda:K240133", "company": "Collagen Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240133: Xenograft Bovine Bone Particulate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240133", "people": [{"name": "Sheila Hunter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240133%22"}, {"id": "fda:K241236", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241236: XTRA Collection sets; XTRA Sequestration set X", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241236", "people": [{"name": "Martina Carlini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241236%22"}, {"id": "fda:K240081", "company": "Jiangxi Wulinxiang Biological Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240081: Human Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240081", "people": [{"name": "Yang Qi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240081%22"}, {"id": "fda:K233896", "company": "Jdentalcare Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233896: JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233896", "people": [{"name": "Antonio Grandi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233896%22"}, {"id": "fda:DEN230090", "company": "Nowdiagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230090: First To Know Syphilis Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230090", "people": [{"name": "Kevin Clark", "role": "510(k) submission contact"}]}, {"id": "denovo:DEN230090", "company": "Nowdiagnostics", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-08-16", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230090 granted: First To Know Syphilis Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230090"}, {"id": "nih:1R43DK138596-01A1", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": 356314, "summary": "NIH award 1R43DK138596-01A1: A system to enhance prevention of diabetic foot ulcers and their recurrence ($356,314)", "source_url": "https://reporter.nih.gov/project-details/11005852", "people": [{"name": "Brian R Clark", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44HD107822-02", "company": "Hillmed Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": 563197, "summary": "NIH award 4R44HD107822-02: An Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management ($563,197)", "source_url": "https://reporter.nih.gov/project-details/11139696", "people": [{"name": "Nicholas Dias", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43ES036401-01", "company": "Juxtopia, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": 99781, "summary": "NIH award 1R43ES036401-01: JiHi, An Artificial Intelligent HAZWOPER e-trainer for tutoring and evaluating emergency first response clinical skill proficiency. ($99,781)", "source_url": "https://reporter.nih.gov/project-details/10888671", "people": [{"name": "Jayfus Tucker Doswell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS139747-01", "company": "Virtici, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": 700000, "summary": "NIH award 1R43NS139747-01: A Novel Blood Test for Early Diagnosis of Frontotemporal Lobar Degeneration ($700,000)", "source_url": "https://reporter.nih.gov/project-details/11005947", "people": [{"name": "Neil A Fanger", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH112216-04", "company": "Fox Learning Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": 250783, "summary": "NIH award 5R44MH112216-04: Development and Randomized Clinical Trial of an App-based Intervention to Reduce Postpartum Depression in High-Risk Women ($250,783)", "source_url": "https://reporter.nih.gov/project-details/10917400", "people": [{"name": "DEBRA L FOX", "role": "Principal Investigator"}, {"name": "ELLEN L POLESHUCK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AI174405-02", "company": "Henley Ion, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": 832868, "summary": "NIH award 5R44AI174405-02: A micronized electrostatic precipitator for next-generation respiratory protection against pathogenic aerosols ($832,868)", "source_url": "https://reporter.nih.gov/project-details/10909139", "people": [{"name": "Julian HENLEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44EB029280-03", "company": "Radiation Detection Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": 905711, "summary": "NIH award 5R44EB029280-03: The Rapid-Production of the High-Performance and Affordable Cadmium Telluride and Cadmium Zinc Telluride for Medical Imaging Applications. ($905,711)", "source_url": "https://reporter.nih.gov/project-details/10933546", "people": [{"name": "LARS R FURENLID", "role": "Principal Investigator"}, {"name": "John S McCloy", "role": "Principal Investigator"}, {"name": "Benjamin Montag", "role": "Principal Investigator"}, {"name": "Santosh Kumar Swain", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K242061", "company": "Creo Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242061: Reusable Interface Cable 1.5 m (PRD-IFC-002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242061", "people": [{"name": "Diane Davis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242061%22"}, {"id": "fda:K241596", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241596: uMI Panvivo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241596", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241596%22"}, {"id": "fda:K241754", "company": "Zimmer Switzerland Manufacturing GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241754: NCB\u00ae Polyaxial Locking Plate System; NCB\u00ae Periprosthetic Femur Plate System; NCB\u00ae Cable Button; NCB\u00ae Straight Narrow Shaft Plate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241754", "people": [{"name": "Melanie Mitrov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241754%22"}, {"id": "fda:K233965", "company": "Parker Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233965: UltraDrape UGPIV Barrier and Securement (34-15)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233965", "people": [{"name": "Candy Beck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233965%22"}, {"id": "fda:K241401", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241401: Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241401", "people": [{"name": "Sekar Divya", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241401%22"}, {"id": "fda:K240961", "company": "Wuxi Nest Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240961: Disposable Pen Injector Assembly", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240961", "people": [{"name": "Cheng Zhiwei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240961%22"}, {"id": "fda:K241522", "company": "Guard Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241522: NPseal (20 and 25)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241522", "people": [{"name": "Machiel van der Leest", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241522%22"}, {"id": "fda:K241750", "company": "Medifun Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241750: Medifun Safety Lancet ( MSL1 series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241750", "people": [{"name": "Aaron Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241750%22"}, {"id": "fda:K241810", "company": "Ascensia Diabetes Care U.S., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241810: MICROLET\u00aeNEXT Lancet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241810", "people": [{"name": "Sangram Yadav", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241810%22"}, {"id": "fda:K241211", "company": "Smart Soft Healthcare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241211: CoLumbo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241211", "people": [{"name": "Nedelcho Georgiev", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241211%22"}, {"id": "fda:K233505", "company": "OrbusNeich Medical (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233505: Sapphire ULTRA Coronary Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233505", "people": [{"name": "Jerry Cheung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233505%22"}, {"id": "fda:K240837", "company": "Rdj Tov Implant, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240837: TOV Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240837", "people": [{"name": "David Elkouby", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240837%22"}, {"id": "sbir:DOD:FA8649-24-P-1016", "company": "NanoGuard Medical Solutions, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-08-15", "observed": "2026-09-18", "amount_usd": 1245650, "summary": "DOD SBIR Phase II award $1,245,650: Saving Lives in Combat \u2013 A Revolutionary Nanofiber Wound Care", "source_url": "https://www.sbir.gov/awards?search=F2D-13846"}, {"id": "sbir:DOD:FA8649-24-P-1106", "company": "Matregenix Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-08-15", "observed": "2026-09-18", "amount_usd": 1797867, "summary": "DOD STTR Phase II award $1,797,867: DermaSpin: Handheld Device for Contactless Application of an Antibacterial Nanofiber Matrix for Rapid Wound Healing at the Point-of-Care", "source_url": "https://www.sbir.gov/awards?search=FX23E-TPCSO1-0245"}, {"id": "nih:1R43MD019594-01", "company": "Bioxytech Retina, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": 406500, "summary": "NIH award 1R43MD019594-01: Advancing Public Eye Health through AI-Driven Prediction of Diabetic Retinopathy ($406,500)", "source_url": "https://reporter.nih.gov/project-details/10923617", "people": [{"name": "Ali Basiri", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DE032290-03", "company": "Radiation Monitoring Devices, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": 854588, "summary": "NIH award 5R44DE032290-03: Semiconductor detector for low-dose, high-resolution dental DR imaging ($854,588)", "source_url": "https://reporter.nih.gov/project-details/10929529", "people": [{"name": "JAMES F CHRISTIAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44NS130864-03", "company": "Neurodex Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": 942163, "summary": "NIH award 5R44NS130864-03: Development of a Blood-based Test for Identifying Synucleinopathy in Patients with Dementia ($942,163)", "source_url": "https://reporter.nih.gov/project-details/10928757", "people": [{"name": "Erez Eitan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R42AG071290-03S1", "company": "Synchrohealth LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R42AG071290-03S1: BandPass: A Remote Monitoring System for Sarcopenia and Functional Decline ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11099531", "people": [{"name": "Ryan Joseph Halter", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DE031194-03", "company": "Praevium Research, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": 861274, "summary": "NIH award 5R44DE031194-03: Next generation MEMS-VCSEL technology for ultra-low-cost dental and periodontal swept source optical coherence tomography imaging ($861,274)", "source_url": "https://reporter.nih.gov/project-details/10929536", "people": [{"name": "Vijaysekhar Jayaraman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AI183961-01A1", "company": "Ossium Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": 375113, "summary": "NIH award 1R44AI183961-01A1: Developing a bank of purified myeloid progenitor cells as a bridging therapy for transient pancytopenia resulting from radiation injury ($375,113)", "source_url": "https://reporter.nih.gov/project-details/11006882", "people": [{"name": "Brian H. Johnstone", "role": "Principal Investigator"}, {"name": "Subhrajit Saha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DE033316-02", "company": "Perceptive Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": 838114, "summary": "NIH award 5R44DE033316-02: Developing an Optical Coherence Tomography (OCT) based handheld intraoral scanner for dentistry ($838,114)", "source_url": "https://reporter.nih.gov/project-details/11003269", "people": [{"name": "Wei Kang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44AR078728-02A1", "company": "Penderia Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": 872774, "summary": "NIH award 2R44AR078728-02A1: Real-time Feedback for Post-Operative Rehabilitation of Rotator Cuff Repairs using Wireless Force-Sensing Suture Anchors ($872,774)", "source_url": "https://reporter.nih.gov/project-details/10919062", "people": [{"name": "Salil Sidharthan Karipott", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K242077", "company": "Aicheck Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242077: PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242077", "people": [{"name": "Lisa Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242077%22"}, {"id": "fda:K240957", "company": "Contract Medical International, GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240957: Catapult Guide Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240957", "people": [{"name": "Jan Kubicek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240957%22"}, {"id": "fda:K241748", "company": "Plus EV Holdings Dba Intimate Rose", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241748: Intimate Rose Vaginal Dilators", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241748", "people": [{"name": "Aaron Wilt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241748%22"}, {"id": "fda:K242057", "company": "Avanos Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242057: COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242057", "people": [{"name": "Liane Miller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242057%22"}, {"id": "fda:K241510", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241510: CROSSLEAD Tracker", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241510", "people": [{"name": "Katsuhiko Fujimura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241510%22"}, {"id": "fda:K241969", "company": "Qingdao Hightop Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241969: Hightop\u00ae Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop\u00ae Fentanyl/Norfentanyl Urine Rapid Test Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241969", "people": [{"name": "Ray Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241969%22"}, {"id": "fda:K232836", "company": "Dimar S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232836: Family of DIMAR DMAX NIV masks", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232836", "people": [{"name": "Maurizio Borsari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232836%22"}, {"id": "fda:K240595", "company": "Utepreva, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240595: Utepreva Endometrial Sampler (UP01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240595", "people": [{"name": "Zanetta Malanowska-Stega", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240595%22"}, {"id": "fda:K242059", "company": "X-Cel Specialty Contacts, A Walman Optical Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242059: Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242059", "people": [{"name": "Hue Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242059%22"}, {"id": "fda:K240713", "company": "Cresilon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240713: TRAUMAGEL\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240713", "people": [{"name": "Hassaan Ahmad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240713%22"}, {"id": "fda:K241571", "company": "Boston Foundation For Sight, Inc. D/B/A Bostonsight", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241571: BostonSight\u00ae Specialty Lenses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241571", "people": [{"name": "Sara Yost", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241571%22"}, {"id": "nih:5R42LM014356-03", "company": "Ubitrix International, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": 917997, "summary": "NIH award 5R42LM014356-03: A Framework for mHealth App Security and Privacy Analysis ($917,997)", "source_url": "https://reporter.nih.gov/project-details/10918331", "people": [{"name": "Sheikh Iqbal Ahamed", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44MH122028-03A1", "company": "Champaign Imaging, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": 1390948, "summary": "NIH award 2R44MH122028-03A1: Next Generation Pediatric Neuroimaging (NGPN) Development ($1,390,948)", "source_url": "https://reporter.nih.gov/project-details/11008691", "people": [{"name": "Curtis Andrew Corum", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AI179440-02", "company": "Orlance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": 990275, "summary": "NIH award 5R44AI179440-02: Clinic-Ready MACH-1 Gene Gun for delivery of a universal influenza DNA vaccine ($990,275)", "source_url": "https://reporter.nih.gov/project-details/10911318", "people": [{"name": "Hannah Frizzell", "role": "Principal Investigator"}, {"name": "Deborah H. Fuller", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42MH124566-04", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": 994696, "summary": "NIH award 5R42MH124566-04: NeuroExM ($994,696)", "source_url": "https://reporter.nih.gov/project-details/10906114", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44NS137845-01", "company": "Neurologic Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": 1204564, "summary": "NIH award 1R44NS137845-01: EpiScalp: An EEG Analytics Solution to Improve Diagnosis of Epilepsy ($1,204,564)", "source_url": "https://reporter.nih.gov/project-details/10918584", "people": [{"name": "Andrew Gotshalk", "role": "Principal Investigator"}, {"name": "Babitha Haridas", "role": "Principal Investigator"}, {"name": "Jennifer L. Hopp", "role": "Principal Investigator"}, {"name": "Michael R Sperling", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA054867-01A1", "company": "See Yourself Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": 294489, "summary": "NIH award 1R43DA054867-01A1: The Chiron Project: Using Virtual Reality to Prevent Substance Use Disorder in Healthcare Workers Facing Burnout ($294,489)", "source_url": "https://reporter.nih.gov/project-details/11008046", "people": [{"name": "Ronald Irwin Harris", "role": "Principal Investigator"}, {"name": "Suzanne Mitchell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41EB036583-01", "company": "Odmr Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": 305000, "summary": "NIH award 1R41EB036583-01: Diamond quantum sensor for magnetoencephalography ($305,000)", "source_url": "https://reporter.nih.gov/project-details/11008869", "people": [{"name": "Victor Marcel Acosta", "role": "Principal Investigator"}, {"name": "Andrejs Jarmola", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD019549-01", "company": "Minnesota Healthsolutions Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": 311579, "summary": "NIH award 1R43MD019549-01: Online Interactive Platform for Parents in Rural Settings to Promote Healthy Habits ($311,579)", "source_url": "https://reporter.nih.gov/project-details/10918832", "people": [{"name": "Bridget Kathleen Biggs", "role": "Principal Investigator"}, {"name": "Matthew Knutson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA060905-01A1", "company": "Vox Biomedical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": 293968, "summary": "NIH award 1R43DA060905-01A1: Breath aerosol capture by electric field concentration ($293,968)", "source_url": "https://reporter.nih.gov/project-details/11007716", "people": [{"name": "KURT J LINDEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL162443-03", "company": "Atomo, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": 825902, "summary": "NIH award 5R44HL162443-03: Finding undiagnosed ATTR-CM patients using AI technology in clinical settings ($825,902)", "source_url": "https://reporter.nih.gov/project-details/10912831", "people": [{"name": "Kelly D Myers", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K241813", "company": "Si-Technology, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241813: SI-TECHNOLOGY\u00ae SI-DESIS\u00ae X\u0099 Sacroiliac Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241813", "people": [{"name": "Donner Chris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241813%22"}, {"id": "fda:K241429", "company": "Fujifilm Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241429: ECHELON Synergy MRI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241429", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241429%22"}, {"id": "fda:K240807", "company": "Ventis Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240807: VM-2000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240807", "people": [{"name": "Glenn Laub", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240807%22"}, {"id": "fda:K241699", "company": "Ilooda Co,., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241699: SUPER VELOCE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241699", "people": [{"name": "Ha Yunjung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241699%22"}, {"id": "fda:K241978", "company": "Hangzhou AllTest Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241978: Shinetell Digital Pregnancy Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241978", "people": [{"name": "Rosa Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241978%22"}, {"id": "fda:K241547", "company": "Weifang Dragonfly Electronics Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241547: Diode Laser Therapy Device (DF-DIODE LASER-S1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241547", "people": [{"name": "Ray Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241547%22"}, {"id": "fda:K241094", "company": "Turing Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241094: Bullsai", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241094", "people": [{"name": "Christa Nova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241094%22"}, {"id": "fda:K241686", "company": "Zhejiang Zhonglei Medical Technology Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241686: Power wheelchair (N6101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241686", "people": [{"name": "Chengwei Ying", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241686%22"}, {"id": "fda:K241387", "company": "In2bones USA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241387: CoLink NeoFuse MIS Plating System (see attached parts list)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241387", "people": [{"name": "Christine Scifert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241387%22"}, {"id": "sbir:DOD:W51701-24-C-0178", "company": "Neurable Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-08-13", "observed": "2026-09-18", "amount_usd": 1885038, "summary": "DOD SBIR Phase II award $1,885,038: EEG-Enabled Form Factors for Army Brain Health Monitoring", "source_url": "https://www.sbir.gov/awards?search=A2D-1409"}, {"id": "sbir:DOD:W911QY-24-P-0089", "company": "Hedgefog Research Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-08-13", "observed": "2026-09-18", "amount_usd": 197280, "summary": "DOD SBIR Phase I award $197,280: Physiological Status Monitor", "source_url": "https://www.sbir.gov/awards?search=C233-003-0009"}, {"id": "nih:5R44HL169158-02", "company": "Perosphere Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": 897824, "summary": "NIH award 5R44HL169158-02: Novel Broad-Spectrum Point-of-Care Coagulometer ($897,824)", "source_url": "https://reporter.nih.gov/project-details/10912646", "people": [{"name": "Sasha H Bakhru", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NS132605-02", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": 1544509, "summary": "NIH award 5R44NS132605-02: Low-Dose Magneto-Thrombolysis to Expand Stroke Care ($1,544,509)", "source_url": "https://reporter.nih.gov/project-details/10871913", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "Thomas M Hemmen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R41NS132625-02", "company": "Vanish Therapeutics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": 346517, "summary": "NIH award 5R41NS132625-02: Opioid-Sparing Non-Surgical, Bioresorbable Nerve Stimulator for Pain Relief ($346,517)", "source_url": "https://reporter.nih.gov/project-details/10932412", "people": [{"name": "XINYAN Tracy CUI", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM143977-03", "company": "Edvotek, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": 751085, "summary": "NIH award 5R44GM143977-03: The EdvoReader: Developing a Quantitative PCR and Colorimetry Instrument for Laboratory Skills Training ($751,085)", "source_url": "https://reporter.nih.gov/project-details/10913572", "people": [{"name": "Brian Ell", "role": "Principal Investigator"}, {"name": "DANIELLE SNOWFLACK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42NS115282-03", "company": "Alcorix", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": 902911, "summary": "NIH award 5R42NS115282-03: Implantable Microarray Probe for Real-Time Glutamate and GABA Detection ($902,911)", "source_url": "https://reporter.nih.gov/project-details/10930948", "people": [{"name": "Prabhu Arumugam", "role": "Principal Investigator"}, {"name": "Nicolaie Andrei Moldovan", "role": "Principal Investigator"}, {"name": "RIO J VETTER", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R44GM151918-01S1", "company": "Qatch Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": 45000, "summary": "NIH award 3R44GM151918-01S1: High-throughput injectability screening of high concentration protein formulations by microfluidic quartz resonators ($45,000)", "source_url": "https://reporter.nih.gov/project-details/11093217", "people": [{"name": "Zehra Parlak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K240868", "company": "Alesi Surgical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240868: Ultravision2\u0099 IonPencil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240868", "people": [{"name": "Pravin Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240868%22"}, {"id": "fda:K241328", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241328: aprevo\u00ae Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo\u00ae Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo\u00ae Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241328", "people": [{"name": "Aly Alvarez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241328%22"}, {"id": "fda:K241365", "company": "Pixie Cup, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241365: Pixie Pulse (SM9068)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241365", "people": [{"name": "Amber English", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241365%22"}, {"id": "fda:K242054", "company": "Rebrain, Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242054: OptimMRI (v2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242054", "people": [{"name": "Thomas Queuche", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242054%22"}, {"id": "fda:K242096", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242096: dS FootAnkle Coil 8ch 1.5T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242096", "people": [{"name": "Ketaki Bendre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242096%22"}, {"id": "fda:DEN210037", "company": "Soclean, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN210037: SoClean 3+ Bacterial Reduction Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN210037", "people": [{"name": "George Peters", "role": "510(k) submission contact"}]}, {"id": "fda:K241402", "company": "Lg Electronics.Inc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241402: Medical Monitor (32HR734S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241402", "people": [{"name": "Hanseul Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241402%22"}, {"id": "fda:K241846", "company": "Evolution Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241846: E3D\u0099-C Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241846", "people": [{"name": "Todd Wallenstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241846%22"}, {"id": "fda:K233367", "company": "Id-Fish Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233367: iDart Lyme IgG ImmunoBlot Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233367", "people": [{"name": "Jyotsna Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233367%22"}, {"id": "fda:K241656", "company": "Termosalud", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241656: Eneka Selectif", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241656", "people": [{"name": "Cristina Cifuentes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241656%22"}, {"id": "denovo:DEN210037", "company": "Soclean, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-08-12", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210037 granted: SoClean 3+ Bacterial Reduction Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210037"}, {"id": "nih:5R44HD111134-03", "company": "Autoivf, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-10", "observed": "2026-08-21", "amount_usd": 998710, "summary": "NIH award 5R44HD111134-03: OvaSafe: A microfluidic device enabling automated oocyte vitrification ($998,710)", "source_url": "https://reporter.nih.gov/project-details/10914691", "people": [{"name": "Ismail Emre Ozkumur", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44EY035203-02", "company": "Vivid Vision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": 786367, "summary": "NIH award 5R44EY035203-02: Clustered home assessment of visual fields in patients with glaucoma ($786,367)", "source_url": "https://reporter.nih.gov/project-details/10928712", "people": [{"name": "James Blaha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA189522-06", "company": "Applikate Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": 1615322, "summary": "NIH award 5R44CA189522-06: Commercial Readiness for Direct-to-Digital Pathology ($1,615,322)", "source_url": "https://reporter.nih.gov/project-details/10931395", "people": [{"name": "Michael John Levene", "role": "Principal Investigator"}, {"name": "RICHARD TORRES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R43GM151884-01A1", "company": "Dotquant, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": 305892, "summary": "NIH award 1R43GM151884-01A1: Development of a WT RNAP-based kit for high-yield synthesis of chemically modified RNA ($305,892)", "source_url": "https://reporter.nih.gov/project-details/11005990", "people": [{"name": "Hong Yan Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K222688", "company": "Genoss Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222688: The Trust", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222688", "people": [{"name": "Myeong Yujin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222688%22"}, {"id": "fda:K240664", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240664: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240664", "people": [{"name": "Guilherme Pires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240664%22"}, {"id": "fda:K240469", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240469: Access TPO Antibody", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240469", "people": [{"name": "Neha Desai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240469%22"}, {"id": "fda:K233697", "company": "CHISON Medical Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233697: SonoMax Series Digital Color Doppler Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233697", "people": [{"name": "Yingying Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233697%22"}, {"id": "fda:K231950", "company": "Medicreations, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231950: MEDIDIODE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231950", "people": [{"name": "Anthony Hardy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231950%22"}, {"id": "fda:K242016", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242016: EnSite\u0099 X EP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242016", "people": [{"name": "Alexandra Agre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242016%22"}, {"id": "fda:K232404", "company": "Medicon Hellas S.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232404: CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232404", "people": [{"name": "Sotia Mitropoulou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232404%22"}, {"id": "fda:K240079", "company": "Suzhou Ideal Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240079: Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240079", "people": [{"name": "Hu Qi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240079%22"}, {"id": "fda:K241376", "company": "Threadstone, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241376: HyperSuture All Blue Extension Line", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241376", "people": [{"name": "Jeremy Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241376%22"}, {"id": "fda:K233643", "company": "Fisher & Paykel Healthcare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233643: F&P Airvo 3 NIV (PT311US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233643", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233643%22"}, {"id": "fda:K234053", "company": "Fisher & Paykel Healthcare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234053: F&P Optiflow Flow Diverter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234053", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234053%22"}, {"id": "nih:1R42TR005299-01", "company": "Cellchorus Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": 349171, "summary": "NIH award 1R42TR005299-01: LF-TIMING: Large-scale label-free profiling of cell-cell interactions ($349,171)", "source_url": "https://reporter.nih.gov/project-details/11008612", "people": [{"name": "Rebecca L Berdeaux", "role": "Principal Investigator"}, {"name": "BADRINATH ROYSAM", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG088131-01A1", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": 295825, "summary": "NIH award 1R43AG088131-01A1: Smartphone Machine Learning Speech Enhancement System for Hearing Aid Devices for the Underserved and Rural Populations ($295,825)", "source_url": "https://reporter.nih.gov/project-details/10920072", "people": [{"name": "Paul Gibson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44NS135792-01S1", "company": "Enclear Therapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": 93199, "summary": "NIH award 3R44NS135792-01S1: Targeted Cerebral Spinal Fluid (CSF) Drug Delivery - Enclear Precision System ($93,199)", "source_url": "https://reporter.nih.gov/project-details/11089161", "people": [{"name": "MARCIE A GLICKSMAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:9R44MH140096-02", "company": "Neurolux, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": 986327, "summary": "NIH award 9R44MH140096-02: Wireless Implantable Mechano-Acoustic Recording Device ($986,327)", "source_url": "https://reporter.nih.gov/project-details/11004885", "people": [{"name": "Cameron Good", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42AG071290-03", "company": "Synchrohealth LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": 894303, "summary": "NIH award 5R42AG071290-03: BandPass: A Remote Monitoring System for Sarcopenia and Functional Decline ($894,303)", "source_url": "https://reporter.nih.gov/project-details/10877887", "people": [{"name": "Ryan Joseph Halter", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DC022220-01", "company": "Qualia Oto, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": 277057, "summary": "NIH award 1R43DC022220-01: Shape-Adaptive Cochlear Implant Electrode Arrays ($277,057)", "source_url": "https://reporter.nih.gov/project-details/11008666", "people": [{"name": "Jimin Maeng", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R41AG082600-02", "company": "Signal Solutions, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": 106472, "summary": "NIH award 5R41AG082600-02: Noninvasive sleep enhancement and behavior monitoring technologies for Alzheimer's model mice ($106,472)", "source_url": "https://reporter.nih.gov/project-details/10863907", "people": [{"name": "BRUCE Frederick O'HARA", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "fda:K233844", "company": "Odne AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233844: OdneClean", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233844", "people": [{"name": "Mark Bispinghoff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233844%22"}, {"id": "fda:K240229", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240229: Masimo W1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240229", "people": [{"name": "Sindura Penubarthi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240229%22"}, {"id": "fda:K242009", "company": "Kico Knee Innovation Company Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242009: 360CAS Knee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242009", "people": [{"name": "Danyon Munro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242009%22"}, {"id": "fda:K233312", "company": "Aktormed GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233312: SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233312", "people": [{"name": "Hanna Kafurke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233312%22"}, {"id": "fda:K240724", "company": "Synthesis Health Intelligence, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240724: SynthVISION 1.0.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240724", "people": [{"name": "Amy Gilchrist", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240724%22"}, {"id": "fda:K233720", "company": "Luminopia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233720: Luminopia", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233720", "people": [{"name": "Endri Angjeli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233720%22"}, {"id": "fda:K231775", "company": "Pro3Dure Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231775: GR Resin System MSI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231775", "people": [{"name": "Frank Gischer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231775%22"}, {"id": "fda:K234058", "company": "Fisher & Paykel Healthcare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234058: F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234058", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234058%22"}, {"id": "fda:K233822", "company": "Mrimath, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233822: i2Contour", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233822", "people": [{"name": "Hassan Fathallah-Shaykh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233822%22"}, {"id": "fda:K233702", "company": "LivaNova USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233702: SMARxT Tubing and Connectors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233702", "people": [{"name": "Tatjana Kuntschik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233702%22"}, {"id": "fda:K241665", "company": "Ge Medical Systems Israel, Functional Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241665: Omni Legend", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241665", "people": [{"name": "Alexandra Lifshits", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241665%22"}, {"id": "fda:K233315", "company": "Surgical Planning Associates, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233315: HipXpert and HipInsight System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233315", "people": [{"name": "Stephen Murphy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233315%22"}, {"id": "fda:K233356", "company": "Laxmi Dental Export Pvt., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233356: Illusion Aligner Pro: Illusion Aligner FLX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233356", "people": [{"name": "Sameer Merchant", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233356%22"}, {"id": "nih:5R44GM134849-04", "company": "Immuto Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": 612291, "summary": "NIH award 5R44GM134849-04: Plasma-Generated Hydroxyl Radicals for Analysis of Three-Dimensional Structures in Protein Therapeutics ($612,291)", "source_url": "https://reporter.nih.gov/project-details/10892250", "people": [{"name": "Faraz Choudhury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44GM148147-02A1", "company": "Cytequest, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": 1002657, "summary": "NIH award 2R44GM148147-02A1: Adaptable and scalable electroporation for cellular therapy ($1,002,657)", "source_url": "https://reporter.nih.gov/project-details/11006102", "people": [{"name": "HAROLD G CRAIGHEAD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44AG071409-03", "company": "Trace-ability, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": 1500000, "summary": "NIH award 2R44AG071409-03: Enabling nationwide AD PET imaging to support most efficient clinical trials by adoption of radically simplified and standardized quality control in commercial production of AD PET tracers. ($1,500,000)", "source_url": "https://reporter.nih.gov/project-details/10921696", "people": [{"name": "Arkadij Elizarov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44NS108850-05", "company": "Backyard Brains, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": 940479, "summary": "NIH award 5R44NS108850-05: Introducing Neuroscience and Neurocomputation Concepts to High School Students using Brain-based Neurorobots ($940,479)", "source_url": "https://reporter.nih.gov/project-details/10915703", "people": [{"name": "Gregory John Gage", "role": "Principal Investigator"}, {"name": "Christopher Aidan Harris", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44HL147667-03", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": 914107, "summary": "NIH award 5R44HL147667-03: Respiratory Oxygen Adherence Monitor for COPD Patients ($914,107)", "source_url": "https://reporter.nih.gov/project-details/10906913", "people": [{"name": "Eileen T. Krepkovich", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AG087872-01", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": 499968, "summary": "NIH award 1R44AG087872-01: Developing an Integrated Brain State Monitor for Personalized Anesthesia Decision Support: Preventing Postoperative Delirium in Elderly and Patients At Risk for Alzheimer's or Related Dementias ($499,968)", "source_url": "https://reporter.nih.gov/project-details/10921860", "people": [{"name": "David Arney", "role": "Principal Investigator"}, {"name": "Tuan Le Mau", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AA030953-02", "company": "Thrive Digital Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": 815024, "summary": "NIH award 4R44AA030953-02: DEVELOPMENT OF A NOVEL PEER RECOVERY SUPPORTER TRAINING PLATFORM TO DISSEMINATE EVIDENCE-BASED TRAINING AT SCALE ($815,024)", "source_url": "https://reporter.nih.gov/project-details/11135615", "people": [{"name": "Christopher Neil Pesce", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K240330", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240330: HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240330", "people": [{"name": "Anureet Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240330%22"}, {"id": "fda:K241530", "company": "Guangdong Optomedic Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241530: Stellar Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241530", "people": [{"name": "Minghua Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241530%22"}, {"id": "fda:K240605", "company": "Vitrolife Sweden AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240605: Ultra RapidWarm\u0099 Blast", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240605", "people": [{"name": "Nina Arvidsson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240605%22"}, {"id": "fda:K240255", "company": "Zhejiang Jianrui Technology Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240255: Electric Wheelchair (JLE-W01A-2023)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240255", "people": [{"name": "Zhihong Lyu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240255%22"}, {"id": "fda:K233605", "company": "Biokit, S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233605: ADVIA Centaur EBV-EBNA IgG", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233605", "people": [{"name": "Dominique Monferrer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233605%22"}, {"id": "fda:K212969", "company": "Lhbiomed Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K212969: Liposaver", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212969", "people": [{"name": "Seongsoo Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K212969%22"}, {"id": "fda:K241685", "company": "Sofwave Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241685: SofWave System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241685", "people": [{"name": "Ruthie Amir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241685%22"}, {"id": "fda:K233606", "company": "Biokit, S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233606: ADVIA Centaur EBV-VCA IgM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233606", "people": [{"name": "Dominique Monferrer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233606%22"}, {"id": "fda:K241644", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241644: SPINEART Navigation Instrument System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241644", "people": [{"name": "Estelle Lefeuvre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241644%22"}, {"id": "fda:K233433", "company": "Medtronic", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233433: Sphere-9Dx Diagnostic Catheter (AFR-00009)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233433", "people": [{"name": "Matthew Lobeck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233433%22"}, {"id": "nih:1R44HL172541-01", "company": "Rithim Biologics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-06", "observed": "2026-08-21", "amount_usd": 317285, "summary": "NIH award 1R44HL172541-01: Novel Gene Therapy, Techniques, and Devices to Prevent Ventricular Tachycardia ($317,285)", "source_url": "https://reporter.nih.gov/project-details/10822751", "people": [{"name": "Ronald Lee Anderson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DA051084-03", "company": "Autonomous Healthcare, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-06", "observed": "2026-08-21", "amount_usd": 300831, "summary": "NIH award 5R44DA051084-03: Using Machine Learning and Blockchain Technology to Reduce Drug Diversion in Hospitals ($300,831)", "source_url": "https://reporter.nih.gov/project-details/10932909", "people": [{"name": "Behnood Gholami", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K241708", "company": "Abiomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241708: Abiomed 14Fr Low Profile Introducer Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241708", "people": [{"name": "Anshul Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241708%22"}, {"id": "fda:K241528", "company": "Comfort Rubber Gloves Industries Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241528: Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241528", "people": [{"name": "Sumathi Saravana Sami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241528%22"}, {"id": "fda:K233920", "company": "Eos Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233920: EOSedge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233920", "people": [{"name": "Mathilde Masurel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233920%22"}, {"id": "fda:K240796", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240796: myAblation Guide (VB80A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240796", "people": [{"name": "Allman Lynn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240796%22"}, {"id": "sbir:DOD:HT9425-23-C-0050", "company": "Daxor Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-08-06", "observed": "2026-09-18", "amount_usd": 1649997, "summary": "DOD SBIR Phase II award $1,649,997: Direct Blood Volume Analyzer for Improvement of Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2S-0039"}, {"id": "nih:5R44CA285121-02", "company": "Spatial Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": 998481, "summary": "NIH award 5R44CA285121-02: Spatial genomics analysis of tumor samples ($998,481)", "source_url": "https://reporter.nih.gov/project-details/10918314", "people": [{"name": "Kirsten Frieda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA291420-01", "company": "Radiopharmaceutical Imaging And Dosimetry, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": 898497, "summary": "NIH award 1R44CA291420-01: Cloud/Subscription based, Customer-Responsive Dosimetry Tool for alpha-Particle Emitters ($898,497)", "source_url": "https://reporter.nih.gov/project-details/10921546", "people": [{"name": "ERIC C. FREY", "role": "Principal Investigator"}, {"name": "Michael Ghaly", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R42CA265316-03", "company": "Filtro Medical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R42CA265316-03: Endovascular ChemoFilter to Reduce Doxorubicin Toxicity during Intra-Arterial Chemotherapy ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10930909", "people": [{"name": "Steven William Hetts", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL176267-01", "company": "Endolynx Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": 506500, "summary": "NIH award 1R43HL176267-01: Optical sensor-enabled endotracheal tube to reduce esophageal intubation and unintended extubation ($506,500)", "source_url": "https://reporter.nih.gov/project-details/11006824", "people": [{"name": "Felek Jachimowicz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42ES034684-03", "company": "Spectree Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": 904304, "summary": "NIH award 5R42ES034684-03: Multispectral Sensor for Chemical Composition Analysis of Ultrafine Aerosols in Air Quality Assessment ($904,304)", "source_url": "https://reporter.nih.gov/project-details/10925399", "people": [{"name": "ALEXANDER V MAMISHEV", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HD110306-02", "company": "Mother's Milk Is Best, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": 798508, "summary": "NIH award 5R44HD110306-02: Point of Care maternal milk concentration device to optimize neonatal growth with targeted nutrition support ($798,508)", "source_url": "https://reporter.nih.gov/project-details/10850683", "people": [{"name": "Elizabeth Randall Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K233577", "company": "Big Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233577: Sleepio\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233577", "people": [{"name": "Reuben Lawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233577%22"}, {"id": "fda:K240127", "company": "Conmed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240127: PlumeSafe X5 Smoke Management System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240127", "people": [{"name": "Erin Hoffman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240127%22"}, {"id": "fda:K233992", "company": "Precision AI Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233992: Precision AI Surgical Planning System (PAI-SPS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233992", "people": [{"name": "Sara Baniadam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233992%22"}, {"id": "fda:K240782", "company": "Pulse Biosciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240782: CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240782", "people": [{"name": "Uyen Mai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240782%22"}, {"id": "fda:K241360", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241360: Universal Seal (5-12 mm)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241360", "people": [{"name": "Taian Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241360%22"}, {"id": "fda:K240953", "company": "Exo Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240953: AI Platform 2.0 (AIP002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240953", "people": [{"name": "Jacqueline Murray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240953%22"}, {"id": "fda:K233761", "company": "Longwood Valley Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233761: Orthopaedic Surgery Planning Software (AIJOINT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233761", "people": [{"name": "Chen Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233761%22"}, {"id": "fda:K241635", "company": "Intuitive Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241635: da Vinci E-200 Electrosurgical Generator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241635", "people": [{"name": "Medha Sateesh Bharadwaj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241635%22"}, {"id": "fda:K233653", "company": "Peregrine Surgical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233653: Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233653", "people": [{"name": "Melissa DeHass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233653%22"}, {"id": "fda:K240932", "company": "Erbe Elektromedizin GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240932: HybridTherm System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240932", "people": [{"name": "Matthias Kollek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240932%22"}, {"id": "sbir:DOD:HT9425-24-C-0067", "company": "Critical Innovations LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-08-05", "observed": "2026-09-18", "amount_usd": 1300000, "summary": "DOD SBIR Phase II award $1,300,000: Succor Combat Foam for Advanced Wound Care of Traumatized Tissue", "source_url": "https://www.sbir.gov/awards?search=H2S-0065"}, {"id": "nih:2R44MD018249-02", "company": "Kdh Research And Communication, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-04", "observed": "2026-08-21", "amount_usd": 925820, "summary": "NIH award 2R44MD018249-02: Intervention to Help Orient Men to Excel (IN-HOME): A culturally appropriate CHW training program to reduce minority caregiver burden ($925,820)", "source_url": "https://reporter.nih.gov/project-details/10922110", "people": [{"name": "Dexter L Cooper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44MD017174-03", "company": "Benten Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-03", "observed": "2026-08-21", "amount_usd": 792546, "summary": "NIH award 5R44MD017174-03: Multi-modal Intervention for Lactation Care (MILC) will be a mHealth platform to increase ($792,546)", "source_url": "https://reporter.nih.gov/project-details/10692677", "people": [{"name": "Tony Xuyen Ma", "role": "Principal Investigator"}, {"name": "Yukiko Washio", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44HD107729-02", "company": "Meditrace LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": 843097, "summary": "NIH award 4R44HD107729-02: Fast-Track Multimodal monitoring for neonatal neurocritical care ($843,097)", "source_url": "https://reporter.nih.gov/project-details/11140578", "people": [{"name": "Tony Christopher Carnes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44EB035078-02", "company": "Magnetic Insight, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": 996469, "summary": "NIH award 5R44EB035078-02: Ultra-low distortion and noise electronics to enable a clinical MPI imaging platform ($996,469)", "source_url": "https://reporter.nih.gov/project-details/10933521", "people": [{"name": "Patrick Goodwill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AR083875-02", "company": "Granite Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": 685746, "summary": "NIH award 5R44AR083875-02: Non-invasively extendable megaprosthesis ($685,746)", "source_url": "https://reporter.nih.gov/project-details/10935989", "people": [{"name": "Jeffrey David Gordon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HD113432-02", "company": "Liberating Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": 817726, "summary": "NIH award 5R44HD113432-02: The Development of a Bimodal Walking-Running Prosthetic Foot ($817,726)", "source_url": "https://reporter.nih.gov/project-details/10931657", "people": [{"name": "Jennifer Lynne Johansson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44MH140129-01", "company": "In Vivo Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": 299896, "summary": "NIH award 1R44MH140129-01: A modular bioluminescence imaging platform using a novel multi-aperture method ($299,896)", "source_url": "https://reporter.nih.gov/project-details/11007824", "people": [{"name": "Alexander D. Klose", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K233601", "company": "Aju Pharm Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233601: Fixone Meniscal Repair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233601", "people": [{"name": "Kwon Mingyeong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233601%22"}, {"id": "fda:K241892", "company": "Xtant Medical Holdings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241892: Cortera\u0099 Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241892", "people": [{"name": "Rebecca Lennemann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241892%22"}, {"id": "fda:K233098", "company": "Sunmed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233098: MYOTouch Muscle Stimulator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233098", "people": [{"name": "Robert Yamashita", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233098%22"}, {"id": "fda:K241268", "company": "Exceleron Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241268: Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241268", "people": [{"name": "Keith Roberts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241268%22"}, {"id": "fda:K241919", "company": "Innovita (Tangshan) Biological Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241919: Innovita HCG Pregnancy Rapid Combo Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241919", "people": [{"name": "Yan Hua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241919%22"}, {"id": "fda:K241359", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241359: Medline UNITE\u00ae MIS Foot Recon Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241359", "people": [{"name": "Jennifer Mason", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241359%22"}, {"id": "fda:K241311", "company": "Bernhard F\u00f6rster GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241311: Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241311", "people": [{"name": "Stefan F\u00f6rster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241311%22"}, {"id": "fda:K233798", "company": "Diality, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233798: Moda-flx Hemodialysis System and Cartridge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233798", "people": [{"name": "Clayton Poppe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233798%22"}, {"id": "fda:K233534", "company": "Hardy Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233534: Viral Transport Medium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233534", "people": [{"name": "Anna Klavins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233534%22"}, {"id": "fda:K241621", "company": "Intuitive Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241621: Da Vinci Monopolar and Bipolar Adapters (378896)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241621", "people": [{"name": "Prerna Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241621%22"}, {"id": "fda:K241716", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241716: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241716", "people": [{"name": "Julia Bally", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241716%22"}, {"id": "fda:K241918", "company": "Mentor Worldwide, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241918: MENTOR\u0099 CPX\u00994 PLUS Enhance Breast Tissue Expander", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241918", "people": [{"name": "Catherine Carvalho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241918%22"}, {"id": "fda:K240909", "company": "Samsung Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240909: Samsung ECG App v 1.3 (ECG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240909", "people": [{"name": "Hon Pak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240909%22"}, {"id": "fda:K241642", "company": "Beijing Mega Beauty Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241642: Diode Laser Hair Removal System (MBT-Diode Laser)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241642", "people": [{"name": "Alex Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241642%22"}, {"id": "fda:K241970", "company": "Kanglongda Vietnam Protection Technology Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241970: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241970", "people": [{"name": "Yao Yuxiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241970%22"}, {"id": "fda:K240981", "company": "Huizhou Xinyi Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240981: Air compression leg massager", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240981", "people": [{"name": "Eason Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240981%22"}, {"id": "fda:K233984", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233984: Acumen Assisted Fluid Management (AFM) Software Feature", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233984", "people": [{"name": "Kshama Pai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233984%22"}, {"id": "fda:K241181", "company": "Dongguan Zsr Biomedical Technology Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241181: Disposable Ureteral Guide Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241181", "people": [{"name": "Sharon Wen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241181%22"}, {"id": "fda:K241987", "company": "Guangzhou Red Pine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241987: Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241987", "people": [{"name": "Weihua Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241987%22"}, {"id": "fda:K242008", "company": "Barco N.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242008: Coronis OneLook", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242008", "people": [{"name": "Julie Vandecandelaere", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242008%22"}, {"id": "fda:K241564", "company": "Baxter Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241564: Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241564", "people": [{"name": "Phillip Romei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241564%22"}, {"id": "fda:K233571", "company": "George Courey, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233571: GCI Surgical Gown", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233571", "people": [{"name": "Cort Naab", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233571%22"}, {"id": "fda:K233706", "company": "Nuvasive", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233706: Bendini Cloud Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233706", "people": [{"name": "Meet Vaghani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233706%22"}, {"id": "nih:5R42DE030040-04", "company": "Virtually Better, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": 412775, "summary": "NIH award 5R42DE030040-04: Disseminable Evidence-Based Treatment for the Dental Office: Virtual Exposure Tools for Dental Fear - neVR Fear the Dentist ($412,775)", "source_url": "https://reporter.nih.gov/project-details/10913377", "people": [{"name": "Margo Adams Larsen", "role": "Principal Investigator"}, {"name": "Richard Eliot Heyman", "role": "Principal Investigator"}, {"name": "AMY Michele Smith SLEP", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R43CA281585-02", "company": "Orlance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": 200000, "summary": "NIH award 5R43CA281585-02: Next Generation Gene-Gun Delivered DNA and RNA Immunotherapeutic Vaccines for Melanoma. ($200,000)", "source_url": "https://reporter.nih.gov/project-details/10932954", "people": [{"name": "Hannah Frizzell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43MH138930-01", "company": "Magnify Biosciences Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": 457026, "summary": "NIH award 1R43MH138930-01: Multiplex Magnify Protocol and Kit for High Plex, Superresolution 3D Synaptic Imaging and Analysis in Neuroscience ($457,026)", "source_url": "https://reporter.nih.gov/project-details/11008538", "people": [{"name": "Aleksandra Klimas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD097017-03", "company": "Couplet Care, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": 649496, "summary": "NIH award 5R44HD097017-03: Development of the Couplet Care Bassinet to support safe implementation of skin-to-skin contact and rooming-in on postnatal units ($649,496)", "source_url": "https://reporter.nih.gov/project-details/10907832", "people": [{"name": "Stacie McEntyre", "role": "Principal Investigator"}, {"name": "Cecilia Tomori", "role": "Principal Investigator"}, {"name": "Kristin Patricia Tully", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DK141303-01", "company": "Allvivo Vascular, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": 295922, "summary": "NIH award 1R43DK141303-01: Catheter Cap with Anti-biofilm Luminal Insert ($295,922)", "source_url": "https://reporter.nih.gov/project-details/11006223", "people": [{"name": "Jennifer Ann Neff", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K233731", "company": "GE Medical Systems SCS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233731: CardIQ Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233731", "people": [{"name": "Peter Uhlir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233731%22"}, {"id": "fda:K241238", "company": "Garrison Dental Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241238: LOOP\u0099 LED Curing Light System (CLK01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241238", "people": [{"name": "Rhonda Allen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241238%22"}, {"id": "fda:K241690", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241690: Logical Liner; World Liner; World Knee Patella", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241690", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241690%22"}, {"id": "fda:K232469", "company": "Teleflexmedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232469: R\u00fcsch Latex Gold Foley Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232469", "people": [{"name": "Angela Bouse", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232469%22"}, {"id": "fda:K241105", "company": "Jvckenwood Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241105: 3MP Color LCD Monitor (CL-S301)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241105", "people": [{"name": "Takayuki Kasahara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241105%22"}, {"id": "fda:K233942", "company": "Pentax of America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233942: PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233942", "people": [{"name": "Gurvinder Singh Nanda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233942%22"}, {"id": "fda:K233580", "company": "Deepwell Dtx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233580: A Breathing System (ABS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233580", "people": [{"name": "Jeff Harris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233580%22"}, {"id": "fda:K233696", "company": "DePuy Synthes", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233696: DePuy Synthes Retrograde Femoral Nail Advanced System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233696", "people": [{"name": "Rebecca Reiter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233696%22"}, {"id": "fda:K242046", "company": "Corentec Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242046: EXULT Knee Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242046", "people": [{"name": "Seo Sanghee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242046%22"}, {"id": "fda:K234141", "company": "Aisap", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234141: AISAP Cardio V1.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234141", "people": [{"name": "Robert Klempfner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234141%22"}, {"id": "fda:K241145", "company": "Argon Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241145: TLAB\u00ae Transvenous Liver Biopsy System (TF-18C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241145", "people": [{"name": "Jacquelyn Huyghue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241145%22"}, {"id": "fda:K240312", "company": "Draeger Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240312: Infinity CentralStation Wide", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240312", "people": [{"name": "Patrice Cocco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240312%22"}, {"id": "fda:K242055", "company": "Skeletal Dynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242055: Freefix Forearm Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242055", "people": [{"name": "Alexandra Rodriguez Rojas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242055%22"}, {"id": "fda:K241140", "company": "Applied Photonix, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241140: ViroZap Indoor Air Purifier, In Duct Model 1008", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241140", "people": [{"name": "D. Yogi Goswami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241140%22"}, {"id": "fda:K241945", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241945: KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241945", "people": [{"name": "Thomas Ostrowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241945%22"}, {"id": "fda:K240035", "company": "Vilex, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240035: TACTIX Vector Syndesmosis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240035", "people": [{"name": "Brock Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240035%22"}, {"id": "fda:DEN230046", "company": "Personal Genome Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230046: PGDx elio plasma focus Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230046", "people": [{"name": "Jennifer Dickey", "role": "510(k) submission contact"}]}, {"id": "fda:K240805", "company": "Pelvital USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240805: Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240805", "people": [{"name": "Lydia Zeller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240805%22"}, {"id": "fda:K240301", "company": "Therapixel", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240301: MammoScreen\u00ae (3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240301", "people": [{"name": "Quentin De Snoeck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240301%22"}, {"id": "fda:K241137", "company": "Clear Moves Aligners", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241137: Clear Moves Aligner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241137", "people": [{"name": "Awais Muhammad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241137%22"}, {"id": "fda:K233793", "company": "CarboFix Orthopedics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233793: CarboClear\u00ae X Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233793", "people": [{"name": "Hila Wachsler-Avrahami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233793%22"}, {"id": "pma:P230016", "company": "Agilent Technologies, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-08-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230016: MAGE-A4 IHC 1F9 pharmDx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230016", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230016%22"}, {"id": "denovo:DEN230046", "company": "Personal Genome Diagnostics, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-08-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230046 granted: PGDx elio plasma focus Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230046"}, {"id": "nih:5R44CA257303-03", "company": "Calla Health Foundation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": 912854, "summary": "NIH award 5R44CA257303-03: Optimizing ablation of cervical precancer with ethyl cellulose ethanol to enable translation to women in low and middle-income countries ($912,854)", "source_url": "https://reporter.nih.gov/project-details/10932427", "people": [{"name": "Brian Crouch", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R44AG082602-01A1S1", "company": "Bellage, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": 166727, "summary": "NIH award 3R44AG082602-01A1S1: Expanding the AWC Prototype with Additional Reporting and Analytics Features (Supplement to R44AG082602, Adult Wellbeing Checkup (AWC)) ($166,727)", "source_url": "https://reporter.nih.gov/project-details/11074812", "people": [{"name": "James P Firman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI142903-04", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": 1025000, "summary": "NIH award 5R44AI142903-04: Hybrid ELISA: Simple and specific one-tier assay for Lyme disease ($1,025,000)", "source_url": "https://reporter.nih.gov/project-details/10927442", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44AG078039-02", "company": "Spark Neuro Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": 1338700, "summary": "NIH award 2R44AG078039-02: Validation of a novel EEG-based neurodiagnostic platform for assessing cognitive impairment and Alzheimer's Disease ($1,338,700)", "source_url": "https://reporter.nih.gov/project-details/10918468", "people": [{"name": "Che Lucero", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241225", "company": "Argentum Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241225: Silverlon\u00ae Wound Contact, Burn Contact Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241225", "people": [{"name": "James Fitzgerald", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241225%22"}, {"id": "fda:K233555", "company": "Philips Respironics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233555: AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233555", "people": [{"name": "Emily Tobin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233555%22"}, {"id": "fda:K233808", "company": "Ossvis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233808: LW Narrow Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233808", "people": [{"name": "Woo Jin Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233808%22"}, {"id": "fda:K240898", "company": "Case Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240898: SteriTite rigid reusable sterilization container with MediTray Products", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240898", "people": [{"name": "Michael Polozani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240898%22"}, {"id": "fda:K241917", "company": "Retropsoas Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241917: EARP Nerve Cuff Electrode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241917", "people": [{"name": "Nicholas Poulos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241917%22"}, {"id": "fda:K233541", "company": "Axis-Shield Diagnostics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233541: ARCHITECT Active-B12 (Holotranscobalamin)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233541", "people": [{"name": "Claire Dora", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233541%22"}, {"id": "fda:K240578", "company": "B.Braun Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240578: VenaTech\u00ae LP Vena Cava Filter System and VenaTech\u00ae Convertible Vena Cava Filter System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240578", "people": [{"name": "Tracy Larish", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240578%22"}, {"id": "fda:K241934", "company": "Anx Robotica Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241934: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241934", "people": [{"name": "Tim Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241934%22"}, {"id": "fda:K240967", "company": "Dongguan TT Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240967: ValvuloPro Valvuloplasty Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240967", "people": [{"name": "Yuying Bi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240967%22"}, {"id": "breakthrough:K241225", "company": "Argentum Medical, LLC.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-07-31", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K241225: SILVERLON WOUND CONTACT, BURN CONTACT DRESSING", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R42EB029888-03", "company": "Yaya Scientific, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-30", "observed": "2026-08-21", "amount_usd": 1111771, "summary": "NIH award 5R42EB029888-03: Real-time Multimodal Diffuse Reflectance and Polarization Imaging Based Nerve Identification in Surgical Field of View ($1,111,771)", "source_url": "https://reporter.nih.gov/project-details/10931684", "people": [{"name": "Justin Baba", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44EY031202-04A1", "company": "Ihealthscreen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-30", "observed": "2026-08-21", "amount_usd": 1049010, "summary": "NIH award 2R44EY031202-04A1: A Model for Predicting 2-Year Risk of Incident Late Age-related Macular Degeneration ($1,049,010)", "source_url": "https://reporter.nih.gov/project-details/10921958", "people": [{"name": "Alauddin Bhuiyan", "role": "Principal Investigator"}, {"name": "Roland THEODORE SMITH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43DC021913-01", "company": "Vivonics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-30", "observed": "2026-08-21", "amount_usd": 319120, "summary": "NIH award 1R43DC021913-01: Galvanic Vestibular Stimulation to mitigate episodic Vertigo ($319,120)", "source_url": "https://reporter.nih.gov/project-details/10921898", "people": [{"name": "GORDON B HIRSCHMAN", "role": "Principal Investigator"}, {"name": "Devin Lochlan McCaslin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS127692-03", "company": "Spikegadgets, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-30", "observed": "2026-08-21", "amount_usd": 652837, "summary": "NIH award 5R44NS127692-03: Commercialization of integrated electrode-electronics system for large scale, long-lasting electrophysiology ($652,837)", "source_url": "https://reporter.nih.gov/project-details/10897943", "people": [{"name": "Loren M Frank", "role": "Principal Investigator"}, {"name": "Mattias Peter Karlsson", "role": "Principal Investigator"}, {"name": "Chong Xie", "role": "Principal Investigator"}, {"name": "Jan Zimmermann", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K241539", "company": "Newclip Technics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241539: Activmotion S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241539", "people": [{"name": "Ga\u00eblle Gourbiere", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241539%22"}, {"id": "fda:K240531", "company": "BioHorizons Implant Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240531: SmartShape\u0099 Healing Abutment; Wide Custom Milled Ti-Blank Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240531", "people": [{"name": "Jared Cooper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240531%22"}, {"id": "fda:K241963", "company": "Picopack Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241963: WERAY", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241963", "people": [{"name": "Dong-Il Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241963%22"}, {"id": "fda:K240446", "company": "Shiva Products", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240446: Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240446", "people": [{"name": "Urvi Doshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240446%22"}, {"id": "fda:K240280", "company": "Nano-Ditech Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240280: Nano-Check\u0099 RSV Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240280", "people": [{"name": "James B Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240280%22"}, {"id": "nih:5R44MH122052-05", "company": "Quiver Bioscience Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": 378127, "summary": "NIH award 5R44MH122052-05: Functional drug fingerprinting with all-optical electrophysiology ($378,127)", "source_url": "https://reporter.nih.gov/project-details/10880299", "people": [{"name": "Benjamin Nathaniel Harwood", "role": "Principal Investigator"}, {"name": "Steven John Ryan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:3R44ES034312-03S1", "company": "Million Marker Wellness Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": 60000, "summary": "NIH award 3R44ES034312-03S1: A Personalized Digital Intervention Program to Reduce Exposure to Endocrine Disrupting Chemicals among a Child-Bearing Age Cohort ($60,000)", "source_url": "https://reporter.nih.gov/project-details/11112191", "people": [{"name": "Jenna Hua", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AI147973-04", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": 1013849, "summary": "NIH award 5R44AI147973-04: Biomarker-Based Test of Cure for Chagas Disease ($1,013,849)", "source_url": "https://reporter.nih.gov/project-details/10920488", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44AI157650-03", "company": "Aldatu Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": 986903, "summary": "NIH award 2R44AI157650-03: PANDAA for universal, pan-lineage molecular detection of Crimean-Congo Hemorrhagic Fever virus. ($986,903)", "source_url": "https://reporter.nih.gov/project-details/11013681", "people": [{"name": "Iain James MacLeod", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42CA275665-02", "company": "Digital Health Navigation Solutions, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": 938786, "summary": "NIH award 4R42CA275665-02: A cloud-based digital health navigation program for colorectal cancer screening ($938,786)", "source_url": "https://reporter.nih.gov/project-details/11116005", "people": [{"name": "David P Miller", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241912", "company": "Nanofiber Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241912: BIOCHARGE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241912", "people": [{"name": "Jason Chakroff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241912%22"}, {"id": "fda:K240326", "company": "Degen Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240326: Solar\u0099 Lumbar Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240326", "people": [{"name": "Craig Black", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240326%22"}, {"id": "fda:K242050", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K242050: Montage Settable Bone Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242050", "people": [{"name": "Aniq Darr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K242050%22"}, {"id": "fda:K241906", "company": "Conmed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241906: BioBrace\u00ae Reinforced Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241906", "people": [{"name": "Mirela Gjini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241906%22"}, {"id": "fda:K241464", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241464: ARx\u00ae SAI Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241464", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241464%22"}, {"id": "fda:K234125", "company": "AtriCure, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234125: AtriClip FLEX-Mini LAA Exclusion System (ACHM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234125", "people": [{"name": "Stephanie Hadnot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234125%22"}, {"id": "fda:K240359", "company": "Becton, Dickinson and Company (Bard Access Systems, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240359: PowerGlide Pro\u0099 Midline Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240359", "people": [{"name": "Abigail Ryder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240359%22"}, {"id": "fda:K233723", "company": "Guangdong Kingfa Sci. & Tech.Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233723: Medical surgical mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233723", "people": [{"name": "Xiaoge Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233723%22"}, {"id": "fda:K241209", "company": "Cook Ireland, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241209: EchoTip AcuCore\u0099 EUS Biopsy Needle (ECHO-BX-19)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241209", "people": [{"name": "Brian O'Mara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241209%22"}, {"id": "nih:5R44HL169065-02", "company": "Bloomer Health Tech Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": 933816, "summary": "NIH award 5R44HL169065-02: Bloomer Augmented Garment Platform-Barrier Removal for women in cArdiac rehab (BRA) ($933,816)", "source_url": "https://reporter.nih.gov/project-details/10911167", "people": [{"name": "Alicia Chong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA281528-02", "company": "Phase Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": 1141676, "summary": "NIH award 5R44CA281528-02: Chromosomal aberration detection in FFPE tissue using proximity ligation sequencing ($1,141,676)", "source_url": "https://reporter.nih.gov/project-details/10934589", "people": [{"name": "Stephen Matthew Eacker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44ES034312-03", "company": "Million Marker Wellness Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": 796881, "summary": "NIH award 5R44ES034312-03: A Personalized Digital Intervention Program to Reduce Exposure to Endocrine Disrupting Chemicals among a Child-Bearing Age Cohort ($796,881)", "source_url": "https://reporter.nih.gov/project-details/10896367", "people": [{"name": "Jenna Hua", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44NS122602-03", "company": "Piraeus Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": 982021, "summary": "NIH award 5R44NS122602-03: Enabling rapid and effective stroke thrombectomy procedures from a Transradial approach: Combining introducer sheath, guide catheter, and distal access catheter into a single device. ($982,021)", "source_url": "https://reporter.nih.gov/project-details/10932227", "people": [{"name": "Jared Hutar", "role": "Principal Investigator"}, {"name": "DAVID F KALLMES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA281529-02", "company": "Lase Innovation Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": 837126, "summary": "NIH award 5R44CA281529-02: Time-lapse Flow Cytometry for Kinetic Profiling of T-Cell Function ($837,126)", "source_url": "https://reporter.nih.gov/project-details/10920383", "people": [{"name": "Sheldon J.J. Kwok", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R42DA053075-03S1", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": 221325, "summary": "NIH award 3R42DA053075-03S1: Developing novel technologies to monitor nociception and opioid administration during surgery and general anesthesia to minimize postoperative opioid requirements ($221,325)", "source_url": "https://reporter.nih.gov/project-details/11012570", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K234131", "company": "Hemostasis, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234131: Resolv Endoscopic Hemostat System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234131", "people": [{"name": "Lakshmi Ganesh Bollina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234131%22"}, {"id": "fda:K233530", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233530: EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233530", "people": [{"name": "Kim Hanbyul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233530%22"}, {"id": "fda:K240401", "company": "Origyn Medical Technology (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240401: ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240401", "people": [{"name": "Cheng Xinyuan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240401%22"}, {"id": "fda:K241845", "company": "B.Braun Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241845: Introcan Safety\u00ae 2 IV Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241845", "people": [{"name": "Tracy Larish", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241845%22"}, {"id": "fda:K233725", "company": "Medivis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233725: Spine Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233725", "people": [{"name": "Amy Lynn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233725%22"}, {"id": "fda:K233287", "company": "Hangzhou Qiantang Longyue Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233287: Vent Vial Adapter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233287", "people": [{"name": "Chunyu Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233287%22"}, {"id": "fda:K233994", "company": "Synthes GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233994: VOLT\u0099 Proximal Humerus 3.5 Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233994", "people": [{"name": "Brendan Daly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233994%22"}, {"id": "fda:K240169", "company": "Bausch and Lomb, Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240169: Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240169", "people": [{"name": "Ken Nehmer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240169%22"}, {"id": "fda:K241028", "company": "Coloplast", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241028: Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241028", "people": [{"name": "Thome Troy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241028%22"}, {"id": "fda:K241898", "company": "Siemens Healthineers", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241898: Symbia SPECT and SPECT/CT Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241898", "people": [{"name": "Tabitha Estes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241898%22"}, {"id": "fda:K241883", "company": "Pro Med Instruments GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241883: DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241883", "people": [{"name": "Anja Krumm", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241883%22"}, {"id": "fda:K220328", "company": "Medica Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220328: EasyStat 300", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220328", "people": [{"name": "Photios Makris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220328%22"}, {"id": "fda:K240246", "company": "Synaptic Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240246: Accusafe Transseptal Guidewire (GTR31180, GTR31230)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240246", "people": [{"name": "Jake Harandi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240246%22"}, {"id": "fda:K241187", "company": "Alien Milling Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241187: Alien Aligners", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241187", "people": [{"name": "Saro Hatzakorizian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241187%22"}, {"id": "fda:K241800", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241800: Atellica\u00ae CH HDL Cholesterol (HDLC)& Atellica\u00ae CH LDL Cholesterol (LDLC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241800", "people": [{"name": "Justin Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241800%22"}, {"id": "fda:K241866", "company": "Convatec Triad Life Sciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241866: InnovaMatrix\u00aeFD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241866", "people": [{"name": "Victoria Beifuss", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241866%22"}, {"id": "fda:K231776", "company": "Streck, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231776: Cell-Free DNA BCT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231776", "people": [{"name": "Wendy Royalty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231776%22"}, {"id": "fda:K233501", "company": "Largan Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233501: \u0093LARGAN Health AI-Tech\u0094 Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233501", "people": [{"name": "Shih-min Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233501%22"}, {"id": "fda:K241078", "company": "Tandem Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241078: Tandem Mobi Insulin Pump with interoperable technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241078", "people": [{"name": "Jordan Barkhimer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241078%22"}, {"id": "fda:K240509", "company": "Rhythm AI, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240509: STAR Apollo\u0099 Mapping System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240509", "people": [{"name": "Linda D'Abate", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240509%22"}, {"id": "fda:K241494", "company": "Pantheon Spinal", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241494: Pantheon Pedicle Screw and Iliac Bolt Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241494", "people": [{"name": "Scott Spann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241494%22"}, {"id": "fda:K241515", "company": "Nexa Medical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241515: NEXA\u0099 NPWT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241515", "people": [{"name": "Robbie Walsh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241515%22"}, {"id": "pma:P230009", "company": "Guardant Health, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-07-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230009: Shield", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230009%22"}, {"id": "nih:1R43AA031638-01", "company": "Soovu Labs Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": 385000, "summary": "NIH award 1R43AA031638-01: Treating stress and anxiety in individuals with alcohol use disorder (AUD) using a combination of TRPV-1 channel and C-tactile fiber activation with measurement of oxytocin and cortisol levels ($385,000)", "source_url": "https://reporter.nih.gov/project-details/10917870", "people": [{"name": "Charles Chabal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM145015-02A1", "company": "Wellsim Biomedical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": 801485, "summary": "NIH award 2R44GM145015-02A1: Multi-omics profiling of individual exosomes for origin-tracing, biomarker discovery, and biological function characterization ($801,485)", "source_url": "https://reporter.nih.gov/project-details/10919626", "people": [{"name": "Yuchao Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DE031195-03", "company": "Ostiio LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": 849999, "summary": "NIH award 5R44DE031195-03: A Smart, Fully Subcutaneous Distraction System to Improve Outcomes in Patients with Congenital or Acquired Craniofacial Differences ($849,999)", "source_url": "https://reporter.nih.gov/project-details/10929326", "people": [{"name": "Jessica DesNoyer", "role": "Principal Investigator"}, {"name": "Ari M Wes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DK136424-02", "company": "Capsulomics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": 832997, "summary": "NIH award 5R44DK136424-02: Validation and Early Commercialization of the ENVISAGE Assay, a Prognostic Test for Barrett's Esophagus ($832,997)", "source_url": "https://reporter.nih.gov/project-details/10923931", "people": [{"name": "Sarah Laun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241361", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241361: Arthrex Synergy Vision Endoscopic Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241361", "people": [{"name": "Lai Saeteurn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241361%22"}, {"id": "fda:K241864", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241864: Grappler Interference Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241864", "people": [{"name": "Edward Wells-Spicer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241864%22"}, {"id": "fda:K233372", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233372: KARL STORZ Fiber Telescopes for Urology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233372", "people": [{"name": "Alita McElroy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233372%22"}, {"id": "fda:K241203", "company": "Dongguan Hunter Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241203: PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241203", "people": [{"name": "Hunter Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241203%22"}, {"id": "fda:K241171", "company": "Stryker Leibinger GmbH & Co KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241171: Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241171", "people": [{"name": "John Chesney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241171%22"}, {"id": "fda:K241063", "company": "Dentis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241063: s-Clean ScanHealing Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241063", "people": [{"name": "Gyu Ri Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241063%22"}, {"id": "fda:K241887", "company": "Cosmo Artificial Intelligence - Ai, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241887: GI Genius\u0099 Module 100 (GGM100.US); GI Genius\u0099 Module 200 (GGM200.US); ColonPRO\u0099 4.0 (CPRO40.US); GI Genius\u0099 Module 300 (GGM300-US); ColonPRO\u0099 4.0 (CPRO40S-US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241887", "people": [{"name": "Ngo Dinh Nhan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241887%22"}, {"id": "fda:K233563", "company": "Claronav, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233563: Navident", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233563", "people": [{"name": "Carly Desmond", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233563%22"}, {"id": "fda:K240886", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240886: Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240886", "people": [{"name": "Meghan Wakeford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240886%22"}, {"id": "fda:K241165", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241165: Atellica\u00ae IM High-Sensitivity Troponin I (TnIH)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241165", "people": [{"name": "Amy Tyler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241165%22"}, {"id": "nih:1R41DK138646-01A1", "company": "Nephsmart LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": 274415, "summary": "NIH award 1R41DK138646-01A1: A Device for Detection of Acute Kidney Injury ($274,415)", "source_url": "https://reporter.nih.gov/project-details/10919989", "people": [{"name": "JOHN M. ARTHUR", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG087855-01", "company": "Neuroscope Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": 1193370, "summary": "NIH award 1R44AG087855-01: Development of perivascular space mapping toolset as a diagnostic aid for Alzheimer's disease ($1,193,370)", "source_url": "https://reporter.nih.gov/project-details/10921984", "people": [{"name": "Jeiran Choupan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH132234-03", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": 996633, "summary": "NIH award 5R44MH132234-03: System for Volumetric 2-photon Imaging of Neuroactivity Using Light Beads Microscopy ($996,633)", "source_url": "https://reporter.nih.gov/project-details/10897999", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44DK141388-01", "company": "Vortex Medical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": 301151, "summary": "NIH award 1R44DK141388-01: Developing a novel vesico-amniotic shunt to treat fetal lower urinary tract obstruction ($301,151)", "source_url": "https://reporter.nih.gov/project-details/11008082", "people": [{"name": "Eric Johnson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44HD110346-02A1", "company": "Ovaryit, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": 1341329, "summary": "NIH award 2R44HD110346-02A1: Development and commercialization of support tools to improve safety and efficiency of pharmacist-prescribed contraceptive services ($1,341,329)", "source_url": "https://reporter.nih.gov/project-details/10916154", "people": [{"name": "Mary Kucek", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI172551-03", "company": "Aldatu Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": 943229, "summary": "NIH award 5R44AI172551-03: PANDAA for universal, pan-lineage molecular detection of filoviruses to enable rapid epidemic response. ($943,229)", "source_url": "https://reporter.nih.gov/project-details/10899546", "people": [{"name": "Iain James MacLeod", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44CA287829-01A1", "company": "Precision Epigenomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": 1004107, "summary": "NIH award 1R44CA287829-01A1: Development of a Molecular Assay to Diagnose Malignant Pleural Effusions ($1,004,107)", "source_url": "https://reporter.nih.gov/project-details/11005186", "people": [{"name": "Mark Anthony Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AG082621-02", "company": "Evon Medics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": 1249244, "summary": "NIH award 4R44AG082621-02: Development and Evaluation of Portable Compendium of Psychophysical and Physiological Tests for Alzheimer's Disease and Related Dementias (ADRD) ($1,249,244)", "source_url": "https://reporter.nih.gov/project-details/11100060", "people": [{"name": "Charles Chiedu Nwaokobia", "role": "Principal Investigator"}, {"name": "Evaristus A Nwulia", "role": "Principal Investigator"}, {"name": "Vamsi Reddy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA285006-02", "company": "Aiq Global Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": 1104267, "summary": "NIH award 5R44CA285006-02: Comprehensive Assessment of Cancer Theranostics Response ($1,104,267)", "source_url": "https://reporter.nih.gov/project-details/10933574", "people": [{"name": "Paul G. Corn", "role": "Principal Investigator"}, {"name": "Timothy Perk", "role": "Principal Investigator"}, {"name": "Scott T Tagawa", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K233352", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233352: Aptima HCV Quant Dx Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233352", "people": [{"name": "Howard Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233352%22"}, {"id": "fda:K240044", "company": "Odin Medical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240044: CADDIE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240044", "people": [{"name": "Luke Sampson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240044%22"}, {"id": "fda:K241243", "company": "Centerline Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241243: Intra-Operative Positioning System (IOPS\u00ae) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS\u00ae) Viewpoint (Double Curve Catheters)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241243", "people": [{"name": "Amanda Shade", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241243%22"}, {"id": "fda:K240714", "company": "Cosmedent, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240714: Insure\u00ae Universal; Insure\u00ae Universal Automix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240714", "people": [{"name": "Gary Chuven", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240714%22"}, {"id": "fda:K240431", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240431: ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240431", "people": [{"name": "Sadwini Suresh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240431%22"}, {"id": "fda:K241502", "company": "Oui Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241502: P-SCOPE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241502", "people": [{"name": "Adarsh M. Patil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241502%22"}, {"id": "fda:K230305", "company": "Purgo Biologics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230305: THE Graft Collagen", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230305", "people": [{"name": "Byungsun Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230305%22"}, {"id": "fda:K233865", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233865: X-Smart Pro; X-Smart Pro+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233865", "people": [{"name": "Laura Sorbin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233865%22"}, {"id": "fda:K241150", "company": "Keosan Trading Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241150: MISTI Silicone Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241150", "people": [{"name": "Jiyoung Nam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241150%22"}, {"id": "fda:K241863", "company": "Clariance", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241863: Erisma\u00ae Lp Spinal Fixation System; Erisma\u00ae LP MIS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241863", "people": [{"name": "Magalie Hennequin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241863%22"}, {"id": "fda:K240457", "company": "Pentax of America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240457: C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240457", "people": [{"name": "Gurvinder Singh Nanda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240457%22"}, {"id": "fda:K240780", "company": "InMode , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240780: InMode RF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240780", "people": [{"name": "Suhair Francis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240780%22"}, {"id": "fda:K231251", "company": "Jeil Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231251: FlexWing Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231251", "people": [{"name": "Sejin Ryu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231251%22"}, {"id": "fda:K241789", "company": "Hony Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241789: Non-Sterile Ultrasound Transmission Gels", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241789", "people": [{"name": "Zhu Huina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241789%22"}, {"id": "fda:K241130", "company": "Point Robotics MedTech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241130: \u0093POINT\u0094 Kinguide Agile Hybrid Navigation System (PSHF01-000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241130", "people": [{"name": "Wayne Kao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241130%22"}, {"id": "nih:5R43MH135814-02", "company": "Spike Neuro LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-23", "observed": "2026-08-21", "amount_usd": 422825, "summary": "NIH award 5R43MH135814-02: Addressing the wireless power problem: A low-power hybrid radio for neuroscience experiments ($422,825)", "source_url": "https://reporter.nih.gov/project-details/10909389", "people": [{"name": "Christopher Leroy Frewin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:3R44AG076256-03S1", "company": "Maphabit, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-23", "observed": "2026-08-21", "amount_usd": 88115, "summary": "NIH award 3R44AG076256-03S1: An assistive-technology based Caregiver Training Program (CTP) to enhance caregiver effectiveness, well-being, and quality of life, which will improve overall care for individuals living with AD/ADRD. ($88,115)", "source_url": "https://reporter.nih.gov/project-details/11142757", "people": [{"name": "Matthew Golden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AA030702-03", "company": "Ria Technology Management Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-23", "observed": "2026-08-21", "amount_usd": 943481, "summary": "NIH award 5R44AA030702-03: A Telehealth Intervention to Increase Screening and Treatment for Alcohol Use Disorder ($943,481)", "source_url": "https://reporter.nih.gov/project-details/10924029", "people": [{"name": "JOHN E. MENDELSON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA285136-02", "company": "Bd Holding, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-23", "observed": "2026-08-21", "amount_usd": 985125, "summary": "NIH award 5R44CA285136-02: An Improved Epigenetic Algorithm for Guiding Low Dose CT Lung Cancer Screening ($985,125)", "source_url": "https://reporter.nih.gov/project-details/10890199", "people": [{"name": "Kelsey Dawes", "role": "Principal Investigator"}, {"name": "Robert A Philibert", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241296", "company": "Netbiologics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241296: Gaudi Proximal Humerus Plate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241296", "people": [{"name": "Avinash Kumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241296%22"}, {"id": "fda:K241114", "company": "Ewoosoft Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241114: EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241114", "people": [{"name": "Young Seok Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241114%22"}, {"id": "fda:K240756", "company": "Aitrics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240756: AITRICS-VC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240756", "people": [{"name": "Dongyeop Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240756%22"}, {"id": "fda:K240906", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240906: TE Air Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240906", "people": [{"name": "Zhang Yuxi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240906%22"}, {"id": "nih:1R43HL174295-01", "company": "Dasisimulations LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": 443544, "summary": "NIH award 1R43HL174295-01: Rapid, Automatic, AI Driven, Aortic Valve Measurement Software ($443,544)", "source_url": "https://reporter.nih.gov/project-details/10921022", "people": [{"name": "Lakshmi Prasad Dasi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL176464-01A1", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": 1044896, "summary": "NIH award 1R44HL176464-01A1: Leveraging Interactive Digital Technology to Increase Access to Family-Based Behavioral Treatment for Childhood Obesity ($1,044,896)", "source_url": "https://reporter.nih.gov/project-details/11013711", "people": [{"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}, {"name": "Leonard H Epstein", "role": "Principal Investigator"}, {"name": "Denise Ella Wilfley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD115494-01", "company": "Brooklyn Innoseq Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": 296351, "summary": "NIH award 1R43HD115494-01: Development and Validation of a Non-Invasive Microbiome-Based Diagnostic Tool for Early Detection of Gestational Diabetes Mellitus ($296,351)", "source_url": "https://reporter.nih.gov/project-details/10921940", "people": [{"name": "Nini Fan", "role": "Principal Investigator"}, {"name": "Andrea Denise Shields", "role": "Principal Investigator"}, {"name": "Yanjiao Zhou", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI152654-04", "company": "Miravista Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": 983736, "summary": "NIH award 5R44AI152654-04: Development of Coccidioides Cytokine Release Assay ($983,736)", "source_url": "https://reporter.nih.gov/project-details/10897063", "people": [{"name": "Eric Holbrook", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R41NR021089-01", "company": "Potentia Analytics Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": 284317, "summary": "NIH award 1R41NR021089-01: MyDocSaid: Deep Learning for Patient-Centric Record, Summarization, and Analysis of Medical Conversations ($284,317)", "source_url": "https://reporter.nih.gov/project-details/10823767", "people": [{"name": "Nina Marhamati", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240339", "company": "Shanghai Bangbang Robotics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240339: Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240339", "people": [{"name": "Canfeng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240339%22"}, {"id": "fda:K241482", "company": "Restor3D", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241482: Kinos Total Ankle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241482", "people": [{"name": "Brianna Prindle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241482%22"}, {"id": "fda:K241119", "company": "Shenzhen Yicai Health Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241119: Transcutaneous Electrical Nerve Stimulator (K6106)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241119", "people": [{"name": "Xie Jie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241119%22"}, {"id": "fda:K234091", "company": "Genalyte, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234091: Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234091", "people": [{"name": "Sasi Mudumba", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234091%22"}, {"id": "fda:K231133", "company": "Neoscan Solution GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231133: neo315", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231133", "people": [{"name": "Roell Stefan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231133%22"}, {"id": "fda:K240704", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240704: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240704", "people": [{"name": "Choi Sulgue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240704%22"}, {"id": "fda:K241445", "company": "Spident Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241445: K-Bond Universal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241445", "people": [{"name": "Eunok Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241445%22"}, {"id": "fda:K241116", "company": "Terasysd&C, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241116: Onycho Laser V", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241116", "people": [{"name": "Sanghyeop Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241116%22"}, {"id": "fda:K240558", "company": "Algodx AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240558: NAVOYCDS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240558", "people": [{"name": "Andreas Macura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240558%22"}, {"id": "fda:K240347", "company": "Zimmer Medizinsysteme GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240347: PTG-05", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240347", "people": [{"name": "Ute Killet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240347%22"}, {"id": "nih:2R44HL164195-02", "company": "Maxwell Biomedical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": 749419, "summary": "NIH award 2R44HL164195-02: Spatial Resynchronization Therapy for AFib ($749,419)", "source_url": "https://reporter.nih.gov/project-details/10922069", "people": [{"name": "Graydon Ernest Beatty", "role": "Principal Investigator"}, {"name": "Benjamin Coppola", "role": "Principal Investigator"}, {"name": "Randy Werneth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41AR084997-01", "company": "Mira Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": 306858, "summary": "NIH award 1R41AR084997-01: AI Enabled App for Fracture Reduction Prediction in Pediatrics ($306,858)", "source_url": "https://reporter.nih.gov/project-details/11006176", "people": [{"name": "Kevin R. Cleary", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL147745-04", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": 476329, "summary": "NIH award 5R44HL147745-04: An Improved Robotic Electrophysiology Platform for Arrhythmia Ablation ($476,329)", "source_url": "https://reporter.nih.gov/project-details/10897294", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "Mitch N Faddis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43MH138260-01", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": 295234, "summary": "NIH award 1R43MH138260-01: Assist-MH digital technologies to support school mental health care ($295,234)", "source_url": "https://reporter.nih.gov/project-details/11007687", "people": [{"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL167294-01A1", "company": "Safebeat Rx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": 994131, "summary": "NIH award 1R44HL167294-01A1: Novel, automated mobile heart rhythm analysis technology to start antiarrhythmic medications safely at home ($994,131)", "source_url": "https://reporter.nih.gov/project-details/10815458", "people": [{"name": "Edward Paul Gerstenfeld", "role": "Principal Investigator"}, {"name": "Rachita Navara", "role": "Principal Investigator"}, {"name": "Kunj G. Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44NS122713-02", "company": "Imggyd LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": 886703, "summary": "NIH award 2R44NS122713-02: AccuGyd: Accelerated Guidance for Accurate MRI-Guided Neurosurgery ($886,703)", "source_url": "https://reporter.nih.gov/project-details/11007367", "people": [{"name": "TERRENCE R OAKES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K233976", "company": "Corvascular Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233976: VasoGuard (V10, V8, V6, V4, V2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233976", "people": [{"name": "Spencer Lien", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233976%22"}, {"id": "fda:K233866", "company": "Asensus Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233866: Senhance Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233866", "people": [{"name": "Madhuvanthi Soundirarajan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233866%22"}, {"id": "fda:K240480", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240480: IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240480", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240480%22"}, {"id": "fda:K241809", "company": "Kane Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241809: coactiv+\u0099 Antimicrobial Wound Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241809", "people": [{"name": "Lori Christofalos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241809%22"}, {"id": "fda:K240835", "company": "Skeletal Dynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240835: Suture Button Repair System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240835", "people": [{"name": "Alexandra Rodriguez Rojas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240835%22"}, {"id": "fda:K240538", "company": "Formlabs Ohio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240538: Premium Teeth Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240538", "people": [{"name": "Paige Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240538%22"}, {"id": "fda:K233979", "company": "Greiner Bio-One North America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233979: VACUETTE\u00ae QUICKSHIELD Complete (Plus)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233979", "people": [{"name": "Manfred Abel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233979%22"}, {"id": "fda:K233067", "company": "Chongqing Rob Linka Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233067: Wireless TENS & EMS (Model SM9110,SM9113,SM9116)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233067", "people": [{"name": "Huirong Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233067%22"}, {"id": "nih:5R44HD109106-02", "company": "Barrett Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": 950894, "summary": "NIH award 5R44HD109106-02: SmartAssist\u2122: Adaptive robotic assistance to maximize patient engagement with the Barrett Upper-Extremity Robotic Trainer (Burt) ($950,894)", "source_url": "https://reporter.nih.gov/project-details/10861062", "people": [{"name": "Randie Black-Schaffer", "role": "Principal Investigator"}, {"name": "Craig McDonald", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241060", "company": "Hardy Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241060: HardyDisk AST Cefiderocol 30\u00b5g (FDC30)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241060", "people": [{"name": "Anna Klavins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241060%22"}, {"id": "fda:K233768", "company": "Elevate Oral Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233768: Papacarie Duo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233768", "people": [{"name": "Steven Pardue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233768%22"}, {"id": "fda:K241240", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241240: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241240", "people": [{"name": "Vlada Rudenko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241240%22"}, {"id": "fda:K221495", "company": "Medscope Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221495: SOLID CLIP\u0099 Single Use Clip Applier", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221495", "people": [{"name": "Waine Su", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221495%22"}, {"id": "fda:K212521", "company": "Kericure, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K212521: Field Shield Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212521", "people": [{"name": "Kerriann Greenhalgh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K212521%22"}, {"id": "fda:K241206", "company": "Spectrum Medical S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241206: Quantum Perfusion Hybrid System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241206", "people": [{"name": "Raffaella Tommasini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241206%22"}, {"id": "fda:K233917", "company": "Ichor", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233917: ICHOR 7F Embolectomy System (ICH-7F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233917", "people": [{"name": "Timothy Blair", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233917%22"}, {"id": "fda:K240821", "company": "Braincare Desenvolvimento E Inova\u00e7\u00e3o Tecnol\u00f3gica S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240821: B4C System - Addition of new sensor model (BcSs-PICNIW-2000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240821", "people": [{"name": "Arnaldo Betta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240821%22"}, {"id": "fda:K241321", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241321: Juliet\u00ae Ti LL Lumbar Interbody Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241321", "people": [{"name": "Estelle Lefeuvre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241321%22"}, {"id": "fda:K240340", "company": "Guangdong Jinme Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240340: Surgical Drive System (Model: ES70, ES90, E8)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240340", "people": [{"name": "Ying Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240340%22"}, {"id": "fda:K241463", "company": "Suzhou Master Machinery Manufacturing Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241463: Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241463", "people": [{"name": "Hongying Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241463%22"}, {"id": "fda:K241879", "company": "Virtual Radiologic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241879: vRad Viewer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241879", "people": [{"name": "Wade Steigauf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241879%22"}, {"id": "fda:K233482", "company": "Exactech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233482: Equinoxe\u00ae Central Screw Baseplate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233482", "people": [{"name": "Liz Howell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233482%22"}, {"id": "fda:K234029", "company": "Cefaly Technology", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234029: CEFALY Connected - OTC, CEFALY Connected - Rx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234029", "people": [{"name": "Jennifer Trainor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234029%22"}, {"id": "breakthrough:K240786", "company": "Heartlung Corporation", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-07-18", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K240786: AUTOCHAMBER", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:2R44AI124871-05A1", "company": "Scanogen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 2R44AI124871-05A1: Bloodstream infection detection directly on whole blood ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11008170", "people": [{"name": "Alfredo Andres Celedon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R43NS132653-02", "company": "Scion Neurostim, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": 327682, "summary": "NIH award 5R43NS132653-02: Simple, Home-use, neurostimulAtion tReatment for Parkinson's disease dEmeNtia (SHARPEN) ($327,682)", "source_url": "https://reporter.nih.gov/project-details/10886725", "people": [{"name": "Kristen Kathleen Foster", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43DE033946-01", "company": "Molecular Theranostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": 294505, "summary": "NIH award 1R43DE033946-01: A peptide targeted fluorescence probe for precision surgery of head and neck cancer ($294,505)", "source_url": "https://reporter.nih.gov/project-details/10922472", "people": [{"name": "Ryan Christopher Hall", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DC022208-01", "company": "Zwicoat Materials Innovations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": 306864, "summary": "NIH award 1R43DC022208-01: Durable Zwitterionic Coatings: Dramatic Reduction of Implant-Induced Inflammation and Fibrosis ($306,864)", "source_url": "https://reporter.nih.gov/project-details/11008220", "people": [{"name": "Kameron Rex Hansen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240609", "company": "S.I.N. - Sistema DE Implante Nacional S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240609: S.I.N. Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240609", "people": [{"name": "Denise Domiciano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240609%22"}, {"id": "fda:K240845", "company": "Azmed Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240845: Rayvolve", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240845", "people": [{"name": "Christelle Baille", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240845%22"}, {"id": "fda:K241467", "company": "Nexus Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241467: Stable-C Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241467", "people": [{"name": "Jared Crocker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241467%22"}, {"id": "fda:K240705", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240705: Vitrea Software Package, VSTP-002A V2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240705", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240705%22"}, {"id": "fda:K241121", "company": "Microstructure Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241121: MICSI-RMT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241121", "people": [{"name": "Gregory Lemberskiy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241121%22"}, {"id": "fda:K233904", "company": "Acist Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233904: ACIST RXi System (016616); ACIST Navvus II Catheter (016675_", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233904", "people": [{"name": "Bobbie Daughters", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233904%22"}, {"id": "fda:K241081", "company": "Topcon Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241081: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241081", "people": [{"name": "Kitawaki Ryota", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241081%22"}, {"id": "fda:K241413", "company": "Acuity Surgical Devices, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241413: sagAlign Lumbar Cage System (Various PNs)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241413", "people": [{"name": "Chuck Forton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241413%22"}, {"id": "fda:K240503", "company": "Gynesonics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240503: Sonata Transcervical Fibroid Ablation System 2.2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240503", "people": [{"name": "Diane King", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240503%22"}, {"id": "nih:5R44CA203038-06", "company": "Veriskin, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-16", "observed": "2026-08-21", "amount_usd": 742845, "summary": "NIH award 5R44CA203038-06: Pivotal Clinical Study of the TruScore Device for Non-Invasive Skin Cancer Diagnostics ($742,845)", "source_url": "https://reporter.nih.gov/project-details/10873089", "people": [{"name": "MIRIANAS CHACHISVILIS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R44MH136865-01", "company": "Spikegadgets, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-16", "observed": "2026-08-21", "amount_usd": 1016232, "summary": "NIH award 1R44MH136865-01: A commercialized platform for diversified large-scale chronic electrophysiology ($1,016,232)", "source_url": "https://reporter.nih.gov/project-details/10921067", "people": [{"name": "Peter Denes", "role": "Principal Investigator"}, {"name": "Mattias Peter Karlsson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K241441", "company": "Eizo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241441: RadiForce RX670; RadiForce RX670-AR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241441", "people": [{"name": "Hiroaki Hashimoto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241441%22"}, {"id": "fda:K233778", "company": "Zhuhai Pusen Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233778: Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233778", "people": [{"name": "Changshen Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233778%22"}, {"id": "fda:K241741", "company": "Guangzhou Wondfo Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241741: SAFElife\u0099 Fentanyl Urine Home Test (Cassette); SAFElife\u0099 Fentanyl (FTY) Urine Test Cassette; SAFElife\u0099 T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife\u0099 T-Dip Fentanyl (FTY) Urine Test Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241741", "people": [{"name": "Kaiyu Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241741%22"}, {"id": "fda:K241056", "company": "Sincera Technology (Changchun) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241056: Light Cure Adhesive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241056", "people": [{"name": "Tony Su", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241056%22"}, {"id": "fda:DEN230061", "company": "Tulavi Therapeutics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230061: allay Nerve Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230061", "people": [{"name": "Corinne Bright", "role": "510(k) submission contact"}]}, {"id": "fda:K240944", "company": "Hyperfine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240944: Swoop\u00ae Portable MR Imaging\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240944", "people": [{"name": "Christine Kupchick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240944%22"}, {"id": "fda:K240272", "company": "Guangdong Prestige Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240272: Electric Scooter (M2085, S2091)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240272", "people": [{"name": "Zhang Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240272%22"}, {"id": "fda:K241740", "company": "Summa Therapeutics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241740: Finesse Injectable\u0099 PTA Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241740", "people": [{"name": "Elena Jugo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241740%22"}, {"id": "fda:K241050", "company": "Crossroads Extremity Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241050: CrossRoads Modular Tray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241050", "people": [{"name": "Jacqueline Gorberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241050%22"}, {"id": "denovo:DEN230061", "company": "Tulavi Therapeutics", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-07-16", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230061 granted: allay Nerve Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230061"}, {"id": "nih:5R44AI179310-02", "company": "Scanogen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": 999900, "summary": "NIH award 5R44AI179310-02: Highly Multiplexed Single Molecule Tethering ($999,900)", "source_url": "https://reporter.nih.gov/project-details/10909305", "people": [{"name": "Alfredo Andres Celedon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44MH134709-01A1", "company": "Equa Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": 291447, "summary": "NIH award 1R44MH134709-01A1: Mindfulness Meditation and Respiration Biosignal Feedback ($291,447)", "source_url": "https://reporter.nih.gov/project-details/10919943", "people": [{"name": "John David Creswell", "role": "Principal Investigator"}, {"name": "Mathew Polowitz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA261381-02A1", "company": "Malcova Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": 1134189, "summary": "NIH award 2R44CA261381-02A1: A comprehensive imaging solution for dense breast cancer screening and diagnostics ($1,134,189)", "source_url": "https://reporter.nih.gov/project-details/10920530", "people": [{"name": "Peymon Ghazi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NR020341-03", "company": "Peacefully, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": 593571, "summary": "NIH award 5R44NR020341-03: A comprehensive web-based program to help advanced cancer patients plan for end of life ($593,571)", "source_url": "https://reporter.nih.gov/project-details/10896275", "people": [{"name": "Jennifer Good", "role": "Principal Investigator"}, {"name": "Megan Johnson Shen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44HL167296-02", "company": "Aventusoft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": 864759, "summary": "NIH award 4R44HL167296-02: A mobile health framework for left ventricular end diastolic pressure diagnostics and monitoring. ($864,759)", "source_url": "https://reporter.nih.gov/project-details/10851435", "people": [{"name": "Kaustubh Kale", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA285075-01A1", "company": "Nord Bio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": 295757, "summary": "NIH award 1R43CA285075-01A1: Non-invasive cancer detection and residual disease monitoring by cell-free nucleic acid from saliva ($295,757)", "source_url": "https://reporter.nih.gov/project-details/10921095", "people": [{"name": "Ignaty Leshchiner", "role": "Principal Investigator"}, {"name": "Dimitri Livitz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41MD018558-01", "company": "Machine And Human Interaction LLC.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": 299573, "summary": "NIH award 1R41MD018558-01: Digitalization of a Multicomponent Family-Based Behavioral Intervention (Digital Wellness Nurse - FIT Families) for Adolescents with Obesity ($299,573)", "source_url": "https://reporter.nih.gov/project-details/10699483", "people": [{"name": "Jerome L McClendon", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44HL169045-02", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": 998891, "summary": "NIH award 4R44HL169045-02: A Near-Patient, Low Blood Volume Platform for Rapid Comprehensive Evaluation of Coagulation in Trauma Patients ($998,891)", "source_url": "https://reporter.nih.gov/project-details/11107566", "people": [{"name": "VAMSEE K. PAMULA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K240616", "company": "Foreo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240616: FAQ\u0099 (102)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240616", "people": [{"name": "Evan Feldstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240616%22"}, {"id": "fda:K241032", "company": "Biomet 3i, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241032: BellaTek Bars", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241032", "people": [{"name": "Krupal Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241032%22"}, {"id": "fda:K241739", "company": "Micromedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241739: Endoscopic Applicator, 41 cm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241739", "people": [{"name": "Joel DeLaTorre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241739%22"}, {"id": "fda:K240178", "company": "Zimmer Medizinsysteme GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240178: RFG-01", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240178", "people": [{"name": "Ute Killet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240178%22"}, {"id": "fda:DEN230092", "company": "Diasorin Molecular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230092: Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230092", "people": [{"name": "Michele Chwedoruk", "role": "510(k) submission contact"}]}, {"id": "fda:K233449", "company": "Hanchang Medic Co., Ltd. (Han Chang Medic)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233449: Avantik VTM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233449", "people": [{"name": "Hyunsoo Shin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233449%22"}, {"id": "fda:K233460", "company": "Connexicon Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233460: CM00622 LINC Skin Closure System (CM00622 LINC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233460", "people": [{"name": "Martin Brennan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233460%22"}, {"id": "fda:K233458", "company": "Connexicon Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233458: CM005 Standard (CM005); CM004 Mini (CM004)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233458", "people": [{"name": "Martin Brennan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233458%22"}, {"id": "fda:K241751", "company": "Positrigo AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241751: NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241751", "people": [{"name": "Jannis Fischer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241751%22"}, {"id": "fda:K240285", "company": "Huxley Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240285: Huxley SANSA Home Sleep Apnea Test (1000-00)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240285", "people": [{"name": "Brennan Torstrick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240285%22"}, {"id": "denovo:DEN230092", "company": "Diasorin Molecular, LLC", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-07-15", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230092 granted: Simplexa C. auris Direct, Simplexa C. au", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230092"}, {"id": "fda:K241385", "company": "B.Braun Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241385: Omnifix Syringe NRFit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241385", "people": [{"name": "Smith Kimberly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241385%22"}, {"id": "nih:1R43DK139914-01", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": 331416, "summary": "NIH award 1R43DK139914-01: Photoacoustic Tool to Improve Visualization and Success Rates in Sacral Neural Modulation Lead Placement ($331,416)", "source_url": "https://reporter.nih.gov/project-details/10930716", "people": [{"name": "Roger Brooks Bagwell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44AI170131-02", "company": "Big Eye Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": 852688, "summary": "NIH award 4R44AI170131-02: Ultrasensitive, High-Specificity Rapid Test to Support the End-Game of the Global Program to Eliminate Lymphatic Filariasis ($852,688)", "source_url": "https://reporter.nih.gov/project-details/11083346", "people": [{"name": "Marco Antonio Biamonte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K234077", "company": "Camber Spine Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234077: SPIRA\u00ae Anterior Lumbar Spacers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234077", "people": [{"name": "Brooks McAdam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234077%22"}, {"id": "fda:K240661", "company": "Geistlich Pharma AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240661: Geistlich Bio-Oss\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240661", "people": [{"name": "Marco Steiner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240661%22"}, {"id": "fda:K241715", "company": "Aidite (Qinhuangdao) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241715: Dental Glass Ceramics Blocks (HT,LT,ST)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241715", "people": [{"name": "Jinzhong Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241715%22"}, {"id": "fda:K241720", "company": "Baylis Medical Company, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241720: VersaCross Connect\u0099 Transseptal Dilator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241720", "people": [{"name": "Ezgi Tas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241720%22"}, {"id": "fda:K241378", "company": "S.I.N. - Sistema DE Implante Nacional S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241378: S.I.N. Instrument Kits", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241378", "people": [{"name": "Denise Domiciano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241378%22"}, {"id": "fda:K241500", "company": "Guangzhou Red Pine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241500: Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241500", "people": [{"name": "Weihua Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241500%22"}, {"id": "fda:K241707", "company": "Unicon Optical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241707: OCuSOFT AMENITY\u0099 (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241707", "people": [{"name": "Nick Liao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241707%22"}, {"id": "fda:DEN220042", "company": "Terragene S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN220042: Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220042", "people": [{"name": "Catalano Maximiliano", "role": "510(k) submission contact"}]}, {"id": "fda:K233644", "company": "Megadyne Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233644: Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233644", "people": [{"name": "Brian Godwin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233644%22"}, {"id": "fda:K241727", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241727: BriefCase-Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241727", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241727%22"}, {"id": "fda:K240651", "company": "Stryker Leibinger GmbH & Co KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240651: MRI Universal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240651", "people": [{"name": "Amelia Kesti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240651%22"}, {"id": "fda:K232372", "company": "Peters Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232372: Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232372", "people": [{"name": "Ellen Henke-Knupp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232372%22"}, {"id": "fda:K240920", "company": "Deka Research and Development", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240920: HemoCare Bicarbonate Concentrate Set (BCS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240920", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240920%22"}, {"id": "fda:K240240", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240240: Inclusive\u00ae Titanium Abutments compatible with: Keystone\u00ae Dental PrimaConnex\u00ae, Neodent\u00ae GM, Straumann\u00ae BLX, Implant Direct\u00ae Legacy\u00ae, Implant Direct\u00ae InterActive\u00ae, Implant Direct\u00ae RePlant\u00ae Implant Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240240", "people": [{"name": "So Hyun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240240%22"}, {"id": "fda:K233557", "company": "Deka Research and Development", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233557: HemoCare Hemodialysis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233557", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233557%22"}, {"id": "fda:K234124", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234124: Single Use Hemoclips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234124", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234124%22"}, {"id": "fda:K240247", "company": "Duogenic Stemcells Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240247: \u0093MoFi\u0094 Cell Culture Basal Medium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240247", "people": [{"name": "Hong Lin Su", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240247%22"}, {"id": "fda:K233457", "company": "Hutom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233457: RUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233457", "people": [{"name": "Heejoo Yun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233457%22"}, {"id": "fda:K241018", "company": "KLS-Martin L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241018: KLS Martin Orthopedic Implants - MR Conditional", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241018", "people": [{"name": "Melissa Bachorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241018%22"}, {"id": "fda:K241031", "company": "THINK Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241031: TMINI Miniature Robotic System (TMINI 1.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241031", "people": [{"name": "Meliha Mulalic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241031%22"}, {"id": "fda:K241085", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241085: Valleylab \u0099FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241085", "people": [{"name": "Aliva Mahunta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241085%22"}, {"id": "fda:K233834", "company": "Draeger Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233834: Infinity Gateway Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233834", "people": [{"name": "Chris Riel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233834%22"}, {"id": "fda:K241713", "company": "Curvebeam, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241713: HiRise (1040-230)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241713", "people": [{"name": "Ryan Conlon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241713%22"}, {"id": "fda:K241705", "company": "Milkmate Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241705: MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241705", "people": [{"name": "Patrice Meagher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241705%22"}, {"id": "fda:K234009", "company": "Mighty Oak Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234009: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234009", "people": [{"name": "Mark Wylie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234009%22"}, {"id": "denovo:DEN220042", "company": "Terragene S.A.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-07-12", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220042 granted: Terragene Bionova Photon Biological Indi", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220042"}, {"id": "nih:5R42MH128101-04", "company": "Lyssn.io, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": 697475, "summary": "NIH award 5R42MH128101-04: Enhancing the quality of CBT in community mental health through AI-generated fidelity feedback ($697,475)", "source_url": "https://reporter.nih.gov/project-details/10885113", "people": [{"name": "David Charles Atkins", "role": "Principal Investigator"}, {"name": "Torrey A. Creed", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R41HL170893-01A1", "company": "Pgxl Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": 328047, "summary": "NIH award 1R41HL170893-01A1: Novel Urine Collection Kit for Obstructive Sleep Apnea ($328,047)", "source_url": "https://reporter.nih.gov/project-details/10920314", "people": [{"name": "Christopher Thomas Burns", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44GM149106-02", "company": "Cellchorus Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": 1483544, "summary": "NIH award 4R44GM149106-02: Dynamic single-cell analysis instrument to evaluate immune cell function ($1,483,544)", "source_url": "https://reporter.nih.gov/project-details/10835420", "people": [{"name": "Laurence J.N. Cooper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DA061387-01", "company": "Sano Healthcare Consultants, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": 319000, "summary": "NIH award 1R43DA061387-01: Advancing Access to Opiate Care and Treatment through a Novel Liquid Methadone Dispensing Device and SMART Container ($319,000)", "source_url": "https://reporter.nih.gov/project-details/10985728", "people": [{"name": "Edwin Kendrick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241006", "company": "Natural Cycles Nordic AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241006: Natural Cycles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241006", "people": [{"name": "Megan Callanan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241006%22"}, {"id": "fda:K241724", "company": "Acell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241724: Cytal\u00ae Wound Matrix; Cytal\u00ae Burn Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241724", "people": [{"name": "Simone Abramczyk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241724%22"}, {"id": "fda:K241706", "company": "Acell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241706: MicroMatrix\u00ae UBM Particulate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241706", "people": [{"name": "Simone Abramczyk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241706%22"}, {"id": "fda:K241329", "company": "Subtle Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241329: SubtleSYNTH (1.x)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241329", "people": [{"name": "Ronny Elor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241329%22"}, {"id": "fda:K241460", "company": "Lichtmega Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241460: Manual Wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241460", "people": [{"name": "Hyman Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241460%22"}, {"id": "fda:K233874", "company": "Techmah Cmf", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233874: tmCMF Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233874", "people": [{"name": "Mohamed Mahfouz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233874%22"}, {"id": "fda:K241022", "company": "Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241022: Sterile single use tip cleaner (WK800-S10 , WK800-S20)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241022", "people": [{"name": "Haobin Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241022%22"}, {"id": "fda:K241711", "company": "Biotronik, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241711: Oscar Peripheral Multifunctional Catheter system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241711", "people": [{"name": "Jon Brumbaugh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241711%22"}, {"id": "fda:K241000", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241000: ATTUNE\u0099 Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM\u0099 NOILES\u0099 Rotating Hinge Knee System; DePuy P.F.C. \u0099 SIGMA\u0099 Total Knee System; DePuy SIGMA\u0099 Total Knee System;", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241000", "people": [{"name": "Meagan Robles", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241000%22"}, {"id": "fda:K233791", "company": "Rapid-Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233791: Drivewire 24 Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233791", "people": [{"name": "Ina Gutman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233791%22"}, {"id": "fda:K240493", "company": "Integra LifeSciences Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240493: CUSA\u00ae Clarity Ultrasonic Surgical Aspirator System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240493", "people": [{"name": "Karen Monaghan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240493%22"}, {"id": "nih:1R41DC022209-01", "company": "Ubitrix International, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": 305788, "summary": "NIH award 1R41DC022209-01: mVOR: An mHealth Approach to the Clinical Assessment of Gaze Stability and Telerehabilitation of Vestibular Dysfunction ($305,788)", "source_url": "https://reporter.nih.gov/project-details/11007478", "people": [{"name": "Sheikh Iqbal Ahamed", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG050326-05", "company": "Advanced Brain Monitoring, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": 955309, "summary": "NIH award 5R44AG050326-05: Multi-site longitudinal Integrated Neurocognitive and Sleep-Behavior Profiler for the Endophenotypic Classification of Dementia Subtypes (INSPECDS) ($955,309)", "source_url": "https://reporter.nih.gov/project-details/10843903", "people": [{"name": "Chris Berka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "fda:K240016", "company": "Shenzhen Jianrong Biomedical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240016: IPL Hair Removal Device (YT01,YT02,YT03,YT04)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240016", "people": [{"name": "Bruce Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240016%22"}, {"id": "fda:K232177", "company": "Solmedix Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232177: Lightin System, Lightin, Lightin Generator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232177", "people": [{"name": "Hyeroung Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232177%22"}, {"id": "fda:K233453", "company": "Life Technologies Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233453: Applied Biosystems\u0099 TaqPath\u0099 COVID-19 Diagnostic PCR Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233453", "people": [{"name": "Ian McGill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233453%22"}, {"id": "fda:K240527", "company": "Devicor Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240527: HydroMARK\u0099 Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240527", "people": [{"name": "Katy Austin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240527%22"}, {"id": "fda:K241661", "company": "Sleepnet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241661: Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241661", "people": [{"name": "Jennifer Kennedy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241661%22"}, {"id": "fda:K241683", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241683: Sterling\u0099 MONORAIL\u0099 PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling\u0099 MONORAIL\u0099 PTA Balloon Dilatation Catheter (H74939031406020); Sterling\u0099 MONORAIL\u0099 PTA Balloon Dilatation Catheter (H74939031408020); Sterling\u0099 MONORAIL\u0099 PTA Balloon Dilatation Catheter (H74939031410020); Sterling\u0099 MONORAIL\u0099 PTA Balloon Dilatation Catheter (H74939031412020); Sterling\u0099 MONORAIL\u0099 PTA Balloon Dilatation Catheter (H74939031415020); Sterling\u0099 MONORAIL\u0099 PTA Balloon Dilatation Catheter (H749390314", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241683", "people": [{"name": "Michael McDonagh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241683%22"}, {"id": "fda:K241426", "company": "Prosidyan, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241426: GPS Advanced; 5 cc GPS Advanced Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241426", "people": [{"name": "Tamala Wampler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241426%22"}, {"id": "fda:K240666", "company": "Medtronic Perfusion Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240666: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240666", "people": [{"name": "Megan Schlichting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240666%22"}, {"id": "fda:K233628", "company": "Alpha-Omega Services, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233628: AOS Interstitial Templates, Needles, and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233628", "people": [{"name": "Bob Robnett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233628%22"}, {"id": "fda:K240614", "company": "Oticon Medical AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240614: Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240614", "people": [{"name": "Pernilla Gustafsson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240614%22"}, {"id": "nih:2R44GM144007-02A1", "company": "Indelible Learning, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": 835202, "summary": "NIH award 2R44GM144007-02A1: Interactive Hand Hygiene Trainer for School-Age Children ($835,202)", "source_url": "https://reporter.nih.gov/project-details/10823124", "people": [{"name": "Jasminka Criley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA291526-01", "company": "Ergami Endoscopy, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": 399789, "summary": "NIH award 1R43CA291526-01: Automated rapid colonoscope insertion device to reduce physician injury and improve productivity ($399,789)", "source_url": "https://reporter.nih.gov/project-details/10922027", "people": [{"name": "Hrishikesh Deo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM156162-01", "company": "Numentus Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": 298999, "summary": "NIH award 1R43GM156162-01: High-Throughput High-Content Nanoscale Extracellular Vesicle Analysis ($298,999)", "source_url": "https://reporter.nih.gov/project-details/11008373", "people": [{"name": "GREGORY W FARIS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG085832-02", "company": "Spatial Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": 1229313, "summary": "NIH award 5R44AG085832-02: Spatial single cell analysis of the human Alzheimer's Disease brain ($1,229,313)", "source_url": "https://reporter.nih.gov/project-details/10932284", "people": [{"name": "Kirsten Frieda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HG012288-03", "company": "Geneial LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44HG012288-03: Privacy-Preserving Connectivity for Rare-Disease Patients ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10886143", "people": [{"name": "Adam Wesley Hansen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AR084406-01", "company": "Flex Orthopaedics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": 299996, "summary": "NIH award 1R43AR084406-01: A COMPLIANT ANKLE ENDOPROSTHESIS TO TREAT ANKLE-HINDFOOT PATHOLOGY ($299,996)", "source_url": "https://reporter.nih.gov/project-details/10923285", "people": [{"name": "Brandon Peterson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R42CA290912-01S1", "company": "Aperture Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R42CA290912-01S1: Rapid, Single Cell Proteomic Profiling for Biomarker Development in Precision Oncology ($55,000)", "source_url": "https://reporter.nih.gov/project-details/11095920", "people": [{"name": "Hannah Marie Peterson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K241372", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241372: Advisor\u0099 HD Grid X Mapping Catheter, Sensor Enabled\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241372", "people": [{"name": "Samantha Stretar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241372%22"}, {"id": "fda:K233937", "company": "Softwave/Trt, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233937: OW100S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233937", "people": [{"name": "Cherita James", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233937%22"}, {"id": "fda:K241343", "company": "Shenzhen Lescolton Electrical Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241343: IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241343", "people": [{"name": "Zhikui Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241343%22"}, {"id": "fda:K240966", "company": "Keystone Dental, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240966: Prima Plus Conical Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240966", "people": [{"name": "Adam Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240966%22"}, {"id": "fda:K240610", "company": "Damae Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240610: deepLive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240610", "people": [{"name": "David Siret", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240610%22"}, {"id": "fda:K241316", "company": "Hunan Hualian Special Ceramics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241316: Zirconia Block", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241316", "people": [{"name": "Fusheng Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241316%22"}, {"id": "fda:K232551", "company": "Forum Engineering Technologies (96) , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232551: EM-07 Cordless Endo Motor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232551", "people": [{"name": "Nissim Oz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232551%22"}, {"id": "fda:K241019", "company": "Carlsmed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241019: aprevo\u00ae TLIF-C Articulating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241019", "people": [{"name": "Aly Alvarez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241019%22"}, {"id": "nih:1R43AI186702-01", "company": "Latde Diagnostics Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-08", "observed": "2026-08-21", "amount_usd": 299170, "summary": "NIH award 1R43AI186702-01: Rapid, equitable, lateral flow-based antibiotic susceptibility testing for urinary tract infections ($299,170)", "source_url": "https://reporter.nih.gov/project-details/11006225", "people": [{"name": "Emily S Melzer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241293", "company": "Yassen Wellness, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241293: LED Light Therapy Device, ELIXIR MD\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241293", "people": [{"name": "Yassen Ewan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241293%22"}, {"id": "fda:K240502", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240502: da Vinci SP Surgical System (SP1098)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240502", "people": [{"name": "Mike Yramategui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240502%22"}, {"id": "fda:K233584", "company": "RhythMedix, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233584: RhythmStar System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233584", "people": [{"name": "Stan Biletsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233584%22"}, {"id": "nih:1R44GM156142-01", "company": "Gmj Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-05", "observed": "2026-08-21", "amount_usd": 350000, "summary": "NIH award 1R44GM156142-01: High-Resolution Native Capillary Zone Electrophoresis with Inline UV and Native Mass Spectrometry for Characterizing Charge Variants in Biologics ($350,000)", "source_url": "https://reporter.nih.gov/project-details/11006980", "people": [{"name": "Oluwatosin Dada", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K241305", "company": "Lucas Lifecare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241305: LifeRay Intraoral Handheld X-ray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241305", "people": [{"name": "Joseph Paul Vincent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241305%22"}, {"id": "fda:K240252", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240252: UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240252", "people": [{"name": "Marie Steigerwalt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240252%22"}, {"id": "fda:K241111", "company": "Applied Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241111: AMT Suture Passer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241111", "people": [{"name": "Jennifer Hazou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241111%22"}, {"id": "fda:K241625", "company": "Remex Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241625: Anatase Navi Disposable Instrument", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241625", "people": [{"name": "Wang Cheng-Hsiung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241625%22"}, {"id": "fda:K241649", "company": "Zinnovi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241649: DUO1 and DUO2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241649", "people": [{"name": "Swaroop Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241649%22"}, {"id": "fda:K241660", "company": "Sioxmed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241660: SiOxD\u00ae Wound Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241660", "people": [{"name": "Adam Jorgensen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241660%22"}, {"id": "fda:K234082", "company": "Advanced Sterilization Products", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234082: STERRAD\u00ae 100NX Sterilizer with ALLClear\u0099 Technology and ULTRA GI\u0099 Cycle (10104); APTIMAX\u0099 Instrument Tray for ULTRA GI\u0099 Cycle (011077)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234082", "people": [{"name": "Ayse Erkan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234082%22"}, {"id": "fda:K240120", "company": "Turbo Wheelchair Co., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240120: Merlexi Craft Bariatric series of manual wheelchairs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240120", "people": [{"name": "Jane Hermes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240120%22"}, {"id": "fda:K234084", "company": "Advanced Sterilization Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234084: STERRAD\u0099 Chemical Indicator (CI) Strip (14100); STERRAD\u00ae SEALSURE\u00ae Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY\u0099 Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY\u0099 Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY\u0099 Reader (43220); ULTRA GI\u0099 Process Challenge Device (PCD) (43400)(30 count)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234084", "people": [{"name": "Brandon Roberts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234084%22"}, {"id": "nih:1R43HD115478-01", "company": "Bsolutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-04", "observed": "2026-08-21", "amount_usd": 242300, "summary": "NIH award 1R43HD115478-01: Cribsy: A platform for home-based automated developmental risk screening ($242,300)", "source_url": "https://reporter.nih.gov/project-details/10920247", "people": [{"name": "BHARATH MODAYUR", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD112248-01A1", "company": "Spirit Fit & Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": 275699, "summary": "NIH award 1R44HD112248-01A1: SPIRIT Club CBI Pathway: A novel streaming platform for physical activity and wellness promotion for chronic brain injury survivors ($275,699)", "source_url": "https://reporter.nih.gov/project-details/10821944", "people": [{"name": "Jared Phillip Ciner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM148126-02A1", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": 1238908, "summary": "NIH award 2R44GM148126-02A1: Improving extraction success of FFPE samples with automated and reliable microfluidic sample preparation ($1,238,908)", "source_url": "https://reporter.nih.gov/project-details/10931835", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NR019963-04", "company": "Cove Technology Consulting LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": 716570, "summary": "NIH award 5R44NR019963-04: A closed-loop gravity infusion control device ($716,570)", "source_url": "https://reporter.nih.gov/project-details/10899623", "people": [{"name": "Chie Kawahara", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:4R44CA268156-03", "company": "Opsiclear LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": 1002315, "summary": "NIH award 4R44CA268156-03: 3D optical histopathology for head and neck intraoperative consultation. ($1,002,315)", "source_url": "https://reporter.nih.gov/project-details/11065582", "people": [{"name": "YEHE LIU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH134733-02", "company": "Appa Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": 604026, "summary": "NIH award 5R44MH134733-02: Digital Delivery of Evidence-Based Mental Health Content and Mentoring to Adolescents ($604,026)", "source_url": "https://reporter.nih.gov/project-details/10879048", "people": [{"name": "Michelle R. Kaufman", "role": "Principal Investigator"}, {"name": "Robert Joseph Miller", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241129", "company": "Shenzhen Goodlymed Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241129: Upper Arm Electronic Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241129", "people": [{"name": "Ma Maria", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241129%22"}, {"id": "fda:K241629", "company": "Ethicon Endo-Surgery, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241629: ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241629", "people": [{"name": "Jisha Mlynarczyk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241629%22"}, {"id": "fda:K241508", "company": "Iterative Scopes, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241508: SKOUT\u00ae system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241508", "people": [{"name": "Caitlyn Seidl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241508%22"}, {"id": "fda:K241600", "company": "Asclepion Laser Technologies GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241600: Dermablate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241600", "people": [{"name": "Tom Gruender", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241600%22"}, {"id": "fda:K241577", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241577: Iconix\u00ae Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241577", "people": [{"name": "Bianca Silva de Sousa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241577%22"}, {"id": "fda:K241606", "company": "Stryker Sustainability Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241606: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241606", "people": [{"name": "Scott English", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241606%22"}, {"id": "fda:K241615", "company": "Hony Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241615: Transducer Probe Cover", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241615", "people": [{"name": "Zhu Huina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241615%22"}, {"id": "fda:K241277", "company": "OSSIO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241277: OSSIOfiber\u00ae Threaded Trimmable Fixation Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241277", "people": [{"name": "Taly Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241277%22"}, {"id": "fda:K241591", "company": "The Standard Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241591: Blue Eye", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241591", "people": [{"name": "Seong Nam Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241591%22"}, {"id": "fda:K241371", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241371: VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241371", "people": [{"name": "Toshio Nakamura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241371%22"}, {"id": "fda:K233574", "company": "Skeletal Dynamics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233574: Total Wrist Arthroplasty System (TWA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233574", "people": [{"name": "Alexandra Rodriguez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233574%22"}, {"id": "fda:K240052", "company": "Beijing L&Z Medical Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240052: Disposable Enteral Feeding Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240052", "people": [{"name": "Zhiling Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240052%22"}, {"id": "fda:K240946", "company": "Alimetry , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240946: Gastric Alimetry", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240946", "people": [{"name": "Yarmut Yaara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240946%22"}, {"id": "fda:K241284", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241284: da Vinci Surgical System (IS5000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241284", "people": [{"name": "Jennifer Karafin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241284%22"}, {"id": "fda:K240996", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240996: Access Thyroglobulin Antibody II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240996", "people": [{"name": "Kate Oelberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240996%22"}, {"id": "fda:K240009", "company": "First Source, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240009: iQFlex Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240009", "people": [{"name": "Woo Sung Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240009%22"}, {"id": "fda:K240987", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240987: Access sTfR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240987", "people": [{"name": "Neha Desai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240987%22"}, {"id": "nih:5R44AR080503-03", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": 895438, "summary": "NIH award 5R44AR080503-03: Simulation and Education Tool for Physical Examinations of Orthopedic Pathologies ($895,438)", "source_url": "https://reporter.nih.gov/project-details/10873276", "people": [{"name": "John Paul Condon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH131514-03", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": 1035183, "summary": "NIH award 5R44MH131514-03: Development of an Acoustic Implant Protection System to Improve Performance and Longevity of Neural Interfaces ($1,035,183)", "source_url": "https://reporter.nih.gov/project-details/10884937", "people": [{"name": "Maureen L. Mulvihill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K241622", "company": "Medtronic Minimed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241622: Extended Reservoir; MiniMed Reservoir", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241622", "people": [{"name": "Shruti Prakash", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241622%22"}, {"id": "fda:K240930", "company": "Sri Trang Gloves Thailand (Public Company Limited)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240930: Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240930", "people": [{"name": "M. Jordan Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240930%22"}, {"id": "fda:K232824", "company": "Owens & Minor (O&M) Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232824: FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232824", "people": [{"name": "Caitlin Senter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232824%22"}, {"id": "fda:K234083", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234083: Next Generation Aspiration Catheter; Balt Aspiration Tubing Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234083", "people": [{"name": "Alicia Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234083%22"}, {"id": "fda:K233626", "company": "Alpha-Omega Services, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233626: AOS Marker Seeds (SMG0242-025)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233626", "people": [{"name": "Bob Robnett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233626%22"}, {"id": "fda:K240736", "company": "Disior, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240736: SMART Bun-Yo-Matic X-Ray", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240736", "people": [{"name": "Aamo Jussila", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240736%22"}, {"id": "fda:K240863", "company": "Maxx Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240863: Freedom\u00ae Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240863", "people": [{"name": "Corey Perine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240863%22"}, {"id": "fda:K234074", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234074: Next Generation Access Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234074", "people": [{"name": "Catherine Chiou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234074%22"}, {"id": "fda:K241300", "company": "Ge Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241300: ViewPoint 6", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241300", "people": [{"name": "Brandon O'Shea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241300%22"}, {"id": "fda:DEN240013", "company": "Gt Metabolic Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240013: MagDI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240013", "people": [{"name": "Lisa Griffin Vincent", "role": "510(k) submission contact"}]}, {"id": "fda:K241330", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241330: Fogarty Fortis Arterial Embolectomy Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241330", "people": [{"name": "Aeree Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241330%22"}, {"id": "fda:K233415", "company": "Remsleep Holdings", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233415: DELTAWAVE Nasal Pillows System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233415", "people": [{"name": "Tom Wood", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233415%22"}, {"id": "fda:K240555", "company": "Tyto Care , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240555: Tyto Insights for Crackles Detection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240555", "people": [{"name": "Stella Raizelman Perry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240555%22"}, {"id": "fda:K233440", "company": "Philips Medizin Systeme Boeblingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233440: Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233440", "people": [{"name": "Trang Adams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233440%22"}, {"id": "fda:K240707", "company": "Shenzhen Micro Electric Intelligence Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240707: Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240707", "people": [{"name": "Fengmeng Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240707%22"}, {"id": "fda:K240915", "company": "Zien Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240915: ZIEN IO Intraosseous Access System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240915", "people": [{"name": "Tim Nieman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240915%22"}, {"id": "fda:K241574", "company": "SI-BONE, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241574: iFuse TORQ\u00ae Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241574", "people": [{"name": "Capobianco Robyn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241574%22"}, {"id": "pma:P220030", "company": "Alcon Research, LLC", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-07-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P220030: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220030", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P220030%22"}, {"id": "denovo:DEN240013", "company": "Gt Metabolic Solutions, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-07-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240013 granted: MagDI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240013"}, {"id": "nih:2R44HG012531-02A1", "company": "Sage Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": 1002420, "summary": "NIH award 2R44HG012531-02A1: High-throughput size-selection system for long-read sequencing library preparation ($1,002,420)", "source_url": "https://reporter.nih.gov/project-details/10915268", "people": [{"name": "TRUETT C BOLES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AI183989-01", "company": "Ionic Pharmaceuticals", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43AI183989-01: Treating Second-Degree Burn Wound Infections with a Quorum Sensing Inhibitor ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10916626", "people": [{"name": "Aaron Henry Colby", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM154502-01", "company": "Revel Pharmaceuticals Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": 346755, "summary": "NIH award 1R43GM154502-01: An enzyme-based assay for the detection of carboxyethyl lysine-protein adducts ($346,755)", "source_url": "https://reporter.nih.gov/project-details/10914230", "people": [{"name": "Aaron Cravens", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA285064-02", "company": "Magnetic Insight, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": 1012220, "summary": "NIH award 5R44CA285064-02: Development of a prototype clinical theranostic platform combining Magnetic Particle Imaging (MPI) and Magnetic Fluid Hyperthermia (MFH) for the treatment of brain tumors ($1,012,220)", "source_url": "https://reporter.nih.gov/project-details/10877810", "people": [{"name": "Patrick Goodwill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM152984-02", "company": "Massmatrix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": 860633, "summary": "NIH award 5R44GM152984-02: Accelerating Gene Therapy and Editing with Advanced MS-Based Data Analysis for Nonstandard and Hybrid Nucleotide Sequences ($860,633)", "source_url": "https://reporter.nih.gov/project-details/10881890", "people": [{"name": "George Hall Johnson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42DA053075-04", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": 987966, "summary": "NIH award 5R42DA053075-04: Developing novel technologies to monitor nociception and opioid administration during surgery and general anesthesia in order to minimize post-operative opioid requirements ($987,966)", "source_url": "https://reporter.nih.gov/project-details/10875550", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44DA055407-03", "company": "Neuroptics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": 1092027, "summary": "NIH award 5R44DA055407-03: Development and Commercialization of a pupillometer to predict postoperative opioid-induced respiratory depression in children ($1,092,027)", "source_url": "https://reporter.nih.gov/project-details/10878990", "people": [{"name": "Jeffrey Wade Oliver", "role": "Principal Investigator"}, {"name": "Claudio Privitera", "role": "Principal Investigator"}, {"name": "Senthilkumar Sadhasivam", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K240572", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240572: Valleylab\u0099 SM Smoke Management Pencil with Edge\u0099 Blade Electrode, 10\u0092 (3m) (VSMP10); Valleylab\u0099 SM Smoke Management Pencil with Edge\u0099 Blade Electrode, 15\u0092 (4.6m) (VSMP15); Valleylab\u0099 SM Smoke Management Pencil with Edge\u0099 Blade Electrode, 10\u0092 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab\u0099 SM Smoke Management Extended Nozzle (for use with 4\u0094 (100mm) electrode) (VSMEN4); Valleylab\u0099 SM Smoke Management Extended Nozzle (for use with 6.5\u0094 (165mm) electrode) (VSMEN6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240572", "people": [{"name": "Miranda Miles", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240572%22"}, {"id": "fda:K241598", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241598: LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -\u0096 Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope \u0096 Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope \u0096 Reverse (without pressure monitoring) (M0067941500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241598", "people": [{"name": "Matthew Minks", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241598%22"}, {"id": "fda:K234061", "company": "Fotona D.O.O.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234061: StarFormer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234061", "people": [{"name": "Tina Bartolic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234061%22"}, {"id": "fda:K240070", "company": "Candela Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240070: Profound Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240070", "people": [{"name": "Rina Ordonez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240070%22"}, {"id": "fda:K231015", "company": "Innovative Health, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231015: Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231015", "people": [{"name": "Rick Ferreira", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231015%22"}, {"id": "fda:K232777", "company": "Owens & Minor (O&M) Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232777: FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232777", "people": [{"name": "Caitlin Senter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232777%22"}, {"id": "fda:K233477", "company": "Shandong Wego Ruisheng Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233477: Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233477", "people": [{"name": "Yan Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233477%22"}, {"id": "fda:K232989", "company": "Shenzhen AOJ Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232989: Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232989", "people": [{"name": "Jack Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232989%22"}, {"id": "fda:K240801", "company": "Dent4you AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240801: BioSonic US200 Ultrasonic Scaler (60034537)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240801", "people": [{"name": "Tricia Cregger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240801%22"}, {"id": "fda:K241202", "company": "Hetaida Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241202: Electric nasal aspirator (HTD2601US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241202", "people": [{"name": "Tom Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241202%22"}, {"id": "fda:K240536", "company": "Shenzhen TPH Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240536: Wearable Breast Pump (Model S32)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240536", "people": [{"name": "Peter Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240536%22"}, {"id": "fda:DEN240007", "company": "Signum Surgical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240007: BioHealx Anal Fistula Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240007", "people": [{"name": "Moshe Zilversmit", "role": "510(k) submission contact"}]}, {"id": "fda:K240477", "company": "St. shine Optical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240477: Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240477", "people": [{"name": "Mina Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240477%22"}, {"id": "fda:K233908", "company": "Combinostics OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233908: cNeuro cDAT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233908", "people": [{"name": "Lennart Thurfjell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233908%22"}, {"id": "fda:K241639", "company": "Huger Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241639: Single-use Video Ureterorenoscope (SVU-220US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241639", "people": [{"name": "Shen Junjie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241639%22"}, {"id": "fda:K240221", "company": "Heidelberg Engineering GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240221: SPECTRALIS HRA+OCT and variants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240221", "people": [{"name": "Arianna Schoess Vargas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240221%22"}, {"id": "fda:K240353", "company": "Sk, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-07-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240353: Hyper Insight - ICH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240353", "people": [{"name": "Jeffrey Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240353%22"}, {"id": "denovo:DEN240007", "company": "Signum Surgical Limited", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-07-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240007 granted: BioHealx Anal Fistula Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240007"}, {"id": "sbir:DOD:FA8649-24-P-0719", "company": "NKA Bio, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-07-01", "observed": "2026-09-18", "amount_usd": 72672, "summary": "DOD SBIR Phase I award $72,672: Anti-Shock Toxin Antibody Drug for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=FX245-PCSO1-0808"}, {"id": "nih:5R44HL162151-03", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": 948080, "summary": "NIH award 5R44HL162151-03: A Low Blood Volume Platform for Recurrent Anticoagulation and Kidney Monitoring during Continuous Renal Replacement Therapy in Critically Ill Children ($948,080)", "source_url": "https://reporter.nih.gov/project-details/10863941", "people": [{"name": "VAMSEE K. PAMULA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DK137702-02", "company": "Sfc Fluidics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": 944944, "summary": "NIH award 5R44DK137702-02: Advanced Development of Gemini-DHAP ($944,944)", "source_url": "https://reporter.nih.gov/project-details/10892876", "people": [{"name": "Forrest Payne", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K240893", "company": "Artfx Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240893: ARTFX MEDICAL Cervical PEEK Cages", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240893", "people": [{"name": "Ozgen Ozfidan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240893%22"}, {"id": "fda:K240164", "company": "Bain Medical Equipment (Guangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240164: NovaLine SP-C35 Transducer Protector (956007)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240164", "people": [{"name": "Zoe Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240164%22"}, {"id": "fda:K241204", "company": "Rizhao Huge Biomaterials Company, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241204: TopCEM-Veneer Light Cure Veneer Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241204", "people": [{"name": "Maggie Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241204%22"}, {"id": "fda:K241154", "company": "If Health (Xiamen) Intelligent Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241154: Electric Wheelchair (YFWB-63)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241154", "people": [{"name": "Xiang Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241154%22"}, {"id": "fda:K241406", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241406: Lavieen", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241406", "people": [{"name": "Hyunsik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241406%22"}, {"id": "fda:K232865", "company": "Endomagnetics Ltd.,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232865: Magseed Pro Magnetic Marker System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232865", "people": [{"name": "Mehryar Behizad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232865%22"}, {"id": "fda:K241229", "company": "Bio Optics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241229: Hello,eyes\u00ae BIO Plug", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241229", "people": [{"name": "SangHoon Jung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241229%22"}, {"id": "fda:K241540", "company": "Biosense Webster, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241540: NUVISION\u0099 Ultrasound Catheter; NUVISION\u0099 NAV Ultrasound Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241540", "people": [{"name": "Sheba Chacko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241540%22"}, {"id": "fda:K240892", "company": "IceCure Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240892: XSense Cryoablation System with Cryoprobes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240892", "people": [{"name": "Maayan Levi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240892%22"}, {"id": "fda:K240215", "company": "Carl Zeiss Meditec, AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240215: BLUE 400; BLUE 400 S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240215", "people": [{"name": "Seitz Anke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240215%22"}, {"id": "fda:K233823", "company": "Shenzhen Jamr Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233823: Ultrasonic Fetal Doppler", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233823", "people": [{"name": "Haiyu Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233823%22"}, {"id": "fda:K233637", "company": "Cordis US Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233637: Cordis BRITECROSS Support Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233637", "people": [{"name": "Linda Ruedy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233637%22"}, {"id": "fda:K240320", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240320: Patient Monitor (RespArray)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240320", "people": [{"name": "Tracy Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240320%22"}, {"id": "fda:K240927", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240927: Access Thyroglobulin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240927", "people": [{"name": "Muhammad Sheikh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240927%22"}, {"id": "fda:K241608", "company": "Nordicneurolab AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241608: nordicMEDiVA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241608", "people": [{"name": "Chandana Gurung Bhandari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241608%22"}, {"id": "nih:5R44DA055396-03", "company": "Dynamicare Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": 894852, "summary": "NIH award 5R44DA055396-03: Incentivized Collaborative Care to Desseminate Contingency Management ($894,852)", "source_url": "https://reporter.nih.gov/project-details/10865024", "people": [{"name": "Anthony DeFulio", "role": "Principal Investigator"}, {"name": "David R Gastfriend", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44NR019516-03", "company": "Qua, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": 821451, "summary": "NIH award 5R44NR019516-03: Development and Evaluation of the PPAL Bedside Commode for Safe Independent Toileting Transfers ($821,451)", "source_url": "https://reporter.nih.gov/project-details/10932402", "people": [{"name": "Margaret Ellen Graham", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43CA291627-01", "company": "3dt Holdings, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R43CA291627-01: Novel Tracheostoma Device ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10919087", "people": [{"name": "Terry Hubbard", "role": "Principal Investigator"}, {"name": "GHASSAN S KASSAB", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA287536-02", "company": "Alara Imaging Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": 656899, "summary": "NIH award 5R44CA287536-02: The Alara Imaging Gateway: Linking Electronic Health Records and Radiology Imaging Exams to Report on National Quality Measures to Reduce Cancer Risk from Computed Tomography (Alara Imaging Gateway) ($656,899)", "source_url": "https://reporter.nih.gov/project-details/10931601", "people": [{"name": "Nathan Mazonson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K240381", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240381: CATALYSTEM Femoral Stems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240381", "people": [{"name": "Chelsea Bagley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240381%22"}, {"id": "fda:K233983", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233983: Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233983", "people": [{"name": "Anna Hwang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233983%22"}, {"id": "fda:DEN230055", "company": "Balance Ophthalmics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230055: FSYX\u0099 Ocular Pressure Adjusting Pump (FSYX\u0099 OPAP) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230055", "people": [{"name": "Gary Mocnik", "role": "510(k) submission contact"}]}, {"id": "fda:K240823", "company": "Saremco Dental AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240823: els extra low shrinkage\u00ae composite & els extra low shrinkage\u00ae flow", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240823", "people": [{"name": "Christoph Evers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240823%22"}, {"id": "fda:K240327", "company": "Unik Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240327: UNIKO PointCloud\u0099 Knee Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240327", "people": [{"name": "Charlie Chi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240327%22"}, {"id": "fda:DEN240016", "company": "Cepheid", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN240016: Xpert HCV; GeneXpert Xpress System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240016", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}]}, {"id": "fda:K241506", "company": "Annabella Tech", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241506: Annabella Double Breast Pump (ADO-US23-1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241506", "people": [{"name": "Dalia Dickman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241506%22"}, {"id": "fda:K240853", "company": "Neptune Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240853: Pathfinder\u00ae CR System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240853", "people": [{"name": "Alex Tilson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240853%22"}, {"id": "fda:K241212", "company": "Kuros Biosciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241212: MagnetOs Easypack Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241212", "people": [{"name": "Hen Baron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241212%22"}, {"id": "fda:K241542", "company": "3M Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241542: 3M\u0099 Attest\u0099 Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241542", "people": [{"name": "Samantha Miller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241542%22"}, {"id": "fda:K241520", "company": "Sleepnet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241520: Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241520", "people": [{"name": "Jennifer Kennedy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241520%22"}, {"id": "fda:K240717", "company": "3M Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240717: 3M\u0099 Attest\u0099 Rapid Readout Biological Indicator 1295 and 3M\u0099 Attest\u0099 Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240717", "people": [{"name": "Heidi Wallis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240717%22"}, {"id": "fda:K233398", "company": "Oertli Instrumente AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233398: Faros Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233398", "people": [{"name": "Marianne Kesseli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233398%22"}, {"id": "fda:K233357", "company": "Nuvaira, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233357: EsoCool Thermal Regulation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233357", "people": [{"name": "John Carline", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233357%22"}, {"id": "fda:K233762", "company": "Ideate Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233762: SteroScope\u00ae Sterilization Technology System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233762", "people": [{"name": "William Wong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233762%22"}, {"id": "fda:K241553", "company": "Eximo Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241553: Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241553", "people": [{"name": "Yoel Zabar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241553%22"}, {"id": "fda:K240938", "company": "Optimotion Implants, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240938: The Optimotion\u0099 Blue Plus Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240938", "people": [{"name": "Cassidy Larwood", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240938%22"}, {"id": "fda:K240564", "company": "Carol Cole Company Dba Nuface\u00ae", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240564: NuFACE\u00ae FIX+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240564", "people": [{"name": "Robert Castro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240564%22"}, {"id": "fda:K241509", "company": "Plexus Yoga, LLC Dba Chirp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241509: TENS&EMS units (SM9109A, SM9109B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241509", "people": [{"name": "Jianhua Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241509%22"}, {"id": "denovo:DEN230055", "company": "Balance Ophthalmics, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-06-27", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230055 granted: FSYX\u2122 Ocular Pressure Adjusting Pump (FS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230055"}, {"id": "denovo:DEN240016", "company": "Cepheid", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-06-27", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN240016 granted: Xpert HCV; GeneXpert Xpress System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240016"}, {"id": "nih:2R44CA228920-04", "company": "Leuko Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": 1702979, "summary": "NIH award 2R44CA228920-04: Reducing the incidence of febrile neutropenia in cancer patients treated with chemotherapy with PointCheck: a portable non-invasive neutropenia analyzer ($1,702,979)", "source_url": "https://reporter.nih.gov/project-details/10911683", "people": [{"name": "Carlos Castro-Gonzalez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44DK135256-02", "company": "Cerulean Scientific Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": 751776, "summary": "NIH award 5R44DK135256-02: Slippery Omniphobic Coating for Hemodialysis Catheter to Resist Fibrin Sheathing and Infection and Improve Patient Outcomes ($751,776)", "source_url": "https://reporter.nih.gov/project-details/10894142", "people": [{"name": "Todd McFarland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241133", "company": "Esaote, S.p.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241133: Magnifico Open (100009900); Magnifico MSK ( 100009910)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241133", "people": [{"name": "Alberto Carcagn\u00ec", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241133%22"}, {"id": "fda:K241507", "company": "Aln S.A.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241507: ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241507", "people": [{"name": "Nigon Alain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241507%22"}, {"id": "fda:K234059", "company": "Forma Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234059: Forma Medical Optimal Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234059", "people": [{"name": "James Gault", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234059%22"}, {"id": "fda:K240875", "company": "Corin U.S.A. Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240875: Unity Knee PS-C Tibial Insert", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240875", "people": [{"name": "Marine De Paoli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240875%22"}, {"id": "fda:K233579", "company": "Fcu Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233579: SC1 Handheld Ultrasound Imaging system (Model: SC1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233579", "people": [{"name": "Song Hyuk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233579%22"}, {"id": "fda:K232829", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232829: Versalock Rib and Sternum Plates System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232829", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232829%22"}, {"id": "fda:K233354", "company": "Athena Gtx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233354: WVSM Pro (Series) (500-0030-XX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233354", "people": [{"name": "Sean Mahoney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233354%22"}, {"id": "fda:K233413", "company": "True Indicating, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233413: Ultraphon Chemical Indicator (TRO-T and TRO-B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233413", "people": [{"name": "Thomas Riha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233413%22"}, {"id": "fda:K233380", "company": "Dornier Medtech America", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233380: TRIDENT Mobile Fluoroscopy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233380", "people": [{"name": "John Hoffer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233380%22"}, {"id": "fda:K232987", "company": "Asset Medikal Tasarim Sanayi VE Ticaret A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232987: FlowArt Valve for Vial Access", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232987", "people": [{"name": "Ebru Sirali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232987%22"}, {"id": "fda:K222771", "company": "Hangzhou Bioer Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222771: Sample Preservative Fluid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222771", "people": [{"name": "Zoey .", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222771%22"}, {"id": "fda:K233840", "company": "Zhuhai Dipu Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233840: Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233840", "people": [{"name": "Huan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233840%22"}, {"id": "nih:5R44CA281615-02", "company": "Kintara Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": 745259, "summary": "NIH award 5R44CA281615-02: An Open-Labeled, Single Arm Phase 2 Efficacy and Safety Study of REM-001 Photodynamic Therapy (PDT) for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) ($745,259)", "source_url": "https://reporter.nih.gov/project-details/10877852", "people": [{"name": "Dennis Brown", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AI186556-01", "company": "Integral Molecular", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": 288515, "summary": "NIH award 1R43AI186556-01: Development of Safe and Rapid Reporter Viruses for Studying Pathogenic and Pandemic Viruses ($288,515)", "source_url": "https://reporter.nih.gov/project-details/11004045", "people": [{"name": "Benjamin J Doranz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK139891-01", "company": "Wearable Artificial Organs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": 459824, "summary": "NIH award 1R44DK139891-01: Dialyzing at home with a new model of the Wearable Artificial Kidney ($459,824)", "source_url": "https://reporter.nih.gov/project-details/10922049", "people": [{"name": "Victor Gura", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS127667-03", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": 1091278, "summary": "NIH award 5R44NS127667-03: Exploring the Parameter Space of High Frequency Magnetic Perturbation in Manipulating Neural Excitability and Plasticity. ($1,091,278)", "source_url": "https://reporter.nih.gov/project-details/10912721", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K233368", "company": "Bioventus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233368: Allograft Delivery Device (OFAC-C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233368", "people": [{"name": "Shanna Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233368%22"}, {"id": "fda:K240582", "company": "Eos Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240582: VEA Align; spineEOS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240582", "people": [{"name": "Moran Celestin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240582%22"}, {"id": "fda:K240824", "company": "Ningxia Qiaoen Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240824: Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240824", "people": [{"name": "Johnson Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240824%22"}, {"id": "fda:K232111", "company": "Laerdal Medical AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232111: NeoBeat, NeoBeat Mini", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232111", "people": [{"name": "Mari Kaada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232111%22"}, {"id": "fda:K233006", "company": "Myndtec, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233006: MyndMove, MyndMove 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233006", "people": [{"name": "Yesmil Pena", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233006%22"}, {"id": "fda:K241158", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241158: ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241158", "people": [{"name": "Fujimura Katsuhiko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241158%22"}, {"id": "fda:K241035", "company": "Providence Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241035: PMT Posterior Cervical Stabilization System (PCSS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241035", "people": [{"name": "Edward Liou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241035%22"}, {"id": "fda:K232640", "company": "Thermabright", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232640: Venowave VW5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232640", "people": [{"name": "Liane Parker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232640%22"}, {"id": "sbir:DOD:FA8649-24-P-0012", "company": "Dream Systems, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-06-25", "observed": "2026-09-18", "amount_usd": 1215103, "summary": "DOD SBIR Phase II award $1,215,103: Medical Device To Improve Warfighter Readiness", "source_url": "https://www.sbir.gov/awards?search=F2D-9183"}, {"id": "nih:3R44AG076067-03S1", "company": "Life Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-24", "observed": "2026-08-21", "amount_usd": 190443, "summary": "NIH award 3R44AG076067-03S1: Optimization of an at-home continuous multi-domain monitoring and assessment system to improve Alzheimer's and related disorders clinical trials ($190,443)", "source_url": "https://reporter.nih.gov/project-details/11013734", "people": [{"name": "Lawrence J Frye", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44GM154507-01", "company": "Applied Biophysics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-24", "observed": "2026-08-21", "amount_usd": 947705, "summary": "NIH award 1R44GM154507-01: Development of an impedance-based cell assurance monitor to aid in identifying and characterizing cells in tissue culture ($947,705)", "source_url": "https://reporter.nih.gov/project-details/10917933", "people": [{"name": "CHARLES R KEESE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K241120", "company": "Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241120: Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241120", "people": [{"name": "Quanhua Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241120%22"}, {"id": "fda:K233204", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233204: Philips IntelliSite Pathology Solution 5.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233204", "people": [{"name": "Liselotte Kornmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233204%22"}, {"id": "fda:K233123", "company": "Hironic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233123: SILKRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233123", "people": [{"name": "Gwijin Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233123%22"}, {"id": "fda:K233630", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233630: Ambu\u00ae aScope\u0099 5 Uretero (Standard Deflection); Ambu\u00ae aScope\u0099 5 Uretero (Reverse Deflection); Ambu\u00ae aBox\u0099 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233630", "people": [{"name": "Mingye Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233630%22"}, {"id": "fda:K232952", "company": "Whitepeaks Dental Solutions GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232952: Copran Zri", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232952", "people": [{"name": "Oliver Puckert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232952%22"}, {"id": "fda:K241144", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241144: Picosecond Nd:YAG Laser (PICOCAREMAJESTY)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241144", "people": [{"name": "Hyun Sik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241144%22"}, {"id": "fda:K233288", "company": "Nakanishi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233288: NLZ Built-In Motor System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233288", "people": [{"name": "Masaaki Kikuchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233288%22"}, {"id": "fda:K240259", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240259: APEX 3D Total Ankle Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240259", "people": [{"name": "Haylie Fast", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240259%22"}, {"id": "nih:5R44MD015221-04", "company": "Isa Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-23", "observed": "2026-08-21", "amount_usd": 306479, "summary": "NIH award 5R44MD015221-04: Enhancing the Effectiveness of Community Health Workers to Reduce Cervical Cancer Disparities in African American Women ($306,479)", "source_url": "https://reporter.nih.gov/project-details/10891569", "people": [{"name": "DOUGLAS W BILLINGS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AG076256-03", "company": "Maphabit, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": 1192054, "summary": "NIH award 5R44AG076256-03: An assistive-technology based Caregiver Training Program (CTP) to enhance caregiver effectiveness, well-being, and quality of life, which will improve overall care for individuals living with AD/ADRD. ($1,192,054)", "source_url": "https://reporter.nih.gov/project-details/10845608", "people": [{"name": "Matthew Golden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AI186834-01", "company": "Inhalon Biopharma, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": 1024926, "summary": "NIH award 1R44AI186834-01: Pharmacokinetics analysis from first-in-human study of IN-002, a potent inhaled muco-trapping antibody therapy for RSV ($1,024,926)", "source_url": "https://reporter.nih.gov/project-details/11008243", "people": [{"name": "JEFF T HUTCHINS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K233253", "company": "Agilemd, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233253: eCARTv5 Clinical Deterioration Suite (\u0093eCART\u0094)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233253", "people": [{"name": "Borna Safabakhsh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233253%22"}, {"id": "fda:K240465", "company": "Medtronic Navigation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240465: O-arm O2 Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240465", "people": [{"name": "Anamika Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240465%22"}, {"id": "fda:K241459", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241459: MOTUS PRO Family", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241459", "people": [{"name": "Peruzzi Paolo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241459%22"}, {"id": "fda:K241117", "company": "Spinal Kinetics / Orthofix / Seaspine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241117: M6-C\u0099 Single Use, Disposable Instrumentation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241117", "people": [{"name": "Tony John", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241117%22"}, {"id": "fda:K233259", "company": "Xerothera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233259: Xerosyn", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233259", "people": [{"name": "Noel Rolon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233259%22"}, {"id": "fda:K241519", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241519: Invictus\u00ae Small Stature Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241519", "people": [{"name": "Andrew Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241519%22"}, {"id": "fda:K240728", "company": "CorDx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240728: CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240728", "people": [{"name": "Haixia Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240728%22"}, {"id": "fda:K233322", "company": "Mochida Pharmaceutical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233322: Mochida Nerve Cuff", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233322", "people": [{"name": "Akiko Koarai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233322%22"}, {"id": "fda:K240649", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240649: Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240649", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240649%22"}, {"id": "fda:K233549", "company": "Tempus AI, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233549: Tempus ECG-AF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233549", "people": [{"name": "Alain Silk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233549%22"}, {"id": "fda:K234095", "company": "Otodynamics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234095: OtoNova/OtoNova Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234095", "people": [{"name": "Daniel Budd", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234095%22"}, {"id": "fda:K233280", "company": "Steadysense GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233280: SteadyTemp", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233280", "people": [{"name": "Werner Koele", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233280%22"}, {"id": "fda:K241476", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241476: ToxiSeal\u0099 Vial Adaptor with External Flip Balloon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241476", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241476%22"}, {"id": "fda:K240643", "company": "Guangzhou Decheng Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240643: MissLan\u00ae Early Detection Pregnancy Test Strip; MissLan\u00ae Early Detection Pregnancy Test Cassette; MissLan\u00ae Early Detection Pregnancy Test Midstream", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240643", "people": [{"name": "Weifang Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240643%22"}, {"id": "fda:K240631", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240631: V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240631", "people": [{"name": "Jee Young Ju", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240631%22"}, {"id": "fda:K233326", "company": "Merge Healthcare Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233326: Merge Hemo, Model RCSV2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233326", "people": [{"name": "Carol Nakagawa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233326%22"}, {"id": "fda:K240125", "company": "Zenith Technical Innovations", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240125: Therm-X (Home); Therm-X (AT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240125", "people": [{"name": "Greg Binversie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240125%22"}, {"id": "fda:K240387", "company": "Asahi Intecc Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240387: MINAMO blue; MINAMO viola", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240387", "people": [{"name": "Fujimura Katsuhiko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240387%22"}, {"id": "fda:K233196", "company": "JLK, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233196: Medihub Prostate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233196", "people": [{"name": "Dongmin Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233196%22"}, {"id": "fda:K241442", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241442: eZSURE\u0099 Empty Fluid Container with ProSeal\u0099 Injection Site", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241442", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241442%22"}, {"id": "fda:K232807", "company": "Owens & Minor (O&M) Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232807: Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232807", "people": [{"name": "Angela L. Bunn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232807%22"}, {"id": "fda:K233876", "company": "Alcon Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233876: UNITY VCS (8065000296); UNITY CS (8065000297)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233876", "people": [{"name": "Ganesh Balachandar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233876%22"}, {"id": "fda:K233230", "company": "Epica International, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233230: See Factor CT3\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233230", "people": [{"name": "Craig Glaiberman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233230%22"}, {"id": "fda:K233361", "company": "Menstrual Mates", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233361: Sunny Cup and Applicator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233361", "people": [{"name": "Cindy Belardo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233361%22"}, {"id": "fda:K234155", "company": "Tactile Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234155: Nimbl (model PD08-N1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234155", "people": [{"name": "Vishal Agarwal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234155%22"}, {"id": "fda:K233885", "company": "Genoss Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233885: rainbow Paste Stain SE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233885", "people": [{"name": "Hayoung Sung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233885%22"}, {"id": "fda:K233096", "company": "Position Health, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233096: PRESSUREALERT\u00ae Pressure Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233096", "people": [{"name": "Kristi Leigh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233096%22"}, {"id": "fda:K233240", "company": "G-Surg GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233240: GERDX-System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233240", "people": [{"name": "Julian Mair", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233240%22"}, {"id": "fda:K232975", "company": "Beijing Choice Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232975: Pulse Oximeter (MD300C228)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232975", "people": [{"name": "Haiying Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232975%22"}, {"id": "fda:K240663", "company": "Guangzhou Red Pine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240663: Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240663", "people": [{"name": "Xiangfei Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240663%22"}, {"id": "fda:K240862", "company": "Medicom Group, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240862: Medicom Sterilization Wrap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240862", "people": [{"name": "Brent Geiger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240862%22"}, {"id": "nih:1R41HL166096-01A1", "company": "Sensoriis, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": 294993, "summary": "NIH award 1R41HL166096-01A1: Novel Acquisition and Computation of Cardiac Functions in Developing Zebrafish Embryos ($294,993)", "source_url": "https://reporter.nih.gov/project-details/10922603", "people": [{"name": "Hung Cao", "role": "Principal Investigator"}, {"name": "Michael P.H. Lau", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HG013631-01", "company": "Atlasxomics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": 399929, "summary": "NIH award 1R43HG013631-01: Development of a user-friendly next generation epigenomic chip adaptable to automation workflows ($399,929)", "source_url": "https://reporter.nih.gov/project-details/10921929", "people": [{"name": "Timothy S McConnell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K233117", "company": "Nakanishi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233117: Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233117", "people": [{"name": "Masaaki Kikuchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233117%22"}, {"id": "fda:K240688", "company": "Belport Company, Inc., Gingi-Pak", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240688: RODIN Titan 3D Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240688", "people": [{"name": "Daniel Gallegos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240688%22"}, {"id": "fda:K241435", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241435: Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241435", "people": [{"name": "Rebecca Peterkins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241435%22"}, {"id": "fda:K240611", "company": "Ivylaser (Beijing) Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240611: IVYLASER Diode laser hair removal system (IVY-HR-Alloy)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240611", "people": [{"name": "Yuan Xiujuan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240611%22"}, {"id": "fda:K240673", "company": "Zhejiang Hfizer Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240673: Electric wheelchair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240673", "people": [{"name": "Ken Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240673%22"}, {"id": "fda:K241466", "company": "SeaSpine Orthopedics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241466: Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241466", "people": [{"name": "Jesse Albright", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241466%22"}, {"id": "fda:K240613", "company": "Medartis AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240613: APTUS Elbow Dorsal Olecranon Plates", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240613", "people": [{"name": "Claudia De Santis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240613%22"}, {"id": "fda:K230675", "company": "Specific Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230675: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230675", "people": [{"name": "Jolyn Tenllado", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230675%22"}, {"id": "fda:K232161", "company": "Medicalgorithmics S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232161: DeepRhythm Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232161", "people": [{"name": "Maciej Gamrot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232161%22"}, {"id": "fda:K233162", "company": "Curonix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233162: Freedom Peripheral Nerve Stimulator (PNS) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233162", "people": [{"name": "Hailey Rooney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233162%22"}, {"id": "fda:K233225", "company": "Schoelly Fiberoptic GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233225: SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233225", "people": [{"name": "Sandra Baumann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233225%22"}, {"id": "fda:K241627", "company": "Tianjin Huahong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241627: Safety Lancet (XXXV)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241627", "people": [{"name": "Ningning Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241627%22"}, {"id": "fda:K233158", "company": "Whitepeaks Dental Solutions GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233158: Copra Smile, Copra Supreme Hyperion", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233158", "people": [{"name": "Oliver Puckert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233158%22"}, {"id": "fda:K240830", "company": "Orthofix Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240830: Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240830", "people": [{"name": "Jesse Albright", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240830%22"}, {"id": "fda:K240669", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240669: ACTIFY\u0099 3D Total Knee System, ACTIFY\u0099 Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240669", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240669%22"}, {"id": "fda:K240642", "company": "Disior, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240642: SMART Bun-Yo-Matic CT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240642", "people": [{"name": "Aarno Jussila", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240642%22"}, {"id": "pma:P230040", "company": "Endotronix, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-06-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230040: Cordella Pulmonary Artery Sensor System (CorPASS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230040", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230040%22"}, {"id": "breakthrough:K230675", "company": "Specific Diagnostics, LLC", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-06-20", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K230675: VITEK REVEAL GN AST ASSAY AND VITEK REVEAL AST SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K232997", "company": "Olympus Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232997: EVIS Exera III Gastrointestinal Videoscope GIF-1TH190", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232997", "people": [{"name": "Shinichiro Kawachi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232997%22"}, {"id": "nih:5R43AI177239-02", "company": "Nightingale Labs Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": 186251, "summary": "NIH award 5R43AI177239-02: Feasibility of early detection of infection and sepsis in the home ($186,251)", "source_url": "https://reporter.nih.gov/project-details/10885081", "people": [{"name": "Raymond C Chan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA281429-01A1", "company": "Enclear Therapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": 295851, "summary": "NIH award 1R43CA281429-01A1: Smart CSF Delivery System for CNS Drug Therapy for Leptomeningeal Disease ($295,851)", "source_url": "https://reporter.nih.gov/project-details/10819360", "people": [{"name": "MARCIE A GLICKSMAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL172530-01A1", "company": "Halomine, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": 295203, "summary": "NIH award 1R43HL172530-01A1: Novel Polymer Additives for Infection Control Intravenous Catheters ($295,203)", "source_url": "https://reporter.nih.gov/project-details/10914548", "people": [{"name": "Ekrem Ozkan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241412", "company": "Align Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241412: Invisalign System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241412", "people": [{"name": "Nestor Vazquez Salgado", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241412%22"}, {"id": "fda:K240678", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240678: ATTUNE\u00ae Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240678", "people": [{"name": "Catherine O Regan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240678%22"}, {"id": "fda:K240774", "company": "Wuxi Nest Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240774: Pen Injector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240774", "people": [{"name": "Cheng Zhiwei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240774%22"}, {"id": "fda:K240196", "company": "Yuwonmeditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240196: Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240196", "people": [{"name": "Ji Hyeon Bae", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240196%22"}, {"id": "fda:K233553", "company": "Thayer Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233553: MiniSpacer\u00ae 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233553", "people": [{"name": "James Strickland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233553%22"}, {"id": "fda:K233036", "company": "Hunan Handlike Minimally Invasive Surgery Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233036: Ultrasonic Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233036", "people": [{"name": "Yang Bihong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233036%22"}, {"id": "fda:K240583", "company": "Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240583: IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240583", "people": [{"name": "Huajun Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240583%22"}, {"id": "fda:K233294", "company": "Itp Innovative Tomography Products GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233294: Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233294", "people": [{"name": "Dominik Fr\u00e4mke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233294%22"}, {"id": "fda:K233867", "company": "Orthofix Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233867: Fitbone Trochanteric", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233867", "people": [{"name": "Elvira Taccarelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233867%22"}, {"id": "fda:K240552", "company": "Irrimax Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240552: Irrisept Antimicrobial Wound Lavage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240552", "people": [{"name": "Tanya Eberle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240552%22"}, {"id": "nih:1R44MH134719-01A1", "company": "Care.coach Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": 361412, "summary": "NIH award 1R44MH134719-01A1: Optimizing and testing the care.coach avatar as a personalized, engaging and adaptive virtual health assistant for maximizing functional and quality of life outcomes in autistic young adults ($361,412)", "source_url": "https://reporter.nih.gov/project-details/10922310", "people": [{"name": "Chantal M Kerssens", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K233987", "company": "Arbor Medical Innovations, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233987: VERABAND\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233987", "people": [{"name": "Grant Kruger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233987%22"}, {"id": "fda:K241428", "company": "Hangzhou AllTest Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241428: AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241428", "people": [{"name": "Rosa Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241428%22"}, {"id": "fda:K233324", "company": "Alb Luz", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233324: Molecular Transport Media - MTM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233324", "people": [{"name": "Ana Luiza Bueno Luz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233324%22"}, {"id": "fda:K232258", "company": "Transit Scientific, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232258: XO Constrain\u0099 Percutaneous Transluminal Angioplasty Constraining Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232258", "people": [{"name": "Lilly Myers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232258%22"}, {"id": "fda:K233256", "company": "DePuy Synthes", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233256: Robotic Integration Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233256", "people": [{"name": "Nicole Aeschbacher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233256%22"}, {"id": "fda:K233060", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233060: Elecsys Folate III", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233060", "people": [{"name": "Amy Pierce", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233060%22"}, {"id": "fda:K233331", "company": "Pmx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233331: MediOMx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233331", "people": [{"name": "Girish Srinivasan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233331%22"}, {"id": "fda:K240747", "company": "Wuhan Pioon Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240747: Medical Diode Laser (M2-GK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240747", "people": [{"name": "Feng Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240747%22"}, {"id": "fda:K233255", "company": "DePuy Synthes", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233255: CROSSNAV Navigation Enabled Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233255", "people": [{"name": "Daniel Meyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233255%22"}, {"id": "fda:K240684", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240684: Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240684", "people": [{"name": "Tang Jing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240684%22"}, {"id": "fda:K241416", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241416: Ion 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241416", "people": [{"name": "Bryan Hellriegel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241416%22"}, {"id": "fda:K231116", "company": "Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231116: Multi-parameter detector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231116", "people": [{"name": "Jerry Liang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231116%22"}, {"id": "fda:K241469", "company": "Sleepnet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241469: iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241469", "people": [{"name": "Jennifer Kennedy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241469%22"}, {"id": "nih:5R44AG073141-03", "company": "Allied Innovative Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": 845968, "summary": "NIH award 5R44AG073141-03: Highly sensitive immunoassay for determination of biomarkers for neurodegenerative diseases ($845,968)", "source_url": "https://reporter.nih.gov/project-details/10837872", "people": [{"name": "Simon Bystryak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA278140-02", "company": "Phase Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44CA278140-02: AI-based AML risk stratification using next generation cytogenomics ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10862769", "people": [{"name": "Stephen Matthew Eacker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44NS129521-03", "company": "Turing Medical Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": 1500000, "summary": "NIH award 4R44NS129521-03: Behavioral feedback and rewards for improving functional brain mapping in presurgical pediatric patients ($1,500,000)", "source_url": "https://reporter.nih.gov/project-details/11044939", "people": [{"name": "Damien A Fair", "role": "Principal Investigator"}, {"name": "Kevin King", "role": "Principal Investigator"}, {"name": "Jarod Roland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA210770-05", "company": "Civatech Oncology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": 1117042, "summary": "NIH award 5R44CA210770-05: Commercializing CivaSheet for Pancreatic Cancer Patients ($1,117,042)", "source_url": "https://reporter.nih.gov/project-details/10884876", "people": [{"name": "Kristy Perez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "fda:K240721", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240721: ExcelsiusFlex\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240721", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240721%22"}, {"id": "fda:K233079", "company": "Cook Ireland, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233079: Zimmon\u00ae Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen\u00ae Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin\u00ae Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen\u00ae Sof-Flex\u00ae Pancreatic Stent (GPSO-SF. GPSOS-SF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233079", "people": [{"name": "Casey Kieran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233079%22"}, {"id": "fda:K241250", "company": "Davol Inc., Subsidiary of C. R. Bard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241250: 3DMax Light Mesh", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241250", "people": [{"name": "Richard Spaziano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241250%22"}, {"id": "fda:K233254", "company": "DePuy Synthes", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233254: TELIGEN System Navigation Ready Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233254", "people": [{"name": "Marina Minnock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233254%22"}, {"id": "fda:K241082", "company": "Innosys Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241082: INNOVERSE Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241082", "people": [{"name": "Hye-Kyung Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241082%22"}, {"id": "fda:K240696", "company": "Suzhou Beiang Smart Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240696: Airdog X8 Air Purifier (KJ800F-X8)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240696", "people": [{"name": "Yan Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240696%22"}, {"id": "fda:K241083", "company": "Surgical Information Sciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241083: SIS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241083", "people": [{"name": "Ann Quinlan-Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241083%22"}, {"id": "fda:K240729", "company": "Shenzhen Pango Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240729: Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240729", "people": [{"name": "Yang Xiaoyun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240729%22"}, {"id": "fda:K233228", "company": "Ecential Robotics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233228: Spine Navigation and Robotic-Assistance Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233228", "people": [{"name": "Amanie Yazidi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233228%22"}, {"id": "fda:K233707", "company": "Invent Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233707: HFT150", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233707", "people": [{"name": "David Gramse", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233707%22"}, {"id": "fda:K233991", "company": "Elutia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233991: CanGaroo RM Antibacterial Envelope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233991", "people": [{"name": "Erica Elchin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233991%22"}, {"id": "fda:K240817", "company": "Alafair Biosciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240817: VersaWrap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240817", "people": [{"name": "Sarah Mayes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240817%22"}, {"id": "fda:K230668", "company": "Precision Medical Plastics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230668: Disposable High-pressure Extension Lines", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230668", "people": [{"name": "Li Xiaotong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230668%22"}, {"id": "fda:K232893", "company": "Contec Medical Systems Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232893: Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232893", "people": [{"name": "Jie Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232893%22"}, {"id": "fda:K232812", "company": "Owens & Minor (O&M) Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232812: Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232812", "people": [{"name": "Angela L. Bunn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232812%22"}, {"id": "fda:K233496", "company": "Akili Interactive Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233496: EndeavorOTC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233496", "people": [{"name": "Bhupinder Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233496%22"}, {"id": "fda:K233043", "company": "Periwinkle Technologies Pvt., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233043: Smart Scope\u00ae CX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233043", "people": [{"name": "Veena Moktali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233043%22"}, {"id": "fda:K232879", "company": "Ventana Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232879: Roche Digital Pathology Dx (VENTANA DP 200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232879", "people": [{"name": "Cameron Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232879%22"}, {"id": "fda:K233238", "company": "Xiamen Weiyou Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233238: Air Pressure Therapy System (Model:VU-IPC4M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233238", "people": [{"name": "Yong Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233238%22"}, {"id": "fda:K240002", "company": "Gimbo Medical Technology Shenzhen Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240002: G-Vitri\u0099 Vitrification Straw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240002", "people": [{"name": "Leo Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240002%22"}, {"id": "fda:K240124", "company": "Vivachek Biotech (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240124: BioSieve\u0099 Fentanyl FIA Test Kit; BioSieve\u0099 ToxiSmart FIA Reader", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240124", "people": [{"name": "Max Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240124%22"}, {"id": "fda:K241407", "company": "Bios S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241407: Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241407", "people": [{"name": "Martina De Iturbe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241407%22"}, {"id": "fda:K233955", "company": "Clarius Mobile Health Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233955: Clarius OB AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233955", "people": [{"name": "Agatha Szeliga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233955%22"}, {"id": "nih:1R41DK139941-01A1", "company": "Anxomics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": 312492, "summary": "NIH award 1R41DK139941-01A1: A Deep Learning-based Platform for the Remote Management and Analysis of Diabetic Foot Ulcers ($312,492)", "source_url": "https://reporter.nih.gov/project-details/10931967", "people": [{"name": "Manoj Bhasin", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA268678-02A1", "company": "Collinge And Associates", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": 968308, "summary": "NIH award 2R44CA268678-02A1: mHealth app for caregiver instruction in manual therapy for chemotherapy-induced peripheral neuropathy ($968,308)", "source_url": "https://reporter.nih.gov/project-details/10922579", "people": [{"name": "WILLIAM B. COLLINGE", "role": "Principal Investigator"}, {"name": "Cindy Tofthagen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43ES036055-01A1", "company": "Nanoaffix Science, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": 293800, "summary": "NIH award 1R43ES036055-01A1: Graphene-based Nanosensors for Rapid Detection of Low-concentration PFAS in Water ($293,800)", "source_url": "https://reporter.nih.gov/project-details/10920945", "people": [{"name": "James Curtis Hill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42MH136878-01", "company": "Mainsquare Co", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": 424754, "summary": "NIH award 1R42MH136878-01: Engagement and clinical impact of the Teleo virtual therapy platform in clinical settings ($424,754)", "source_url": "https://reporter.nih.gov/project-details/10922556", "people": [{"name": "DAVID S HONG", "role": "Principal Investigator"}, {"name": "Eric Roland Kuhn", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43EY035206-01S1", "company": "Visionquest Biomedical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": 54709, "summary": "NIH award 3R43EY035206-01S1: Automated system to improve compliance to diabetic retinopathy screening ($54,709)", "source_url": "https://reporter.nih.gov/project-details/11020835", "people": [{"name": "Vinayak S Joshi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K232930", "company": "Oculomotor Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232930: VERVE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232930", "people": [{"name": "Chang Yaramothu, Ph.D.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232930%22"}, {"id": "fda:K233321", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233321: Double Balloon Endoscope EN-840T, Over-tube TS-1214C", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233321", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233321%22"}, {"id": "fda:K233925", "company": "Relu BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233925: Relu Creator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233925", "people": [{"name": "Holger Willems", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233925%22"}, {"id": "fda:K231060", "company": "Belport Company, Inc., Gingi-Pak", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231060: ProMin Dental Desensitizing Gel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231060", "people": [{"name": "Jingtian Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231060%22"}, {"id": "fda:K233892", "company": "Zhuhai Dipu Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233892: 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233892", "people": [{"name": "Huan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233892%22"}, {"id": "fda:K240017", "company": "InMode , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240017: InMode System with the Morpheus8 90 Applicator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240017", "people": [{"name": "Suhair Francis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240017%22"}, {"id": "fda:K233821", "company": "Fisher & Paykel Healthcare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233821: F&P Optiflow Oxygen Kit (AA451J)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233821", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233821%22"}, {"id": "fda:K240149", "company": "Gimbo Medical Technology Shenzhen Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240149: Giftlife\u0099 Fertilization Medium; Giftlife\u0099 Cleavage Medium; Giftlife\u0099 Blastocyst Medium; Giftlife\u0099 Single Step Medium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240149", "people": [{"name": "Leo Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240149%22"}, {"id": "fda:K232953", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232953: AquaBplus; AquaB LITE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232953", "people": [{"name": "Greg Calder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232953%22"}, {"id": "fda:K240460", "company": "FMD Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240460: FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240460", "people": [{"name": "Higashikubo Takashi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240460%22"}, {"id": "fda:K233662", "company": "Philips Medical Systems Dmc GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233662: Radiography 7300 C", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233662", "people": [{"name": "Ming Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233662%22"}, {"id": "fda:K241358", "company": "Sun Pharmaceutical Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241358: BLU-U\u00ae Blue Light Photodynamic Therapy Illuminator, Model 4170E", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241358", "people": [{"name": "Scott Lundahl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241358%22"}, {"id": "fda:K241499", "company": "Acula Technology Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241499: 21.3\u0094 5MP Color LCD Display UMD5-21B01", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241499", "people": [{"name": "Sheng-Sung Jian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241499%22"}, {"id": "fda:K240815", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240815: Arthrex Cannulated Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240815", "people": [{"name": "Jessica Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240815%22"}, {"id": "fda:K241370", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241370: Agilis\u0099 NxT Steerable Introducer Dual-Reach\u0099 (I-V2-MED)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241370", "people": [{"name": "Alyssa Timmers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241370%22"}, {"id": "nih:5R41NS132732-02", "company": "Aneuvas Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": 147200, "summary": "NIH award 5R41NS132732-02: Developing a new aspiration catheter solution for the treatment of large and medium vessel occlusions ($147,200)", "source_url": "https://reporter.nih.gov/project-details/10877073", "people": [{"name": "Timothy Andrew Becker", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R42DC019877-03", "company": "Modality.ai , Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": 976474, "summary": "NIH award 5R42DC019877-03: A digital tool for monitoring speech decline in ALS ($976,474)", "source_url": "https://reporter.nih.gov/project-details/10875504", "people": [{"name": "JORDAN R GREEN", "role": "Principal Investigator"}, {"name": "Vikram Ramanarayanan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DA059448-01", "company": "Spark Biomedical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": 318875, "summary": "NIH award 1R43DA059448-01: Development of a Machine Learning Algorithm to Detect Opioid Withdrawal and Cravings to Increase Treatment Retention ($318,875)", "source_url": "https://reporter.nih.gov/project-details/10783563", "people": [{"name": "Navid Khodaparast", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240876", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240876: Identity Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240876", "people": [{"name": "Patricia Beres", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240876%22"}, {"id": "fda:K233613", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233613: ACUSON SC2000 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233613", "people": [{"name": "Shilpa Rapaka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233613%22"}, {"id": "fda:K232967", "company": "bioMerieux, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232967: VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232967", "people": [{"name": "Esther Hernandez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232967%22"}, {"id": "fda:K241034", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241034: Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241034", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241034%22"}, {"id": "fda:K240516", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240516: RS85 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240516", "people": [{"name": "So-Yeon Jang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240516%22"}, {"id": "fda:K240256", "company": "Deka Research and Development", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240256: Remunity System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240256", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240256%22"}, {"id": "fda:K233007", "company": "Ami, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233007: Picosecond Nd:YAG Laser System; PICO LEGEND", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233007", "people": [{"name": "Hae Lee Youn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233007%22"}, {"id": "fda:K240910", "company": "Propper Manufacturing Co., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240910: EO Chex Indicator Tape", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240910", "people": [{"name": "Andrew Sharavara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240910%22"}, {"id": "fda:K241352", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241352: Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241352", "people": [{"name": "Kaitlin Cady", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241352%22"}, {"id": "fda:K232950", "company": "Perfect Medical Industry (Vn) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232950: Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232950", "people": [{"name": "Nancy Phan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232950%22"}, {"id": "fda:K240504", "company": "Lamidey Noury Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240504: PLASMA EDGE System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240504", "people": [{"name": "Guillaume Noury", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240504%22"}, {"id": "fda:K233266", "company": "Mediblu Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233266: MEDIBLU ECG SYSTEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233266", "people": [{"name": "Fernando Ramon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233266%22"}, {"id": "fda:K233610", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233610: ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233610", "people": [{"name": "Shilpa Rapaka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233610%22"}, {"id": "fda:K240050", "company": "Biosense Webster, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240050: SOUNDSTAR\u0099 CRYSTAL Ultrasound Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240050", "people": [{"name": "Sheba Chacko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240050%22"}, {"id": "nih:1R41HD113429-01A1", "company": "Neocare Innovations, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-11", "observed": "2026-08-21", "amount_usd": 295897, "summary": "NIH award 1R41HD113429-01A1: Pedi-Sync: A Clinical Decision Support Tool to Improve Oral Feeding Outcomes in Preterm Infants ($295,897)", "source_url": "https://reporter.nih.gov/project-details/10915089", "people": [{"name": "Caryn Bradley", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R41DA056276-01S2", "company": "Altrumed LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-11", "observed": "2026-08-21", "amount_usd": 44902, "summary": "NIH award 3R41DA056276-01S2: The DOVE Device to Prevent Opioid Overdose Deaths: An Armband That Senses Overdose and Automatically Injects Naloxone ($44,902)", "source_url": "https://reporter.nih.gov/project-details/11045128", "people": [{"name": "Jacob Brenner", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AR083316-01A1", "company": "Myolex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-11", "observed": "2026-08-21", "amount_usd": 1006120, "summary": "NIH award 1R44AR083316-01A1: Convenient quantification of myopathic change in muscle via electrical impedance myography ($1,006,120)", "source_url": "https://reporter.nih.gov/project-details/10921274", "people": [{"name": "David P. Dickinson", "role": "Principal Investigator"}, {"name": "Pushpa Narayanaswami", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DE032564-02", "company": "Revbio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-11", "observed": "2026-08-21", "amount_usd": 730212, "summary": "NIH award 5R44DE032564-02: Development of a Novel Bone Adhesive Scaffold to Accelerate Bone Regeneration and Improve Ridge Height Maintenance for the Treatment of Patients with Residual Ridge Resorption ($730,212)", "source_url": "https://reporter.nih.gov/project-details/10851795", "people": [{"name": "Rahul Jadia", "role": "Principal Investigator"}, {"name": "George Kay", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K241344", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241344: MetriCide\u0099 OPA Plus Solution Test Strip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241344", "people": [{"name": "Anthony Piotrkowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241344%22"}, {"id": "fda:DEN230069", "company": "Lsi Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230069: Mi-CHORD System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230069", "people": [{"name": "Christopher B. Miller", "role": "510(k) submission contact"}]}, {"id": "fda:K241025", "company": "OrbusNeich Medical (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241025: JADE PLUS PTA Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241025", "people": [{"name": "Jerry Cheung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241025%22"}, {"id": "fda:K241011", "company": "Mako Surgical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241011: Mako Total Knee Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241011", "people": [{"name": "Edwards Anne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241011%22"}, {"id": "fda:K221547", "company": "Fertipro NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221547: InActiv Blue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221547", "people": [{"name": "Liesbeth Faes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221547%22"}, {"id": "fda:K230546", "company": "Osteonic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230546: SIGNEX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230546", "people": [{"name": "Hye-Min Ahn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230546%22"}, {"id": "fda:K232749", "company": "Ybrain, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232749: DOOPANG", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232749", "people": [{"name": "Kiwon Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232749%22"}, {"id": "denovo:DEN230069", "company": "Lsi Solutions, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-06-11", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230069 granted: Mi-CHORD System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230069"}, {"id": "fda:K240111", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240111: Venue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240111", "people": [{"name": "Karin Shimoni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240111%22"}, {"id": "fda:K240053", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240053: Venue Go", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240053", "people": [{"name": "Karin Shimoni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240053%22"}, {"id": "fda:K241399", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241399: Indigo\u00ae Lightning Flash Aspiration System \u0096 Select +\u0099 Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241399", "people": [{"name": "Samyukta Rangachari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241399%22"}, {"id": "fda:K240106", "company": "Cryoconcepts LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240106: Histofreezer V", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240106", "people": [{"name": "Sam Niedbala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240106%22"}, {"id": "fda:K240206", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240206: Venue Sprint", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240206", "people": [{"name": "Karin Shimoni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240206%22"}, {"id": "fda:K240283", "company": "MacroLux Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240283: BubbleView\u0099 Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub\u00ae Video Processor (S13, S13-T, S13-N, S13-S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240283", "people": [{"name": "Linbin Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240283%22"}, {"id": "fda:K240644", "company": "Wuhan Pioon Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240644: Medical Diode Laser (S1Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240644", "people": [{"name": "Feng Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240644%22"}, {"id": "fda:K232911", "company": "Karl Storz Endovision, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232911: KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232911", "people": [{"name": "Thomas Ostrowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232911%22"}, {"id": "fda:K233767", "company": "Neurologica Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233767: OmniTom Elite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233767", "people": [{"name": "Ninad Gujar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233767%22"}, {"id": "fda:K240108", "company": "Gymmax Technology Shenzhen Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240108: Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240108", "people": [{"name": "Benson Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240108%22"}, {"id": "fda:K234106", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234106: Venue Fit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234106", "people": [{"name": "Karin Shimoni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234106%22"}, {"id": "nih:1R44CA285197-01A1", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R44CA285197-01A1: A parallelized computational microscope platform for high-throughput live imaging of patient-derived organoids ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10921191", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK136396-02", "company": "X-therma Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": 1015699, "summary": "NIH award 5R44DK136396-02: Greatly Extended Subzero Ischemic Storage of Renal Allografts Using Novel Bio-inspired Next Generation Cryoprotectants ($1,015,699)", "source_url": "https://reporter.nih.gov/project-details/10895527", "people": [{"name": "Gerald Brandacher", "role": "Principal Investigator"}, {"name": "Mark A Kline", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA281709-01A1", "company": "Voxel Healthcare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": 718740, "summary": "NIH award 1R44CA281709-01A1: Long term radiation treatment planning in brain tumors in the pediatric population ($718,740)", "source_url": "https://reporter.nih.gov/project-details/10821570", "people": [{"name": "Natasha Lepore", "role": "Principal Investigator"}, {"name": "Justin Low", "role": "Principal Investigator"}, {"name": "ARTHUR Jacob OLCH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K241069", "company": "Noras Mri Products GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241069: iLoop Interventional Coil 0.55T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241069", "people": [{"name": "Manuel Noras", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241069%22"}, {"id": "fda:K240672", "company": "Zhejiang Zahndent Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240672: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240672", "people": [{"name": "Yaping Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240672%22"}, {"id": "fda:K234042", "company": "Ever Fortune.Ai, Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234042: EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234042", "people": [{"name": "Joseph Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234042%22"}, {"id": "fda:K232963", "company": "bioMerieux, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232963: VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232963", "people": [{"name": "Esther Hernandez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232963%22"}, {"id": "fda:K240832", "company": "Guangdong Transtek Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240832: Blood Pressure Monitor (BBZ32-AA01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240832", "people": [{"name": "Jerry Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240832%22"}, {"id": "fda:K241038", "company": "Circle Cardiovascular Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241038: Cardiac CT Function Software Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241038", "people": [{"name": "Sydney Toutant-Lijnse", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241038%22"}, {"id": "fda:K233825", "company": "Innovative Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233825: Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233825", "people": [{"name": "Meerna Muradvich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233825%22"}, {"id": "fda:K234099", "company": "Select Labs, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234099: Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234099", "people": [{"name": "Om Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234099%22"}, {"id": "fda:K241423", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241423: Access Thyroglobulin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241423", "people": [{"name": "Muhammad Sheikh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241423%22"}, {"id": "fda:K231010", "company": "AliveCor, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231010: Corvair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231010", "people": [{"name": "Samip Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231010%22"}, {"id": "fda:K232837", "company": "Uroviu Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232837: Uro-G HD Flexible Cystoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232837", "people": [{"name": "Thom Lawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232837%22"}, {"id": "fda:K232035", "company": "AliveCor, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232035: Impala", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232035", "people": [{"name": "Samip Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232035%22"}, {"id": "fda:K232816", "company": "Shenzhen LE Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232816: Electrocardiograph, model: ECG301", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232816", "people": [{"name": "Wuyaxiong .", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232816%22"}, {"id": "fda:K233861", "company": "Abbott Diabetes Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233861: Libre Rio Continuous Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233861", "people": [{"name": "Tenzin Ngadon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233861%22"}, {"id": "fda:K232804", "company": "Qompium NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232804: FibriCheck", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232804", "people": [{"name": "Jo Van der Auwera", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232804%22"}, {"id": "fda:K240570", "company": "Implant Protesis Dental 2004, S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240570: IPD Dental Implant Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240570", "people": [{"name": "Francesc Fumanal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240570%22"}, {"id": "fda:K232625", "company": "Wipak OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232625: Steriking\u00ae Pouch for Robotic Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232625", "people": [{"name": "Hanna Marttila", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232625%22"}, {"id": "fda:K240972", "company": "Surgical Instrument Service and Savings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240972: Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240972", "people": [{"name": "Stephanie Boyle Mays", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240972%22"}, {"id": "fda:K232806", "company": "Owens & Minor (O&M) Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232806: HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232806", "people": [{"name": "Anureet Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232806%22"}, {"id": "fda:K232969", "company": "Ningbo Xinwell Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232969: Disposable Hemostatic Clips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232969", "people": [{"name": "Lei Xi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232969%22"}, {"id": "nih:1R43DC021116-01A1", "company": "Intelligent Hearing Systems", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": 295770, "summary": "NIH award 1R43DC021116-01A1: Device for assessment of 8th nerve function and cochlear implant candidacy ($295,770)", "source_url": "https://reporter.nih.gov/project-details/10820618", "people": [{"name": "Rafael E Delgado", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241304", "company": "Agamatrix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241304: WaveSense Jazz Blood Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241304", "people": [{"name": "Dave Valcourt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241304%22"}, {"id": "fda:K233824", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233824: Swan-Ganz catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233824", "people": [{"name": "Bedalin Lugo Rodriguez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233824%22"}, {"id": "fda:K232968", "company": "Golden Grande Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232968: Grande Medical Masks, Model SF-600", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232968", "people": [{"name": "Hsin Hui Tseng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232968%22"}, {"id": "fda:K240657", "company": "Livsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240657: ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240657", "people": [{"name": "Hyeonbin Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240657%22"}, {"id": "fda:K240951", "company": "Alphatec Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240951: Invictus Robotic Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240951", "people": [{"name": "Alanna Joshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240951%22"}, {"id": "fda:K240965", "company": "Avanos Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240965: CORTRAK* 2 Enteral Access System (20-0950)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240965", "people": [{"name": "Erin Rowley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240965%22"}, {"id": "fda:K232774", "company": "Ningbo Dearevery Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232774: Wearable Breast Pump,Model S18", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232774", "people": [{"name": "Kelong Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232774%22"}, {"id": "fda:K240202", "company": "Noris Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240202: Conical Platform Dental Implants System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240202", "people": [{"name": "Noa Mor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240202%22"}, {"id": "fda:K240662", "company": "Stryker Leibinger GmbH & Co KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240662: Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240662", "people": [{"name": "Andrea Wallen-Gerding", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240662%22"}, {"id": "fda:K240948", "company": "Imperative Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240948: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240948", "people": [{"name": "Kristin Ellis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240948%22"}, {"id": "fda:K240963", "company": "Teslake, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240963: Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240963", "people": [{"name": "Lukas Eisermann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240963%22"}, {"id": "fda:K233094", "company": "Well Lead Medical (Hainan) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233094: Wellead\u00ae Latex Foley Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233094", "people": [{"name": "Jenny Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233094%22"}, {"id": "pma:P230026", "company": "Goodman Co., Ltd.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-06-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230026: Lacrosse NSE ALPHA Coronary Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230026", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230026%22"}, {"id": "nih:1R41DA059303-01A1", "company": "Ncap Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-05", "observed": "2026-08-21", "amount_usd": 416443, "summary": "NIH award 1R41DA059303-01A1: Enhancing pain management for knee replacement patients through an innovative non-invasive and opioid-sparing device ($416,443)", "source_url": "https://reporter.nih.gov/project-details/10921429", "people": [{"name": "Jacques E. Chelly", "role": "Principal Investigator"}, {"name": "Senthilkumar Sadhasivam", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM154625-01A1", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-05", "observed": "2026-08-21", "amount_usd": 274839, "summary": "NIH award 1R43GM154625-01A1: Stellate Ganglion Stimulation in Septic Shock to Improve Hemodynamics and Vasopressor Requirements ($274,839)", "source_url": "https://reporter.nih.gov/project-details/10921573", "people": [{"name": "Howard Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241262", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241262: Baby Gorilla/Gorilla Plating System; Monster Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241262", "people": [{"name": "Edward Wells-Spicer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241262%22"}, {"id": "fda:K240211", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240211: VELYS Robotic-Assisted Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240211", "people": [{"name": "Erin Combs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240211%22"}, {"id": "fda:K240648", "company": "Radiant Innovation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240648: Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240648", "people": [{"name": "Lynn Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240648%22"}, {"id": "fda:K240187", "company": "BioHorizons Implant Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240187: Tapered Pro Conical Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240187", "people": [{"name": "Jared Cooper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240187%22"}, {"id": "fda:K240358", "company": "Shenzhen Dongdixin Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240358: ShockPhysio Mobile (model SW3200 Basic)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240358", "people": [{"name": "Yuan Siping", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240358%22"}, {"id": "fda:K240603", "company": "Arum Dentistry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240603: Ti-Base & Master Fix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240603", "people": [{"name": "Won-Yi Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240603%22"}, {"id": "fda:K233008", "company": "Aap Implantate AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233008: Cannulated Headless Bone Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233008", "people": [{"name": "Agnieszka Mierzejewska", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233008%22"}, {"id": "fda:K240008", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240008: Mobility Scooter (W3331)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240008", "people": [{"name": "Grace Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240008%22"}, {"id": "nih:5R44DA053078-03", "company": "Real Prevention, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": 848604, "summary": "NIH award 5R44DA053078-03: Developing and testing the Opioid Rapid Response System ($848,604)", "source_url": "https://reporter.nih.gov/project-details/10872315", "people": [{"name": "Hye Jeong Choi", "role": "Principal Investigator"}, {"name": "Michael Hecht", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K240505", "company": "Eminent Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240505: Eminent Spine SI Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240505", "people": [{"name": "Stephen Courtney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240505%22"}, {"id": "fda:K232820", "company": "Owens & Minor (O&M) Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232820: HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232820", "people": [{"name": "Anureet Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232820%22"}, {"id": "fda:K232773", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232773: da Vinci SP Surgical System (SP1098)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232773", "people": [{"name": "Connor McCarty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232773%22"}, {"id": "fda:K234032", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234032: Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234032", "people": [{"name": "Phyllis Kondor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234032%22"}, {"id": "fda:K240877", "company": "Monteris Medical,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240877: Monteris Medical NeuroBlate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240877", "people": [{"name": "David H. Mueller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240877%22"}, {"id": "fda:K240222", "company": "Aesthetic Technology, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240222: Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240222", "people": [{"name": "Martin Hodgson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240222%22"}, {"id": "fda:K240100", "company": "Snap Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240100: SAM Model 9-10000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240100", "people": [{"name": "Gil Raviv", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240100%22"}, {"id": "fda:K233971", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233971: Arthrex AlloSync PushLock Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233971", "people": [{"name": "Emmarie Halteman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233971%22"}, {"id": "fda:K241258", "company": "Ingenium Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241258: Ingenix Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241258", "people": [{"name": "David Brumfield", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241258%22"}, {"id": "fda:K240463", "company": "Slow Wave, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240463: Slow Wave DS8 (SWDS802)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240463", "people": [{"name": "Sam Murray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240463%22"}, {"id": "fda:K240627", "company": "Luminex Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240627: LIAISON PLEX Yeast Blood Culture Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240627", "people": [{"name": "Sarah Herzog", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240627%22"}, {"id": "nih:5R43HL169134-02", "company": "Medluidics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-03", "observed": "2026-08-21", "amount_usd": 193130, "summary": "NIH award 5R43HL169134-02: PAH-on-a-chip: a novel disease-on-a-device model for studying the pathobiology of and screening drugs for pulmonary arterial hypertension ($193,130)", "source_url": "https://reporter.nih.gov/project-details/10851877", "people": [{"name": "Fakhrul Ahsan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43ES036478-01", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-06-03", "observed": "2026-08-21", "amount_usd": 294253, "summary": "NIH award 1R43ES036478-01: High-Sensitivity Benzene Detector for Environmental Field Surveys ($294,253)", "source_url": "https://reporter.nih.gov/project-details/10920888", "people": [{"name": "Shin-Juh Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240947", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240947: TENSOR\u00ae Suture Button System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240947", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240947%22"}, {"id": "fda:K233587", "company": "Zest Anchors, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233587: LOCATOR Angled Abutment (Various)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233587", "people": [{"name": "David Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233587%22"}, {"id": "fda:K231291", "company": "Richard Wolf Medical Instruments Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231291: Perforated Baskets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231291", "people": [{"name": "Mike McAndrew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231291%22"}, {"id": "fda:K240251", "company": "Sibel Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240251: ANNE Chest", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240251", "people": [{"name": "Sarah Coughlin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240251%22"}, {"id": "fda:K240834", "company": "Implantcast GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240834: EcoFit\u00ae short stem cementless cpTi", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240834", "people": [{"name": "Juliane Hoeppner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240834%22"}, {"id": "fda:K240598", "company": "Moon Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240598: Maestro System (REF100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240598", "people": [{"name": "Anne Osdoit", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240598%22"}, {"id": "fda:K233751", "company": "Soterix Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233751: Milieve (YPS-301BD)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233751", "people": [{"name": "Danielle Dadona", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233751%22"}, {"id": "fda:K240617", "company": "Olympus Medical Systems Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240617: Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240617", "people": [{"name": "Seiko Yunoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240617%22"}, {"id": "fda:K241259", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-06-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241259: Amplatz Goose Neck Snare Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241259", "people": [{"name": "Erin Roquemore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241259%22"}, {"id": "nih:5R44CA247639-04", "company": "Trace Biosciences Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": 810809, "summary": "NIH award 5R44CA247639-04: Clinical Translation of Near Infrared Nerve-Specific Fluorophores for Nerve-sparing Prostatectomy ($810,809)", "source_url": "https://reporter.nih.gov/project-details/10651903", "people": [{"name": "Connor William Barth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R41NS135749-01A1", "company": "Conway Medical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": 492983, "summary": "NIH award 1R41NS135749-01A1: Lumbo-venous CSF Shunt for Treatment of Communicating Hydrocephalus. ($492,983)", "source_url": "https://reporter.nih.gov/project-details/10921427", "people": [{"name": "Waleed Brinjikji", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EY032424-03", "company": "Lynthera Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": 795000, "summary": "NIH award 5R44EY032424-03: Sustained delivery technology for Cyclosporine A in the treatment of autoimmune response ($795,000)", "source_url": "https://reporter.nih.gov/project-details/10857317", "people": [{"name": "Roman Domszy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R42GM140538-02", "company": "Durametrix LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": 1011661, "summary": "NIH award 2R42GM140538-02: Establishing the market-readiness of an in vivo technology for assessing drug toxicity-induced tissue damage ($1,011,661)", "source_url": "https://reporter.nih.gov/project-details/10921369", "people": [{"name": "Steven Edward Johnson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K232715", "company": "ACON Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232715: Distinct\u00ae Digital Pregnancy Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232715", "people": [{"name": "Qiyi Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232715%22"}, {"id": "fda:K231151", "company": "Kenota, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231151: Kenota 1 Total IgE; Kenota 1 (instrument)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231151", "people": [{"name": "Martin Mann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231151%22"}, {"id": "fda:K241218", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241218: Tyber Medical Anatomical Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241218", "people": [{"name": "Scott Feeley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241218%22"}, {"id": "fda:K232080", "company": "Innovacyn, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232080: Puracyn\u00ae Plus Antimicrobial Irrigation Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232080", "people": [{"name": "Hungnan Lo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232080%22"}, {"id": "fda:K240912", "company": "Anhui Miisen Intelligence Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240912: Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240912", "people": [{"name": "Charles Shen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240912%22"}, {"id": "fda:K240913", "company": "Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240913: Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240913", "people": [{"name": "Joy Ding", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240913%22"}, {"id": "fda:K232738", "company": "Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232738: BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232738", "people": [{"name": "Sandor-Csaba Ats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232738%22"}, {"id": "fda:K233591", "company": "Degania Silicone , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233591: Stylus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233591", "people": [{"name": "Tali Raz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233591%22"}, {"id": "fda:K241055", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241055: Electro Lube NXT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241055", "people": [{"name": "Steve Elliott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241055%22"}, {"id": "fda:K240969", "company": "Shenzhen Semlamp Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240969: IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240969", "people": [{"name": "Qi Wenjun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240969%22"}, {"id": "fda:K233729", "company": "Vascular Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233729: Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233729", "people": [{"name": "Becky Astrup", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233729%22"}, {"id": "fda:K240281", "company": "Konica Minolta, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240281: Bone Suppression Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240281", "people": [{"name": "Tsutomu Fukui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240281%22"}, {"id": "fda:K240612", "company": "Avicenna.Ai", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240612: CINA-VCF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240612", "people": [{"name": "Stephane Berger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240612%22"}, {"id": "fda:K240394", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240394: multiFlux 1000 (F00012408)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240394", "people": [{"name": "Timothy Groves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240394%22"}, {"id": "fda:K233842", "company": "Ihealth Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233842: iHealth COVID-19 Antigen Rapid Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233842", "people": [{"name": "Tianyang Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233842%22"}, {"id": "fda:K222196", "company": "Brainsway , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222196: Deep TMS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222196", "people": [{"name": "Ahava Stein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222196%22"}, {"id": "fda:K232821", "company": "S.I.N. - Sistema DE Implante Nacional S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232821: S.I.N. Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232821", "people": [{"name": "Denise Domiciano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232821%22"}, {"id": "fda:K241226", "company": "Dreve Denatmid GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241226: Fixtemp\u00ae C&B 4:1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241226", "people": [{"name": "Anke H\u00fcttenbrauck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241226%22"}, {"id": "fda:K232107", "company": "Mequ A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232107: \u00b0M Warmer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232107", "people": [{"name": "Ulrik Andersen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232107%22"}, {"id": "fda:K240254", "company": "Guangdong Transtek Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240254: Blood Pressure Monitor (TMB-2296-BT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240254", "people": [{"name": "Jerry Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240254%22"}, {"id": "fda:K241248", "company": "Spectrum Medical S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241248: Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241248", "people": [{"name": "Raffaella Tommasini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241248%22"}, {"id": "fda:K232601", "company": "Broncus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232601: BroncTru\u0099 Transbronchial Access Tool", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232601", "people": [{"name": "Charles Ogbonna", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232601%22"}, {"id": "fda:K223427", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223427: Mimics Enlight CMF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223427", "people": [{"name": "Simona Beri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223427%22"}, {"id": "fda:K233295", "company": "Evolution Optiks Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233295: LFR-260", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233295", "people": [{"name": "Raul Mihali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233295%22"}, {"id": "fda:K232333", "company": "Jinhua Jingdi Medical Supplies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232333: Anti-bacterial bandage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232333", "people": [{"name": "Xiaojiang Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232333%22"}, {"id": "fda:K220062", "company": "QIAGEN GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220062: QIAstat-Dx Gastrointestinal Panel 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220062", "people": [{"name": "Stephany Foster Spahr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220062%22"}, {"id": "fda:K232943", "company": "Smiths Medical Asd, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232943: Hypodermic Needle-Pro\u00ae EDGE\u0099 Safety Device with Low Dead Space Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232943", "people": [{"name": "Ben Rappaport", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232943%22"}, {"id": "sbir:DOD:W911QY-24-P-0069", "company": "FireHUD, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-05-31", "observed": "2026-09-18", "amount_usd": 197283, "summary": "DOD SBIR Phase I award $197,283: Real Time Physiological Status Monitor for MicroClimate Control", "source_url": "https://www.sbir.gov/awards?search=C233-003-0049"}, {"id": "nih:1R43DE032985-01A1", "company": "Veravanti, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-30", "observed": "2026-08-21", "amount_usd": 309428, "summary": "NIH award 1R43DE032985-01A1: Development of Quantitative In Vivo Imaging of Oral Biofilm pH to Allow Prevention of Enamel Demineralization ($309,428)", "source_url": "https://reporter.nih.gov/project-details/10819788", "people": [{"name": "Gerald McMorrow", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K241194", "company": "Biofire Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241194: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241194", "people": [{"name": "Karli Plenert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241194%22"}, {"id": "fda:K233025", "company": "New Standard Device Dba Metalogix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233025: Revolution External Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233025", "people": [{"name": "Rachel Grimes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233025%22"}, {"id": "fda:K232934", "company": "Hangzhou Yangshun Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232934: Sunsphere", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232934", "people": [{"name": "Hui Dong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232934%22"}, {"id": "fda:K241289", "company": "Maine Molecular Quality Controls, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241289: SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241289", "people": [{"name": "Joan Gordon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241289%22"}, {"id": "fda:K240687", "company": "Sofwave Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240687: SofWave System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240687", "people": [{"name": "Ruthie Amir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240687%22"}, {"id": "fda:K234003", "company": "Circadia Technologies, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234003: The Circadia C200 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234003", "people": [{"name": "Erhan Ilhan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234003%22"}, {"id": "fda:K232505", "company": "Zhejiang Curaway Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232505: Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232505", "people": [{"name": "Ruiran Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232505%22"}, {"id": "fda:K233674", "company": "Ascension Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233674: Freedom Wrist Arthroplasty System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233674", "people": [{"name": "Stephanie Rincones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233674%22"}, {"id": "fda:K233126", "company": "Aetherai Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233126: aetherSlide", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233126", "people": [{"name": "Leticia Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233126%22"}, {"id": "fda:K240838", "company": "Spectrum Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240838: Spectrum Spine Cervical Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240838", "people": [{"name": "Jim Sevey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240838%22"}, {"id": "nih:4R42AI177108-02", "company": "Clairyon, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 4R42AI177108-02: AIVIS: Next Generation Vigilant Information Seeking Artificial Intelligence-based Clinical Decision Support for Sepsis ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/11060671", "people": [{"name": "Christopher Josef", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K233166", "company": "Net Recovery", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233166: NET Recovery Corp/NET Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233166", "people": [{"name": "Joe Winston", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233166%22"}, {"id": "fda:K232672", "company": "Genetic Signatures Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232672: EasyScreen Gastrointestinal Parasite Detection Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232672", "people": [{"name": "Neralie Coulston", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232672%22"}, {"id": "fda:K241207", "company": "Devoro Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241207: SmartClaw\u0099 Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw\u0099 Thrombectomy Catheter, 32 mm (FD0660-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241207", "people": [{"name": "Aaron Lynch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241207%22"}, {"id": "fda:K241190", "company": "Poonglim Pharmatech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241190: PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241190", "people": [{"name": "HeeMin Cho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241190%22"}, {"id": "fda:K233655", "company": "Abbott", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233655: Lingo Glucose System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233655", "people": [{"name": "Juni Sarkar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233655%22"}, {"id": "fda:K233481", "company": "Encore Medical L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233481: AltiVate Reverse\u00ae Glenoid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233481", "people": [{"name": "Sherri Mellingen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233481%22"}, {"id": "fda:K233389", "company": "Hiossen, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233389: EK Digital Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233389", "people": [{"name": "Peter Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233389%22"}, {"id": "fda:K240784", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240784: Temperature Sensor Probe (ABL-18TP20)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240784", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240784%22"}, {"id": "fda:K240049", "company": "Metric Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240049: LINK(TM) External Fixator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240049", "people": [{"name": "William Casey Fox", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240049%22"}, {"id": "fda:K241235", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241235: Arthrex TightRope II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241235", "people": [{"name": "Kristi Frisch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241235%22"}, {"id": "fda:K232741", "company": "Insulet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232741: SmartAdjust(TM) technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232741", "people": [{"name": "Alexander Hamad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232741%22"}, {"id": "fda:K240159", "company": "Innovoyce", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240159: InnoVoyce VYLO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240159", "people": [{"name": "Stephen Mais", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240159%22"}, {"id": "nih:1R41AI184218-01", "company": "L2 Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-28", "observed": "2026-08-21", "amount_usd": 299878, "summary": "NIH award 1R41AI184218-01: Delivery of a candidate AgTRIOVx malaria vaccine by thermostable microneedle patches ($299,878)", "source_url": "https://reporter.nih.gov/project-details/10922217", "people": [{"name": "KAREN G. ANTHONY", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240749", "company": "Orthofix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240749: PILLAR SA Ti Spacer System (82-XXX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240749", "people": [{"name": "Tony John", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240749%22"}, {"id": "fda:K240410", "company": "Malinckrodt Manufacturing, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240410: EVOLVE Nitric Oxide Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240410", "people": [{"name": "Jennifer Brett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240410%22"}, {"id": "fda:K223629", "company": "Eresearchtechnology GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223629: SpiroSphere, SpiroSphereECG, CardioSphere", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223629", "people": [{"name": "Kristin Feld", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223629%22"}, {"id": "fda:K240629", "company": "Xingyu Medical Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240629: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240629", "people": [{"name": "Carrie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240629%22"}, {"id": "fda:K233076", "company": "Rwd Life Science Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233076: Laser Speckle Imaging System (RFLSI CZW)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233076", "people": [{"name": "Xuhong Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233076%22"}, {"id": "fda:K240874", "company": "Theralaser Medtech (China) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240874: Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240874", "people": [{"name": "Danhong Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240874%22"}, {"id": "fda:K240304", "company": "Enpuno Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240304: Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240304", "people": [{"name": "Hao He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240304%22"}, {"id": "fda:K233344", "company": "Ipg Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233344: Regenalase Laser System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233344", "people": [{"name": "Samuel D Wade", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233344%22"}, {"id": "fda:K240305", "company": "Sibel Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240305: ANNE Limb", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240305", "people": [{"name": "Sarah Coughlin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240305%22"}, {"id": "fda:K241177", "company": "Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241177: React 71 Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241177", "people": [{"name": "Alexander Abe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241177%22"}, {"id": "nih:1R41NS130958-01", "company": "Epiwatch, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": 275547, "summary": "NIH award 1R41NS130958-01: Focal seizure monitoring with a consumer wearable: algorithmic development and validation ($275,547)", "source_url": "https://reporter.nih.gov/project-details/10604654", "people": [{"name": "NATHAN E CRONE", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AA030948-02", "company": "Managed Health Connections, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": 1338347, "summary": "NIH award 5R44AA030948-02: Advanced Contingency Management System for Reduction of Alcohol Use. ($1,338,347)", "source_url": "https://reporter.nih.gov/project-details/10865112", "people": [{"name": "Ron Kimberly Johnson", "role": "Principal Investigator"}, {"name": "Michael G McDonell", "role": "Principal Investigator"}, {"name": "Sterling M McPherson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K240592", "company": "Spinal Simplicity, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240592: Wolff's Law Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240592", "people": [{"name": "Adam Rogers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240592%22"}, {"id": "fda:K240810", "company": "Xiamen Yizhou Imp. & Exp. Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240810: Anti Grinding Guard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240810", "people": [{"name": "Elaine Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240810%22"}, {"id": "fda:K241178", "company": "Deka Research and Development", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241178: DEKA ACE Pump System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241178", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241178%22"}, {"id": "fda:K240827", "company": "Shimadzu Corporation Medical Systems Division", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240827: SET-5002", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240827", "people": [{"name": "Koichi Kataoka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240827%22"}, {"id": "fda:K233111", "company": "Foshan United Medical Technologies, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233111: ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233111", "people": [{"name": "Albert Rego", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233111%22"}, {"id": "fda:K232788", "company": "Inspira Technologies Oxy B.H.N. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232788: INSPIRA ART100", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232788", "people": [{"name": "Dganit Litinsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232788%22"}, {"id": "fda:K233089", "company": "In2bones USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233089: NeoSpan\u00ae Compression Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233089", "people": [{"name": "Christine Scifert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233089%22"}, {"id": "fda:K233285", "company": "Kuraray Noritake Dental, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233285: KATANA Zirconia ONE For IMPLANT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233285", "people": [{"name": "Yasujiro Ohara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233285%22"}, {"id": "fda:K233386", "company": "M/s. Meril Endo Surgery Private Limited.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233386: Monik\u0099 - Disposable Endoscopic Trocar", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233386", "people": [{"name": "Umesh Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233386%22"}, {"id": "fda:K234154", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234154: uPMR 790", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234154", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234154%22"}, {"id": "fda:K240769", "company": "Dia Imaging Analysis, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240769: LVivo IQS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240769", "people": [{"name": "Michal Yaacobi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240769%22"}, {"id": "fda:K240864", "company": "Opsens, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240864: PacePro Wire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240864", "people": [{"name": "Marc Chaunet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240864%22"}, {"id": "fda:K233777", "company": "Primed Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233777: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233777", "people": [{"name": "Mitra Fard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233777%22"}, {"id": "fda:K231426", "company": "Hoowon Edi Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231426: 8plant Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231426", "people": [{"name": "Jihun Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231426%22"}, {"id": "fda:K240723", "company": "Intuitive Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240723: da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240723", "people": [{"name": "Emily Hovick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240723%22"}, {"id": "fda:K232646", "company": "Cook Biotech Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232646: Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232646", "people": [{"name": "Christopher Lotzow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232646%22"}, {"id": "fda:K231939", "company": "Smith & Nephew Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231939: Renasys Edge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231939", "people": [{"name": "Uttley Ruby", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231939%22"}, {"id": "fda:K232639", "company": "Mag & More GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232639: Apollo TMS Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232639", "people": [{"name": "Kerstin Haeringer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232639%22"}, {"id": "fda:K232632", "company": "Epimed International", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232632: Racz Neurostat RF Generator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232632", "people": [{"name": "Preston Frasier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232632%22"}, {"id": "nih:5R44AI155367-03", "company": "Godx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": 960626, "summary": "NIH award 5R44AI155367-03: Rapid, Handheld, Point-of-Care Stool Sample-prep Device for the Extraction and Detection of Nucleic Acid from Diarrheal Pathogens ($960,626)", "source_url": "https://reporter.nih.gov/project-details/10850789", "people": [{"name": "Chang Hee Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K232603", "company": "Camdiab , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232603: CamAPS FX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232603", "people": [{"name": "Roman Hovorka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232603%22"}, {"id": "fda:K232602", "company": "Printbio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232602: 3DMatrix Surgical Mesh", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232602", "people": [{"name": "Kevin Slawin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232602%22"}, {"id": "fda:K240701", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240701: Drill Guide; Drill Bit; Spine & Trauma Navigation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240701", "people": [{"name": "Esther Moreno Garcia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240701%22"}, {"id": "fda:K233251", "company": "Linde Gas & Equipment, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233251: NOxBOXi Nitric Oxide Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233251", "people": [{"name": "Dave Loflin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233251%22"}, {"id": "fda:K233120", "company": "Chungwoo Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233120: CWM-930S, FIXER DV9", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233120", "people": [{"name": "Su Jin Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233120%22"}, {"id": "fda:K241134", "company": "Kci USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241134: 3M\u0099 ActiV.A.C.\u0099 Canister - 300ml with Gel (M8275058/5, M8275058/10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241134", "people": [{"name": "Jacqulyn Rosinski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241134%22"}, {"id": "fda:K240294", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240294: Syngo Carbon Enterprise Access (VA40A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240294", "people": [{"name": "Vijay Ramadas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240294%22"}, {"id": "fda:K233108", "company": "Vinbigdata Joint Stock Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233108: VinDr-Mammo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233108", "people": [{"name": "Nguyet (Jun) Phan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233108%22"}, {"id": "fda:K232642", "company": "Healkee Medical Pte, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232642: AirKEE T900", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232642", "people": [{"name": "William Tao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232642%22"}, {"id": "fda:K241396", "company": "Ulrich Medical USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241396: uCerv Flux\u0099-C 3D Porous Titanium Cervical Interbody", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241396", "people": [{"name": "Eric Lucas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241396%22"}, {"id": "fda:K233868", "company": "Kulzer, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233868: dima Print Teeth & Temp", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233868", "people": [{"name": "David Vincent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233868%22"}, {"id": "sbir:DOD:FA8649-24-P-0525", "company": "Lumia Health, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-05-23", "observed": "2026-09-18", "amount_usd": 1799851, "summary": "DOD STTR Phase II award $1,799,851: STAT Earpiece Wearable for Blood Pressure Monitoring in Aviation and En Route Medical Care", "source_url": "https://www.sbir.gov/awards?search=FX23D-TCSO1-0018"}, {"id": "nih:2R44AA030512-02", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": 1001961, "summary": "NIH award 2R44AA030512-02: Oscillated Insertion Tool for Minimally Invasive, Low-Damage, Accurate Placement of Delivery Cannula to Improve Efficacy for DREADDS Therapy in Alcohol Addiction Treatment ($1,001,961)", "source_url": "https://reporter.nih.gov/project-details/10931873", "people": [{"name": "Roger Brooks Bagwell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AA031448-01", "company": "Kasa Bio, L.l.c.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": 273974, "summary": "NIH award 1R43AA031448-01: A novel and inexpensive multiplex miRNA platform for liver diseases screening ($273,974)", "source_url": "https://reporter.nih.gov/project-details/10821132", "people": [{"name": "Shashi Bala", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43AI174562-02", "company": "Amplifidx Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": 293189, "summary": "NIH award 5R43AI174562-02: STI NG Plus, a Swab to Answer Molecular Panel Test for Point of Care Diagnosis and Treatment Recommendation ($293,189)", "source_url": "https://reporter.nih.gov/project-details/10832974", "people": [{"name": "Shoulian Dong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH128076-03", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": 850421, "summary": "NIH award 5R44MH128076-03: Next generation axonal quantification and classification using AI ($850,421)", "source_url": "https://reporter.nih.gov/project-details/10868467", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43TR005112-01", "company": "Cellular Vehicles Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": 294541, "summary": "NIH award 1R43TR005112-01: Development of a novel tool for cell therapies that automates the formation and injection of cell-laden hydrogels directly into tissue ($294,541)", "source_url": "https://reporter.nih.gov/project-details/10919361", "people": [{"name": "Nikhil S. Joshi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240097", "company": "Ushare Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240097: Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240097", "people": [{"name": "Yun Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240097%22"}, {"id": "fda:K241014", "company": "Biomet, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241014: Biomet Kirschner Wires (K-Wires)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241014", "people": [{"name": "Akash Savalia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241014%22"}, {"id": "fda:K233884", "company": "Galvanize Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233884: INUMI\u0099 Flex Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233884", "people": [{"name": "Deborah Sheffield", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233884%22"}, {"id": "fda:K240224", "company": "Philips Medical Systems Nederlands B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240224: Zenition 90", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240224", "people": [{"name": "Rahul Kumar Sinha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240224%22"}, {"id": "fda:K232740", "company": "Paltop Advanced Dental Solutions, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232740: Paltop Short Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232740", "people": [{"name": "Nancy DeAngelo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232740%22"}, {"id": "fda:K240456", "company": "Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240456: Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240456", "people": [{"name": "Ira Nusbaum", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240456%22"}, {"id": "fda:K241106", "company": "Shenzhen Mlay Intelligent Technology Co., , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241106: Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241106", "people": [{"name": "Libin Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241106%22"}, {"id": "fda:K241100", "company": "Co-Innovation Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241100: Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241100", "people": [{"name": "Hong Feng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241100%22"}, {"id": "fda:K232655", "company": "Stemcyte, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232655: Bonvadis\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232655", "people": [{"name": "Angel Hsieh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232655%22"}, {"id": "fda:K233099", "company": "Rohrer Aesthetics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233099: Gladiator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233099", "people": [{"name": "Mark Rohrer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233099%22"}, {"id": "fda:K233268", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233268: Impress Angiographic Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233268", "people": [{"name": "Gamaliel Figueroa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233268%22"}, {"id": "fda:K233820", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233820: Fogarty Arterial Embolectomy Catheter with Gate Valve", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233820", "people": [{"name": "Yagna Angirish", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233820%22"}, {"id": "fda:K241143", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241143: Materialise Shoulder System\u0099, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241143", "people": [{"name": "Lisa Barbara Parolari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241143%22"}, {"id": "fda:K233819", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233819: Fogarty Venous Thrombectomy Catheters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233819", "people": [{"name": "Unji Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233819%22"}, {"id": "fda:K240199", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240199: IntraOp Alignment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240199", "people": [{"name": "Unnati Bhuptani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240199%22"}, {"id": "fda:K241126", "company": "TELA Bio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241126: OviTex PRS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241126", "people": [{"name": "John Urtz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241126%22"}, {"id": "nih:5R44DK136390-02", "company": "Affinergy, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-21", "observed": "2026-08-21", "amount_usd": 590935, "summary": "NIH award 5R44DK136390-02: A novel peptide assay for hepcidin clinical monitoring ($590,935)", "source_url": "https://reporter.nih.gov/project-details/10889097", "people": [{"name": "Martyn Darby", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:DEN230068", "company": "3M Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230068: 3M\u0099 Attest\u0099 eBowie-Dick Test Card 10135 3M\u0099 Attest\u0099 eBowie-Dick Card Holder 10135CH 3M\u0099 Attest\u0099 eBowie-Dick Auto-reader 1190", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230068", "people": [{"name": "Michelle Larsen", "role": "510(k) submission contact"}]}, {"id": "fda:K232759", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232759: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232759", "people": [{"name": "Sadwini Suresh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232759%22"}, {"id": "fda:K233336", "company": "Acula Technology Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233336: 21.3\u0094 3MP Color LCD Display UMD3-21B01 (MD3-21B01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233336", "people": [{"name": "Sheng-Sung Jian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233336%22"}, {"id": "fda:K232677", "company": "Reia, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232677: Reia pessary", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232677", "people": [{"name": "Kaitlin Maier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232677%22"}, {"id": "fda:K241110", "company": "Centers for Disease Control and Prevention", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241110: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241110", "people": [{"name": "John Barnes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241110%22"}, {"id": "fda:K233442", "company": "Biotex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233442: troCarWash\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233442", "people": [{"name": "Wade Munsch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233442%22"}, {"id": "fda:K232946", "company": "Horiba Abx Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232946: Yumizen H2500", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232946", "people": [{"name": "Caroline Ferrer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232946%22"}, {"id": "fda:K240433", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240433: ProSeal\u0099 Injection Site Extended Male Luer Lock (422140)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240433", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240433%22"}, {"id": "fda:K233543", "company": "Siemens Medical Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233543: YSIO X.pree", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233543", "people": [{"name": "Camila Rodriguez Valentin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233543%22"}, {"id": "fda:K240806", "company": "Tianjin Huahong Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240806: Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240806", "people": [{"name": "Wang Ningning", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240806%22"}, {"id": "denovo:DEN230068", "company": "3M Company", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-05-21", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230068 granted: 3M\u2122 Attest\u2122 eBowie-Dick Test Card", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230068"}, {"id": "nih:2R44GM145194-02A1", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": 1223863, "summary": "NIH award 2R44GM145194-02A1: System for unitary automation of library preparation ($1,223,863)", "source_url": "https://reporter.nih.gov/project-details/10931834", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HD114244-01A1", "company": "Nimbus Research Laboratory, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": 295812, "summary": "NIH award 1R43HD114244-01A1: AdvanceBox System with Networked, Monitored, and Mapped Rescue Supply Containers (Phase I) ($295,812)", "source_url": "https://reporter.nih.gov/project-details/10919940", "people": [{"name": "GEOFFREY A CAPRARO", "role": "Principal Investigator"}, {"name": "Leo Kobayashi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK139828-01", "company": "Biodevek Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": 977992, "summary": "NIH award 1R44DK139828-01: Production of a Hydrogel-based Mucosal Sealant for Gastrointestinal Bleeding Prevention ($977,992)", "source_url": "https://reporter.nih.gov/project-details/10919961", "people": [{"name": "Gonzalo Munoz Taboada", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K232702", "company": "Aventamed Dac", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232702: Solo+ Tympanostomy Tube Device (TTD)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232702", "people": [{"name": "Keith Jansen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232702%22"}, {"id": "fda:K240772", "company": "Hunan Ceramaster Material Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240772: Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240772", "people": [{"name": "Bin Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240772%22"}, {"id": "fda:K240520", "company": "Beijing Sea Heart International Science and Technologyco.Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240520: Diode Laser Hair Removal System (SH-VD910)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240520", "people": [{"name": "Xiaoli He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240520%22"}, {"id": "fda:K240511", "company": "Dentis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240511: Dentis s-Clean SQ-SL Fixture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240511", "people": [{"name": "Gyu Ri Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240511%22"}, {"id": "fda:K233620", "company": "Mim Software, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233620: MIM - Centiloid Scaling", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233620", "people": [{"name": "Sydney Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233620%22"}, {"id": "fda:K223399", "company": "Avita Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223399: AViTA Pulse Oximeter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223399", "people": [{"name": "Joanna Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223399%22"}, {"id": "fda:K241276", "company": "Innovasis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241276: Vector\u0099 Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241276", "people": [{"name": "Michael Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241276%22"}, {"id": "fda:K233341", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233341: Shiley\u0099 Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233341", "people": [{"name": "Stephanie Reneau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233341%22"}, {"id": "fda:K241252", "company": "Anqing Pukang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241252: Disposable Vinyl Examination Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241252", "people": [{"name": "Min Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241252%22"}, {"id": "fda:K240474", "company": "Shanghai Bele Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240474: Multi-function Platform Systems (BL-M10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240474", "people": [{"name": "Jeremy Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240474%22"}, {"id": "fda:K233619", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233619: Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233619", "people": [{"name": "Aeree Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233619%22"}, {"id": "nih:1R44HL172325-01A1", "company": "Lazzaro Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": 1323708, "summary": "NIH award 1R44HL172325-01A1: Lazzaro Medical Scaffold System for improved treatment of tracheobronchomalacia ($1,323,708)", "source_url": "https://reporter.nih.gov/project-details/10918000", "people": [{"name": "Dawn Dawn Bitz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43EY035861-01A1", "company": "Retivue", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": 350000, "summary": "NIH award 1R43EY035861-01A1: RetiVue EntireEyeScope: A high resolution, top-down view, stereo, endoscopic viewing system for vitreoretinal surgery ($350,000)", "source_url": "https://reporter.nih.gov/project-details/10921969", "people": [{"name": "Ed DeHoog", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL174341-01", "company": "Levisonics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": 299309, "summary": "NIH award 1R43HL174341-01: Coagulation Monitoring in Hemophilia via Acoustic Tweezing Spectroscopy ($299,309)", "source_url": "https://reporter.nih.gov/project-details/10922338", "people": [{"name": "Nithya Kasireddy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K233236", "company": "Gmv Soluciones Globales Internet S.A.U.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233236: Radiance V5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233236", "people": [{"name": "Carlos Illana", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233236%22"}, {"id": "fda:K240482", "company": "Smedtrum Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240482: Intense Pulsed Light System (ST-690)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240482", "people": [{"name": "Crimson Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240482%22"}, {"id": "fda:K232525", "company": "Watkins-Conti Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232525: Yoni.Fit Bladder Support", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232525", "people": [{"name": "Allison L Watkins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232525%22"}, {"id": "fda:K232516", "company": "Sentec AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232516: Sentec Digital Monitoring System (SDMS) tCOM+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232516", "people": [{"name": "Caroline Moller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232516%22"}, {"id": "fda:K233209", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233209: uOmnispace.CT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233209", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233209%22"}, {"id": "fda:DEN230035", "company": "Dental Monitoring Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230035: DentalMonitoring", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230035", "people": [{"name": "Isabelle Puraye", "role": "510(k) submission contact"}]}, {"id": "fda:K233933", "company": "Carl Zeiss Meditec, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233933: CIRRUS\u0099 HD-OCT Model 6000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233933", "people": [{"name": "Vidita Desai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233933%22"}, {"id": "fda:K220891", "company": "New World Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220891: Kahook Dual Blade Glide (KDB Glide)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220891", "people": [{"name": "Victor Arellano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220891%22"}, {"id": "fda:K240935", "company": "Effortmed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240935: ARENAL Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240935", "people": [{"name": "Steven Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240935%22"}, {"id": "fda:K241175", "company": "MiRus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241175: MiRus MoRe Lumbar Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241175", "people": [{"name": "Anuradha Nagulapati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241175%22"}, {"id": "fda:K233215", "company": "Icotec AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233215: icotec Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233215", "people": [{"name": "Marina Hess", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233215%22"}, {"id": "fda:K232793", "company": "Zevex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232793: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232793", "people": [{"name": "Christopher Dodge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232793%22"}, {"id": "fda:K241042", "company": "Pressure Products Medical Device Manufacturing, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241042: SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241042", "people": [{"name": "Andrew Armour", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241042%22"}, {"id": "denovo:DEN230035", "company": "Dental Monitoring Sas", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-05-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230035 granted: DentalMonitoring", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230035"}, {"id": "breakthrough:K233215", "company": "Icotec Ag", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-05-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K233215: ICOTEC ANTERIOR CERVICAL PLATE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:FA8649-24-P-0886", "company": "Selas Bio, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-05-17", "observed": "2026-09-18", "amount_usd": 109876, "summary": "DOD STTR Phase I award $109,876: Personalized Blood Concentrate for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=FX24D-PTCSO1-0747"}, {"id": "nih:5R44AI167330-03", "company": "Scanogen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": 999898, "summary": "NIH award 5R44AI167330-03: Culture and amplification-free bacterial sepsis diagnosis ($999,898)", "source_url": "https://reporter.nih.gov/project-details/10863894", "people": [{"name": "Alfredo Andres Celedon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R43DA059474-01S2", "company": "Pirouette Pharma Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": 97580, "summary": "NIH award 3R43DA059474-01S2: A Rugged, Reliable, Portable, Safe, and Simple Naloxone HCl Auto-Injector for Life-Saving Treatment of Opioid Overdose ($97,580)", "source_url": "https://reporter.nih.gov/project-details/11054514", "people": [{"name": "Conor R Cullinane", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DC018760-02A1", "company": "Restorear Devices, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": 970535, "summary": "NIH award 2R44DC018760-02A1: Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss ($970,535)", "source_url": "https://reporter.nih.gov/project-details/10921181", "people": [{"name": "Curtis Scott King", "role": "Principal Investigator"}, {"name": "Suhrud M. Rajguru", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K232542", "company": "MicroVention, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232542: Wedge XL Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232542", "people": [{"name": "Alick Tan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232542%22"}, {"id": "fda:K233473", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233473: DEKA LOTUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233473", "people": [{"name": "Paolo Peruzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233473%22"}, {"id": "fda:K232495", "company": "Sempulse Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232495: Sempulse Halo Vital Signs Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232495", "people": [{"name": "Matt Barrera", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232495%22"}, {"id": "fda:K232849", "company": "Owens & Minor (O&M) Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232849: Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232849", "people": [{"name": "Gabriel Dockery", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232849%22"}, {"id": "fda:K240328", "company": "Signifier Medical Technologies, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240328: eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240328", "people": [{"name": "Yasser Zayni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240328%22"}, {"id": "fda:K233841", "company": "Qingdao Hisense Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233841: HD80 Series Ultrasound Diagnostic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233841", "people": [{"name": "Yalan Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233841%22"}, {"id": "fda:K240752", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240752: DEKA TORO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240752", "people": [{"name": "Paolo Peruzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240752%22"}, {"id": "fda:K240445", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240445: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240445", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240445%22"}, {"id": "fda:K233625", "company": "Ray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233625: RAYDENT SW", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233625", "people": [{"name": "Huh Soo Ji", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233625%22"}, {"id": "fda:K241039", "company": "Reshape Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241039: ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241039", "people": [{"name": "Eva Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241039%22"}, {"id": "fda:K230711", "company": "Guangzhou Xinbo Electronic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230711: Pain Therapy Device(Model: P.T.S-X)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230711", "people": [{"name": "Sammy Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230711%22"}, {"id": "fda:K232786", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232786: Stimulation System (PA series, PR series, S series and Q series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232786", "people": [{"name": "Tracy Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232786%22"}, {"id": "fda:K232933", "company": "Healkee Medical Pte, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232933: AirKEE P900", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232933", "people": [{"name": "William Tao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232933%22"}, {"id": "fda:K233137", "company": "Mozograu S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233137: Ticare Dental Implant Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233137", "people": [{"name": "Beatriz Santos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233137%22"}, {"id": "fda:K240059", "company": "Tedequim Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240059: FAgamin\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240059", "people": [{"name": "Leonor Pasteris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240059%22"}, {"id": "fda:K240386", "company": "Shanghai Bele Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240386: Picosecond Nd:YAG Laser Systems (BL-C10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240386", "people": [{"name": "Jeremy Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240386%22"}, {"id": "nih:1R44AI181347-01A1", "company": "Inhalon Biopharma, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": 1024942, "summary": "NIH award 1R44AI181347-01A1: IND-enabling development for IN-003, an inhaled mAb therapy against human metapneumovirus infection ($1,024,942)", "source_url": "https://reporter.nih.gov/project-details/10921913", "people": [{"name": "JEFF T HUTCHINS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R42CA290912-01", "company": "Aperture Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": 339990, "summary": "NIH award 1R42CA290912-01: Rapid, Single Cell Proteomic Profiling for Biomarker Development in Precision Oncology ($339,990)", "source_url": "https://reporter.nih.gov/project-details/10911716", "people": [{"name": "Hannah Marie Peterson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K241043", "company": "Fix Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241043: Augment Off-Axis Instrument System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241043", "people": [{"name": "Brian Karpinski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241043%22"}, {"id": "fda:DEN230043", "company": "Notal Vision, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230043: Notal Vision Home Optical Coherence Tomography (OCT) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230043", "people": [{"name": "Kester Nahen", "role": "510(k) submission contact"}]}, {"id": "fda:K240278", "company": "Fx Shoulder USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240278: Full Wedge Lateralized and Augmented Baseplates", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240278", "people": [{"name": "Cory Trier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240278%22"}, {"id": "fda:K241053", "company": "Medtronic Cardiac Surgery", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241053: MVR\u0099 Venous Reservoir Bag 800 mL; MVR\u0099 Venous Reservoir Bag 1600 mL; MVR\u0099 Venous Reservoir Bag with Cortiva\u0099 BioActive Surface 800 mL; MVR\u0099 Venous Reservoir Bag with Cortiva\u0099 BioActive Surface 1600 mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241053", "people": [{"name": "Yidi Hou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241053%22"}, {"id": "fda:K241112", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241112: BriefCase-Quantification", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241112", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241112%22"}, {"id": "fda:K231940", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231940: BruxZir\u00ae NOW SRC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231940", "people": [{"name": "So Hyun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231940%22"}, {"id": "fda:K241049", "company": "Canon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241049: CANON Fundus Camera CR-10 (CR-10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241049", "people": [{"name": "Shigeo Watanabe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241049%22"}, {"id": "fda:K233247", "company": "Heuron Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233247: Heuron ICH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233247", "people": [{"name": "Inah Jeong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233247%22"}, {"id": "fda:K240368", "company": "Evolution Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240368: E3D\u0099-A Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240368", "people": [{"name": "Todd Wallenstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240368%22"}, {"id": "fda:K233985", "company": "Megin OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233985: TRIUX\u0099 neo (NM27000N ); MEGreview (SW26241N-B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233985", "people": [{"name": "Laura Vanonen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233985%22"}, {"id": "denovo:DEN230043", "company": "Notal Vision, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-05-15", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230043 granted: Notal Vision Home Optical Coherence Tomo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230043"}, {"id": "breakthrough:DEN230043", "company": "Notal Vision, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-05-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN230043: NOTAL VISION HOME OPTICAL COHERENCE TOMOGRAPHY (OCT) SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R44MH128484-03S1", "company": "Ksana Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-14", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44MH128484-03S1: Development and testing of a digitally assisted risk reduction platform for youth at high risk for suicide ($50,000)", "source_url": "https://reporter.nih.gov/project-details/11040859", "people": [{"name": "NICHOLAS B ALLEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K240426", "company": "Inquis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240426: Aventus Clot Management System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240426", "people": [{"name": "Mojgan Sadaat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240426%22"}, {"id": "fda:K233913", "company": "Aoj Health Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233913: Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233913", "people": [{"name": "Jack Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233913%22"}, {"id": "fda:K232662", "company": "Biomerics Nle", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232662: BNLE Hydrophilic Jacketed Peripheral Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232662", "people": [{"name": "Maggie Goshert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232662%22"}, {"id": "nih:3R42HL162214-03S1", "company": "Biochip Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-13", "observed": "2026-08-21", "amount_usd": 70840, "summary": "NIH award 3R42HL162214-03S1: Microfluidic Technology for Concurrent Assessment of Red Blood Cell Adhesion and Deformability (Administrative Supplement) ($70,840)", "source_url": "https://reporter.nih.gov/project-details/10851651", "people": [{"name": "Chiara Federici", "role": "Principal Investigator"}, {"name": "Umut A. Gurkan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R43AG084801-01S2", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-13", "observed": "2026-08-21", "amount_usd": 24971, "summary": "NIH award 3R43AG084801-01S2: Diversity Supplement for Development of an Oscillated Insertion tool to Eliminate Surgically Induced Neurodegeneration for Optical Neuroimaging of Cognitive Aging and Dementia ($24,971)", "source_url": "https://reporter.nih.gov/project-details/11018410", "people": [{"name": "Kyle William Gheres", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K232242", "company": "Foreo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232242: BEAR 2 Body", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232242", "people": [{"name": "Evan Feldstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232242%22"}, {"id": "fda:K240949", "company": "Healgen Scientific,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240949: Healgen\u00ae Accurate Fentanyl Rapid Test Cassette (Urine); Healgen\u00ae Accurate Rapid Fentanyl Test Cassette (Urine); Healgen\u00ae Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen\u00ae Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen\u00ae Accurate Fentanyl Rapid Test Strip (Urine); Healgen\u00ae Accurate Rapid Fentanyl Test Strip (Urine)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240949", "people": [{"name": "Bryan Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240949%22"}, {"id": "fda:K240658", "company": "Hebei JT Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240658: 1060nm laser body slimming machine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240658", "people": [{"name": "Karen Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240658%22"}, {"id": "fda:K232862", "company": "Mim Software, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232862: MIM \u0096 Monte Carlo Dosimetry", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232862", "people": [{"name": "Sydney Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232862%22"}, {"id": "fda:K233875", "company": "Brainomix Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233875: Brainomix 360 e-Lung", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233875", "people": [{"name": "Thais Sala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233875%22"}, {"id": "fda:K232529", "company": "Shenzhen Insighters Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232529: Disposable Double Lumen Endobronchial Tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232529", "people": [{"name": "Bonnie Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232529%22"}, {"id": "fda:K232614", "company": "Sri Trang Gloves (Thailand) Public Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232614: Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232614", "people": [{"name": "Jarinya Jirojkul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232614%22"}, {"id": "fda:K240759", "company": "Remedi Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240759: REMEX-GR100", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240759", "people": [{"name": "Sungho Cho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240759%22"}, {"id": "nih:5R44MH133502-02", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": 877405, "summary": "NIH award 5R44MH133502-02: Integrated software platform to enhance school mental health assessment and data-driven student services ($877,405)", "source_url": "https://reporter.nih.gov/project-details/10835066", "people": [{"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}, {"name": "SHARON H Hoover", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43AG084801-01S1", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": 24971, "summary": "NIH award 3R43AG084801-01S1: Diversity Supplement for Development of an Oscillated Insertion tool to Eliminate Surgically Induced Neurodegeneration for Optical Neuroimaging of Cognitive Aging and Dementia ($24,971)", "source_url": "https://reporter.nih.gov/project-details/11018398", "people": [{"name": "Kyle William Gheres", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44OD036187-01", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": 999997, "summary": "NIH award 1R44OD036187-01: High-content behavioral phenotyping of model organisms in three dimensions with a gigapixel microscope ($999,997)", "source_url": "https://reporter.nih.gov/project-details/10822410", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K240479", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240479: Access OV Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240479", "people": [{"name": "Kuljeet Kaur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240479%22"}, {"id": "fda:K240374", "company": "Shenzhen HugeMed Medical Technical Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240374: Ureterorenoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240374", "people": [{"name": "Cathy Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240374%22"}, {"id": "fda:K240708", "company": "Suzhou Borage Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240708: Organic Cotton Tampon; Organic Cotton PESCVcord Tampon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240708", "people": [{"name": "Zhou Nana", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240708%22"}, {"id": "fda:K240365", "company": "Beijing C-Root Dental Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240365: Bioceramic Root Repair Material (C-Root BP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240365", "people": [{"name": "Bingmin Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240365%22"}, {"id": "fda:K232507", "company": "Aerogen, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232507: Aerogen\u00aeSolo Nebulizer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232507", "people": [{"name": "Thelma Marley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232507%22"}, {"id": "fda:K233950", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233950: pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233950", "people": [{"name": "Timothy Groves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233950%22"}, {"id": "fda:K233277", "company": "Hangzhou Qiantang Longyue Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233277: Filter Needle for Single Use", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233277", "people": [{"name": "Chunyu Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233277%22"}, {"id": "fda:K233629", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233629: APERTO Lucent MRI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233629", "people": [{"name": "Duan Threats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233629%22"}, {"id": "fda:K234079", "company": "Threadstone, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234079: HyperSuture Extension Line", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234079", "people": [{"name": "Jeremy Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234079%22"}, {"id": "fda:K232475", "company": "Shandong Zhushi Pharmaceutical Group Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232475: Disposable infusion set with needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232475", "people": [{"name": "Junhui Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232475%22"}, {"id": "fda:K234023", "company": "Gimbo Medical Technology Shenzhen Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234023: Oocyte Flushing & Retrieval Medium; Gamete Buffer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234023", "people": [{"name": "Leo Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234023%22"}, {"id": "fda:K233100", "company": "QIAGEN GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233100: QIAstat-Dx\u00ae Respiratory Panel Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233100", "people": [{"name": "Autumn Collasius", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233100%22"}, {"id": "fda:K232410", "company": "Milvue", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232410: SmartChest", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232410", "people": [{"name": "Oumaya Ibrahim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232410%22"}, {"id": "fda:K240698", "company": "Guangzhou Decheng Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240698: Dochek\u00ae Multi-Drug Urine Test Dipcard Rx; Dochek\u00ae Multi-Drug Urine Test Dipcard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240698", "people": [{"name": "Mango Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240698%22"}, {"id": "fda:K240699", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240699: SCARLET\u00ae AC-Ti", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240699", "people": [{"name": "Estelle Lefeuvre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240699%22"}, {"id": "fda:K240276", "company": "Given Imaging Ltd. (D.B.A. Medtronic)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240276: PillCam\u0099 Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240276", "people": [{"name": "Aaron Niklaus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240276%22"}, {"id": "sbir:DOD:FA8649-24-P-0835", "company": "Sonera, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-05-10", "observed": "2026-09-18", "amount_usd": 109691, "summary": "DOD STTR Phase I award $109,691: Physiological Monitoring Via Biomagnetic Sensor Application", "source_url": "https://www.sbir.gov/awards?search=FX24D-PTCSO1-0182"}, {"id": "fda:K232470", "company": "Suretex Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232470: Polyisoprene Extra Large Condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232470", "people": [{"name": "Alison Arnot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232470%22"}, {"id": "fda:K233602", "company": "Optos Plc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233602: P200TE (A10700)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233602", "people": [{"name": "Graham McLeod", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233602%22"}, {"id": "fda:K240495", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240495: Flexible Fixation Device for Gynecological Applicators (GM11001960)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240495", "people": [{"name": "Dr. Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240495%22"}, {"id": "fda:K240403", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240403: Access BR Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240403", "people": [{"name": "Kate Oelberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240403%22"}, {"id": "fda:K233967", "company": "Synthes GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233967: DePuy Synthes MatrixSTERNUM Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233967", "people": [{"name": "Georgina Mueller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233967%22"}, {"id": "fda:K232976", "company": "Vuze Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232976: VUZE System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232976", "people": [{"name": "David Tolkowsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232976%22"}, {"id": "fda:K233418", "company": "Biofourmis Singapore Pte., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233418: Biofourmis Everion+ (G2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233418", "people": [{"name": "Seth Kuzdzal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233418%22"}, {"id": "fda:K233982", "company": "Cerenovus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233982: CEREGLIDE 92 Catheter System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233982", "people": [{"name": "Niall Fox", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233982%22"}, {"id": "fda:K232477", "company": "Jiangxi AOV Maternity & Baby Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232477: Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232477", "people": [{"name": "Huang Xueping", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232477%22"}, {"id": "fda:K233918", "company": "Yongqing Huaguan Dental Instruments Factory", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233918: Dental Barrier and Sleeves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233918", "people": [{"name": "ZengYan Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233918%22"}, {"id": "fda:K232025", "company": "Good Sleep CO Pte , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232025: Hushd Pro Avera", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232025", "people": [{"name": "Joel Simoson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232025%22"}, {"id": "fda:K232468", "company": "Sc Medica", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232468: SC Medica FFX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232468", "people": [{"name": "Camille Srour", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232468%22"}, {"id": "fda:K240296", "company": "Profound Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240296: Tulsa Pro System (Pad-105)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240296", "people": [{"name": "Golddy Kaur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240296%22"}, {"id": "fda:K234112", "company": "Arum Dentistry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234112: Customized Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234112", "people": [{"name": "Boyeon Lim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234112%22"}, {"id": "fda:K241008", "company": "Relign Corporation, Subsidiary of Zimmer Biomet", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K241008: Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241008", "people": [{"name": "Tadakala Saikanth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K241008%22"}, {"id": "fda:K232649", "company": "Pegavision Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232649: Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232649", "people": [{"name": "Estela Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232649%22"}, {"id": "fda:K240999", "company": "Pollogen, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240999: Legend X Applicator VO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240999", "people": [{"name": "Lola Fajinmi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240999%22"}, {"id": "fda:K240964", "company": "ArthroCare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240964: FLOW 90? Wand", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240964", "people": [{"name": "Srividya Pothana", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240964%22"}, {"id": "fda:K222292", "company": "Fisher & Paykel Healthcare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222292: F&P myAirvo 3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222292", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222292%22"}, {"id": "fda:K233581", "company": "Ortho Clinical Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233581: VITROS Immunodiagnostic Products Total \u00df-hCG II Reagent Pack", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233581", "people": [{"name": "Rebecca Lewis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233581%22"}, {"id": "fda:K233803", "company": "Acclaro Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233803: UltraClear Laser System (N/A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233803", "people": [{"name": "Shlomo Assa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233803%22"}, {"id": "nih:1R41AI181135-01A1", "company": "Luna Bioscience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R41AI181135-01A1: Leptospiral VM Protein Antigen Detection for Rapid Diagnosis of Leptospirosis ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10921003", "people": [{"name": "Reetika Chaurasia", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA235915-03", "company": "Surgivance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": 1007907, "summary": "NIH award 5R44CA235915-03: Advanced Surgical Pathology Device ($1,007,907)", "source_url": "https://reporter.nih.gov/project-details/10832690", "people": [{"name": "Daniel Summer Gareau", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K234039", "company": "Lexington Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234039: AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234039", "people": [{"name": "Sali Gully", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234039%22"}, {"id": "fda:K240954", "company": "Shockwave Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240954: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240954", "people": [{"name": "Anna Bushart", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240954%22"}, {"id": "fda:K240377", "company": "Stryker Physio-Control", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240377: LIFEPAK\u00ae ECG Cables", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240377", "people": [{"name": "Craig Schultz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240377%22"}, {"id": "fda:K231612", "company": "Leo Cancer Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231612: Eve Patient Positioner System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231612", "people": [{"name": "Graham Lukey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231612%22"}, {"id": "fda:K232928", "company": "Wisdom Technologies., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232928: DeepContour (V1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232928", "people": [{"name": "Xie George Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232928%22"}, {"id": "fda:K232486", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232486: KARL STORZ Monopolar Resectoscopes with HF Cable", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232486", "people": [{"name": "Leigh Spotten", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232486%22"}, {"id": "fda:K233695", "company": "Cyberdyne, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233695: Medical HAL Lower Limb Type (HAL-ML)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233695", "people": [{"name": "Yohei Suzuki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233695%22"}, {"id": "fda:K234018", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234018: CEREC Cercon 4D\u0099 Abutment Blocks, CEREC Cercon 4D\u0099 Abutment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234018", "people": [{"name": "Rebecca Sporer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234018%22"}, {"id": "fda:K232493", "company": "Wuhan Huchuang Union Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232493: Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232493", "people": [{"name": "Yuanyuan Zhan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232493%22"}, {"id": "fda:K232833", "company": "Indica Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232833: HALO AP Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232833", "people": [{"name": "Michele Fredrickson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232833%22"}, {"id": "fda:K233766", "company": "Pollogen, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233766: Geneo X Elite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233766", "people": [{"name": "Karen Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233766%22"}, {"id": "fda:K233864", "company": "Kestra Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233864: ASSURE Wearable ECG", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233864", "people": [{"name": "Beverly Magrane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233864%22"}, {"id": "nih:5R44AI109891-07", "company": "Dxdiscovery, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-06", "observed": "2026-08-21", "amount_usd": 999716, "summary": "NIH award 5R44AI109891-07: Point-of-care lateral flow immunoassay for diagnosis of pertussis ($999,716)", "source_url": "https://reporter.nih.gov/project-details/10844386", "people": [{"name": "Amanda Burnham-Marusich", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "nih:5R42HL162214-03", "company": "Biochip Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-06", "observed": "2026-08-21", "amount_usd": 865375, "summary": "NIH award 5R42HL162214-03: Microfluidic Technology for Concurrent Assessment of Red Blood Cell Adhesion and Deformability ($865,375)", "source_url": "https://reporter.nih.gov/project-details/10835125", "people": [{"name": "Chiara Federici", "role": "Principal Investigator"}, {"name": "Umut A. Gurkan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44DA056259-02", "company": "Sonara Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-06", "observed": "2026-08-21", "amount_usd": 812322, "summary": "NIH award 2R44DA056259-02: Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care ($812,322)", "source_url": "https://reporter.nih.gov/project-details/10820879", "people": [{"name": "MICHAEL L. DENNIS", "role": "Principal Investigator"}, {"name": "Michael Giles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K232514", "company": "Mim Software, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232514: MIM \u0096 Dose Analysis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232514", "people": [{"name": "Sydney Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232514%22"}, {"id": "fda:K240007", "company": "Laborie Medical Technologies, Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240007: Solar Compact (G4-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240007", "people": [{"name": "Ingrid Dirtzu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240007%22"}, {"id": "fda:K240392", "company": "Implanet", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240392: JAZZ Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240392", "people": [{"name": "Regis Le Couedic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240392%22"}, {"id": "fda:K240685", "company": "Spine Wave, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240685: Salvo\u00ae Spine System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240685", "people": [{"name": "Ronald Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240685%22"}, {"id": "fda:K233800", "company": "Vertos Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233800: Vertos mild Device Kit (MDK-0002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233800", "people": [{"name": "Russ Alexander", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233800%22"}, {"id": "fda:K234033", "company": "Boehringer Laboratories, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234033: ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234033", "people": [{"name": "Ondrej Nikel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234033%22"}, {"id": "nih:1R43AI181303-01A1", "company": "Orlance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43AI181303-01A1: Gene Gun-delivered RNA vaccines. ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10921192", "people": [{"name": "Hannah Frizzell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD097809-05", "company": "Reia, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": 999169, "summary": "NIH award 5R44HD097809-05: Non-surgical treatment option for pelvic organ prolapse ($999,169)", "source_url": "https://reporter.nih.gov/project-details/10840333", "people": [{"name": "Paul Hanissian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44DK139913-01", "company": "Cathbuddy, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": 404988, "summary": "NIH award 1R44DK139913-01: Feasibility, Pilot, and Communication studies towards Translation of Aurie Reusable Catheter System into Clinical Practice. ($404,988)", "source_url": "https://reporter.nih.gov/project-details/10920608", "people": [{"name": "Souvik Paul", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K234088", "company": "Lactation Lab, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234088: Emily's Care Nourish Test System (Model 1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234088", "people": [{"name": "Stephanie Canale", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234088%22"}, {"id": "fda:K232941", "company": "Suzhou Endophix Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232941: Megaloop Button System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232941", "people": [{"name": "Juan Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232941%22"}, {"id": "fda:K240919", "company": "Sofregen Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240919: Silk Voice (SMI-04)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240919", "people": [{"name": "Vivian Ruan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240919%22"}, {"id": "fda:K240800", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240800: Access Intrinsic Factor Ab", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240800", "people": [{"name": "Kate Oelberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240800%22"}, {"id": "fda:K233524", "company": "Hollister Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233524: Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233524", "people": [{"name": "Michelle Schiltz-Taing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233524%22"}, {"id": "fda:K232491", "company": "Philips Healthcare (Suzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232491: CT 5300", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232491", "people": [{"name": "An Shiguang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232491%22"}, {"id": "fda:K240625", "company": "Providence Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240625: CORUS Navigation Access System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240625", "people": [{"name": "Edward Liou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240625%22"}, {"id": "fda:K240297", "company": "Us Medical Innovations, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240297: Canady Helios Cold Plasma\u0099 XL-1000CP\u0099 Ablation System (XL-1000CPSYS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240297", "people": [{"name": "Jerome Canady", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240297%22"}, {"id": "fda:K233687", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233687: ECHELON Synergy V10.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233687", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233687%22"}, {"id": "fda:K232648", "company": "Orthofix Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232648: RODEO Telescopic Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232648", "people": [{"name": "Elvira Taccarelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232648%22"}, {"id": "fda:K240126", "company": "Pro Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240126: ProAM ALIF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240126", "people": [{"name": "Blain Jason", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240126%22"}, {"id": "fda:K232776", "company": "Outset Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232776: Tablo\u00ae Hemodialysis System; TabloCart\u0099 with Prefiltration Drawer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232776", "people": [{"name": "Joshua Mink", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232776%22"}, {"id": "fda:K232895", "company": "Contec Medical Systems Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232895: B-Ultrasound Diagnostic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232895", "people": [{"name": "Xueyong Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232895%22"}, {"id": "fda:K233349", "company": "Abbott Molecular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233349: Alinity m HSV 1 & 2 / VZV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233349", "people": [{"name": "Stacy Ferguson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233349%22"}, {"id": "fda:K232416", "company": "Arkray, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232416: AUTION EYE AI-4510 Urine Particle Analysis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232416", "people": [{"name": "Shinya Nakajima", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232416%22"}, {"id": "fda:K240185", "company": "Cypris Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240185: Cypris eXact Suture Placement Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240185", "people": [{"name": "Dan Holton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240185%22"}, {"id": "fda:K232733", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232733: Mbrace Cable", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232733", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232733%22"}, {"id": "fda:K234021", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234021: Masimo Stork", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234021", "people": [{"name": "Kertana Shankar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234021%22"}, {"id": "fda:K232735", "company": "Ema Sleep Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232735: EMA 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232735", "people": [{"name": "Joseph Frantz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232735%22"}, {"id": "fda:K233157", "company": "Innovaquartz, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233157: VaporMAX LDD; MOJo LDD; MegaJOULE LDD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233157", "people": [{"name": "Stephen Griffin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233157%22"}, {"id": "fda:K232454", "company": "Alb Luz", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232454: Viral Transport Media (VTM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232454", "people": [{"name": "Ana Luiza Bueno Luz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232454%22"}, {"id": "fda:K240940", "company": "West Pharmaceutical Services, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240940: Vial2Bag Advanced\u00ae 20mm Admixture Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240940", "people": [{"name": "Fred Cowdery", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240940%22"}, {"id": "pma:P230001", "company": "Geneoscopy, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-05-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230001: ColoSense\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230001", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230001%22"}, {"id": "breakthrough:K234088", "company": "Lactation Lab, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-05-03", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K234088: EMILY'S CARE NOURISH TEST SYSTEM (MODEL 1)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P230001", "company": "Geneoscopy, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-05-03", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230001: COLOSENSE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K240261", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240261: Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240261", "people": [{"name": "James Kenny", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240261%22"}, {"id": "fda:K240636", "company": "Pixcell Medical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240636: HemoScreen Hematology Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240636", "people": [{"name": "Yaara Ben-Yosef", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240636%22"}, {"id": "fda:K240037", "company": "Bluewind Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240037: Revi\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240037", "people": [{"name": "Jason Woehrle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240037%22"}, {"id": "fda:K232445", "company": "Cardiacsense", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232445: CSF-4 (CSF-4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232445", "people": [{"name": "Benita Lanzer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232445%22"}, {"id": "fda:K232464", "company": "Freyja Healthcare, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232464: VereSee Optical Veres Needle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232464", "people": [{"name": "Ronald Adams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232464%22"}, {"id": "fda:K233857", "company": "JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233857: Neodent Implant System \u0096 Custom Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233857", "people": [{"name": "Leticia Milani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233857%22"}, {"id": "fda:K232908", "company": "Contec Medical Systems Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232908: Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232908", "people": [{"name": "Wang Donghao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232908%22"}, {"id": "fda:K240012", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240012: Mobility Scooter (W3431)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240012", "people": [{"name": "Grace Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240012%22"}, {"id": "fda:K233752", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233752: Dragonfly\u0099 Pancreaticobiliary Scope; Dragonfly\u0099 Digital Controller; Dragonfly\u0099 Instrument Channel Caps", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233752", "people": [{"name": "Conner Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233752%22"}, {"id": "fda:K232902", "company": "Palliare , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232902: EVA15 insufflator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232902", "people": [{"name": "John O'Dea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232902%22"}, {"id": "fda:K233689", "company": "Lujena, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233689: Hope&Her Vaginal Dilators", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233689", "people": [{"name": "Troy Gemmer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233689%22"}, {"id": "nih:1R43MD018229-01A1", "company": "Pediadose LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": 333630, "summary": "NIH award 1R43MD018229-01A1: Novel Mobile Application to Reduce Health Disparities by Improving Dosing Accuracy of Children's Medication ($333,630)", "source_url": "https://reporter.nih.gov/project-details/10815132", "people": [{"name": "Tuzdy Currlin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI157022-03", "company": "Cell Microsystems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": 752527, "summary": "NIH award 5R44AI157022-03: Rapid identification and selection of functional antigen-specific monoclonalantibodies by FcGR-enabled screening on CellRaft Arrays in the CellRaft AIRSystem ($752,527)", "source_url": "https://reporter.nih.gov/project-details/10843286", "people": [{"name": "Jessica Hartman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HD090811-05", "company": "Infinite Biomedical Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": 833621, "summary": "NIH award 5R44HD090811-05: Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses ($833,621)", "source_url": "https://reporter.nih.gov/project-details/10843217", "people": [{"name": "Rahul Reddy Kaliki", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R43MH135674-01A1", "company": "Empathy Rocks Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": 219212, "summary": "NIH award 1R43MH135674-01A1: Empathy for Everyone: Generative AI that Improves Patient-Provider Cultural Attunement in Real Time ($219,212)", "source_url": "https://reporter.nih.gov/project-details/10921758", "people": [{"name": "Sarah Peregrine Lord", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K234113", "company": "Medimaging Integrated Solution, Inc (Miis)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234113: MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234113", "people": [{"name": "Sandy Chou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234113%22"}, {"id": "fda:K240900", "company": "Atraverse Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240900: HOTWIRE\u0099 RF Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240900", "people": [{"name": "Charles Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240900%22"}, {"id": "fda:K233513", "company": "Remex Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233513: Remex Spine Surgery Navigation System II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233513", "people": [{"name": "Wang Cheng-Hsiung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233513%22"}, {"id": "fda:K240986", "company": "Jkh Health Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240986: Cold Compression", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240986", "people": [{"name": "Pu Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240986%22"}, {"id": "fda:K233516", "company": "Reichert, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233516: Tono-Vera\u00ae Tonometer and Ocu-Dot\u00ae Tonometer Probes (16305, 16306, 16318)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233516", "people": [{"name": "Elizabeth Schultz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233516%22"}, {"id": "fda:K233203", "company": "Collagen Matrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233203: Soft Tissue Augmentation Resorbable Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233203", "people": [{"name": "Daniel Fernandez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233203%22"}, {"id": "fda:K240925", "company": "Marizyme", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240925: DuraGraft Vascular Conduit Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240925", "people": [{"name": "Catherine Pachuk", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240925%22"}, {"id": "fda:K240882", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240882: BruxZir\u00ae Esthetic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240882", "people": [{"name": "So Hyun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240882%22"}, {"id": "fda:K240829", "company": "CenterPoint Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240829: AuST Steerable Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240829", "people": [{"name": "Johnson Conner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240829%22"}, {"id": "fda:K232858", "company": "Megabay S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232858: ORskin Blue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232858", "people": [{"name": "Oren Gabay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232858%22"}, {"id": "fda:K233284", "company": "Hangzhou Qiantang Longyue Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233284: Vial Adapter with Filter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233284", "people": [{"name": "Chunyu Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233284%22"}, {"id": "fda:K231722", "company": "Smartooth Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231722: SmarTooth", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231722", "people": [{"name": "Seohyun Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231722%22"}, {"id": "fda:K240279", "company": "bioMerieux, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240279: VIDAS TBI (GFAP, UCH-L1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240279", "people": [{"name": "Chris Goodpaster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240279%22"}, {"id": "fda:K232370", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-05-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232370: Percutaneous Nephroscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232370", "people": [{"name": "Alita McElroy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232370%22"}, {"id": "nih:5R44AI153011-04", "company": "Orlance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI153011-04: Universal Influenza A/B Vaccine ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10846562", "people": [{"name": "Kenneth C Bagley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44TR005137-01", "company": "Cellchorus Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": 350000, "summary": "NIH award 1R44TR005137-01: Integrated assays of single-cell dynamics and molecular phenotype for cell therapy manufacturing ($350,000)", "source_url": "https://reporter.nih.gov/project-details/10922484", "people": [{"name": "Rebecca L Berdeaux", "role": "Principal Investigator"}, {"name": "Laurence J.N. Cooper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA287803-01", "company": "Ne Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": 603206, "summary": "NIH award 1R44CA287803-01: Computer Guided Microwave Liver Ablation ($603,206)", "source_url": "https://reporter.nih.gov/project-details/10822701", "people": [{"name": "Andrea Borsic", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK140946-01", "company": "Hemingway Designs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": 324190, "summary": "NIH award 1R43DK140946-01: Lancet with dissolvable blade and biodegradable base ($324,190)", "source_url": "https://reporter.nih.gov/project-details/10920466", "people": [{"name": "Brian Brandell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240156", "company": "Physio-Control, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240156: LIFEPAK\u00ae Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK\u00ae Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240156", "people": [{"name": "Elisha McGaff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240156%22"}, {"id": "fda:K233403", "company": "Zeto, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233403: Flexset System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233403", "people": [{"name": "Aswin Gunasekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233403%22"}, {"id": "fda:K232923", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232923: Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232923", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232923%22"}, {"id": "fda:K240621", "company": "Biogennix, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240621: Morpheus\u00ae Moldable; Agilon\u00ae Moldable", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240621", "people": [{"name": "Laura Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240621%22"}, {"id": "fda:K232528", "company": "Neobiotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232528: Protective Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232528", "people": [{"name": "Yoeng Ku Hoe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232528%22"}, {"id": "fda:K233122", "company": "Litu Tech , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233122: High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233122", "people": [{"name": "Guangzhao Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233122%22"}, {"id": "fda:K233231", "company": "Ditron Dental, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233231: Dental Implants and Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233231", "people": [{"name": "Ariel Zuhovitzky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233231%22"}, {"id": "fda:K232889", "company": "Meticuly Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232889: METICULY Patient-specific titanium maxillofacial mesh implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232889", "people": [{"name": "Peeranoot Lohwongwatana", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232889%22"}, {"id": "fda:K240118", "company": "Smedtrum Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240118: Picosecond Nd:YAG Laser System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240118", "people": [{"name": "Crimson Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240118%22"}, {"id": "fda:K240584", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240584: XTRA Autotransfusion System (with XTRA Bowl sets)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240584", "people": [{"name": "Luigi Vecchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240584%22"}, {"id": "fda:K240568", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240568: DuraPro\u0099 Oscillating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240568", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240568%22"}, {"id": "fda:K240591", "company": "Restor3D, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240591: restor3d Kinos Axiom Total Ankle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240591", "people": [{"name": "Anika Moorjani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240591%22"}, {"id": "fda:K240102", "company": "Guangdong Transtek Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240102: Blood Pressure Monitor (TMB-2287-B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240102", "people": [{"name": "Jerry Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240102%22"}, {"id": "fda:K233699", "company": "Subtle Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233699: SubtleREFORMAT (1.x)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233699", "people": [{"name": "Ronny Elor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233699%22"}, {"id": "fda:DEN230052", "company": "Senseonics, Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230052: Eversense AP CGM System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230052", "people": [{"name": "Mukul Jain", "role": "510(k) submission contact"}]}, {"id": "fda:K240526", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240526: POWEReam Xia/Serrato", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240526", "people": [{"name": "Kelebogile Moumakwa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240526%22"}, {"id": "fda:K233939", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233939: Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233939", "people": [{"name": "Yanine Garcia-Quezada", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233939%22"}, {"id": "fda:K240062", "company": "Insight Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240062: ARVIS\u00ae Shoulder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240062", "people": [{"name": "Matthew Ryan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240062%22"}, {"id": "fda:K232511", "company": "Surgical Instrument Service and Savings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232511: Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232511", "people": [{"name": "Stephanie Boyle Mays", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232511%22"}, {"id": "fda:K240248", "company": "Classys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240248: Volnewmer\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240248", "people": [{"name": "James Hoon Lim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240248%22"}, {"id": "denovo:DEN230052", "company": "Senseonics, Incorporated", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-04-29", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230052 granted: Eversense AP CGM System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230052"}, {"id": "nih:1R43HL172367-01A1", "company": "Respair, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": 299101, "summary": "NIH award 1R43HL172367-01A1: RelianceET: a novel endotracheal tube design with a superior sealing mechanism to improve clinical efficiency and reduce lung injury and infection for patients. ($299,101)", "source_url": "https://reporter.nih.gov/project-details/10915902", "people": [{"name": "Ross Beresford", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK139811-01", "company": "Silicon Kidney, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": 256501, "summary": "NIH award 1R43DK139811-01: The intracorporeal hemodialysis system (iHemo) for eliminating the mortality health disparity of rural and remote End-stage Kidney Disease patients ($256,501)", "source_url": "https://reporter.nih.gov/project-details/10921305", "people": [{"name": "Charles Blaha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R41AG082591-01S1", "company": "Brain Thrive Technology LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R41AG082591-01S1: I-Corps - Developing of a computer-based multimodal mind and body approach for mild cognitive decline ($55,000)", "source_url": "https://reporter.nih.gov/project-details/11019479", "people": [{"name": "JIAN KONG", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI181234-01A1", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": 303250, "summary": "NIH award 1R43AI181234-01A1: Diagnostic assay for congenital Chagas disease ($303,250)", "source_url": "https://reporter.nih.gov/project-details/10921719", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44AG080843-02S1", "company": "Silverbills Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": 35000, "summary": "NIH award 3R44AG080843-02S1: SilverBills: A Legal, Technical and Financial Tool for Aging LGBTQ+ Individuals with Impaired Cognition. ($35,000)", "source_url": "https://reporter.nih.gov/project-details/10947443", "people": [{"name": "Eric Chess", "role": "Principal Investigator"}, {"name": "Marci Lobel-Esrig", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K240091", "company": "Arum Dentistry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240091: NB Mini Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240091", "people": [{"name": "Won-Yi Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240091%22"}, {"id": "fda:K232261", "company": "Osypka AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232261: TME Temporary Myocardial Electrode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232261", "people": [{"name": "Nicola Osypka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232261%22"}, {"id": "fda:K232435", "company": "Shenzhen HugeMed Medical Technical Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232435: Rhinolaryngoscope system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232435", "people": [{"name": "Cathy Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232435%22"}, {"id": "fda:K233583", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233583: FCT iSTREAM Phase 1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233583", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233583%22"}, {"id": "fda:K232317", "company": "Urit Medical Electronic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232317: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232317", "people": [{"name": "Jiang Jun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232317%22"}, {"id": "fda:K233673", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233673: uMR Jupiter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233673", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233673%22"}, {"id": "fda:K240872", "company": "Clariance", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240872: Erisma\u00ae Deformity Spinal System; Erisma\u00ae Lp Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240872", "people": [{"name": "Magalie Hennequin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240872%22"}, {"id": "fda:K240406", "company": "Sonio", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240406: Sonio Detect", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240406", "people": [{"name": "Florian Akpakpa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240406%22"}, {"id": "fda:K233703", "company": "ClearPoint Neuro, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233703: Bone Anchor (NGS-BA-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233703", "people": [{"name": "Brennan Sullivan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233703%22"}, {"id": "fda:K220272", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220272: cobas pulse blood glucose monitoring system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220272", "people": [{"name": "Teresa Carrow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220272%22"}, {"id": "fda:K240566", "company": "SeaSpine Orthopedics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240566: Reef L Interbody System; WaveForm L Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240566", "people": [{"name": "Jesse Albright", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240566%22"}, {"id": "fda:K240324", "company": "Encore Medical, L.P. (Dba Enovis)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240324: EMPOWR Revision Symmetric Knee Cones", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240324", "people": [{"name": "Trey Thorsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240324%22"}, {"id": "fda:K232298", "company": "Canon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232298: DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232298", "people": [{"name": "Shigeo Watanabe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232298%22"}, {"id": "fda:K232799", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232799: syngo.via RT Image Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232799", "people": [{"name": "Monsuru Bello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232799%22"}, {"id": "fda:K232302", "company": "Quantel Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232302: Pocket III", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232302", "people": [{"name": "Bruno Pages", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232302%22"}, {"id": "fda:K233873", "company": "Ortho Life Systems Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233873: XLO Brand of Locking Distal Humerus Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233873", "people": [{"name": "Tamandeep Kochhar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233873%22"}, {"id": "fda:K240879", "company": "Endogastric Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240879: EsophyX Z+ Device with SerosaFuse Fasteners and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240879", "people": [{"name": "Shala Famil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240879%22"}, {"id": "fda:K221688", "company": "Q-Linea AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221688: ASTar BC G- Kit and ASTar Instrument", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221688", "people": [{"name": "Jonas Melin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221688%22"}, {"id": "fda:K232038", "company": "Broncus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232038: BioStar Single Use Transbronchial Aspiration Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232038", "people": [{"name": "Charles Ogbonna", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232038%22"}, {"id": "fda:K240299", "company": "Zimmer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240299: Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240299", "people": [{"name": "Gregory Foster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240299%22"}, {"id": "pma:P230036", "company": "Abbott Medical", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-04-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230036: Esprit\u0099 BTK Everolimus Eluting Resorbable Scaffold System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230036", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230036%22"}, {"id": "breakthrough:K221688", "company": "Q-linea Ab", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-04-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K221688: ASTAR BC G- KIT AND ASTAR INSTRUMENT", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P230036", "company": "Abbott Medical", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-04-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230036: ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R44AI184015-01", "company": "Big Eye Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": 797183, "summary": "NIH award 1R44AI184015-01: Supporting WHO Lymphatic Filariasis Elimination Programs: Progressing a Highly Sensitive and Specific Rapid Diagnostic Test for Brugia Species Infection to Commercialization Readiness ($797,183)", "source_url": "https://reporter.nih.gov/project-details/10919722", "people": [{"name": "Marco Antonio Biamonte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K231142", "company": "Dws S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231142: Temporis, Irix Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231142", "people": [{"name": "Anna De Maria", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231142%22"}, {"id": "fda:K233810", "company": "Ge Medical Systems Information Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233810: Portrait VSM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233810", "people": [{"name": "Jung William", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233810%22"}, {"id": "fda:K240846", "company": "CarboFix Orthopedics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240846: CarboClear\u00ae Hybrid Pedicle Screw System; CarboClear\u00ae Hybrid Navigated Instruments; CarboClear\u00ae Hybrid Fenestrated Pedicle Screw System and High V+\u00ae Bone Cement; CarboClear\u00ae X Fenestrated Pedicle Screw System and High V+\u00ae Bone Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240846", "people": [{"name": "Hila Wachsler-Avrahami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240846%22"}, {"id": "fda:K240535", "company": "Clarus Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240535: Digital ClarusScope System; Digital NeuroPEN System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240535", "people": [{"name": "Mark Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240535%22"}, {"id": "fda:K240855", "company": "Yian Medical Technology (Haining) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240855: Dental Cone-beam Computed Tomography", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240855", "people": [{"name": "Yan Lili", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240855%22"}, {"id": "fda:K232357", "company": "Copan Italia Spa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232357: Copan Universal Transport Medium (UTM-RT) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232357", "people": [{"name": "Silvia Caprini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232357%22"}, {"id": "fda:K232331", "company": "InVision Medical Technology Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232331: InVision Precision LVEF (LVEF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232331", "people": [{"name": "David Ouyang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232331%22"}, {"id": "fda:K233308", "company": "Nakanishi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233308: Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233308", "people": [{"name": "Masaaki Kikuchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233308%22"}, {"id": "fda:K232246", "company": "M/s. Meril Endo Surgery Private Limited.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232246: 1) PINION\u0099 PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION\u0099 PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232246", "people": [{"name": "Umesh Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232246%22"}, {"id": "fda:K232405", "company": "Aktormed GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232405: ENDOFIX EXO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232405", "people": [{"name": "Hanna Kafurke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232405%22"}, {"id": "fda:K234065", "company": "Terumo Cardiovascular Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234065: CDI OneView Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234065", "people": [{"name": "Rahul Reddy Chinkeri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234065%22"}, {"id": "fda:K232805", "company": "Single Pass, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232805: Kronos Electrocautery Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232805", "people": [{"name": "Bill Colone", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232805%22"}, {"id": "fda:K232796", "company": "Huizhou Foryou Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232796: LUOFUCON\u00ae Collagen Particles (Collagen Wound Dressing)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232796", "people": [{"name": "Taylor Deng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232796%22"}, {"id": "hde:H230005", "company": "LabCorp Drug Development", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2024-04-25", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H230005: nAbCyte Anti-AAVRh74var HB-FE Assay", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "nih:1R44HL170779-01A1", "company": "Innovative Biotherapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": 1314026, "summary": "NIH award 1R44HL170779-01A1: Cell Directed Immunomodulation Therapy as a Bridge to Left Ventricular Device Implantation in Chronic Heart Failure Patients ($1,314,026)", "source_url": "https://reporter.nih.gov/project-details/10917599", "people": [{"name": "Kimberly Anne Johnston", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K240839", "company": "Openrad Services Uk, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240839: OpenRad Cloud", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240839", "people": [{"name": "Thomas Falcon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240839%22"}, {"id": "fda:K232181", "company": "Hebei JT Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232181: Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232181", "people": [{"name": "Karen Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232181%22"}, {"id": "fda:K240623", "company": "Omnia Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240623: Omnia Medical TiBrid\u0099-SA System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240623", "people": [{"name": "Troy Schifano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240623%22"}, {"id": "fda:K240850", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240850: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240850", "people": [{"name": "Michael Chambers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240850%22"}, {"id": "fda:K234025", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234025: 22.2mm BIOLOX\u00ae delta Ceramic V40\u0099 Femoral Heads", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234025", "people": [{"name": "Meenakshi Verma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234025%22"}, {"id": "fda:K240319", "company": "Pro Med Instruments GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240319: DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240319", "people": [{"name": "Rabel Talpur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240319%22"}, {"id": "fda:K240822", "company": "Philips Medical Systems Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240822: Image Management V15", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240822", "people": [{"name": "Shlomit Brandis Kepler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240822%22"}, {"id": "fda:K233172", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233172: NextAR\u0099 Spine Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233172", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233172%22"}, {"id": "fda:K233764", "company": "Fujifilm Irvine Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233764: SSS-NX (Serum Substitute Supplement-NX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233764", "people": [{"name": "Cindy Kha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233764%22"}, {"id": "fda:K240093", "company": "Shenzhen Shuge Medical Beauty Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240093: IPL Home Use Hair Removal Device (SJ15)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240093", "people": [{"name": "Shengbiao Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240093%22"}, {"id": "fda:K240208", "company": "Terrats Medical SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240208: DESS Dental Smart Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240208", "people": [{"name": "Roger Terrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240208%22"}, {"id": "fda:K234056", "company": "Canary Medical USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234056: canturio\u00ae se (Canturio Smart Extension)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234056", "people": [{"name": "Kevin Leung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234056%22"}, {"id": "nih:1R43ES036389-01", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": 295000, "summary": "NIH award 1R43ES036389-01: Integrating developmental neurotoxicity screening using automated neuro-behavioral, morphological and neuro-developmental tests in the larval zebrafish ($295,000)", "source_url": "https://reporter.nih.gov/project-details/10884749", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DC020684-02", "company": "Thrive Neuromedical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": 717782, "summary": "NIH award 5R44DC020684-02: Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants ($717,782)", "source_url": "https://reporter.nih.gov/project-details/10836568", "people": [{"name": "Dean R Koch", "role": "Principal Investigator"}, {"name": "Nathalie Maitre", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44ES031881-03S1", "company": "Lebrun Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": 17735, "summary": "NIH award 3R44ES031881-03S1: IVD EIT a Nonanimal Kit and Service for the Detection of Ocular Irritants: Phase II ($17,735)", "source_url": "https://reporter.nih.gov/project-details/11076992", "people": [{"name": "Stewart Lebrun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42HL152921-03", "company": "Inovodel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": 1478869, "summary": "NIH award 5R42HL152921-03: Chemical-based Nitric Oxide Gas-generating Drug Device for the Treatment of Pulmonary Hypertension ($1,478,869)", "source_url": "https://reporter.nih.gov/project-details/10845503", "people": [{"name": "Gary Lessing", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43GM155903-01A1", "company": "Kasa Bio, L.l.c.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": 297458, "summary": "NIH award 1R43GM155903-01A1: A multiplex platform for quantitative analysis of clinically important gene expression signatures ($297,458)", "source_url": "https://reporter.nih.gov/project-details/10920595", "people": [{"name": "Kiran Madanahally Divakar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL170886-01A1", "company": "Coalesenz Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": 295915, "summary": "NIH award 1R41HL170886-01A1: Multifunctional coagulation and platelet profiling during cardiaccirculatory support ($295,915)", "source_url": "https://reporter.nih.gov/project-details/10922390", "people": [{"name": "Seemantini K Nadkarni", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HL142491-02A1", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": 965910, "summary": "NIH award 2R44HL142491-02A1: A Novel, Low-Cost Mobile Metabolic Measurement (M3) System ($965,910)", "source_url": "https://reporter.nih.gov/project-details/10920938", "people": [{"name": "Brian R Clark", "role": "Principal Investigator"}, {"name": "B EUGENE PARKER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K233948", "company": "Provisio Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233948: Provisio\u0099 SLT IVUS\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233948", "people": [{"name": "Robert Ashley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233948%22"}, {"id": "fda:K240816", "company": "Asclepion Laser Technologies GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240816: MeDioStar", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240816", "people": [{"name": "Tom Gruender", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240816%22"}, {"id": "fda:K222958", "company": "Sciton, Inc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222958: mJOULE RF System and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222958", "people": [{"name": "Jay Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222958%22"}, {"id": "fda:K234107", "company": "Laborie Medical Technologies, Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234107: Solar\u0099 Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234107", "people": [{"name": "Arpit Sisodiya", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234107%22"}, {"id": "fda:K233329", "company": "Route 92 Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233329: Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233329", "people": [{"name": "Kirsten Valley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233329%22"}, {"id": "fda:K231699", "company": "In2bones Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231699: QUANTUM\u00ae Patient Specific Instrumentation (PSI) System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231699", "people": [{"name": "Stephan Epinette", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231699%22"}, {"id": "fda:K233849", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233849: BTL-499", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233849", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233849%22"}, {"id": "fda:K240058", "company": "Aeye Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240058: AEYE-DS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240058", "people": [{"name": "Zack Dvey-Aharon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240058%22"}, {"id": "fda:K240902", "company": "Dexcom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240902: Dexcom G7 Continuous Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240902", "people": [{"name": "Neeta Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240902%22"}, {"id": "fda:K234147", "company": "Microline Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234147: ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234147", "people": [{"name": "Scott Marchand Davis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234147%22"}, {"id": "fda:K233537", "company": "Abbott Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233537: FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233537", "people": [{"name": "Sapna Ghelani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233537%22"}, {"id": "fda:K240518", "company": "Emblation Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240518: swiftPro\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240518", "people": [{"name": "Mairi MacFadyen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240518%22"}, {"id": "nih:4R44DA057122-02", "company": "Evidence-based Practice Institute, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": 1312919, "summary": "NIH award 4R44DA057122-02: iKinnect Mobile Technology to Reduce Teen Substance Misuse and Health Disparities ($1,312,919)", "source_url": "https://reporter.nih.gov/project-details/11074149", "people": [{"name": "Linda A Dimeff", "role": "Principal Investigator"}, {"name": "Cindy M. Schaeffer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44NS125892-02A1", "company": "Axonova Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": 766451, "summary": "NIH award 2R44NS125892-02A1: Development of Tissue Engineered Neuromuscular Interfaces from GalSafe Neurons ($766,451)", "source_url": "https://reporter.nih.gov/project-details/10922127", "people": [{"name": "Kritika Katiyar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44HL167428-02S1", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": 122700, "summary": "NIH award 3R44HL167428-02S1: Minimally Invasive High Intensity Therapeutic Ultrasound for the Treatment of Obstructive Hypertrophic Cardiomyopathy ($122,700)", "source_url": "https://reporter.nih.gov/project-details/11063380", "people": [{"name": "Howard Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K232319", "company": "Ug Global Resources Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232319: Black Pearl Nitrile Examination Glove", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232319", "people": [{"name": "Lee Mei Ling", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232319%22"}, {"id": "fda:K240182", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240182: Access EPO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240182", "people": [{"name": "Kate Oelberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240182%22"}, {"id": "fda:K240115", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240115: Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240115", "people": [{"name": "Tang Jing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240115%22"}, {"id": "fda:K233582", "company": "Ischemaview, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233582: Rapid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233582", "people": [{"name": "Dr. Subok Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233582%22"}, {"id": "fda:K234041", "company": "Andon Health Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234041: Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234041", "people": [{"name": "Yi Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234041%22"}, {"id": "fda:K234068", "company": "Therapanacea Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234068: ART-Plan (v.2.2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234068", "people": [{"name": "Bhairavi Ajachandra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234068%22"}, {"id": "fda:K233966", "company": "4Web Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233966: Anterior Spine Truss System-Stand Alone (ASTS-SA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233966", "people": [{"name": "Richard Jansen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233966%22"}, {"id": "fda:K233311", "company": "Acumed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233311: Acumed Wrist Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233311", "people": [{"name": "Anusha Gedala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233311%22"}, {"id": "fda:K223515", "company": "Curio Digital Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223515: MamaLift Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223515", "people": [{"name": "Sidhartha Shankar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223515%22"}, {"id": "fda:K232149", "company": "Sail Fusion, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232149: BowTie\u0099 SI Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232149", "people": [{"name": "Benjamin Arnold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232149%22"}, {"id": "nih:5R44ES031881-03", "company": "Lebrun Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": 913819, "summary": "NIH award 5R44ES031881-03: IVD EIT a Nonanimal Kit and Service for the Detection of Ocular Irritants: Phase II ($913,819)", "source_url": "https://reporter.nih.gov/project-details/10839465", "people": [{"name": "Stewart Lebrun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL167428-02", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": 941991, "summary": "NIH award 5R44HL167428-02: Minimally Invasive High Intensity Therapeutic Ultrasound for the Treatment of Obstructive Hypertrophic Cardiomyopathy ($941,991)", "source_url": "https://reporter.nih.gov/project-details/10834827", "people": [{"name": "Howard Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K230120", "company": "Beijing Keyi Medical Device Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230120: KeYi Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230120", "people": [{"name": "Jenny Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230120%22"}, {"id": "fda:K232259", "company": "Spinal Simplicity, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232259: Patriot-SI Posterior Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232259", "people": [{"name": "Adam Rogers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232259%22"}, {"id": "fda:K232962", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232962: Patient Monitor (iX10, iX12, iX15)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232962", "people": [{"name": "Tracy Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232962%22"}, {"id": "fda:K233106", "company": "Bard Access Systems, Inc. (C.R. Bard, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233106: AccuCath Ace\u0099 Intravascular Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233106", "people": [{"name": "Samira Saeed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233106%22"}, {"id": "fda:K233737", "company": "Ulrich GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233737: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233737", "people": [{"name": "Sven Erdmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233737%22"}, {"id": "fda:K232105", "company": "Medartis AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232105: APTUS Foot System 2.8-3.5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232105", "people": [{"name": "Claudia De Santis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232105%22"}, {"id": "fda:K234092", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234092: SafeOp 3: Neural Informatix Systeem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234092", "people": [{"name": "Unnati Bhuptani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234092%22"}, {"id": "fda:K240378", "company": "Foreo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240378: FAQ\u0099 201, FAQ\u0099 202", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240378", "people": [{"name": "Evan Feldstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240378%22"}, {"id": "fda:K233046", "company": "Oriental Inspiration Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233046: Electrical Neuromuscular Stimulator, Cure Trio", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233046", "people": [{"name": "Francis Ko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233046%22"}, {"id": "fda:K240508", "company": "Laclede, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240508: Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240508", "people": [{"name": "Stephen Pellico", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240508%22"}, {"id": "fda:K232377", "company": "Healgen Scientific,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232377: Healgen Rapid COVID-19 Antigen Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232377", "people": [{"name": "Jinjie Hu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232377%22"}, {"id": "fda:K240781", "company": "Iterative Scopes, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240781: SKOUT\u00ae system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240781", "people": [{"name": "Caitlyn Seidl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240781%22"}, {"id": "fda:K240162", "company": "Stryker Physio-Control", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240162: LIFEPAK\u00ae 35 AC Power Adapter (41335-000001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240162", "people": [{"name": "Roshonda Knight", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240162%22"}, {"id": "fda:K234073", "company": "Expanse Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234073: ICE Aspiration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234073", "people": [{"name": "Shiva Ardakani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234073%22"}, {"id": "fda:K233373", "company": "ACON Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233373: Flowflex\u00ae Plus COVID-19 Home Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233373", "people": [{"name": "Qiyi Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233373%22"}, {"id": "fda:K234119", "company": "Innosys Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234119: UniSpace\u00ae Stand-Alone C Cage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234119", "people": [{"name": "Chae-Hyeon Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234119%22"}, {"id": "fda:K232204", "company": "Fettech", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232204: ReyaGel (RG03 - MTP gel 3mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232204", "people": [{"name": "Clay Fette", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232204%22"}, {"id": "fda:K232566", "company": "SeaSpine Orthopedics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232566: NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232566", "people": [{"name": "Jacki Koch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232566%22"}, {"id": "fda:K240534", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240534: Bio-Medicus Life Support Catheter and Introducer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240534", "people": [{"name": "Anna Wetherille", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240534%22"}, {"id": "fda:K232216", "company": "Incore Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232216: Hemoblock_S (Prescription); Hemoblock_S (OTC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232216", "people": [{"name": "Jae-Hun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232216%22"}, {"id": "fda:K240753", "company": "Reprise Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240753: Miro3D Fibers Wound Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240753", "people": [{"name": "Erin Badali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240753%22"}, {"id": "nih:1R43GM154546-01", "company": "Megadalton Solutions, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": 294200, "summary": "NIH award 1R43GM154546-01: Multi-detector Array CD-MS for Rapid Analysis of Very High Mass Analytes ($294,200)", "source_url": "https://reporter.nih.gov/project-details/10921092", "people": [{"name": "Benjamin E Draper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44HL147734-03S1", "company": "Retham Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": 49399, "summary": "NIH award 3R44HL147734-03S1: An in vitro diagnostic assay for the early and accurate detection of platelet-activating antibodies associated with Heparin-induced Thrombocytopenia ($49,399)", "source_url": "https://reporter.nih.gov/project-details/11055939", "people": [{"name": "Curtis Jones", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44AI141283-04", "company": "Prothera Biologics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": 987396, "summary": "NIH award 2R44AI141283-04: Rapid Test to Assist Therapy in Neonatal Sepsis and Necrotizing Enterocolitis ($987,396)", "source_url": "https://reporter.nih.gov/project-details/10921282", "people": [{"name": "YOW-PIN LIM", "role": "Principal Investigator"}, {"name": "James F Padbury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43NS135645-01", "company": "Patchclamp Medtech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": 499956, "summary": "NIH award 1R43NS135645-01: Novel device for the repair and sealing of dural perforations in minimally invasive surgery ($499,956)", "source_url": "https://reporter.nih.gov/project-details/10818254", "people": [{"name": "Marc Robert Mayberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K230233", "company": "Deroyal Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230233: Prospera Spectruum Negative Pressure Wound Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230233", "people": [{"name": "Mary Catherine Reeves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230233%22"}, {"id": "fda:K240046", "company": "Microport Orthopedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240046: Ethylene Oxide Sterilization Supplier Change for MPO Hips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240046", "people": [{"name": "Sam Robertson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240046%22"}, {"id": "fda:K232627", "company": "Augustine Temperature Management, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232627: HotDog Warming Mattress + Return Electrode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232627", "people": [{"name": "Garrett Augustine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232627%22"}, {"id": "fda:K232325", "company": "Ray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232325: RAYSCAN a-Expert", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232325", "people": [{"name": "Sooji Huh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232325%22"}, {"id": "fda:K233924", "company": "Neuravi Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233924: EMBOGUARD Balloon Guide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233924", "people": [{"name": "Niall Fox", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233924%22"}, {"id": "fda:K240258", "company": "Makrite Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240258: Disposable Medical Face Mask (M643BE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240258", "people": [{"name": "Bob Wen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240258%22"}, {"id": "fda:K240155", "company": "Cochlear Americas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240155: Cochlear Osia System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240155", "people": [{"name": "Whitney Alexander", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240155%22"}, {"id": "fda:K233850", "company": "Fissiontech, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233850: Difiney Anti Snoring Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233850", "people": [{"name": "Mike Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233850%22"}, {"id": "fda:K240085", "company": "Zygofix , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240085: zLOCK Lumbar Facet Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240085", "people": [{"name": "Ofer Levy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240085%22"}, {"id": "fda:K234098", "company": "Yongkang Yile Vehicle Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234098: Mobility Scooter (C4+)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234098", "people": [{"name": "David Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234098%22"}, {"id": "nih:5R44DA051257-04", "company": "Ayuda Medical", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-17", "observed": "2026-08-21", "amount_usd": 674604, "summary": "NIH award 5R44DA051257-04: A Naloxone Parachute: Novel Wearable Dual-Sensor Regional Oximeter to Detect Opioid-Induced Hypoxia and Enable Emergent Naloxone Rescue ($674,604)", "source_url": "https://reporter.nih.gov/project-details/10829428", "people": [{"name": "Desislava Zlatanova Hite", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K240519", "company": "Innova Vision, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240519: Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240519", "people": [{"name": "Celine Hsu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240519%22"}, {"id": "fda:K240039", "company": "Hangzhou Primecare Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240039: Enteral Feeding Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240039", "people": [{"name": "Li Xuedong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240039%22"}, {"id": "fda:K240484", "company": "Mikron Makina Sanayi VE Ticaret Ltd. Sti.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240484: MSFX Mikron Cervical Anterior Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240484", "people": [{"name": "Mustafa Ekiz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240484%22"}, {"id": "fda:K232238", "company": "Dimedikorea", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232238: Goyo Mouthpiece S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232238", "people": [{"name": "DongHun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232238%22"}, {"id": "fda:K231646", "company": "Carilex Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231646: Carilex VT\u00bf200-i NX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231646", "people": [{"name": "Pauline Su", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231646%22"}, {"id": "fda:K233863", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233863: TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233863", "people": [{"name": "David Anderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233863%22"}, {"id": "fda:K240032", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240032: Celerity Chemical Indicator for enspire 3000 CLCSPS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240032", "people": [{"name": "Gregory Land", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240032%22"}, {"id": "fda:K240057", "company": "Sentinel Medical Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240057: TraumaGuard Intra-abdominal Pressure Sensing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240057", "people": [{"name": "Robert Mueller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240057%22"}, {"id": "fda:K233186", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233186: uOmnispace.MR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233186", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233186%22"}, {"id": "pma:P230014", "company": "Lumicell, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-04-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230014: Lumicell Direct Visualization System (DVS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230014", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230014%22"}, {"id": "breakthrough:P230014", "company": "Lumicell, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-04-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230014: LUMICELL DIRECT VISUALIZATION SYSTEM (DVS)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K232208", "company": "Sectra AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232208: Sectra Digital Pathology Module (Version 3.3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232208", "people": [{"name": "Edoardo Mastrovito", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232208%22"}, {"id": "fda:K232202", "company": "Leica Biosystems Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232202: Aperio GT 450 DX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232202", "people": [{"name": "April Komplin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232202%22"}, {"id": "fda:K233886", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233886: Ambu\u00ae aScope\u0099 Duodeno 2, Ambu\u00ae aBox\u0099 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233886", "people": [{"name": "Mette Andersen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233886%22"}, {"id": "fda:K233962", "company": "Lightfective , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233962: ReBorn (1050nm)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233962", "people": [{"name": "Tsvi Bahat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233962%22"}, {"id": "fda:K232256", "company": "Camber Spine Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232256: Alcantara Thoracolumbar Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232256", "people": [{"name": "Brooks McAdam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232256%22"}, {"id": "fda:K232133", "company": "Cpmt Laser (Canadian Pioneer Medical Technology Corporation)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232133: Co2 Laser System, Models: PureLase And VanLase", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232133", "people": [{"name": "Rashid Reza Mir Sayah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232133%22"}, {"id": "fda:K240748", "company": "Sfm Medical Devices GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240748: nextaro\u00ae v, 20/20", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240748", "people": [{"name": "Olaf Broemsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240748%22"}, {"id": "nih:3R44DE031461-03S2", "company": "Pediametrix Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44DE031461-03S2: Mobile Three-Dimensional Screening for Cranial Malformations ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10946856", "people": [{"name": "Fereshteh Aalamifar", "role": "Principal Investigator"}, {"name": "Reza Seifabadi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL174201-01", "company": "3dt Holdings, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": 497401, "summary": "NIH award 1R43HL174201-01: Low Profile Transcatheter Aortic Valve Implant ($497,401)", "source_url": "https://reporter.nih.gov/project-details/10917693", "people": [{"name": "Xiaomei Guo", "role": "Principal Investigator"}, {"name": "GHASSAN S KASSAB", "role": "Principal Investigator"}, {"name": "Gregory S Kelley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43AI174499-01A1S1", "company": "Truly Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43AI174499-01A1S1: Enabling standardized point-of-care tuberculosis diagnostics via rapid osmotic concentration ($55,000)", "source_url": "https://reporter.nih.gov/project-details/11020860", "people": [{"name": "James Lai", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44ES036065-01", "company": "Lebrun Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": 238257, "summary": "NIH award 1R44ES036065-01: An In Chemico Test to Identify Dermal Corrosives ($238,257)", "source_url": "https://reporter.nih.gov/project-details/10822593", "people": [{"name": "Stewart Lebrun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44ES032369-02A1", "company": "Zebra Analytix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": 919218, "summary": "NIH award 2R44ES032369-02A1: Autonomous Monitor for Toxic Gas Exposure ($919,218)", "source_url": "https://reporter.nih.gov/project-details/10821774", "people": [{"name": "John Anthony Michalek", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41HL174307-01", "company": "Pericor, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": 295922, "summary": "NIH award 1R41HL174307-01: PeriScope: A Novel Videoscope and Toolkit to Enable Fluoro-free Pericardial Access for Epicardial Ablation ($295,922)", "source_url": "https://reporter.nih.gov/project-details/10920941", "people": [{"name": "CHARLES I BERUL", "role": "Principal Investigator"}, {"name": "Rohan Kumthekar", "role": "Principal Investigator"}, {"name": "Justin Opfermann", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240205", "company": "Veol Medical Technologies Pvt , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240205: Ez Catch Auto; Ez Catch YR; Ez Catch TR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240205", "people": [{"name": "Sneha Pandit", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240205%22"}, {"id": "fda:K240773", "company": "Techsomed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240773: VisAble.IO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240773", "people": [{"name": "Dalia Dickman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240773%22"}, {"id": "fda:K240884", "company": "Infinite Biomedical Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240884: Glide (91000-GL-X)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240884", "people": [{"name": "Damini Agarwal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240884%22"}, {"id": "fda:K232904", "company": "Beckman Coulter", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232904: Access Ostase", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232904", "people": [{"name": "Kate Oelberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232904%22"}, {"id": "fda:K223113", "company": "Medentika GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223113: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223113", "people": [{"name": "Alexandra Schulz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223113%22"}, {"id": "fda:K232926", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232926: Novalung ultimate kit (US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232926", "people": [{"name": "Amelia Huynh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232926%22"}, {"id": "fda:K233411", "company": "Coloplast Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233411: Folysil Silicone Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233411", "people": [{"name": "Brian Schmidt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233411%22"}, {"id": "fda:K232175", "company": "Beijing Chunlizhengda Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232175: XN Knee Prosthesis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232175", "people": [{"name": "Xie Fengbao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232175%22"}, {"id": "nih:5R44AI177245-02", "company": "Zeteo Tech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": 944850, "summary": "NIH award 5R44AI177245-02: Noninvasive Diagnostic Markers of Lower Respiratory Tract Infection in Mechanically Ventilated Patients ($944,850)", "source_url": "https://reporter.nih.gov/project-details/10834252", "people": [{"name": "Dapeng Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K232489", "company": "Linatech, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232489: VenusX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232489", "people": [{"name": "Jonathan Yao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232489%22"}, {"id": "fda:K240686", "company": "Healgen Scientific,, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240686: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240686", "people": [{"name": "Jianqiu Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240686%22"}, {"id": "fda:K240418", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240418: Stryker Orthopaedics Hip Systems Labeling Update", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240418", "people": [{"name": "Julia Bally", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240418%22"}, {"id": "fda:K232608", "company": "Medela, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232608: Duo Hands-free Breast Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232608", "people": [{"name": "Jenni Vescovo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232608%22"}, {"id": "fda:K240703", "company": "Bodycad Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240703: Fine Osteotomy\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240703", "people": [{"name": "Nadine Adia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240703%22"}, {"id": "fda:K233624", "company": "Hangzhou Aichek Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233624: HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233624", "people": [{"name": "Lisa Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233624%22"}, {"id": "fda:K222766", "company": "Shandong Ande Healthcare Apparatus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222766: Disposable Extension Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222766", "people": [{"name": "Xiaolei Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222766%22"}, {"id": "fda:K240238", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240238: Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240238", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240238%22"}, {"id": "fda:K232060", "company": "Tosama, D.O.O.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232060: TOSAMA Reusable Applicator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232060", "people": [{"name": "Janez Obreza", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232060%22"}, {"id": "fda:K240452", "company": "Microport Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240452: Ceramic Femoral Head", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240452", "people": [{"name": "Hunter Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240452%22"}, {"id": "fda:K232164", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232164: Access NT-proBNP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232164", "people": [{"name": "Rachel Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232164%22"}, {"id": "fda:K240571", "company": "Fujifilm Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240571: OASIS MRI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240571", "people": [{"name": "David Loeser", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240571%22"}, {"id": "fda:K233034", "company": "Rockfield Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233034: Mobility+ Enteral Feeding System OTC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233034", "people": [{"name": "Orla Connaughton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233034%22"}, {"id": "fda:K240419", "company": "Boston Micro Fabrication", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240419: UltraThineer Zirconia Slurry (5Y-B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240419", "people": [{"name": "John Kawola", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240419%22"}, {"id": "fda:K232200", "company": "Ningbo Xinwell Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232200: Disposable Injection Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232200", "people": [{"name": "Lei Xi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232200%22"}, {"id": "fda:K240109", "company": "Zhuzhou Goldenhot Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240109: Medical electronic thermometer (FC01, FC02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240109", "people": [{"name": "Xianwu Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240109%22"}, {"id": "fda:K232587", "company": "Shenzhen New Industries Biomedical Engineering Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232587: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232587", "people": [{"name": "Xiaoli Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232587%22"}, {"id": "nih:3R44HL140669-05S1", "company": "Volumetrix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-11", "observed": "2026-08-21", "amount_usd": 175700, "summary": "NIH award 3R44HL140669-05S1: Non-Invasive Venous Waveform Analysis (NIVA) in patients with Heart Failure (HF) ($175,700)", "source_url": "https://reporter.nih.gov/project-details/11001052", "people": [{"name": "Kyle Mitchell Hocking", "role": "Principal Investigator"}, {"name": "JOANN LINDENFELD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "fda:K233698", "company": "Ge Healthcare Japan Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233698: True Enhance DL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233698", "people": [{"name": "Laura Turner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233698%22"}, {"id": "fda:K202531", "company": "Azer Scientific, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K202531: Azer Scientific Universal Transport Medium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202531", "people": [{"name": "Autumn N. Tellup", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K202531%22"}, {"id": "fda:K232999", "company": "Sonova AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232999: Lyric4 Hearing Aid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232999", "people": [{"name": "Kateryna Konovalenko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232999%22"}, {"id": "fda:K233757", "company": "Rhein Laser Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233757: TitanPico Laser Workstation (PICO-450)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233757", "people": [{"name": "Na Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233757%22"}, {"id": "fda:K221847", "company": "Newton Implant Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221847: Ni2 Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221847", "people": [{"name": "Pedro Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221847%22"}, {"id": "fda:K240720", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240720: TiLink-P SI Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240720", "people": [{"name": "Guilherme Pires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240720%22"}, {"id": "fda:K240719", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240719: OC JuggerKnot Soft Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240719", "people": [{"name": "Becca DeFrancia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240719%22"}, {"id": "nih:1R41MD018220-01", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": 275661, "summary": "NIH award 1R41MD018220-01: Improving Access and Automating Fitting for Hearing Aid Devices for the Underserved and Rural Populations ($275,661)", "source_url": "https://reporter.nih.gov/project-details/10599811", "people": [{"name": "Allalaghatta Pavan", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240744", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240744: uMR 680", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240744", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240744%22"}, {"id": "fda:K240760", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240760: CELERITY HP Indicator Tape", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240760", "people": [{"name": "Anthony Piotrkowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240760%22"}, {"id": "fda:K233313", "company": "Lapsi Health Holding B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233313: Keikku Electronic stethoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233313", "people": [{"name": "Koskinen Katja", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233313%22"}, {"id": "fda:K233789", "company": "Surnic Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233789: 8Q10 Surclear Smoke Plume Evacuation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233789", "people": [{"name": "Helen Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233789%22"}, {"id": "fda:K233509", "company": "Zavation Medical Products, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233509: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233509", "people": [{"name": "Colby Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233509%22"}, {"id": "fda:K240654", "company": "Safecare Biotech (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240654: SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240654", "people": [{"name": "Alex Qiu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240654%22"}, {"id": "fda:K232409", "company": "Shanghai Apolo Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232409: Electromagnetic Stimulation Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232409", "people": [{"name": "Felix Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232409%22"}, {"id": "fda:K232641", "company": "Everrtech Software Pvt, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232641: Neorad Pacs (Neorad Pacs)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232641", "people": [{"name": "Josh Baker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232641%22"}, {"id": "fda:K233561", "company": "Topcon Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233561: 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233561", "people": [{"name": "Ryota Kitawaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233561%22"}, {"id": "fda:K240089", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240089: Face Patches (MT-12MA, MT-12MC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240089", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240089%22"}, {"id": "fda:K234057", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234057: NIRVANA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234057", "people": [{"name": "Paolo Peruzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234057%22"}, {"id": "fda:K232523", "company": "Mankind Pharma Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232523: Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232523", "people": [{"name": "Rajender Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232523%22"}, {"id": "nih:3R43AI177051-01S1", "company": "Acatechol, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-09", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43AI177051-01S1: Hybrid repellant-antimicrobial gemini coatings for prevention of catheter-associated bloodstream infections ($55,000)", "source_url": "https://reporter.nih.gov/project-details/11010890", "people": [{"name": "Kollbe Ahn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K232599", "company": "Genesee Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232599: TransForm McCarthy Mitral Annuloplasty Ring (TF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232599", "people": [{"name": "Woodrow Mathison", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232599%22"}, {"id": "fda:K233999", "company": "Tepha, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233999: GalaFLEX LITE Scaffold", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233999", "people": [{"name": "Rajagopalan Prithi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233999%22"}, {"id": "fda:K232623", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232623: Universal Endometrial Applicator Set (GM11009840)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232623", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232623%22"}, {"id": "fda:K233263", "company": "Hangzhou Kangji Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233263: Disposable Trocars", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233263", "people": [{"name": "Martin Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233263%22"}, {"id": "fda:K232147", "company": "Pie Medical Imaging BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232147: CAAS Workstation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232147", "people": [{"name": "Annemiek Bouts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232147%22"}, {"id": "fda:DEN230023", "company": "16 Bit, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230023: Rho", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230023", "people": [{"name": "Dr. Catriona Syme", "role": "510(k) submission contact"}]}, {"id": "denovo:DEN230023", "company": "16 Bit, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-04-09", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230023 granted: Rho", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230023"}, {"id": "breakthrough:DEN230023", "company": "16 Bit, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-04-09", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN230023: RHO", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R44MH135605-01", "company": "Ksana Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-08", "observed": "2026-08-21", "amount_usd": 295504, "summary": "NIH award 1R44MH135605-01: BRITE 2.0: A just-in-time adaptive intervention for suicide safety planning in adolescents ($295,504)", "source_url": "https://reporter.nih.gov/project-details/10827766", "people": [{"name": "NICHOLAS B ALLEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL140669-05", "company": "Volumetrix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-08", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44HL140669-05: Non-Invasive Venous Waveform Analysis (NIVA) in patients with Heart Failure (HF) ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10798142", "people": [{"name": "Kyle Mitchell Hocking", "role": "Principal Investigator"}, {"name": "JOANN LINDENFELD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:4R44DA056316-02", "company": "Axcend, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-08", "observed": "2026-08-21", "amount_usd": 801971, "summary": "NIH award 4R44DA056316-02: Compact Liquid Chromatography for Routine Screening in Drug Treatment Centers ($801,971)", "source_url": "https://reporter.nih.gov/project-details/11019610", "people": [{"name": "MILTON L. LEE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44NR021119-03A1", "company": "Handl Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-08", "observed": "2026-08-21", "amount_usd": 1185981, "summary": "NIH award 2R44NR021119-03A1: A mobile application to offer upfront healthcare prices and automated medical billing for socioeconomically disadvantaged Americans ($1,185,981)", "source_url": "https://reporter.nih.gov/project-details/10761476", "people": [{"name": "Ahmed Marmoush", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K240291", "company": "Ever Fortune.Ai, Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240291: EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240291", "people": [{"name": "Joseph Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240291%22"}, {"id": "fda:K231728", "company": "Abmrc, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231728: BiWaze Clear System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231728", "people": [{"name": "Leah Noaeill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231728%22"}, {"id": "fda:K212878", "company": "Zhejiang Gene Science Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K212878: Sample preservation solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212878", "people": [{"name": "Zhang Feng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K212878%22"}, {"id": "fda:K240423", "company": "Tdm Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240423: TDM Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240423", "people": [{"name": "Choi Jung Wook", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240423%22"}, {"id": "fda:K240021", "company": "Yue Kang Anhui Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240021: Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240021", "people": [{"name": "Amy Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240021%22"}, {"id": "nih:5R44AI149903-04", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI149903-04: Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10840985", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K233249", "company": "The Surgeon General, Department of the Army (TSG-DA)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233249: APPRAISE-HRI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233249", "people": [{"name": "Emily Badraslionglu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233249%22"}, {"id": "fda:K233935", "company": "Park Dental Research Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233935: DigiLine Direct Print Aligner System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233935", "people": [{"name": "Logan Simmons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233935%22"}, {"id": "fda:K232823", "company": "Amcg Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232823: MCG-S (AM1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232823", "people": [{"name": "Soyeon Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232823%22"}, {"id": "fda:DEN210058", "company": "Onkos Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN210058: ELEOSx\u0099 Limb Salvage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN210058", "people": [{"name": "Matthew (Matt) Vernak", "role": "510(k) submission contact"}]}, {"id": "fda:K233779", "company": "MacroLux Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233779: LoopView\u00ae Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub\u00ae Video Processor (S13)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233779", "people": [{"name": "Linbin Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233779%22"}, {"id": "fda:K233666", "company": "Analytics For Life, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233666: CorVista System with PH Add-On", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233666", "people": [{"name": "Gabrielle Zaeska", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233666%22"}, {"id": "fda:K223914", "company": "Cleansite Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223914: ACTIV\u0099 Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223914", "people": [{"name": "Neal Hartman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223914%22"}, {"id": "fda:K233192", "company": "Famidoc Technology Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233192: Wireless Smart Thermometer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233192", "people": [{"name": "Amos Zou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233192%22"}, {"id": "fda:K232103", "company": "Terragene S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232103: Terragene\u00ae Chemdye\u00ae Multivariable Chemical Indicator (CD40), Terragene\u00ae Chemdye\u00ae Chemical Process Indicator (CD42), Terragene\u00ae Cintape\u00ae Chemical Process Indicator Tape (CT40)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232103", "people": [{"name": "Hernando Carrizo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232103%22"}, {"id": "fda:DEN230032", "company": "Mmi North America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230032: Symani Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230032", "people": [{"name": "Mauro Ercolani", "role": "510(k) submission contact"}]}, {"id": "fda:K232115", "company": "Tdm Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232115: TDM Large Bone Plate and Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232115", "people": [{"name": "Dave Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232115%22"}, {"id": "fda:DEN220015", "company": "Orthobond Coporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN220015: Orthobond Mariner Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220015", "people": [{"name": "David Nichols", "role": "510(k) submission contact"}]}, {"id": "fda:K234152", "company": "Aceso Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234152: ACESO Early Pregnancy Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234152", "people": [{"name": "Yinfei Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234152%22"}, {"id": "fda:K240360", "company": "Shenzhen Qianyu Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240360: Wrinkle Treatment Device (JM2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240360", "people": [{"name": "Guoyang Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240360%22"}, {"id": "fda:K232792", "company": "Icotec AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232792: icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn\u0099 TLIF Lumbar Cage)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232792", "people": [{"name": "Marina Hess", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232792%22"}, {"id": "fda:K232919", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232919: Ambu\u00ae aScope\u0099 Gastro Large; Ambu\u00ae aBox\u0099 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232919", "people": [{"name": "Mette Andersen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232919%22"}, {"id": "fda:K234105", "company": "Catalyst Orthoscience, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234105: Catalyst F1x Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234105", "people": [{"name": "Dale Davison", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234105%22"}, {"id": "fda:K240737", "company": "G Surgical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240737: G Surgical Marksman MIS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240737", "people": [{"name": "Don Grafton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240737%22"}, {"id": "fda:K240647", "company": "Zimvie Spine (Zimmer Biomet Spine, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240647: Virage\u00ae Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240647", "people": [{"name": "Regan Ream", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240647%22"}, {"id": "denovo:DEN230032", "company": "Mmi North America, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-04-05", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230032 granted: Symani Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230032"}, {"id": "denovo:DEN210058", "company": "Onkos Surgical", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-04-05", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210058 granted: ELEOSx\u2122 Limb Salvage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210058"}, {"id": "denovo:DEN220015", "company": "Orthobond Coporation", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-04-05", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220015 granted: Orthobond Mariner Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220015"}, {"id": "breakthrough:K233666", "company": "Analytics For Life, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-04-05", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K233666: CORVISTA SYSTEM WITH PH ADD-ON", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K232792", "company": "Icotec Ag", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-04-05", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K232792: ICOTEC INTERBODY CAGE SYSTEM (ICOTEC CERVICAL CAGE, ICOTEC PLIF LUMBAR CAGE, ICOTEC ETURN TLIF LUMBAR CAGE)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K240639", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240639: PINNACLETM Constrained Acetabular Liners", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240639", "people": [{"name": "Jennifer Hill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240639%22"}, {"id": "fda:K232037", "company": "Innovative Health, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232037: Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232037", "people": [{"name": "Rick Ferreira", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232037%22"}, {"id": "fda:K233026", "company": "Midmark Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233026: Midmark Smart M9\u00ae Sterilizer, Midmark Smart M11\u00ae Sterilizer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233026", "people": [{"name": "Adam Clutter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233026%22"}, {"id": "fda:K232227", "company": "Neuwave Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232227: ABLATE-IQ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232227", "people": [{"name": "Allison Francis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232227%22"}, {"id": "fda:K232790", "company": "Icotec AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232790: KONG\u00ae-TL VBR System and KONG\u00ae C VBR System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232790", "people": [{"name": "Marina Hess", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232790%22"}, {"id": "fda:K240038", "company": "Space Maintainers Laboratories (Sml)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240038: Clear Moves Aligners", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240038", "people": [{"name": "Scott Veis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240038%22"}, {"id": "fda:K240652", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240652: Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240652", "people": [{"name": "Blue Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240652%22"}, {"id": "fda:K240172", "company": "Genesis Software Innovations", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240172: Preview Shoulder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240172", "people": [{"name": "Matt Miller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240172%22"}, {"id": "fda:K232114", "company": "Kyocera Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232114: TRIBRID\u00ae Unicompartmental Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232114", "people": [{"name": "Jason Lansdown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232114%22"}, {"id": "fda:K240071", "company": "Peleton Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240071: Peleton Universal Single Use Power System and Attachments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240071", "people": [{"name": "Andy Bala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240071%22"}, {"id": "fda:K232027", "company": "Sebia", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232027: CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232027", "people": [{"name": "Karen Anderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232027%22"}, {"id": "fda:K240361", "company": "Hebei Titans Hongsen Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240361: Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240361", "people": [{"name": "Xiaojing Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240361%22"}, {"id": "fda:K233050", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233050: ADVIA Centaur\u00ae TSH3-Ultra II (TSH3ULII)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233050", "people": [{"name": "Kelly Scuderi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233050%22"}, {"id": "fda:K231834", "company": "3D Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231834: VSP PEEK Cranial Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231834", "people": [{"name": "Ashley Dawson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231834%22"}, {"id": "fda:K233837", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233837: Agile Esophageal Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233837", "people": [{"name": "Alexis Erazo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233837%22"}, {"id": "fda:K233910", "company": "Orthoxel Dac", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233910: Vertex Hip Fracture Nailing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233910", "people": [{"name": "Mark Moynihan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233910%22"}, {"id": "breakthrough:K232790", "company": "Icotec Ag", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-04-04", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K232790: KONG-TL VBR SYSTEM AND KONG C VBR SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K240135", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240135: Ion\u0099 Endoluminal System (Ion\u0099 Fully Articulating Catheter) (IF1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240135", "people": [{"name": "Jennifer Siu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240135%22"}, {"id": "fda:K240350", "company": "GS Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240350: AnyPlus II Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240350", "people": [{"name": "Seon Yeon Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240350%22"}, {"id": "fda:K233548", "company": "Resilia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233548: Uresta\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233548", "people": [{"name": "Sam Imbeault", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233548%22"}, {"id": "fda:K232899", "company": "Siemens Medical Solutions U.S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232899: AI-Rad Companion Organs RT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232899", "people": [{"name": "Kira Morales", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232899%22"}, {"id": "fda:K240282", "company": "Dongguan Boyuan Intelligent Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240282: IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240282", "people": [{"name": "Jinlong Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240282%22"}, {"id": "fda:K233618", "company": "Oxehealth Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233618: Oxevision Sleep Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233618", "people": [{"name": "Joao Jorge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233618%22"}, {"id": "fda:K230889", "company": "Wenzhou Yosun Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230889: Digital Thermometer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230889", "people": [{"name": "Lihao Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230889%22"}, {"id": "fda:K240618", "company": "Acuity Polymers, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240618: Acuity 200\u0099 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100\u0099 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200\u0099 with Tangible\u00ae Hydra-PEG\u00ae (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100\u0099 with Tangible\u00ae Hydra-PEG\u00ae (hexafocon A) Rigid Gas Permeable Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240618", "people": [{"name": "James A. Bonafini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240618%22"}, {"id": "fda:K232653", "company": "Blue Sky Bio, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232653: Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232653", "people": [{"name": "Albert Zickmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232653%22"}, {"id": "nih:5R44MH128484-03", "company": "Ksana Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": 818819, "summary": "NIH award 5R44MH128484-03: Development and testing of a digitally assisted risk reduction platform for youth at high risk for suicide ($818,819)", "source_url": "https://reporter.nih.gov/project-details/10784770", "people": [{"name": "NICHOLAS B ALLEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44AI157508-02", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": 999310, "summary": "NIH award 2R44AI157508-02: Rapid point-of-care molecular test for HCV VL ($999,310)", "source_url": "https://reporter.nih.gov/project-details/10932002", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43DA058470-01S1", "company": "Autonomous Healthcare, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": 54997, "summary": "NIH award 3R43DA058470-01S1: Noncontact Remote Monitoring for the Detection of Opioid-Induced Respiratory Depression ($54,997)", "source_url": "https://reporter.nih.gov/project-details/11020646", "people": [{"name": "Behnood Gholami", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI181482-01", "company": "Bioamp Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": 243806, "summary": "NIH award 1R43AI181482-01: Evolving the standard of care for carbapenem resistant infections, through the development of a phenotypic assay capable of DETECTing and classifying carbapenemases ($243,806)", "source_url": "https://reporter.nih.gov/project-details/10830205", "people": [{"name": "Nicole Jackson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K232112", "company": "R&G Seguridad E Higiene Industrial S.A.C.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232112: R&G Surgical Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232112", "people": [{"name": "Pola Guanilo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232112%22"}, {"id": "fda:K240601", "company": "Kent Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240601: SnapshotNIR model KD205", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240601", "people": [{"name": "Hitalo Arume", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240601%22"}, {"id": "fda:K240080", "company": "Syntex Healthcare Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240080: Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240080", "people": [{"name": "Zhiqiang Qiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240080%22"}, {"id": "fda:DEN230036", "company": "Prenosis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230036: Sepsis ImmunoScore", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230036", "people": [{"name": "Bobby Reddy", "role": "510(k) submission contact"}]}, {"id": "fda:K240888", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240888: Calibra Abutment Resin Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240888", "people": [{"name": "Rebecca Sporer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240888%22"}, {"id": "fda:K233750", "company": "Ge Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233750: ECG-less Cardiac", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233750", "people": [{"name": "Katelyn Rowley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233750%22"}, {"id": "fda:K211815", "company": "Affinity Biosensors", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K211815: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211815", "people": [{"name": "Ken Babcock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K211815%22"}, {"id": "fda:K233975", "company": "Imperative Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233975: Zoom 6F Insert Catheters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233975", "people": [{"name": "Nguyen Teri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233975%22"}, {"id": "fda:K232835", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232835: Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232835", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232835%22"}, {"id": "denovo:DEN230036", "company": "Prenosis, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-04-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230036 granted: Sepsis ImmunoScore", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230036"}, {"id": "nih:1R41HD115477-01", "company": "Cbez, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": 373877, "summary": "NIH award 1R41HD115477-01: Custom Accessories for Breastfeeding Success ($373,877)", "source_url": "https://reporter.nih.gov/project-details/10920319", "people": [{"name": "Laura R Kair", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43AI174487-02", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 5R43AI174487-02: Development of an ELISA for serosurveillance of human hookworm ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10815737", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:4R44AG078009-02", "company": "Potluck, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": 1010133, "summary": "NIH award 4R44AG078009-02: Enhancing Social Engagement through Online Gameplay for Older Adults with and without Mild Cognitive Impairment ($1,010,133)", "source_url": "https://reporter.nih.gov/project-details/11032073", "people": [{"name": "Maribeth Gandy Coleman", "role": "Principal Investigator"}, {"name": "Dillon Myers", "role": "Principal Investigator"}, {"name": "Kayci Vickers", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA243764-04", "company": "Acoustic Range Estimates, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": 553260, "summary": "NIH award 5R44CA243764-04: Thermoacoustic Range Verification During Delivery of a Clinical Plan by a Synchrocyclotron: transition from research prototype to turnkey clinical device ($553,260)", "source_url": "https://reporter.nih.gov/project-details/10827457", "people": [{"name": "SARAH Kathryn PATCH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K240635", "company": "Ximedica", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240635: ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240635", "people": [{"name": "Corie Vazquez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240635%22"}, {"id": "fda:K233676", "company": "Eko.Ai Pte Ltd. D/B/A Us2.Ai", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233676: Us2.v2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233676", "people": [{"name": "Hui Qun Tay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233676%22"}, {"id": "fda:K233990", "company": "Shandong Xingyu Gloves Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233990: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233990", "people": [{"name": "Carrie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233990%22"}, {"id": "fda:K240043", "company": "Microport Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240043: EVOLUTION\u00ae Hinge Knee System;GUARDIAN\u0099 limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS\u0099 Limb Salvage System;EVOLUTION\u00ae MP Total Knee System; EVOLUTION\u00ae MP Total Knee System; EVOLUTION\u00ae MP Adaptive CS Insert; EVOLUTION\u00ae MP Adaptive PS Tibial Insert; EVOLUTION\u00ae MP CS/CR Porous Femur/EVOLUTION\u00ae Adaptive CS and PS Inserts; EVOLUTION\u00ae Revision CCK System; ADVANCE\u00ae Double High Insert; ADVANCE\u00ae A-CLASS\u00ae Tibial Insert; ADVANCE\u00ae Knee System; ADVANCE\u00ae Ultra-Congruent Tibial Inse", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240043", "people": [{"name": "Thaiz Cruz Vasquez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240043%22"}, {"id": "fda:K233133", "company": "Talis Clinical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233133: Talis EMR with Talis +ACG (Talis EMR with +ACG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233133", "people": [{"name": "William Murphy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233133%22"}, {"id": "fda:K230895", "company": "Cefla S.C.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230895: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230895", "people": [{"name": "Daidone Simona", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230895%22"}, {"id": "fda:K240288", "company": "Surgical Fusion Technologies GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240288: SF Push- in Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240288", "people": [{"name": "Joerg Mayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240288%22"}, {"id": "fda:K232726", "company": "Southern Implants (Pty), Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232726: External Hex Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232726", "people": [{"name": "Colin Saffy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232726%22"}, {"id": "fda:K240442", "company": "Kuros Biosciences B.V", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240442: MagnetOs Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240442", "people": [{"name": "Hen Baron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240442%22"}, {"id": "fda:K240397", "company": "AngioDynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240397: AlphaVac MMA F1885 System (H787253020)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240397", "people": [{"name": "Kasey Newcomb", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240397%22"}, {"id": "pma:P230007", "company": "Abbott Medical", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-04-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230007: TriClip G4 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230007", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230007%22"}, {"id": "breakthrough:P230007", "company": "Abbott Medical", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-04-01", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230007: TRICLIP G4 SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K231209", "company": "Otsuka America Pharmaceutical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231209: Rejoyn", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231209", "people": [{"name": "Nancy Teague", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231209%22"}, {"id": "nih:5R44DC018437-04", "company": "Altec, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": 560546, "summary": "NIH award 5R44DC018437-04: Adaptive & Individualized AAC ($560,546)", "source_url": "https://reporter.nih.gov/project-details/10814399", "people": [{"name": "Gianluca De Luca", "role": "Principal Investigator"}, {"name": "Jennifer Vojtech", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K233068", "company": "Nanning Tecbod Biological Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233068: Disposable Surgical Gown", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233068", "people": [{"name": "Bing Yao Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233068%22"}, {"id": "fda:K233622", "company": "Vision Rt, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233622: AlignRT Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233622", "people": [{"name": "Ludlow Chelsey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233622%22"}, {"id": "fda:K211122", "company": "Baxter Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K211122: Novum IQ Large Volume Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211122", "people": [{"name": "Donna Haraden", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K211122%22"}, {"id": "fda:K232031", "company": "Lap GmbH Laser Applikationen", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232031: LUNA 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232031", "people": [{"name": "Sebastian Boldhaus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232031%22"}, {"id": "fda:K233211", "company": "Coreline Soft Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233211: AVIEW CAC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233211", "people": [{"name": "Hye Yi Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233211%22"}, {"id": "fda:K232018", "company": "Haemonetics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232018: Citrated: K, KH, RTH, FFH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232018", "people": [{"name": "Julie Ewend", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232018%22"}, {"id": "fda:K230665", "company": "Baxter Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230665: Dose IQ Safety Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230665", "people": [{"name": "Dhiraj Bizzul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230665%22"}, {"id": "fda:K232825", "company": "Jiangsu Vedkang Medical Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232825: Disposable Sphincterotome", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232825", "people": [{"name": "Yulu Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232825%22"}, {"id": "fda:K233595", "company": "Genesys Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233595: Genesys Spine Sacroiliac Joint Fusion System with Navigation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233595", "people": [{"name": "Derek Southard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233595%22"}, {"id": "fda:K240608", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240608: MAGNETOM Viato.Mobile", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240608", "people": [{"name": "Alina Goodman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240608%22"}, {"id": "fda:K240587", "company": "Cyden Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240587: SmoothSkin Pure Unplugged (SSB3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240587", "people": [{"name": "Adam Stephens", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240587%22"}, {"id": "fda:K240310", "company": "Shenzhen Beacon Display Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240310: LCD Monitors C310S, G310S, C316S, G316S, C616W", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240310", "people": [{"name": "Li Yafei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240310%22"}, {"id": "pma:P220034", "company": "DiaSorin, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-03-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P220034: LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220034", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P220034%22"}, {"id": "nih:5R44AG082605-02", "company": "Together Senior Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": 948690, "summary": "NIH award 5R44AG082605-02: A Novel Algorithm to Identify People with Undiagnosed Alzheimer's Disease and Related Dementias ($948,690)", "source_url": "https://reporter.nih.gov/project-details/10863843", "people": [{"name": "Deborah E. Barnes", "role": "Principal Investigator"}, {"name": "Cynthia Louise Benjamin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI162425-03", "company": "Vectech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": 942842, "summary": "NIH award 5R44AI162425-03: High accuracy automated tick classification using computer vision ($942,842)", "source_url": "https://reporter.nih.gov/project-details/10833654", "people": [{"name": "Autumn Goodwin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R42EY031628-02A1", "company": "Unar Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": 674598, "summary": "NIH award 2R42EY031628-02A1: STTR Phase II - Development of a visual-to-tactile conversion system for automating the tactile graphic generation process ($674,598)", "source_url": "https://reporter.nih.gov/project-details/10819968", "people": [{"name": "Hari Prasath Palani", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K240693", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240693: LINQ II\u0099 Insertable Cardiac Monitor (ICM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240693", "people": [{"name": "Andrea Artman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240693%22"}, {"id": "fda:K232049", "company": "Neobiotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232049: IS-III active Short Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232049", "people": [{"name": "Young-Ku Heo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232049%22"}, {"id": "fda:K232079", "company": "Wrp Asia Pacific Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232079: Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232079", "people": [{"name": "Saravanan Ramasamy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232079%22"}, {"id": "fda:K232047", "company": "Unimom.Co", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232047: VIVACE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232047", "people": [{"name": "Chon Yeong-Bin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232047%22"}, {"id": "fda:K232013", "company": "Goodman Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232013: Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232013", "people": [{"name": "Aida Kanechika", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232013%22"}, {"id": "fda:K231972", "company": "Atrium Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231972: Advanta VXT Vascular Graft, Flixene Vascular Graft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231972", "people": [{"name": "Hannah Scribner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231972%22"}, {"id": "fda:K233719", "company": "Shimadzu Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233719: FDR Visionary Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233719", "people": [{"name": "Koichi Kataoka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233719%22"}, {"id": "fda:K240295", "company": "Instanosis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240295: InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240295", "people": [{"name": "Xiaofeng Xia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240295%22"}, {"id": "fda:K233409", "company": "Eko Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233409: Eko Low Ejection Fraction Tool (ELEFT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233409", "people": [{"name": "Sam Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233409%22"}, {"id": "fda:K233609", "company": "Eko Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233609: CORE 500 Digital Stethoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233609", "people": [{"name": "Sam Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233609%22"}, {"id": "fda:K233604", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233604: BTL-785S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233604", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233604%22"}, {"id": "fda:K233838", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233838: Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien\u0099 Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien\u0099 Remote Temperature Probe (RTP20); Covidien\u0099 Remote Temperature Probe, Bulk (RTP20B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233838", "people": [{"name": "Steve Pavlik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233838%22"}, {"id": "fda:K240567", "company": "Fin-Ceramica Faenza S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240567: CustomizedBone Service", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240567", "people": [{"name": "Marina Monticelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240567%22"}, {"id": "fda:K240284", "company": "Shenzhen Browiner Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240284: Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240284", "people": [{"name": "Chen Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240284%22"}, {"id": "fda:K233657", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233657: NAEOTOM Alpha", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233657", "people": [{"name": "Tabitha Estes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233657%22"}, {"id": "fda:K233669", "company": "Ge Oec Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233669: OEC 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233669", "people": [{"name": "Shawn Quigley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233669%22"}, {"id": "fda:K233909", "company": "Argon Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233909: Cleaner\u0099 Plus 18F Thrombectomy System - Cleaner\u0099 Plus 18F Aspiration Catheter, Cleaner\u0099 Plus 18F Handpiece with Maceration Wire, Cleaner\u0099 Plus 18F Aspiration Canister", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233909", "people": [{"name": "Ana Jimenez-Hughes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233909%22"}, {"id": "fda:K240171", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240171: ProSeal\u0099 Injector Plus (Model no. 421050)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240171", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240171%22"}, {"id": "breakthrough:K240295", "company": "Instanosis, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-03-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K240295: INSTASTRIP FENTANYL RAPID TEST (URINE); INSTASTRIP FENTANYL DIPSTICK TEST (URINE)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K233409", "company": "Eko Health, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-03-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K233409: EKO LOW EJECTION FRACTION TOOL (ELEFT)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44AI136172-04", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": 1015000, "summary": "NIH award 5R44AI136172-04: Point-of-care diagnostic test for T. cruzi (Chagas) infection ($1,015,000)", "source_url": "https://reporter.nih.gov/project-details/10817826", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43AI181122-01", "company": "Salus Discovery, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": 275736, "summary": "NIH award 1R43AI181122-01: 3STEP: A swab-seal-read, point-of-care nucleic acid test to address disparity in STI screening and prevention ($275,736)", "source_url": "https://reporter.nih.gov/project-details/10820325", "people": [{"name": "Brianna Mullins", "role": "Principal Investigator"}, {"name": "Jay Wyatt Warrick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K232891", "company": "Carpl Ai, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232891: CARPL (CARPL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232891", "people": [{"name": "Josh Baker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232891%22"}, {"id": "fda:DEN210049", "company": "Medline Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN210049: Medline ART Skin Harvesting System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN210049", "people": [{"name": "Stephanie Augsburg", "role": "510(k) submission contact"}]}, {"id": "fda:K223360", "company": "Huizhou Foryou Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223360: LUOFUCON\u00ae Silicone Ag+ Foam Dressing, LUOFUCON\u00ae Silicone Ag+ Antibacterial Foam Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223360", "people": [{"name": "Guosheng Tan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223360%22"}, {"id": "fda:K222613", "company": "Arx Sciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222613: ARX Liquid Amies Collection & Transport System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222613", "people": [{"name": "Chad Werts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222613%22"}, {"id": "fda:K233201", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233201: MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233201", "people": [{"name": "Sheina Rajkumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233201%22"}, {"id": "fda:K233951", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233951: CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233951", "people": [{"name": "Justin O'Connor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233951%22"}, {"id": "fda:K233989", "company": "CarboFix Orthopedics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233989: CarboClear\u00ae Posterior Cervical Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233989", "people": [{"name": "Batya Cohen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233989%22"}, {"id": "fda:K234143", "company": "Abbott Point of Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234143: i-STAT TBI Cartridge with the i-STAT Alinity System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234143", "people": [{"name": "Brian Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234143%22"}, {"id": "fda:K232253", "company": "Neurovalens Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232253: Modius Stress", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232253", "people": [{"name": "Jason Mckeown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232253%22"}, {"id": "fda:K231425", "company": "Wuxi Jiajian Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231425: Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231425", "people": [{"name": "Wu Zhifang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231425%22"}, {"id": "fda:K234150", "company": "Spinal Elements", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234150: Lucent\u00ae XP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234150", "people": [{"name": "Julie Lamothe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234150%22"}, {"id": "fda:K240045", "company": "Hemosonics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240045: QStat Cartridge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240045", "people": [{"name": "Deborah Winegar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240045%22"}, {"id": "fda:K234097", "company": "Ever Growth (Vietnam) Corporation Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234097: Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234097", "people": [{"name": "Deng Elizabeth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234097%22"}, {"id": "fda:K240389", "company": "Hyundae Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240389: Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240389", "people": [{"name": "Ju-in Oh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240389%22"}, {"id": "fda:K233539", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233539: MAMMOMAT B.brilliant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233539", "people": [{"name": "Denise Adams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233539%22"}, {"id": "denovo:DEN210049", "company": "Medline Industries, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-03-27", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210049 granted: Medline ART Skin Harvesting System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210049"}, {"id": "breakthrough:K234143", "company": "Abbott Point Of Care", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-03-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K234143: I-STAT TBI CARTRIDGE WITH THE I-STAT ALINITY SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K233611", "company": "Maine Molecular Quality Controls, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233611: SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233611", "people": [{"name": "Joan Gordon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233611%22"}, {"id": "fda:K233151", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233151: PluroGel\u00ae Antimicrobial Burn and Wound Dressing, PluroGel\u00ae Burn and Wound Dressing (OTC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233151", "people": [{"name": "Dinah Rincones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233151%22"}, {"id": "fda:K233733", "company": "Syntheticmr AB (Publ.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233733: SyMRI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233733", "people": [{"name": "Madeleine Enstr\u00f6m", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233733%22"}, {"id": "fda:K233069", "company": "Inari Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233069: Removal System Large Bore 60 cc Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233069", "people": [{"name": "Kaitlyn Weinkauf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233069%22"}, {"id": "fda:K231132", "company": "J & P Dental Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231132: J & P Click Attachments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231132", "people": [{"name": "Babak Aaron Paz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231132%22"}, {"id": "fda:K233650", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233650: SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233650", "people": [{"name": "Clayton Ginn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233650%22"}, {"id": "fda:K232954", "company": "Biofire Diagnostics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232954: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232954", "people": [{"name": "Kevin Bourzac", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232954%22"}, {"id": "fda:K231984", "company": "Shenzhen Hingmed Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231984: Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231984", "people": [{"name": "Huang YongBan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231984%22"}, {"id": "fda:K240594", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240594: Grappler Suture Anchor R3FLEX IOL System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240594", "people": [{"name": "Edward Wells-Spicer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240594%22"}, {"id": "fda:K231793", "company": "Belport Company, Inc., Gingi-Pak", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231793: RODIN 3D Resin SPLINT, Hard/Flex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231793", "people": [{"name": "Jingtian Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231793%22"}, {"id": "fda:K240589", "company": "Cook Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240589: Micropuncture Introducer Sets; Micropuncture Pedal Access Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240589", "people": [{"name": "David Lehr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240589%22"}, {"id": "fda:K233167", "company": "Ossvis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233167: LW Implant System \u0096 Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233167", "people": [{"name": "Woo Jin Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233167%22"}, {"id": "fda:K233275", "company": "Gyrus Acmi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233275: RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233275", "people": [{"name": "Andrea Curria", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233275%22"}, {"id": "fda:K240292", "company": "Hong Kong Etech Groups Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240292: Transcutaneous Electrical Nerve Stimulator (9029SCM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240292", "people": [{"name": "Haixin Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240292%22"}, {"id": "fda:K231986", "company": "Synaptive Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231986: Modus IR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231986", "people": [{"name": "Tahmina Afzali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231986%22"}, {"id": "fda:K240620", "company": "Medical Templates AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240620: Cube Navigator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240620", "people": [{"name": "Joscha H\u00fcttel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240620%22"}, {"id": "fda:K232268", "company": "Zeros Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232268: STERI-OSS Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232268", "people": [{"name": "Uk Hyon Joo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232268%22"}, {"id": "fda:K233919", "company": "Stryker GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233919: VariAx 2 Distal Radius System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233919", "people": [{"name": "Ileana Freige", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233919%22"}, {"id": "fda:K240329", "company": "Yongkang Youha Electric Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240329: Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240329", "people": [{"name": "Eva Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240329%22"}, {"id": "fda:K234080", "company": "Soterix Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234080: MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234080", "people": [{"name": "Danielle Dadona", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234080%22"}, {"id": "fda:K234085", "company": "Enamel Pure", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234085: LUNE\u0099 PureHygiene", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234085", "people": [{"name": "Nathan Monty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234085%22"}, {"id": "breakthrough:K234008", "company": "Bonesupport Ab", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-03-24", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K234008: CERAMENT G", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:2R44HL147771-04", "company": "Annoviant, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": 833493, "summary": "NIH award 2R44HL147771-04: Pulmonary Valved Graft with Regeneration Potential for Pediatric Patients ($833,493)", "source_url": "https://reporter.nih.gov/project-details/10796422", "people": [{"name": "Ajay Houde", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K231953", "company": "Coloplast Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231953: Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231953", "people": [{"name": "Laura Kelly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231953%22"}, {"id": "fda:K232354", "company": "Murata Vios, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232354: Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232354", "people": [{"name": "Amit Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232354%22"}, {"id": "fda:K231926", "company": "Neuronetics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231926: NeuroStar Advanced Therapy System (All previously cleared models)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231926", "people": [{"name": "Robin Fatzinger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231926%22"}, {"id": "fda:K233148", "company": "Fix Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233148: Augment Off-Axis Instrument System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233148", "people": [{"name": "Brian Karpinski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233148%22"}, {"id": "fda:K232920", "company": "Ureteral Stent Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232920: RELIEF\u0099 Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF\u0099 Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232920", "people": [{"name": "Mike Bunker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232920%22"}, {"id": "fda:K232282", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232282: aprevo\u00ae anterior and lateral lumbar interbody fusion device, aprevo\u00ae transforaminal lumbar interbody fusion device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232282", "people": [{"name": "Karen Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232282%22"}, {"id": "fda:K240225", "company": "Shockwave Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240225: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240225", "people": [{"name": "Anna Bushart", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240225%22"}, {"id": "fda:K232322", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232322: MAGNETOM Terra; MAGNETOM Terra.X", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232322", "people": [{"name": "Milind Dhamankar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232322%22"}, {"id": "fda:K240522", "company": "Taewoong Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240522: Esophageal TTS Stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240522", "people": [{"name": "Yongjin \"Jeff\" Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240522%22"}, {"id": "fda:K232548", "company": "Corsano Health B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232548: Corsano CardioWatch 287-2 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232548", "people": [{"name": "Peter Stas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232548%22"}, {"id": "fda:K231795", "company": "Quidel Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231795: QuickVue COVID-19 Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231795", "people": [{"name": "Suzanne Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231795%22"}, {"id": "fda:K231806", "company": "Oxoid Limited (Part of Thermo Fisher Scientific)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231806: Thermo Scientific Oxoid Rezafungin Disc (5 \u00b5g) RZF5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231806", "people": [{"name": "Amie Lovatt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231806%22"}, {"id": "fda:K240715", "company": "Clariance", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240715: Idys\u00ae C ZP 3DTi", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240715", "people": [{"name": "Magalie Hennequin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240715%22"}, {"id": "fda:K233713", "company": "Teleflex Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233713: Pilling Tracheostomy Tubes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233713", "people": [{"name": "Hannah Boning", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233713%22"}, {"id": "fda:DEN230034", "company": "Scopio Labs , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230034: X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230034", "people": [{"name": "Shahar Karny", "role": "510(k) submission contact"}]}, {"id": "fda:K231927", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231927: Elecsys PTH , Elecsys PTH STAT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231927", "people": [{"name": "Amy Pierce", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231927%22"}, {"id": "fda:K233262", "company": "Dukal, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233262: Dukal SMS Sterilization Wrap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233262", "people": [{"name": "Megan Quevedo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233262%22"}, {"id": "fda:K233578", "company": "Bahadir USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233578: BAHADIR STERILIZATION CONTAINERS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233578", "people": [{"name": "Ismail Kilic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233578%22"}, {"id": "fda:K232169", "company": "Orthofix Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232169: FITBONE\u00ae Transport and Lengthening System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232169", "people": [{"name": "Elvira Taccarelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232169%22"}, {"id": "fda:K231938", "company": "O&M Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231938: Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231938", "people": [{"name": "Caitlin Senter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231938%22"}, {"id": "fda:K240540", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240540: uMR Omega", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240540", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240540%22"}, {"id": "fda:K232067", "company": "Medivators (A Subsidiary of Steris Corporation)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232067: Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232067", "people": [{"name": "Nick Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232067%22"}, {"id": "fda:K232431", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232431: syngo.CT Brain Hemorrhage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232431", "people": [{"name": "Monsuru Bello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232431%22"}, {"id": "fda:K231930", "company": "Guangdong Youkey Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231930: Digital Ultrasonic Diagnostic Imaging System (Model: F6)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231930", "people": [{"name": "Hu Zeyi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231930%22"}, {"id": "fda:K233569", "company": "Spirair, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233569: SeptAlign", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233569", "people": [{"name": "Tracey Henry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233569%22"}, {"id": "fda:K233441", "company": "Baxter Healthcare Corportation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233441: The Vest APX System (PVAPX1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233441", "people": [{"name": "Steven Co", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233441%22"}, {"id": "fda:K240690", "company": "Nexxt Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240690: STRUXXURE\u00ae MCS Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240690", "people": [{"name": "Andy Elsbury", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240690%22"}, {"id": "denovo:DEN230034", "company": "Scopio Labs , Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-03-22", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230034 granted: X100 with Full Field Bone Marrow Aspirat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230034"}, {"id": "fda:K232568", "company": "Ipg Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232568: IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232568", "people": [{"name": "Samuel D Wade", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232568%22"}, {"id": "fda:K234062", "company": "Medartis AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234062: APTUS Hand Scaphoid Plates", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234062", "people": [{"name": "Claudia De Santis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234062%22"}, {"id": "fda:K233980", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233980: ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233980", "people": [{"name": "Meagan Robles", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233980%22"}, {"id": "fda:K234081", "company": "Reddrop DX", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234081: RedDrop ONE (One)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234081", "people": [{"name": "Kris Buchanan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234081%22"}, {"id": "fda:K240754", "company": "Megagen Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240754: N2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240754", "people": [{"name": "Lee Hyo-Eun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240754%22"}, {"id": "fda:K240530", "company": "MedShape, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240530: DynaNail Mini Tapered Hybrid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240530", "people": [{"name": "Amberlee Soto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240530%22"}, {"id": "fda:K240309", "company": "Tandem Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240309: Tandem Mobi insulin pump with interoperable technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240309", "people": [{"name": "Jordan Barkhimer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240309%22"}, {"id": "fda:K240122", "company": "NormaTec Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240122: Normatec Elite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240122", "people": [{"name": "Steve Henderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240122%22"}, {"id": "fda:K240179", "company": "Wuhan Pioon Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240179: Medical Diode Laser (Model: L2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240179", "people": [{"name": "Feng Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240179%22"}, {"id": "fda:K230088", "company": "4Web Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230088: Ankle Truss System (ATS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230088", "people": [{"name": "Lewis Harrison", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230088%22"}, {"id": "fda:K233665", "company": "DePuy Synthes", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233665: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233665", "people": [{"name": "Jeffrey Krawiec", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233665%22"}, {"id": "fda:K234006", "company": "Allsource Screening Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234006: AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234006", "people": [{"name": "Peter O'Connor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234006%22"}, {"id": "fda:K240253", "company": "Aerin Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240253: Reach Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240253", "people": [{"name": "Teri Feeley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240253%22"}, {"id": "fda:K232439", "company": "Gymmax Technology Shenzen Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232439: Electrical Stimulator System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232439", "people": [{"name": "Benson Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232439%22"}, {"id": "fda:K233926", "company": "Mettler Electronics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233926: accufit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233926", "people": [{"name": "An Le", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233926%22"}, {"id": "fda:K233753", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233753: AI-Rad Companion (Pulmonary)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233753", "people": [{"name": "Kira Morales", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233753%22"}, {"id": "breakthrough:K230088", "company": "4web Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-03-21", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K230088: ANKLE TRUSS SYSTEM (ATS)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K240165", "company": "Wenzhou Longwan Medical Device Factory", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240165: Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240165", "people": [{"name": "Bernard Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240165%22"}, {"id": "fda:K233375", "company": "Nexus Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233375: Tranquil-L Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233375", "people": [{"name": "Jared Crocker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233375%22"}, {"id": "fda:K232125", "company": "Vitromed GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232125: V-PVP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232125", "people": [{"name": "Greg Holland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232125%22"}, {"id": "fda:K240574", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240574: BruxZir\u00ae Radiant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240574", "people": [{"name": "Su Hyun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240574%22"}, {"id": "fda:K240537", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240537: SMARTXIDE PRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240537", "people": [{"name": "Paolo Peruzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240537%22"}, {"id": "fda:K240743", "company": "Ultradent Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240743: Peak Universal Bond", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240743", "people": [{"name": "Carolyn Taylor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240743%22"}, {"id": "fda:K234049", "company": "Institut Straumann AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234049: Straumann\u00ae BLC and TLC Implants - Line extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234049", "people": [{"name": "Laure Kuhner Borsenberger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234049%22"}, {"id": "fda:K234090", "company": "Surgvision GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234090: EXPLORER AIR\u00ae II (8001, 8002, 8003); EXPLORER AIR\u00ae Sterile Drape (8004)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234090", "people": [{"name": "Daniela Mahan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234090%22"}, {"id": "fda:K234052", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234052: Access Ferritin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234052", "people": [{"name": "Kate Oelberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234052%22"}, {"id": "fda:K233002", "company": "Excelsior Resources, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233002: BEED 2,5, BEED 3,8", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233002", "people": [{"name": "Christopher P Weber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233002%22"}, {"id": "fda:K240507", "company": "Nuvasive, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240507: NuVasive AttraX Scaffold", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240507", "people": [{"name": "Krunal Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240507%22"}, {"id": "fda:K234130", "company": "Ge Medical Systems Information Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234130: Portrait\u0099 Mobile Monitoring Solution consists of: \u0095 Portrait\u0099 Central Viewer Application (Portrait CVAXB) \u0095 Portrait\u0099 Core Services (Portrait CSSXB) \u0095 Portrait\u0099 Clinical Alarming Unit (Portrait CAU01) \u0095 Portrait\u0099 Mobile Patient Monitor Hardware (Portrait HUBXB) \u0095 Portrait\u0099 Mobile Patient Monitor Software (Portrait HSWXB) \u0095 Portrait\u0099 Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) \u0095 Portrait\u0099 Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) \u0095 Portrait\u0099 Wearable Pulse O", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234130", "people": [{"name": "Joel Kent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234130%22"}, {"id": "fda:K231974", "company": "Phc Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231974: PATHFAST\u00aehs-cTnI-II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231974", "people": [{"name": "Misato Igarashi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231974%22"}, {"id": "fda:K234047", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234047: Automatic Registration", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234047", "people": [{"name": "Esther Moreno Garcia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234047%22"}, {"id": "fda:K233901", "company": "Shenzhen Desida Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233901: Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233901", "people": [{"name": "Shuangcheng Yuan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233901%22"}, {"id": "fda:K233642", "company": "InMode , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233642: InMode RF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233642", "people": [{"name": "Suhair Francis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233642%22"}, {"id": "fda:K232654", "company": "Nephron Nitrile, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232654: Nephron Nitrile\u0099, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232654", "people": [{"name": "Lou Kennedy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232654%22"}, {"id": "fda:K231719", "company": "Azur Medical Company, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231719: Medical Surgical Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231719", "people": [{"name": "Di Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231719%22"}, {"id": "fda:K232682", "company": "Chengdu Besmile Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232682: Pre-Sintered Zirconia Coloring Liquid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232682", "people": [{"name": "Moushan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232682%22"}, {"id": "fda:K231843", "company": "Arx Sciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231843: ARX Viral Transport Media Collection and Transport System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231843", "people": [{"name": "Chad Werts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231843%22"}, {"id": "fda:K233146", "company": "Shenzhen Jamr Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233146: Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233146", "people": [{"name": "Haiyu Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233146%22"}, {"id": "fda:K240668", "company": "Shenzhen Amydi-Med Electrics Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240668: Amydi-med Disposable Non-invasive EEG electrodes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240668", "people": [{"name": "Cuifang Yuan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240668%22"}, {"id": "fda:K232619", "company": "Sapphire Medical Group", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232619: MATRIX HA PEEK Cervical IBF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232619", "people": [{"name": "Anthony Ruggiero", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232619%22"}, {"id": "fda:K234024", "company": "Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234024: HWJECT Auto-disable syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234024", "people": [{"name": "Bingyi Xiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234024%22"}, {"id": "fda:K233772", "company": "Mirco-Tech (Nanjing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233772: Disposable Dual Action Tissue Closure Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233772", "people": [{"name": "He Sally", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233772%22"}, {"id": "fda:K240139", "company": "Blue Belt Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240139: Real Intelligence\u0099 CORI\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240139", "people": [{"name": "Herlinger Corrine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240139%22"}, {"id": "fda:K233660", "company": "Ionic Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233660: nCommand Lite System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233660", "people": [{"name": "Jose Leovigildo de Melo Coelho Filho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233660%22"}, {"id": "fda:K233599", "company": "Lg Electronics.Inc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233599: X-Clever (ASHK100G)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233599", "people": [{"name": "Hanseul Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233599%22"}, {"id": "fda:K240515", "company": "Ulrich Medical USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240515: uNion\u00ae MAX Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240515", "people": [{"name": "Eric Lucas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240515%22"}, {"id": "fda:K240113", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240113: CORIOGRAPH Knee Pre-Op Plan", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240113", "people": [{"name": "Wilcox Miriam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240113%22"}, {"id": "fda:K230981", "company": "M/s. Meril Endo Surgery Private Limited.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230981: Meriglu Topical Skin Adhesive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230981", "people": [{"name": "Umesh Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230981%22"}, {"id": "nih:5R44AI157123-03", "company": "Aerosol Dynamics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": 572439, "summary": "NIH award 5R44AI157123-03: Biocascade inlet ($572,439)", "source_url": "https://reporter.nih.gov/project-details/10828919", "people": [{"name": "Arantzazu Eiguren Fernandez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K240454", "company": "Starch Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240454: RESPONDER\u00ae Polysaccharide Hemostat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240454", "people": [{"name": "Alice Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240454%22"}, {"id": "fda:K230802", "company": "Universal Biosensors Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230802: Xprecia Prime Coagulation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230802", "people": [{"name": "Nosheen Hameed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230802%22"}, {"id": "fda:K233307", "company": "Beijing Adss Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233307: Intensity Pulsed Light Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233307", "people": [{"name": "Jijuan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233307%22"}, {"id": "fda:K233881", "company": "Ivwatch, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233881: ivWatch\u00ae Model 400", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233881", "people": [{"name": "Holly Novak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233881%22"}, {"id": "fda:K240441", "company": "Depuy Mitek", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240441: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240441", "people": [{"name": "Ashley Aromando", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240441%22"}, {"id": "fda:K233342", "company": "Avicenna.Ai", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233342: CINA-ASPECTS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233342", "people": [{"name": "Stephane Berger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233342%22"}, {"id": "fda:K234115", "company": "Alembic, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234115: APRO 55 Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234115", "people": [{"name": "Lisa Yen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234115%22"}, {"id": "fda:K234104", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234104: PICOANDY (Q-Switched Nd:YAG Laser)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234104", "people": [{"name": "Hyunsik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234104%22"}, {"id": "fda:K233748", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233748: CIARTIC Move (VB10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233748", "people": [{"name": "Patricia Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233748%22"}, {"id": "fda:K240430", "company": "Otodynamics, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240430: Otoport Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240430", "people": [{"name": "Daniel Budd", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240430%22"}, {"id": "fda:K240539", "company": "Zimvie Spine (Zimmer Biomet Spine, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240539: Vital\u0099 Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240539", "people": [{"name": "Anjanet Mort", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240539%22"}, {"id": "fda:K233986", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233986: BD Phoenix\u0099 Automated Microbiology System - GN Ciprofloxacin (0.0156\u00964 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233986", "people": [{"name": "Kamisha Gray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233986%22"}, {"id": "fda:K231856", "company": "Medexel Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231856: TopFine\u00ae LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231856", "people": [{"name": "Juntaek Seo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231856%22"}, {"id": "fda:K240112", "company": "Sincera Technology (Changchun) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240112: Light Cure Composite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240112", "people": [{"name": "Tony Su", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240112%22"}, {"id": "fda:K233799", "company": "Shenzhen Yuezhongxing Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233799: Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233799", "people": [{"name": "Yuchao Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233799%22"}, {"id": "fda:K232327", "company": "Endostart S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232327: Endorail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232327", "people": [{"name": "Alessandro Tozzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232327%22"}, {"id": "fda:K233747", "company": "Concha Labs", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233747: Concha Sol Hearing Aids (CL-1001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233747", "people": [{"name": "Carlos Bullock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233747%22"}, {"id": "fda:K240117", "company": "Inquis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240117: Aventus Thrombectomy System (IM-2001/IM-0002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240117", "people": [{"name": "Mojgan Saadat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240117%22"}, {"id": "fda:K240694", "company": "Ultradent Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240694: FORMA Composite (Shade A3D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240694", "people": [{"name": "Adam Black", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240694%22"}, {"id": "fda:K240466", "company": "Orthomerica Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240466: STARband 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240466", "people": [{"name": "Najiba Katir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240466%22"}, {"id": "fda:K232234", "company": "Poly Medicure Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232234: Nouvo Safety Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232234", "people": [{"name": "Ramdas Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232234%22"}, {"id": "fda:K233814", "company": "3M Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233814: 3M\u0099 Attest\u0099 Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M\u0099 Attest\u0099 Auto-reader (490); 3M\u0099 Attest\u0099 Auto-reader (490H); 3M\u0099 Attest\u0099 Mini Auto-reader (490M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233814", "people": [{"name": "Michelle Larsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233814%22"}, {"id": "nih:3R43NS129363-01A1S2", "company": "Eysz, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-14", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43NS129363-01A1S2: A Mobile Health Application to Detect Absence Seizures using Hyperventilation and Eye-Movement Recordings ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10948266", "people": [{"name": "Rachel Kuperman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K232803", "company": "Nxstage Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232803: NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232803", "people": [{"name": "Denise Oppermann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232803%22"}, {"id": "fda:K231850", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231850: QUARTEX\u00ae Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS\u00ae Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231850", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231850%22"}, {"id": "fda:K233542", "company": "Stryker Leibinger GmbH & Co KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233542: Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233542", "people": [{"name": "Megan B Guilbault", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233542%22"}, {"id": "fda:K232567", "company": "Nico Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232567: Myriad SPECTRA Light Source", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232567", "people": [{"name": "Megan Becker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232567%22"}, {"id": "fda:K232980", "company": "Cytoswim, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232980: SpermAlign Sperm Separation Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232980", "people": [{"name": "Max Meissner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232980%22"}, {"id": "fda:K232610", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232610: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232610", "people": [{"name": "Melissa S Gonzalez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232610%22"}, {"id": "fda:K233853", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233853: LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233853", "people": [{"name": "Jeanette Becker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233853%22"}, {"id": "fda:K231529", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231529: CloudPoint FastDesign Chairside", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231529", "people": [{"name": "Jiahe Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231529%22"}, {"id": "fda:K233958", "company": "Zethon, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233958: hekaDrill", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233958", "people": [{"name": "Faith Robertson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233958%22"}, {"id": "fda:K232301", "company": "Aesthetic Management Partners", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232301: Define RF Microneedling System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232301", "people": [{"name": "Shlomo Assa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232301%22"}, {"id": "fda:K233946", "company": "Siemens Healthcare Diagnostics Products, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233946: IMMULITE\u00ae 2000 BR-MA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233946", "people": [{"name": "Karlyn Kellogg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233946%22"}, {"id": "fda:K233466", "company": "HistoSonics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233466: Edison System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233466", "people": [{"name": "Daniel Kosednar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233466%22"}, {"id": "fda:K232022", "company": "Cascination AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232022: CAS-One IR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232022", "people": [{"name": "Andreas Meschberger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232022%22"}, {"id": "fda:K234008", "company": "Bonesupport AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234008: CERAMENT G", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234008", "people": [{"name": "Blerta Shuka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234008%22"}, {"id": "fda:K233968", "company": "Avicenna.Ai", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233968: CINA-iPE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233968", "people": [{"name": "Stephane Berger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233968%22"}, {"id": "fda:K233592", "company": "BioPoly, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233592: BioPoly Radial Head Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233592", "people": [{"name": "Herb Schwartz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233592%22"}, {"id": "fda:K233949", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233949: ACCORD Cable System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233949", "people": [{"name": "Anne Remington", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233949%22"}, {"id": "fda:K233952", "company": "Deka Research and Development", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233952: DEKA ACE Pump System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233952", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233952%22"}, {"id": "fda:K234002", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234002: ICEfx Cryoablation System (FPRCH8000-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234002", "people": [{"name": "Benjamin Van Santen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234002%22"}, {"id": "fda:K233136", "company": "Hygeia II Medical Group, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233136: Hygeia Express Powered Breast Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233136", "people": [{"name": "Brett Nakfoor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233136%22"}, {"id": "fda:K233930", "company": "Perspectum", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233930: MRCP+ version 2 (MRCP+ v2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233930", "people": [{"name": "Keri Hildick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233930%22"}, {"id": "fda:K233070", "company": "Chongqing Rob Linka Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233070: Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233070", "people": [{"name": "Huirong Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233070%22"}, {"id": "fda:K234055", "company": "Deka Research and Development", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234055: DEKA Loop", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234055", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234055%22"}, {"id": "fda:K232564", "company": "Laon Medi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232564: Align Studio", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232564", "people": [{"name": "Mina Yun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232564%22"}, {"id": "fda:K240416", "company": "Nexus Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240416: Tranquil-C Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240416", "people": [{"name": "Jared Crocker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240416%22"}, {"id": "fda:K233381", "company": "Carestream Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233381: DRX-Evolution Plus System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233381", "people": [{"name": "Robert Faust", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233381%22"}, {"id": "fda:K240497", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240497: Smartxide Tetra Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240497", "people": [{"name": "Paolo Peruzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240497%22"}, {"id": "fda:K240132", "company": "Emoled, Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240132: EmoLED (v. 2-USA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240132", "people": [{"name": "Lorenzo Targetti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240132%22"}, {"id": "fda:K231849", "company": "Baxter Healthcare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231849: MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231849", "people": [{"name": "Brad Roynon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231849%22"}, {"id": "fda:K240424", "company": "Collagen Matrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240424: Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240424", "people": [{"name": "Daniel Fernandez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240424%22"}, {"id": "nih:3R42NS134505-01S1", "company": "Neurinsight, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-11", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R42NS134505-01S1: Towards intra-operative guidance in brain tumor surgery using real-time resting-state functional MRI ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10987834", "people": [{"name": "Dieter W Dennig", "role": "Principal Investigator"}, {"name": "Stefan Posse", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44NS125745-02", "company": "Evon Medics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-11", "observed": "2026-08-21", "amount_usd": 1349130, "summary": "NIH award 4R44NS125745-02: Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P) ($1,349,130)", "source_url": "https://reporter.nih.gov/project-details/10710325", "people": [{"name": "Charles Chiedu Nwaokobia", "role": "Principal Investigator"}, {"name": "Evaristus A Nwulia", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K231789", "company": "Guangzhou Xinbo Electronic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231789: Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231789", "people": [{"name": "Sammy Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231789%22"}, {"id": "fda:K233912", "company": "Jeil Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233912: ARIX Cannulated Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233912", "people": [{"name": "Jinwoo Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233912%22"}, {"id": "fda:K233724", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233724: 28mm/38D MDM X3 Insert for MDM Liner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233724", "people": [{"name": "Meenakshi Verma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233724%22"}, {"id": "fda:K231758", "company": "Luminex Molecular Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231758: NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231758", "people": [{"name": "Kate Goscha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231758%22"}, {"id": "fda:K231864", "company": "Codent Technical Industry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231864: Fiber Optic Brushless Electronic Micromotor, model: iM100", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231864", "people": [{"name": "Jyun-Ming Shuo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231864%22"}, {"id": "fda:K234000", "company": "bioMerieux, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234000: VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 \u00b5g/mL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234000", "people": [{"name": "Anne Rasponi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234000%22"}, {"id": "fda:K234015", "company": "Eusa Pharma (Uk) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234015: Caphosol\u00ae Artifical Saliva (32 doses sachet box)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234015", "people": [{"name": "Sandy Suh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234015%22"}, {"id": "fda:K232140", "company": "Ortoma AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232140: OTS Hip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232140", "people": [{"name": "Linus Bystr\u00f6m", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232140%22"}, {"id": "fda:K233922", "company": "Satelec - Acteon Group", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233922: SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233922", "people": [{"name": "Philippe Girard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233922%22"}, {"id": "fda:K233083", "company": "Implant Solutions Pty Ltd (Aka Osteon Medical)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233083: Osteon Precision Milled Suprastructure", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233083", "people": [{"name": "Farah Rahman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233083%22"}, {"id": "nih:5R44DC019586-04", "company": "Restorear Devices, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": 340604, "summary": "NIH award 5R44DC019586-04: Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation ($340,604)", "source_url": "https://reporter.nih.gov/project-details/10806249", "people": [{"name": "Curtis Scott King", "role": "Principal Investigator"}, {"name": "Suhrud M. Rajguru", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44CA281474-02", "company": "Isabl Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": 991890, "summary": "NIH award 5R44CA281474-02: Isabl GxT: A clinically actionable whole genome and transcriptome precision medicine platform ($991,890)", "source_url": "https://reporter.nih.gov/project-details/10815789", "people": [{"name": "Juan Santiago Medina", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K233758", "company": "Ortho Development Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233758: Trivicta\u0099 Hip Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233758", "people": [{"name": "Drew Weaver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233758%22"}, {"id": "fda:K233649", "company": "Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233649: ALGO Pro Newborn Hearing Screener (ALGO Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233649", "people": [{"name": "Bronwyn Kelly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233649%22"}, {"id": "fda:K231760", "company": "Cylite Pty. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231760: HP-OCT (HP-OCT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231760", "people": [{"name": "Arnold Ouyang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231760%22"}, {"id": "fda:K232826", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232826: Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232826", "people": [{"name": "Carroll Martin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232826%22"}, {"id": "fda:K231813", "company": "Sonoscape Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231813: Ultrasonic Gastrovideoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231813", "people": [{"name": "Toki Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231813%22"}, {"id": "fda:K234046", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234046: WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234046", "people": [{"name": "Tijana Prodanovic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234046%22"}, {"id": "fda:K240384", "company": "Okami Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240384: SENDERO Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240384", "people": [{"name": "Jill Delsman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240384%22"}, {"id": "fda:K233943", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233943: Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233943", "people": [{"name": "Matthew Lobeck", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233943%22"}, {"id": "fda:K233438", "company": "Beacon Biosignals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233438: SleepStageML", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233438", "people": [{"name": "Delphine Lemoine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233438%22"}, {"id": "fda:K240264", "company": "Shenzhen Mlay Intelligent Technology Co., , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240264: Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240264", "people": [{"name": "Liu Libin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240264%22"}, {"id": "fda:K233705", "company": "Pulse Biosciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233705: CellFX Percutaneous Electrode System (SYS3000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233705", "people": [{"name": "Uyen Mai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233705%22"}, {"id": "fda:K233198", "company": "OSSIO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233198: OSSIOfiber\u00ae Threaded Trimmable Fixation Nails", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233198", "people": [{"name": "Taly Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233198%22"}, {"id": "fda:K233899", "company": "Pixee Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233899: Knee+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233899", "people": [{"name": "Lucie Pecheur", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233899%22"}, {"id": "fda:K233421", "company": "Carl Zeiss Meditec, AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233421: RESCAN 700", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233421", "people": [{"name": "Katrin Faber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233421%22"}, {"id": "fda:K230195", "company": "Comerge AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230195: Neo ADVISE software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230195", "people": [{"name": "Beat Hugi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230195%22"}, {"id": "fda:K240396", "company": "Cynosure, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240396: Elite iQ PRO (M122K1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240396", "people": [{"name": "Cynthia Aguirre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240396%22"}, {"id": "fda:K233038", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233038: Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233038", "people": [{"name": "Tracy Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233038%22"}, {"id": "fda:K231056", "company": "Wallaby Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231056: Esperance Distal Access Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231056", "people": [{"name": "Nathaniel Knock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231056%22"}, {"id": "fda:K231734", "company": "Tsk Laboratory International Japan KK", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231734: STERiJECT Low Dead Space, STERiJECT The Invisible Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231734", "people": [{"name": "Kana Ebina", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231734%22"}, {"id": "fda:K231904", "company": "Co-Innovation Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231904: Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231904", "people": [{"name": "Hong Feng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231904%22"}, {"id": "fda:K233177", "company": "Cook Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233177: Nest VT Vitrification Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233177", "people": [{"name": "Christopher Sontag", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233177%22"}, {"id": "fda:K233359", "company": "Astura Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233359: DOMINION Expandable Corpectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233359", "people": [{"name": "Parker Kelch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233359%22"}, {"id": "nih:5R44AI174495-02", "company": "Big Eye Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-07", "observed": "2026-08-21", "amount_usd": 908264, "summary": "NIH award 5R44AI174495-02: SUPPORTING WHO ONCHOCERCIASIS ELIMINATION PROGRAMS: PROGRESSING A HIGHLY SENSITIVE AND ULTRA-SPECIFIC RAPID DIAGNOSTIC TEST TO COMMERCIALIZATION READINESS ($908,264)", "source_url": "https://reporter.nih.gov/project-details/10810633", "people": [{"name": "Marco Antonio Biamonte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K240407", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240407: ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240407", "people": [{"name": "Matt Corbett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240407%22"}, {"id": "fda:K232207", "company": "Dk Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232207: D\u00b7Kutting\u0099 PTA Scoring Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232207", "people": [{"name": "Shi Quan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232207%22"}, {"id": "fda:K240371", "company": "Rayence Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240371: 0909FCC, 0909FCC-HS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240371", "people": [{"name": "Inhwan Bang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240371%22"}, {"id": "fda:K232781", "company": "Jiangsu Caina Medical Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232781: Safety Sliding Blood Collection Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232781", "people": [{"name": "Camel Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232781%22"}, {"id": "fda:K240458", "company": "Ventris Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240458: Synthetic Bone Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240458", "people": [{"name": "John Brunelle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240458%22"}, {"id": "fda:K233692", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233692: Voluson Signature 20, Voluson Signature 18", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233692", "people": [{"name": "Bryan Behn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233692%22"}, {"id": "sbir:DOD:FA8649-24-P-0508", "company": "Gelsana Therapeutics Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-03-07", "observed": "2026-09-18", "amount_usd": 1249624, "summary": "DOD SBIR Phase II award $1,249,624: Advancing Military Healthcare: Novel Zwitterionic Hydrogels for Enhanced Wound Healing in Combat-Related Burn Injuries", "source_url": "https://www.sbir.gov/awards?search=FX235-CSO1-1384"}, {"id": "nih:5R44CA281581-02", "company": "Invenio Imaging Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": 1054721, "summary": "NIH award 5R44CA281581-02: A multicenter study in bronchoscopy combining Stimulated Raman Histology with Artificial intelligence for rapid lung cancer detection - The ON-SITE study ($1,054,721)", "source_url": "https://reporter.nih.gov/project-details/10798269", "people": [{"name": "Jason A. Akulian", "role": "Principal Investigator"}, {"name": "Christian Freudiger", "role": "Principal Investigator"}, {"name": "Bryan Christopher Husta", "role": "Principal Investigator"}, {"name": "David Edward Ost", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K240273", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240273: Access Free T4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240273", "people": [{"name": "Muhammad Sheikh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240273%22"}, {"id": "fda:K232004", "company": "Medivators (A Subsidiary of Steris Corporation)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232004: Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232004", "people": [{"name": "Nick Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232004%22"}, {"id": "fda:K240352", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240352: Defendo Single Use Cleaning Adapter for Olympus Endoscopes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240352", "people": [{"name": "Carroll Martin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240352%22"}, {"id": "fda:K231497", "company": "Shenzhen HugeMed Medical Technical Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231497: Choledochoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231497", "people": [{"name": "Cathy Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231497%22"}, {"id": "fda:K233075", "company": "Biogend Therapeutics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233075: \u0093BioGend\u0094 Interbody Fusion System 001 Cage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233075", "people": [{"name": "Chienpei Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233075%22"}, {"id": "fda:K233794", "company": "Spm Medicare Pvt. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233794: Insulin Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233794", "people": [{"name": "Vipin Panwar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233794%22"}, {"id": "fda:K231677", "company": "Edgecare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231677: EdgeFlow UH10", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231677", "people": [{"name": "Park Sangeun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231677%22"}, {"id": "fda:K232270", "company": "Koge Micro Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232270: DVT Motion Pneumatic Compression Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232270", "people": [{"name": "Doris Chiu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232270%22"}, {"id": "fda:K232703", "company": "Jiangsu Hope Biomedical Science & Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232703: Disposable Bipolar Forceps", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232703", "people": [{"name": "Shaote Geng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232703%22"}, {"id": "fda:K233021", "company": "Care Fusion", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233021: BD SmartSite\u0099 13mm Vial Access Device; BD SmartSite\u0099 20mm Vial Access Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233021", "people": [{"name": "Stefanee Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233021%22"}, {"id": "fda:K240619", "company": "Kids-E-Dental Llp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240619: e-SDF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240619", "people": [{"name": "Mukul Jain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240619%22"}, {"id": "fda:K240351", "company": "Assure Tech., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240351: FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240351", "people": [{"name": "Allen Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240351%22"}, {"id": "fda:K231403", "company": "Evonos GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231403: evoDrill Cranial Perforator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231403", "people": [{"name": "J\u00f6rg Mans", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231403%22"}, {"id": "fda:K233572", "company": "Pymedix", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233572: Autofuse", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233572", "people": [{"name": "Kris Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233572%22"}, {"id": "fda:K233880", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233880: Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233880", "people": [{"name": "Athena Pan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233880%22"}, {"id": "fda:K232424", "company": "El Global Trade, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232424: CurrentBody Skin RF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232424", "people": [{"name": "Sivan Fishman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232424%22"}, {"id": "fda:K231786", "company": "Cosm Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231786: Gynethotics\u0099 Pessary", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231786", "people": [{"name": "Linda Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231786%22"}, {"id": "fda:K231210", "company": "Modern Dental Laboratory (Dg) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231210: DGA Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231210", "people": [{"name": "Robin Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231210%22"}, {"id": "fda:K231260", "company": "Suzhou AcuVu Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231260: HTx Disposable Hysteroscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231260", "people": [{"name": "Sam Mostafavi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231260%22"}, {"id": "fda:K240459", "company": "Bonesupport AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240459: Cerament Bone Void Filler", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240459", "people": [{"name": "Blerta Shuka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240459%22"}, {"id": "fda:K233526", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233526: Medline Open-back Level 3 Protective Gown", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233526", "people": [{"name": "Kelsey Closen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233526%22"}, {"id": "fda:K240404", "company": "Novabone Products, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240404: NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240404", "people": [{"name": "Ed Horton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240404%22"}, {"id": "fda:K240597", "company": "Graphy, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240597: TERA HARZ CLEAR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240597", "people": [{"name": "Moon-Soo Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240597%22"}, {"id": "fda:K233859", "company": "YAMAHACHI DENTAL MFG., Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233859: BASIS FLOW II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233859", "people": [{"name": "Masashi Toyama", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233859%22"}, {"id": "fda:K240090", "company": "Conmed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240090: Argo Knotless GENESYS Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240090", "people": [{"name": "Dionne Sanders", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240090%22"}, {"id": "fda:K234070", "company": "Dexcom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234070: Stelo Glucose Biosensor System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234070", "people": [{"name": "Neeta Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234070%22"}, {"id": "nih:3R44GM145183-03S1", "company": "Microsensor Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-04", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44GM145183-03S1: SBIR Fast Track: Development of a High-throughput Magnetic Cytometer for Single Cell Sorting ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10947076", "people": [{"name": "Peng Paul Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DK131766-02", "company": "Fistula Solution Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-04", "observed": "2026-08-21", "amount_usd": 652866, "summary": "NIH award 5R44DK131766-02: Novel Post-surgical Incision Management Device to Prevent Ostomy Complications ($652,866)", "source_url": "https://reporter.nih.gov/project-details/10788344", "people": [{"name": "Andrew T Obst", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K231288", "company": "Vyvo Technology Corp.(Vt)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231288: Vyvo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231288", "people": [{"name": "Alfonso Cioffi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231288%22"}, {"id": "fda:K233877", "company": "Magic Mobility", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233877: XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233877", "people": [{"name": "Terence Walsh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233877%22"}, {"id": "fda:K230047", "company": "Gigaalaser Company , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230047: Medical Diode Laser Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230047", "people": [{"name": "Xinxing Nie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230047%22"}, {"id": "fda:K233738", "company": "Overjet, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233738: Overjet Caries Assist-Pediatric", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233738", "people": [{"name": "Deepthi Paknikar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233738%22"}, {"id": "fda:K240453", "company": "Orthorebirth Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240453: ReBOSSIS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240453", "people": [{"name": "Yasutoshi Nishikawa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240453%22"}, {"id": "nih:1R44AI177199-01A1", "company": "Inhalon Biopharma, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": 1024986, "summary": "NIH award 1R44AI177199-01A1: SBIR: IND-enabling development of IN-007, an inhaled muco-trapping immunotherapy for COVID19 and other ACE2-targeted infections ($1,024,986)", "source_url": "https://reporter.nih.gov/project-details/10822870", "people": [{"name": "JEFF T HUTCHINS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K231365", "company": "Anhui Intco Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231365: Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231365", "people": [{"name": "Max li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231365%22"}, {"id": "fda:K232385", "company": "Iss Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232385: OxiplexTS200", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232385", "people": [{"name": "Beniamino Barbieri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232385%22"}, {"id": "fda:K232328", "company": "Innovative Health Sciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232328: Insignis\u0099 Syringe Infusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232328", "people": [{"name": "Phil Daetwyler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232328%22"}, {"id": "fda:K233030", "company": "Mriguidance B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233030: BoneMRI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233030", "people": [{"name": "David Sparks", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233030%22"}, {"id": "fda:K233410", "company": "Luminex Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233410: LIAISON PLEX Respiratory Flex Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233410", "people": [{"name": "Tara Viviani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233410%22"}, {"id": "fda:K231915", "company": "Zfx GmbH - A Company of Zimvie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231915: Zfx Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231915", "people": [{"name": "Ana Leit\u00e3o", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231915%22"}, {"id": "fda:K232828", "company": "Topcon Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232828: IMAGEnet6 Ophthalmic Data System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232828", "people": [{"name": "Ryota Kitawaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232828%22"}, {"id": "fda:K240083", "company": "W. L. Gore & Associates, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240083: GORE\u00ae PROPATEN\u00ae Vascular Graft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240083", "people": [{"name": "Christine Snyder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240083%22"}, {"id": "fda:K233095", "company": "Micro Current Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233095: S21 OTC Transcutaneous Electrical Nerve Stimulator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233095", "people": [{"name": "David Suzuki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233095%22"}, {"id": "fda:K232316", "company": "Deka Research and Development", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232316: DEKA Infusion System, DEKA Administration Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232316", "people": [{"name": "Paul Smolenski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232316%22"}, {"id": "fda:K240277", "company": "Reprise Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240277: MiroDry Wound Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240277", "people": [{"name": "Badali Erin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240277%22"}, {"id": "fda:K231648", "company": "Shenzhen Yiran Intelligent Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231648: Muscle Stimulator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231648", "people": [{"name": "Fengqing Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231648%22"}, {"id": "fda:K233862", "company": "Premier North America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233862: NUNA LUX (NUNL528)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233862", "people": [{"name": "Doris Dong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233862%22"}, {"id": "fda:K232791", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232791: Access Intact PTH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232791", "people": [{"name": "Neha Desai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232791%22"}, {"id": "fda:K240023", "company": "Shenzhen YI Fang Blister Packaging Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240023: Probe Covers (YF-001, YF-002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240023", "people": [{"name": "Xu Junwen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240023%22"}, {"id": "fda:K232040", "company": "Tyros Biopharma, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232040: Gynatrof", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232040", "people": [{"name": "Anthony Gouvoussis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232040%22"}, {"id": "fda:K231778", "company": "Nihon Kohden Orangemed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231778: Nihon Kohden NKV-550 Series Ventilator System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231778", "people": [{"name": "Sheryl Higgins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231778%22"}, {"id": "fda:K231690", "company": "Highrad , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-03-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231690: iCAS-LV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231690", "people": [{"name": "Yossi Srour", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231690%22"}, {"id": "nih:5R44DK120242-03", "company": "Silicon Kidney, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": 1019958, "summary": "NIH award 5R44DK120242-03: A silicon nanopore membrane blood filter enabling anticoagulant free continuous renal replacement therapy for acute kidney injury ($1,019,958)", "source_url": "https://reporter.nih.gov/project-details/10784679", "people": [{"name": "Charles Blaha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44GM143996-03", "company": "Infotech Soft, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": 714276, "summary": "NIH award 5R44GM143996-03: Deep-CDS: Deep Learning Semantic Data Lake for Clinical Decision Support ($714,276)", "source_url": "https://reporter.nih.gov/project-details/10799703", "people": [{"name": "Mansur R. Kabuka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42MD014943-04", "company": "Klein Buendel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": 108370, "summary": "NIH award 5R42MD014943-04: Translating an In-Person Brief, Bystander Bullying Intervention (STAC) to a Technology-Based - Phase II ($108,370)", "source_url": "https://reporter.nih.gov/project-details/10911780", "people": [{"name": "Aida Midgett", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K240051", "company": "Lingshi Hongruida Health Protection Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240051: Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240051", "people": [{"name": "Tinglong Chai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240051%22"}, {"id": "fda:K232842", "company": "Ningbo Hicren Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232842: Balloon Inflation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232842", "people": [{"name": "Qian Jia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232842%22"}, {"id": "fda:K230837", "company": "Agnes Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230837: PlazMagik", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230837", "people": [{"name": "Jiwon Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230837%22"}, {"id": "fda:K232765", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232765: MAGNETOM Cima.X Fit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232765", "people": [{"name": "Alina Goodman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232765%22"}, {"id": "fda:K240257", "company": "Bd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240257: Denali\u0099 Vena Cava Filter System \u0096 Femoral and Jugular/Subclavian Delivery Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240257", "people": [{"name": "Andrew Quach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240257%22"}, {"id": "fda:K240244", "company": "Guard Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240244: NPseal (Small, Medium, Large)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240244", "people": [{"name": "Machiel Van der Leest", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240244%22"}, {"id": "fda:K232971", "company": "Alembic, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232971: APRO 55 Catheter and Alembic Aspiration Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232971", "people": [{"name": "Lisa Yen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232971%22"}, {"id": "fda:K233360", "company": "Curiteva, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233360: Curiteva Thoracolumbar Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233360", "people": [{"name": "Eric Linder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233360%22"}, {"id": "fda:K240268", "company": "Accufix Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240268: Accu-Joint Hemi Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240268", "people": [{"name": "Michael Parisi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240268%22"}, {"id": "fda:K231683", "company": "Inheart, Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231683: in HEART Models", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231683", "people": [{"name": "Audrey Labeque", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231683%22"}, {"id": "pma:P230035", "company": "Boston Scientific Corporation", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-02-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230035: AGENT Paclitaxel-Coated Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230035", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230035%22"}, {"id": "breakthrough:P230035", "company": "Boston Scientific Corporation", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-02-29", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230035: AGENT PACLITAXEL-COATED BALLOON CATHETER", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44EY029906-03", "company": "Lightoptech Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-28", "observed": "2026-08-21", "amount_usd": 886898, "summary": "NIH award 5R44EY029906-03: In vivo high-definition 3D corneal imaging ($886,898)", "source_url": "https://reporter.nih.gov/project-details/10783792", "people": [{"name": "Cristina Canavesi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44HL151147-03", "company": "DNA Medicine Institute", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-28", "observed": "2026-08-21", "amount_usd": 999888, "summary": "NIH award 2R44HL151147-03: Hemophilia Point-of-Care Monitoring Device and App ($999,888)", "source_url": "https://reporter.nih.gov/project-details/10793052", "people": [{"name": "Eugene Yan-ho Chan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K231845", "company": "Foshan Safety Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231845: Dental unit Model: Mare", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231845", "people": [{"name": "May Xian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231845%22"}, {"id": "fda:K232885", "company": "Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232885: Dawn Diode Laser System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232885", "people": [{"name": "Lily Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232885%22"}, {"id": "fda:K233830", "company": "Medtronic Sofamor Danek USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233830: OsteoCool\u0099 2.0 RF Ablation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233830", "people": [{"name": "Jeff Sprague", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233830%22"}, {"id": "fda:K232562", "company": "Baylis Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232562: PowerWire Radiofrequency Guidewire Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232562", "people": [{"name": "Stephanie Gallone", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232562%22"}, {"id": "fda:K233488", "company": "Vioptix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233488: Intra.Ox\u0099 2.0 Handheld Tissue Oximeter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233488", "people": [{"name": "Scott Coleridge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233488%22"}, {"id": "fda:K232613", "company": "Innolitics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232613: CT Cardiomegaly", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232613", "people": [{"name": "Yujan Shrestha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232613%22"}, {"id": "fda:DEN230024", "company": "Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230024: Technozym ADAMTS13 Activity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230024", "people": [{"name": "Nikolaus Binder", "role": "510(k) submission contact"}]}, {"id": "denovo:DEN230024", "company": "Technoclone Herstellung Von Diagnostika", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-02-28", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230024 granted: Technozym ADAMTS13 Activity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230024"}, {"id": "nih:1R43EY035946-01", "company": "Myriad Advanced Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-27", "observed": "2026-08-21", "amount_usd": 269472, "summary": "NIH award 1R43EY035946-01: System on Chip for Intraoperative OCT ($269,472)", "source_url": "https://reporter.nih.gov/project-details/10823142", "people": [{"name": "Muhammad Al-Qaisi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43AI174349-02", "company": "Jbs Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-27", "observed": "2026-08-21", "amount_usd": 289302, "summary": "NIH award 5R43AI174349-02: Development of a PCR assay for quantitative detection of HBV cccDNA ($289,302)", "source_url": "https://reporter.nih.gov/project-details/10804690", "people": [{"name": "Selena Lin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "fda:K233879", "company": "Maquet Cardiovascular, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233879: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233879", "people": [{"name": "Timothy Rice", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233879%22"}, {"id": "fda:K233972", "company": "Camber Spine Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233972: Camber Sacroiliac (SI) Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233972", "people": [{"name": "Brooks McAdam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233972%22"}, {"id": "fda:K233435", "company": "Pnq Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233435: Peace N Quiet (0.7.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233435", "people": [{"name": "Kurtis Goos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233435%22"}, {"id": "fda:K232522", "company": "Ark Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232522: ARK Levetiracetam II Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232522", "people": [{"name": "Dionne Labatore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232522%22"}, {"id": "fda:K232607", "company": "Solco Biomedical Copany India Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232607: 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232607", "people": [{"name": "Darshak Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232607%22"}, {"id": "fda:K233623", "company": "Medxl, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233623: Praxiject\u0099 SP 0.9% NaCl", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233623", "people": [{"name": "Faiza Benazza", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233623%22"}, {"id": "fda:K234014", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234014: Obsidian\u00ae NOW", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234014", "people": [{"name": "Nina Chiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234014%22"}, {"id": "fda:K222400", "company": "K1Med Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222400: Coresculpt & Magsculpt", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222400", "people": [{"name": "Chang Ho Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222400%22"}, {"id": "nih:1R44AI181154-01", "company": "Nanopathdx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-26", "observed": "2026-08-21", "amount_usd": 996726, "summary": "NIH award 1R44AI181154-01: Multiplexed Assay for Point-of-Care UTI Diagnosis (ID/AMR) ($996,726)", "source_url": "https://reporter.nih.gov/project-details/10820854", "people": [{"name": "Alison Burklund", "role": "Principal Investigator"}, {"name": "Amogha Tadimety", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R42HD100251-02", "company": "Sersense, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-26", "observed": "2026-08-21", "amount_usd": 780138, "summary": "NIH award 2R42HD100251-02: Automated microfluidic device for blood analysis in neonates ($780,138)", "source_url": "https://reporter.nih.gov/project-details/10822187", "people": [{"name": "Alan M Gonzalez-Suarez", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K233560", "company": "Eco Medi Glove Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233560: Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233560", "people": [{"name": "Suresh Kumar Sivalingam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233560%22"}, {"id": "fda:K232628", "company": "Icotec AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232628: VADER\u00ae Pedicle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232628", "people": [{"name": "Marina Hess", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232628%22"}, {"id": "fda:K233675", "company": "DePuy Mitek, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233675: FMS VUE\u0099 Fluid Management and Tissue Debridement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233675", "people": [{"name": "Pol Fort Grebol", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233675%22"}, {"id": "fda:K232752", "company": "Jiangsu Vedkang Medical Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232752: Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232752", "people": [{"name": "Zheng Xinxing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232752%22"}, {"id": "fda:K230693", "company": "Covidien, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230693: BIS\u0099 Advance Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230693", "people": [{"name": "Moshe J Cohen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230693%22"}, {"id": "fda:K231822", "company": "Batrik Medical Manufacturing, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231822: GOLFF Sterile Anti-Fog Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231822", "people": [{"name": "Suzy Bairos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231822%22"}, {"id": "fda:K230782", "company": "Wat Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230782: TENS device-HeadaTerm 2 (Model: YF-HT2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230782", "people": [{"name": "Joe Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230782%22"}, {"id": "fda:K234133", "company": "Dexcom, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234133: Dexcom G7 Continuous Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234133", "people": [{"name": "Neeta Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234133%22"}, {"id": "fda:K232084", "company": "Bausch and Lomb", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232084: Stellaris Elite vision enhancement system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232084", "people": [{"name": "Rekha Janarthanan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232084%22"}, {"id": "breakthrough:K232628", "company": "Icotec Ag", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-02-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K232628: VADER PEDICLE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:FA8649-24-P-0429", "company": "Certus Critical Care, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-02-26", "observed": "2026-09-18", "amount_usd": 1249788, "summary": "DOD SBIR Phase II award $1,249,788: Endovascular Aortic Control (EVAC) Modular Disposable Catheter Research & Development", "source_url": "https://www.sbir.gov/awards?search=F2D-11283"}, {"id": "nih:3R43NS129363-01A1S1", "company": "Eysz, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": 137261, "summary": "NIH award 3R43NS129363-01A1S1: A Mobile Health Application to Detect Absence Seizures using Hyperventilation and Eye-Movement Recordings ($137,261)", "source_url": "https://reporter.nih.gov/project-details/10986212", "people": [{"name": "Rachel Kuperman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240213", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240213: Iconix Knotless Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240213", "people": [{"name": "Bianca Silva de Sousa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240213%22"}, {"id": "fda:K240011", "company": "Jkh Health Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240011: Lymphedema Compression", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240011", "people": [{"name": "Pu Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240011%22"}, {"id": "fda:K233995", "company": "Ivoclar Vivadent, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233995: Ivotion Base Print", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233995", "people": [{"name": "Anderjeet Gulati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233995%22"}, {"id": "fda:K232800", "company": "SI-BONE, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232800: Navigation Tracking Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232800", "people": [{"name": "Daniel Cher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232800%22"}, {"id": "fda:K232174", "company": "Genoss Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232174: rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232174", "people": [{"name": "Hayoung Sung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232174%22"}, {"id": "fda:K233784", "company": "Hinge Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233784: ENSO (Model 2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233784", "people": [{"name": "Brandon Casa de Calvo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233784%22"}, {"id": "fda:K240190", "company": "Medtronic", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240190: MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240190", "people": [{"name": "Kaitlin Cady", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240190%22"}, {"id": "fda:K232075", "company": "Nova Biomedical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232075: StatStrip Glucose Hospital Meter System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232075", "people": [{"name": "Abhinav Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232075%22"}, {"id": "fda:K230423", "company": "Taian Dalu Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230423: Electronic Peak Flow Meter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230423", "people": [{"name": "Wang Yuqin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230423%22"}, {"id": "fda:K240201", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240201: PathLoc SI Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240201", "people": [{"name": "Kihyang Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240201%22"}, {"id": "fda:K232536", "company": "Embolx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232536: Soldier Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232536", "people": [{"name": "Louise Musante", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232536%22"}, {"id": "fda:K233754", "company": "Aiomega, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233754: AIO Breathe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233754", "people": [{"name": "Raghavendra Ghuge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233754%22"}, {"id": "fda:DEN230025", "company": "Virtual Incision", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230025: MIRA Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230025", "people": [{"name": "Florence Beck", "role": "510(k) submission contact"}]}, {"id": "fda:K240212", "company": "Ortho Solutions UK , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240212: COGNiTiON\u0099 Staple System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240212", "people": [{"name": "Alex Faley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240212%22"}, {"id": "fda:K233590", "company": "Overjet, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233590: Overjet Charting Assist", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233590", "people": [{"name": "Deepthi Paknikar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233590%22"}, {"id": "fda:K233709", "company": "Mt. Derm GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233709: Exceed Unlimited", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233709", "people": [{"name": "Andreas Pachten", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233709%22"}, {"id": "fda:K233576", "company": "Shenzhen Konmed Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233576: Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233576", "people": [{"name": "Shuishan Yin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233576%22"}, {"id": "fda:K231679", "company": "Ascensia Diabetes Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231679: CONTOUR\u00ae PLUS BLUE Blood Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231679", "people": [{"name": "Shahrir Alam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231679%22"}, {"id": "fda:K233722", "company": "Shimadzu Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233722: RADspeed Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233722", "people": [{"name": "Koichi Kataoka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233722%22"}, {"id": "fda:K231601", "company": "Sebia", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231601: FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231601", "people": [{"name": "Karen Anderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231601%22"}, {"id": "fda:K232228", "company": "Shanghai Accurature Diagnostics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232228: Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232228", "people": [{"name": "Shuang He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232228%22"}, {"id": "denovo:DEN230025", "company": "Virtual Incision", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-02-23", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230025 granted: MIRA Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230025"}, {"id": "nih:3R44DE031461-03S1", "company": "Pediametrix Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": 44553, "summary": "NIH award 3R44DE031461-03S1: Mobile Three-Dimensional Screening for Cranial Malformations ($44,553)", "source_url": "https://reporter.nih.gov/project-details/11040436", "people": [{"name": "Fereshteh Aalamifar", "role": "Principal Investigator"}, {"name": "Reza Seifabadi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K240313", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240313: Oligio X", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240313", "people": [{"name": "Yoon Hyunsik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240313%22"}, {"id": "fda:K240173", "company": "Treace Medical Concepts, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240173: Treace Medical Systems (TMC) Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240173", "people": [{"name": "Melissa Coloroso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240173%22"}, {"id": "fda:K240193", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240193: R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240193", "people": [{"name": "Luigi Vecchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240193%22"}, {"id": "fda:K214037", "company": "Ergo-Flex Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K214037: Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K214037", "people": [{"name": "Linda Anderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K214037%22"}, {"id": "fda:K233544", "company": "Dentis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233544: MESHEET", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233544", "people": [{"name": "Gyu Ri Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233544%22"}, {"id": "fda:K233749", "company": "Ge Hangwei Medical Systems Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233749: Revolution Ascend Sliding", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233749", "people": [{"name": "Wenqing Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233749%22"}, {"id": "fda:K223826", "company": "Drawbridge Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223826: NanoDrop Lancet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223826", "people": [{"name": "Dan McEvoy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223826%22"}, {"id": "fda:K231876", "company": "Asclepion Laser Technologies GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231876: MultiPulse HoPLUS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231876", "people": [{"name": "Tom Gruender", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231876%22"}, {"id": "fda:K233640", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233640: Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233640", "people": [{"name": "Andrew Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233640%22"}, {"id": "fda:K231875", "company": "Advanced Tactile Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231875: Vaginal Tactile Ultrasound Imager", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231875", "people": [{"name": "Brendan Francy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231875%22"}, {"id": "fda:K232074", "company": "Tns Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232074: Serafin\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232074", "people": [{"name": "Won-gun Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232074%22"}, {"id": "fda:K233775", "company": "Bosch Healthcare Solutions GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233775: Vivatmo pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233775", "people": [{"name": "Carola D\u00f6ffinger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233775%22"}, {"id": "fda:K232163", "company": "Zhejiang Horizon Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232163: Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232163", "people": [{"name": "Wu Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232163%22"}, {"id": "fda:K232831", "company": "Anoxia Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232831: Quiver Aspiration Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232831", "people": [{"name": "Henry Nita", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232831%22"}, {"id": "fda:K240174", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240174: 1688 4K Camera System with Advanced Imaging Modality", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240174", "people": [{"name": "Marlene Fraga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240174%22"}, {"id": "fda:K233996", "company": "Ulthera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233996: Ulthera System (UC-1 Control Unit PRIME)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233996", "people": [{"name": "Kim Kelly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233996%22"}, {"id": "nih:1R43AI181390-01", "company": "Numentus Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-21", "observed": "2026-08-21", "amount_usd": 297872, "summary": "NIH award 1R43AI181390-01: Rapid, versatile PCR ($297,872)", "source_url": "https://reporter.nih.gov/project-details/10822555", "people": [{"name": "GREGORY W FARIS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K232148", "company": "X-Nav Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232148: X-Guide Surgical Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232148", "people": [{"name": "Kimberly Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232148%22"}, {"id": "fda:K233199", "company": "Orthosoft Inc (D/B/A Zimmer Cas)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233199: ROSA\u00ae Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233199", "people": [{"name": "Sankalp Dere", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233199%22"}, {"id": "fda:K233439", "company": "Qingdao Hisense Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233439: HD60 Series Ultrasound Diagnostic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233439", "people": [{"name": "Yalan Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233439%22"}, {"id": "fda:K232265", "company": "Tornier S.A.S.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232265: BLUEPRINT\u0099 Patient Specific Instrumentation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232265", "people": [{"name": "Aymen Azaiez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232265%22"}, {"id": "fda:DEN230064", "company": "Rapid Medical Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230064: BraidE Embolization Assist Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230064", "people": [{"name": "Ina Gutman", "role": "510(k) submission contact"}]}, {"id": "fda:K231561", "company": "Guangzhou Homesun Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231561: Pulmonary Function Tester, Model: A9", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231561", "people": [{"name": "Suijie Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231561%22"}, {"id": "fda:K231753", "company": "Oneday Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231753: Oneday Implant Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231753", "people": [{"name": "Jinhwan Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231753%22"}, {"id": "fda:K240194", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240194: ProCinch, QuadCinch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240194", "people": [{"name": "Paulie Vagts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240194%22"}, {"id": "fda:K232502", "company": "Care Essentials Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232502: Cocoon Convective Warming System, Model CWS7000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232502", "people": [{"name": "Abhay Sinha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232502%22"}, {"id": "fda:K233325", "company": "Visionary Optics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233325: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233325", "people": [{"name": "Donald Sanders", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233325%22"}, {"id": "denovo:DEN230064", "company": "Rapid Medical Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-02-21", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230064 granted: BraidE Embolization Assist Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230064"}, {"id": "nih:1R44HG013591-01", "company": "Lase Innovation Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-20", "observed": "2026-08-21", "amount_usd": 239680, "summary": "NIH award 1R44HG013591-01: DNA-optical barcoding technology for spatiotemporal single-cell analysis ($239,680)", "source_url": "https://reporter.nih.gov/project-details/10822207", "people": [{"name": "Sheldon J.J. Kwok", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD019203-01", "company": "Oregon Res Behavioral Intervention Strat", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-20", "observed": "2026-08-21", "amount_usd": 295922, "summary": "NIH award 1R43MD019203-01: HealthyU-Native: A Technology-Based Tool for Addressing Health Literacy in Native American/Alaska Native Secondary Students ($295,922)", "source_url": "https://reporter.nih.gov/project-details/10821128", "people": [{"name": "Alexandra Hamilton", "role": "Principal Investigator"}, {"name": "Jacqueline Huscroft-D'Angelo", "role": "Principal Investigator"}, {"name": "Jessie Marquez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K233471", "company": "Stryker Sustainability Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233471: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233471", "people": [{"name": "Aphrodeja Crutch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233471%22"}, {"id": "fda:K233194", "company": "Osstem Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233194: TS Abutment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233194", "people": [{"name": "Seungju Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233194%22"}, {"id": "fda:K231896", "company": "Beijing Adss Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231896: Diode Laser Therapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231896", "people": [{"name": "Song Ying", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231896%22"}, {"id": "fda:K233760", "company": "Shenzhen Leaflife Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233760: Mjolnir Pro. (Multi\u0096electrode plasma)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233760", "people": [{"name": "Qiang Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233760%22"}, {"id": "fda:K233150", "company": "Narang Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233150: NET BRAND Osteosynthesis Nailing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233150", "people": [{"name": "Vivek Narang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233150%22"}, {"id": "fda:K233454", "company": "Roche Diagnostics Operations", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233454: ONLINE TDM Methotrexate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233454", "people": [{"name": "Elina Voronovsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233454%22"}, {"id": "nih:3R43AG081111-01S2", "company": "Outlier Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-19", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43AG081111-01S2: A Gesture-Powered Software Platform of Neurologic Music Therapy Games and Puzzles: To Stimulate Neuroplasticity and Prolong Functional Independence in Individuals Diagnosed with Alzheimer's Disease ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10988114", "people": [{"name": "Peter Gray", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240146", "company": "Bard Access Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240146: BD Prevue\u0099 II Peripheral Vascular Access System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240146", "people": [{"name": "Samira Saeed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240146%22"}, {"id": "fda:K231513", "company": "Beijing Biosis Healing Biolog Ical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231513: Oral Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231513", "people": [{"name": "Ting Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231513%22"}, {"id": "fda:K231657", "company": "Implantcast GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231657: AGILON\u00ae XO Shoulder Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231657", "people": [{"name": "Juliane H\u00f6ppner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231657%22"}, {"id": "fda:K232645", "company": "Airgle Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232645: Airgle Room Air Purifier", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232645", "people": [{"name": "Jerry Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232645%22"}, {"id": "fda:K231985", "company": "Shenzhen Mecun Medical Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231985: Disposable Grounding Pad", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231985", "people": [{"name": "Zheng Bo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231985%22"}, {"id": "fda:K232087", "company": "Formlabs Ohio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232087: Dental LT Comfort Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232087", "people": [{"name": "Ritika Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232087%22"}, {"id": "fda:K233708", "company": "Synaptic Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233708: NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233708", "people": [{"name": "Jake Harandi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233708%22"}, {"id": "fda:K230235", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230235: Medline Luer Lock Syringes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230235", "people": [{"name": "Kelsey Closen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230235%22"}, {"id": "fda:K233906", "company": "Wellysis Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233906: S-Patch (S-Patch ExL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233906", "people": [{"name": "Sam Engelman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233906%22"}, {"id": "fda:K232771", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232771: Montage Flowable Settable, Resorbable Bone Paste", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232771", "people": [{"name": "Aniq Darr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232771%22"}, {"id": "fda:K240137", "company": "Neos Surgery S.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240137: Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240137", "people": [{"name": "Eduard Garcia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240137%22"}, {"id": "fda:K232043", "company": "Guangzhou Red Pine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232043: Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232043", "people": [{"name": "Weihua Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232043%22"}, {"id": "fda:K234005", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234005: Access CK-MB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234005", "people": [{"name": "Neha Desai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234005%22"}, {"id": "fda:K240148", "company": "Emed Technologies Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240148: SCIg60 Infusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240148", "people": [{"name": "Olena Whalen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240148%22"}, {"id": "fda:K232420", "company": "Philips Medical Systems Nederland B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232420: Zenition 30", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232420", "people": [{"name": "Gyanendra Mani Tripathi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232420%22"}, {"id": "fda:K233658", "company": "Biowy Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233658: Biowy Tym Tube (TT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233658", "people": [{"name": "Zhihua Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233658%22"}, {"id": "fda:K231453", "company": "Nvision Biomedical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231453: SnapHammer Hammertoe Correction System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231453", "people": [{"name": "Diana Langham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231453%22"}, {"id": "fda:K233652", "company": "Quality Electrodynamics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233652: Contour Hand/Wrist (Q7000232)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233652", "people": [{"name": "JoVanna Boudreaux", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233652%22"}, {"id": "fda:K240119", "company": "Laminate Medical Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240119: VasQ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240119", "people": [{"name": "Orit Yarden", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240119%22"}, {"id": "fda:K232245", "company": "Jiangsu Vedkang Medical Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232245: VedDilator ^TM (3-Stage Balloon Dilation Catheter)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232245", "people": [{"name": "Bao Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232245%22"}, {"id": "fda:K233656", "company": "Quality Electrodynamics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233656: Contour Shoulder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233656", "people": [{"name": "JoVanna Boudreaux", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233656%22"}, {"id": "fda:K231659", "company": "Medisono", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231659: MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231659", "people": [{"name": "Jorge Millan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231659%22"}, {"id": "fda:K222917", "company": "Shaoxing Haitech Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222917: Breathing circuit bacterial/viral filter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222917", "people": [{"name": "Liming Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222917%22"}, {"id": "fda:K240130", "company": "Lg Electronics.Inc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240130: Medical Monitor (21HQ613D)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240130", "people": [{"name": "Hanseul Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240130%22"}, {"id": "fda:K234036", "company": "Neuro Spinal Innovation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234036: SONIK MONARK 100", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234036", "people": [{"name": "Aslam Khan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234036%22"}, {"id": "fda:K234028", "company": "Heraeus Medical GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234028: COPAL\u00ae exchange G hip spacer; COPAL\u00ae G+V", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234028", "people": [{"name": "Heike Gustke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234028%22"}, {"id": "fda:K232915", "company": "Empatica S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232915: EpiMonitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232915", "people": [{"name": "Alberto Poli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232915%22"}, {"id": "fda:K240157", "company": "Deerfield Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240157: InVision\u0099 1.5 Surgical Theatre", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240157", "people": [{"name": "Liz Ashworth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240157%22"}, {"id": "fda:K231107", "company": "Hunan Endoso Life Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231107: Bronchoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231107", "people": [{"name": "Fu Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231107%22"}, {"id": "fda:K233483", "company": "Cardio Flow Inc.,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233483: FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233483", "people": [{"name": "Michael Kallok", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233483%22"}, {"id": "fda:K231522", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231522: EMPHASYS\u0099 Dual Mobility System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231522", "people": [{"name": "Farah Valli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231522%22"}, {"id": "fda:K223493", "company": "Selux Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223493: PBC Separator with Selux AST System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223493", "people": [{"name": "Eric Stern", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223493%22"}, {"id": "breakthrough:K223493", "company": "Selux Diagnostics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-02-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K223493: PBC SEPARATOR", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:HR001124C0396", "company": "The Ultran Group, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-02-15", "observed": "2026-09-18", "amount_usd": 2999629, "summary": "DOD SBIR Phase II award $2,999,629: Wearable Ultrasonic Device for Patient Self-Administered Treatment of Inflammation", "source_url": "https://www.sbir.gov/awards?search=D2S-0070"}, {"id": "nih:3R43CA281547-01A1S1", "company": "Vizlitics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-14", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43CA281547-01A1S1: VIPCare: A cancer patient surveillance platform that runs clinical workflow for identifying, tracking, evaluating and engaging cancer surveillance cases. ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10987225", "people": [{"name": "Sharon Hensley Alford", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K233678", "company": "Philips Medical Systems Dmc GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233678: Radiography 7000 M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233678", "people": [{"name": "Shalin Dave", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233678%22"}, {"id": "fda:K240427", "company": "Gelb Practice Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240427: airVata\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240427", "people": [{"name": "Layne Martin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240427%22"}, {"id": "fda:K231514", "company": "Daeshin Enterprise Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231514: Azure", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231514", "people": [{"name": "Kyu Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231514%22"}, {"id": "nih:3R44AA030953-01A1S1", "company": "Thrive Digital Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": 54901, "summary": "NIH award 3R44AA030953-01A1S1: DEVELOPMENT OF A NOVEL PEER RECOVERY SUPPORTER TRAINING PLATFORM TO DISSEMINATE EVIDENCE-BASED TRAINING AT SCALE - I-CORPS ($54,901)", "source_url": "https://reporter.nih.gov/project-details/10987273", "people": [{"name": "Christopher Neil Pesce", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K233661", "company": "Sofradim Production", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233661: Transorb\u0099 Self-Gripping Resorbable Mesh", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233661", "people": [{"name": "Micka\u00ebl Nicolas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233661%22"}, {"id": "fda:K231990", "company": "Cefla S.C.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231990: Apex Locator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231990", "people": [{"name": "Daidone Simona", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231990%22"}, {"id": "fda:K231134", "company": "Signature Orthopaedics Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231134: VerteLoc Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231134", "people": [{"name": "Declan Brazil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231134%22"}, {"id": "fda:K232082", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232082: EXPD 4343S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232082", "people": [{"name": "Lee Juhee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232082%22"}, {"id": "fda:K233740", "company": "W.A. Rubbermate Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233740: Black Nitrile Powder Free Patient Examination Glove, Non Sterile", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233740", "people": [{"name": "Prachai Kongwaree", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233740%22"}, {"id": "fda:K233959", "company": "AtriCure, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233959: EPi-Ease Epicardial Access Device (EAS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233959", "people": [{"name": "Jenifer Ulrikson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233959%22"}, {"id": "fda:K234123", "company": "Abk Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234123: Easi-Vue\u00ae embolic microspheres System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234123", "people": [{"name": "Brandi Woods", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234123%22"}, {"id": "fda:K231855", "company": "Quanta Computer, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231855: QOCA\u00ae image Smart RT Contouring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231855", "people": [{"name": "Joe Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231855%22"}, {"id": "fda:K233788", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233788: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233788", "people": [{"name": "Michael Chambers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233788%22"}, {"id": "fda:K233954", "company": "B&E Korea Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233954: Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233954", "people": [{"name": "Jayong Shin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233954%22"}, {"id": "fda:K234048", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234048: M.U.S.T. Pedicle Screw System - Extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234048", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234048%22"}, {"id": "sbir:DOD:W51701-24-C-0045", "company": "Vcom3d Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-02-13", "observed": "2026-09-18", "amount_usd": 2699640, "summary": "DOD SBIR Phase II award $2,699,640: Mixed Reality Trainer for Female Combat Casualty Care (MRT-FC3)", "source_url": "https://www.sbir.gov/awards?search=A234-009-0977"}, {"id": "nih:3R44NS132605-01S1", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": 78820, "summary": "NIH award 3R44NS132605-01S1: Low-Dose Magneto-Thrombolysis to Expand Stroke Care ($78,820)", "source_url": "https://reporter.nih.gov/project-details/10925773", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "COLIN Pieter DERDEYN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K231468", "company": "Merit Medical System, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231468: SCOUT MD Surgical Guidance System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231468", "people": [{"name": "Saboo Sandeep", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231468%22"}, {"id": "fda:K233217", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233217: Mimics Cardiac Planner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233217", "people": [{"name": "Victoria Becheva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233217%22"}, {"id": "fda:K233401", "company": "Eieling Technology Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233401: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233401", "people": [{"name": "Yangmin Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233401%22"}, {"id": "fda:K233533", "company": "Biocircuit Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233533: NerveTape", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233533", "people": [{"name": "Jack Griffis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233533%22"}, {"id": "fda:K233635", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233635: SPY Cystoscope/Hysteroscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233635", "people": [{"name": "Michelle Ross", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233635%22"}, {"id": "fda:K233260", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233260: Univers Revers CA Head and Adapter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233260", "people": [{"name": "Ivette Galmez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233260%22"}, {"id": "fda:K233040", "company": "Shenzhen Imdk Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233040: EMS/TENS Massager Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233040", "people": [{"name": "Yuan Xia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233040%22"}, {"id": "fda:K232003", "company": "Guangzhou Red Pine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232003: Endoscopic Video Image Processor, Single-Use Video Hysteroscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232003", "people": [{"name": "Xiangfei Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232003%22"}, {"id": "fda:K233092", "company": "Chongqing Rob Linka Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233092: Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233092", "people": [{"name": "Huirong Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233092%22"}, {"id": "fda:K232674", "company": "Nuance Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232674: PainFreeze II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232674", "people": [{"name": "Neal Hartman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232674%22"}, {"id": "fda:K233134", "company": "I.T.S. GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233134: I.T.S. INS Proximal Femur Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233134", "people": [{"name": "Florian Grill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233134%22"}, {"id": "fda:K233667", "company": "Body Trim Industrial Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233667: Facial Toning device (UIC-189); Facial Toning device (UIC-589)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233667", "people": [{"name": "Hanwen Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233667%22"}, {"id": "breakthrough:K231468", "company": "Merit Medical System, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-02-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K231468: SCOUT MD SURGICAL GUIDANCE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43HD114303-01", "company": "Ps-fertility, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": 195000, "summary": "NIH award 1R43HD114303-01: Synthetic Egg:Sperm Fusion Assay (SEFA): A Diagnostic Test for Male Fertility ($195,000)", "source_url": "https://reporter.nih.gov/project-details/10821689", "people": [{"name": "JEFFREY J LYSIAK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K231355", "company": "Ensodata", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231355: Aurora", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231355", "people": [{"name": "Sigrid Schoepel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231355%22"}, {"id": "fda:K232473", "company": "Zhuhai Yueja Medical Device Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232473: Infrared Thermometer: Model YJ600", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232473", "people": [{"name": "Feng Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232473%22"}, {"id": "fda:K234037", "company": "Cats Tonometer, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234037: CATS-L Tonometer\u0099 Prism", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234037", "people": [{"name": "Sean McCafferty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234037%22"}, {"id": "fda:K231733", "company": "Neteera Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231733: Neteera 130H-Plus Vital Sign Monitoring Sensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231733", "people": [{"name": "Yossi Muncher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231733%22"}, {"id": "fda:K232072", "company": "H.S Hospital Service S.P.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232072: AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232072", "people": [{"name": "Nevio Tosoratti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232072%22"}, {"id": "fda:K240066", "company": "Bodycad Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240066: Fine Osteotomy\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240066", "people": [{"name": "Nadine Adia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240066%22"}, {"id": "fda:K233638", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233638: VERZA\u0099 High Speed Drills", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233638", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233638%22"}, {"id": "fda:K240084", "company": "Hyprevention", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240084: V-STRUT\u00ae Vertebral Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240084", "people": [{"name": "Cecile Vienney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240084%22"}, {"id": "fda:K240072", "company": "Luliang Hongruida Health Protection Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240072: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240072", "people": [{"name": "Guocai Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240072%22"}, {"id": "fda:K233464", "company": "Wsaud A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233464: WSA Self-Fitting Hearing Aid Gen 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233464", "people": [{"name": "La-Shaunda Joseph", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233464%22"}, {"id": "fda:K240098", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240098: DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240098", "people": [{"name": "Jackie Oliver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240098%22"}, {"id": "fda:K234034", "company": "Inari Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234034: VenaCore Thrombectomy Catheter (46-101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234034", "people": [{"name": "Kaitlyn Weinkauf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234034%22"}, {"id": "fda:K233631", "company": "Revital Lab, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233631: ZapStim Controller Application (Z1023)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233631", "people": [{"name": "Conway Ho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233631%22"}, {"id": "pma:P230025", "company": "Xstim, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-02-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230025: Xstim Spine Fusion Stimulator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230025", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230025%22"}, {"id": "sbir:DOD:FA8649-24-P-0440", "company": "Lifeware Labs LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-02-09", "observed": "2026-09-18", "amount_usd": 1248914, "summary": "DOD SBIR Phase II award $1,248,914: Augmenting ProPatch, a BATDOK-Integrated Compact Patient Monitor, with Compensatory Reserve Measure using Physiological Simulator", "source_url": "https://www.sbir.gov/awards?search=F2D-10431"}, {"id": "nih:3R44DA059018-01S1", "company": "Charles River Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": 54996, "summary": "NIH award 3R44DA059018-01S1: Novel, On-demand VR to Amplify Practice Efficacy (NO VAPE) ($54,996)", "source_url": "https://reporter.nih.gov/project-details/10987660", "people": [{"name": "Bethany K Bracken", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R41DA056276-01S1", "company": "Altrumed LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R41DA056276-01S1: The DOVE Device to Prevent Opioid Overdose Deaths: An Armband That Senses Overdose and Automatically Injects Naloxone ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10987948", "people": [{"name": "Jacob Brenner", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43DA059474-01S1", "company": "Pirouette Pharma Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43DA059474-01S1: A Rugged, Reliable, Portable, Safe, and Simple Naloxone HCl Auto-Injector for Life-Saving Treatment of Opioid Overdose ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10987197", "people": [{"name": "Conor R Cullinane", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K231662", "company": "Iaid", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231662: Aid-U", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231662", "people": [{"name": "Jooyoung Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231662%22"}, {"id": "fda:K232854", "company": "Elekta Solutions AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232854: Leksell GammaPlan (LGP)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232854", "people": [{"name": "Simon Sjohage", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232854%22"}, {"id": "fda:K233080", "company": "Nano-X AI , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233080: HealthFLD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233080", "people": [{"name": "Neta Sherman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233080%22"}, {"id": "fda:K231913", "company": "Techwin Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231913: T-FIT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231913", "people": [{"name": "Min-jae Jo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231913%22"}, {"id": "fda:K232644", "company": "Neuro42, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232644: neuro42 MRI System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232644", "people": [{"name": "Abhita Batra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232644%22"}, {"id": "fda:K233480", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233480: Access SHBG", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233480", "people": [{"name": "Kate Oelberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233480%22"}, {"id": "fda:K240086", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240086: Ion 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240086", "people": [{"name": "Guilherme Pires", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240086%22"}, {"id": "fda:K231536", "company": "Avails Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231536: eQUANT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231536", "people": [{"name": "Meike Herget", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231536%22"}, {"id": "fda:K233476", "company": "Orchard Medical Development", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233476: Z1 Hip System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233476", "people": [{"name": "Brett Zarda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233476%22"}, {"id": "fda:K233024", "company": "Alma Lasers, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233024: Alma Harmony", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233024", "people": [{"name": "Jessica Rivera-Montejo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233024%22"}, {"id": "fda:K233184", "company": "T2biosystems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233184: T2Bacteria\u00ae Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233184", "people": [{"name": "Rachel Gilbert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233184%22"}, {"id": "fda:K233914", "company": "Shenzhen Xpectvision Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233914: XVbeam2000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233914", "people": [{"name": "Silver Cai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233914%22"}, {"id": "fda:K233350", "company": "Reflow Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233350: SINC Support Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233350", "people": [{"name": "Lori Grace", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233350%22"}, {"id": "fda:K231575", "company": "Artaflex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231575: Vecttor VT-300", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231575", "people": [{"name": "Gerry Iuliano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231575%22"}, {"id": "fda:K230839", "company": "Proscia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230839: Concentriq Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230839", "people": [{"name": "Kim Rendon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230839%22"}, {"id": "fda:K240069", "company": "Endolumik", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240069: Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240069", "people": [{"name": "Mara McFadden", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240069%22"}, {"id": "fda:K233504", "company": "W&H Sterilization S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233504: Lexa MINI (RIS-303, RIS-305)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233504", "people": [{"name": "Paola Zampino", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233504%22"}, {"id": "nih:5R44AI174618-02", "company": "Dplexbio Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-07", "observed": "2026-08-21", "amount_usd": 494340, "summary": "NIH award 5R44AI174618-02: Emulsion digital PCR ($494,340)", "source_url": "https://reporter.nih.gov/project-details/10811721", "people": [{"name": "Peter B Allen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH122115-05", "company": "Spectragenetics", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-07", "observed": "2026-08-21", "amount_usd": 893166, "summary": "NIH award 5R44MH122115-05: Highly Multiplexed Cell-Based GPCR Assay. ($893,166)", "source_url": "https://reporter.nih.gov/project-details/10794227", "people": [{"name": "G. Reid Asbury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "fda:K240075", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240075: FUJIFILM Endoscope Model EB-710XT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240075", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240075%22"}, {"id": "fda:K232171", "company": "Tecnoideal America", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232171: Purema\u00ae H Hemoconcentrator (EtO Sterilized)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232171", "people": [{"name": "Paul Rodbhajon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232171%22"}, {"id": "fda:K232764", "company": "Eco Medi Glove Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232764: Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232764", "people": [{"name": "Suresh Kumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232764%22"}, {"id": "fda:K231956", "company": "Fisher & Paykel Healthcare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231956: F&P Optiflow+ Duet Nasal Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231956", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231956%22"}, {"id": "fda:K240064", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240064: Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240064", "people": [{"name": "Yoon HyunSik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240064%22"}, {"id": "fda:DEN230041", "company": "Samsung Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230041: Sleep Apnea Feature", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230041", "people": [{"name": "Hon Pak", "role": "510(k) submission contact"}]}, {"id": "fda:K233960", "company": "Innosys Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233960: INNOVERSE Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233960", "people": [{"name": "Hye-Kyung Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233960%22"}, {"id": "fda:K233221", "company": "Metro Optics of Austin, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233221: Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233221", "people": [{"name": "Steve Webb", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233221%22"}, {"id": "fda:K233115", "company": "E Surgical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233115: Hawkeye Control Unit with Eyas Endoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233115", "people": [{"name": "Michael Blomeyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233115%22"}, {"id": "fda:K232057", "company": "B\u00fchlmann Laboratories AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232057: B\u00dcHLMANN fCAL\u00ae turbo and CALEX\u00ae Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232057", "people": [{"name": "Laura Zurbrugg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232057%22"}, {"id": "fda:K233593", "company": "Nuvasive Specialized Orthopedics, Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233593: MAGEC Spinal Bracing and Distraction System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233593", "people": [{"name": "Miriam Cervantes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233593%22"}, {"id": "fda:K233416", "company": "Beijing Sano Laser S&T Development Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233416: Cryojet Plus (SHE-ACP001-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233416", "people": [{"name": "Zhang Hongbo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233416%22"}, {"id": "fda:K233897", "company": "Shenzhen Beacon Display Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233897: 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233897", "people": [{"name": "Li Yafei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233897%22"}, {"id": "denovo:DEN230041", "company": "Samsung Electronics Co., Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-02-06", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230041 granted: Sleep Apnea Feature", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230041"}, {"id": "nih:5R44AI157776-04", "company": "Accel Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-05", "observed": "2026-08-21", "amount_usd": 398753, "summary": "NIH award 5R44AI157776-04: A COVID-19 Point of Care Serological Assay for Rapid Quantification of Antibody Titer. ($398,753)", "source_url": "https://reporter.nih.gov/project-details/10831024", "people": [{"name": "Alberto Gandini", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44HL172564-01", "company": "Informai, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-05", "observed": "2026-08-21", "amount_usd": 289762, "summary": "NIH award 1R44HL172564-01: Artificial Intelligence Tool to Optimize Organ Transplantation Outcomes (Transplant-AI) ($289,762)", "source_url": "https://reporter.nih.gov/project-details/10823061", "people": [{"name": "Jim Havelka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K233174", "company": "Assure Tech. (Hangzhou) Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233174: FaStep\u0099 Pregnancy Rapid Test Strip; FaStep\u0099 Pregnancy Rapid Test Midstream", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233174", "people": [{"name": "Shisheng Ling", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233174%22"}, {"id": "fda:K232379", "company": "Clear Choice Therapeutics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232379: PREVENT Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232379", "people": [{"name": "Bret Batchelder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232379%22"}, {"id": "fda:K232363", "company": "Viz. Ai, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232363: Viz HDS, Viz Volume Plus, Viz ICH+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232363", "people": [{"name": "Pooja Shah", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232363%22"}, {"id": "fda:K240099", "company": "Ziehm Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240099: Ziehm Vision RFD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240099", "people": [{"name": "Tsvetelina Milanova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240099%22"}, {"id": "fda:K234075", "company": "Flow-Fx, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234075: Flow-Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234075", "people": [{"name": "Patrick Sweeney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234075%22"}, {"id": "fda:K233895", "company": "Edwards Lifesciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233895: EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233895", "people": [{"name": "Peter Lindwall", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233895%22"}, {"id": "fda:K232694", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232694: Central Monitoring System (MFM-CMS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232694", "people": [{"name": "Tracy Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232694%22"}, {"id": "fda:K233600", "company": "Philips Healthcare (Suzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233600: Smart Fit Knee 3.0T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233600", "people": [{"name": "Li Sherry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233600%22"}, {"id": "fda:K234013", "company": "Bone Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234013: Mg OSTEOINJECT\u0099; Mg OSTEOREVIVE\u0099; Mg OSTEOCRETE\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234013", "people": [{"name": "Drew Diaz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234013%22"}, {"id": "nih:4R44HD112264-02", "company": "Inherent Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-04", "observed": "2026-08-21", "amount_usd": 762166, "summary": "NIH award 4R44HD112264-02: Novel Epigenetic Test for the Treatment and Improvement of Longitudinal Health-Outcomes for Men with Severe Infertility ($762,166)", "source_url": "https://reporter.nih.gov/project-details/11011007", "people": [{"name": "Kristin R Brogaard", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K232210", "company": "X-Trodes", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232210: X-trodes System M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232210", "people": [{"name": "Ziv Peremen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232210%22"}, {"id": "fda:K232890", "company": "Integra Lifesciences Production Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232890: CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232890", "people": [{"name": "Kali Sacco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232890%22"}, {"id": "nih:1R44AG082602-01A1", "company": "Bellage, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": 497829, "summary": "NIH award 1R44AG082602-01A1: Innovative web-based service platform called Adult Wellbeing CheckUp (AWC) to assess older adults wellbeing, obtain evidence-based recommendations, and receive support to take action ($497,829)", "source_url": "https://reporter.nih.gov/project-details/10822186", "people": [{"name": "James P Firman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K231625", "company": "Wellvii, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231625: VitalDetect", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231625", "people": [{"name": "Mark Khachaturian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231625%22"}, {"id": "fda:K233855", "company": "Enchant Tek Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233855: AllPEP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233855", "people": [{"name": "Leonard Ling", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233855%22"}, {"id": "fda:K233531", "company": "Orthopaedic Implant Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233531: OIC FLEX-FIX\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233531", "people": [{"name": "Douglas Fulton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233531%22"}, {"id": "fda:K240030", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240030: Indigo\u00ae Aspiration System - Lightning\u00ae Flash", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240030", "people": [{"name": "Nikita Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240030%22"}, {"id": "fda:K231373", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231373: BD Vacutainer\u00ae K2 EDTA Blood Collection Tubes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231373", "people": [{"name": "Pablo Martinez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231373%22"}, {"id": "fda:K231325", "company": "Stimlabs, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231325: Corplex P / Theracor P / Allacor P", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231325", "people": [{"name": "Melissa O'Connor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231325%22"}, {"id": "fda:K233143", "company": "Rohrer Aesthetics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233143: PiXel8-Reveal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233143", "people": [{"name": "Mark Rohrer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233143%22"}, {"id": "fda:K230548", "company": "Myohealth Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230548: Myoaligner Appliance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230548", "people": [{"name": "Maryam Motlagh, DMD", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230548%22"}, {"id": "fda:K233756", "company": "Rhein Laser Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233756: Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233756", "people": [{"name": "Na Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233756%22"}, {"id": "fda:K231534", "company": "Fresenius Medical Care", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231534: 5008X Hemodialysis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231534", "people": [{"name": "Denise M Oppermann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231534%22"}, {"id": "fda:K233472", "company": "Calyxo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233472: CVAC Aspiration System + CVAC Image Processor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233472", "people": [{"name": "Joseph Catanese III", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233472%22"}, {"id": "sbir:DOD:HT9425-24-P-0027", "company": "Quantum Applied Science & Research Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-02-02", "observed": "2026-09-18", "amount_usd": 249992, "summary": "DOD SBIR Phase I award $249,992: Cognitive Health Impact and Physiological Sensors (CHIPS) Helmet", "source_url": "https://www.sbir.gov/awards?search=H233-003-0026"}, {"id": "sbir:DOD:HT9425-24-P-0026", "company": "Nirsense, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2024-02-02", "observed": "2026-09-18", "amount_usd": 250000, "summary": "DOD SBIR Phase I award $250,000: Ultra-thin Helmet-Compatible NIRS-Based Cerebral and Peripheral Oxygenation Sensor for Future Vertical Lift Operator State Monitoring Integration", "source_url": "https://www.sbir.gov/awards?search=H233-003-0120"}, {"id": "nih:5R44DA050214-03", "company": "Chess Mobile Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-02-01", "observed": "2026-08-21", "amount_usd": 538031, "summary": "NIH award 5R44DA050214-03: An innovative platform and smartphone app to deliver tailored interventions and facilitate completed referrals related to substance use. ($538,031)", "source_url": "https://reporter.nih.gov/project-details/10766809", "people": [{"name": "Lisa Ellen Graves", "role": "Principal Investigator"}, {"name": "Hans Morefield", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K233183", "company": "Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233183: Surgical Gown (40083)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233183", "people": [{"name": "Melody Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233183%22"}, {"id": "fda:K230657", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230657: BTL-99-OC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230657", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230657%22"}, {"id": "fda:K232165", "company": "Berpu Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232165: Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232165", "people": [{"name": "Buxin Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232165%22"}, {"id": "fda:K233804", "company": "Zeltiq Aesthetics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233804: Resonic Rapid Acoustic Pulse Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233804", "people": [{"name": "Vicky Chai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233804%22"}, {"id": "fda:K232007", "company": "Pie Medical Imaging BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232007: CAAS MR Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232007", "people": [{"name": "Annemiek Bouts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232007%22"}, {"id": "fda:K232339", "company": "Sira Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232339: Augmented Reality Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232339", "people": [{"name": "Rick Beberman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232339%22"}, {"id": "fda:K232949", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232949: Kelowna GYN and Crook Prostate Templates", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232949", "people": [{"name": "Dr. Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232949%22"}, {"id": "fda:K240018", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-02-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240018: WATCHMAN TruSteer Access System (M635TU90050)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240018", "people": [{"name": "Alexa Keenan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240018%22"}, {"id": "pma:P230013", "company": "Edwards Lifesciences, LLC", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-02-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230013: Edwards EVOQUE Tricuspid Valve Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230013", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230013%22"}, {"id": "breakthrough:P230013", "company": "Edwards Lifesciences, LLC", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-02-01", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230013: EDWARDS EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44ES034314-02", "company": "Giner, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": 899139, "summary": "NIH award 5R44ES034314-02: Field Instrument for Assessment of Arsenic Exposure ($899,139)", "source_url": "https://reporter.nih.gov/project-details/10782457", "people": [{"name": "Avni A Argun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44DA059491-01S1", "company": "Rtm Vital Signs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R44DA059491-01S1: Wearable Wireless Respiratory Monitoring System that Detects and Predicts Opioid Induced Respiratory Depression ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10986772", "people": [{"name": "Magdalena Kirlakovsky Bosak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG047722-08", "company": "Posit Science Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": 867247, "summary": "NIH award 5R44AG047722-08: Phase IIB Plasticity-based Adaptive Cognitive Remediation for Alzheimers Disease ($867,247)", "source_url": "https://reporter.nih.gov/project-details/10766753", "people": [{"name": "Hyun Kyu Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 8, "new_award": false}, {"id": "nih:3R44DA056316-01A1S1", "company": "Axcend, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R44DA056316-01A1S1: Compact Liquid Chromatography for Routine Screening in Drug Treatment Centers ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10986700", "people": [{"name": "MILTON L. LEE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R41DA056334-01A1S1", "company": "Spacerx LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R41DA056334-01A1S1: Using in-vivo Real-time Biosensor to Evaluate Prodrugs Designed to Prolong Therapeutic Effects for Smoking Cessation. ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10987756", "people": [{"name": "John Nicholas Betley", "role": "Principal Investigator"}, {"name": "Peter H Lee", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL172397-01", "company": "Mosaic Engineering LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": 321963, "summary": "NIH award 1R43HL172397-01: Programmable Microfluidic Perfusion Bioreactor for 3D Organoid Culture and Screening Applications ($321,963)", "source_url": "https://reporter.nih.gov/project-details/10821563", "people": [{"name": "Frank Myers", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K240025", "company": "Spd Swiss Precision Diagnostics GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240025: Clearblue\u00ae Early Detection Pregnancy Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240025", "people": [{"name": "Kim French", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240025%22"}, {"id": "fda:K231396", "company": "Orca Dental AI , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231396: CEPHX- Cephalometric Analysis Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231396", "people": [{"name": "Daniel Abraham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231396%22"}, {"id": "fda:K240004", "company": "Circa Scientific, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240004: CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240004", "people": [{"name": "Alice Ouyang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240004%22"}, {"id": "fda:K233140", "company": "Hygea Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233140: Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233140", "people": [{"name": "Jinping Duan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233140%22"}, {"id": "fda:K214115", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K214115: MightySat -OTC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K214115", "people": [{"name": "Kertana Shankar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K214115%22"}, {"id": "fda:DEN210035", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN210035: \u0093Genius\u0099 Digital Diagnostics System with the Genius\u0099 Cervical AI algorithm\u0094", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN210035", "people": [{"name": "Bryce Dzialo", "role": "510(k) submission contact"}]}, {"id": "fda:K232678", "company": "Guangdong Genial Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232678: Digital Thermometer, Model T28, T28L", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232678", "people": [{"name": "Yu Jun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232678%22"}, {"id": "denovo:DEN210035", "company": "Hologic, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-01-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210035 granted: \u201cGenius\u2122 Digital Diagnostics System with", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210035"}, {"id": "fda:K231910", "company": "Wuhan Lotuxs Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231910: DermRays Revive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231910", "people": [{"name": "Na Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231910%22"}, {"id": "fda:K232986", "company": "Circumfix Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232986: VariTrax Sternal CircumFixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232986", "people": [{"name": "Ken Richardson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232986%22"}, {"id": "fda:K240020", "company": "Ziehm Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K240020: Ziehm Vision FD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240020", "people": [{"name": "Tsvetelina Milanova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K240020%22"}, {"id": "fda:K232432", "company": "Evolution Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232432: E3D\u0099-A Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232432", "people": [{"name": "Todd Wallenstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232432%22"}, {"id": "fda:K234140", "company": "Starmed Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234140: VIVA combo RF System (VIVA combo RF System)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234140", "people": [{"name": "Honggeun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234140%22"}, {"id": "fda:K231343", "company": "Vilex, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231343: Redemption Duo Hindfoot Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231343", "people": [{"name": "Brock Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231343%22"}, {"id": "fda:K232942", "company": "Gimbo Medical Technology Shenzhen Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232942: G-Vitri\u0099 Vitrification Freeze Media; G-Vitri\u0099 Vitrification Thawing Media", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232942", "people": [{"name": "Leo Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232942%22"}, {"id": "pma:P230030", "company": "Farapulse, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-01-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230030: FARAPULSE\u0099 Pulsed Field Ablation System (FARAWAVE\u0099 Pulsed Field Ablation Catheter, FARASTAR\u0099 Catheter Connection Cable,", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230030", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230030%22"}, {"id": "breakthrough:P230030", "company": "Farapulse, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-01-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230030: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R44AG058312-04S1", "company": "Osteodx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-29", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44AG058312-04S1: Development of Cortical Bone Mechanics Technology for Enhancing the Diagnosis of Osteoporosis ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10948972", "people": [{"name": "Brian C Clark", "role": "Principal Investigator"}, {"name": "Andrew Dick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44MH125238-04", "company": "Istovisr", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-29", "observed": "2026-08-21", "amount_usd": 1205971, "summary": "NIH award 5R44MH125238-04: Scaling Volumetric Imaging, Analysis and Science Communication Using Immersive Virtual Reality ($1,205,971)", "source_url": "https://reporter.nih.gov/project-details/10773628", "people": [{"name": "Gianfranco Doretto", "role": "Principal Investigator"}, {"name": "Michael David Morehead", "role": "Principal Investigator"}, {"name": "GEORGE A SPIROU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K230794", "company": "Celestray Biotech Company, LLC.,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230794: Rebuilder Nerve Guidance Conduit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230794", "people": [{"name": "Charles C. Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230794%22"}, {"id": "fda:K233394", "company": "Synovis Micro Companies Alliance", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233394: Gem Flow Now (GEM2770-FN)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233394", "people": [{"name": "Julie Carlston", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233394%22"}, {"id": "fda:K233224", "company": "Epilady 2000, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233224: Epilaser Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233224", "people": [{"name": "Moshe Rosenthal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233224%22"}, {"id": "fda:K231785", "company": "X6 Innovations", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231785: Perifit Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231785", "people": [{"name": "Artem Rodionov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231785%22"}, {"id": "fda:K232864", "company": "Nantong Egens Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232864: EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232864", "people": [{"name": "Ouweijun .", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232864%22"}, {"id": "fda:K232182", "company": "Mediclus Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232182: One-Fil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232182", "people": [{"name": "Priscilla Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232182%22"}, {"id": "fda:K231715", "company": "Ctl Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231715: MONDRIAN\u0099 Anterior Lumbar Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231715", "people": [{"name": "Sean Suh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231715%22"}, {"id": "fda:K233508", "company": "SI-BONE, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233508: iFuse Bedrock Granite\u00ae Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233508", "people": [{"name": "Jayasri Prabakaran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233508%22"}, {"id": "fda:K231329", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231329: Aptima Neisseria gonorrhoeae Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231329", "people": [{"name": "Jon Kukowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231329%22"}, {"id": "fda:K233598", "company": "Anhui Intco Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233598: Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233598", "people": [{"name": "Max Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233598%22"}, {"id": "fda:K232450", "company": "Zhejiang Soudon Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232450: Disposable Hemostatic Clips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232450", "people": [{"name": "Junshi Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232450%22"}, {"id": "fda:K234109", "company": "Ziehm Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234109: Ziehm Solo FD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234109", "people": [{"name": "Tsvetelina Milanova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234109%22"}, {"id": "fda:K234118", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234118: CentriMag\u0099 Acute Circulatory Support System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234118", "people": [{"name": "Bendre Ketaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234118%22"}, {"id": "fda:K231303", "company": "Joytech Healthcare Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231303: Arm-type Fully Automatic Digital Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231303", "people": [{"name": "Ren Yunhua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231303%22"}, {"id": "fda:K231282", "company": "Lifeoutcomes, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231282: LifeOutcomes C-Quest\u0099 Blood Culture Sampling Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231282", "people": [{"name": "Robert J. McKinnon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231282%22"}, {"id": "fda:K234145", "company": "Boehringer Laboratories", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234145: ViSiGi 3D Gastric Sizing Tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234145", "people": [{"name": "Nathan Simasek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234145%22"}, {"id": "fda:K234116", "company": "Nvision Biomedical Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234116: Trigon Trigon HA Stand-Alone Wedge Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234116", "people": [{"name": "Analaura Villarreal Berain", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234116%22"}, {"id": "fda:K233485", "company": "Zynex Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233485: M-Wave", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233485", "people": [{"name": "Thomas Sandgaard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233485%22"}, {"id": "fda:K233299", "company": "Blue Ortho", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233299: ExactechGPS\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233299", "people": [{"name": "Matthieu Coic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233299%22"}, {"id": "nih:6R42NS125895-02", "company": "Navinetics Neuromodulation, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-25", "observed": "2026-08-21", "amount_usd": 9035, "summary": "NIH award 6R42NS125895-02: An Integrated Neurochemical/Electrophysiological Recording and Neuromodulation System for Basic and Clinical Research ($9,035)", "source_url": "https://reporter.nih.gov/project-details/11003809", "people": [{"name": "Kevin Elliott Bennet", "role": "Principal Investigator"}, {"name": "Kendall Lee", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K233893", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233893: AlphaVent Knotless SP PEEK Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233893", "people": [{"name": "Madison Mutchler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233893%22"}, {"id": "fda:K232417", "company": "Meridian AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232417: MR Q; MR Q SUPINE; MR Q SLT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232417", "people": [{"name": "Eric Odenheimer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232417%22"}, {"id": "fda:K232665", "company": "Convatec", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232665: GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232665", "people": [{"name": "Kim Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232665%22"}, {"id": "fda:K232912", "company": "Facet Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232912: Facet Aurora Reusable Lancet Base", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232912", "people": [{"name": "James Bonds", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232912%22"}, {"id": "fda:K234127", "company": "CooperVision, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234127: Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234127", "people": [{"name": "Sahana Rajashekar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234127%22"}, {"id": "fda:K233425", "company": "Sutter Medizintechnik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233425: FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233425", "people": [{"name": "Simone Peschl", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233425%22"}, {"id": "fda:K233714", "company": "GE Medical Systems SCS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233714: BreView", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233714", "people": [{"name": "Indu Karun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233714%22"}, {"id": "fda:K233735", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233735: ADIRA\u0099 Lateral Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233735", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233735%22"}, {"id": "fda:K233208", "company": "Nobel Biocare AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233208: NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233208", "people": [{"name": "Bernice Jim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233208%22"}, {"id": "fda:K231290", "company": "The Binding Site, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231290: Optilite\u00ae Freelite\u00ae Kappa Free Kit, Optilite\u00ae Freelite\u00ae Lambda Free Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231290", "people": [{"name": "Jolanta Wolff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231290%22"}, {"id": "fda:K231607", "company": "Axial Medical Printing Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231607: Axial3D Cloud Segmentation Service", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231607", "people": [{"name": "Jenna McGarry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231607%22"}, {"id": "fda:K233195", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233195: Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233195", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233195%22"}, {"id": "fda:K232917", "company": "Chemo Mouthpiece, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232917: Chemo Mouthpiece", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232917", "people": [{"name": "David Yoskowitz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232917%22"}, {"id": "fda:K232673", "company": "Chengdu Besmile Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232673: Dental Glass Ceramics", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232673", "people": [{"name": "Moushan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232673%22"}, {"id": "fda:K230836", "company": "Surgmark GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230836: SchurSign Tissue Marker", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230836", "people": [{"name": "Christine K\u00f6nig", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230836%22"}, {"id": "fda:K231187", "company": "Nano-Ditech Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231187: Nano-Check\u0099 COVID-19 Antigen Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231187", "people": [{"name": "James B Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231187%22"}, {"id": "fda:K233013", "company": "Silq Technologies Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233013: 2-Way 100% Silicone Cleartract Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233013", "people": [{"name": "D. Verne Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233013%22"}, {"id": "fda:K231305", "company": "Aroa Biosurgery , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231305: Endoform Dental Membrane", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231305", "people": [{"name": "Tina O'Brien", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231305%22"}, {"id": "fda:K232676", "company": "Chengdu Besmile Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232676: Dental Porcelain Powder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232676", "people": [{"name": "Moushan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232676%22"}, {"id": "breakthrough:K232917", "company": "Chemo Mouthpiece, LLC", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-01-23", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K232917: CHEMO MOUTHPIECE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44GM139468-03", "company": "Doty Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-22", "observed": "2026-08-21", "amount_usd": 848143, "summary": "NIH award 5R44GM139468-03: A Novel Waveguide to Enable MAS-DNP-NMR in Standard-bore High-field Magnets ($848,143)", "source_url": "https://reporter.nih.gov/project-details/10760278", "people": [{"name": "Francis DAVID Doty", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K231423", "company": "Shenzhen Roundwhale Technology Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231423: Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231423", "people": [{"name": "Zeng Chunming", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231423%22"}, {"id": "fda:K230841", "company": "Jps Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230841: NailLift", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230841", "people": [{"name": "Yasuko Kida", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230841%22"}, {"id": "fda:K231299", "company": "Cair Lgl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231299: Nutricair enteral ENFit adapter: ENFit male \u0096 stepped/Christmas tree connector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231299", "people": [{"name": "Irving L Wiesen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231299%22"}, {"id": "fda:K233887", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233887: IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233887", "people": [{"name": "Blue Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233887%22"}, {"id": "fda:K234087", "company": "Restor3D", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234087: restor3d TIDAL Lumbar Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234087", "people": [{"name": "Anika Moorjani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234087%22"}, {"id": "fda:K233450", "company": "Megagen Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233450: MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233450", "people": [{"name": "Seo MinGi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233450%22"}, {"id": "fda:K233105", "company": "OrthoPediatrics Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233105: RESPONSE\u0099 Rib and Pelvic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233105", "people": [{"name": "Yan Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233105%22"}, {"id": "fda:K233142", "company": "Cyted Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233142: EndoSign\u00ae Cell collection device (ES-CYT-102)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233142", "people": [{"name": "Neha Goel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233142%22"}, {"id": "fda:K230133", "company": "Gelesis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230133: Plenity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230133", "people": [{"name": "Yverre Bobay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230133%22"}, {"id": "fda:K232783", "company": "Jiangsu Jumao X-Care Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232783: Power wheelchair (Model: JMPW-01W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232783", "people": [{"name": "Weixia Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232783%22"}, {"id": "fda:K232347", "company": "Kuros Biosciences B.V", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232347: MagnetOs Granules", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232347", "people": [{"name": "Hen Baron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232347%22"}, {"id": "fda:K232466", "company": "Guangdong Youmeng Electrical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232466: Electric Breast Pump, model: YM-8166", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232466", "people": [{"name": "Liu Zongjun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232466%22"}, {"id": "fda:K233436", "company": "Illuminoss Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233436: IlluminOss Photodynamic Bone Stabilization System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233436", "people": [{"name": "Robert Rabiner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233436%22"}, {"id": "fda:K231071", "company": "West Pharma. Services IL, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231071: Mix2Vial\u00ae Transfer Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231071", "people": [{"name": "llanit Goldgraber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231071%22"}, {"id": "fda:K231237", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231237: BD Vacutainer\u00ae Fluoride Blood Collection Tubes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231237", "people": [{"name": "Manal Morcos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231237%22"}, {"id": "fda:K231218", "company": "Accumedical Beijing , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231218: Distal Access Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231218", "people": [{"name": "Dawei Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231218%22"}, {"id": "fda:K231873", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231873: DePuy SUMMIT Porocoat Hip Prosthesis \u0096 MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis \u0096 MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis \u0096 MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis \u0096 MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis \u0096 MR Conditional", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231873", "people": [{"name": "Jennifer Hill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231873%22"}, {"id": "fda:K233736", "company": "Cardiacassist, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233736: LifeSPARC System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233736", "people": [{"name": "Arielle Drummond", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233736%22"}, {"id": "fda:K230524", "company": "Chengdu Cryo-Push Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230524: Cold Compression Wrap Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230524", "people": [{"name": "Zhang Peiyong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230524%22"}, {"id": "fda:K233461", "company": "Hi-Dow International, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233461: Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233461", "people": [{"name": "Eric Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233461%22"}, {"id": "fda:K232679", "company": "Argon Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232679: Cleaner\u0099 Pro Thrombectomy System; Cleaner\u0099 Pro Aspiration Catheter with Handpiece; Cleaner\u0099 Pro Aspiration Canister", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232679", "people": [{"name": "Ana Jimenez-Hughes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232679%22"}, {"id": "fda:K230817", "company": "Deltacor GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230817: TORPEDO Implant System\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230817", "people": [{"name": "Maximilian Reuss", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230817%22"}, {"id": "fda:K232156", "company": "Ischemaview, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232156: Rapid ASPECTS (v3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232156", "people": [{"name": "Jim Rosa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232156%22"}, {"id": "fda:DEN220009", "company": "Intuitap Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN220009: VerTouch Spinal Imaging Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220009", "people": [{"name": "Jessica Traver", "role": "510(k) submission contact"}]}, {"id": "fda:K231192", "company": "Bionime Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231192: RIGHTEST Blood Glucose Monitoring System Max Tel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231192", "people": [{"name": "Yu chi Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231192%22"}, {"id": "fda:K233728", "company": "Ge Healthcare (Tianjin) Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233728: SIGNA Champion", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233728", "people": [{"name": "Xinyu Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233728%22"}, {"id": "fda:K231213", "company": "Hankil Tech Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231213: HKT Anatomical Locking Trauma System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231213", "people": [{"name": "Kim Jeong-Yup", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231213%22"}, {"id": "denovo:DEN220009", "company": "Intuitap Medical, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-01-19", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220009 granted: VerTouch Spinal Imaging Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220009"}, {"id": "nih:5R44GM149063-02", "company": "Ferrologix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": 1074227, "summary": "NIH award 5R44GM149063-02: Functionally Closed Purification and Elution of Untouched Cells using Cleavable Magnetic Beads with Digital Magnetic Sorting ($1,074,227)", "source_url": "https://reporter.nih.gov/project-details/10773627", "people": [{"name": "Coleman Murray", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K231416", "company": "Nuvoair AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231416: Air Next (NVD-02)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231416", "people": [{"name": "Furat Shawki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231416%22"}, {"id": "fda:K233242", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233242: Atellica\u00ae CH High Sensitivity C-Reactive Protein 2 (hCRP2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233242", "people": [{"name": "Anthony Calabro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233242%22"}, {"id": "fda:K231405", "company": "Jiangsu Rong FU Kang Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231405: Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231405", "people": [{"name": "Steve Livneh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231405%22"}, {"id": "fda:K233077", "company": "Inwound Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233077: FlashHeal 2 (FlashHeal 2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233077", "people": [{"name": "Otto \u00d8mann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233077%22"}, {"id": "fda:K232577", "company": "Ningbo Dizegens Medical Science Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232577: Radial Compression Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232577", "people": [{"name": "Zhang Wenwei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232577%22"}, {"id": "fda:K231573", "company": "Dosisoft SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231573: ThinkQA (Edition 2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231573", "people": [{"name": "Marc Uszynski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231573%22"}, {"id": "fda:K231166", "company": "Zmi Electronics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231166: Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231166", "people": [{"name": "Lawrence Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231166%22"}, {"id": "fda:K233507", "company": "Microport Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233507: EVOLUTION\u00ae Tibial Cones", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233507", "people": [{"name": "Jonas Susaraba", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233507%22"}, {"id": "fda:K234051", "company": "Spinal Simplicity, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234051: Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234051", "people": [{"name": "Adam Rogers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234051%22"}, {"id": "fda:K221866", "company": "Newton Implant Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221866: S-Plant Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221866", "people": [{"name": "Pedro Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221866%22"}, {"id": "fda:K231762", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231762: uEXPLORER", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231762", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231762%22"}, {"id": "fda:K233447", "company": "Cequr SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233447: CeQur Simplicity\u0099 On-Demand Insulin Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233447", "people": [{"name": "Michael Simpson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233447%22"}, {"id": "fda:K230592", "company": "LuxCreo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230592: LuxCreo Dental Night Guard Resin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230592", "people": [{"name": "Mike Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230592%22"}, {"id": "fda:K232373", "company": "Sofradim Production", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232373: Progrip\u0099 Self-Gripping Polypropylene Mesh", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232373", "people": [{"name": "Anne Bertron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232373%22"}, {"id": "fda:K233744", "company": "Curiteva, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233744: Curiteva Porous PEEK Lumbar Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233744", "people": [{"name": "Eric Linder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233744%22"}, {"id": "fda:K234040", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234040: TriMed Threaded Intramedullary Nail System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234040", "people": [{"name": "David Medoff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234040%22"}, {"id": "fda:K231860", "company": "Tdm Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231860: TDM Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231860", "people": [{"name": "Jung Wook Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231860%22"}, {"id": "fda:K234011", "company": "Lima Corporate S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234011: AMF TT Cones", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234011", "people": [{"name": "Michela Zanotto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234011%22"}, {"id": "fda:K234031", "company": "Medline Industires, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234031: Medline UNITE Ancillary Foot Recon Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234031", "people": [{"name": "Jennifer Mason", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234031%22"}, {"id": "fda:K232698", "company": "Software Nemotec S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232698: NemoScan", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232698", "people": [{"name": "Miguel Del Moral", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232698%22"}, {"id": "fda:K233680", "company": "William Cook Europe Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233680: Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); G\u00fcnther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); G\u00fcnther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); G\u00fcnther Tulip Vena Cava Filter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233680", "people": [{"name": "Mie Dyrholm", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233680%22"}, {"id": "fda:K233190", "company": "Jiangsu Caina Medical Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233190: ENFit Adaptor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233190", "people": [{"name": "Camel Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233190%22"}, {"id": "fda:K233213", "company": "Nxstage Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233213: NxStage PureFlow Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233213", "people": [{"name": "Caitlin Kalda", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233213%22"}, {"id": "fda:K233451", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233451: Arthrex Synergy Vision Endoscopic Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233451", "people": [{"name": "Lai Saeteurn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233451%22"}, {"id": "fda:K232860", "company": "Pentax of America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232860: PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232860", "people": [{"name": "William Goeller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232860%22"}, {"id": "fda:K233031", "company": "Canyon Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233031: M\u00b7Biopsy /SureCore Automatic Disposable Biopsy Needle, M\u00b7Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M\u00b7Biopsy /SureAim Coaxial Biopsy Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233031", "people": [{"name": "Jin Mingzhi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233031%22"}, {"id": "fda:K231871", "company": "Envisionit Deepai, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231871: Radify Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231871", "people": [{"name": "Jaishree Naidoo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231871%22"}, {"id": "fda:K233730", "company": "Smith & Nephew", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233730: Footprint Mini PK, 3.5mm Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233730", "people": [{"name": "Catherine Phelan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233730%22"}, {"id": "fda:K233783", "company": "Peca Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233783: exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233783", "people": [{"name": "Doug Bernstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233783%22"}, {"id": "fda:K232732", "company": "Co-Innovation Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232732: Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232732", "people": [{"name": "Hong Feng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232732%22"}, {"id": "fda:K233445", "company": "Integra Lifesciences Production Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233445: Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233445", "people": [{"name": "Amanda Erwin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233445%22"}, {"id": "fda:K233226", "company": "Radical Imaging, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233226: FlexView Diagnostic (v1.1.20)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233226", "people": [{"name": "Rob Lewis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233226%22"}, {"id": "fda:K231135", "company": "Hunan Vathin Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231135: Video Ureteroscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231135", "people": [{"name": "Du Jing", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231135%22"}, {"id": "fda:K233710", "company": "Minerva Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233710: Symphion Operative Hysteroscopy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233710", "people": [{"name": "Michelle Becker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233710%22"}, {"id": "fda:K233988", "company": "Cerenovus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233988: Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233988", "people": [{"name": "Ryan Rivera", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233988%22"}, {"id": "fda:K234030", "company": "Clear Guide Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234030: Clear Guide SCENERGY", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234030", "people": [{"name": "Alican Demir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234030%22"}, {"id": "fda:K223234", "company": "Scandidos AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223234: Delta4 Insight", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223234", "people": [{"name": "Daniel Pederson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223234%22"}, {"id": "fda:K231138", "company": "Oscimed SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231138: Aniti-Snore Mouthguard+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231138", "people": [{"name": "Jacques Magnin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231138%22"}, {"id": "fda:K233512", "company": "Ischemaview, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233512: Rapid (6.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233512", "people": [{"name": "Jim Rosa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233512%22"}, {"id": "fda:K232062", "company": "Dalim Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232062: Uni-port", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232062", "people": [{"name": "Ji Hoon Eom", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232062%22"}, {"id": "fda:K233796", "company": "SteriLance Medical (Suzhou), Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233796: Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233796", "people": [{"name": "Susan Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233796%22"}, {"id": "fda:K233293", "company": "Neurosigma, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233293: Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233293", "people": [{"name": "Colin P. Kealey, M.D.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233293%22"}, {"id": "fda:K223266", "company": "Thoracent, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223266: Hilzo Esophageal Stents", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223266", "people": [{"name": "Brian Lynch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223266%22"}, {"id": "fda:K232355", "company": "Shandong Haidike Medical Product Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232355: Non absorbable Surgical Silk Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232355", "people": [{"name": "Yan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232355%22"}, {"id": "fda:K231144", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231144: Washtrays", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231144", "people": [{"name": "Rebecca Sporer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231144%22"}, {"id": "fda:K233970", "company": "Nephron Nitrile, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233970: Nephron Nitrile\u0099, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233970", "people": [{"name": "Lou Kennedy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233970%22"}, {"id": "nih:3R44HL147745-03S2", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-15", "observed": "2026-08-21", "amount_usd": 98385, "summary": "NIH award 3R44HL147745-03S2: An Improved Robotic Electrophysiology Platform for Arrhythmia Ablation ($98,385)", "source_url": "https://reporter.nih.gov/project-details/10982999", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "Mitch N Faddis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44HL152835-04", "company": "Vantis Vascular Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-15", "observed": "2026-08-21", "amount_usd": 994964, "summary": "NIH award 2R44HL152835-04: Catheter for Complex Percutaneous Coronary Intervention ($994,964)", "source_url": "https://reporter.nih.gov/project-details/10797845", "people": [{"name": "Tim Alexander Fischell", "role": "Principal Investigator"}, {"name": "Michael Mirizzi", "role": "Principal Investigator"}, {"name": "Frank S Saltiel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44HL142440-04", "company": "Alleviant Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-15", "observed": "2026-08-21", "amount_usd": 997944, "summary": "NIH award 2R44HL142440-04: Transcatheter Device for Congestive Heart Failure Treatment Through Left Atrial Decompression ($997,944)", "source_url": "https://reporter.nih.gov/project-details/10795686", "people": [{"name": "Thomas Diffley Pate", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43TR004536-01A1", "company": "Vector Surgical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-15", "observed": "2026-08-21", "amount_usd": 331034, "summary": "NIH award 1R43TR004536-01A1: Enhanced Gene Therapy Delivery Through Electric Pulsing Double-Balloon Catheter ($331,034)", "source_url": "https://reporter.nih.gov/project-details/10821764", "people": [{"name": "SUSAN C HAGNESS", "role": "Principal Investigator"}, {"name": "Janet Phillips", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K233216", "company": "Clew Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233216: CLEWICU System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233216", "people": [{"name": "Avidgor Faians", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233216%22"}, {"id": "fda:K232350", "company": "Stryker Craniomaxillofacial", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232350: Stryker Facial iD System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232350", "people": [{"name": "Jonathan Schell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232350%22"}, {"id": "nih:1R43HL172546-01", "company": "Potentiometric Probes, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": 282266, "summary": "NIH award 1R43HL172546-01: A Palette of Near-Infrared Voltage Sensors for Cardiac Research and Safety Pharmacology ($282,266)", "source_url": "https://reporter.nih.gov/project-details/10822619", "people": [{"name": "Corey Acker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:9R44AI162202-02A1", "company": "Trace-ability, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 9R44AI162202-02A1: Improving availability of ImmunoPET via automation of radio-synthesis and quality control of antibody-based HIV imaging PET tracers on a single platform. ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10821870", "people": [{"name": "Arkadij Elizarov", "role": "Principal Investigator"}, {"name": "Henry F. VanBrocklin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K233144", "company": "ClearPoint Neuro, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233144: ClearPoint Bone Screw Fiducials", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233144", "people": [{"name": "Brennan Sullivan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233144%22"}, {"id": "fda:DEN230015", "company": "Bone Health Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230015: Osteoboost Belt", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230015", "people": [{"name": "Laura Yecies", "role": "510(k) submission contact"}]}, {"id": "fda:K231315", "company": "Velox Manufacturing, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231315: Velox Power Chair", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231315", "people": [{"name": "Ryan Batke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231315%22"}, {"id": "fda:K232990", "company": "Rmr Ortho, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232990: A\u0092TOMIC\u0099 Nitinol Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232990", "people": [{"name": "Joe Ritz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232990%22"}, {"id": "fda:K232615", "company": "Devicor Medical Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232615: LumiMARK\u0099 Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK\u0099 Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK\u0099 Biopsy Site Marker (LM0215R (Rose shape))", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232615", "people": [{"name": "Katy Austin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232615%22"}, {"id": "fda:K231970", "company": "Pentax of America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231970: PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231970", "people": [{"name": "William Goeller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231970%22"}, {"id": "fda:K232170", "company": "Izenimplant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232170: Ti Link Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232170", "people": [{"name": "Mi-Kyung Kwon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232170%22"}, {"id": "fda:K231820", "company": "Biocorp Production", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231820: SoloSmart Injection Pen Adapter (SoloSmart\u00ae)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231820", "people": [{"name": "Alexia Garin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231820%22"}, {"id": "fda:K231371", "company": "NGMedical GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231371: BEE Cervical Cage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231371", "people": [{"name": "Stella Hahn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231371%22"}, {"id": "fda:K231684", "company": "GM Dos Reis Industria e Comercio Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231684: Quick - Radius Disposable Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231684", "people": [{"name": "Guilherme Esteves Pontes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231684%22"}, {"id": "fda:K231558", "company": "Smb Corporation of India", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231558: SMB Luer lock disposable syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231558", "people": [{"name": "Anupam Rai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231558%22"}, {"id": "fda:K233520", "company": "Anhui Powerguard Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233520: Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233520", "people": [{"name": "Nick Dai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233520%22"}, {"id": "fda:K233964", "company": "Cosmo Artificial Intelligence - Ai, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233964: GI Genius\u0099 Module 100 (GGM100.US); GI Genius\u0099 Module 200 (GGM200.US); ColonPRO\u0099 4.0 (CPRO40.US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233964", "people": [{"name": "Nhan Ngo Dinh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233964%22"}, {"id": "fda:DEN220040", "company": "Imvaria, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN220040: Fibresolve", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220040", "people": [{"name": "Joshua Reicher", "role": "510(k) submission contact"}]}, {"id": "fda:K233155", "company": "ClearPoint Neuro, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233155: ClearPointer Optical Navigation Wand", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233155", "people": [{"name": "Brennan Sullivan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233155%22"}, {"id": "fda:K222783", "company": "Lsi Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222783: MD Mattress Suture Placement Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222783", "people": [{"name": "Christopher B Miller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222783%22"}, {"id": "fda:K233022", "company": "Owens & Minor (O&M) Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233022: Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233022", "people": [{"name": "Anureet Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233022%22"}, {"id": "fda:K233694", "company": "SeaSpine Orthopedics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233694: Meridian Interbody System; WaveForm A Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233694", "people": [{"name": "Jesse Albright", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233694%22"}, {"id": "fda:K233020", "company": "Tautona Group Research & Development, Co., LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233020: TauTona Pneumoperitoneum Assist Device (TPAD)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233020", "people": [{"name": "Michael Blanchette", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233020%22"}, {"id": "fda:K233141", "company": "ClearPoint Neuro, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233141: SmartFrame OR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233141", "people": [{"name": "Brennan Sullivan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233141%22"}, {"id": "fda:K233125", "company": "Hangzhou Ivista Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233125: Zirconia Block", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233125", "people": [{"name": "Yao Cheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233125%22"}, {"id": "fda:DEN230008", "company": "Dermasensor, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230008: DermaSensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230008", "people": [{"name": "Cody Simmons", "role": "510(k) submission contact"}]}, {"id": "fda:K232970", "company": "Teleflex Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232970: Hem-o-lok\u00ae Ligating Clips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232970", "people": [{"name": "Hope West", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232970%22"}, {"id": "fda:K233677", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233677: Biograph VK10", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233677", "people": [{"name": "Alaine Medio", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233677%22"}, {"id": "fda:K232032", "company": "Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232032: PROBEAT-FR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232032", "people": [{"name": "Tomoko Irisa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232032%22"}, {"id": "fda:K233355", "company": "Cypris Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233355: Cypris eXact Suturing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233355", "people": [{"name": "Dan Holton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233355%22"}, {"id": "fda:K233114", "company": "Shenzhen Idea Light Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233114: LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233114", "people": [{"name": "Liu Nicole", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233114%22"}, {"id": "pma:P230023", "company": "W. L. Gore & Associates, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-01-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230023: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230023", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230023%22"}, {"id": "denovo:DEN230015", "company": "Bone Health Technologies, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-01-12", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230015 granted: Osteoboost Belt", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230015"}, {"id": "denovo:DEN230008", "company": "Dermasensor, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-01-12", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230008 granted: DermaSensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230008"}, {"id": "denovo:DEN220040", "company": "Imvaria, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-01-12", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220040 granted: Fibresolve", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220040"}, {"id": "breakthrough:DEN230008", "company": "Dermasensor, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-01-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN230008: DERMASENSOR", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:DEN230015", "company": "Bone Health Technologies, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-01-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN230015: OSTEOBOOST BELT", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P230023", "company": "W.l. Gore & Associates, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-01-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230023: GORE EXCLUDER THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:DEN220066", "company": "Darmiyan, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-01-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220066: BRAINSEE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K233945", "company": "Philips Medical Systems Dmc GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233945: ProxiDiagnost N90 / Precision CRF (706110, 706400)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233945", "people": [{"name": "Ming Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233945%22"}, {"id": "fda:K233712", "company": "Lima Corporate S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233712: PRIMA Humeral System; PRIMA TT Glenoid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233712", "people": [{"name": "Michela Zanotto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233712%22"}, {"id": "fda:K233616", "company": "Clevaligner, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233616: Clevaligner Software (V1.0.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233616", "people": [{"name": "Jonathan Tabet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233616%22"}, {"id": "fda:K231774", "company": "MacroLux Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231774: CoralView\u00ae Single-use Digital Flexible Ureteroscope (U10); CoralView\u00ae Single-use Digital Flexible Ureteroscope (U10-B); CoralView\u00ae Single-use Digital Flexible Ureteroscope (U10-BR); CoralView\u00ae Single-use Digital Flexible Ureteroscope (U20); CoralView\u00ae Single-use Digital Flexible Ureteroscope (U20-B); CoralView\u00ae Single-use Digital Flexible Ureteroscope (U20-BR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231774", "people": [{"name": "Linbin Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231774%22"}, {"id": "fda:K222929", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222929: ToxiSeal Vial Adapter with External Balloon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222929", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222929%22"}, {"id": "fda:K231088", "company": "Roosin Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231088: Copper Foam Dressing (Prescription and OTC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231088", "people": [{"name": "Dayong Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231088%22"}, {"id": "fda:K232250", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232250: SurgiCount+ System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232250", "people": [{"name": "Patti Arndt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232250%22"}, {"id": "fda:DEN220066", "company": "Darmiyan, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN220066: BrainSee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220066", "people": [{"name": "Kaveh Vejdani", "role": "510(k) submission contact"}]}, {"id": "fda:K231633", "company": "Alton (Shanghai) Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231633: Disposable Hemoclip (AF series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231633", "people": [{"name": "Vivian Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231633%22"}, {"id": "fda:K232995", "company": "Shenzhen Roundwhale Technology Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232995: Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232995", "people": [{"name": "Zeng Chunming", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232995%22"}, {"id": "fda:K233664", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233664: IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233664", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233664%22"}, {"id": "fda:K232285", "company": "Sonoscanner Sarl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232285: U-Lite PRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232285", "people": [{"name": "Vincent Lux", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232285%22"}, {"id": "denovo:DEN220066", "company": "Darmiyan, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2024-01-11", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220066 granted: BrainSee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220066"}, {"id": "breakthrough:DEN220040", "company": "Imvaria, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2024-01-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220040: FIBRESOLVE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R44HL147745-03S1", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-10", "observed": "2026-08-21", "amount_usd": 8699, "summary": "NIH award 3R44HL147745-03S1: An Improved Robotic Electrophysiology Platform for Arrhythmia Ablation ($8,699)", "source_url": "https://reporter.nih.gov/project-details/10982997", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "Mitch N Faddis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K233364", "company": "Neuralace Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233364: Axon Therapy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233364", "people": [{"name": "Joe Milkovits", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233364%22"}, {"id": "fda:K232955", "company": "MicroPort NeuroTech (Shanghai) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232955: Numen Coil Embolization System; NumenFR Detachment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232955", "people": [{"name": "Jiayin Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232955%22"}, {"id": "fda:K233902", "company": "Alcon Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233902: Centurion\u0099 Vision System (Active Sentry\u0099) (8065753057)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233902", "people": [{"name": "De Rama Rita", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233902%22"}, {"id": "fda:K233903", "company": "Zeta Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233903: Zeta Cranial Navigation System (ZNS131-US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233903", "people": [{"name": "Roman Stolyarov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233903%22"}, {"id": "fda:K232604", "company": "Hangzhou Laihe Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232604: LYHER\u00ae Urine Marijuana (THC) Test Kit (Strip), LYHER\u00ae Urine Marijuana (THC) Test Kit (Cassette)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232604", "people": [{"name": "Yaohua Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232604%22"}, {"id": "fda:K233944", "company": "CarboFix Orthopedics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233944: CarboClear\u00ae X Pedicle Screw System; CarboClear\u00ae X Navigated Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233944", "people": [{"name": "Hila Wachsler-Avrahami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233944%22"}, {"id": "fda:K233327", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233327: 1788 4K Camera System with Advanced Imaging Modality", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233327", "people": [{"name": "Michelle Stephens", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233327%22"}, {"id": "fda:K232710", "company": "Yian Medical Technology (Haining) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232710: Dental Cone-beam Computed Tomography", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232710", "people": [{"name": "Lili Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232710%22"}, {"id": "fda:K232312", "company": "W. L. Gore & Associates, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232312: GORE\u00ae PROPATEN\u00ae Vascular Graft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232312", "people": [{"name": "Sarah Pastrnak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232312%22"}, {"id": "fda:K232597", "company": "Hangzhou Laihe Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232597: LYHER\u00ae Urine Multi-Drug Test Kit(Cup), LYHER\u00ae Urine Multi-Drug Test Kit(Cassette), LYHER\u00ae Urine Multi-Drug Test Kit(Dipcard)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232597", "people": [{"name": "Yaohua Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232597%22"}, {"id": "pma:P200005", "company": "Tz Medical, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2024-01-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P200005: TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200005", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P200005%22"}, {"id": "nih:6R44CA189522-05", "company": "Applikate Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-08", "observed": "2026-08-21", "amount_usd": 466081, "summary": "NIH award 6R44CA189522-05: Commercial Readiness for Direct-to-Digital Pathology ($466,081)", "source_url": "https://reporter.nih.gov/project-details/11000919", "people": [{"name": "Michael John Levene", "role": "Principal Investigator"}, {"name": "RICHARD TORRES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "fda:K233035", "company": "Shenzhen Hengbosi Industrial Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233035: Electronic Muscle Stimulator (Model MP01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233035", "people": [{"name": "Zhiwei Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233035%22"}, {"id": "fda:K232894", "company": "Owens & Minor (O&M) Halyard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232894: HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232894", "people": [{"name": "Anureet Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232894%22"}, {"id": "fda:K231324", "company": "Dasi Simulations", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231324: DASI Dimensions (V1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231324", "people": [{"name": "Sri Krishna Sivakumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231324%22"}, {"id": "fda:K232412", "company": "Thirona BV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232412: LungQ v3.0.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232412", "people": [{"name": "Eva Van Rikxoort", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232412%22"}, {"id": "fda:K233444", "company": "Inkspace Imaging, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233444: InkSpace Imaging Small Body Array", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233444", "people": [{"name": "Peter Fischer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233444%22"}, {"id": "fda:K233615", "company": "Baisheng Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233615: Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233615", "people": [{"name": "Xi Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233615%22"}, {"id": "fda:K232106", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232106: Air Gap Fiber", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232106", "people": [{"name": "Hyun Sik Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232106%22"}, {"id": "fda:K231068", "company": "Holberg Eeg AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231068: autoSCORE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231068", "people": [{"name": "Smriti Franklin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231068%22"}, {"id": "fda:K231608", "company": "OrbusNeich Medical (Shenzhen) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231608: Teleport XT Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231608", "people": [{"name": "Jerry Cheung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231608%22"}, {"id": "fda:K232721", "company": "Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232721: Lifetech Cardio Temporary Pacemaker", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232721", "people": [{"name": "Stephy Pan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232721%22"}, {"id": "nih:5R44MH114773-05", "company": "Habitaware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-05", "observed": "2026-08-21", "amount_usd": 1237649, "summary": "NIH award 5R44MH114773-05: Technology Assisted Treatment for Trichotillomania ($1,237,649)", "source_url": "https://reporter.nih.gov/project-details/10766710", "people": [{"name": "Christopher A. Flessner", "role": "Principal Investigator"}, {"name": "Sameer Kumar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "fda:K233229", "company": "Anx Robotica Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233229: NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233229", "people": [{"name": "Tim Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233229%22"}, {"id": "fda:K221766", "company": "Lmg Lasers Comercio, Importacao E Exportacao Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221766: Solon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221766", "people": [{"name": "Leticia de Paula Souza Moraes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221766%22"}, {"id": "fda:K233679", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233679: IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233679", "people": [{"name": "Blue Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233679%22"}, {"id": "fda:K231917", "company": "Eos Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231917: VEA Align", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231917", "people": [{"name": "Moran Celestin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231917%22"}, {"id": "fda:K231273", "company": "Wisdom Technologies., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231273: ArcherQA (V1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231273", "people": [{"name": "Xie Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231273%22"}, {"id": "fda:K233316", "company": "Terrats Medical SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233316: DESS Dental Smart Solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233316", "people": [{"name": "Roger Terrats", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233316%22"}, {"id": "fda:K232519", "company": "Ximedica", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232519: ENDOCOLLECT Specimen Retrieval Bag", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232519", "people": [{"name": "Corie Vazquez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232519%22"}, {"id": "fda:K231163", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231163: HS Fiber Sutures", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231163", "people": [{"name": "Paul Vagts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231163%22"}, {"id": "fda:K231263", "company": "Prevest Denpro Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231263: Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231263", "people": [{"name": "Atul Modi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231263%22"}, {"id": "nih:5R44NS120591-03", "company": "Brain Electrophysiology Laboratory Company, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": 590345, "summary": "NIH award 5R44NS120591-03: Sourcerer IC: A Web-Based Integrative Multi-Modal Workflow for Epilepsy Surgical Planning ($590,345)", "source_url": "https://reporter.nih.gov/project-details/10763399", "people": [{"name": "PHAN LUU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MD013644-03", "company": "Sentient Research, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": 738989, "summary": "NIH award 5R44MD013644-03: A Video-Based mHealth Program to Support People Living with HIV Across the HIV Care Continuum ($738,989)", "source_url": "https://reporter.nih.gov/project-details/10458468", "people": [{"name": "Jorge Alejandro Montoya", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K233671", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233671: Ambu\u00ae aScope\u0099 5 Broncho 4.2/2.2; Ambu\u00ae aScope\u0099 5 Broncho 2.7/1.2; Ambu\u00ae aView\u0099 2 Advance", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233671", "people": [{"name": "Lasse Sohrt-Petersen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233671%22"}, {"id": "fda:K221110", "company": "Huizhou Foryou Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221110: LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221110", "people": [{"name": "Jie Dong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221110%22"}, {"id": "fda:K231058", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231058: Hudson RCI\u00ae AddiPak\u00ae Unit Dose Vial", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231058", "people": [{"name": "Phyllis Kondor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231058%22"}, {"id": "fda:K231072", "company": "Anthogyr", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231072: Anthogyr FlexiBase\u00ae titanium bases for Axiom\u00ae BL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231072", "people": [{"name": "Estelle Salle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231072%22"}, {"id": "fda:K223228", "company": "Koya Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223228: Dayspring", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223228", "people": [{"name": "Jarren Baldwin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223228%22"}, {"id": "fda:K231033", "company": "Healthium Medtech Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231033: CEPTRE\u00ae Knotted UHMWPE Suture PEEK Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231033", "people": [{"name": "Pankaj Dawar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231033%22"}, {"id": "fda:K230507", "company": "Zimed Medikal", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230507: Zimed Distal Medial Tibial Plate and Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230507", "people": [{"name": "H.Nurcan Bilgi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230507%22"}, {"id": "fda:K232808", "company": "Butterfly Network, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232808: Butterfly iQ3 Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232808", "people": [{"name": "Nathan Sabich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232808%22"}, {"id": "fda:K232330", "company": "Ningbo Medsun Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232330: Lancing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232330", "people": [{"name": "Liu Ping", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232330%22"}, {"id": "fda:K230277", "company": "Cofoe Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230277: Pulse Oximeter(Model OHT60,OXH78)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230277", "people": [{"name": "Yang Cui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230277%22"}, {"id": "fda:K230996", "company": "Pursuant Health", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230996: Pursuant Health Kiosk (G1.D5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230996", "people": [{"name": "Leslie Sommers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230996%22"}, {"id": "fda:K232136", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232136: syngo.CT Applications", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232136", "people": [{"name": "Clayton Ginn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232136%22"}, {"id": "fda:K233556", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233556: LED Eye mask (EY-20R, A20, EY-20N)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233556", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233556%22"}, {"id": "fda:K232589", "company": "Icat Solutions, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232589: Horos MD\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232589", "people": [{"name": "Georgios Michalopoulos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232589%22"}, {"id": "fda:K223397", "company": "Hoya Lamphun , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223397: HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223397", "people": [{"name": "Timothy Ting", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223397%22"}, {"id": "fda:K231256", "company": "Carecubes, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231256: Carecube Negative Pressure Isolation Chamber", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231256", "people": [{"name": "Alexander Laskey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231256%22"}, {"id": "fda:K231779", "company": "Epitel, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231779: REMI AI Discrete Detection Module", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231779", "people": [{"name": "Christopher Phillips", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231779%22"}, {"id": "fda:K231707", "company": "Q For Plastic Industries", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231707: ResQ Administration Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231707", "people": [{"name": "Islam Nazieh Mohamed Ali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231707%22"}, {"id": "fda:K233395", "company": "Alliage S/A Industrias M\u00e9dico Odontol\u00f3gica", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233395: Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233395", "people": [{"name": "Daniel Camargo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233395%22"}, {"id": "fda:K233550", "company": "Lutronic Aesthetic", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2024-01-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233550: MOSAIC 3D (Surgical Laser)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233550", "people": [{"name": "Sarah Dunne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233550%22"}, {"id": "nih:1R44DC021123-01A1", "company": "Creare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-29", "observed": "2026-08-21", "amount_usd": 1100864, "summary": "NIH award 1R44DC021123-01A1: Open Source Hearing Assessment System for Open Science ($1,100,864)", "source_url": "https://reporter.nih.gov/project-details/10820919", "people": [{"name": "ODILE H CLAVIER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K230438", "company": "Truabutment, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230438: URIS Smart Path Implant System & Prosthetic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230438", "people": [{"name": "Ki Yoon Nam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230438%22"}, {"id": "fda:K233790", "company": "Instrumentation Laboratory", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233790: ACL TOP 970 CL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233790", "people": [{"name": "Nikita Malladi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233790%22"}, {"id": "fda:K223714", "company": "Adin Dental Implant Systems , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223714: UniFit Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223714", "people": [{"name": "Ilana Lutvak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223714%22"}, {"id": "fda:K233362", "company": "Pelvital USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233362: Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233362", "people": [{"name": "Lydia Zeller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233362%22"}, {"id": "fda:K230986", "company": "Avantsonic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230986: Bladder Scanner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230986", "people": [{"name": "Winnie Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230986%22"}, {"id": "fda:K233856", "company": "Alcon Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233856: Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233856", "people": [{"name": "Sherri Lakota", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233856%22"}, {"id": "fda:K232688", "company": "Neuroqore, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232688: NQ TMS for MDD (NQv1-MU-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232688", "people": [{"name": "Mehran Talebinejad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232688%22"}, {"id": "pma:P200032", "company": "Occlutech Holding AG", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2023-12-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P200032: Occlutech\u00ae ASD Occluder and Occlutech\u00ae Pistol Pusher", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200032", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P200032%22"}, {"id": "nih:1R44NS135792-01", "company": "Enclear Therapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-28", "observed": "2026-08-21", "amount_usd": 494693, "summary": "NIH award 1R44NS135792-01: Targeted Cerebral Spinal Fluid (CSF) Drug Delivery - Enclear Precision System ($494,693)", "source_url": "https://reporter.nih.gov/project-details/10822162", "people": [{"name": "MARCIE A GLICKSMAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K233405", "company": "Eco Medi Glove Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233405: Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233405", "people": [{"name": "Suresh Kumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233405%22"}, {"id": "fda:K230006", "company": "Mentice Spain S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230006: Ankyras", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230006", "people": [{"name": "Hector Fernandez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230006%22"}, {"id": "fda:K231055", "company": "De G\u00f6tzen S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231055: x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231055", "people": [{"name": "Fabio Lissandrello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231055%22"}, {"id": "fda:K230985", "company": "Planmeca Oy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230985: Planmeca Viso", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230985", "people": [{"name": "Niina Vuorikallas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230985%22"}, {"id": "fda:K230997", "company": "Evolution Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230997: EvoWalk 1.0 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230997", "people": [{"name": "Pierluigi Mantovani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230997%22"}, {"id": "fda:K230891", "company": "Healthium Medtech Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230891: SURESTITCH\u0099 UHMWPE Suture PEEK Button Meniscus Repair Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230891", "people": [{"name": "Pankaj Dawar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230891%22"}, {"id": "nih:5R44MD015947-03", "company": "Oregon Res Behavioral Intervention Strat", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-27", "observed": "2026-08-21", "amount_usd": 807986, "summary": "NIH award 5R44MD015947-03: SIBTime: Media-enhanced Technology for Promoting the Behavioral Health and Family Relationships of Typically Developing Young Siblings ($807,986)", "source_url": "https://reporter.nih.gov/project-details/10890789", "people": [{"name": "CAROL W METZLER", "role": "Principal Investigator"}, {"name": "Jessie Marquez", "role": "Principal Investigator"}, {"name": "PATRICIA F VADASY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K231914", "company": "Headsafe Mfg Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231914: Nurochek-II System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231914", "people": [{"name": "Adrian Cohen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231914%22"}, {"id": "fda:K232518", "company": "Endosound, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232518: EndoSound Vision System; EVS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232518", "people": [{"name": "Patrick Herriman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232518%22"}, {"id": "fda:K232756", "company": "Copan Wasp Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232756: Colibr\u00ed", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232756", "people": [{"name": "Giovanna Catalano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232756%22"}, {"id": "fda:K233858", "company": "Trisalus Life Sciences", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233858: TriSalus TriGuideTM Guiding Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233858", "people": [{"name": "Michael Aymami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233858%22"}, {"id": "fda:K231084", "company": "Sight Sciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231084: TearCare MGX System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231084", "people": [{"name": "Rachel M. Franco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231084%22"}, {"id": "breakthrough:K232518", "company": "Endosound, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-12-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K232518: ENDOSOUND VISION SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K233659", "company": "Osteonic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233659: Suture Wing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233659", "people": [{"name": "Da Hee Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233659%22"}, {"id": "fda:K232937", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232937: BTL-899M", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232937", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232937%22"}, {"id": "fda:K233515", "company": "Nuwellis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233515: Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233515", "people": [{"name": "Dawn Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233515%22"}, {"id": "fda:K233300", "company": "Stryker Instruments", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233300: POWEReam 1/4 Drive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233300", "people": [{"name": "Marie Gildea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233300%22"}, {"id": "fda:K231130", "company": "SimBioSys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231130: TumorSight Viz", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231130", "people": [{"name": "Tricia Carrigan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231130%22"}, {"id": "pma:P230021", "company": "Philips Image Guided Therapy Corporation", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2023-12-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230021: Duo Venous Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230021", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230021%22"}, {"id": "nih:1R43ES036089-01", "company": "Tda Research, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-25", "observed": "2026-08-21", "amount_usd": 274853, "summary": "NIH award 1R43ES036089-01: High Efficiency Sorption System for Removing Harmful Contaminants from Indoor Air ($274,853)", "source_url": "https://reporter.nih.gov/project-details/10823086", "people": [{"name": "Ambalavanan Jayaraman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH129023-03", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": 990933, "summary": "NIH award 5R44MH129023-03: Microscope system for large scale optical imaging of neuronal activity using kilohertz frame rates ($990,933)", "source_url": "https://reporter.nih.gov/project-details/10778186", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K232338", "company": "Alicn Medical Shenzhen, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232338: Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232338", "people": [{"name": "Fang Meisong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232338%22"}, {"id": "fda:K230439", "company": "Well Care (Wuhan) Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230439: WellCare Anoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230439", "people": [{"name": "Zhou Huimin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230439%22"}, {"id": "fda:K233734", "company": "Interson Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233734: Interson USB Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233734", "people": [{"name": "Vamsi Vangipuram", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233734%22"}, {"id": "fda:K231794", "company": "Viramal Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231794: Elegant\u0099 Advanced CompHort", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231794", "people": [{"name": "Simona Fiore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231794%22"}, {"id": "fda:K233205", "company": "Shanghai Heartcare Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233205: Distal Access Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233205", "people": [{"name": "Tianrong Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233205%22"}, {"id": "fda:K232717", "company": "Changzhou Haili Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232717: Apex Locator (AL-Pex), Apex Locator (AL-Pex+)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232717", "people": [{"name": "Wang Xiaofang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232717%22"}, {"id": "fda:K233058", "company": "Vivachek Biotech (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233058: VivaChek Link Plus Blood Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233058", "people": [{"name": "Mark Qian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233058%22"}, {"id": "fda:K232881", "company": "Jiangsu Kangbao Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232881: Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232881", "people": [{"name": "Wenbin Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232881%22"}, {"id": "fda:K233109", "company": "Civco Medical Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233109: TP Pivot Pro\u0099 Needle Guide", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233109", "people": [{"name": "James Leong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233109%22"}, {"id": "fda:K233304", "company": "Sharplight Technologies, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233304: Omnimax S3, Omnimax S4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233304", "people": [{"name": "Rada Trifonov", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233304%22"}, {"id": "fda:K232789", "company": "Enspectra Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232789: VIO System (V-1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232789", "people": [{"name": "Grace Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232789%22"}, {"id": "fda:K232479", "company": "Therapanacea", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232479: ART-Plan", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232479", "people": [{"name": "Bhairavi Ajachandra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232479%22"}, {"id": "fda:K230267", "company": "Neumodx Molecular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230267: NeuMoDx CT/NG Assay 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230267", "people": [{"name": "Eveline Arnold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230267%22"}, {"id": "fda:K231086", "company": "Analog Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231086: CPM System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231086", "people": [{"name": "Sam Rajkumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231086%22"}, {"id": "fda:K232535", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232535: MAGNETOM Sola; MAGNETOM Altea", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232535", "people": [{"name": "Milind Dhamankar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232535%22"}, {"id": "fda:K233742", "company": "Teleemg, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233742: CloudTMS Edge for OCD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233742", "people": [{"name": "Joe Jabre", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233742%22"}, {"id": "fda:K223745", "company": "Serf", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223745: Novae\u00ae Dual Mobility System, Hype\u00ae Hip System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223745", "people": [{"name": "Jean-Charles Moncenis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223745%22"}, {"id": "fda:DEN230020", "company": "Techsomed Medical Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230020: BioTraceIO Lite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230020", "people": [{"name": "Dalia Dickman", "role": "510(k) submission contact"}]}, {"id": "fda:K233027", "company": "Hamamatsu Photonics K.K.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233027: NanoZoomer S360MD Slide scanner system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233027", "people": [{"name": "Shinichi Fujisaka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233027%22"}, {"id": "fda:K233082", "company": "Rizhao Huge Biomaterials Company, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233082: TopCEM Dual Cure Resin Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233082", "people": [{"name": "Maggie Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233082%22"}, {"id": "fda:K234043", "company": "3M Unitek Orthodontic Products", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K234043: 3M\u0099 Transbond\u0099 Orthodontic Adhesive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234043", "people": [{"name": "Chandrapaul Parsram", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K234043%22"}, {"id": "fda:K231805", "company": "Qure.Ai Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231805: qXR-LN", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231805", "people": [{"name": "Sri Anusha Matta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231805%22"}, {"id": "fda:K232293", "company": "Kallisio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232293: kallisio stentra\u0099 oral stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232293", "people": [{"name": "Rajan Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232293%22"}, {"id": "fda:K233264", "company": "Anthogyr", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233264: Anthogyr INTEGRAL Guided Surgery Cassettes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233264", "people": [{"name": "Aude Goulet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233264%22"}, {"id": "fda:K233104", "company": "Sofwave Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233104: SofWave System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233104", "people": [{"name": "Ruthie Amir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233104%22"}, {"id": "fda:K232300", "company": "Elastimed , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232300: ElastiMed SACS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232300", "people": [{"name": "Omer Zelka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232300%22"}, {"id": "denovo:DEN230020", "company": "Techsomed Medical Technologies , Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-12-22", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230020 granted: BioTraceIO Lite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230020"}, {"id": "fda:K233465", "company": "Eizo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233465: RadiForce MX317W", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233465", "people": [{"name": "Hiroaki Hashimoto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233465%22"}, {"id": "fda:K233741", "company": "Stryker GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233741: Hoffmann LRF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233741", "people": [{"name": "Amy Noccioli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233741%22"}, {"id": "fda:K232888", "company": "Suzhou Haishen Medical Device Associates Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232888: Disposable Laryngeal Electrodes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232888", "people": [{"name": "Leyi Dai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232888%22"}, {"id": "fda:K233276", "company": "Suzhou Minhua Medical Apparatus Supplies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233276: Reusable Blood Pressure Cuff", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233276", "people": [{"name": "Michael Ying", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233276%22"}, {"id": "fda:K232744", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232744: syngo Virtual Cockpit (VB10A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232744", "people": [{"name": "Jiayan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232744%22"}, {"id": "fda:K233423", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233423: Tyber Medical Anatomical Plating System \u0096 Line extension to the Mini-Frag System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233423", "people": [{"name": "Lisa Boyle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233423%22"}, {"id": "fda:K233848", "company": "Gynesonics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233848: Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233848", "people": [{"name": "Christine Ehmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233848%22"}, {"id": "fda:K231889", "company": "Ultrasound Biotechnology (Shanghai) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231889: Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231889", "people": [{"name": "Yingnan Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231889%22"}, {"id": "fda:K233813", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233813: Bearing nsPVA Express\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233813", "people": [{"name": "Mark Mullaney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233813%22"}, {"id": "fda:K223359", "company": "Huizhou Foryou Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223359: LUOFUCON\u00ae Ag+ Foam Dressing, LUOFUCON\u00ae Ag+ Antibacterial Foam Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223359", "people": [{"name": "Guosheng Tan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223359%22"}, {"id": "fda:K231307", "company": "Elos Medtech Pinol A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231307: Elos Accurate Customized Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231307", "people": [{"name": "Lise Terkelsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231307%22"}, {"id": "fda:K231027", "company": "Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231027: KaiBiLi Extended ViralTrans", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231027", "people": [{"name": "Guan Emma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231027%22"}, {"id": "fda:K232944", "company": "Carl Zeiss Meditec, AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232944: CALLISTO eye", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232944", "people": [{"name": "Aditya Rao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232944%22"}, {"id": "fda:K233498", "company": "Howmedica Osteonics Corp., Dba Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233498: Stryker Orthopaedics Hip Systems Labeling Update", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233498", "people": [{"name": "Julia Bally", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233498%22"}, {"id": "fda:K230887", "company": "Sysmex America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230887: Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230887", "people": [{"name": "Yvonne Doswell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230887%22"}, {"id": "fda:K233016", "company": "Shenzhen Yurucheng Dental Materials Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233016: Dental Glass Ceramics", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233016", "people": [{"name": "Hongfei Liao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233016%22"}, {"id": "fda:K221753", "company": "Xinxiang Kangbeier Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221753: Kangbeier Child Surgical Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221753", "people": [{"name": "Shaoju Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221753%22"}, {"id": "fda:K231531", "company": "Hinlab, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231531: Pediarity\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231531", "people": [{"name": "Denys-Michel de Larouziere", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231531%22"}, {"id": "fda:K232329", "company": "Medivators (A Subsidiary of Steris Corporation)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232329: Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232329", "people": [{"name": "Nick Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232329%22"}, {"id": "fda:K231099", "company": "Lima Corporate S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231099: SMR Hybrid Glenoid System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231099", "people": [{"name": "Michela Zanotto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231099%22"}, {"id": "fda:K232784", "company": "Alcresta Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232784: RELiZORB\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232784", "people": [{"name": "Matthew King", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232784%22"}, {"id": "fda:K233154", "company": "Sky Surgical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233154: SkyOPS\u0099 Orthopedic Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233154", "people": [{"name": "Jeff Sander", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233154%22"}, {"id": "fda:K232870", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232870: TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232870", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232870%22"}, {"id": "fda:K232579", "company": "Hannah Life Technologies Pte , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232579: Twoplus Applicator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232579", "people": [{"name": "Prusothman M Sina Raja", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232579%22"}, {"id": "fda:K233112", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233112: HM70 EVO Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233112", "people": [{"name": "So-yeon Jang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233112%22"}, {"id": "fda:K232320", "company": "Biobot Surgical Pte., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232320: iSR`obot Mona Lisa 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232320", "people": [{"name": "Lim Yan Shin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232320%22"}, {"id": "fda:K223729", "company": "Medella Health Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223729: FLOWpresso", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223729", "people": [{"name": "Desiree De Spong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223729%22"}, {"id": "fda:K233018", "company": "Ids, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233018: PICOSECOND Nd:YAG Laser System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233018", "people": [{"name": "Kwang Yeong Ahn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233018%22"}, {"id": "fda:K233396", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233396: Cannulated Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233396", "people": [{"name": "Chelsea Bagley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233396%22"}, {"id": "fda:K230545", "company": "Triple Jump Israel , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230545: Inessa System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230545", "people": [{"name": "Liron Hadar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230545%22"}, {"id": "fda:K230736", "company": "Kuros Biosciences B.V", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230736: MagnetOs Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230736", "people": [{"name": "Hen Baron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230736%22"}, {"id": "fda:K232017", "company": "Ark Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232017: ARK Methotrexate II Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232017", "people": [{"name": "Thomas Houts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232017%22"}, {"id": "fda:K231556", "company": "Osteoremedies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231556: SPECTRUM\u00ae GV Bone Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231556", "people": [{"name": "Eric Stookey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231556%22"}, {"id": "fda:K230855", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230855: BD Vacutainer\u00ae Serum Separator (SST\u0099) Blood Collection Tubes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230855", "people": [{"name": "Matthew Tennen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230855%22"}, {"id": "fda:K232736", "company": "Chemtron Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232736: Chemtrue\u00ae Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue\u00ae Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue\u00ae Multi-Panel Drug Screen Cup Test, Chemtrue\u00ae Multi-Panel Drug Screen Dip Card Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232736", "people": [{"name": "Jane Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232736%22"}, {"id": "fda:K231411", "company": "Cowellmedi Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231411: INNO SLA Submerged Hybrid Ti-Base System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231411", "people": [{"name": "Haejun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231411%22"}, {"id": "fda:K231780", "company": "X6 Innovations", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231780: Perifit Care+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231780", "people": [{"name": "Robin Reynaud", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231780%22"}, {"id": "fda:K232444", "company": "Grand Work Plastic Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232444: Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232444", "people": [{"name": "Wu Yuli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232444%22"}, {"id": "fda:K231660", "company": "Jiangsu Dynamic Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231660: Digital image scanner of dental", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231660", "people": [{"name": "Xiang Long Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231660%22"}, {"id": "fda:K233839", "company": "Gbs Commonwealth Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233839: Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233839", "people": [{"name": "Sungji Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233839%22"}, {"id": "fda:K233176", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233176: uOmnispace.MI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233176", "people": [{"name": "Gao Xin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233176%22"}, {"id": "fda:K230850", "company": "Enhatch, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230850: United Orthopedic Knee Patient Specific Instrumentation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230850", "people": [{"name": "Monica Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230850%22"}, {"id": "fda:K232286", "company": "Quidel Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232286: Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232286", "people": [{"name": "Ronald Lollar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232286%22"}, {"id": "fda:K230955", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230955: syngo Application Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230955", "people": [{"name": "Patricia D Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230955%22"}, {"id": "fda:K231227", "company": "Baylis Medical Company, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231227: SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231227", "people": [{"name": "Shilpa Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231227%22"}, {"id": "fda:K223585", "company": "Yung Sheng Optical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223585: Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223585", "people": [{"name": "Wen-Han Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223585%22"}, {"id": "fda:K232992", "company": "Tentech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232992: 10THERMA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232992", "people": [{"name": "Dongok Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232992%22"}, {"id": "fda:K231354", "company": "Beijing Konted Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231354: Pocket Ultrasound System (C10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231354", "people": [{"name": "Deyi Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231354%22"}, {"id": "fda:K233782", "company": "Cyden Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233782: SmoothSkin Pure Adapt (SSG3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233782", "people": [{"name": "Adam Stephens", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233782%22"}, {"id": "fda:K231402", "company": "Kossel Medtech (Suzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231402: HP PTA Balloon Dilatation Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231402", "people": [{"name": "Ron Lv", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231402%22"}, {"id": "fda:K232048", "company": "Icu Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232048: Cogent\u0099 Hemodynamic Monitoring System; Cogent\u0099 HMS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232048", "people": [{"name": "Diane Stockman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232048%22"}, {"id": "fda:K233492", "company": "Xiamen Comfier Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233492: EMS Neck Massager", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233492", "people": [{"name": "Petoula N/A", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233492%22"}, {"id": "fda:K233017", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233017: TM Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233017", "people": [{"name": "Lisa Boyle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233017%22"}, {"id": "fda:K233130", "company": "Guangdong Transtek Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233130: Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233130", "people": [{"name": "Jerry Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233130%22"}, {"id": "fda:K231968", "company": "Anika Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231968: Tactoset\u00ae Injectable Bone Substitute", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231968", "people": [{"name": "Wei Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231968%22"}, {"id": "fda:K233470", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233470: DEKA LILY", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233470", "people": [{"name": "Paolo Peruzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233470%22"}, {"id": "fda:K221199", "company": "Green Island International Tcm Group Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221199: Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221199", "people": [{"name": "Zhang Shuai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221199%22"}, {"id": "fda:K230840", "company": "Providence Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230840", "people": [{"name": "Edward Liou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230840%22"}, {"id": "fda:K231671", "company": "Philips Medizin Systeme Boeblingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231671: IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231671", "people": [{"name": "Siegfried Breitling", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231671%22"}, {"id": "fda:K222810", "company": "Gostar Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222810: TD-7301 Peak Flow meter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222810", "people": [{"name": "Pei-Fen Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222810%22"}, {"id": "fda:K233448", "company": "Integra Lifesciences Production Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233448: Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233448", "people": [{"name": "Amanda Erwin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233448%22"}, {"id": "fda:K233132", "company": "Primus Sterilizer Company, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233132: PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233132", "people": [{"name": "Patrick Hansen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233132%22"}, {"id": "fda:K232560", "company": "Arum Dentistry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232560: Angled Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232560", "people": [{"name": "Won-yi Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232560%22"}, {"id": "fda:K231526", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231526: CORAIL Cemented Femoral Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231526", "people": [{"name": "Amy Joyce", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231526%22"}, {"id": "fda:K232458", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232458: JETi\u0099Hydrodynamic Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232458", "people": [{"name": "Maidy Cordova Audon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232458%22"}, {"id": "fda:K233163", "company": "Izenimplant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233163: ZENEX Implant System_Short", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233163", "people": [{"name": "Mi-Kyung Kwon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233163%22"}, {"id": "fda:K233551", "company": "W. L. Gore & Associates, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233551: GORE\u00ae ACUSEAL Vascular Graft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233551", "people": [{"name": "Christine Snyder", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233551%22"}, {"id": "pma:P230032", "company": "AutoGenomics, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2023-12-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230032: AvertD and AvertD Buccal Sample Collection Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230032", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230032%22"}, {"id": "breakthrough:P230032", "company": "Autogenomics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-12-19", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230032: AVERTD and AVERTD BUCCAL SAMPLE COLLECTION KIT", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R44HL140669-04A1S1", "company": "Volumetrix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-18", "observed": "2026-08-21", "amount_usd": 44560, "summary": "NIH award 3R44HL140669-04A1S1: Non-Invasive Venous Waveform Analysis (NIVA) in patients with Heart Failure (HF) ($44,560)", "source_url": "https://reporter.nih.gov/project-details/10980479", "people": [{"name": "Kyle Mitchell Hocking", "role": "Principal Investigator"}, {"name": "JOANN LINDENFELD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K222881", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222881: Access hsTnI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222881", "people": [{"name": "Kate Oelberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222881%22"}, {"id": "fda:K232847", "company": "Sioxmed, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232847: SiOxD Wound Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232847", "people": [{"name": "Adam Jorgensen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232847%22"}, {"id": "fda:K231066", "company": "Eizo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231066: CuratOR EX3242-FD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231066", "people": [{"name": "Hiroaki Hashimoto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231066%22"}, {"id": "fda:K233815", "company": "Inari Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233815: ClotTriever Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233815", "people": [{"name": "Tosan Eweka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233815%22"}, {"id": "fda:K231429", "company": "Idis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231429: S-Plant Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231429", "people": [{"name": "Aiden Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231429%22"}, {"id": "fda:K231929", "company": "Sydney Neuroimaging Analysis Centre Pty, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231929: iQ-solutions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231929", "people": [{"name": "Chenyu Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231929%22"}, {"id": "fda:K232780", "company": "Cc-Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232780: CC-Clip\u00ae Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232780", "people": [{"name": "Juha Ranne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232780%22"}, {"id": "fda:K231587", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231587: MAGNETOM Cima.X", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231587", "people": [{"name": "Alina Goodman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231587%22"}, {"id": "fda:K232984", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232984: Ion Endoluminal System (IF1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232984", "people": [{"name": "Jyoti Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232984%22"}, {"id": "fda:K222846", "company": "Applied Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222846: AMT G-Tube Balloon Gastrostomy Feeding Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222846", "people": [{"name": "Jennifer Hazou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222846%22"}, {"id": "sbir:DOD:FA8649-24-P-0161", "company": "Matregenix Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-12-18", "observed": "2026-09-18", "amount_usd": 109921, "summary": "DOD STTR Phase I award $109,921: SpinHeal: Handheld Device for Contactless Application of an Antibacterial Nanofiber Matrix for Rapid Wound Healing at the Point-of-Care", "source_url": "https://www.sbir.gov/awards?search=FX23E-TPCSO1-0245"}, {"id": "fda:K233691", "company": "Acutus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233691: FlexCath Cross Transseptal Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233691", "people": [{"name": "Sarah Clay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233691%22"}, {"id": "fda:K233536", "company": "Shenzhen Dongjilian Medical Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233536: Air Compression Recovery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233536", "people": [{"name": "Nancy Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233536%22"}, {"id": "nih:2R44TR003956-02A1", "company": "Immersive Tech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": 758394, "summary": "NIH award 2R44TR003956-02A1: Advancing emergency medicine training with remote stereoscopic livestream technology ($758,394)", "source_url": "https://reporter.nih.gov/project-details/10821247", "people": [{"name": "Shannon Kyle Tedder Bailey", "role": "Principal Investigator"}, {"name": "Micheal Burns", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43MH133521-01A1", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": 475002, "summary": "NIH award 1R43MH133521-01A1: A parallelized imaging platform for accurate and efficient long-term assessment of brain organoid development ($475,002)", "source_url": "https://reporter.nih.gov/project-details/10821523", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44ES031881-02A1S1", "company": "Lebrun Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": 71112, "summary": "NIH award 3R44ES031881-02A1S1: Joana Romero: IVD EIT - Administrative Supplement to Promote Diversity in Research and Development Small Businesses ($71,112)", "source_url": "https://reporter.nih.gov/project-details/10916738", "people": [{"name": "Stewart Lebrun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K233182", "company": "Zibo Kaiyue Mould Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233182: Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233182", "people": [{"name": "Cindy Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233182%22"}, {"id": "fda:K232957", "company": "Jianerkang Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232957: Sterile and Non-Sterile Ultrasound Gels", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232957", "people": [{"name": "Zhang Zhigang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232957%22"}, {"id": "fda:K231478", "company": "Wenzhou Yosun Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231478: Digital Blood Pressure Monitor (Model: YB-800)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231478", "people": [{"name": "Xiao Yuan Lan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231478%22"}, {"id": "fda:K233681", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233681: ConFirm 20 Minute Incubator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233681", "people": [{"name": "Logan Persons", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233681%22"}, {"id": "fda:K232130", "company": "Surgical Instrument Services and Savings, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232130: Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232130", "people": [{"name": "Stephanie Boyle Mays", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232130%22"}, {"id": "fda:K232939", "company": "Shenzhen Borria Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232939: IPL Hair Removal Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232939", "people": [{"name": "Tiantian Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232939%22"}, {"id": "fda:K232394", "company": "Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232394: Internal Locking Plate and Screw Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232394", "people": [{"name": "Jing Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232394%22"}, {"id": "fda:K232095", "company": "Immunexpress, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232095: SeptiCyte RAPID", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232095", "people": [{"name": "LaKesha Hunt-Dickens", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232095%22"}, {"id": "fda:K232384", "company": "Videahealth, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232384: Videa Dental Assist", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232384", "people": [{"name": "Adam Foresman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232384%22"}, {"id": "fda:K233607", "company": "Kuros Biosciences B.V", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233607: MagnetOs Easypack Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233607", "people": [{"name": "Hen Baron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233607%22"}, {"id": "fda:K232267", "company": "Nuvasive Specialized Orthopedics, Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232267: Precice Max System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232267", "people": [{"name": "Madison Heffron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232267%22"}, {"id": "fda:K233682", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233682: VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233682", "people": [{"name": "Gregory Land", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233682%22"}, {"id": "fda:K223721", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223721: Masimo Stork", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223721", "people": [{"name": "Sindura Penubarthi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223721%22"}, {"id": "fda:K230926", "company": "Tenscare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230926: Ova+ (K-OVAP-USA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230926", "people": [{"name": "Saskia Eldridge-Hinmers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230926%22"}, {"id": "fda:K230949", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230949: ARTIS pheno (VE30A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230949", "people": [{"name": "Patricia D. Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230949%22"}, {"id": "fda:K232887", "company": "Align Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232887: Invisalign Palatal Expander System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232887", "people": [{"name": "Sindhura Gaddamanugu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232887%22"}, {"id": "fda:K231825", "company": "Prowess, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231825: Panther TPS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231825", "people": [{"name": "Rachel Scarano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231825%22"}, {"id": "fda:K232598", "company": "Unibeauty (Hubei) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232598: Unscented Menstrual Tampon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232598", "people": [{"name": "Lin Fongshun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232598%22"}, {"id": "fda:K231160", "company": "Bionet Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231160: Cardio Q50, Cardio Q70", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231160", "people": [{"name": "Kyungeun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231160%22"}, {"id": "fda:K231700", "company": "Ziehm Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231700: Ziehm Vision FD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231700", "people": [{"name": "Stefan Fiedler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231700%22"}, {"id": "fda:K230501", "company": "Mir Medical International Research USA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230501: Spirobank Oxi", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230501", "people": [{"name": "Dale Novy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230501%22"}, {"id": "fda:K233237", "company": "Cutera, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233237: xeo+ Family", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233237", "people": [{"name": "Irina Glazkova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233237%22"}, {"id": "fda:K231447", "company": "Skeletal Dynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231447: Double Internal Joint Stabilizer- Elbow", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231447", "people": [{"name": "Alexandra Rodriguez Rojas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231447%22"}, {"id": "fda:K230751", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230751: EW10-EC02 Endoscopy Support Program", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230751", "people": [{"name": "Randy Vader", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230751%22"}, {"id": "fda:K232892", "company": "Biomerica, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232892: Hp Detect\u0099 Stool Antigen ELISA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232892", "people": [{"name": "Bonnie Qiu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232892%22"}, {"id": "fda:DEN230050", "company": "Fitbit, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230050: Body Temperature Software (BTS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230050", "people": [{"name": "Nathan Austin", "role": "510(k) submission contact"}]}, {"id": "fda:K233668", "company": "Eximo Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233668: Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233668", "people": [{"name": "Yoel Zabar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233668%22"}, {"id": "fda:K233564", "company": "Fluoptics Sas (A Getinge Group Company)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233564: FLUOBEAM\u00ae LX Imaging System (FB-LX); FLUOBEAM\u00ae LX Red Imaging System (FB-LXR)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233564", "people": [{"name": "Marion Boudet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233564%22"}, {"id": "denovo:DEN230050", "company": "Fitbit, LLC", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-12-15", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230050 granted: Body Temperature Software (BTS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230050"}, {"id": "nih:3R44AG076256-02S1", "company": "Maphabit, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": 45405, "summary": "NIH award 3R44AG076256-02S1: An assistive-technology based Caregiver Training Program (CTP) to enhance caregiver effectiveness, well-being, and quality of life, which will improve overall care for individuals living with AD/ADRD. ($45,405)", "source_url": "https://reporter.nih.gov/project-details/10847316", "people": [{"name": "Matthew Golden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44AG079734-02S1", "company": "Einsenca Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44AG079734-02S1: PET Imaging of Damaging Neuroinflammation in Alzheimer's Disease Technical and Business Assistance (TABA) ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10914562", "people": [{"name": "Andrew Christian Larson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K232283", "company": "Physician Software Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232283: PhySoftAMS\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232283", "people": [{"name": "Lewis Mitchell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232283%22"}, {"id": "fda:K233374", "company": "Ilooda Co,., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233374: Secret Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233374", "people": [{"name": "Kathy Maynor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233374%22"}, {"id": "fda:K230950", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230950: ARTIS icono (VE30A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230950", "people": [{"name": "Patricia D. Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230950%22"}, {"id": "fda:K231801", "company": "Medhealth Medical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231801: MedHealth DVT compression Devices MHH900S/MHH900E", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231801", "people": [{"name": "Steven Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231801%22"}, {"id": "fda:K231721", "company": "Beijing Zksk Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231721: Disposable Hot Biopsy Forceps", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231721", "people": [{"name": "Ma Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231721%22"}, {"id": "fda:K232401", "company": "Hangzhou Kangji Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232401: Disposable Veress Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232401", "people": [{"name": "Martin Sun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232401%22"}, {"id": "fda:K231570", "company": "Nico-Lab B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231570: StrokeViewer Perfusion", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231570", "people": [{"name": "Veronica Padharia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231570%22"}, {"id": "fda:K233647", "company": "Baylis Medical Company, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233647: VersaCross Connect\u0099 Transseptal Dilator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233647", "people": [{"name": "Christina Dowd", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233647%22"}, {"id": "fda:K233648", "company": "Perfuze, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233648: Millipede 088 Access Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233648", "people": [{"name": "Anne-Marie Gannon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233648%22"}, {"id": "fda:K232455", "company": "Sofwave Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232455: SofWave System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232455", "people": [{"name": "Ruthie Amir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232455%22"}, {"id": "fda:K232580", "company": "Shenzhen Insighters Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232580: Disposable Endobronchial Blocker Tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232580", "people": [{"name": "Bonnie Fang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232580%22"}, {"id": "fda:K231645", "company": "Pherdal Fertility Science, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231645: PherDal\u00ae At-Home Insemination Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231645", "people": [{"name": "Dr. Jennifer Hintzsche Westphal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231645%22"}, {"id": "fda:K233670", "company": "Ascension Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233670: Ascension Silicone MCP; Ascension Silicone PIP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233670", "people": [{"name": "Omunique Luke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233670%22"}, {"id": "fda:K231181", "company": "Dentium Co., Ltd (Ict Branch)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231181: bright CT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231181", "people": [{"name": "Sang Woo Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231181%22"}, {"id": "fda:K223470", "company": "Sopro", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223470: C50", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223470", "people": [{"name": "Kim Rouahi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223470%22"}, {"id": "fda:K232875", "company": "West Pharma. Services IL, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232875: Vial Adapter 20mm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232875", "people": [{"name": "David Ceretti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232875%22"}, {"id": "fda:K233227", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233227: VELYS\u0099 Robotic-Assisted Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233227", "people": [{"name": "Bastien Michel d'Annoville", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233227%22"}, {"id": "fda:K231887", "company": "Jeil Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231887: ARIX Ankle Distal Tibia System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231887", "people": [{"name": "Dajung Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231887%22"}, {"id": "nih:5R44NS130769-02", "company": "Drinksavvy, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": 840440, "summary": "NIH award 5R44NS130769-02: Development of a Colorimetric Sensor for Detection of Cerebrospinal Fluid Leaks ($840,440)", "source_url": "https://reporter.nih.gov/project-details/10758856", "people": [{"name": "Min Hu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42MH125688-03", "company": "Miresource, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": 498809, "summary": "NIH award 5R42MH125688-03: Automated Mental Health Referral System ($498,809)", "source_url": "https://reporter.nih.gov/project-details/10766819", "people": [{"name": "Arno Klein", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K231666", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231666: Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231666", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231666%22"}, {"id": "fda:K230742", "company": "Acclarent, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230742: ACCLARENT AERA Eustachian Tube Dilation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230742", "people": [{"name": "Kamrie Sarnosky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230742%22"}, {"id": "fda:K230964", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230964: Power Wheelchair (N5909)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230964", "people": [{"name": "Grace Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230964%22"}, {"id": "fda:K232572", "company": "Kalitec Direct, LLC Doing Business AS Kalitec Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232572: Kalitec Navigated Instrument System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232572", "people": [{"name": "Winn Scott", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232572%22"}, {"id": "fda:K232231", "company": "Quibim S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232231: QP-Brain\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232231", "people": [{"name": "Angel Alberich Bayarri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232231%22"}, {"id": "fda:K233811", "company": "Daavlin Distributing Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233811: DT Controlled Phototherapy Equipment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233811", "people": [{"name": "Michele Thiel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233811%22"}, {"id": "fda:K232877", "company": "K&J Consulting Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232877: FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C\u0099 Stand Alone System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232877", "people": [{"name": "Milan George", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232877%22"}, {"id": "fda:K230852", "company": "Instrumentation Laboratory Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230852: HemosIL Chromogenic Factor IX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230852", "people": [{"name": "Carol Marble", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230852%22"}, {"id": "fda:K231870", "company": "Ge Medical Systems Information Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231870: CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231870", "people": [{"name": "Manjunatha K N", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231870%22"}, {"id": "fda:K233621", "company": "Neuronetics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233621: NeuroStar Advanced Therapy System (Version 3.8)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233621", "people": [{"name": "Amanda Pentecost", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233621%22"}, {"id": "fda:K233688", "company": "Quidel Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233688: Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233688", "people": [{"name": "Xiaoxi Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233688%22"}, {"id": "fda:K232063", "company": "Saliwell , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232063: SaliPen", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232063", "people": [{"name": "Ben Z. Beiski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232063%22"}, {"id": "fda:K231337", "company": "Akili Interactive Labs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231337: EndeavorRx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231337", "people": [{"name": "Bhupinder Singh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231337%22"}, {"id": "fda:K232652", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232652: Anatomical Plating System (various)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232652", "people": [{"name": "Lisa Boyle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232652%22"}, {"id": "fda:K232237", "company": "Tyto Care , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232237: Tyto Insights for Wheeze Detection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232237", "people": [{"name": "Stella Raizelman Perry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232237%22"}, {"id": "fda:K232680", "company": "Nordicneurolab AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232680: fMRI Hardware System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232680", "people": [{"name": "Chandana Gurung Bhandari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232680%22"}, {"id": "fda:K231614", "company": "Reprise Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231614: MiroTract Wound Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231614", "people": [{"name": "Powers Carrie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231614%22"}, {"id": "fda:K232659", "company": "Guangzhou Decheng Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232659: Dochek\u00ae Multi-Drug Urine Test Cup Rx, Dochek\u00ae Multi-Drug Urine Test Cup", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232659", "people": [{"name": "Weifang Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232659%22"}, {"id": "fda:K232863", "company": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232863: Radiant Renewal Skincare Wand (HD-15, HD-15A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232863", "people": [{"name": "Alain Dijkstra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232863%22"}, {"id": "fda:K233019", "company": "Hangzhou AllTest Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233019: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233019", "people": [{"name": "Rosa Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233019%22"}, {"id": "fda:K231803", "company": "JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231803: Neodent Implant System - Zirconia Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231803", "people": [{"name": "Mariana Soares Hartmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231803%22"}, {"id": "fda:K232077", "company": "Wandercraft SAS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232077: Atalante X", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232077", "people": [{"name": "Matthieu Masselin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232077%22"}, {"id": "fda:K233663", "company": "Siemens Healthcare Diagnostics Products GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233663: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233663", "people": [{"name": "Sanja Matern", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233663%22"}, {"id": "fda:K233594", "company": "Genesys Spine", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233594: Genesys Spine 3DP AIS-C II Cervical Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233594", "people": [{"name": "Andrew Davison", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233594%22"}, {"id": "fda:K231039", "company": "Kuraray Noritake Dental, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231039: CLEARFIL Universal Bond Quick 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231039", "people": [{"name": "Yasujiro Ohara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231039%22"}, {"id": "pma:P230017", "company": "Medtronic, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2023-12-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230017: PulseSelect\u0099 Pulsed Field Ablation (PFA) system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230017", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230017%22"}, {"id": "breakthrough:P230017", "company": "Medtronic, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-12-13", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P230017: PULSESELECT PULSED FIELD ABLATION (PFA) SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R41HL172662-01", "company": "Hemex Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": 295920, "summary": "NIH award 1R41HL172662-01: RHODA: Rapid Hemoglobin-Oxygen Dissociation Assay ($295,920)", "source_url": "https://reporter.nih.gov/project-details/10830614", "people": [{"name": "PETER GALEN", "role": "Principal Investigator"}, {"name": "Umut A. Gurkan", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD101201-03", "company": "Salus Discovery, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": 818507, "summary": "NIH award 5R44HD101201-03: Enhancing Pediatric Diagnosis of Tuberculosis with FLOW Technology ($818,507)", "source_url": "https://reporter.nih.gov/project-details/10620287", "people": [{"name": "Brianna Mullins", "role": "Principal Investigator"}, {"name": "Jay Wyatt Warrick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K233634", "company": "Bb Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233634: TeleScan", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233634", "people": [{"name": "Britt Einspahr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233634%22"}, {"id": "fda:K233645", "company": "Boston Scientific Corporation -", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233645: StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233645", "people": [{"name": "Alexandra Skinner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233645%22"}, {"id": "fda:K230872", "company": "Shanghai Sanyou Medical Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230872: Halis\u0099 Lumbar Cage System, Lydia\u0099 Anterior Lumbar Fusion System, Dica\u0099 Direction Changeable Lumbar Cage System, KEYSTONE Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230872", "people": [{"name": "David Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230872%22"}, {"id": "fda:K233037", "company": "Zhejiang Kindly Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233037: Sterile Hypodermic Needles for Single Use", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233037", "people": [{"name": "Zhang Qian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233037%22"}, {"id": "fda:K233684", "company": "Medos International SARL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233684: TriALTIS\u0099 Spine System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233684", "people": [{"name": "Denielle Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233684%22"}, {"id": "fda:K233222", "company": "Aygun Surgical Instruments Co., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233222: Ayg\u00fcn Sterilization Container Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233222", "people": [{"name": "Engin Basoglu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233222%22"}, {"id": "fda:K232947", "company": "Innoblative Designs, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232947: SIRA\u0099 RFA Electrosurgical Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232947", "people": [{"name": "Katherine Crowley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232947%22"}, {"id": "fda:K231669", "company": "Ziehm Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231669: Ziehm Solo FD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231669", "people": [{"name": "Stefan Fiedler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231669%22"}, {"id": "fda:DEN230027", "company": "Ankon Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230027: NaviCam ProScan", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230027", "people": [{"name": "Feng Wang", "role": "510(k) submission contact"}]}, {"id": "fda:K233455", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233455: ARx MIS Spinal Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233455", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233455%22"}, {"id": "fda:K232451", "company": "Voluntis Sa.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232451: Insulia Bolus Companion", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232451", "people": [{"name": "Kevin Howard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232451%22"}, {"id": "fda:K232425", "company": "Orthosoft Inc. (D/B/A) Zimmer Cas)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232425: Signature\u0099 ONE System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232425", "people": [{"name": "Nilam Dave", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232425%22"}, {"id": "fda:K233646", "company": "Inari Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233646: Intri24 Introducer Sheath (52-101)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233646", "people": [{"name": "Kaitlyn Weinkauf", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233646%22"}, {"id": "denovo:DEN230027", "company": "Ankon Technologies Co., Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-12-12", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230027 granted: NaviCam ProScan", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230027"}, {"id": "fda:K232815", "company": "Zhuhai Yueja Medical Device Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232815: Wrist Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232815", "people": [{"name": "Feng Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232815%22"}, {"id": "fda:K232303", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232303: ATTUNE\u00ae Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM\u0099 3DP Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232303", "people": [{"name": "Kathy Boggs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232303%22"}, {"id": "fda:K232985", "company": "Lg Electronics.Inc", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232985: 24HR513C", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232985", "people": [{"name": "Jinhwan Jun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232985%22"}, {"id": "fda:K232096", "company": "Screenpoint Medical B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232096: Transpara Density 1.0.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232096", "people": [{"name": "Robin Barwegen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232096%22"}, {"id": "fda:K223340", "company": "Essential Dental Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223340: EDS Calculus Softener TURBO CR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223340", "people": [{"name": "Jason Guzman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223340%22"}, {"id": "fda:K233248", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233248: FARADRIVE\u0099 Steerable Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233248", "people": [{"name": "Nicholas Zurn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233248%22"}, {"id": "fda:K233693", "company": "Barco N.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233693: Nio Color 8MP (MDNC-8132)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233693", "people": [{"name": "Julie Vandecandelaere", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233693%22"}, {"id": "fda:K232797", "company": "Shenzhen Hygenix Industrial Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232797: Hygenix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232797", "people": [{"name": "Jia Du", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232797%22"}, {"id": "fda:K223690", "company": "Shenzhen Yhlo Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223690: iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223690", "people": [{"name": "Ying Dai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223690%22"}, {"id": "fda:K232290", "company": "ArthroCare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232290: INTELLIO SHIFT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232290", "people": [{"name": "Jennifer Burns", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232290%22"}, {"id": "sbir:DOD:FA8649-24-P-0166", "company": "Bilt Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-12-11", "observed": "2026-09-18", "amount_usd": 108644, "summary": "DOD STTR Phase I award $108,644: 3D Interactive Instructions for Technical Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=FX23E-TPCSO1-0283"}, {"id": "nih:4R44AG079777-02", "company": "Bmseed, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": 861339, "summary": "NIH award 4R44AG079777-02: A physiologically relevant pre-clinical drug screening platform for Alzheimer's Disease and Traumatic Brain Injury with integrated stretchable microelectrodes ($861,339)", "source_url": "https://reporter.nih.gov/project-details/10947426", "people": [{"name": "Oliver Graudejus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K232737", "company": "Bard Peripheral Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232737: PowerPort\u0099 ClearVUE\u0099 Slim ECG Enabled Implantable Port; PowerPort\u0099 ClearVUE\u0099 isp ECG Enabled Implantable Port; PowerPort\u0099 isp M.R.I.\u0099 ECG Enabled Implantable Port; PowerPort\u0099 Slim ECG Enabled Implantable Port", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232737", "people": [{"name": "Kristen Ortiz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232737%22"}, {"id": "fda:K231743", "company": "Corelink, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231743: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231743", "people": [{"name": "Steven Mounts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231743%22"}, {"id": "fda:K233432", "company": "Argon Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233432: 10F Sheath and Dilator Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233432", "people": [{"name": "Ana Jimenez-Hughes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233432%22"}, {"id": "fda:K232750", "company": "B.T.I. Biotechnology Institute, Sl.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232750: BTI Interna Prosthetic Components", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232750", "people": [{"name": "Jose Ramon Rivero", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232750%22"}, {"id": "fda:K230722", "company": "Belkin Vision, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230722: Eagle device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230722", "people": [{"name": "Daria Lemann-Blumenthal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230722%22"}, {"id": "fda:K233261", "company": "Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233261: Global Modular Replacement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233261", "people": [{"name": "Denise Daugert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233261%22"}, {"id": "fda:K232517", "company": "Shenzhen Kentro Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232517: Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232517", "people": [{"name": "Zewu Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232517%22"}, {"id": "fda:K232830", "company": "Vibrant, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232830: Vibrant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232830", "people": [{"name": "Martha Bezalel, Ph.D.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232830%22"}, {"id": "fda:K231964", "company": "Datex Ohmeda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231964: Novii+ Wireless Patch System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "people": [{"name": "Isabel McGann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231964%22"}, {"id": "fda:K232053", "company": "Nanowear, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232053: SimpleSense-BP, SimpleSense-BP Software Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232053", "people": [{"name": "Venkatesh Varadan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232053%22"}, {"id": "fda:K221851", "company": "Criteria Industria E Comercio DE Produtos Medicinais", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221851: Lumina-PTFE Titanium", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221851", "people": [{"name": "Andre Hamar Braga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221851%22"}, {"id": "fda:K231898", "company": "Nobel Biocare AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231898: DTX Studio Clinic (4.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231898", "people": [{"name": "Mieke Roelants", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231898%22"}, {"id": "fda:K223757", "company": "Disior, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223757: Bonelogic", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223757", "people": [{"name": "Aarno Jussila", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223757%22"}, {"id": "fda:K232085", "company": "Genoray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232085: DVAS (DVAS-M, DVAS-W)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232085", "people": [{"name": "Inyoung Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232085%22"}, {"id": "fda:K232515", "company": "Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232515: Valkyrie Thoracic Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232515", "people": [{"name": "Katie Barron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232515%22"}, {"id": "fda:K231061", "company": "Monteris Medical,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231061: NeuroBlate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231061", "people": [{"name": "David H Mueller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231061%22"}, {"id": "fda:K233654", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233654: VERIFY\u00ae Chemical Indicator for SYSTEM 1E\u00ae and SYSTEM 1\u00ae endo Liquid Chemical Sterilant Processing Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233654", "people": [{"name": "Anthony Piotrkowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233654%22"}, {"id": "fda:K232761", "company": "Bioporto Diagnostic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232761: ProNephro AKI\u0099 (NGAL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232761", "people": [{"name": "Asger Dahlgaard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232761%22"}, {"id": "fda:K231515", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231515: MySpine Cervical Guides", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231515", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231515%22"}, {"id": "fda:K232795", "company": "Stg24 Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232795: Led Mask Platinum Exclusive MD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232795", "people": [{"name": "Seojeong Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232795%22"}, {"id": "fda:K232381", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232381: LOGIQ Totus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232381", "people": [{"name": "Bryan Behn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232381%22"}, {"id": "fda:K231967", "company": "Megagen Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231967: ARi ExCon Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231967", "people": [{"name": "Kyung-Hee Back", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231967%22"}, {"id": "fda:K233429", "company": "Ots Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233429: OTS 25 (100-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233429", "people": [{"name": "Assaf Dekel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233429%22"}, {"id": "fda:K230137", "company": "Ahlstrom-Munksjo Nonwovens, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230137: Reliance\u00ae Fusion Sterilization Wraps", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230137", "people": [{"name": "Gary Jackson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230137%22"}, {"id": "fda:K231206", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231206: DLP Silicone Coronary Artery Ostial Cannulae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231206", "people": [{"name": "Stephen Beier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231206%22"}, {"id": "fda:K232846", "company": "Shenzhen Meik Beauty Industry Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232846: Light Based Hair Removal Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232846", "people": [{"name": "Xuegang Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232846%22"}, {"id": "fda:K232273", "company": "Retmap, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232273: RM Electrode (RMH 23-01)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232273", "people": [{"name": "Shresta Patangay", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232273%22"}, {"id": "fda:K232661", "company": "Circle Cardiovascular Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232661: Myocardial Strain Software Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232661", "people": [{"name": "Sydney Toutant", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232661%22"}, {"id": "fda:K231127", "company": "S.I.N. - Sistema DE Implante Nacional S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231127: S.I.N. Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231127", "people": [{"name": "Denise Domiciano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231127%22"}, {"id": "breakthrough:K232761", "company": "Bioporto Diagnostic, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-12-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K232761: PRONEPHRO AKI (NGAL)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K222930", "company": "Mallinckrodt Manufacturing, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222930: Evolve Nitric Oxide Delivery System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222930", "people": [{"name": "David Trueblood", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222930%22"}, {"id": "fda:K230677", "company": "Cork Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230677: Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230677", "people": [{"name": "Antonio Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230677%22"}, {"id": "fda:K230712", "company": "Sewon Medical Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230712: SG Lanset I, SG Lancets, Soft Lancets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230712", "people": [{"name": "Ji-yeon Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230712%22"}, {"id": "fda:K233521", "company": "QT Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233521: QT ECG (QTERD100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233521", "people": [{"name": "Jui-Hung Hung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233521%22"}, {"id": "fda:K232769", "company": "Bt Beamedical Tachnoogies Ltd. (Beamed)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232769: BeaMed Laser Surgery Fibers", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232769", "people": [{"name": "Gil Shapira", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232769%22"}, {"id": "fda:K232206", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232206: SOMATOM Pro.Pulse", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232206", "people": [{"name": "Clayton Ginn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232206%22"}, {"id": "fda:K233334", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233334: Aquilion Serve SP (TSX-307B/1) V1.3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233334", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233334%22"}, {"id": "fda:K233562", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233562: LINQ II Insertable Cardiac Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233562", "people": [{"name": "Kerry Luyster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233562%22"}, {"id": "fda:K231675", "company": "Neuroone Medical Technologies Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231675: OneRF Ablation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231675", "people": [{"name": "Debra Kridner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231675%22"}, {"id": "fda:K231125", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231125: 2008T BlueStar Hemodialysis Machine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231125", "people": [{"name": "Denise M. Oppermann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231125%22"}, {"id": "fda:K233597", "company": "FUJIFILM Sonosite, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233597: Sonosite LX Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233597", "people": [{"name": "Anoush Frankian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233597%22"}, {"id": "fda:K231465", "company": "Qurasense", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231465: Q-Pad Test System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231465", "people": [{"name": "Sara Naseri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231465%22"}, {"id": "fda:K233042", "company": "Shandong Intco Medical Products Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233042: Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233042", "people": [{"name": "Max Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233042%22"}, {"id": "sbir:DOD:HT9425-24-C-0012", "company": "Nakamir Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-12-06", "observed": "2026-09-18", "amount_usd": 1299038, "summary": "DOD SBIR Phase II award $1,299,038: Augmented Reality Surgical Vizualization Tool for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2S-0056"}, {"id": "nih:3R41AT011822-01A1S1", "company": "Massachusetts Neuro Technology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": 183153, "summary": "NIH award 3R41AT011822-01A1S1: Developing a virtual reality guided acupuncture imagery treatment for Chronic low back pain ($183,153)", "source_url": "https://reporter.nih.gov/project-details/10976167", "people": [{"name": "JIAN KONG", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K222057", "company": "T&R BIOFAB CO., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222057: THERMOCLICK", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222057", "people": [{"name": "Woo-Soo Yun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222057%22"}, {"id": "fda:K232814", "company": "Zhuhai Yueja Medical Device Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232814: Electronic Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232814", "people": [{"name": "Feng Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232814%22"}, {"id": "fda:K233568", "company": "Ceevra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233568: Ceevra Reveal 3+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233568", "people": [{"name": "Ken Koster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233568%22"}, {"id": "fda:K232440", "company": "Adra Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232440: Adravision Perio", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232440", "people": [{"name": "Yasaman Nematbakhsh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232440%22"}, {"id": "fda:K232434", "company": "Bd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232434: BD Veritor\u0099 System for Rapid Detection of Flu A+B CLIA Waived Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232434", "people": [{"name": "Michelle Bowerman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232434%22"}, {"id": "fda:K232220", "company": "Osstem Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232220: SS Abutment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232220", "people": [{"name": "Seungju Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232220%22"}, {"id": "fda:K233335", "company": "Outset Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233335: Tablo\u00ae Hemodialysis System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233335", "people": [{"name": "Claire Bao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233335%22"}, {"id": "fda:K231005", "company": "Supermax Healthcare Canada-Supermax Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231005: Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231005", "people": [{"name": "Nicolas Bergeron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231005%22"}, {"id": "fda:K233490", "company": "Bioventus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233490: SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233490", "people": [{"name": "Kellie Stefaniak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233490%22"}, {"id": "fda:K231230", "company": "Optina Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231230: Optina-4C (MHRC-C1N)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231230", "people": [{"name": "Sarah Lemaire", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231230%22"}, {"id": "fda:K223170", "company": "Hetaida Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223170: Electronic Blood Pressure Monitor, model: HTD6602US", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223170", "people": [{"name": "Tom Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223170%22"}, {"id": "fda:K231615", "company": "Jiangsu Hope Biomedical Science & Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231615: Disposable Endoscopic Bipolar", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231615", "people": [{"name": "Shaote Geng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231615%22"}, {"id": "fda:K231923", "company": "Spinal Simplicity, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231923: Liberty SI Lateral Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231923", "people": [{"name": "Adam Rogers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231923%22"}, {"id": "fda:K230734", "company": "Precision Healing, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230734: Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230734", "people": [{"name": "Robert Brik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230734%22"}, {"id": "fda:K223783", "company": "Roche Molecular Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223783: cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223783", "people": [{"name": "Aradhana Karthikeyan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223783%22"}, {"id": "fda:K232308", "company": "The Monarch Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232308: Monarch Blood Collection Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232308", "people": [{"name": "Jonathan Trawick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232308%22"}, {"id": "fda:K232932", "company": "Shenzhen Greatro Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232932: Intense Pulse Light Therapeutic Apparatus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232932", "people": [{"name": "Xinhua Yue", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232932%22"}, {"id": "fda:K232581", "company": "Suzhou Haishen Medical Device Associates Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232581: Medical Disposable Sterile Needle Electrode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232581", "people": [{"name": "Leyi Dai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232581%22"}, {"id": "fda:DEN230045", "company": "Sound Health Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230045: Sonu", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230045", "people": [{"name": "Parameswaran Gopi", "role": "510(k) submission contact"}]}, {"id": "fda:K230724", "company": "Novastep", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230724: arcad\u00ae 2.0 Duo & Quadro osteosynthesis compressive staples", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230724", "people": [{"name": "Gilles Audic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230724%22"}, {"id": "fda:K220525", "company": "Starch Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220525: RESPONDER Polysaccharide Hemostat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220525", "people": [{"name": "Alice Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220525%22"}, {"id": "fda:K230648", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230648: Access hsTnI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230648", "people": [{"name": "Stephanie Garth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230648%22"}, {"id": "fda:K233347", "company": "Cryosurgery, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233347: Verruca-Freeze\u00ae H", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233347", "people": [{"name": "Ronald A. McDow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233347%22"}, {"id": "fda:K231895", "company": "Maxtec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231895: Maxtec MaxBlend2+p", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231895", "people": [{"name": "Sidra Hankins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231895%22"}, {"id": "fda:K232693", "company": "Tyber Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232693: Tyber Medical Distal Radius Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232693", "people": [{"name": "Lisa Boyle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232693%22"}, {"id": "denovo:DEN230045", "company": "Sound Health Systems, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-12-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230045 granted: Sonu", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230045"}, {"id": "fda:K233397", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233397: Cosine-10TM Diagnostic Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233397", "people": [{"name": "Karine Lortie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233397%22"}, {"id": "nih:5R42GM144999-03", "company": "Cohere-med, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": 925681, "summary": "NIH award 5R42GM144999-03: Solving Sepsis: Early Identification and Prompt Management Using Machine Learning ($925,681)", "source_url": "https://reporter.nih.gov/project-details/10746843", "people": [{"name": "Manesh R Patel", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K230639", "company": "Acuity Surgical Devices, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230639: Align Cervical Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230639", "people": [{"name": "Bryan Cowan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230639%22"}, {"id": "fda:K232249", "company": "Pentax of America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232249: PENTAX Medical Gas/Water Feeding Valve OE-B14", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232249", "people": [{"name": "William Goeller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232249%22"}, {"id": "fda:K232093", "company": "Woo Essentials, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232093: Woo More Play Coconut Love Oil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232093", "people": [{"name": "Mackie Swan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232093%22"}, {"id": "fda:K233149", "company": "L&Z Us, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233149: CATHTONG III Tapered PICC Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233149", "people": [{"name": "James Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233149%22"}, {"id": "fda:K231817", "company": "Voco GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231817: AlignerFlow LC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231817", "people": [{"name": "Verena Kollek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231817%22"}, {"id": "fda:K230988", "company": "West Pharma. Services IL, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230988: Vial2Bag Advanced\u00ae 13mm Admixture Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230988", "people": [{"name": "llanit Goldgraber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230988%22"}, {"id": "fda:K231179", "company": "Anoxia Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231179: Slinky Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231179", "people": [{"name": "Henry Nita", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231179%22"}, {"id": "fda:K232856", "company": "Siemens Healthcare GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232856: Syngo Carbon Clinicals", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232856", "people": [{"name": "Ramadas Ramadas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232856%22"}, {"id": "fda:K232418", "company": "Southern Implants (Pty), Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232418: Single Platform SP1 Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232418", "people": [{"name": "Colin Saffy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232418%22"}, {"id": "fda:K232708", "company": "Hebei Zhemai Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232708: Intense pulsed light therapy device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232708", "people": [{"name": "Yuting Qu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232708%22"}, {"id": "fda:K231272", "company": "OSSIO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231272: OSSIOfiber\u00ae Pin Product Family, OSSIOfiber\u00ae Compression Screw, OSSIOfiber\u00ae Trimmable Fixation Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231272", "people": [{"name": "Taly Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231272%22"}, {"id": "fda:K230391", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230391: BD MiniDraw\u0099 Capillary Blood Collection System with BD MiniDraw\u0099 SST\u0099 Capillary Blood Collection Tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230391", "people": [{"name": "Katherine Kenner Lemus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230391%22"}, {"id": "fda:K230621", "company": "Surgical Principals, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230621: LaproGlide\u0099 Disposable Monopolar PTFE Coated Laparoscopic Probes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230621", "people": [{"name": "Timothy Wynne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230621%22"}, {"id": "fda:K231057", "company": "Winner Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231057: Antibacterial Gel Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231057", "people": [{"name": "Yeqing Cai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231057%22"}, {"id": "fda:K232758", "company": "Strukmyer Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232758: Comatryx OTC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232758", "people": [{"name": "Christian Quinto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232758%22"}, {"id": "fda:K231211", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231211: Medline ComfortTemp Patient Warming System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231211", "people": [{"name": "Claire Pigman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231211%22"}, {"id": "fda:K230528", "company": "Medcaptain Life Science Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230528: Extension Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230528", "people": [{"name": "Alan Tao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230528%22"}, {"id": "fda:K232438", "company": "Aibodent Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232438: Dental Glass Ceramics Blocks", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232438", "people": [{"name": "Qingliang Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232438%22"}, {"id": "fda:K231476", "company": "Sinocare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231476: TRUENESS\u0099 AIR Blood Glucose Monitoring System; TRUENESS\u0099 Blood Glucose Monitoring System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231476", "people": [{"name": "Qian Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231476%22"}, {"id": "fda:K233529", "company": "Becton Dickinson Infusion Therapy Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233529: BD Nexiva\u0099 Diffusics\u0099 Closed IV Catheter System with BD MaxZero\u0099 Needle-free Connector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233529", "people": [{"name": "Sunny Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233529%22"}, {"id": "fda:K233301", "company": "Lumenis Be, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233301: ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233301", "people": [{"name": "Shlomit Segman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233301%22"}, {"id": "fda:K233159", "company": "Fresenius Medical Care Renal Therapies Group, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-12-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233159: pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233159", "people": [{"name": "Timothy Groves", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233159%22"}, {"id": "fda:K232262", "company": "Surgease Innovations Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232262: LumenEye\u00ae X1 endoscope (LX1-SCP-203); LumenEye\u00ae X1 consumables (LX1-CSB-201); LumenEye\u00ae X1 Consumable Carton (25 Sets) (LX1-CSP-201 )", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232262", "people": [{"name": "Roger Parker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232262%22"}, {"id": "fda:K232155", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232155: syngo.CT Dual Energy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232155", "people": [{"name": "Monsuru K. Bello", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232155%22"}, {"id": "fda:K231877", "company": "Lineage Biomedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231877: NavaClick Injection System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231877", "people": [{"name": "Bradley Pliskow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231877%22"}, {"id": "fda:K231393", "company": "Maduro Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231393: Radical the Dude 7F Guide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231393", "people": [{"name": "Janice Kemp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231393%22"}, {"id": "fda:K230061", "company": "Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230061: Insulin Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230061", "people": [{"name": "Bingyi Xiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230061%22"}, {"id": "fda:K233500", "company": "Caldera Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233500: Benesta Tissue Removal Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233500", "people": [{"name": "Vicki Gail", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233500%22"}, {"id": "fda:K233545", "company": "Philips Ultrasound, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233545: EPIQ Series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233545", "people": [{"name": "Michael Chambers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233545%22"}, {"id": "fda:K230669", "company": "Argon Medical Devices", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230669: L-Cath\u0099 Single and Dual Lumen Catheters, L-Cath\u0099 Midline Catheters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230669", "people": [{"name": "Scott Bishop", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230669%22"}, {"id": "fda:K232716", "company": "Hebei Zhemai Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232716: Q-Switched Nd:Yag laser", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232716", "people": [{"name": "Yuting Qu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232716%22"}, {"id": "fda:K231546", "company": "Compumedics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231546: Somfit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231546", "people": [{"name": "Michael Frischman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231546%22"}, {"id": "fda:K230587", "company": "Beijing Choice Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230587: Wrist Pulse Oximeter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230587", "people": [{"name": "Haiying Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230587%22"}, {"id": "fda:K232709", "company": "Hebei Zhemai Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232709: Diode laser therapy device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232709", "people": [{"name": "Yuting Qu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232709%22"}, {"id": "fda:K233503", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233503: 14F iSLEEVE Introducer Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233503", "people": [{"name": "Alyssa Manno", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233503%22"}, {"id": "fda:K232611", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232611: TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232611", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232611%22"}, {"id": "fda:K233552", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233552: IDEAL Ziploop", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233552", "people": [{"name": "Becca DeFrancia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233552%22"}, {"id": "fda:K221787", "company": "Auxein Medical Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221787: Auxein's DHS/DCS Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221787", "people": [{"name": "Rahul Luthra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221787%22"}, {"id": "fda:K232244", "company": "Changzhou Endoclean Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232244: Disposable Endoscope Valves System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232244", "people": [{"name": "Qi Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232244%22"}, {"id": "fda:K232772", "company": "Shenzhen Plinma Technology Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232772: Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232772", "people": [{"name": "Zhang Mongdi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232772%22"}, {"id": "fda:K230179", "company": "Esaote, S.p.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230179: 6440 MyLabX90", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230179", "people": [{"name": "Alberto Carcagni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230179%22"}, {"id": "fda:K232684", "company": "Surgify Medical OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232684: Surgify Halo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232684", "people": [{"name": "Jukka Kreander", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232684%22"}, {"id": "fda:K233527", "company": "Spinal Simplicity, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233527: Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233527", "people": [{"name": "Adam Rogers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233527%22"}, {"id": "fda:K231203", "company": "Mosie Baby", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231203: Mosie Baby Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231203", "people": [{"name": "Maureen Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231203%22"}, {"id": "fda:K230726", "company": "Cerenovus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230726: CEREGLIDE 92 Intermediate Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230726", "people": [{"name": "Ryan Rivera", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230726%22"}, {"id": "fda:K230646", "company": "Uro-1 Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230646: SUREcore Prime Biopsy Instrument", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230646", "people": [{"name": "Thomas Lawson, PhD", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230646%22"}, {"id": "fda:K231482", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231482: uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231482", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231482%22"}, {"id": "fda:K232033", "company": "Erbe Elektromedizin GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232033: HYBRIDknife\u00ae flex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232033", "people": [{"name": "Matthias Kollek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232033%22"}, {"id": "fda:K231821", "company": "Transit Scientific, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231821: XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231821", "people": [{"name": "Jennifer Arnold", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231821%22"}, {"id": "fda:K233532", "company": "Siemens Medical Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233532: MULTIX Impact E", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233532", "people": [{"name": "Camila Rodriguez Valentin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233532%22"}, {"id": "fda:K232069", "company": "Shanghai Reach Medical Instrument Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232069: Expandable Lumbar Fusion Cage (Type I,Type II)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232069", "people": [{"name": "Jian Shen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232069%22"}, {"id": "nih:3R44AG078121-03S1", "company": "Adaptelligence, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44AG078121-03S1: Automated Health Assessment through Mobile Sensing and Machine Learning of Daily Activities ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10915054", "people": [{"name": "Diane Joyce Cook", "role": "Principal Investigator"}, {"name": "Lawrence Holder", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K231250", "company": "Guangdong Genial Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231250: Digital Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231250", "people": [{"name": "Yu Jun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231250%22"}, {"id": "fda:K232633", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232633: Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232633", "people": [{"name": "Lingling Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232633%22"}, {"id": "fda:K231473", "company": "Auris Health, Inc., A Johnson and Johnson Family Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231473: Monarch Bronchoscope", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231473", "people": [{"name": "Somi Ekwealor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231473%22"}, {"id": "fda:K231631", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231631: BriefCase-Quantification", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231631", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231631%22"}, {"id": "fda:K232643", "company": "Cue Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232643: Cue COVID-19 Molecular Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232643", "people": [{"name": "Sharon Young", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232643%22"}, {"id": "fda:K222845", "company": "Frey Oral Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222845: Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222845", "people": [{"name": "David Frey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222845%22"}, {"id": "fda:K233414", "company": "SeaSpine Orthopedics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233414: Shoreline ACS Interbody System; Shoreline RT Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233414", "people": [{"name": "Kendal Moulton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233414%22"}, {"id": "fda:K233493", "company": "Relign Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233493: Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233493", "people": [{"name": "Nathan Nguyen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233493%22"}, {"id": "fda:K232117", "company": "Wuhan Lotuxs Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232117: Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232117", "people": [{"name": "Na Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232117%22"}, {"id": "fda:K232000", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232000: syngo.via MI Workflows; Scenium; syngo MBF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232000", "people": [{"name": "Clayton Ginn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232000%22"}, {"id": "fda:K230883", "company": "Emed Technologies Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230883: VersaPump Infusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230883", "people": [{"name": "Olena Whalen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230883%22"}, {"id": "fda:K232595", "company": "Restor3D", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232595: Kinos Axiom Total Ankle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232595", "people": [{"name": "Brianna Prindle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232595%22"}, {"id": "fda:K230947", "company": "Vivos Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230947: C.A.R.E. Appliance (DNA, mRNA, mmRNA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230947", "people": [{"name": "Kimberly Griffith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230947%22"}, {"id": "fda:K232252", "company": "Dehai (Shandong) Medical Gloves, Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232252: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232252", "people": [{"name": "Max Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232252%22"}, {"id": "fda:K232012", "company": "Osstem Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232012: N1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232012", "people": [{"name": "Jimin Hyun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232012%22"}, {"id": "fda:K232713", "company": "Guangdong Transtek Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232713: Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232713", "people": [{"name": "Jerry Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232713%22"}, {"id": "fda:K232222", "company": "Medency S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232222: Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232222", "people": [{"name": "Alessandro Zorgati", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232222%22"}, {"id": "fda:K231104", "company": "Somnomedics GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231104: ABPMpro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231104", "people": [{"name": "Timo Gehring", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231104%22"}, {"id": "fda:K233332", "company": "K&J Consulting Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233332: Statera-C\u0099 Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233332", "people": [{"name": "Milan George", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233332%22"}, {"id": "fda:K232624", "company": "Siemens Healthcare Diagnostic Products GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232624: CardioPhase\u00ae hsCRP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232624", "people": [{"name": "Petra Dissmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232624%22"}, {"id": "fda:K233171", "company": "Clemde SA DE CV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233171: PF Keep; Cad Cam Keep Block", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233171", "people": [{"name": "Francisco Cabrera", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233171%22"}, {"id": "fda:K232658", "company": "Tuttnauer U.S.A Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232658: T-Top 10 & T-Top T-Top 11", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232658", "people": [{"name": "Jonathan Lane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232658%22"}, {"id": "fda:K230379", "company": "Dongguan Simzo Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230379: Portable (Ultrasonic) Nebulizer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230379", "people": [{"name": "Jack Jin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230379%22"}, {"id": "fda:K230493", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230493: BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230493", "people": [{"name": "Katherine Kenner Lemus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230493%22"}, {"id": "fda:K231661", "company": "Medinux (Tianjin) Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231661: CryoThin\u0099 Surgical System and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231661", "people": [{"name": "Diana Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231661%22"}, {"id": "fda:K233243", "company": "ClearPoint Neuro, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233243: ClearPoint System (Software Version 2.2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233243", "people": [{"name": "Brennan Sullivan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233243%22"}, {"id": "fda:K233343", "company": "Ocuject, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233343: SteriCap Safety Needle; VitreJect Safety Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233343", "people": [{"name": "Leonid Lerner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233343%22"}, {"id": "fda:K233160", "company": "Anumana, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233160: NeuTrace EP Mapping System v.2.1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233160", "people": [{"name": "Suzanne Goodman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233160%22"}, {"id": "fda:K230311", "company": "Threadstone, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230311: HyperSuture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230311", "people": [{"name": "Jeremy Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230311%22"}, {"id": "fda:K230319", "company": "Bearpac Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230319: Passio Pump Drainage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230319", "people": [{"name": "Jay Zimmerman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230319%22"}, {"id": "fda:K230701", "company": "PAJUNK GmbH Medizintechnologie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230701: Stim2Go", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230701", "people": [{"name": "Christian Quass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230701%22"}, {"id": "fda:K232059", "company": "Grace Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232059: Tympanostomy Tubes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232059", "people": [{"name": "Mark Melton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232059%22"}, {"id": "fda:K233525", "company": "Micro Current Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233525: MF SC Facial Toning System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233525", "people": [{"name": "David Suzuki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233525%22"}, {"id": "fda:K232621", "company": "Guangdong Transtek Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232621: Blood pressure monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232621", "people": [{"name": "Jerry Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232621%22"}, {"id": "fda:K233078", "company": "Double Medical Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233078: Posterior Cervical Spine System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233078", "people": [{"name": "Yan Zuo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233078%22"}, {"id": "fda:K233110", "company": "Bardy Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233110: Carnation Ambulatory Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233110", "people": [{"name": "Ben Hornsey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233110%22"}, {"id": "fda:K222712", "company": "Fogg System Company, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222712: Fogg System Patient Monitoring Cables", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222712", "people": [{"name": "Ken Neef", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222712%22"}, {"id": "fda:K232635", "company": "Boston Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232635: IceSeed 1.5 CX 90\u00ba Needle (H7493967433170); IceSeed 1.5 CX S 90\u00ba Needle (H7493967233100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232635", "people": [{"name": "Jake Burke", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232635%22"}, {"id": "fda:K230604", "company": "Philips Medizin Systeme Boeblingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230604: IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230604", "people": [{"name": "Monica Da Silva", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230604%22"}, {"id": "fda:K232600", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232600: DxFLEX Flow Cytometer; ClearLLab 10C Panels", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232600", "people": [{"name": "Stephanie Harlacz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232600%22"}, {"id": "fda:K231797", "company": "Medifun Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231797: Medifun Lancing Device, Model No. LD-E1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231797", "people": [{"name": "Aaron Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231797%22"}, {"id": "fda:K230529", "company": "Maxigen Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230529: HealiAid Dental Collagen Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230529", "people": [{"name": "Cheng-Han Zhou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230529%22"}, {"id": "fda:K222499", "company": "Shanghai SeeGen Photoelectric Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222499: Disposable Endoscope Valves Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222499", "people": [{"name": "Yihua Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222499%22"}, {"id": "fda:K231245", "company": "Guangdong Genial Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231245: Digital Blood Pressure Monitor (Arm Type)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231245", "people": [{"name": "Yu Jun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231245%22"}, {"id": "fda:K232593", "company": "Keosan Trading Co.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232593: FITme Customized Silicone Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232593", "people": [{"name": "Priscilla Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232593%22"}, {"id": "nih:3R44AG072990-03S1", "company": "See Yourself Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44AG072990-03S1: TABA for The HOPE App: An Immersive Telehealth Solution for Older Adults with Diabetes ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10853575", "people": [{"name": "Suzanne Mitchell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K230834", "company": "Trismed Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230834: CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230834", "people": [{"name": "Sul Ki Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230834%22"}, {"id": "fda:K231975", "company": "Tjc Life Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231975: PNK Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231975", "people": [{"name": "Srinu Krotha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231975%22"}, {"id": "fda:K232549", "company": "Software Nemotec S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232549: NemoCast", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232549", "people": [{"name": "Miguel del Moral", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232549%22"}, {"id": "fda:K221606", "company": "Chendu Medart Medical Scientific Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221606: Absorbable Cranial Flap Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221606", "people": [{"name": "Huaping Ran", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221606%22"}, {"id": "fda:K233084", "company": "Gbs Commonwealth Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233084: Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233084", "people": [{"name": "Jimmy Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233084%22"}, {"id": "fda:K232388", "company": "Ningbo Dizegens Medical Science Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232388: High Pressure Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232388", "people": [{"name": "Zhang Wenwei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232388%22"}, {"id": "fda:K230773", "company": "Zhejiang Chuangxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230773: Endoscopy Irrigation Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230773", "people": [{"name": "Lucius Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230773%22"}, {"id": "fda:K233191", "company": "Spinal Analytics & Geometrical Implant Co, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233191: TotalTi ACDF by SAGICO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233191", "people": [{"name": "James J. Gibson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233191%22"}, {"id": "fda:K230211", "company": "KLS-Martin L.P.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230211: CranioXpand", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230211", "people": [{"name": "Melissa Bachorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230211%22"}, {"id": "fda:K232988", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232988: Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232988", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232988%22"}, {"id": "fda:K223615", "company": "Clarus Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223615: Digital ClarusScope System, Digital NeuroPEN System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223615", "people": [{"name": "Mark F. Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223615%22"}, {"id": "fda:K222511", "company": "Southmedic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222511: Oxy2Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222511", "people": [{"name": "Christine Puddicombe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222511%22"}, {"id": "fda:K232573", "company": "Cordis US Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232573: INFINITI\u0099 Ambi Angiographic Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232573", "people": [{"name": "Zheng Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232573%22"}, {"id": "fda:K231443", "company": "Osteomed Ind\u00fastria E Com\u00e9rcio DE Implantes Ltda", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231443: Mini-OSTEO Pedicle Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231443", "people": [{"name": "Fernando Argenton Neto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231443%22"}, {"id": "fda:K233333", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233333: KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233333", "people": [{"name": "Emily Rhiel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233333%22"}, {"id": "fda:K233049", "company": "Cs Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233049: TD 200\u00ae Automated TEE Probe Disinfector with TD-12\u00ae High-Level Disinfectant with QwikCheck\u0099 Chemical Indicator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233049", "people": [{"name": "Kendall Ashe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233049%22"}, {"id": "fda:K232719", "company": "Premia Spine, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232719: ProMIS Extension Rod System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232719", "people": [{"name": "Dorit Winitz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232719%22"}, {"id": "fda:K230641", "company": "Guilin Refine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230641: Ultrasonic Scaler Tips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230641", "people": [{"name": "Chen Judong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230641%22"}, {"id": "fda:K230287", "company": "Suzhou Savicred Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230287: SaviSafe Safety Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230287", "people": [{"name": "Jiajun Zhu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230287%22"}, {"id": "fda:K232898", "company": "Immunalysis Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232898: Quantisal\u0099 Oral Fluid Collection Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232898", "people": [{"name": "Shubhajit Mitra", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232898%22"}, {"id": "fda:K232977", "company": "Biophotas, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232977: Biophotas Celluma CONTOUR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232977", "people": [{"name": "Patrick Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232977%22"}, {"id": "fda:K233053", "company": "Dental Imaging Technologies Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233053: DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233053", "people": [{"name": "Anuradha Moholkar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233053%22"}, {"id": "fda:K233245", "company": "Kuros Biosciences B.V", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233245: MagnetOs Flex Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233245", "people": [{"name": "Hen Baron", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233245%22"}, {"id": "fda:K232546", "company": "Cowellmedi Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232546: Meta G UCLA Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232546", "people": [{"name": "Haejun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232546%22"}, {"id": "fda:K232496", "company": "Brainomix Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232496: Brainomix 360 Triage Stroke", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232496", "people": [{"name": "Zsolt Szrnka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232496%22"}, {"id": "fda:K232576", "company": "Jiangsu Complete Sincerity Medical New Materials Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232576: Medical Nitrile Examination Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232576", "people": [{"name": "Shangjun Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232576%22"}, {"id": "fda:K232001", "company": "Nse Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232001: Nu Skin RenuSpa iO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232001", "people": [{"name": "McKay Noll", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232001%22"}, {"id": "fda:K233010", "company": "Belega, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233010: Beagank 4T Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233010", "people": [{"name": "Masayuki Okumura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233010%22"}, {"id": "fda:K231498", "company": "Brainlab , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231498: TraumaCad Neo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231498", "people": [{"name": "Yael Guttentag", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231498%22"}, {"id": "fda:K231692", "company": "Ziehm Imaging GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231692: Ziehm Vision RFD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231692", "people": [{"name": "Stefan Fiedler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231692%22"}, {"id": "fda:K230627", "company": "Zilia, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230627: Zilia Ocular FC (ZIL-10002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230627", "people": [{"name": "Sauvageau Patrick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230627%22"}, {"id": "fda:K232545", "company": "First Light Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232545: The SensiTox B. anthracis Toxin Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232545", "people": [{"name": "Joanne Spadoro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232545%22"}, {"id": "fda:K233351", "company": "Hg Innovations, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233351: Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233351", "people": [{"name": "M Umran Rafiq", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233351%22"}, {"id": "fda:K231941", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231941: ARIETTA x10", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231941", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231941%22"}, {"id": "fda:K232555", "company": "Topcon Healthcare Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232555: Harmony", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232555", "people": [{"name": "Tobias Schwarz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232555%22"}, {"id": "fda:K232575", "company": "Shenzhen Jianchao Intelligent Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232575: Hair Removal Device, Model(s): R2815-G Pro, R2815-G", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232575", "people": [{"name": "Fred Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232575%22"}, {"id": "fda:K233346", "company": "Hg Innovations, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233346: Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233346", "people": [{"name": "M Umran Rafiq", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233346%22"}, {"id": "fda:K230700", "company": "Fiagon GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230700: RIWOtrack Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230700", "people": [{"name": "Dirk Mucha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230700%22"}, {"id": "fda:K232512", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232512: Masimo W1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232512", "people": [{"name": "Sindura Penubarthi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232512%22"}, {"id": "fda:K230589", "company": "Medtrade Products , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230589: Celox Rapid X-Ray Gauze", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230589", "people": [{"name": "Kelsey Gomes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230589%22"}, {"id": "fda:K231020", "company": "Microgenics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231020: Alinity c Tricyclic Antidepressants Reagent Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231020", "people": [{"name": "Pranjali Shinde", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231020%22"}, {"id": "fda:K231600", "company": "Okami Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231600: SENDERO Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231600", "people": [{"name": "Jill Delsman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231600%22"}, {"id": "fda:K230190", "company": "Roosin Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230190: Polyver Silver Alginate Dressing (Prescription and OTC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230190", "people": [{"name": "Dayong Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230190%22"}, {"id": "fda:K232028", "company": "Iq Endoscopes Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232028: Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232028", "people": [{"name": "Chris Jenkins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232028%22"}, {"id": "fda:K230954", "company": "Bausch + Lomb, Incorporated", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230954: Samfilcon B Custom Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230954", "people": [{"name": "Barbara Klube-Falso", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230954%22"}, {"id": "fda:K232538", "company": "Wrp Asia Pacific Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232538: DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232538", "people": [{"name": "Muhammad Ameer Arief Mohd Mujab", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232538%22"}, {"id": "fda:K232925", "company": "Alimetry , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232925: Gastric Alimetry System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232925", "people": [{"name": "Yaara Yarmut", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232925%22"}, {"id": "fda:K230612", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230612: Edwards Algorithm for Measurement of Blood Hemoglobin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230612", "people": [{"name": "Kshama Pai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230612%22"}, {"id": "fda:K231559", "company": "Talladium Espa\u00f1a, SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231559: Multi-Unit DAS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231559", "people": [{"name": "Xavier Soca Filella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231559%22"}, {"id": "fda:K232501", "company": "Exo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232501: AI Platform (AIP001)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232501", "people": [{"name": "Jacqueline Murray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232501%22"}, {"id": "fda:K232974", "company": "Ekgenius, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232974: EKGenius Smart System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232974", "people": [{"name": "Shachar Barel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232974%22"}, {"id": "pma:P220026", "company": "Medtronic, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2023-11-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P220026: Symplicity Spyral\u0099 Renal Denervation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220026", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P220026%22"}, {"id": "breakthrough:P220026", "company": "Medtronic, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-11-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P220026: SYMPLICITY SPYRAL RENAL DENERVATION SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "hde:H230003", "company": "Restor3d, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2023-11-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H230003: restor3d Total Talus Replacement", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "fda:K232521", "company": "Blue Ortho", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232521: ExactechGPS\u00ae Total Ankle Application", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232521", "people": [{"name": "Matthieu Coic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232521%22"}, {"id": "fda:K233443", "company": "Zimvie Spine (Zimmer Biomet Spine, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233443: Vital\u0099 Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233443", "people": [{"name": "Anjanet Mort", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233443%22"}, {"id": "fda:K231694", "company": "Astura Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231694: MASADA Modular Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231694", "people": [{"name": "Parker Kelch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231694%22"}, {"id": "fda:K232921", "company": "Alcon Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232921: DAILIES TOTAL1\u00ae; DAILIES TOTAL1\u00ae Toric; DAILIES TOTAL1\u00ae Multifocal; DAILIES TOTAL1\u00ae Multifocal Toric", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232921", "people": [{"name": "Martina Heim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232921%22"}, {"id": "fda:K232533", "company": "Orthosoft D/B/A Zimmer Cas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232533: ROSA Partial Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232533", "people": [{"name": "Rakhi Toravane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232533%22"}, {"id": "fda:K233302", "company": "OSSIO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233302: OSSIOfiber\u00ae Compression Staple", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233302", "people": [{"name": "Taly Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233302%22"}, {"id": "fda:K232945", "company": "Medical Components, Inc. (dba MedComp)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232945: Trio-CT\u00ad\u00ae Triple Lumen Catheter w/ Curved Extensions", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232945", "people": [{"name": "Danielle McKinney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232945%22"}, {"id": "fda:K232392", "company": "4Dmedical Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232392: CT Lung Ventilation Analysis Software (CT:V)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232392", "people": [{"name": "Nichole Murray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232392%22"}, {"id": "fda:K231445", "company": "Waldemar Link GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231445: LINK Embrace Shoulder System - Reverse Configuration", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231445", "people": [{"name": "Stefanie Fuchs", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231445%22"}, {"id": "fda:K231738", "company": "Neuwave Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231738: NEUWAVE\u0099 Microwave Ablation System and Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231738", "people": [{"name": "Mohamed Shariff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231738%22"}, {"id": "fda:K230451", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230451: Aptima\u00ae Chlamydia trachomatis Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230451", "people": [{"name": "Jon Kukowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230451%22"}, {"id": "fda:K232753", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232753: EXPD 4343D; EXPD 3643D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232753", "people": [{"name": "Kim Minjeong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232753%22"}, {"id": "fda:K232139", "company": "Innova Vision, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232139: Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232139", "people": [{"name": "Celine Hsu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232139%22"}, {"id": "fda:K231652", "company": "Sorin Group Italia S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231652: D100 KIDS; D101 KIDS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231652", "people": [{"name": "Luigi Vecchi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231652%22"}, {"id": "fda:K233200", "company": "Gemss Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233200: XPLUS 35 Series (XPLUS 35, XPLUS 35FD)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233200", "people": [{"name": "Jiho Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233200%22"}, {"id": "nih:3R44NR019516-02A1S1", "company": "Qua, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-11-15", "observed": "2026-08-21", "amount_usd": 611302, "summary": "NIH award 3R44NR019516-02A1S1: Development and Evaluation of the PPAL Bedside Commode for Safe Independent Toileting Transfers ($611,302)", "source_url": "https://reporter.nih.gov/project-details/10974271", "people": [{"name": "Margaret Ellen Graham", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K231818", "company": "M/S Meril Life Sciences Pvt. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231818: METIC\u0099- Airway Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231818", "people": [{"name": "Umesh Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231818%22"}, {"id": "fda:K232841", "company": "Axial Medical Printing Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232841: Axial3D Insight", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232841", "people": [{"name": "Joanne Flatley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232841%22"}, {"id": "fda:DEN200070", "company": "Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN200070: Simple 2 Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN200070", "people": [{"name": "Karen Walsh", "role": "510(k) submission contact"}]}, {"id": "fda:K231852", "company": "Papricalab", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231852: BinkieRT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231852", "people": [{"name": "Sohyeon Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231852%22"}, {"id": "fda:K232973", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232973: Arthrex Knee FiberTak\u00ae Button Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232973", "people": [{"name": "Kristi Frisch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232973%22"}, {"id": "fda:K230463", "company": "Nsite, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230463: NSite Scoliosis Assessment App", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230463", "people": [{"name": "Michael J. Gardner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230463%22"}, {"id": "fda:K223414", "company": "Guilin Refine Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223414: Curing Light, Model: MaxCure 9", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223414", "people": [{"name": "Chen Judong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223414%22"}, {"id": "fda:K231012", "company": "Bolder Surgical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231012: CoolSeal Trinity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231012", "people": [{"name": "Nicholas Wong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231012%22"}, {"id": "denovo:DEN200070", "company": "Letsgetchecked Inc. (Formerly Privapath", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-11-15", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200070 granted: Simple 2 Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200070"}, {"id": "fda:K231554", "company": "Suzhou Haowei Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231554: UniPearls\u00ae Embolic Microspheres", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231554", "people": [{"name": "Jinyan Shi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231554%22"}, {"id": "fda:K232050", "company": "Saremco Dental AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232050: saremco print BRIDGETEC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232050", "people": [{"name": "Franca Schmid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232050%22"}, {"id": "fda:K231783", "company": "CIVCO Medical Instruments Co., Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231783: VitroPRO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231783", "people": [{"name": "James Leong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231783%22"}, {"id": "fda:K232845", "company": "Shenzhen Siken 3D Technology Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232845: IPL Cooling Hair Removal Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232845", "people": [{"name": "Jingquan Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232845%22"}, {"id": "fda:K232494", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232494: MAGNETOM Avanto fit; MAGNETOM Skyra fit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232494", "people": [{"name": "Milind Dhamankar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232494%22"}, {"id": "fda:K232092", "company": "Vela Operations USA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232092: Great Basin Toxigenic C. difficile Direct Test (CDF2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232092", "people": [{"name": "Larry Rea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232092%22"}, {"id": "fda:K233434", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233434: Silent Nite\u00ae Sleep Appliance with the Glidewell Hinge\u0099 (SNGLHG)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233434", "people": [{"name": "Jiahe Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233434%22"}, {"id": "fda:K230856", "company": "Brainspec, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230856: BrainSpec Core\u0099 Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230856", "people": [{"name": "Alexandra Zimmerman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230856%22"}, {"id": "fda:K232461", "company": "Kossan International Sdn Bhd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232461: Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232461", "people": [{"name": "Cho Sow Fong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232461%22"}, {"id": "fda:K231097", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231097: Inclusive\u00ae Titanium Abutments compatible with: Neoss\u00ae ProActive\u00ae Narrow, Neoss\u00ae ProActive\u00ae Standard, MIS\u00ae SEVEN\u00ae, Zimmer\u00ae Eztetic\u00ae Implant Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231097", "people": [{"name": "So Hyun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231097%22"}, {"id": "fda:K232656", "company": "Premier North America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232656: BLU TOTALE (Model: ENEOB852)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232656", "people": [{"name": "Ellis Tamari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232656%22"}, {"id": "fda:K231521", "company": "Scivita Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231521: Broncho Videoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231521", "people": [{"name": "Ruqin Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231521%22"}, {"id": "fda:K233468", "company": "Riverpoint Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233468: Iconix Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233468", "people": [{"name": "Bianca Silva de Sousa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233468%22"}, {"id": "fda:K230878", "company": "Ad Astra Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230878: QScout Lab; QScout RLD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230878", "people": [{"name": "Jasper Pollard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230878%22"}, {"id": "fda:K232488", "company": "Roche Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232488: Accu-Chek Safe-T-Pro Plus Lancing Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232488", "people": [{"name": "Kacia Mills", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232488%22"}, {"id": "fda:K232509", "company": "Roche Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232509: Accu-Chek Safe-T-Pro Uno Lancing Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232509", "people": [{"name": "Kacia Mills", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232509%22"}, {"id": "fda:K232241", "company": "Betters(Suzhou) Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232241: Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232241", "people": [{"name": "Lei Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232241%22"}, {"id": "fda:K231118", "company": "Shenzhen HugeMed Medical Technical Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231118: Cystoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231118", "people": [{"name": "Jiang Yuanning", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231118%22"}, {"id": "fda:K232083", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232083: BriefCase-Quantification", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232083", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232083%22"}, {"id": "fda:K232257", "company": "Clarius Mobile Health Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232257: Clarius Bladder AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232257", "people": [{"name": "Agatha Szeliga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232257%22"}, {"id": "fda:K232240", "company": "Betters(Suzhou) Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232240: Microwave Ablation System (BD-GT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232240", "people": [{"name": "Lei Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232240%22"}, {"id": "fda:K230831", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230831: INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230831", "people": [{"name": "Yayoi Fujimaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230831%22"}, {"id": "fda:K230849", "company": "Sinapi Biomedical (Pty) , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230849: ELLAVI UBT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230849", "people": [{"name": "Chris de Villiers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230849%22"}, {"id": "fda:K231937", "company": "Bionova Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231937: Foundation Dermal Regeneration Scaffold (DRS) Solo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231937", "people": [{"name": "Alex Greene", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231937%22"}, {"id": "fda:K231564", "company": "Winner Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231564: Skin and Wound Cleanser", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231564", "people": [{"name": "Mingni Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231564%22"}, {"id": "nih:4R44MH133517-02", "company": "Lyssn.io, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": 998118, "summary": "NIH award 4R44MH133517-02: Voice-based AI to scale evaluation of crisis counseling in 988 rollout ($998,118)", "source_url": "https://reporter.nih.gov/project-details/10836176", "people": [{"name": "David Charles Atkins", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG062069-05", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": 951526, "summary": "NIH award 5R44AG062069-05: Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy (KneeBRIGHT) ($951,526)", "source_url": "https://reporter.nih.gov/project-details/10754273", "people": [{"name": "Eileen T. Krepkovich", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "fda:K231366", "company": "Bioserenity Sas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231366: Neuronaute Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231366", "people": [{"name": "Madubuike Okafor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231366%22"}, {"id": "fda:K231277", "company": "Durastat, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231277: TissueStat", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231277", "people": [{"name": "Adam Azzara", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231277%22"}, {"id": "fda:K223682", "company": "Sirius Medical Systems B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223682: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223682", "people": [{"name": "Bram Schermers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223682%22"}, {"id": "fda:K233366", "company": "Medos International SARL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233366: SYMPHONY OCT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233366", "people": [{"name": "Sheree Geller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233366%22"}, {"id": "fda:K231752", "company": "Ark Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231752: ARK Hydrocodone Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231752", "people": [{"name": "Thomas Houts, Ph.D", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231752%22"}, {"id": "fda:K230828", "company": "ACON Laboratories, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230828: Flowflex COVID-19 Antigen Home Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230828", "people": [{"name": "Qiyi Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230828%22"}, {"id": "fda:K231617", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231617: MAGNETOM Free.Max; MAGNETOM Free.Star", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231617", "people": [{"name": "Alina Goodman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231617%22"}, {"id": "fda:K223754", "company": "Bering, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223754: BraveCX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223754", "people": [{"name": "Drozdov Ignat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223754%22"}, {"id": "fda:K231150", "company": "Bionet Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231150: Cardio P1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231150", "people": [{"name": "Kyungeun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231150%22"}, {"id": "fda:K231724", "company": "Spm Medicare Pvt. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231724: Flush Syringe (Prefilled 0.9% normal saline solution)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231724", "people": [{"name": "Sanjay Kumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231724%22"}, {"id": "fda:K230969", "company": "Jiangsu Jumao X-Care Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230969: Oxygen Concentrator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230969", "people": [{"name": "Yu Yao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230969%22"}, {"id": "fda:K231804", "company": "Fujifilm Irvine Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231804: PRIME-XV FreezIS DMSO-Free MD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231804", "people": [{"name": "Amanda Cinquin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231804%22"}, {"id": "fda:K232442", "company": "Zhejiang Soudon Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232442: Disposable Endoscope Injection Needles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232442", "people": [{"name": "Junshi Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232442%22"}, {"id": "fda:K232810", "company": "Micro-Nx Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232810: Dental Handpiece, Wireless Endodontic Handpiece, endoit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232810", "people": [{"name": "Haim Yoon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232810%22"}, {"id": "fda:K231911", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231911: Glenoid Reconstruction System \u0096 Full Wedge Baseplate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231911", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231911%22"}, {"id": "fda:K231508", "company": "Zhejiang Innuovo Rehabilitation Devices Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231508: Power Wheelchair, W5521", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231508", "people": [{"name": "Grace Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231508%22"}, {"id": "fda:K233408", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233408: Materialise Shoulder System\u0099, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233408", "people": [{"name": "Giulia Girola", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233408%22"}, {"id": "fda:K222780", "company": "Lily Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222780: LILY Extension Tube and Needleless Connector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222780", "people": [{"name": "Steven Shen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222780%22"}, {"id": "fda:K231920", "company": "Longeviti Neuro Solutions, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231920: Longeviti ClearFit OTS Cranial Implant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231920", "people": [{"name": "Jesse Christopher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231920%22"}, {"id": "fda:K233596", "company": "Bego Bremer Goldschl\u00e4gerei Wilh. Herbst GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233596: VarseoSmile TriniQ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233596", "people": [{"name": "Marcel M\u00fcller", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233596%22"}, {"id": "nih:4R44TR004557-02", "company": "Curi Bio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-11-08", "observed": "2026-08-21", "amount_usd": 832365, "summary": "NIH award 4R44TR004557-02: A cross-species preclinical platform to enhance the translation of new medicines ($832,365)", "source_url": "https://reporter.nih.gov/project-details/10898279", "people": [{"name": "Nicholas Andrew Geisse", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K232152", "company": "Theranica Bioelectronics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232152: NerivioInfinity", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232152", "people": [{"name": "Alon Ironi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232152%22"}, {"id": "fda:K232886", "company": "Healthium Medtech Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232886: INFILOOP\u00ae Fixed Loop UHMWPE Suture Titanium Button", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232886", "people": [{"name": "Pankaj Dawar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232886%22"}, {"id": "fda:DEN220091", "company": "Owlet Babycare, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN220091: Dream Sock", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220091", "people": [{"name": "Jim Fidacaro", "role": "510(k) submission contact"}]}, {"id": "fda:K230534", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230534: BriefCase-Quantification", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230534", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230534%22"}, {"id": "fda:K231773", "company": "Qura S.R.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231773: Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231773", "people": [{"name": "Raffaella Tommasini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231773%22"}, {"id": "fda:K223739", "company": "Medimaging Integrated Solution, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223739: VS Tabletop Tonometer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223739", "people": [{"name": "Joanne Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223739%22"}, {"id": "fda:K230400", "company": "Convatec, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230400: Cure Catheter Closed System; Cure Dextra Closed System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230400", "people": [{"name": "Courtney Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230400%22"}, {"id": "fda:K231798", "company": "Intuitive Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231798: da Vinci SP Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231798", "people": [{"name": "Connor McCarty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231798%22"}, {"id": "fda:K231765", "company": "Mim Software, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231765: Contour Prot\u00e9g\u00e9AI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231765", "people": [{"name": "Lynn Hanigan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231765%22"}, {"id": "denovo:DEN220091", "company": "Owlet Babycare, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-11-08", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220091 granted: Dream Sock", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220091"}, {"id": "fda:K232292", "company": "Gbs Commonwealth Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232292: Peridot-EX Expandable Intervertebral Body Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232292", "people": [{"name": "Jimmy Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232292%22"}, {"id": "fda:K232866", "company": "Jiangsu Channel Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232866: Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232866", "people": [{"name": "Eric Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232866%22"}, {"id": "fda:K233420", "company": "Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233420: Axium Detachable Coil; Axium Prime Detachable Coil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233420", "people": [{"name": "Lekshmi Ajaykumar Pillai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233420%22"}, {"id": "fda:K232476", "company": "Zhejiang Soudon Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232476: Disposable Sphincterotome", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232476", "people": [{"name": "Wang Junshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232476%22"}, {"id": "fda:K231155", "company": "Guangdong Kingfa Sci. & Tech.Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231155: Biodegradable Medical surgical mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231155", "people": [{"name": "Xiaoge Yu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231155%22"}, {"id": "fda:K231989", "company": "Ge Medical Systems Ultrasound and Primary Care Diagnostic,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231989: LOGIQ E10s, LOGIQ Fortis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231989", "people": [{"name": "Bryan Behn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231989%22"}, {"id": "fda:K231966", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231966: LOGIQ E10", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231966", "people": [{"name": "Bryan Behn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231966%22"}, {"id": "pma:P220023", "company": "Recor Medical, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2023-11-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P220023: Paradise\u00ae Ultrasound Renal Denervation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220023", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P220023%22"}, {"id": "breakthrough:P220023", "company": "Recor Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-11-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P220023: PARADISE ULTRASOUND RENAL DENERVATION SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K231519", "company": "Revital Healthcare (Epz) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231519: Revital Cady", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231519", "people": [{"name": "Ankur Vora", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231519%22"}, {"id": "fda:K231865", "company": "Reazeal Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231865: Mouth Guard (ATG0603R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231865", "people": [{"name": "Liu Fuhua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231865%22"}, {"id": "fda:K231470", "company": "Lunit, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231470: Lunit INSIGHT DBT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231470", "people": [{"name": "Hyung Tak Han", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231470%22"}, {"id": "fda:K232857", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232857: KARL STORZ ICG Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232857", "people": [{"name": "Alita McElroy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232857%22"}, {"id": "fda:DEN220090", "company": "Stemcell Technologies Canada, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN220090: EasySep\u0099 Human Bone Marrow CD138 Positive Selection Kit (100-0748)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220090", "people": [{"name": "Jason Peng", "role": "510(k) submission contact"}]}, {"id": "fda:K231316", "company": "Hologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231316: Aptima Trichomonas vaginalis Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231316", "people": [{"name": "Jingwen Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231316%22"}, {"id": "denovo:DEN220090", "company": "Stemcell Technologies Canada, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-11-06", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220090 granted: EasySep\u2122 Human Bone Marrow CD138 Positiv", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220090"}, {"id": "nih:3R41NR020458-01A1S1", "company": "Silicon Cures LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": 66220, "summary": "NIH award 3R41NR020458-01A1S1: ICU-CARE: An interactive mobile app to enhance the efficiency of daily informal caregiving in the intensive care unit ($66,220)", "source_url": "https://reporter.nih.gov/project-details/10974148", "people": [{"name": "Breanna D Hetland", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K232380", "company": "Tandem Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232380: t:slim X2 Insulin Pump with Interoperable Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232380", "people": [{"name": "Christin Dunn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232380%22"}, {"id": "fda:K230100", "company": "Classys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230100: SCIZER (SC1-M410)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230100", "people": [{"name": "Elin Hong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230100%22"}, {"id": "fda:K230481", "company": "Evenflo Feeding, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230481: Evenflo Premium Double Electric Breast Pump (Model 4018)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230481", "people": [{"name": "Michael Sewak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230481%22"}, {"id": "fda:K232382", "company": "Tandem Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232382: Control-IQ Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232382", "people": [{"name": "Christin Dunn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232382%22"}, {"id": "fda:K231955", "company": "Carlsmed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231955: aprevo\u00ae Digital Segmentation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231955", "people": [{"name": "Karen Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231955%22"}, {"id": "fda:K232742", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232742: Arthrex FiberTak Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232742", "people": [{"name": "Kristi Frisch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232742%22"}, {"id": "fda:K232251", "company": "Medartis AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232251: APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232251", "people": [{"name": "Claudia De Santis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232251%22"}, {"id": "fda:K230078", "company": "Amplitude", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230078: TRAX\u00ae CR Total Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230078", "people": [{"name": "Hugo Catois", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230078%22"}, {"id": "fda:K230343", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230343: ProSeal\u0099 Closed System Administration Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230343", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230343%22"}, {"id": "fda:K231254", "company": "Actuated Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231254: GripTract-GI Endoscopic Tissue Manipulator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231254", "people": [{"name": "Douglas R. Dillon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231254%22"}, {"id": "fda:K232113", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232113: Halcyon, Ethos Radiotherapy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232113", "people": [{"name": "Peter J. Coronado", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232113%22"}, {"id": "fda:K231182", "company": "Zoll Circulation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231182: Thermogard HQ\u0099 Temperature Management System, Thermogard XP\u00ae Temperature Management System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231182", "people": [{"name": "Sean Manning", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231182%22"}, {"id": "fda:K231586", "company": "Endophys Technologies, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231586: Endophys Blood Pressure Monitor model BPM-30", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231586", "people": [{"name": "Zachary Sowell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231586%22"}, {"id": "fda:K231440", "company": "Shenzhen Roundwhale Technology Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231440: Combo Electrotherapy Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231440", "people": [{"name": "Zeng Chunming", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231440%22"}, {"id": "fda:K231918", "company": "Koru Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231918: Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231918", "people": [{"name": "Emily DiMambro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231918%22"}, {"id": "fda:K231569", "company": "Manamed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231569: ManaFlexx 2 (model: MF002-RX, MF002-OTC)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231569", "people": [{"name": "Trevor Theriot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231569%22"}, {"id": "fda:K230475", "company": "Huger Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230475: Medical Video Endoscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230475", "people": [{"name": "Lei Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230475%22"}, {"id": "fda:K232266", "company": "Better Care Plastic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232266: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232266", "people": [{"name": "Zhu Chunyan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232266%22"}, {"id": "fda:K233428", "company": "Guangzhou Easycess Medical Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233428: Easycess Aspiration Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233428", "people": [{"name": "Xingcheng Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233428%22"}, {"id": "fda:K232186", "company": "Ge Medical Systems Ultrasound and Primary Care Diagnostic,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232186: LOGIQ e", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232186", "people": [{"name": "Lee Bush", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232186%22"}, {"id": "fda:K233056", "company": "Guidestar Medical Devices", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233056: EpiZact", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233056", "people": [{"name": "Michael Dolphin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233056%22"}, {"id": "fda:K232076", "company": "Lumendo AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232076: Fibercure", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232076", "people": [{"name": "Mark Bispinghoff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232076%22"}, {"id": "fda:K233407", "company": "AtriCure, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233407: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233407", "people": [{"name": "Stephanie Hadnot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233407%22"}, {"id": "fda:K232176", "company": "Polarisar, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232176: STELLAR Knee", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232176", "people": [{"name": "Paul Mikus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232176%22"}, {"id": "fda:K230326", "company": "Vesco Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230326: ENFit to ENFit Extension Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230326", "people": [{"name": "Chris O'Keefe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230326%22"}, {"id": "fda:K232029", "company": "Alafair Biosciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232029: VersaWrap Nerve Protector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232029", "people": [{"name": "Angela Mallery", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232029%22"}, {"id": "fda:K232345", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232345: ATEC Posterior Navigated Disc Prep Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232345", "people": [{"name": "Sandy Gill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232345%22"}, {"id": "fda:K230800", "company": "Gemss Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230800: XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230800", "people": [{"name": "Jiho Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230800%22"}, {"id": "fda:K232725", "company": "Suzhou Endophix Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232725: Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232725", "people": [{"name": "Juan Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232725%22"}, {"id": "fda:K233062", "company": "Vivachek Biotech (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233062: BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233062", "people": [{"name": "Jessica Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233062%22"}, {"id": "fda:K233518", "company": "Handpiece Headquarters", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233518: BASE290 LED Curing Light", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233518", "people": [{"name": "Frederick Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233518%22"}, {"id": "fda:K232532", "company": "Beijing Unt Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232532: Nd:Yag Laser Therapy Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232532", "people": [{"name": "Qianwen Sheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232532%22"}, {"id": "fda:K233402", "company": "Davol Inc., Subsidiary of C. R. Bard, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233402: Bard 3DMax Mesh", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233402", "people": [{"name": "Richard Spaziano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233402%22"}, {"id": "fda:K232730", "company": "Inquis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232730: Aventus Thrombectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232730", "people": [{"name": "Mojgan Saadat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232730%22"}, {"id": "fda:K231414", "company": "Chalice Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231414: CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231414", "people": [{"name": "Stephen Horan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231414%22"}, {"id": "fda:K232880", "company": "Applied Medical Resources Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232880: Inzii Ripstop Redeployable Retrieval System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232880", "people": [{"name": "Niharika Niranjan Mirji", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232880%22"}, {"id": "fda:K230927", "company": "Spineology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230927: OptiMesh Multiplanar Expandable Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230927", "people": [{"name": "Andrew Adams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230927%22"}, {"id": "fda:K233502", "company": "Graphy, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233502: TERA HARZ II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233502", "people": [{"name": "Moon Soo Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233502%22"}, {"id": "pma:P230003", "company": "Abbott Molecular, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2023-11-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P230003: Alinity m HR HPV", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230003", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P230003%22"}, {"id": "fda:K232099", "company": "JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232099: Neodent Implant System - GM Zygomatic Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232099", "people": [{"name": "Mariana Soares Hartmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232099%22"}, {"id": "fda:K230083", "company": "Medovate Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230083: SAFIRA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230083", "people": [{"name": "Alan Finnerty", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230083%22"}, {"id": "fda:K231362", "company": "TransMedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231362: OCS Heart Leukocyte Depleting Filter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231362", "people": [{"name": "Miriam Provost", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231362%22"}, {"id": "fda:K233320", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233320: LINQ II\u0099 Insertable Cardiac Monitor (LNQ22)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233320", "people": [{"name": "Dustin Hawbaker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233320%22"}, {"id": "fda:K231947", "company": "Microport Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231947: EVOLUTION\u00ae Cement Keel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231947", "people": [{"name": "Jonas Susaraba", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231947%22"}, {"id": "fda:K230352", "company": "Tornier, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230352: Tornier Humeral Nail and Tornier Long Humeral Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230352", "people": [{"name": "Renato Juan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230352%22"}, {"id": "fda:K230814", "company": "Cognifisense, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230814: VRNT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230814", "people": [{"name": "Tassilo Baeuerle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230814%22"}, {"id": "fda:K232318", "company": "Globus Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232318: VICTORY\u0099 Lumbar Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232318", "people": [{"name": "Jennifer Antonacci", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232318%22"}, {"id": "fda:K231243", "company": "Guangdong Genial Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231243: Finger Clip Pulse Oximeter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231243", "people": [{"name": "Yu Jun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231243%22"}, {"id": "fda:K230602", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230602: Hudson RCI\u00ae TurboMist\u0099 Nebulizer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230602", "people": [{"name": "Lakshmi Kanuri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230602%22"}, {"id": "fda:K231298", "company": "Alesi Surgical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231298: Ultravision2\u0099 System Integrated Monopolar L-Hook (H/S)\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231298", "people": [{"name": "Dominic Griffiths", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231298%22"}, {"id": "fda:K232294", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232294: HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta\u0099 Advanced Monitor (Smart Recovery); HemoSphere Alta\u0099 Advanced Monitor (Cardiac); HemoSphere Alta\u0099 Advanced Monitor (All-on-One)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232294", "people": [{"name": "Varad Raghuwanshi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232294%22"}, {"id": "fda:K231238", "company": "Alesi Surgical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231238: Ultravision2\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231238", "people": [{"name": "Michele Lucey", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231238%22"}, {"id": "fda:K231868", "company": "Shanghai Bangbang Robotics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231868: Electric Wheelchair (Robooter E40), Model name: BBR-E40-01", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231868", "people": [{"name": "Liu Canfeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231868%22"}, {"id": "fda:K232310", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232310: Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232310", "people": [{"name": "Cynthia Knapp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232310%22"}, {"id": "fda:K231629", "company": "Eosolutions, Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231629: 091 Balloon Guide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231629", "people": [{"name": "Marc Litzenberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231629%22"}, {"id": "fda:K232321", "company": "Medtronic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232321: FlexCath Contour\u0099 Steerable Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232321", "people": [{"name": "Kripa Pandya", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232321%22"}, {"id": "fda:K230328", "company": "Creo Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230328: Speedboat Flush SB1 Instrument", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230328", "people": [{"name": "Diane Davis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230328%22"}, {"id": "fda:K230457", "company": "Empatica S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230457", "people": [{"name": "Alberto Poli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230457%22"}, {"id": "fda:K232751", "company": "Aidoc Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232751: BriefCase-Triage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232751", "people": [{"name": "Amalia Schreier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232751%22"}, {"id": "fda:K231965", "company": "GE Medical Systems Ultrasound and Primary Care Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231965: Voluson Expert 22, Voluson Expert 20, Voluson Expert 18", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231965", "people": [{"name": "Bryan Behn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231965%22"}, {"id": "fda:K231340", "company": "Biopsybell S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231340: Renova Spine Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231340", "people": [{"name": "Carlo Ricca Prandi Bellini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231340%22"}, {"id": "fda:K231836", "company": "Vy Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231836: ClariVy\u0099 Cervical IBF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231836", "people": [{"name": "Jordan Hendrickson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231836%22"}, {"id": "fda:K232145", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232145: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232145", "people": [{"name": "Sulgue Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232145%22"}, {"id": "fda:K231029", "company": "Zhonghong Pulin Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231029: Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231029", "people": [{"name": "Li Yunjiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231029%22"}, {"id": "fda:K231222", "company": "Topcon Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231222: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231222", "people": [{"name": "Ryota Kitawaki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231222%22"}, {"id": "fda:K230755", "company": "Bios S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230755: NuEra Tight RF Model OptiStream", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230755", "people": [{"name": "Martina De Iturbe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230755%22"}, {"id": "fda:K231378", "company": "Insightec, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231378: Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231378", "people": [{"name": "Inbal Ben Tzvi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231378%22"}, {"id": "fda:K231874", "company": "Truabutment, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231874: AOT & T-L Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231874", "people": [{"name": "Ki Yoon Nam", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231874%22"}, {"id": "fda:K232280", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232280: NextAR\u0099 TSA Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232280", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232280%22"}, {"id": "fda:K230418", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230418: Mighty Wire Guide Wire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230418", "people": [{"name": "James Kenny", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230418%22"}, {"id": "fda:K233270", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233270: AcuNav Crystal Ultrasound Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233270", "people": [{"name": "Bongsoo Cho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233270%22"}, {"id": "fda:K232348", "company": "MiRus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232348: RIGEL\u0099 3DR Standalone Anterior Cervical Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232348", "people": [{"name": "Jordan Bauman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232348%22"}, {"id": "fda:K233292", "company": "Inomed Medizintechnik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233292: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233292", "people": [{"name": "Tomasz Moszkowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233292%22"}, {"id": "fda:K230285", "company": "Abbott Point of Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230285: i-STAT CG8+ cartridge with the i-STAT 1 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230285", "people": [{"name": "Jacquelyn Gesumaria", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230285%22"}, {"id": "fda:K230275", "company": "Abbott Point of Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230275: i-STAT CG8+ cartridge with the i-STAT 1 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230275", "people": [{"name": "Brian Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230275%22"}, {"id": "fda:K231494", "company": "Corelink, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231494: CoreLink Robotic Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231494", "people": [{"name": "Steven Mounts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231494%22"}, {"id": "fda:K231761", "company": "Skanray Technologies Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231761: PodSKAN HF Diagnostic X-ray System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231761", "people": [{"name": "Vasundhara R", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231761%22"}, {"id": "fda:K232667", "company": "Smith & Nephew, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232667: OR3O Dual Mobility Liners", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232667", "people": [{"name": "Madison Padgett", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232667%22"}, {"id": "fda:K213146", "company": "Jiangsu Rongye Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213146: Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213146", "people": [{"name": "Tina Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213146%22"}, {"id": "fda:K231934", "company": "Covidien", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231934: GIA\u0099 Stapler with Tri-Staple\u0099 Technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231934", "people": [{"name": "Leo Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231934%22"}, {"id": "fda:K223541", "company": "Jkh Health Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223541: Cold/Hot Compression", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223541", "people": [{"name": "Pu Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223541%22"}, {"id": "fda:K230854", "company": "Airs Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230854: SwiftMR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230854", "people": [{"name": "Jihyeon Seo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230854%22"}, {"id": "fda:K231908", "company": "Suretex Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231908: 45 Micron Polyisoprene Condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231908", "people": [{"name": "Alison Arnot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231908%22"}, {"id": "fda:K230826", "company": "Neurovalens , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230826: Modius Sleep", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230826", "people": [{"name": "Jason McKeown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230826%22"}, {"id": "fda:K233187", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233187: Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233187", "people": [{"name": "Anthony Piotrkowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233187%22"}, {"id": "fda:K232393", "company": "Proedge Dental Products, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232393: BluTube\u00ae Dental Unit Water Purification Cartridge (BluTube\u00ae); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232393", "people": [{"name": "Mark Frampton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232393%22"}, {"id": "fda:K233318", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233318: AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233318", "people": [{"name": "Mr. Ian Broome", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233318%22"}, {"id": "fda:K220493", "company": "Gcs Co. Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220493: Plaxpot Multi Plasma", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220493", "people": [{"name": "Su Kyung Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220493%22"}, {"id": "fda:K230490", "company": "Dongguan Hunter Electronic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230490: PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230490", "people": [{"name": "Hunter Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230490%22"}, {"id": "fda:K233207", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233207: Polaris X\u0099 Unidirectional Steerable Diagnostic Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233207", "people": [{"name": "Amy Reilly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233207%22"}, {"id": "fda:K232045", "company": "MeVis Medical Solutions AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232045: MeVis Liver Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232045", "people": [{"name": "Rolf Rzodeczko", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232045%22"}, {"id": "fda:K231545", "company": "Hearx SA (Pty) , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231545: hearOAE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231545", "people": [{"name": "Seline Van Der Wat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231545%22"}, {"id": "fda:K232346", "company": "GE Healthcare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232346: Digital Expert Access with Remote Scanning", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232346", "people": [{"name": "Allena Holzworth", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232346%22"}, {"id": "fda:K233241", "company": "Ht Medical, LLC Dba Xenix Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233241: SOLACE Sacroiliac Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233241", "people": [{"name": "Teresa Cherry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233241%22"}, {"id": "fda:K230300", "company": "Abbott Point of Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230300: i-STAT CG8+ cartridge with the i-STAT 1 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230300", "people": [{"name": "Brian Ma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230300%22"}, {"id": "fda:K231214", "company": "DiaSorin, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231214: LIAISON VZV IgG HT, LIAISON Control VZV IgG HT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231214", "people": [{"name": "Kelly Olien", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231214%22"}, {"id": "fda:K232618", "company": "Rebound Therapeutics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232618: Aurora Surgiscope System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232618", "people": [{"name": "Timothy Connors", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232618%22"}, {"id": "fda:K233090", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233090: DEKA AGAIN PRO family", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233090", "people": [{"name": "Paolo Peruzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233090%22"}, {"id": "fda:K231310", "company": "Shenzhen Jumper Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231310: Electronic Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231310", "people": [{"name": "Danyin Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231310%22"}, {"id": "fda:K222459", "company": "Centrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222459: Centrix FluoroSilver Silver Diamine Fluoride 38%", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222459", "people": [{"name": "Greg Moreau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222459%22"}, {"id": "fda:K231165", "company": "Shina Med Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231165: Shina Syringe; Shina Safety Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231165", "people": [{"name": "Tae Joo Ha", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231165%22"}, {"id": "fda:K233220", "company": "Senorx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233220: EnCor Enspire\u0099Breast Biopsy System (E4115, E4230); EnCor\u0099 Breast Biopsy Driver (DRENCOR); EnCor\u0099 MRI Breast Biopsy Driver (DRENCORMR); EnCor\u0099 Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor\u0099 MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233220", "people": [{"name": "Kathryn Swanstrom", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233220%22"}, {"id": "fda:K230559", "company": "Medline Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230559: Hudson RCI\u00ae Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI\u00ae Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230559", "people": [{"name": "Nicole Schaffer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230559%22"}, {"id": "fda:K213473", "company": "Advanced Medical Solutions, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213473: Antimicrobial Gelling Fiber Dressing with PHMB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213473", "people": [{"name": "Kay McGrath", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213473%22"}, {"id": "fda:K231579", "company": "Molli Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231579: MOLLI 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231579", "people": [{"name": "Joseph De Croos", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231579%22"}, {"id": "fda:K233223", "company": "Woven Orthopedic Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233223: OGmend\u00ae Implant Enhancement System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233223", "people": [{"name": "Brandon Bendes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233223%22"}, {"id": "fda:K231685", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231685: TE Air Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231685", "people": [{"name": "Zhang Yuxi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231685%22"}, {"id": "fda:K231550", "company": "Soundwave Hearing, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231550: Sontro\u00ae OTC Hearing Aids (AI)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231550", "people": [{"name": "Anthony Florek", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231550%22"}, {"id": "fda:K233170", "company": "AtriCure, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233170: cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233170", "people": [{"name": "Erica Schwab", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233170%22"}, {"id": "fda:K233091", "company": "Qura S.R.L", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233091: Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233091", "people": [{"name": "Raffaella Tommasini", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233091%22"}, {"id": "fda:K232271", "company": "Simda Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232271: SIMDA abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232271", "people": [{"name": "Cha Young Woo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232271%22"}, {"id": "fda:K230662", "company": "Zhonghong Pulin Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230662: Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230662", "people": [{"name": "Li Yunjiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230662%22"}, {"id": "fda:K233234", "company": "Nexus Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233234: PressON Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233234", "people": [{"name": "Jared Crocker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233234%22"}, {"id": "fda:K230320", "company": "Medtronic Xomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230320: NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230320", "people": [{"name": "Alexandra Oliver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230320%22"}, {"id": "fda:K232500", "company": "Philips Ultrasound", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232500: Lumify Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232500", "people": [{"name": "Sudipta Chakrabarti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232500%22"}, {"id": "fda:K231595", "company": "Shenzhen Changkun Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231595: Electric Breast Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231595", "people": [{"name": "Wang Qingpeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231595%22"}, {"id": "fda:K231737", "company": "Innosys Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231737: ANAX\u0099 5.5 Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231737", "people": [{"name": "Hye-Kyung Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231737%22"}, {"id": "fda:K230500", "company": "Jiangsu Maxf Electric Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230500: Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230500", "people": [{"name": "Zhang Jianfang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230500%22"}, {"id": "fda:K233101", "company": "Coloplast Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233101: Luja Coude (20108 Male CH18 - large packaging)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233101", "people": [{"name": "Troy Thome", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233101%22"}, {"id": "fda:K233417", "company": "Hangzhou AllTest Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233417: AllTest Fentanyl Urine Test Cassette", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233417", "people": [{"name": "Rosa Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233417%22"}, {"id": "nih:5R44AG076067-03", "company": "Life Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": 1216858, "summary": "NIH award 5R44AG076067-03: Optimization of an at-home continuous multi-domain monitoring and assessment system to improve Alzheimer's and related disorders clinical trials ($1,216,858)", "source_url": "https://reporter.nih.gov/project-details/10745742", "people": [{"name": "Lawrence J Frye", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K230511", "company": "Maui Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230511: K3900 Ultrasound Imaging System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230511", "people": [{"name": "David Specht", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230511%22"}, {"id": "fda:K230645", "company": "Avery Dennison Medical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230645: BeneHold\u0099 Surgical Incise Drape with CHG antimicrobial II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230645", "people": [{"name": "Lisa Bartakovics", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230645%22"}, {"id": "fda:K231327", "company": "Gyrus Acmi, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231327: POWERSEAL Sealer and Divider", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231327", "people": [{"name": "Dolan Mills", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231327%22"}, {"id": "fda:K231995", "company": "Radmedix, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231995: AcuityUDR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231995", "people": [{"name": "Gabriel Issa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231995%22"}, {"id": "fda:K221315", "company": "Unidental Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221315: UNIdental Symphony Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221315", "people": [{"name": "Nam Kyu Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221315%22"}, {"id": "fda:K221615", "company": "Newclip Technics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221615: Newclip Patient-matched instrumentation non sterile PSI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221615", "people": [{"name": "Gaelle Gourbiere", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221615%22"}, {"id": "fda:K230842", "company": "Implicity, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230842: SignalHF (IM008)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230842", "people": [{"name": "Caroline Florequin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230842%22"}, {"id": "fda:K232436", "company": "Ischemaview, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232436: Rapid SDH", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232436", "people": [{"name": "Jim Rosa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232436%22"}, {"id": "fda:K230284", "company": "Penumbra, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230284: Penumbra LP Coil System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230284", "people": [{"name": "Samyukta Rangachari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230284%22"}, {"id": "fda:K232235", "company": "The Magstim Company , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232235: Magstim\u00aeHorizon\u00ae 3.0 TMS Therapy System; Horizon\u00ae 3.0 System; Horizon\u00ae 3.0; Horizon\u00ae 3.0 with Navigation; Horizon\u00ae 3.0 with StimGuide Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232235", "people": [{"name": "Daniel Gregory", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232235%22"}, {"id": "fda:K231069", "company": "Spineart SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231069: PERLA\u00ae TL Posterior Thoraco-lumbar Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231069", "people": [{"name": "Franck Pennesi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231069%22"}, {"id": "fda:K233113", "company": "Starmed Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233113: ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233113", "people": [{"name": "Honggeun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233113%22"}, {"id": "fda:K233147", "company": "Rohrer Aesthetics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233147: PiXel8-RF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233147", "people": [{"name": "Mark Rohrer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233147%22"}, {"id": "fda:K233093", "company": "Ortho Development Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233093: Balanced Knee\u00ae System TriMax PS Plus Tibial Insert", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233093", "people": [{"name": "Drew Weaver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233093%22"}, {"id": "fda:K222997", "company": "Starmed Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222997: VVR Generator system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222997", "people": [{"name": "Honggeun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222997%22"}, {"id": "fda:K233210", "company": "ZetrOZ Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233210: sam CS Long Duration Ultrasound Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233210", "people": [{"name": "Sabrina Lewis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233210%22"}, {"id": "fda:K232211", "company": "Astura Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232211: REUNION Sacroiliac Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232211", "people": [{"name": "Parker Kelch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232211%22"}, {"id": "fda:K232356", "company": "Hubei Yjt Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232356: Laser Cap, Model: Hat-01", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232356", "people": [{"name": "Jiali Xie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232356%22"}, {"id": "fda:K232570", "company": "Medtronic Vascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232570: Steerant\u0099 Super Stiff Guidewire", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232570", "people": [{"name": "Amy Sanders", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232570%22"}, {"id": "fda:K232223", "company": "ShenB Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232223: PlaDuo System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232223", "people": [{"name": "Sunny Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232223%22"}, {"id": "fda:K232683", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232683: Knotilus+ PEEK Knotless Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232683", "people": [{"name": "Madison Mutchler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232683%22"}, {"id": "fda:K232086", "company": "Eos Imaging", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232086: spineEOS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232086", "people": [{"name": "Mathilde Masurel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232086%22"}, {"id": "fda:K230919", "company": "Edwards Lifesciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230919: Acumen IQ finger cuff", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230919", "people": [{"name": "Anna Hwang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230919%22"}, {"id": "fda:K232584", "company": "Vein 360, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232584: Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232584", "people": [{"name": "Suzanne Meyer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232584%22"}, {"id": "fda:K233348", "company": "Philips Medical System Nederlands B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233348: 16 Breast Coil", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233348", "people": [{"name": "Shruti Sancheti", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233348%22"}, {"id": "fda:K232051", "company": "Carl Zeiss Meditec", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232051: VISULAS green", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232051", "people": [{"name": "Tanesha Bland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232051%22"}, {"id": "fda:K233185", "company": "C2dx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233185: MODEL P8400 Controller for C2DX\u0092s Hemostatix Thermal Scalpel System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233185", "people": [{"name": "Brad Beale", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233185%22"}, {"id": "fda:K230472", "company": "Enraf-Nonius, B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230472: Sonopuls 190", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230472", "people": [{"name": "Thomas Jozef Doodkorte", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230472%22"}, {"id": "fda:K232638", "company": "Iob Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232638: FilteredFlo Warming Blankets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232638", "people": [{"name": "Jonathan Kovach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232638%22"}, {"id": "fda:K231509", "company": "Aco Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231509: Aco Apache Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231509", "people": [{"name": "Henry Huang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231509%22"}, {"id": "fda:K232586", "company": "K&J Consulting Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232586: Rexious Spinal Fixation System, Statera\u0099 Spinal System, Statera-M\u0099 Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232586", "people": [{"name": "Jeena Mathai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232586%22"}, {"id": "fda:K230893", "company": "E.M.S Electro Medical Systems S.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230893: Swiss LthoClast Trilogy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230893", "people": [{"name": "Timoth\u00e9e Deblock", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230893%22"}, {"id": "fda:K231764", "company": "Bk Medical Aps", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231764: Ultrasound System 1300", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231764", "people": [{"name": "Bryan Behn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231764%22"}, {"id": "fda:K232143", "company": "Huvitz Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232143: Applanation Tonometer HT-5000", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232143", "people": [{"name": "Heo Hyung-Min", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232143%22"}, {"id": "fda:K232205", "company": "Vesco Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232205: Vesco Q\u0099 Enteral Feeding Pump; Vesco Q\u0099 500mL Bag Feed Set; Vesco Q\u0099 1000mL Bag Feed Set; Vesco Q\u0099 40mm Screw Cap Feed Set; Vesco Q\u0099 ENPlus Feed Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232205", "people": [{"name": "Chris O'Keefe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232205%22"}, {"id": "fda:K232561", "company": "Sagico VA USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232561: Ripley Spinal Screw System by SAGICO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232561", "people": [{"name": "James Gibson, PhD, CPA", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232561%22"}, {"id": "fda:K232201", "company": "bioMerieux, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232201: VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 \u00b5g/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 \u00b5g/mL), VITEK 2 Streptococcus Penicillin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232201", "people": [{"name": "Jared Bronson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232201%22"}, {"id": "fda:K232305", "company": "Siemens Medical Solutions U.S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232305: AI-Rad Companion Brain MR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232305", "people": [{"name": "Kira Morales", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232305%22"}, {"id": "fda:K231560", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231560: MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231560", "people": [{"name": "Alina Goodman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231560%22"}, {"id": "fda:K230281", "company": "Kono Seisakusho Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230281: PICOCLAMP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230281", "people": [{"name": "Aya Takagi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230281%22"}, {"id": "fda:K231732", "company": "Conmed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231732: CleanSeal Advanced Bipolar Vessel Sealer Maryland", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231732", "people": [{"name": "Ali AbuSaleh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231732%22"}, {"id": "fda:K233258", "company": "Responsive Arthroscopy, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233258: Shadow Knotless All-Suture Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233258", "people": [{"name": "Garrett Ahlborg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233258%22"}, {"id": "fda:K232091", "company": "CC Wellness, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232091: JO Coconut Hybrid Cooling Personal Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232091", "people": [{"name": "Marlent Perez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232091%22"}, {"id": "fda:K231539", "company": "Phenox Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231539: pRESET LITE Thrombectomy Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231539", "people": [{"name": "Rachel McDaid", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231539%22"}, {"id": "fda:K230983", "company": "Tenscare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230983: Unicare (K-UNICARE-USA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230983", "people": [{"name": "Saskia Eldridge-Hinmers", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230983%22"}, {"id": "fda:K233065", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233065: V-PRO maX 2 Low Temperature Sterilization System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233065", "people": [{"name": "Jennifer Nalepka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233065%22"}, {"id": "fda:K231902", "company": "Ansell Healthcare", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231902: GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231902", "people": [{"name": "Carson Delaloye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231902%22"}, {"id": "fda:K231809", "company": "Ulrich Medical USA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231809: Momentum\u00ae Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum\u00ae MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231809", "people": [{"name": "Eric Lucas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231809%22"}, {"id": "fda:K232552", "company": "Tuxedo Imaging, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232552: TuxDeluxe (Size 1 6100B, Size 2 6101B)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232552", "people": [{"name": "Patrick Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232552%22"}, {"id": "fda:K230209", "company": "Ontact Health Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230209: Sonix Health", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230209", "people": [{"name": "Hyuk-Jae Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230209%22"}, {"id": "fda:K223557", "company": "Heidelberg Engineering GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223557: SPECTRALIS HRA+OCT and variants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223557", "people": [{"name": "Arianna Schoess Vargas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223557%22"}, {"id": "fda:K232236", "company": "Quanta System Spa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232236: Echo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232236", "people": [{"name": "Dario Bandiera", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232236%22"}, {"id": "fda:K232042", "company": "Mediconcepts Technology (Shenzhen) Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232042: NexPort\u0099 Trocar System (TS211001); NexPort\u0099 Trocar System (TS211002); NexPort\u0099 Trocar System (TS211003); NexPort\u0099 Trocar System (TS211010); NexPort\u0099 Trocar System (TS211011); NexPort\u0099 Trocar System (TS211012); NexPort\u0099 Trocar System (TS221001); NexPort\u0099 Trocar System (TS221002); NexPort\u0099 Trocar System (TS221003); NexPort\u0099 Trocar System (TS221010); NexPort\u0099 Trocar System (TS221011); NexPort\u0099 Trocar System (TS221012); NexPort\u0099 Trocar System (TS221020); NexPort\u0099 Trocar System (TS221021);", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232042", "people": [{"name": "Nick Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232042%22"}, {"id": "fda:K232922", "company": "Motus GI Medical Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232922: Pure-Vu EVS System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232922", "people": [{"name": "Mark Pomeranz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232922%22"}, {"id": "fda:K230998", "company": "Iray Imaging Technology (Haining) Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230998: Digital Wireless Intraoral X-Ray Sensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230998", "people": [{"name": "Junjie Qian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230998%22"}, {"id": "fda:K231578", "company": "Dentsply Sirona", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231578: Lucitone Digital Print Denture System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231578", "people": [{"name": "Rebecca Sporer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231578%22"}, {"id": "fda:K232550", "company": "Shanxi Hongjin Plastic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232550: Nitrile Examination Gloves, Dual Color Black-Blue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232550", "people": [{"name": "Zhigang Wu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232550%22"}, {"id": "fda:K232951", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232951: BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232951", "people": [{"name": "Carroll Martin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232951%22"}, {"id": "fda:K231388", "company": "Vertex-Dental B.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231388: NextDent Base", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231388", "people": [{"name": "Connie Peterse-van der Koppel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231388%22"}, {"id": "fda:K223909", "company": "Megagen Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223909: R2GATE Lite TM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223909", "people": [{"name": "Tae Gyoun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223909%22"}, {"id": "pma:P220012", "company": "Medtronic, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2023-10-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P220012: Aurora EV-ICD System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220012", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P220012%22"}, {"id": "fda:K230178", "company": "Ndd Medizintechnik AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230178: EasyOne Sky Spirometer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230178", "people": [{"name": "Andreas Senn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230178%22"}, {"id": "fda:K232371", "company": "Implantcast GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232371: Actinia\u00ae hip stems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232371", "people": [{"name": "Juliane H\u00f6ppner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232371%22"}, {"id": "fda:K232484", "company": "Amplio Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232484: KeyLift\u0099 Expandable Interlaminar Stabilization System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232484", "people": [{"name": "Waldi Harris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232484%22"}, {"id": "fda:K230476", "company": "Resmed Pty Ltd (Registration Number: 3004604967)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230476: Oran Park Mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230476", "people": [{"name": "Daniellia Chan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230476%22"}, {"id": "fda:K231976", "company": "Medtronic Navigation, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231976: StealthStation Cranial Software, v3.1.5 (9735585)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231976", "people": [{"name": "Rishi Mehta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231976%22"}, {"id": "fda:K230478", "company": "Acro Composites, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230478: Acro Composites Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230478", "people": [{"name": "Mitchell Bass", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230478%22"}, {"id": "fda:K231381", "company": "Cepheid", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231381: Xpert Xpress MVP; GeneXpert Xpress System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231381", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231381%22"}, {"id": "fda:K230459", "company": "21 Equipment S.R.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230459: C.C. Life 21", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230459", "people": [{"name": "Dolores Moretto", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230459%22"}, {"id": "fda:K232910", "company": "Philips Medical Systems Dmc GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232910: CombiDiagnost R90", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232910", "people": [{"name": "Ming Xiao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232910%22"}, {"id": "fda:K231664", "company": "Irras USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231664: IRRAflow Active Fluid Exchange System (AFES)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231664", "people": [{"name": "Jeanne S. Warner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231664%22"}, {"id": "fda:K231704", "company": "Life Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231704: Pro-Link\u00ae & Pro-Link\u00ae Ti Barbs Cervical Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231704", "people": [{"name": "Angela Batker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231704%22"}, {"id": "fda:K231749", "company": "Shenzhenshi Sincoheren S&T Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231749: Radio Frequency System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231749", "people": [{"name": "Cai Jialong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231749%22"}, {"id": "fda:K232905", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232905: Medline UNITE\u00ae REFLEX\u00ae Nitinol Staple Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232905", "people": [{"name": "Jennifer Mason", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232905%22"}, {"id": "fda:K231225", "company": "DRTECH Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231225: EConsole1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231225", "people": [{"name": "Kim Hanbyul", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231225%22"}, {"id": "fda:K231824", "company": "Insulet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231824: SmartBolus Calculator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231824", "people": [{"name": "Maria Brower", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231824%22"}, {"id": "fda:K232524", "company": "Perfuze, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232524: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232524", "people": [{"name": "Anne-Marie Gannon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232524%22"}, {"id": "fda:K230702", "company": "Qingdao Kingon Medical Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230702: Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230702", "people": [{"name": "Benrong Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230702%22"}, {"id": "fda:K230199", "company": "Dentsply Sirona, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230199: Byte Aligner System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230199", "people": [{"name": "Sobrin Laura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230199%22"}, {"id": "fda:K231781", "company": "Spineology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231781: OptiMesh Multiplanar Expandable Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231781", "people": [{"name": "Andrew Adams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231781%22"}, {"id": "fda:K232924", "company": "Deep Blue Medical Advances, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232924: T-Line\u00ae Hernia Mesh", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232924", "people": [{"name": "William Perry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232924%22"}, {"id": "fda:K231826", "company": "Insulet Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231826: Omnipod 5 ACE Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231826", "people": [{"name": "Maria Brower", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231826%22"}, {"id": "fda:K232897", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232897: Arthrex Small External Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232897", "people": [{"name": "Jessica Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232897%22"}, {"id": "fda:K232123", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232123: MectaLIF Anterior Lag Extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232123", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232123%22"}, {"id": "fda:K230951", "company": "Terumo Europe N.V.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230951: Terumo Injection Filter Needle (NF-3013RBKE05M)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230951", "people": [{"name": "Liesbeth Decoster", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230951%22"}, {"id": "fda:K231395", "company": "Cowellmedi Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231395: INNO SLA Submerged Narrow Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231395", "people": [{"name": "Haejun Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231395%22"}, {"id": "fda:K231907", "company": "Medline Industries, LP", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231907: Medline Safety Insulin and TB Syringes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231907", "people": [{"name": "Kelsey Closen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231907%22"}, {"id": "breakthrough:K232524", "company": "Perfuze, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-10-18", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K232524: MILLIPEDE 070 ASPIRATION CATHETER, PERFUZE ASPIRATION TUBE SET", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K232878", "company": "Foundation Fusion Solutions, LLC (Dba Cornerloc)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232878: TransLoc 3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232878", "people": [{"name": "Robert Compton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232878%22"}, {"id": "fda:K232151", "company": "Talladium Espa\u00f1a, SL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232151: Dynamic TiBase", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232151", "people": [{"name": "Xavier Soca Filella", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232151%22"}, {"id": "fda:K222214", "company": "Thi Total Healthcare Innovation GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222214: ViVi\u00ae Surgical Helmet System (ViVi\u00ae Helmet, ViVi\u00ae Helmet HPL, ViVi\u00ae Hood)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222214", "people": [{"name": "Karl Hintermann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222214%22"}, {"id": "fda:K231477", "company": "Draeger Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231477: Infinity CentralStation Wide, Infinity M300, Infinity M300+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231477", "people": [{"name": "Deborah Herrington", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231477%22"}, {"id": "fda:K223911", "company": "Intricon Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223911: Lumen 155-SF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223911", "people": [{"name": "David Akbari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223911%22"}, {"id": "fda:K231105", "company": "Shanghai AnQing Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231105: Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231105", "people": [{"name": "Shuwen Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231105%22"}, {"id": "fda:K232903", "company": "Pollogen, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232903: Legend X Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232903", "people": [{"name": "Karen Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232903%22"}, {"id": "fda:K231899", "company": "Innovasis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231899: HAtetracell\u0099-C Titanium Cervical IBF System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231899", "people": [{"name": "Michael Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231899%22"}, {"id": "fda:K232089", "company": "ImpediMed Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-17", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232089: SOZO Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232089", "people": [{"name": "Dennis Schlaht", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232089%22"}, {"id": "fda:K231725", "company": "Hunan Endoso Life Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231725: Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231725", "people": [{"name": "Fu Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231725%22"}, {"id": "fda:K232118", "company": "Ga Health Company Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232118: ANDORATE\u00ae Valve Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232118", "people": [{"name": "Cindy Ye", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232118%22"}, {"id": "fda:K230249", "company": "Immersivetouch", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230249: Ikshana", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230249", "people": [{"name": "Prashant Banerjee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230249%22"}, {"id": "fda:K230104", "company": "Anthogyr", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230104: Anthogyr AXIOM\u00ae BL X3 implants, Anthogyr Multi-Unit components for AXIOM\u00ae BL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230104", "people": [{"name": "Estelle Salle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230104%22"}, {"id": "fda:K232020", "company": "Top-Rank Health Care Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232020: Iontophoresis Electrodes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232020", "people": [{"name": "Yao Feijie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232020%22"}, {"id": "fda:K230570", "company": "Willow Innovations, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230570: Willow Generation 3 Breast Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230570", "people": [{"name": "Shruti Jayakumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230570%22"}, {"id": "fda:K232128", "company": "Shenzhen AOJ Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232128: Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232128", "people": [{"name": "Jack Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232128%22"}, {"id": "fda:K223863", "company": "Telesair, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223863: BONHAWA Respiratory Humidifier", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223863", "people": [{"name": "Yong (Bryan) Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223863%22"}, {"id": "fda:K232429", "company": "Clearadvance, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232429: Titan Dental Design", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232429", "people": [{"name": "Frank Puig", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232429%22"}, {"id": "fda:K211676", "company": "Motiva USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K211676: Motiva Flora SmoothSilk Tissue Expander", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211676", "people": [{"name": "Rosalyn d'Incelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K211676%22"}, {"id": "fda:K231744", "company": "Vy Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231744: VyLink\u0099 Spinal Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231744", "people": [{"name": "Jordan Hendrickson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231744%22"}, {"id": "fda:K230741", "company": "Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230741: Macro & Micro-Test HCG Pregnancy Test Midstream", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230741", "people": [{"name": "Bella Xu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230741%22"}, {"id": "fda:K231642", "company": "Heuron Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231642: Veuron-Brain-pAb3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231642", "people": [{"name": "Lee Hae Ri", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231642%22"}, {"id": "fda:K230125", "company": "Clearmind Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230125: Neuroblade System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230125", "people": [{"name": "Vance Lin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230125%22"}, {"id": "fda:K222143", "company": "Sweetbio, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222143: APIS (R), VERIS (TM)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222143", "people": [{"name": "Kayla Graff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222143%22"}, {"id": "fda:K232437", "company": "Wallaby Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232437: Paragon 8F Balloon Guide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232437", "people": [{"name": "Joseph Tang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232437%22"}, {"id": "fda:K232822", "company": "Gbs Commonwealth Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232822: Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232822", "people": [{"name": "Jimmy Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232822%22"}, {"id": "fda:K230495", "company": "Meris Investment Group", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230495: Serena Sleep Night Guard", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230495", "people": [{"name": "Gary Maas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230495%22"}, {"id": "fda:K232481", "company": "MiRus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232481: RIGEL\u0099 3DR Anterior Cervical Corpectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232481", "people": [{"name": "Jordan Bauman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232481%22"}, {"id": "fda:K232504", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232504: Calibrate CCX Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232504", "people": [{"name": "Neha Mohindroo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232504%22"}, {"id": "fda:K231672", "company": "Medpark Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231672: S1", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231672", "people": [{"name": "Woojong Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231672%22"}, {"id": "fda:K230440", "company": "Cepheid\u00ae", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230440: Xpert\u00ae Xpress CoV-2 plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230440", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230440%22"}, {"id": "fda:K231495", "company": "InMode , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231495: The Evolve System with the Transform Applicator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231495", "people": [{"name": "Suhair Francis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231495%22"}, {"id": "fda:K223697", "company": "BioHorizons Implant Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223697: MRI compatibility for existing BioHorizons dental implants and abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223697", "people": [{"name": "Paul Leppo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223697%22"}, {"id": "fda:K230370", "company": "Arineta , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230370: SpotLight/SpotLight Duo (with DLIR option)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230370", "people": [{"name": "Tanya Shalem", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230370%22"}, {"id": "fda:K231486", "company": "Nexus Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231486: Stable-L Standalone Lumbar Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231486", "people": [{"name": "Jared Crocker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231486%22"}, {"id": "fda:DEN200076", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN200076: ORi", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN200076", "people": [{"name": "Linus Park", "role": "510(k) submission contact"}]}, {"id": "fda:K231551", "company": "Sparrow Acoustics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231551: Stethophone", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231551", "people": [{"name": "Nadia Ivanova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231551%22"}, {"id": "fda:K231708", "company": "Axogen Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231708: Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231708", "people": [{"name": "Shravani Shastry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231708%22"}, {"id": "fda:K231814", "company": "Dongguan TT Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231814: ValvuloPro Valvuloplasty Balloon Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231814", "people": [{"name": "Yuying Bi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231814%22"}, {"id": "fda:K231475", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231475: MONTAGE-QS Settable, Resorbable Bone Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231475", "people": [{"name": "Aniq Darr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231475%22"}, {"id": "fda:K231574", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231574: Scenaria View 4.2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231574", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231574%22"}, {"id": "fda:K230650", "company": "Vhmed (Nantong) Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230650: Monopolar Electrode Surgical Instrument", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230650", "people": [{"name": "Guan Yunjuan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230650%22"}, {"id": "fda:K231152", "company": "Winner Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231152: Collagen Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231152", "people": [{"name": "Yi Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231152%22"}, {"id": "fda:K231231", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231231: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231231", "people": [{"name": "Haylie Hertz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231231%22"}, {"id": "fda:K230707", "company": "Skypro Medical Supplies Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230707: Skypro, Surgical Gown 6021", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230707", "people": [{"name": "Cyrus Wong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230707%22"}, {"id": "fda:K222222", "company": "Eigen", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222222: Artemis, Artemis TPO, Artemis MX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222222", "people": [{"name": "William Mandel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222222%22"}, {"id": "fda:K232448", "company": "Detax GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232448: FREEPRINT\u00ae splintmaster", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232448", "people": [{"name": "Markus Stratmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232448%22"}, {"id": "fda:K232802", "company": "THINK Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232802: TMINI\u0099 Miniature Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232802", "people": [{"name": "Anand Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232802%22"}, {"id": "fda:K232838", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232838: Monkey RingsTM External Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232838", "people": [{"name": "Edward Wells-Spicer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232838%22"}, {"id": "fda:K232998", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232998: Montage- XT Settable, Resorbable Hemostatic Bone Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232998", "people": [{"name": "Howard Schrayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232998%22"}, {"id": "fda:K230717", "company": "Exactech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230717: Exactech\u00ae Vantage\u00ae Total Ankle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230717", "people": [{"name": "Pedro Ravelo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230717%22"}, {"id": "fda:K232809", "company": "Cross Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232809: Cross Vascular RF Generator and Footswitch (optional accessory)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232809", "people": [{"name": "Jennifer Willner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232809%22"}, {"id": "fda:K232852", "company": "Cross Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232852: Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232852", "people": [{"name": "Jennifer Willner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232852%22"}, {"id": "denovo:DEN200076", "company": "Masimo Corporation", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-10-12", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200076 granted: ORi", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200076"}, {"id": "fda:K232574", "company": "Filmec Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232574: VASSALLO GT Crossing14", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232574", "people": [{"name": "Toshiya Osawa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232574%22"}, {"id": "fda:K230116", "company": "Zimvie Spine (Zimmer Biomet Spine, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230116: Vital\u0099 Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230116", "people": [{"name": "Hanna Aucoin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230116%22"}, {"id": "fda:K232981", "company": "Synaptive Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232981: Synq Software Version 1.3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232981", "people": [{"name": "Ahmed Hamed", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232981%22"}, {"id": "fda:K233233", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233233: EMPHASYS Femoral Stems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233233", "people": [{"name": "Sarah Matamisa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233233%22"}, {"id": "fda:K232499", "company": "Shenzhen Lescolton Electrical Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232499: IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232499", "people": [{"name": "Chen Zhikui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232499%22"}, {"id": "fda:K232070", "company": "Better Care Plastic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232070: Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232070", "people": [{"name": "Zhu Chunyan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232070%22"}, {"id": "fda:K230148", "company": "Dormotech Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230148: Vlab", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230148", "people": [{"name": "Abed Nassir", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230148%22"}, {"id": "fda:K231050", "company": "Alicn Medical Shenzhen, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231050: Arm Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231050", "people": [{"name": "Fang Meisong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231050%22"}, {"id": "fda:K223126", "company": "Maxigen Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223126: SurgiAid\u00ae Collagen Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223126", "people": [{"name": "Cheng-Han Chou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223126%22"}, {"id": "fda:K230618", "company": "Megagen Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230618: MegaGen Dental Implant Systems Portfolio - MR Conditional", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230618", "people": [{"name": "Hyejin Jung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230618%22"}, {"id": "fda:K232344", "company": "GE Medical Systems SCS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232344: Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232344", "people": [{"name": "Hubert Welsch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232344%22"}, {"id": "fda:K232460", "company": "Shenzhen Mecun Medical Supply Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232460: Disposable electrosurgical pencil (MD1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232460", "people": [{"name": "Bo Zheng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232460%22"}, {"id": "fda:K230897", "company": "Heidelberg Engineering GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230897: Anterion", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230897", "people": [{"name": "Arianna Schoess Vargas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230897%22"}, {"id": "fda:K230220", "company": "Neusoft Medical Systems Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230220: NeuViz 128 Multi-Slice CT Scanner System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230220", "people": [{"name": "Tian Yuehui", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230220%22"}, {"id": "fda:K232090", "company": "CC Wellness, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232090: JO Coconut Hybrid Warming Personal Lubricant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232090", "people": [{"name": "Marlent Perez", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232090%22"}, {"id": "fda:K222025", "company": "Gel4med, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222025: G4Derm / G4Derm Plus Synthetic Wound Matrix", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222025", "people": [{"name": "Ana Tellechea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222025%22"}, {"id": "fda:K232578", "company": "Filmec Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232578: VASSALLO GT 018 G12; VASSALLO GT 018 G30", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232578", "people": [{"name": "Toshiya Osawa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232578%22"}, {"id": "fda:K232775", "company": "Abbott Diagnostics Scarborough, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232775: ID NOW Influenza A & B 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232775", "people": [{"name": "Jessica Stahle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232775%22"}, {"id": "fda:K230961", "company": "Shanghai Sanyou Medical Co, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230961: Zeus Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230961", "people": [{"name": "David Fan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230961%22"}, {"id": "fda:K231413", "company": "Implant Protesis Dental 2004, S.L.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231413: IPD Dental Implant Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231413", "people": [{"name": "Francesc Fumanal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231413%22"}, {"id": "fda:K230916", "company": "Picopack, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230916: WeSensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230916", "people": [{"name": "Dong-Il Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230916%22"}, {"id": "fda:K231658", "company": "Spineway", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231658: VEOS Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231658", "people": [{"name": "Maurad Ben Mokhtar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231658%22"}, {"id": "fda:K232341", "company": "CarboFix Orthopedics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232341: CarboClear\u00ae Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232341", "people": [{"name": "Hila Wachsler Avrahami", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232341%22"}, {"id": "fda:K223027", "company": "Neurotrigger", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223027: NeuroTrigger Basic (NTB)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223027", "people": [{"name": "Nikolai Kuincher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223027%22"}, {"id": "fda:K232471", "company": "Vy Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232471: Vy Spine\u0099 VyLam\u0099 Laminoplasty System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232471", "people": [{"name": "Jordan Hendrickson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232471%22"}, {"id": "fda:K230130", "company": "Isys Medizintechnik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-10", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230130: Micromate\u0099 Navi+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230130", "people": [{"name": "Pedro Costa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230130%22"}, {"id": "fda:K230777", "company": "3A Glove Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230777: Patient Examination Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230777", "people": [{"name": "Kumar Durarajen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230777%22"}, {"id": "fda:K232044", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232044: Invictus Robotic Navigation Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232044", "people": [{"name": "Unnati Bhuptani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232044%22"}, {"id": "fda:K232407", "company": "Safer Surgeries Medical Devices, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232407: Cautery Protective Actuation System (CPAS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232407", "people": [{"name": "Rowland Grattan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232407%22"}, {"id": "fda:K232276", "company": "Oxoid Limited (Part of Thermo Fisher Scientific)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232276: Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 \u00b5g) SUD20", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232276", "people": [{"name": "Amie Lovatt", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232276%22"}, {"id": "fda:K231300", "company": "Cair Lgl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231300: Nutricair Enteral Syringe with ENFit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231300", "people": [{"name": "Irving L. Wiesen, Esq.", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231300%22"}, {"id": "fda:K223905", "company": "Avicena, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223905: Vivio\u00ae LVEDP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223905", "people": [{"name": "Sean Brady", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223905%22"}, {"id": "fda:K232492", "company": "Medos International SARL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232492: 2.7 mm GRYPHON\u0099 Flex Knotless PEEK Anchor; 2.7 mm GRYPHON\u0099 Flex Knotless Biocomposite Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232492", "people": [{"name": "Elizabeth P. Messana", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232492%22"}, {"id": "fda:K232173", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232173: Ascend VBR System, Ascend NanoTec VBR System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232173", "people": [{"name": "Sandy Gill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232173%22"}, {"id": "fda:K232055", "company": "Shanghai Lingfu Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232055: Vial Adapter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232055", "people": [{"name": "Esther Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232055%22"}, {"id": "fda:DEN220087", "company": "HistoSonics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN220087: Edison System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220087", "people": [{"name": "Daniel Kosednar", "role": "510(k) submission contact"}]}, {"id": "fda:K223802", "company": "Mettler Electronics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223802: accufit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223802", "people": [{"name": "An Le", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223802%22"}, {"id": "fda:K232046", "company": "Xeridiem Medical Devices, A Spectrum Plastics Group Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232046: Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232046", "people": [{"name": "Steve Murray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232046%22"}, {"id": "fda:K232411", "company": "Riverpoint Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232411: JuggerKnot Soft Anchor OC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232411", "people": [{"name": "Becca DeFrancia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232411%22"}, {"id": "fda:K231603", "company": "Standard Bariatrics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231603: Standard Staple-Line Reinforcement (SSLR23)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231603", "people": [{"name": "Trevor Barton", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231603%22"}, {"id": "fda:K232760", "company": "Hyperfine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232760: Swoop\u00ae Portable MR Imaging System\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232760", "people": [{"name": "Christine Kupchick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232760%22"}, {"id": "fda:K230091", "company": "Purgo Biologics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230091: THE Cover", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230091", "people": [{"name": "Byungsun Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230091%22"}, {"id": "fda:K232056", "company": "Dongguan Lide Electric Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232056: IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232056", "people": [{"name": "Xiang Guojun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232056%22"}, {"id": "fda:K231863", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231863: ProBeam 360\u00b0 Proton Therapy System v2.0 (Multiroom)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231863", "people": [{"name": "Peter Coronado", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231863%22"}, {"id": "fda:K232787", "company": "Intelligent Ultrasound Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232787: ScanNav Anatomy Peripheral Nerve Block", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232787", "people": [{"name": "Bhaskar Chikkanna", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232787%22"}, {"id": "fda:K223926", "company": "Medimaging Integrated Solution, Inc (Miis)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223926: VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223926", "people": [{"name": "Jung-Yi Yen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223926%22"}, {"id": "fda:K230265", "company": "Infobionic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230265: MoMe\u00ae ARC Wireless Ambulatory ECG Monitoring and Detection System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230265", "people": [{"name": "Dave MacCutcheon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230265%22"}, {"id": "fda:K230853", "company": "Nvision Biomedical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230853: EARP Nerve Cuff Electrode", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230853", "people": [{"name": "Diana Langham", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230853%22"}, {"id": "fda:K221777", "company": "Weihai Shengjie Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221777: Disposable Sterile Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221777", "people": [{"name": "Huihui Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221777%22"}, {"id": "fda:K232480", "company": "Cardiacassist, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232480: ProtekDuo Veno-Venous Cannula Sets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232480", "people": [{"name": "Mariah McMinn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232480%22"}, {"id": "fda:K230144", "company": "Denti.Ai Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230144: Denti.AI Detect", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230144", "people": [{"name": "Lyudmila Tuzova", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230144%22"}, {"id": "fda:K232755", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232755: Arthrex FiberTape and TigerTape Cerclage Sutures", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232755", "people": [{"name": "Ruth Segall", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232755%22"}, {"id": "denovo:DEN220087", "company": "HistoSonics, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-10-06", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220087 granted: Edison System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220087"}, {"id": "breakthrough:DEN220087", "company": "Histosonics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-10-06", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220087: EDISON SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K232395", "company": "Biom\u00e9rieux", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232395: ETEST\u00ae Sulbactam/Durlobactam (SUD) (0.004/4-64/4 \u00b5g/mL), ETEST\u00ae SUD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232395", "people": [{"name": "Sophie Quiblier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232395%22"}, {"id": "fda:K232704", "company": "Clarius Mobile Health Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232704: Clarius Ultrasound Scanner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232704", "people": [{"name": "Agatha Szeliga", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232704%22"}, {"id": "fda:K220451", "company": "Randox Laboratories Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220451: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220451", "people": [{"name": "Karena Shaw", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220451%22"}, {"id": "fda:K223740", "company": "Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223740: Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223740", "people": [{"name": "Heidi Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223740%22"}, {"id": "fda:K231001", "company": "Deeptek Medical Imaging Pvt, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231001: DeepTek CXR Analyzer v1.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231001", "people": [{"name": "Carrillo Rory", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231001%22"}, {"id": "fda:K232279", "company": "Suretex Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232279: LifeStyles NRL Textured Condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232279", "people": [{"name": "Alison Arnot", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232279%22"}, {"id": "fda:K230780", "company": "Zimmer Medizinsysteme GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230780: MFG-05", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230780", "people": [{"name": "Ute Killet", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230780%22"}, {"id": "fda:K230070", "company": "Promamedical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230070: MESORAM\u00ae Hypodermic Needle (710301); MESORAM\u00ae Hypodermic Needle (710302); MESORAM\u00ae Hypodermic Needle (712305); MESORAM\u00ae Hypodermic Needle (712315); MESORAM\u00ae Hypodermic Needle (710303); MESORAM\u00ae Hypodermic Needle (710307); MESORAM\u00ae Hypodermic Needle (710306); MESORAM\u00ae Hypodermic Needle (712308); MESORAM\u00ae Hypodermic Needle (712318); MESORAM\u00ae Hypodermic Needle (712303); MESORAM\u00ae Hypodermic Needle (712307); MESORAM\u00ae Hypodermic Needle (712306); MESORAM\u00ae Hypodermic Needle (812400); MESORAM\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230070", "people": [{"name": "Christian Wehrenpfenning", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230070%22"}, {"id": "fda:K230242", "company": "OsteoCentric Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230242: OsteoCentric Dental Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230242", "people": [{"name": "Todd Evans", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230242%22"}, {"id": "fda:K232675", "company": "Hivox Biotek, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232675: Heating Tens, FT-615", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232675", "people": [{"name": "Leslie Peng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232675%22"}, {"id": "fda:K232367", "company": "Curemetrix, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232367: cmAngio\u00ae V1.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232367", "people": [{"name": "Kevin Harris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232367%22"}, {"id": "fda:K221550", "company": "Randox Laboratories Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221550: Evidence MultiSTAT DOA Urine MultiPlex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221550", "people": [{"name": "Karena Shaw", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221550%22"}, {"id": "fda:K233044", "company": "Tandem Diabetes Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233044: Tandem Mobi insulin pump with interoperable technology", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233044", "people": [{"name": "Louise Focht", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233044%22"}, {"id": "fda:K231078", "company": "Riverpoint Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231078: All-Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231078", "people": [{"name": "Edwin Anderson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231078%22"}, {"id": "fda:DEN230002", "company": "Marizyme, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230002: DuraGraft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230002", "people": [{"name": "Navdeep Kaur Cheema", "role": "510(k) submission contact"}]}, {"id": "fda:K231025", "company": "Ever Fortune.Ai, Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231025: EFAI NeuroSuite CT ICH Assessment System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231025", "people": [{"name": "Joseph Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231025%22"}, {"id": "fda:K231398", "company": "Vuno, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231398: VUNO Med-DeepBrain", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231398", "people": [{"name": "Jiwon Song", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231398%22"}, {"id": "fda:K232844", "company": "Braincool AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232844: The IQoolTM System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232844", "people": [{"name": "Martin Waleij", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232844%22"}, {"id": "fda:K231567", "company": "Better Care Plastic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231567: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231567", "people": [{"name": "Zhu Chunyan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231567%22"}, {"id": "fda:K232763", "company": "RF Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232763: Electrode Handpieces (VCT, RFTV, BMDT series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232763", "people": [{"name": "Kwang S Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232763%22"}, {"id": "fda:K232767", "company": "Mc3, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232767: Nautilus VF ECMO Oxygenator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232767", "people": [{"name": "Martha Rumford", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232767%22"}, {"id": "fda:K232023", "company": "Momentum Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232023: Momentum Spine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232023", "people": [{"name": "Evan Dimentberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232023%22"}, {"id": "fda:K230135", "company": "Copioumed International, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-04", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230135: Copioumed Chemotherapy Isolation Gown", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230135", "people": [{"name": "James Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230135%22"}, {"id": "denovo:DEN230002", "company": "Marizyme, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-10-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230002 granted: DuraGraft", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230002"}, {"id": "fda:K231772", "company": "Samsung Medison Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231772: V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231772", "people": [{"name": "Jee Young Ju", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231772%22"}, {"id": "fda:K232712", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232712: uMI Panorama", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232712", "people": [{"name": "Xin Gao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232712%22"}, {"id": "fda:K232918", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232918: enspire 300 Series Automated Endoscope Reprocessor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232918", "people": [{"name": "Nalepka Jennifer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232918%22"}, {"id": "fda:K232406", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232406: KARL STORZ OR1\u0099 SCB CONTROL (WU300)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232406", "people": [{"name": "Thomas Ostrowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232406%22"}, {"id": "fda:K230085", "company": "Imagen Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230085: Lung-CAD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230085", "people": [{"name": "Rebecca Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230085%22"}, {"id": "fda:K232230", "company": "Zhenjiang Assure Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232230: YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232230", "people": [{"name": "Ying Mei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232230%22"}, {"id": "fda:K232914", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232914: SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232914", "people": [{"name": "Jennifer Nalepka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232914%22"}, {"id": "fda:K232762", "company": "Invivo Corporation (Business Trade Name: Philips)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232762: dS Breast Coil 7ch 1.5T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232762", "people": [{"name": "Liselotte Kornmann", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232762%22"}, {"id": "fda:K231960", "company": "Anx Robotica Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231960: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231960", "people": [{"name": "Tim Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231960%22"}, {"id": "fda:K232094", "company": "Linear Health Sciences, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232094: Orchid Safety Release ValveTM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232094", "people": [{"name": "Daniel Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232094%22"}, {"id": "fda:K232722", "company": "DreaMed Diabetes, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-03", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232722: endo.digital Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232722", "people": [{"name": "Eran Atlas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232722%22"}, {"id": "fda:K231716", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231716: OsteoFlo\u00ae HydroPutty\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231716", "people": [{"name": "Travis Greenhalgh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231716%22"}, {"id": "fda:K230681", "company": "Central Medicare Sdn Bhd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230681: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230681", "people": [{"name": "Chua Kah Ying", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230681%22"}, {"id": "fda:K231520", "company": "Techmah Cmf", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231520: tmCMF Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231520", "people": [{"name": "Mohamed Mahfouz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231520%22"}, {"id": "fda:K232359", "company": "Kingstar Medical (Xianning) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232359: Surgical face mask", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232359", "people": [{"name": "Fan Rong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232359%22"}, {"id": "fda:K221972", "company": "Warantec Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221972: Warantec Custom Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221972", "people": [{"name": "Younggwang Choi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221972%22"}, {"id": "fda:K232064", "company": "Isikel Manufacturing, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-10-02", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232064: Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232064", "people": [{"name": "Chris Betts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232064%22"}, {"id": "fda:K221890", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221890: Elecsys Tg II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221890", "people": [{"name": "Edie Eads", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221890%22"}, {"id": "nih:1R43FD007805-01", "company": "Triple Ring Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": 199443, "summary": "NIH award 1R43FD007805-01: Adaptive Mechanical Models for Realistic Radiation Sterilization Simulations ($199,443)", "source_url": "https://reporter.nih.gov/project-details/10696759", "people": [{"name": "TOBIAS FUNK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44FD007584-02", "company": "Triple Ring Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": 661773, "summary": "NIH award 2R44FD007584-02: Virtual dose mapping for radiation sterilization ($661,773)", "source_url": "https://reporter.nih.gov/project-details/10829490", "people": [{"name": "TOBIAS FUNK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43FD007809-01", "company": "Fannin Partners, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": 199972, "summary": "NIH award 1R43FD007809-01: Bedside right-heart catheterization for early diagnosis and more effective management of patients with heart failure and primary pulmonary hypertension ($199,972)", "source_url": "https://reporter.nih.gov/project-details/10696663", "people": [{"name": "MICHAEL JOHN HEFFERNAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K232647", "company": "Surmodics,Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232647: Microcatheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232647", "people": [{"name": "Jodie Christe", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232647%22"}, {"id": "fda:K230847", "company": "3A Glove Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230847: Chemotherapy Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230847", "people": [{"name": "Kumar Durarajen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230847%22"}, {"id": "fda:K231973", "company": "Ineo Tech Sdn Bhd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231973: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231973", "people": [{"name": "Pierre Hoerner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231973%22"}, {"id": "fda:K233257", "company": "3M Company, Unitek Orthodontic Products", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233257: 3M\u0099 Clarity\u0099Aligners with Quick Attachments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233257", "people": [{"name": "Hillary Peetsch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233257%22"}, {"id": "fda:K231649", "company": "Auxano Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231649: Intraosseous Fusion Device System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231649", "people": [{"name": "Jennifer Hazou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231649%22"}, {"id": "fda:DEN210011", "company": "Invitae Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN210011: Invitae Common Hereditary Cancers Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN210011", "people": [{"name": "Elaine Cull", "role": "510(k) submission contact"}]}, {"id": "fda:K231702", "company": "OTU Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231702: WiScope\u00ae Digital Cystoscope System, WiScope\u00ae Single-Use Digital Flexible Cystoscope, WiScope\u00ae Medical Tablet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231702", "people": [{"name": "Geping Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231702%22"}, {"id": "fda:K223085", "company": "Miris AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223085: Miris Human Milk Analyzer (HMA)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223085", "people": [{"name": "Elin Hallen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223085%22"}, {"id": "fda:DEN220023", "company": "Procisedx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN220023: Procise ADL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220023", "people": [{"name": "Kurt Bray", "role": "510(k) submission contact"}]}, {"id": "fda:K232651", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232651: BLAZER\u0099 Dx-20 Bidirectional Steerable Diagnostic Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232651", "people": [{"name": "Laura Wotta", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232651%22"}, {"id": "fda:K231622", "company": "Reger Medizintechnik, GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231622: REGER Nebulizer Irrigation Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231622", "people": [{"name": "Christopher Kohn", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231622%22"}, {"id": "fda:K232669", "company": "Abbott Laboratories", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232669: TBI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232669", "people": [{"name": "Lisa Kelly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232669%22"}, {"id": "fda:K212769", "company": "Dynex Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K212769: DYNEX SmartPLEX MMRV IgG Assay Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212769", "people": [{"name": "Jeff Fisher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K212769%22"}, {"id": "fda:K221274", "company": "Fotona D.O.O.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221274: StarFormer, TightWave", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221274", "people": [{"name": "Tina Bartolic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221274%22"}, {"id": "fda:K231957", "company": "Lineus Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231957: SafeBreak\u00ae Vascular", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231957", "people": [{"name": "Vance Clement", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231957%22"}, {"id": "fda:K213403", "company": "Inova Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213403: Aptiva CTD Essential Reagent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213403", "people": [{"name": "Andrea Seaman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213403%22"}, {"id": "fda:K230187", "company": "Terran Biosciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230187: Terran NM-101", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230187", "people": [{"name": "Sam Clark", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230187%22"}, {"id": "fda:K230591", "company": "Crossroads Extremity Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230591: TriLEAP Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230591", "people": [{"name": "Keith Knapp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230591%22"}, {"id": "fda:K221508", "company": "Sanguina, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221508: AnemoCheck Home", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221508", "people": [{"name": "Cathryn Cambria", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221508%22"}, {"id": "fda:K221570", "company": "Allmed Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221570: Antibacterial bandage", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221570", "people": [{"name": "Vince Tian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221570%22"}, {"id": "fda:K231527", "company": "Medos International S\u00e0rl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231527: TriALTIS Navigation Enabled Instruments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231527", "people": [{"name": "Nicole Aeschbacher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231527%22"}, {"id": "fda:K230045", "company": "Stryker Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230045: HipCheck", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230045", "people": [{"name": "Lucas Dan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230045%22"}, {"id": "fda:K232701", "company": "Advanced Surgical Concepts", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232701: Guardenia (GAR-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232701", "people": [{"name": "Edward Hyland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232701%22"}, {"id": "fda:K220458", "company": "Innovative Medical Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220458: UltraFlo-R Push Button Blood Collection Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220458", "people": [{"name": "Brad Brown", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220458%22"}, {"id": "fda:K223873", "company": "Pyrames, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223873: Boppli Infant Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223873", "people": [{"name": "Xina Quan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223873%22"}, {"id": "fda:K231628", "company": "Beshape Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231628: BeShape One\u0099 Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231628", "people": [{"name": "Amit Goren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231628%22"}, {"id": "fda:K221359", "company": "Instrumentation Laboratory CO", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221359: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-\u00df2 Glycoprotein-I IgM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221359", "people": [{"name": "Nikita Malladi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221359%22"}, {"id": "fda:K232650", "company": "S.m.a.i.o", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232650: KHEIRON\u00ae Spinal Fixation System, including patient specific K-ROD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232650", "people": [{"name": "Jean-Charles Roussouly", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232650%22"}, {"id": "fda:K232299", "company": "Meta Biomed Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232299: CeraPutty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232299", "people": [{"name": "Suk Song Oh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232299%22"}, {"id": "fda:K232690", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232690: Amulet\u0099 Steerable Delivery Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232690", "people": [{"name": "Dan Gapp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232690%22"}, {"id": "fda:DEN210056", "company": "Procisedx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN210056: Procise IFX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN210056", "people": [{"name": "Kurtis R. Bray", "role": "510(k) submission contact"}]}, {"id": "fda:K221900", "company": "Nova Biomedical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221900: Stat Profile Prime Plus Analyzer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221900", "people": [{"name": "Sharvari Nayak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221900%22"}, {"id": "pma:P220005", "company": "Entrogen, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2023-09-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P220005: CRCDx RAS Mutation Detection Assay Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220005", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P220005%22"}, {"id": "denovo:DEN210011", "company": "Invitae Corporation", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-09-29", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210011 granted: Invitae Common Hereditary Cancers Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210011"}, {"id": "denovo:DEN210056", "company": "Procisedx, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-09-29", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210056 granted: Procise IFX", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210056"}, {"id": "denovo:DEN220023", "company": "Procisedx, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-09-29", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220023 granted: Procise ADL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220023"}, {"id": "sbir:DOD:FA2384-23-P-B011", "company": "Hedgefog Research Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-09-29", "observed": "2026-09-18", "amount_usd": 179997, "summary": "DOD STTR Phase I award $179,997: Contact Lens Integrated Physiological Sensors", "source_url": "https://www.sbir.gov/awards?search=F23A-T003-0014"}, {"id": "fda:K232605", "company": "Lesspine Innovations", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232605: Sacrix\u00ae Sacroiliac Joint Fusion Device System, Inspan\u00ae ScrewLES Fusion System, Invue\u00ae MAX\u0099 + Invue Inset Anterior Cervical Plate System, and FacetFuse\u00ae Screw Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232605", "people": [{"name": "Vito Lore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232605%22"}, {"id": "fda:K231792", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231792: VeriSafe Safety sterile syringes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231792", "people": [{"name": "Zearou Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231792%22"}, {"id": "fda:K231013", "company": "Zymo Research", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231013: DNA/RNA Shield SafeCollect Saliva Collection kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231013", "people": [{"name": "Julie Ogi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231013%22"}, {"id": "fda:K233161", "company": "Shofu Dental Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K233161: BeautiLink SA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233161", "people": [{"name": "Mauro Malzyner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K233161%22"}, {"id": "fda:K231188", "company": "Skeletal Dynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231188: ALIGN Radial Head System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231188", "people": [{"name": "Alexandra Rodriguez Rojas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231188%22"}, {"id": "fda:K231837", "company": "Brainomix Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231837: Brainomix 360 Triage LVO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231837", "people": [{"name": "Thais Sala", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231837%22"}, {"id": "fda:K231901", "company": "Medical San Ind\u00fastria DE Equipamentos M\u00e9dicos Ltda.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231901: Hakon, Hakon Smart", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231901", "people": [{"name": "Francis Laion de Padua", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231901%22"}, {"id": "fda:K232699", "company": "Anumana, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232699: Low Ejection Fraction AI-ECG Algorithm", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232699", "people": [{"name": "Suzanne Goodman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232699%22"}, {"id": "fda:K232274", "company": "Lumenessa Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232274: IPL hair removal device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232274", "people": [{"name": "Peter Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232274%22"}, {"id": "fda:K230865", "company": "Becton Dickinson Infusion Therapy Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230865: PIVO\u0099 Pro Needle-free Blood Collection Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230865", "people": [{"name": "Amy Moore", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230865%22"}, {"id": "breakthrough:K232699", "company": "Anumana, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-09-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K232699: LOW EJECTION FRACTION AI-ECG ALGORITHM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K232255", "company": "Qpix Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232255: EZSensor XHD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232255", "people": [{"name": "Seungman Yun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232255%22"}, {"id": "fda:K230925", "company": "Alton (Shanghai) Medical Instruments Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230925: Disposable Injection Needle AF series", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230925", "people": [{"name": "Vivian Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230925%22"}, {"id": "fda:K231076", "company": "Wenzel Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231076: VariLift\u00ae-C Interbody Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231076", "people": [{"name": "William Wilson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231076%22"}, {"id": "fda:K230563", "company": "Microport Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230563: EVOLUTION\u00ae Hinge Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230563", "people": [{"name": "Ryan Ross", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230563%22"}, {"id": "fda:K231108", "company": "Inari Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231108: Talon Transseptal Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231108", "people": [{"name": "Ellen Nguyen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231108%22"}, {"id": "fda:K232167", "company": "Vy Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232167: VySpan\u0099 PCT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232167", "people": [{"name": "Jordan Hendrickson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232167%22"}, {"id": "fda:K232616", "company": "Volta Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232616: Volta AF-Xplorer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232616", "people": [{"name": "Paola Milpied", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232616%22"}, {"id": "fda:K222638", "company": "Cepheid", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222638: Xpert\u00ae Xpress GBS, GeneXpert\u00ae Dx System, GeneXpert\u00ae Infinity Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222638", "people": [{"name": "Suzette Chance", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222638%22"}, {"id": "fda:K232609", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232609: Micro Ace\u0099 Advanced Micro Access System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232609", "people": [{"name": "Garry Courtney", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232609%22"}, {"id": "fda:K231007", "company": "Microgenics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231007: CEDIA Heroin Metabolite (6-AM) Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231007", "people": [{"name": "Amrit Takhar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231007%22"}, {"id": "fda:K232596", "company": "Endogi Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232596: EndoGI S-Path Biliary Stent System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232596", "people": [{"name": "Omri Naveh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232596%22"}, {"id": "fda:K231363", "company": "Hantech Medical Device Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231363: Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231363", "people": [{"name": "Arnold Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231363%22"}, {"id": "fda:K232260", "company": "Inneuroco, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232260: Thinline Sheath Introducer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232260", "people": [{"name": "Marc Litzenberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232260%22"}, {"id": "fda:K214117", "company": "Abbott Diagnostics Technologies AS", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K214117: Afinion\u0099 HbA1c, Afinion\u0099 2 and Alere Afinion\u0099 AS100 Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K214117", "people": [{"name": "Danial Kirmani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K214117%22"}, {"id": "fda:K231538", "company": "Cardio Flow Inc.,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231538: FreedomFlow Orbital Circumferential Atherectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231538", "people": [{"name": "Michael J. Kallok", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231538%22"}, {"id": "fda:K232668", "company": "SeaSpine Orthopedics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232668: Cove Strip, OsteoCove Strip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232668", "people": [{"name": "Cindy Toyama", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232668%22"}, {"id": "fda:K232275", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-27", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232275: Invictus\u00ae Spinal Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232275", "people": [{"name": "Cynthia Dorne", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232275%22"}, {"id": "nih:1R43AG085776-01", "company": "Great Lakes Neurotechnologies", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": 289515, "summary": "NIH award 1R43AG085776-01: ETAware: Continuous monitoring of the functional impact of essential tremor ($289,515)", "source_url": "https://reporter.nih.gov/project-details/10819790", "people": [{"name": "Rabie Fadil", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K223496", "company": "Prismatik Dentalcraft, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223496: Inclusive\u00ae Titanium Abutments compatible with: Straumann\u00ae Bone Level SC, BioHorizons\u00ae Tapered Internal, MIS\u00ae C1 Implant Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223496", "people": [{"name": "So Hyun Park", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223496%22"}, {"id": "fda:K230398", "company": "Medcad", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230398: MedCAD\u00ae AccuPlate\u00ae 3DTi Patient-Specific Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230398", "people": [{"name": "Brian Buss", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230398%22"}, {"id": "fda:K230252", "company": "Orthofix US, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230252: OFIX MIS App", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230252", "people": [{"name": "Shant Aghyarian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230252%22"}, {"id": "fda:K220396", "company": "Medica Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220396: EasyStat 300", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220396", "people": [{"name": "Photios Makris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220396%22"}, {"id": "fda:K230884", "company": "Boston Scientific Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230884: AVVIGO'+ Multi-Modality Guidance System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230884", "people": [{"name": "Kevin Catalano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230884%22"}, {"id": "fda:K232336", "company": "E-Scopics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232336: ES Series V2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232336", "people": [{"name": "Claude Cohen Bacrie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232336%22"}, {"id": "fda:K232617", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232617: ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232617", "people": [{"name": "Shilpa Rapaka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232617%22"}, {"id": "fda:DEN220026", "company": "Laminate Medical Technologies , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN220026: VasQ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220026", "people": [{"name": "Orit Yarden", "role": "510(k) submission contact"}]}, {"id": "fda:K230513", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230513: Arthrex Univers Apex OptiFit Humeral Stem", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230513", "people": [{"name": "Tiffany Mentzel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230513%22"}, {"id": "fda:K231971", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231971: DEKA PHYSIQ 360", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231971", "people": [{"name": "Paolo Peruzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231971%22"}, {"id": "fda:K232233", "company": "Align Technology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232233: Invisalign System with Mandibular Advancement Featuring Occlusal Blocks", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232233", "people": [{"name": "John Ray", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232233%22"}, {"id": "fda:K213517", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213517: Access Thyroglobulin Antibody II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213517", "people": [{"name": "Abhi Kannan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213517%22"}, {"id": "pma:P210017", "company": "Terumo Medical Corporation", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2023-09-26", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P210017: Cross-Seal Suture-Mediated Vascular Closure Device System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210017", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P210017%22"}, {"id": "denovo:DEN220026", "company": "Laminate Medical Technologies , Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-09-26", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220026 granted: VasQ", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220026"}, {"id": "breakthrough:DEN220026", "company": "Laminate Medical Technologies, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-09-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220026: VASQ", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "hde:H220001", "company": "TheraBionic, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2023-09-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H220001: TheraBionic P1", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "nih:1R43HD114347-01", "company": "Bold Type LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": 384558, "summary": "NIH award 1R43HD114347-01: Development of an electrical impedance myography (EIM) vaginal device for the evaluation of pelvic skeletal muscles ($384,558)", "source_url": "https://reporter.nih.gov/project-details/10822537", "people": [{"name": "Jose Luis Bohorquez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA281528-01A1", "company": "Phase Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": 858324, "summary": "NIH award 1R44CA281528-01A1: Chromosomal aberration detection in FFPE tissue using proximity ligation sequencing ($858,324)", "source_url": "https://reporter.nih.gov/project-details/10759887", "people": [{"name": "Stephen Matthew Eacker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG066263-02A1", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": 768585, "summary": "NIH award 2R44AG066263-02A1: Using Structured Light Sensing with Machine Learning to Detect Unwitnessed In-Home Falls ($768,585)", "source_url": "https://reporter.nih.gov/project-details/10818017", "people": [{"name": "Paul Gibson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AR083875-01", "company": "Granite Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": 936082, "summary": "NIH award 1R44AR083875-01: Non-invasively extendable megaprosthesis ($936,082)", "source_url": "https://reporter.nih.gov/project-details/10818977", "people": [{"name": "Jeffrey David Gordon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD114508-01", "company": "Jun Innovations, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": 275001, "summary": "NIH award 1R43HD114508-01: Oscillating Magnetic Field Assisted Supercooling Preservation of Fresh and Unfrozen Ovaries at Subzero Temperatures ($275,001)", "source_url": "https://reporter.nih.gov/project-details/10821622", "people": [{"name": "Soojin Jun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42AG063655-03", "company": "L. Krenk, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": 499470, "summary": "NIH award 5R42AG063655-03: Algorithm to Identify Patients at Risk of Medication-Related Hospitalization ($499,470)", "source_url": "https://reporter.nih.gov/project-details/10696190", "people": [{"name": "Francis T Chan", "role": "Principal Investigator"}, {"name": "Leslie Krenk", "role": "Principal Investigator"}, {"name": "Karen Lisa Pellegrin", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AG082604-01A1", "company": "Neurosessments LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": 345604, "summary": "NIH award 1R43AG082604-01A1: Neurosessments: Developing a quick, objective motor test to prompt cognitivetesting in primary care ($345,604)", "source_url": "https://reporter.nih.gov/project-details/10759203", "people": [{"name": "Jill Winquist Love", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD112219-01A1", "company": "H3pelvic Therapy Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": 384737, "summary": "NIH award 1R43HD112219-01A1: Targeted Temperature Modulation with Smart Radiometric Monitoring for Effective and Long-Lasting Opioid-Free Pelvic Pain Relief - A Novel Low-Cost, Portable, Tampon-sized Thermal Transfer Device. ($384,737)", "source_url": "https://reporter.nih.gov/project-details/10760002", "people": [{"name": "Zachary W Lyon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG082637-01", "company": "Moai Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": 811421, "summary": "NIH award 1R44AG082637-01: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in at-risk Older Adults ($811,421)", "source_url": "https://reporter.nih.gov/project-details/10696409", "people": [{"name": "Olu Olofinboba", "role": "Principal Investigator"}, {"name": "Dereck L Salisbury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K232097", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232097: IdentiTi ALIF Interbody Systems", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232097", "people": [{"name": "Andrew Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232097%22"}, {"id": "fda:K231888", "company": "Care Fusion", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231888: BD Texium\u0099 Needle-Free Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231888", "people": [{"name": "Breanna Casados", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231888%22"}, {"id": "fda:K223933", "company": "Exactech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223933: Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223933", "people": [{"name": "Valdimir Talley", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223933%22"}, {"id": "fda:K230778", "company": "Praxis Medical, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230778: EndoCore", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230778", "people": [{"name": "John Fisher", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230778%22"}, {"id": "fda:K231928", "company": "Ever Fortune.Ai, Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231928: EFAI RTSUITE CT HCAP-Segmentation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231928", "people": [{"name": "Joseph Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231928%22"}, {"id": "fda:K231739", "company": "4Web Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231739: Cervical Spine Truss System (CSTS)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231739", "people": [{"name": "Lewis Harrison", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231739%22"}, {"id": "fda:K230857", "company": "SurGenTec, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230857: TiLink-P SI Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230857", "people": [{"name": "Travis Greenhalgh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230857%22"}, {"id": "fda:K230825", "company": "Smileyscope Holding, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230825: Smileyscope System (Therapy Mode)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230825", "people": [{"name": "Paul Leong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230825%22"}, {"id": "fda:K231891", "company": "Coloplast", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231891: Virtue Male Sling System with Alexis Wound Retractor Convenience Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231891", "people": [{"name": "Jennifer Mrkvicka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231891%22"}, {"id": "fda:K230184", "company": "Edan Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230184: Holter ECG and ABP System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230184", "people": [{"name": "Lavender Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230184%22"}, {"id": "fda:K221052", "company": "Huizhou Jinghao Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221052: Self-Fitting hearing aids", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221052", "people": [{"name": "Yuanxia Mao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221052%22"}, {"id": "fda:K231977", "company": "Foreo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231977: PEACH 2, PEACH 2 Duo, PEACH 2 go", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231977", "people": [{"name": "Evan Feldstein", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231977%22"}, {"id": "fda:K220265", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220265: ADVIA Centaur\u00ae NT-proBNPII (PBNPII)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220265", "people": [{"name": "Asha Gartland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220265%22"}, {"id": "nih:1R42EB034605-01", "company": "Axioforce Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-23", "observed": "2026-08-21", "amount_usd": 250310, "summary": "NIH award 1R42EB034605-01: 3D force sensing insoles for wearable, AI empowered, high-fidelity gait monitoring ($250,310)", "source_url": "https://reporter.nih.gov/project-details/10688715", "people": [{"name": "Jonathan Daniel Miller", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K222778", "company": "Osstem Implant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222778: Osstem Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222778", "people": [{"name": "Seungju Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222778%22"}, {"id": "fda:K223919", "company": "Bemer Int AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223919: B.Light Clear Evo and B.Light Restore Evo", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223919", "people": [{"name": "Sandra Schwarzenberger", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223919%22"}, {"id": "nih:2R44AR083836-02", "company": "Sintx Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": 1227401, "summary": "NIH award 2R44AR083836-02: 3D Printed Silicon Nitride Porous PEEK Composite Spinal Cages for Anti-Infection ($1,227,401)", "source_url": "https://reporter.nih.gov/project-details/10819309", "people": [{"name": "Ryan Bock", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HD114266-01", "company": "Liberating Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": 295907, "summary": "NIH award 1R43HD114266-01: Unintrusive Pediatric Logging Orthotic Adherence Device: UPLOAD ($295,907)", "source_url": "https://reporter.nih.gov/project-details/10821172", "people": [{"name": "Todd Richard Farrell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44EB035078-01", "company": "Magnetic Insight, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": 1008452, "summary": "NIH award 1R44EB035078-01: Ultra-low distortion and noise electronics to enable a clinical MPI imaging platform ($1,008,452)", "source_url": "https://reporter.nih.gov/project-details/10761613", "people": [{"name": "Patrick Goodwill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43AG081111-01S1", "company": "Outlier Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": 249999, "summary": "NIH award 3R43AG081111-01S1: A Gesture-Powered Software Platform of Neurologic Music Therapy Games and Puzzles: To Stimulate Neuroplasticity and Prolong Functional Independence in Individuals Diagnosed with Alzheimer's Disease ($249,999)", "source_url": "https://reporter.nih.gov/project-details/10852784", "people": [{"name": "Peter Gray", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM151935-01", "company": "Pumpkinseed Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": 289866, "summary": "NIH award 1R43GM151935-01: Vibrational spectroscopy with metasurface optics (VISMO) for high-throughput identification of protein post-translational modifications ($289,866)", "source_url": "https://reporter.nih.gov/project-details/10761601", "people": [{"name": "Jack Hu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR083782-01", "company": "Aravis Biotech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": 299999, "summary": "NIH award 1R43AR083782-01: The X-VISUAL (X-ray Visualized Indicator for Screw-strain Under Applied Load) ($299,999)", "source_url": "https://reporter.nih.gov/project-details/10822470", "people": [{"name": "John David DesJardins", "role": "Principal Investigator"}, {"name": "ROBERT A LATOUR", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44EB029280-02A1", "company": "Radiation Detection Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": 1024886, "summary": "NIH award 2R44EB029280-02A1: The Rapid-Production of the High-Performance and Affordable Cadmium Telluride and Cadmium Zinc Telluride for Medical Imaging Applications. ($1,024,886)", "source_url": "https://reporter.nih.gov/project-details/10761330", "people": [{"name": "LARS R FURENLID", "role": "Principal Investigator"}, {"name": "John S McCloy", "role": "Principal Investigator"}, {"name": "Benjamin Montag", "role": "Principal Investigator"}, {"name": "Santosh Kumar Swain", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG082615-01A1", "company": "Neurocomp Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": 266035, "summary": "NIH award 1R43AG082615-01A1: Assessment Validation ($266,035)", "source_url": "https://reporter.nih.gov/project-details/10766041", "people": [{"name": "JAMES P O'HALLORAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA285006-01", "company": "Aiq Global Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": 881573, "summary": "NIH award 1R44CA285006-01: Comprehensive Assessment of Cancer Theranostics Response ($881,573)", "source_url": "https://reporter.nih.gov/project-details/10758983", "people": [{"name": "Paul G. Corn", "role": "Principal Investigator"}, {"name": "Timothy Perk", "role": "Principal Investigator"}, {"name": "Scott T Tagawa", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K231767", "company": "Annalise-Ai Pty , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231767: Annalise Enterprise CTB Triage Trauma", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231767", "people": [{"name": "Haylee Bosshard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231767%22"}, {"id": "fda:K231149", "company": "Qure.Ai Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231149: qXR-CTR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231149", "people": [{"name": "Srinidhi Ragunathan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231149%22"}, {"id": "fda:K221817", "company": "Immunostics Inc.,", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221817: ALFIS Vitamin D, ALFIS-3 Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221817", "people": [{"name": "Young Mi Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221817%22"}, {"id": "fda:K223921", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223921: Access CEA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223921", "people": [{"name": "Abhi Kannan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223921%22"}, {"id": "fda:K230067", "company": "New Paradigm Biomedical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230067: Para-Fix External Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230067", "people": [{"name": "John Wixted", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230067%22"}, {"id": "fda:K231092", "company": "B&M S.R.L. Marketing Nel Benessere", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231092: T-SHAPE 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231092", "people": [{"name": "Brando Baldan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231092%22"}, {"id": "fda:K231730", "company": "Femasys, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231730: FemaSeed Intratubal Insemination", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231730", "people": [{"name": "Christine Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231730%22"}, {"id": "fda:K232978", "company": "Sino-Dentex Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232978: DX. Bond V Dental Bonding Adhesive", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232978", "people": [{"name": "Pengtao Yan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232978%22"}, {"id": "fda:K230980", "company": "Acell, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230980: MicroMatrix\u00ae Flex", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230980", "people": [{"name": "Simone Oliver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230980%22"}, {"id": "fda:K232193", "company": "Yurob Rehabilitation Medical Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232193: Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232193", "people": [{"name": "Pan Daoping", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232193%22"}, {"id": "fda:K232571", "company": "L&Z Us, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232571: CATHTONG\u0099 II PICC Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232571", "people": [{"name": "James Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232571%22"}, {"id": "fda:K223659", "company": "Ai Medical AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223659: Jazz", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223659", "people": [{"name": "Christian Federau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223659%22"}, {"id": "fda:K231384", "company": "Annalise-Ai Pty , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231384: Annalise Enterprise CTB Triage Trauma", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231384", "people": [{"name": "Haylee Bosshard", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231384%22"}, {"id": "fda:K230350", "company": "Carl Zeiss Meditec, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230350: VISULAS yag", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230350", "people": [{"name": "Tanesha Bland", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230350%22"}, {"id": "fda:K220179", "company": "Foshan Coxo Medical Instrument Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220179: High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220179", "people": [{"name": "Zheng Yongjian", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220179%22"}, {"id": "fda:K232224", "company": "Beta Bionics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232224: iLet\u00ae Dosing Decision Software", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232224", "people": [{"name": "Liz Cooper", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232224%22"}, {"id": "fda:K231446", "company": "Fitone Latex Products Co., Ltd. Guangdong", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231446: Single-Use Latex Sterile Surgical Gloves (SG100)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231446", "people": [{"name": "Christine Ou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231446%22"}, {"id": "fda:K232183", "company": "Shenzhen Koli Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232183: IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232183", "people": [{"name": "Qizhen Fu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232183%22"}, {"id": "fda:K231239", "company": "Becton Dickinson Infusion Therapy Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231239: Nexiva\u0099 Closed IV Catheter System with NearPort\u0099 IV Access", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231239", "people": [{"name": "Paul Holman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231239%22"}, {"id": "fda:K232594", "company": "L&Z Us, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232594: CATHTONG\u0099 II PICC Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232594", "people": [{"name": "James Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232594%22"}, {"id": "fda:K231479", "company": "Medos International SARL", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231479: TriALTIS Spine System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231479", "people": [{"name": "Megan Smith", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231479%22"}, {"id": "fda:K232558", "company": "Neotract, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232558: UroLift 2 ATC Advanced Tissue Control System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232558", "people": [{"name": "Kelsey Krische", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232558%22"}, {"id": "sbir:DOD:HT9425-23-C-0070", "company": "Augmntr, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-09-22", "observed": "2026-09-18", "amount_usd": 1299972, "summary": "DOD SBIR Phase II award $1,299,972: Augmented Reality Surgical Visualization Tool for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2S-0050"}, {"id": "nih:1R43CA281585-01A1", "company": "Orlance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": 200000, "summary": "NIH award 1R43CA281585-01A1: Next Generation Gene-Gun Delivered DNA and RNA Immunotherapeutic Vaccines for Melanoma. ($200,000)", "source_url": "https://reporter.nih.gov/project-details/10760452", "people": [{"name": "Kenneth C Bagley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DP006817-01", "company": "Engage Rx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": 245159, "summary": "NIH award 1R43DP006817-01: Engage-Rx a web-based clinical decision support tool for management of hypertension through patient engagement and automated algorithmic clinical decision support ($245,159)", "source_url": "https://reporter.nih.gov/project-details/10605138", "people": [{"name": "Valy Fontil", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41DK137677-01", "company": "Kuleana Technology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": 299646, "summary": "NIH award 1R41DK137677-01: Dialysate regeneration system based on photo-electrochemical urea oxidation and reactive adsorption to enable portable hemodialysis ($299,646)", "source_url": "https://reporter.nih.gov/project-details/10761594", "people": [{"name": "Barry Fulkerson", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG084801-01", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": 406263, "summary": "NIH award 1R43AG084801-01: Development of an Oscillated Insertion tool to Eliminate Surgically Induced Neurodegeneration for Optical Neuroimaging of Cognitive Aging and Dementia ($406,263)", "source_url": "https://reporter.nih.gov/project-details/10792064", "people": [{"name": "Kyle William Gheres", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG084434-01", "company": "Dimagi, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": 274878, "summary": "NIH award 1R43AG084434-01: A Digital Serious Illness Conversation Coach ($274,878)", "source_url": "https://reporter.nih.gov/project-details/10759161", "people": [{"name": "Y. Xian Ho", "role": "Principal Investigator"}, {"name": "Neal Lesh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42AG084399-01", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": 299893, "summary": "NIH award 1R42AG084399-01: Developing a novel system combining cognitive assessment with PASCALL FDA-cleared intraoperative anesthesia EEG brain monitor to prevent postoperative neurocognitive disorders in aging patients ($299,893)", "source_url": "https://reporter.nih.gov/project-details/10760816", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K230767", "company": "Nanjing Vishee Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230767: Pelvic Floor Muscle Stimulator", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230767", "people": [{"name": "Qiu Kai", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230767%22"}, {"id": "fda:K232159", "company": "Carl Zeiss Meditec, AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232159: QEVO System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232159", "people": [{"name": "Eva Jankovics", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232159%22"}, {"id": "fda:K223354", "company": "S&G Biotech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223354: EGIS Biliary Single Bare Stent", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223354", "people": [{"name": "Sung-Kwon Kang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223354%22"}, {"id": "fda:K230102", "company": "Huizhou Lvb Maternal and Infant Supplies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230102: Smart double sides wearable breast pump, Electric bilateral breast pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230102", "people": [{"name": "Dongan Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230102%22"}, {"id": "fda:K223214", "company": "Global Protection Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223214: Powder-Free Nitrile Examination Gloves", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223214", "people": [{"name": "Christina Cataldo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223214%22"}, {"id": "fda:K231401", "company": "Poly Medicure Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231401: Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231401", "people": [{"name": "Ramdas Sharma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231401%22"}, {"id": "fda:K231678", "company": "Overjet, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231678: Overjet Periapical Radiolucency Assist", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231678", "people": [{"name": "Deepthi Paknikar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231678%22"}, {"id": "fda:K230193", "company": "S.A.L.F. Spa", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230193: Servator P Plus SALF Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230193", "people": [{"name": "Carmelo Gagliano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230193%22"}, {"id": "fda:K230467", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230467: BTL-899F", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230467", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230467%22"}, {"id": "fda:K232569", "company": "General Equipment For Medical Imaging, S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232569: CAREMIBRAIN", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232569", "people": [{"name": "Maria Climent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232569%22"}, {"id": "fda:K231248", "company": "Edwards Lifesciencess, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231248: Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231248", "people": [{"name": "Anne Lo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231248%22"}, {"id": "fda:K230226", "company": "OsteoCentric Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-21", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230226: Integrity-SI\u00ae Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230226", "people": [{"name": "Todd Evans", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230226%22"}, {"id": "sbir:DOD:HT9425-23-C-0047", "company": "Triton Systems, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-09-21", "observed": "2026-09-18", "amount_usd": 1099757, "summary": "DOD SBIR Phase II award $1,099,757: Developing a Hardened Portable EEG System", "source_url": "https://www.sbir.gov/awards?search=H2-0752"}, {"id": "sbir:DOD:HT9425-23-C-0048", "company": "Quantum Applied Science & Research Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-09-21", "observed": "2026-09-18", "amount_usd": 1099994, "summary": "DOD SBIR Phase II award $1,099,994: Dry Electrode Flight helmet Integrated Eeg System (DEFIES), Phase II", "source_url": "https://www.sbir.gov/awards?search=H2-0754"}, {"id": "sbir:DOD:FA2384-23-P-B015", "company": "Integrated Deposition Solutions Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-09-21", "observed": "2026-09-18", "amount_usd": 179945, "summary": "DOD STTR Phase I award $179,945: Digital Printing for Smart Contact Lenses", "source_url": "https://www.sbir.gov/awards?search=F23A-T003-0021"}, {"id": "nih:1R41HD112228-01A1", "company": "Circa Bioscience, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 295724, "summary": "NIH award 1R41HD112228-01A1: Development of a Urine Test for At-Home Monitoring of Blood Phe Levels for PKU ($295,724)", "source_url": "https://reporter.nih.gov/project-details/10822515", "people": [{"name": "Kevin D Champaigne", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA257303-02A1", "company": "Calla Health Foundation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 909585, "summary": "NIH award 2R44CA257303-02A1: Optimizing ablation of cervical precancer with ethyl cellulose ethanol to enable translation to women in low and middle-income countries ($909,585)", "source_url": "https://reporter.nih.gov/project-details/10821975", "people": [{"name": "Brian Crouch", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HG013068-01A1", "company": "Genomind, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 399593, "summary": "NIH award 1R43HG013068-01A1: Development of a Patient-Facing Portal for the Receipt, Interpretation and Tracking Utility of Pharmacogenetic (PGx) Data ($399,593)", "source_url": "https://reporter.nih.gov/project-details/10758862", "people": [{"name": "Daniel F Dowd", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:7R42AG069629-02", "company": "Rip Road, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 1500000, "summary": "NIH award 7R42AG069629-02: The Assessment of Smart Phone Everyday Tasks (ASSET): A new IADL test for early AD ($1,500,000)", "source_url": "https://reporter.nih.gov/project-details/10855814", "people": [{"name": "Eric Leven Eric Leven Eric Leven", "role": "Principal Investigator"}, {"name": "GAD ASHER MARSHALL", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HG012961-01", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 407291, "summary": "NIH award 1R43HG012961-01: Nanopores for Processing Proteins ($407,291)", "source_url": "https://reporter.nih.gov/project-details/10645984", "people": [{"name": "Eric Ervin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG084405-01", "company": "Borrow My Glasses, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 191913, "summary": "NIH award 1R41AG084405-01: A Novel Technology to Disseminate WOOP (Wish, Outcome, Obstacle, Plan) to Dementia Caregivers ($191,913)", "source_url": "https://reporter.nih.gov/project-details/10760438", "people": [{"name": "Donna B Fedus", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG085832-01", "company": "Spatial Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 1229313, "summary": "NIH award 1R44AG085832-01: Spatial single cell analysis of the human Alzheimer's Disease brain ($1,229,313)", "source_url": "https://reporter.nih.gov/project-details/10822988", "people": [{"name": "Kirsten Frieda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44DA051084-02A1", "company": "Autonomous Healthcare, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 1577231, "summary": "NIH award 2R44DA051084-02A1: Using Machine Learning and Blockchain Technology to Reduce Drug Diversion in Hospitals ($1,577,231)", "source_url": "https://reporter.nih.gov/project-details/10761130", "people": [{"name": "Behnood Gholami", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44NR019516-02A1", "company": "Qua, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 273056, "summary": "NIH award 2R44NR019516-02A1: Development and Evaluation of the PPAL Bedside Commode for Safe Independent Toileting Transfers ($273,056)", "source_url": "https://reporter.nih.gov/project-details/10761219", "people": [{"name": "Margaret Ellen Graham", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HD114325-01", "company": "Analytical Diagnostic Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 295923, "summary": "NIH award 1R43HD114325-01: A point of care-device for the determination of creatinine phosphokinase (CPK), the CPK Now ($295,923)", "source_url": "https://reporter.nih.gov/project-details/10822139", "people": [{"name": "Robert Harper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41NR020458-01A1", "company": "Silicon Cures LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 228561, "summary": "NIH award 1R41NR020458-01A1: ICU-CARE: An interactive mobile app to enhance the efficiency of daily informal caregiving in the intensive care unit ($228,561)", "source_url": "https://reporter.nih.gov/project-details/10602917", "people": [{"name": "Breanna D Hetland", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44CA247137-03", "company": "Dl Analytics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 1286675, "summary": "NIH award 4R44CA247137-03: Validation of a lab-free low-cost screening test for prevention of cervical cancer: automated visual evaluation ($1,286,675)", "source_url": "https://reporter.nih.gov/project-details/10920866", "people": [{"name": "David Levitz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44CA287952-01", "company": "Xilis, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": 399738, "summary": "NIH award 1R44CA287952-01: An integrated microfluidic device for patient-derived micro-organospheres ($399,738)", "source_url": "https://reporter.nih.gov/project-details/10828576", "people": [{"name": "Daniel Aaron Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K231342", "company": "Guangdong Optomedic Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231342: Insufflator (OPTO-IFL1000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231342", "people": [{"name": "Weijuan Guo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231342%22"}, {"id": "fda:K223179", "company": "Alere San Diego, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223179: Cholestech LDX \u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223179", "people": [{"name": "Nathifa Bradshaw", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223179%22"}, {"id": "fda:K230043", "company": "Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230043: Insulin Pen Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230043", "people": [{"name": "Bingyi Xiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230043%22"}, {"id": "fda:K231854", "company": "Stryker", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231854: 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231854", "people": [{"name": "April Malmborg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231854%22"}, {"id": "fda:K230011", "company": "Medacta International S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230011: Mpact Extension", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230011", "people": [{"name": "Stefano Baj", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230011%22"}, {"id": "fda:K230239", "company": "Conmed Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230239: AirSeal iFS System; AirSeal dV Solution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230239", "people": [{"name": "Tina Mornak", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230239%22"}, {"id": "fda:K223421", "company": "Medcad", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223421: MedCAD AccuPlan Orthopedics System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223421", "people": [{"name": "Brian Buss", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223421%22"}, {"id": "fda:K230692", "company": "Profound Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230692: TULSA-PRO System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230692", "people": [{"name": "Nicole Baker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230692%22"}, {"id": "fda:K232582", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232582: Ambu\u00ae aScope\u0099 5 Broncho 4.2/2.2 Sampler Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232582", "people": [{"name": "Eva Lind Rasmussen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232582%22"}, {"id": "fda:K232583", "company": "Catalyst Orthoscience, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232583: Catalyst R1 Reverse Shoulder System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232583", "people": [{"name": "Dale Davison", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232583%22"}, {"id": "fda:K231385", "company": "Rology, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231385: Rology Teleradiology Platform (v.1.22.1103)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231385", "people": [{"name": "Amr Abodraiaa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231385%22"}, {"id": "fda:K213987", "company": "Biokit, S.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213987: ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213987", "people": [{"name": "Angels Roma", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213987%22"}, {"id": "fda:K232556", "company": "Depuy Ireland UC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232556: DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232556", "people": [{"name": "Susan Mullane", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232556%22"}, {"id": "fda:K231894", "company": "Shenzhenshi Sincoheren S&T Development Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231894: LED Spectrum therapy instrument", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231894", "people": [{"name": "Zhongzhou Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231894%22"}, {"id": "fda:K223913", "company": "Scientia Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223913: Socrates Aspiration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223913", "people": [{"name": "Thomas Lippert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223913%22"}, {"id": "fda:K232592", "company": "Acuitive Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-20", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232592: CITRELOCK\u00ae DUO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232592", "people": [{"name": "Matthew Poggie", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232592%22"}, {"id": "sbir:DOD:HT9425-23-C-0069", "company": "Kericure Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-09-20", "observed": "2026-09-18", "amount_usd": 1299857, "summary": "DOD SBIR Phase II award $1,299,857: Deployable Wound Care Products to Decrease Preventable Death Outcomes by Mitigating Infection on Battlefield and through Long Term Care", "source_url": "https://www.sbir.gov/awards?search=H2S-0049"}, {"id": "nih:1R43HD114307-01", "company": "Orthocare Innovations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 293514, "summary": "NIH award 1R43HD114307-01: Apto-Ankle: Passive, Compliant Ankle with Enhanced Energy Storage and Return in Gait ($293,514)", "source_url": "https://reporter.nih.gov/project-details/10821193", "people": [{"name": "Adam Karekin Arabian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R42EB029888-02", "company": "Yaya Scientific, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 998991, "summary": "NIH award 2R42EB029888-02: Real-time Multimodal Diffuse Reflectance and Polarization Imaging Based Nerve Identification in Surgical Field of View ($998,991)", "source_url": "https://reporter.nih.gov/project-details/10831112", "people": [{"name": "Justin Baba", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AR082785-01A1", "company": "Polymerix LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 241778, "summary": "NIH award 1R43AR082785-01A1: A new process to improve the mechanical performance of crosslinked UHMWPE injoint replacement prostheses ($241,778)", "source_url": "https://reporter.nih.gov/project-details/10760837", "people": [{"name": "Anuj Bellare", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR083301-01A1", "company": "Tissue Testing Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 302037, "summary": "NIH award 1R43AR083301-01A1: Ice-free vitrification and nanowarming of meniscal grafts for transplantation ($302,037)", "source_url": "https://reporter.nih.gov/project-details/10819333", "people": [{"name": "Kelvin G.M. Brockbank", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA254586-02", "company": "Pensievision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 1116921, "summary": "NIH award 2R44CA254586-02: A Novel, Low-Cost, Handheld, 3D Imaging System for Improved Screening of Cervical Neoplasia in Resource Limited Settings ($1,116,921)", "source_url": "https://reporter.nih.gov/project-details/10761604", "people": [{"name": "Joseph Carson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41EY035609-01", "company": "Phononz Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 276306, "summary": "NIH award 1R41EY035609-01: Wearable Array for Ultrasound Stimulation on the Retina ($276,306)", "source_url": "https://reporter.nih.gov/project-details/10766622", "people": [{"name": "Hamid Reza Chabok", "role": "Principal Investigator"}, {"name": "Qifa Zhou", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41NS132625-01A1", "company": "Vanish Therapeutics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 346955, "summary": "NIH award 1R41NS132625-01A1: Opioid-Sparing Non-Surgical, Bioresorbable Nerve Stimulator for Pain Relief ($346,955)", "source_url": "https://reporter.nih.gov/project-details/10759642", "people": [{"name": "XINYAN Tracy CUI", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41EY034738-01", "company": "Haptx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 257200, "summary": "NIH award 1R41EY034738-01: Glove-based Tactile Streaming of Braille Characters and Digital Images for the Visually Impaired ($257,200)", "source_url": "https://reporter.nih.gov/project-details/10601900", "people": [{"name": "Michel Albert Audette", "role": "Principal Investigator"}, {"name": "Michael Eichermueller", "role": "Principal Investigator"}, {"name": "Bruce N Walker", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41GM151921-01", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 349996, "summary": "NIH award 1R41GM151921-01: Nanopore Array for Multiparameter Analysis of Single Extracellular Vesicles ($349,996)", "source_url": "https://reporter.nih.gov/project-details/10760154", "people": [{"name": "Sean German", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA277875-01", "company": "Newventureiq, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 403240, "summary": "NIH award 1R41CA277875-01: Clinical biomarker for early prediction of chemotherapy-induced peripheral neuropathy ($403,240)", "source_url": "https://reporter.nih.gov/project-details/10604018", "people": [{"name": "Simon Haroutounian", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS134482-01", "company": "Analytical Diagnostic Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 291361, "summary": "NIH award 1R43NS134482-01: PKU Now-Connect: An intelligent digital ecosystem to improve health outcomes in Phenylketonuria ($291,361)", "source_url": "https://reporter.nih.gov/project-details/10760659", "people": [{"name": "Robert Harper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44NS122602-02", "company": "Piraeus Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 992721, "summary": "NIH award 2R44NS122602-02: Enabling rapid and effective stroke thrombectomy procedures from a Transradial approach: Combining introducer sheath, guide catheter, and distal access catheter into a single device. ($992,721)", "source_url": "https://reporter.nih.gov/project-details/10761331", "people": [{"name": "Jared Hutar", "role": "Principal Investigator"}, {"name": "DAVID F KALLMES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44DE029369-02", "company": "Revbio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 2050357, "summary": "NIH award 2R44DE029369-02: A Novel Opioid-Free Targeted Pain Control Method for Acute Post-Operative Localized Pain Related to Oral Surgical Procedures ($2,050,357)", "source_url": "https://reporter.nih.gov/project-details/10761260", "people": [{"name": "Rahul Jadia", "role": "Principal Investigator"}, {"name": "George Kay", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44HD113432-01", "company": "Liberating Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 1142863, "summary": "NIH award 1R44HD113432-01: The Development of a Bimodal Walking-Running Prosthetic Foot ($1,142,863)", "source_url": "https://reporter.nih.gov/project-details/10757119", "people": [{"name": "Jennifer Lynne Johansson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44EY035596-01", "company": "Siloam Vision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 1907135, "summary": "NIH award 1R44EY035596-01: Validation of artificial intelligence (AI) based software as medical device (SaMD) for retinopathy of prematurity (ROP) ($1,907,135)", "source_url": "https://reporter.nih.gov/project-details/10760401", "people": [{"name": "John Peter Campbell", "role": "Principal Investigator"}, {"name": "Karyn Jonas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41NS129448-01A1", "company": "Piraeus Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 499765, "summary": "NIH award 1R41NS129448-01A1: Two-for-one Stroke Thrombectomy: A novel Dual DAC to enhance navigability, lumen size, aspiration efficiency, and persistent flow arrest in mechanical thrombectomy ($499,765)", "source_url": "https://reporter.nih.gov/project-details/10698538", "people": [{"name": "DAVID F KALLMES", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DE033316-01", "company": "Perceptive Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 872998, "summary": "NIH award 1R44DE033316-01: Developing an Optical Coherence Tomography (OCT) based handheld intraoral scanner for dentistry ($872,998)", "source_url": "https://reporter.nih.gov/project-details/10759333", "people": [{"name": "Wei Kang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41AT011822-01A1", "company": "Massachusetts Neuro Technology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 140605, "summary": "NIH award 1R41AT011822-01A1: Developing a virtual reality guided acupuncture imagery treatment for Chronic low back pain ($140,605)", "source_url": "https://reporter.nih.gov/project-details/10695389", "people": [{"name": "JIAN KONG", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS129363-01A1", "company": "Eysz, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 499867, "summary": "NIH award 1R43NS129363-01A1: A Mobile Health Application to Detect Absence Seizures using Hyperventilation and Eye-Movement Recordings ($499,867)", "source_url": "https://reporter.nih.gov/project-details/10696649", "people": [{"name": "Rachel Kuperman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR083310-01", "company": "Evoke Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 275467, "summary": "NIH award 1R43AR083310-01: Development of a Piezoelectric Intramedullary Nail for Enhanced Fracture Healing ($275,467)", "source_url": "https://reporter.nih.gov/project-details/10759862", "people": [{"name": "Leighton LaPierre", "role": "Principal Investigator"}, {"name": "Zygmunt Porada", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41NS132700-01A1", "company": "Popneuron LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 438501, "summary": "NIH award 1R41NS132700-01A1: Live spike sorting for multichannel and high-channel recordings ($438,501)", "source_url": "https://reporter.nih.gov/project-details/10759767", "people": [{"name": "Achim Klug", "role": "Principal Investigator"}, {"name": "Tim Chifong Lei", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA189522-04A1", "company": "Applikate Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 224925, "summary": "NIH award 2R44CA189522-04A1: Commercial Readiness for Direct-to-Digital Pathology ($224,925)", "source_url": "https://reporter.nih.gov/project-details/10678409", "people": [{"name": "Michael John Levene", "role": "Principal Investigator"}, {"name": "RICHARD TORRES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43HD107740-01A1", "company": "Benten Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 385000, "summary": "NIH award 1R43HD107740-01A1: PRECARE is an innovative and integrated platform designed to improve the developmental surveillance of the baby. ($385,000)", "source_url": "https://reporter.nih.gov/project-details/10603833", "people": [{"name": "Tony Xuyen Ma", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA287536-01", "company": "Alara Imaging Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 1316275, "summary": "NIH award 1R44CA287536-01: The Alara Imaging Gateway: Linking Electronic Health Records and Radiology Imaging Exams to Report on National Quality Measures to Reduce Cancer Risk from Computed Tomography (Alara Imaging Gateway) ($1,316,275)", "source_url": "https://reporter.nih.gov/project-details/10820279", "people": [{"name": "Nathan Mazonson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD114377-01", "company": "Momease Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": 288733, "summary": "NIH award 1R43HD114377-01: Novel warming and massaging bra for improved breast milk expression ($288,733)", "source_url": "https://reporter.nih.gov/project-details/10822849", "people": [{"name": "Ashley Mooneyham", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K231802", "company": "Perfuze, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231802: Millipede 088 Access Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231802", "people": [{"name": "Anne-Marie Gannon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231802%22"}, {"id": "fda:K222948", "company": "Mivi Neuroscience, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222948: Q Distal Access Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222948", "people": [{"name": "Srija Reddy Bandari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222948%22"}, {"id": "fda:K230966", "company": "A2 Medical Systems, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230966: angiOCCLUDE Ligating Clips", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230966", "people": [{"name": "Robert Hall", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230966%22"}, {"id": "fda:K231106", "company": "Medicel AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231106: Accuject Refra Injector AR2900", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231106", "people": [{"name": "Erik Braziulis", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231106%22"}, {"id": "fda:K232178", "company": "DRGEM Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232178: GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232178", "people": [{"name": "Park Sunghee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232178%22"}, {"id": "fda:K221309", "company": "Sigtuple Technologies Pvt. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221309: AI100 with Shonit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221309", "people": [{"name": "Tathagato Rai Dastidar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221309%22"}, {"id": "fda:K231281", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231281: Aquilion Serve (TSX-307A/1) V1.3", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231281", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231281%22"}, {"id": "nih:1R44NS134432-01", "company": "Blackrock Microsystems", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 1487586, "summary": "NIH award 1R44NS134432-01: Commercial translation of high-density carbon fiber electrode arrays for multi-modal analysis of neural microcircuits ($1,487,586)", "source_url": "https://reporter.nih.gov/project-details/10761217", "people": [{"name": "Rajmohan Bhandari", "role": "Principal Investigator"}, {"name": "Cynthia Anne Chestek", "role": "Principal Investigator"}, {"name": "Daniel Powell", "role": "Principal Investigator"}, {"name": "Florian Solzbacher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44DA059517-01", "company": "Neurotype Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 328963, "summary": "NIH award 1R44DA059517-01: Cue-induced drug craving monitoring for opioid use disorder with visual evoked potentials ($328,963)", "source_url": "https://reporter.nih.gov/project-details/10787065", "people": [{"name": "Scott Burwell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43NS127710-02S1", "company": "Modendo Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 121255, "summary": "NIH award 3R43NS127710-02S1: Multi-probe minimally invasive endomicroscope ($121,255)", "source_url": "https://reporter.nih.gov/project-details/10898521", "people": [{"name": "Antonio Miguel Caravaca Aguirre", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R43NS127710-02", "company": "Modendo Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 238840, "summary": "NIH award 5R43NS127710-02: Multi-probe minimally invasive endomicroscope ($238,840)", "source_url": "https://reporter.nih.gov/project-details/10709909", "people": [{"name": "Antonio Miguel Caravaca Aguirre", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:4R44CA250663-02", "company": "Crosslife Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 994004, "summary": "NIH award 4R44CA250663-02: Point of Care HPV 16/18/45 DNA Test for Cervical Cancer ($994,004)", "source_url": "https://reporter.nih.gov/project-details/10896570", "people": [{"name": "HyunDae Cho", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44HD114305-01", "company": "Luna Labs USA, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 874732, "summary": "NIH award 1R44HD114305-01: Improving Maternal Outcomes of Cesarean Delivery with the Prevention of Postoperative Adhesions ($874,732)", "source_url": "https://reporter.nih.gov/project-details/10821599", "people": [{"name": "Lauren Costella", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R42NS134505-01", "company": "Neurinsight, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 378233, "summary": "NIH award 1R42NS134505-01: Towards intra-operative guidance in brain tumor surgery using real-time resting-state functional MRI ($378,233)", "source_url": "https://reporter.nih.gov/project-details/10761498", "people": [{"name": "Dieter W Dennig", "role": "Principal Investigator"}, {"name": "Stefan Posse", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44HL164222-02", "company": "Linshom Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 1470984, "summary": "NIH award 4R44HL164222-02: Advanced Prediction of Emerging Respiratory Decline with the Linshom Continuous Predictive Respiratory Sensor (CPRS) ($1,470,984)", "source_url": "https://reporter.nih.gov/project-details/10750718", "people": [{"name": "Ronen Feldman", "role": "Principal Investigator"}, {"name": "Richard D. Urman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HD114360-01", "company": "Delfina Care Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 275739, "summary": "NIH award 1R43HD114360-01: Leveraging remote blood pressure monitoring and interpretable machine learning to improve clinical workflows for hypertensive disorders of pregnancy ($275,739)", "source_url": "https://reporter.nih.gov/project-details/10822625", "people": [{"name": "Isabel Fulcher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AT012302-01A1", "company": "Brightoutcome Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 747191, "summary": "NIH award 1R44AT012302-01A1: GEMINI: Virtual Integrative Medical Group Visits for Managing Chronic Pain ($747,191)", "source_url": "https://reporter.nih.gov/project-details/10699898", "people": [{"name": "Paula Marie Gardiner", "role": "Principal Investigator"}, {"name": "Niina M. Haas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG082635-01A1", "company": "Rytek Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 275762, "summary": "NIH award 1R41AG082635-01A1: Ultrasound-coupled Electrical Impedance Tomography for Sarcopenia Assessment ($275,762)", "source_url": "https://reporter.nih.gov/project-details/10760707", "people": [{"name": "Ryan Joseph Halter", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42CA265316-02", "company": "Filtro Medical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 4R42CA265316-02: Endovascular ChemoFilter to Reduce Doxorubicin Toxicity during Intra-Arterial Chemotherapy ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10840035", "people": [{"name": "Steven William Hetts", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R42NS129395-01A1", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 474416, "summary": "NIH award 1R42NS129395-01A1: Developing Active Stimulation and Monitoring Technologies to Optimize Pain and Nociception Management During Regional Anesthesia, General Anesthesia, and Post-Operative Care ($474,416)", "source_url": "https://reporter.nih.gov/project-details/10604993", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AT011593-03", "company": "2morrow, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 498970, "summary": "NIH award 5R44AT011593-03: HEAL - Development and implementation of a provider prescribed, behavioral digital therapeutic designed to support, educate, screen and remotely monitor patients with chronic pain ($498,970)", "source_url": "https://reporter.nih.gov/project-details/10706555", "people": [{"name": "Jo Masterson", "role": "Principal Investigator"}, {"name": "Deanna Waters", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R42CA261259-02A1", "company": "Trevarx Biomedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 1043889, "summary": "NIH award 2R42CA261259-02A1: Optimizing Radiosynthetic Yield of [18F]FTT For Wide-Spread Distribution ($1,043,889)", "source_url": "https://reporter.nih.gov/project-details/10821733", "people": [{"name": "Hsiaoju Sharon Lee", "role": "Principal Investigator"}, {"name": "Michel Mikhail", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R42NS115282-02A1", "company": "Alcorix", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 903957, "summary": "NIH award 2R42NS115282-02A1: Implantable Microarray Probe for Real-Time Glutamate and GABA Detection ($903,957)", "source_url": "https://reporter.nih.gov/project-details/10761486", "people": [{"name": "Prabhu Arumugam", "role": "Principal Investigator"}, {"name": "Nicolaie Andrei Moldovan", "role": "Principal Investigator"}, {"name": "RIO J VETTER", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL169073-01", "company": "M5 Enterprise, LLC D/b/a Emedical Sentry", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 459127, "summary": "NIH award 1R43HL169073-01: Extraction of Vital Signs using a Telehealth Application for Asthma - EViTA-AThe purpose of this grant is to evaluate mobile devices to extract vitals signs to monitor patients with Asthma ($459,127)", "source_url": "https://reporter.nih.gov/project-details/10699530", "people": [{"name": "Steven Myers", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH124334-04", "company": "Talkspace LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": 1118161, "summary": "NIH award 5R44MH124334-04: Message-based psychotherapy and digital treatment sequences for depression ($1,118,161)", "source_url": "https://reporter.nih.gov/project-details/10701040", "people": [{"name": "Aarthi Padmanabhan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "fda:K231663", "company": "Innovative Health Technologies (Nz), Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231663: The AVEOtsd (Tongue Stabilizing Device) Mouthpiece", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231663", "people": [{"name": "Chapman Philip", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231663%22"}, {"id": "fda:K223835", "company": "Medify Air, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223835: MA-40, MA-112", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223835", "people": [{"name": "Pragati Anand", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223835%22"}, {"id": "fda:K231832", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231832: Access Myoglobin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231832", "people": [{"name": "Kate Oelberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231832%22"}, {"id": "fda:K232544", "company": "Apollo Endosurgery, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232544: Apollo ESG NXT System, Apollo REVISE NXT System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232544", "people": [{"name": "James Shene", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232544%22"}, {"id": "fda:K232513", "company": "Parcus Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232513: X-Twist Biocomposite Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232513", "people": [{"name": "Calen Souther", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232513%22"}, {"id": "fda:K231367", "company": "Shenzhen Finicare Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231367: Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231367", "people": [{"name": "Chao Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231367%22"}, {"id": "fda:K232530", "company": "Nexus Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232530", "people": [{"name": "Jared Crocker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232530%22"}, {"id": "fda:K222251", "company": "B.R.A.H.M.S GmbH, Part of Thermo Fisher", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222251: B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S CgA II KRYPTOR, B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S CgA II KRYPTOR CAL, B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S CgA II KRYPTOR QC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222251", "people": [{"name": "Anne Kummerow", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222251%22"}, {"id": "fda:K232172", "company": "BTL Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-18", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232172: BTL-785BNF Handpiece", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232172", "people": [{"name": "David Chmel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232172%22"}, {"id": "fda:K231688", "company": "Impact Applications, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231688: ImPACT Version 4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231688", "people": [{"name": "Michael Zagorski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231688%22"}, {"id": "fda:K230483", "company": "Passy-Muir, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-16", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230483: Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230483", "people": [{"name": "Donna Malter", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230483%22"}, {"id": "nih:2R44DK127835-03", "company": "Urogenie LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": 889432, "summary": "NIH award 2R44DK127835-03: Digital Uroflowmetry for Office and Home ($889,432)", "source_url": "https://reporter.nih.gov/project-details/10821803", "people": [{"name": "Roman Fedorovsky", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL167405-01A1", "company": "Blue Marble Rehab, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": 306427, "summary": "NIH award 1R43HL167405-01A1: BREATHE-BRinging Exercise, Asthma Assessments, TeacHing to Everyone ($306,427)", "source_url": "https://reporter.nih.gov/project-details/10757190", "people": [{"name": "Sheryl Flynn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44EB034614-01A1", "company": "Base Pair Biotechnologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": 266072, "summary": "NIH award 1R44EB034614-01A1: Bench-top Reader and Aptamer-based Assay for Rapid, High-sensitivity Drug/Opiate Detection ($266,072)", "source_url": "https://reporter.nih.gov/project-details/10760088", "people": [{"name": "George W Jackson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK138688-01", "company": "Nephropathology Associates", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": 976283, "summary": "NIH award 1R44DK138688-01: A proprietary digital platform for precision patient identification and enrollment of clinical trials for rare kidney diseases ($976,283)", "source_url": "https://reporter.nih.gov/project-details/10822581", "people": [{"name": "Christopher P Larsen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM146574-02", "company": "Aleo Bme, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": 718613, "summary": "NIH award 5R44GM146574-02: SBIR Direct Phase II: Nature Inspired Biphasic Glue for Dura Repair ($718,613)", "source_url": "https://reporter.nih.gov/project-details/10707091", "people": [{"name": "Chao Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK137685-01", "company": "Panluminate Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": 274419, "summary": "NIH award 1R43DK137685-01: Development of a sample preparation protocol for 3D kidney ultrastructural analysis and immunolabeling by light microscopy ($274,419)", "source_url": "https://reporter.nih.gov/project-details/10760947", "people": [{"name": "Ons M'Saad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG082599-01", "company": "Vigorous Mind, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": 450000, "summary": "NIH award 1R43AG082599-01: Autonomous Navigating Robot for Detecting Falls and Risk of Falls in Nursing Home Residents with Alzheimer's Disease /ADRD ($450,000)", "source_url": "https://reporter.nih.gov/project-details/10698704", "people": [{"name": "Yuval Malinsky", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG085732-01", "company": "Captis Diagnostics", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": 306509, "summary": "NIH award 1R43AG085732-01: A nanosized magnetic particle system for fast and efficient neuronal extracellular vesicle enrichment from plasma ($306,509)", "source_url": "https://reporter.nih.gov/project-details/10820640", "people": [{"name": "Jadranka Milosevic", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA285081-01", "company": "Am Operating LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": 386919, "summary": "NIH award 1R43CA285081-01: Development of a novel visualization, labeling, communication and tracking engine for human anatomy. ($386,919)", "source_url": "https://reporter.nih.gov/project-details/10761060", "people": [{"name": "Matthew Alexander Molenda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL167300-01", "company": "Wi-sense, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": 291896, "summary": "NIH award 1R43HL167300-01: A Low-Cost Wearable Connected Health Device for Monitoring Environmental Pollution Triggers of Asthma in Communities with Health Disparities ($291,896)", "source_url": "https://reporter.nih.gov/project-details/10601615", "people": [{"name": "Krishna Naishadham", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K223788", "company": "Medsource International, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223788: The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223788", "people": [{"name": "Amanda Salentine", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223788%22"}, {"id": "fda:K232102", "company": "ClearPoint Neuro, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232102: ClearPoint Array System (Version 1.2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232102", "people": [{"name": "Brennan Sullivan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232102%22"}, {"id": "fda:K222610", "company": "Roche Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222610: Elecsys Anti-Tg", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222610", "people": [{"name": "Phil Williams", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222610%22"}, {"id": "fda:K232198", "company": "Zhenjiang Assure Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232198: Reclining wheelchair (YJ-011S 16\u0094D, YJ-011S 16\u0094DF, YJ-011S 18\u0094D, YJ-011S 18\u0094DF, YJ-011S 20\u0094D, YJ-011S 20\u0094DF)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232198", "people": [{"name": "Ying Mei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232198%22"}, {"id": "fda:K223812", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223812: Sensis Vibe (VD15)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223812", "people": [{"name": "Patricia D Jones", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223812%22"}, {"id": "fda:K232315", "company": "Ossdsign AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232315: Catalyst Bone Void Filler", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232315", "people": [{"name": "Jonas Aberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232315%22"}, {"id": "fda:K231791", "company": "Ilooda Co,., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231791: PENTO Nd:YAG and Alexandrite laser system", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231791", "people": [{"name": "Mason Moon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231791%22"}, {"id": "fda:K230974", "company": "Kalitec Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230974: NIDO\u0099 Pedicle Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230974", "people": [{"name": "Keith Cannon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230974%22"}, {"id": "fda:K232508", "company": "Molnlycke Health Care Us, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232508: Barrier EasyWarm Active Self-Warming Blanket", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232508", "people": [{"name": "Megan Bevill", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232508%22"}, {"id": "fda:K231242", "company": "B.Braun Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231242: Perifix FX Catheter; Contiplex FX Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231242", "people": [{"name": "Tracy Larish", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231242%22"}, {"id": "fda:K230752", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230752: Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230752", "people": [{"name": "Kotei Aoki", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230752%22"}, {"id": "fda:K220735", "company": "Premier North America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220735: Avologi Gel Primer (Model: Av25)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220735", "people": [{"name": "Ellis Tamari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220735%22"}, {"id": "fda:K231827", "company": "B.T.I. Biotechnology Institute, Sl.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231827: BTI Dental Implant System UnicCa\u00ae \u0096 Aesthetic Post Abutments", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231827", "people": [{"name": "Jos\u00e9 Ram\u00f3n Rivero", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231827%22"}, {"id": "fda:K230946", "company": "Trax Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230946: Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230946", "people": [{"name": "Steven Tallarida", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230946%22"}, {"id": "fda:K231336", "company": "T2biosystems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231336: T2 Biothreat Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231336", "people": [{"name": "Rachel Gilbert", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231336%22"}, {"id": "fda:K231235", "company": "Ossvis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231235: LW UCLA Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231235", "people": [{"name": "Young Jae Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231235%22"}, {"id": "fda:K232199", "company": "Zhenjiang Assure Medical Equipment Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232199: Bariatric Heavy Duty Wheelchair (YJ-010B 20\u0092\u0092DS; YJ-010B 20\u0092\u0092DE; YJ-010B 20\u0092\u0092DFS; YJ-010B 20\u0092\u0092DFE;YJ-010B 20\u0092\u0092ADS; YJ-010B 20\u0092\u0092ADE; YJ-010B 20\u0092\u0092ADFS; YJ-010B 20\u0092\u0092ADFE; YJ-010B 22\u0092\u0092DS; YJ-010B 22\u0092\u0092DE; YJ-010B 22\u0092\u0092DFS;YJ-010B 22\u0092\u0092DFE; YJ-010B 22\u0092\u0092ADS;YJ-010B 22\u0092\u0092ADE; YJ-010B 22\u0092\u0092ADFS; YJ-010B 22\u0092\u0092ADFE; YJ-010B 24\u0092\u0092DS; YJ-010B 24\u0092\u0092DE; YJ-010B 24\u0092\u0092DFS; YJ-010B 24\u0092\u0092DFE; YJ-010B 24\u0092\u0092ADS; YJ-010B 24\u0092\u0092ADE; YJ-010B 22\u0092\u0092ADFS; YJ-010B 24\u0092\u0092ADFE)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232199", "people": [{"name": "Ying Mei", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232199%22"}, {"id": "fda:K232121", "company": "Ningbo Baichen Medical Devices Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232121: Power wheelchair (Model:BC-EA8000)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232121", "people": [{"name": "Wu Xiao Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232121%22"}, {"id": "fda:K230066", "company": "Shenzhen Wisonic Medical Technology Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230066: Carnation series Diagnostic Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230066", "people": [{"name": "Jiang Xiaosan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230066%22"}, {"id": "fda:K220972", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220972: Access Thyroglobulin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220972", "people": [{"name": "Abhi Kannan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220972%22"}, {"id": "fda:K223857", "company": "Abbott Point of Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223857: i-STAT G3+ cartridge with the i-STAT 1 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223857", "people": [{"name": "Jacquelyn Gesumaria", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223857%22"}, {"id": "fda:K221860", "company": "Poonglim Pharmatech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221860: PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221860", "people": [{"name": "Hee Min Cho", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221860%22"}, {"id": "fda:K230332", "company": "Ambu A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-15", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230332: Ambu\u00ae aScope\u0099 Colon; Ambu\u00ae aBox\u0099 2", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230332", "people": [{"name": "Mette Andersen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230332%22"}, {"id": "nih:5R44NS129521-02", "company": "Turing Medical Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": 198815, "summary": "NIH award 5R44NS129521-02: Behavioral feedback and rewards for improving functional brain mapping in presurgical pediatric patients ($198,815)", "source_url": "https://reporter.nih.gov/project-details/10707227", "people": [{"name": "Ken Bruener", "role": "Principal Investigator"}, {"name": "Damien A Fair", "role": "Principal Investigator"}, {"name": "Jarod Roland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44DE032290-02", "company": "Radiation Monitoring Devices, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": 867429, "summary": "NIH award 4R44DE032290-02: Semiconductor detector for low-dose, high-resolution dental DR imaging ($867,429)", "source_url": "https://reporter.nih.gov/project-details/10927579", "people": [{"name": "JAMES F CHRISTIAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44DE031195-02", "company": "Ostiio LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": 892501, "summary": "NIH award 2R44DE031195-02: A Smart, Fully Subcutaneous Distraction System to Improve Outcomes in Patients with Congenital or Acquired Craniofacial Differences ($892,501)", "source_url": "https://reporter.nih.gov/project-details/10696721", "people": [{"name": "Jessica DesNoyer", "role": "Principal Investigator"}, {"name": "Ari M Wes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA281444-01", "company": "Stratagen Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": 399888, "summary": "NIH award 1R43CA281444-01: Minimally invasive quantitative tissue oxygen sensors to personalize cancer care ($399,888)", "source_url": "https://reporter.nih.gov/project-details/10698650", "people": [{"name": "Gregory Ekchian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NR020275-03", "company": "Neoneur LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": 756164, "summary": "NIH award 5R44NR020275-03: Improving high-risk infant care: from Hospital to Home with Neoneur Telehealth ($756,164)", "source_url": "https://reporter.nih.gov/project-details/10701053", "people": [{"name": "Caroline Hoedemaker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42AG078721-02", "company": "Gateway Biotechnology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": 473509, "summary": "NIH award 4R42AG078721-02: Developing a clinical diagnostic tool for age-related cochlear synaptopathy. ($473,509)", "source_url": "https://reporter.nih.gov/project-details/10888474", "people": [{"name": "Joseph Pinkl", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K230237", "company": "Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230237: Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230237", "people": [{"name": "Chen Yang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230237%22"}, {"id": "fda:K232462", "company": "Usa Therm, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232462: ThermPix Thermovisual Camera", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232462", "people": [{"name": "Eric Heil", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232462%22"}, {"id": "fda:K230108", "company": "Institut Straumann AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230108: Straumann\u00ae BLC and TLC Implants", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230108", "people": [{"name": "Corinne Arimatea", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230108%22"}, {"id": "fda:K231576", "company": "Combinostics OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231576: cNeuro cPET", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231576", "people": [{"name": "Thurfjell Lennart", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231576%22"}, {"id": "fda:K230746", "company": "Shandong Haidike Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230746: Non absorbable Surgical Polypropylene Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230746", "people": [{"name": "Yan Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230746%22"}, {"id": "fda:K230959", "company": "Ocuject, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230959: VitreJect\u00ae Needle; OcuSafe\u00ae Needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230959", "people": [{"name": "Leonid Lerner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230959%22"}, {"id": "fda:K230526", "company": "Transtimulation Research, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230526: TEA Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230526", "people": [{"name": "Jieyun Yin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230526%22"}, {"id": "fda:K231484", "company": "Pureway Compliance, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231484: PureWay 1.4 Quart Sharps Collector", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231484", "people": [{"name": "Jeffery Miglicco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231484%22"}, {"id": "fda:K232827", "company": "Lightforce Orthodontics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232827: LightForce Orthodontic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232827", "people": [{"name": "Jeffrey Roberts", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232827%22"}, {"id": "fda:K231079", "company": "Ossvis Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231079: LW Retraction Cap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231079", "people": [{"name": "Young Jae Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231079%22"}, {"id": "fda:K223833", "company": "Exactech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223833: Exactech\u00ae Equinoxe\u00ae Reverse Humeral Liners and Humeral Adapter Trays", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223833", "people": [{"name": "Liz Howell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223833%22"}, {"id": "fda:K223885", "company": "Karl Storz Endoscopy America, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223885: HOPKINS Telescopes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223885", "people": [{"name": "Jordan Lydia Verla", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223885%22"}, {"id": "fda:K232467", "company": "Baxter Healthcare Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232467: CleanCart A, CleanCart C, AK 98 Hemodialysis Machine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232467", "people": [{"name": "Kristen Bozzelli", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232467%22"}, {"id": "fda:K220034", "company": "In-Med Prognostics L3c", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220034: NEUROShield", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220034", "people": [{"name": "Latha Poonamalle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220034%22"}, {"id": "fda:K223869", "company": "Choice Spine, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223869: ChoiceSpine Blackhawk Ti Cervical Spacer System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223869", "people": [{"name": "Kim Finch", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223869%22"}, {"id": "fda:K230775", "company": "MicroVention, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230775: SOFIA EX Intracranial Support Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230775", "people": [{"name": "Miranda Beach", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230775%22"}, {"id": "fda:K232146", "company": "Momentis Surgical , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232146: Anovo Pedestal", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232146", "people": [{"name": "Maya Leib Shlomo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232146%22"}, {"id": "fda:K231030", "company": "SeaSpine Orthopedics Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231030: Cove Putty, OsteoCove Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231030", "people": [{"name": "Cindy Toyama", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231030%22"}, {"id": "fda:K231147", "company": "Intelivation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231147: Hammerdesis\u0099 Interphalangeal Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231147", "people": [{"name": "David Posillico", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231147%22"}, {"id": "fda:K232487", "company": "Durr Dental SE", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232487: Provecta 3D Prime and Provecta 3D Prime Ceph", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232487", "people": [{"name": "Oliver Lange", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232487%22"}, {"id": "fda:K230167", "company": "Swims America Corp", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230167: BACK 4", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230167", "people": [{"name": "Matthieu Commeau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230167%22"}, {"id": "fda:K231353", "company": "ArteryFlow Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231353: AccuCTP Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231353", "people": [{"name": "Jianping Xiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231353%22"}, {"id": "fda:K232189", "company": "Hoth Intelligence, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232189: OrionXR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232189", "people": [{"name": "Jonathan Cohen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232189%22"}, {"id": "fda:K230987", "company": "Baldus Sedation GmbH & Co. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230987: FlowStar Analog Mixer Flowmeter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230987", "people": [{"name": "Lisa Baldus", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230987%22"}, {"id": "fda:K232124", "company": "Shenzhen Wochuan Electronic Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-14", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232124: IPL Hair Removal, Model: W-1095, W-1098", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232124", "people": [{"name": "Rebecca Jiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232124%22"}, {"id": "nih:1R44EY034758-01", "company": "Aesculatech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": 250487, "summary": "NIH award 1R44EY034758-01: Humidifeye Plug for Dry Eye Disease ($250,487)", "source_url": "https://reporter.nih.gov/project-details/10604903", "people": [{"name": "Niki Bayat", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM144000-02", "company": "Partillion Bioscience Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": 767559, "summary": "NIH award 2R44GM144000-02: Linking antibody sequences to function at the single-cell level using nanovial technology ($767,559)", "source_url": "https://reporter.nih.gov/project-details/10697372", "people": [{"name": "Joseph de Rutte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44NS130864-02", "company": "Neurodex Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": 1009625, "summary": "NIH award 4R44NS130864-02: Development of a Blood-based Test for Identifying Synucleinopathy in Patients with Dementia ($1,009,625)", "source_url": "https://reporter.nih.gov/project-details/10710327", "people": [{"name": "Erez Eitan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44DE031194-02", "company": "Praevium Research, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": 875000, "summary": "NIH award 4R44DE031194-02: Next generation MEMS-VCSEL technology for ultra-low-cost dental and periodontal swept source optical coherence tomography imaging ($875,000)", "source_url": "https://reporter.nih.gov/project-details/10927480", "people": [{"name": "Vijaysekhar Jayaraman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44MH114773-04S1", "company": "Habitaware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": 148785, "summary": "NIH award 3R44MH114773-04S1: Technology Assisted Treatment for Trichotillomania ($148,785)", "source_url": "https://reporter.nih.gov/project-details/10868106", "people": [{"name": "Christopher A. Flessner", "role": "Principal Investigator"}, {"name": "Sameer Kumar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43EY034066-01A1", "company": "X-biomedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": 293470, "summary": "NIH award 1R43EY034066-01A1: Development of a tele-mentoring system integrated into an ultra-portable surgical microscope to treat cataract in underserved populations ($293,470)", "source_url": "https://reporter.nih.gov/project-details/10602749", "people": [{"name": "Matthew Rudolph Maltese", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K230735", "company": "Brain Ultimate, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230735: Ultimate rTMS; Yingchi rTMS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230735", "people": [{"name": "Frank Ge", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230735%22"}, {"id": "fda:K232158", "company": "Genoray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232158: GenX-CR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232158", "people": [{"name": "Inyoung Kim", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232158%22"}, {"id": "fda:K221640", "company": "Caredx, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221640: AlloMap Heart Molecular Expression Testing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221640", "people": [{"name": "Camilla Lu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221640%22"}, {"id": "fda:K222831", "company": "Precision Biologic, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222831: CRYOcheck Factor VIII Deficient Plasma with VWF", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222831", "people": [{"name": "Karen Black", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222831%22"}, {"id": "fda:K232485", "company": "Steris", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232485: AMSCO 600 Steam Sterilizer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232485", "people": [{"name": "Anthony Piotrkowski", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232485%22"}, {"id": "fda:K223811", "company": "Imagen Technologies, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223811: Lung-CAD", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223811", "people": [{"name": "Rebecca Jones, PhD", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223811%22"}, {"id": "fda:DEN230021", "company": "Advanced Cooling Therapy, Inc. D/B/A Attune Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230021: ensoETM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230021", "people": [{"name": "Erik Kulstad", "role": "510(k) submission contact"}]}, {"id": "fda:K230750", "company": "OSSIO , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230750: OSSIOfiber\u00ae Cannulated Trimmable Fixation Nail", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230750", "people": [{"name": "Taly Lindner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230750%22"}, {"id": "fda:K230609", "company": "Balt USA, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-13", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230609: NG Delivery Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230609", "people": [{"name": "Catherine Chiou", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230609%22"}, {"id": "denovo:DEN230021", "company": "Advanced Cooling Therapy, Inc. D/B/A Att", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-09-13", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230021 granted: ensoETM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230021"}, {"id": "nih:1R44HL169112-01A1", "company": "Thermedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": 1342339, "summary": "NIH award 1R44HL169112-01A1: Eliminating Ventricular Tachycardia: Pivotal Clinical Trial using the Durablate\u00ae Catheter ($1,342,339)", "source_url": "https://reporter.nih.gov/project-details/10762302", "people": [{"name": "MICHAEL G CURLEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44DA050218-02", "company": "Dimagi, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": 927938, "summary": "NIH award 2R44DA050218-02: A conversational agent to support remote care for individuals with substance use disorder ($927,938)", "source_url": "https://reporter.nih.gov/project-details/10695327", "people": [{"name": "Y. Xian Ho", "role": "Principal Investigator"}, {"name": "Jonathan Lee Jackson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK137665-01A1", "company": "Sojourn Medtech LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": 312088, "summary": "NIH award 1R43DK137665-01A1: A Smart Simulator for Metrics-based Cannulation Skills Training for Hemodialysis ($312,088)", "source_url": "https://reporter.nih.gov/project-details/10830667", "people": [{"name": "Lydia Petersen", "role": "Principal Investigator"}, {"name": "PRABIR ROY-CHAUDHURY", "role": "Principal Investigator"}, {"name": "Ravikiran Singapogu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K231766", "company": "Kyocera Medical Technologies Inc. (KMTI)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231766: Skyway Anterior Cervical Plate System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231766", "people": [{"name": "Joey Thompson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231766%22"}, {"id": "fda:K231892", "company": "Ge Hualun Medical Systems Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231892: Definium Pace Select", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231892", "people": [{"name": "Miny Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231892%22"}, {"id": "fda:K231317", "company": "Varian Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231317: TrueBeam, TrueBeam STx, Edge, VitalBeam", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231317", "people": [{"name": "Peter J. Coronado", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231317%22"}, {"id": "fda:K231011", "company": "Meridian AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231011: Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231011", "people": [{"name": "Eric Odenheimer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231011%22"}, {"id": "fda:K232526", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232526: XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232526", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232526%22"}, {"id": "fda:K231112", "company": "Materialise NV", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231112: Materialise Shoulder System\u0099, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231112", "people": [{"name": "Giulia Girola", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231112%22"}, {"id": "fda:K213767", "company": "Endure Industries, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213767: Endure ETCO2/02 Nasal Cannula", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213767", "people": [{"name": "Manoj Kumar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213767%22"}, {"id": "fda:K232459", "company": "Sonic Incytes", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232459: Velacur", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232459", "people": [{"name": "Barry Allen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232459%22"}, {"id": "fda:K230598", "company": "Jiangsu Vedkang Medical Science and Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230598: Stone Extraction Baskets", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230598", "people": [{"name": "Qian Wen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230598%22"}, {"id": "fda:K231748", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231748: Cartesion Prime (PCD-1000A/3) V10.15", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231748", "people": [{"name": "Paul Biggins", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231748%22"}, {"id": "fda:K222938", "company": "R.a.w. S.r.l", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-12", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222938: Ablation-fit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222938", "people": [{"name": "Chiara Ferrari", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222938%22"}, {"id": "nih:1R44CA275590-01A1", "company": "Collagen Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": 395933, "summary": "NIH award 1R44CA275590-01A1: Theranostic for gastric cancer ($395,933)", "source_url": "https://reporter.nih.gov/project-details/10699365", "people": [{"name": "Valerie Humblet", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AI142903-03A1", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": 1025000, "summary": "NIH award 2R44AI142903-03A1: Hybrid ELISA: Simple and specific one-tier assay for Lyme disease ($1,025,000)", "source_url": "https://reporter.nih.gov/project-details/10758919", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AR083337-01", "company": "Rivanna Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": 1011938, "summary": "NIH award 1R44AR083337-01: Development of a regional anesthesia guidance system to increase patient access to opioid-sparing analgesia for hip fracture pain ($1,011,938)", "source_url": "https://reporter.nih.gov/project-details/10759550", "people": [{"name": "Frank William Mauldin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K232154", "company": "MiRus, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232154: MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232154", "people": [{"name": "Jordan Bauman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232154%22"}, {"id": "fda:K231504", "company": "Vilex, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231504: TITANEX\u0099 MICROBEAM Screw System, TITANEX\u0099 ARTEMIS Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231504", "people": [{"name": "Brock Johnson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231504%22"}, {"id": "fda:K232192", "company": "Venus Concept, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232192: Venus Versa PRO System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232192", "people": [{"name": "William H. McGrail", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232192%22"}, {"id": "fda:K231283", "company": "Bard Access Systems, Inc. (C.R. Bard, Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231283: SiteRite\u0099 9 Ultrasound System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231283", "people": [{"name": "Fabio De Pasquale", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231283%22"}, {"id": "fda:K231746", "company": "STERIS Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231746: VERIFY Spore Test Strip for S40 Sterilant Concentrate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231746", "people": [{"name": "Gregory Land", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231746%22"}, {"id": "fda:K230517", "company": "Jarmon Medical, LLC (Dba Legends Orthopedics)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230517: Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230517", "people": [{"name": "Jeremy Jarmon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230517%22"}, {"id": "fda:K223755", "company": "Abbott Point of Care, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223755: i-STAT G cartridge with the i-STAT 1 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223755", "people": [{"name": "Mojgan Soleimani", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223755%22"}, {"id": "fda:K230362", "company": "Shenzhen Leaflife Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230362: Planar LED mate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230362", "people": [{"name": "Cheng Qiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230362%22"}, {"id": "fda:K232002", "company": "Exactech, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232002: Vantage\u00ae Total Ankle System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232002", "people": [{"name": "Liz Howell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232002%22"}, {"id": "fda:K230881", "company": "Change Healthcare Israel , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230881: Change Healthcare Cardiology Hemodynamics\u0099", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230881", "people": [{"name": "Alona Golik", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230881%22"}, {"id": "pma:P220025", "company": "LimFlow, Inc.", "kind": "fda_pma", "kind_label": "FDA PMA approval", "date": "2023-09-11", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA PMA approval P220025: LimFlow System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220025", "source_url_api": "https://api.fda.gov/device/pma.json?search=pma_number:%22P220025%22"}, {"id": "breakthrough:P220025", "company": "Limflow, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-09-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P220025: LIMFLOW SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "fda:K223864", "company": "Brainlab AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-09", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223864: Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223864", "people": [{"name": "Esther Moreno Garcia", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223864%22"}, {"id": "nih:1R44GM152985-01A1", "company": "Potentiometric Probes, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": 958484, "summary": "NIH award 1R44GM152985-01A1: Optimized Ratiometric Voltage-Sensitive Dyes for Cardiac Research, Safety Pharmacology ($958,484)", "source_url": "https://reporter.nih.gov/project-details/10699121", "people": [{"name": "Corey Acker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44DA059491-01", "company": "Rtm Vital Signs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": 325601, "summary": "NIH award 1R44DA059491-01: Wearable Wireless Respiratory Monitoring System that Detects and Predicts Opioid Induced Respiratory Depression ($325,601)", "source_url": "https://reporter.nih.gov/project-details/10784983", "people": [{"name": "Magdalena Kirlakovsky Bosak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD111082-01A1", "company": "V-flow Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": 299518, "summary": "NIH award 1R43HD111082-01A1: Novel Venous Device for the Treatment of Chronic Pelvic Pain ($299,518)", "source_url": "https://reporter.nih.gov/project-details/10696574", "people": [{"name": "Rodney Brenneman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44GM135957-03S2", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": 27669, "summary": "NIH award 3R44GM135957-03S2: Ultra-Sensitive Vapor Phase Hydrogen Peroxide Sensor for Decontaminating Pharmaceutical Manufacturing Facilities ($27,669)", "source_url": "https://reporter.nih.gov/project-details/10882735", "people": [{"name": "Brian E Brumfield", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44EB034645-01", "company": "Quadridox, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": 875347, "summary": "NIH award 1R44EB034645-01: Development and evaluation of a combined X-ray transmission and diffraction imaging system for pathology ($875,347)", "source_url": "https://reporter.nih.gov/project-details/10699271", "people": [{"name": "Joel Greenberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44EB035063-01", "company": "Virtuoso Surgical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": 913993, "summary": "NIH award 1R44EB035063-01: A Robotic System to Remove Bladder Tumors Intact: The Key to Making Lifesaving Treatment Decisions ($913,993)", "source_url": "https://reporter.nih.gov/project-details/10760853", "people": [{"name": "Richard Joseph Hendrick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44FD006910-03", "company": "Nanohmics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": 207723, "summary": "NIH award 5R44FD006910-03: Polarization Metasurface Detection Device for Food Safety ($207,723)", "source_url": "https://reporter.nih.gov/project-details/10710045", "people": [{"name": "Mark E. Lucente", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42ES034684-02", "company": "Spectree Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": 888148, "summary": "NIH award 4R42ES034684-02: Multispectral Sensor for Chemical Composition Analysis of Ultrafine Aerosols in Air Quality Assessment ($888,148)", "source_url": "https://reporter.nih.gov/project-details/10887673", "people": [{"name": "ALEXANDER V MAMISHEV", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NS127725-02", "company": "Open Ephys, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": 727245, "summary": "NIH award 5R44NS127725-02: ONIX: A Neural Acquisition System for Unencumbered, Closed-Loop Recordings in Small, Freely Moving Animals ($727,245)", "source_url": "https://reporter.nih.gov/project-details/10690059", "people": [{"name": "Jonathan Newman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK137630-01", "company": "Vivonics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": 331455, "summary": "NIH award 1R43DK137630-01: Near InfraRed Layered Imaging of Tissue Hemodynamics (NIR-LITH) ($331,455)", "source_url": "https://reporter.nih.gov/project-details/10758694", "people": [{"name": "LAWRENCE A LAVERY", "role": "Principal Investigator"}, {"name": "Michele Pierro", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K232400", "company": "Varian Medical Systems", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232400: VariSeed (v10)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232400", "people": [{"name": "Lynn Allman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232400%22"}, {"id": "fda:K223827", "company": "Fujifilm Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223827: FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223827", "people": [{"name": "Randy Vader", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223827%22"}, {"id": "fda:K232166", "company": "Prexion Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232166: PreXion3D Expedition", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232166", "people": [{"name": "Kenji Tanaka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232166%22"}, {"id": "fda:K230372", "company": "Ocuject, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230372: VitreJect Syringe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230372", "people": [{"name": "Leonid Lerner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230372%22"}, {"id": "fda:K213510", "company": "Siemens Healthcare Diagnostics Products, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213510: IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213510", "people": [{"name": "Stefani Vinkemeier", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213510%22"}, {"id": "fda:K232426", "company": "Conformis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232426: Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232426", "people": [{"name": "Mary Kruitwagen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232426%22"}, {"id": "fda:K223621", "company": "Alpha Intelligence Manifolds, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223621: DeepXray", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223621", "people": [{"name": "Qingzong Tseng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223621%22"}, {"id": "fda:K231720", "company": "Wepon Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231720: Sterile Hypodermic Needles for Single Use", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231720", "people": [{"name": "Di Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231720%22"}, {"id": "fda:K231146", "company": "Alic Iotech, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231146: AliTight", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231146", "people": [{"name": "Like Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231146%22"}, {"id": "fda:K231284", "company": "Onpoint Surgical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231284: OnPoint Augmented Reality Spine System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231284", "people": [{"name": "Amy ODonnell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231284%22"}, {"id": "fda:K231643", "company": "Syntex Healthcare Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231643: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231643", "people": [{"name": "Qiao Zhiqiang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231643%22"}, {"id": "fda:K231727", "company": "Wepon Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231727: Sterile Auto-Disable Syringes with/without Needle for Single Use", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231727", "people": [{"name": "Di Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231727%22"}, {"id": "fda:K231240", "company": "Covidien", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231240: MaxTack\u0099 Motorized Fixation Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231240", "people": [{"name": "Megha Patel", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231240%22"}, {"id": "fda:K223848", "company": "Tuned , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223848: Intrisound\u0099 Tuned Lumen\u00ae 155 Hearing Aids", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223848", "people": [{"name": "Orit lanco", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223848%22"}, {"id": "fda:K231141", "company": "FHC, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231141: STarFix Designer Software C0265", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231141", "people": [{"name": "Kelly Moeykens", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231141%22"}, {"id": "fda:K222921", "company": "Healthy.Io, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222921: Minuteful-kidney test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222921", "people": [{"name": "Ron Zohar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222921%22"}, {"id": "fda:K231729", "company": "Wepon Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231729: Sterile syringes for single use with/without needle", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231729", "people": [{"name": "Di Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231729%22"}, {"id": "fda:K231723", "company": "Wepon Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231723: Sterile Safety Hypodermic Needles for Single Use", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231723", "people": [{"name": "Di Zhao", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231723%22"}, {"id": "fda:K232686", "company": "Corvista Health, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232686: CorVista\u00ae System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232686", "people": [{"name": "Gabrielle Zaeska", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232686%22"}, {"id": "fda:K231335", "company": "Cleerly, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231335: Cleerly ISCHEMIA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231335", "people": [{"name": "Candice Bautista-Biddle", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231335%22"}, {"id": "fda:K230310", "company": "Stat Medical Devices", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230310: STAT Medical Device Lancing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230310", "people": [{"name": "Hemel Mariano", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230310%22"}, {"id": "fda:K231471", "company": "Zhejiang Chuangxiang Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231471: Air/Water Bottle Tubing, CO2 Source Tubing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231471", "people": [{"name": "Lucius Long", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231471%22"}, {"id": "fda:K232413", "company": "Alphatec Spine, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232413: Fusion Robotic Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232413", "people": [{"name": "Sarah Braun", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232413%22"}, {"id": "fda:K230890", "company": "Randox Laboratories, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230890: ISE Electrodes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230890", "people": [{"name": "Karena Shaw", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230890%22"}, {"id": "fda:K232386", "company": "Abbott Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232386: ILUMIEN\u0099 OPTIS\u0099 System, OPTIS\u0099 Integrated System, OPTIS\u0099 Mobile System, with AptiVue\u0099 Imaging Software version E.6", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232386", "people": [{"name": "Derek Pike", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232386%22"}, {"id": "fda:K232457", "company": "Smith & Nephew", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232457: Q-FIX ULTRA All-Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232457", "people": [{"name": "Catherine Phelan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232457%22"}, {"id": "fda:K230535", "company": "Karl Storz SE & CO. KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230535: KARL STORZ Urological Laser Accessories", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230535", "people": [{"name": "Alita McElroy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230535%22"}, {"id": "fda:K232414", "company": "Total Joint Othopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232414: Klassic\u00ae Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232414", "people": [{"name": "Chris Weaber", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232414%22"}, {"id": "fda:K230661", "company": "Zeta Surgical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-08", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230661: Zeta Cranial Navigation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230661", "people": [{"name": "Jose Amich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230661%22"}, {"id": "sbir:DOD:FA2384-23-P-B014", "company": "Luna Labs USA LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-09-08", "observed": "2026-09-18", "amount_usd": 179998, "summary": "DOD STTR Phase I award $179,998: ReadiPlex - Implantable Biosensor for Continuous Monitoring of Indicators of Human Performance", "source_url": "https://www.sbir.gov/awards?search=F23A-T002-0015"}, {"id": "nih:6R44CA247639-03", "company": "Trace Biosciences Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": 937594, "summary": "NIH award 6R44CA247639-03: Clinical Translation of Near Infrared Nerve-Specific Fluorophores for Nerve-sparing Prostatectomy ($937,594)", "source_url": "https://reporter.nih.gov/project-details/10838010", "people": [{"name": "Connor William Barth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44GM148138-02", "company": "Auragent Bioscience, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": 786574, "summary": "NIH award 5R44GM148138-02: High performance and widely accessible secretomics assay platform ($786,574)", "source_url": "https://reporter.nih.gov/project-details/10705734", "people": [{"name": "Scott L Crick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43LM014350-01", "company": "Geneial LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": 349432, "summary": "NIH award 1R43LM014350-01: Increasing the Value of Genomic Medicine through Private Pharmacogenomic Reporting ($349,432)", "source_url": "https://reporter.nih.gov/project-details/10760119", "people": [{"name": "Adam Wesley Hansen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL158375-03", "company": "Advanced Cooling Therapy, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": 1300000, "summary": "NIH award 5R44HL158375-03: Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation ($1,300,000)", "source_url": "https://reporter.nih.gov/project-details/10693273", "people": [{"name": "DAVID J CALLANS", "role": "Principal Investigator"}, {"name": "Erik Benjamin Kulstad", "role": "Principal Investigator"}, {"name": "Cory Michael Tschabrunn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44DK136424-01A1", "company": "Capsulomics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": 973322, "summary": "NIH award 1R44DK136424-01A1: Validation and Early Commercialization of the ENVISAGE Assay, a Prognostic Test for Barrett's Esophagus ($973,322)", "source_url": "https://reporter.nih.gov/project-details/10761328", "people": [{"name": "Sarah Laun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AA030702-02", "company": "Ria Technology Management Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": 886202, "summary": "NIH award 4R44AA030702-02: A Telehealth Intervention to Increase Screening and Treatment for Alcohol Use Disorder ($886,202)", "source_url": "https://reporter.nih.gov/project-details/10902295", "people": [{"name": "JOHN E. MENDELSON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:6R44HL154937-03", "company": "Qrs Diagnostic", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": 650906, "summary": "NIH award 6R44HL154937-03: Novel Therapy System for Atrial Fibrillation ($650,906)", "source_url": "https://reporter.nih.gov/project-details/10915804", "people": [{"name": "Jeffrey Peters", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:6R44HL107055-06", "company": "Qrs Diagnostic", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": 998941, "summary": "NIH award 6R44HL107055-06: Implantable Unpinning Termination Therapy for Cardiac Arrhythmias ($998,941)", "source_url": "https://reporter.nih.gov/project-details/10676117", "people": [{"name": "Jeffrey Peters", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "fda:K230649", "company": "Alicn Medical Shenzhen, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230649: Arm Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230649", "people": [{"name": "Fang Meisong", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230649%22"}, {"id": "fda:K231828", "company": "Surmodics,Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231828: Pounce\u0099 Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231828", "people": [{"name": "Peter Bather", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231828%22"}, {"id": "fda:K230049", "company": "Ttk Healthcare Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230049: SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230049", "people": [{"name": "Daniel J S", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230049%22"}, {"id": "fda:K231207", "company": "Biosense Webster, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231207: CARTO\u0099 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231207", "people": [{"name": "Caleb Lau", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231207%22"}, {"id": "fda:K231800", "company": "Shenzhen Qianyu Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231800: IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231800", "people": [{"name": "Guoyang Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231800%22"}, {"id": "fda:K231999", "company": "Wipak OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231999: Steriking\u00ae LT-Blueline Pouches with Tyvek\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231999", "people": [{"name": "Hanna Marttila", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231999%22"}, {"id": "fda:K232443", "company": "Argon Medical Devices, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232443: Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232443", "people": [{"name": "Ana Jimenez-Hughes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232443%22"}, {"id": "fda:K221743", "company": "Jiangsu Bonss Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221743: Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221743", "people": [{"name": "Feir Zeng", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221743%22"}, {"id": "fda:K231542", "company": "Weony (Shenzhen) Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231542: Digital Blood Pressure Monitor WBP Series", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231542", "people": [{"name": "Autumn Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231542%22"}, {"id": "fda:K222823", "company": "Sun Scientific, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222823: AeroDVx Arm System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222823", "people": [{"name": "Allan Alward", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222823%22"}, {"id": "fda:K230644", "company": "Kulzer, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230644: Signum opaque F", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230644", "people": [{"name": "David Vincent", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230644%22"}, {"id": "fda:K231996", "company": "Wipak OY", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231996: Steriking\u00ae LT-Blueline Pouches with Tyvek\u00ae", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231996", "people": [{"name": "Hanna Marttila", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231996%22"}, {"id": "fda:K231687", "company": "Liaoning Upcera Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231687: Gradual Dental Zirconia Blank", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231687", "people": [{"name": "Li Luo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231687%22"}, {"id": "fda:K232389", "company": "Masimo Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-07", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232389: Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232389", "people": [{"name": "Kertana Shankar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232389%22"}, {"id": "sbir:DOD:FA8649-23-P-1000", "company": "Tournitek Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-09-07", "observed": "2026-09-18", "amount_usd": 1749219, "summary": "DOD STTR Phase II award $1,749,219: TourniTek: Pre-Hospital Thermal Regulation For The Prolonged Field Care of Traumatic Injuries", "source_url": "https://www.sbir.gov/awards?search=FX21A-TCSO1-0045"}, {"id": "sbir:DOD:W51701-23-C-0263", "company": "Design Interactive, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-09-07", "observed": "2026-09-18", "amount_usd": 1900000, "summary": "DOD SBIR Phase II award $1,900,000: Wearable Technology Ecosystem for Physiological Monitoring and Actionable Insights", "source_url": "https://www.sbir.gov/awards?search=A2-9794"}, {"id": "nih:1R44GM149102-01", "company": "Partillion Bioscience Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": 754792, "summary": "NIH award 1R44GM149102-01: Hydrogel microparticle technology for high-throughout screening of chimeric antigen receptor-T cells based on single cell effector function ($754,792)", "source_url": "https://reporter.nih.gov/project-details/10604170", "people": [{"name": "Joseph de Rutte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA254560-03", "company": "Cooler Heads Care Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": 1036917, "summary": "NIH award 5R44CA254560-03: Portable, Patient-Administered Scalp Cooling Cap to Reduce Provider Burden, Improve Patient Access, and Improve Patient Outcomes for Chemotherapy-Induced Alopecia ($1,036,917)", "source_url": "https://reporter.nih.gov/project-details/10677863", "people": [{"name": "Kate Dilligan", "role": "Principal Investigator"}, {"name": "HOPE S RUGO", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R42HD104325-03S1", "company": "Recupero Robotics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": 67770, "summary": "NIH award 3R42HD104325-03S1: Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES) ($67,770)", "source_url": "https://reporter.nih.gov/project-details/10923752", "people": [{"name": "MICHELLE J. JOHNSON", "role": "Principal Investigator"}, {"name": "Alwyn P. Johnson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43CA275537-01A1", "company": "O2m Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R43CA275537-01A1: Methods for Fast and Efficient Oxygen Imaging ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10698818", "people": [{"name": "Mrignayani Kotecha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R41HD109131-02", "company": "Precision Neuroscopics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": 128685, "summary": "NIH award 5R41HD109131-02: New Electrodes for Enabling Inclusive EEG Monitoring in Black Populations ($128,685)", "source_url": "https://reporter.nih.gov/project-details/10692799", "people": [{"name": "Jasmine Kwasa", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44DK117813-07", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": 1354672, "summary": "NIH award 5R44DK117813-07: Active Disposable Cap for Endoscope Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps ($1,354,672)", "source_url": "https://reporter.nih.gov/project-details/10708957", "people": [{"name": "Maureen L. Mulvihill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "nih:1R43GM150293-01", "company": "Indee, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": 295924, "summary": "NIH award 1R43GM150293-01: High efficiency microfluidic device for large scale engineered cell therapy manufacturing ($295,924)", "source_url": "https://reporter.nih.gov/project-details/10693775", "people": [{"name": "Ryan Pawell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K223575", "company": "Neolight, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223575: Phoenix ICON, Phoenix ICON GO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223575", "people": [{"name": "Amy Oakes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223575%22"}, {"id": "fda:K231717", "company": "Foshan Jindi Electric Appliance Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231717: IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231717", "people": [{"name": "Zhaozhi Li", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231717%22"}, {"id": "fda:K230127", "company": "Micro-Tech (Nanjing) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230127: Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230127", "people": [{"name": "Sally He", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230127%22"}, {"id": "fda:K230824", "company": "Art Optical Contact Lens, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230824: IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230824", "people": [{"name": "Jill Anastor", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230824%22"}, {"id": "fda:K230024", "company": "Beijing Sano Laser S&T Development Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230024: HI-EMT MAGSHAPE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230024", "people": [{"name": "Hongbo Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230024%22"}, {"id": "fda:K232482", "company": "Siemens Medical Solutions USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232482: MAGNETOM Viato.Mobile", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232482", "people": [{"name": "Alina Goodman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232482%22"}, {"id": "fda:DEN230006", "company": "S4 Medical Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-06", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230006: esolution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230006", "people": [{"name": "William Fuller", "role": "510(k) submission contact"}]}, {"id": "denovo:DEN230006", "company": "S4 Medical Corp.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-09-06", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230006 granted: esolution", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230006"}, {"id": "nih:5R44HD104973-03", "company": "Total Child Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": 815751, "summary": "NIH award 5R44HD104973-03: Validation of the online Toddler Autism and Development Adaptive Screener (TADAS) at 18 months ($815,751)", "source_url": "https://reporter.nih.gov/project-details/10695020", "people": [{"name": "Barbara Jo Howard", "role": "Principal Investigator"}, {"name": "Raymond STURNER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44CA281529-01", "company": "Lase Innovation Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": 1002340, "summary": "NIH award 1R44CA281529-01: Time-lapse Flow Cytometry for Kinetic Profiling of T-Cell Function ($1,002,340)", "source_url": "https://reporter.nih.gov/project-details/10699148", "people": [{"name": "Sheldon J.J. Kwok", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AI147973-03", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": 1014999, "summary": "NIH award 2R44AI147973-03: Biomarker-Based Test of Cure for Chagas Disease ($1,014,999)", "source_url": "https://reporter.nih.gov/project-details/10761244", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K200583", "company": "Ki Mobility, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K200583: Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200583", "people": [{"name": "Mark Murphy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K200583%22"}, {"id": "fda:K221197", "company": "Ortho Clinical Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221197: VITROS Immunodiagnostic Products Intact PTH II Reagent Pack", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221197", "people": [{"name": "Declan Hynes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221197%22"}, {"id": "fda:K230743", "company": "Ichor", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230743: ICHOR 14F Embolectomy System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230743", "people": [{"name": "Angela Mallery", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230743%22"}, {"id": "fda:K221869", "company": "Suzhou Sniper Medical Technologies Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221869: BCR-ABL1 (p210) % IS Kit (Digital PCR Method)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221869", "people": [{"name": "Peng Zhang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221869%22"}, {"id": "fda:K223684", "company": "Fisher & Paykel Healthcare, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223684: F&P 820 Humidification System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223684", "people": [{"name": "Reena Daken", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223684%22"}, {"id": "fda:K232361", "company": "Promaxo, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232361: Promaxo MRI System II", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232361", "people": [{"name": "Veronica Sanz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232361%22"}, {"id": "fda:K232691", "company": "Zirkonzahn Srl", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232691: Polibond", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232691", "people": [{"name": "Sorana Siclovan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232691%22"}, {"id": "fda:K201869", "company": "Ki Mobility, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K201869: Ki Power Tilt System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201869", "people": [{"name": "Mark Murphy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K201869%22"}, {"id": "fda:K231819", "company": "Innovate Orthopaedics Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-05", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231819: Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231819", "people": [{"name": "Mike Bilson", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231819%22"}, {"id": "nih:9R42LM014356-02A1", "company": "Ubitrix International, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 788794, "summary": "NIH award 9R42LM014356-02A1: A Framework for mHealth App Security and Privacy Analysis ($788,794)", "source_url": "https://reporter.nih.gov/project-details/10760047", "people": [{"name": "Sheikh Iqbal Ahamed", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41DK135167-01", "company": "Glycopath, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 275397, "summary": "NIH award 1R41DK135167-01: Glycan biomarker panels in liquid biopsies for predicting treatment response in lupus nephritis ($275,397)", "source_url": "https://reporter.nih.gov/project-details/10601270", "people": [{"name": "Stephen Castellino", "role": "Principal Investigator"}, {"name": "TAMMY (TAMARA) NOWLING", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44CA261579-02", "company": "Xilis, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 998506, "summary": "NIH award 4R44CA261579-02: Micro-Organospheres Drug Screen to Lead Care (MODEL): a Precision Oncology Platform to Guide Breast Cancer Therapy ($998,506)", "source_url": "https://reporter.nih.gov/project-details/10836600", "people": [{"name": "Daniel Delubac", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R42HL162214-02S1", "company": "Biochip Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 70840, "summary": "NIH award 3R42HL162214-02S1: Microfluidic Technology for Concurrent Assessment of Red Blood Cell Adhesion and Deformability ($70,840)", "source_url": "https://reporter.nih.gov/project-details/10915870", "people": [{"name": "Chiara Federici", "role": "Principal Investigator"}, {"name": "Umut A. Gurkan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA285121-01", "company": "Spatial Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 998481, "summary": "NIH award 1R44CA285121-01: Spatial genomics analysis of tumor samples ($998,481)", "source_url": "https://reporter.nih.gov/project-details/10761582", "people": [{"name": "Kirsten Frieda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL170906-01", "company": "Sigt, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 293880, "summary": "NIH award 1R43HL170906-01: Intraoperative Pulsed Field Ablation and Lesion Assessment System ($293,880)", "source_url": "https://reporter.nih.gov/project-details/10762116", "people": [{"name": "Parag Karmarkar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG082578-01", "company": "Minnesota Healthsolutions Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 300251, "summary": "NIH award 1R43AG082578-01: Hand Tremor Compensation Approach for Touch Screens ($300,251)", "source_url": "https://reporter.nih.gov/project-details/10695531", "people": [{"name": "Kevin M. Kramer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS120798-03", "company": "Rivanna Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 837818, "summary": "NIH award 5R44NS120798-03: Real-time three-dimensional spinal navigation system for bedside lumbar puncture placement ($837,818)", "source_url": "https://reporter.nih.gov/project-details/10689113", "people": [{"name": "Frank William Mauldin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43TR004743-01", "company": "Vala Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 350064, "summary": "NIH award 1R43TR004743-01: The Pain in a Dish Assay (PIDA): a high throughput system featuring human stem cell-derived nociceptors and dorsal horn neurons to test compounds for analgesic activity ($350,064)", "source_url": "https://reporter.nih.gov/project-details/10759735", "people": [{"name": "PATRICK M MCDONOUGH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44MH125238-03S1", "company": "Istovisr", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 392855, "summary": "NIH award 3R44MH125238-03S1: Scaling Volumetric Imaging, Analysis and Science Communication Using Immersive Virtual Reality: Administrative Supplement ($392,855)", "source_url": "https://reporter.nih.gov/project-details/10887718", "people": [{"name": "Gianfranco Doretto", "role": "Principal Investigator"}, {"name": "Michael David Morehead", "role": "Principal Investigator"}, {"name": "GEORGE A SPIROU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL170872-01", "company": "Contour Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 299904, "summary": "NIH award 1R43HL170872-01: Soft robotic sensor arrays for fast and efficient mapping of cardiac arrhythmias. ($299,904)", "source_url": "https://reporter.nih.gov/project-details/10760164", "people": [{"name": "Simon Dunham", "role": "Principal Investigator"}, {"name": "Bobak Mosadegh", "role": "Principal Investigator"}, {"name": "Erik C Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DA058431-01", "company": "Wavi Company", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": 319080, "summary": "NIH award 1R44DA058431-01: Development of an AI-empowered device that utilizes multimodal data-visualization to aid in the diagnosis, and treatment, of OUD ($319,080)", "source_url": "https://reporter.nih.gov/project-details/10683816", "people": [{"name": "DAVID OAKLEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K232068", "company": "Changzhou Sifary Medical Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232068: HyperLight Portable X-ray Unit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232068", "people": [{"name": "Tao Huan", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232068%22"}, {"id": "fda:K231047", "company": "Convergent Imaging Solutions", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231047: UniSyn Molecular Imaging (6-3-1)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231047", "people": [{"name": "Mathew Thomas", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231047%22"}, {"id": "fda:K231710", "company": "Softwave/Trt, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231710: OW100S", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231710", "people": [{"name": "John Warlick", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231710%22"}, {"id": "fda:DEN230007", "company": "Xenex Disinfection Services, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN230007: LightStrike+ (MXSUV1-SL and MXSUV1-FT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230007", "people": [{"name": "Juan L. Gonzalez", "role": "510(k) submission contact"}]}, {"id": "fda:K232657", "company": "Perimetrics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232657: InnerView LC", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232657", "people": [{"name": "Alicia Mszyca", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232657%22"}, {"id": "fda:K231270", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231270: Montage Flowable Settable, Resorbable Bone Paste", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231270", "people": [{"name": "Aniq Darr", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231270%22"}, {"id": "fda:K230317", "company": "Elos Medtech Pinol A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230317: Elos Accurate Hybrid Base", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230317", "people": [{"name": "Lise Terkelsen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230317%22"}, {"id": "fda:K231884", "company": "Modern Dental Laboratory (Dg) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231884: TRIOCLEAR System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231884", "people": [{"name": "Robin Liu", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231884%22"}, {"id": "fda:K232014", "company": "Enztec Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232014: CONDUIT\u0099 ATP Inserters", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232014", "people": [{"name": "James Sheat", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232014%22"}, {"id": "fda:K223622", "company": "Faceheart Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223622: FaceHeart Vitals Software Development Kit (FH vitals SDK)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223622", "people": [{"name": "Morris Chung", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223622%22"}, {"id": "fda:K223901", "company": "Apnea Sciences Coporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223901: ApneaRX Pro", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223901", "people": [{"name": "James Fallon", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223901%22"}, {"id": "fda:K213273", "company": "Cortical Dynamics , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213273: Brain Anesthesia Response Monitor (Bar Monitor)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213273", "people": [{"name": "Louis Delacretaz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213273%22"}, {"id": "fda:K230623", "company": "Intrauma S.P.A", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230623: KITE Distal Fibula Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230623", "people": [{"name": "Piero Costa", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230623%22"}, {"id": "fda:K230918", "company": "Medicatech USA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230918: MasterX 800 Series", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230918", "people": [{"name": "George Makar", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230918%22"}, {"id": "fda:K232340", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232340: Arthrex 2.4mm Knotless Hip SutureTak\u00ae Suture Anchor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232340", "people": [{"name": "Alex Underberg", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232340%22"}, {"id": "fda:K213413", "company": "Jiangsu Newvalue Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213413: Hemostatic Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213413", "people": [{"name": "Lu Wang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213413%22"}, {"id": "fda:K232314", "company": "FUJIFILM Healthcare Americas Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232314: Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232314", "people": [{"name": "Chaitrali Kulkarni", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232314%22"}, {"id": "fda:K221601", "company": "C.s.o. S.r.l.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221601: MS-39", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221601", "people": [{"name": "Gilda Mura", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221601%22"}, {"id": "fda:K223674", "company": "Epic Medical Pte. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223674: eZSURE\u0099 Empty Fluid Container (models 426030, 426040, 426110)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223674", "people": [{"name": "Freddie Lee", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223674%22"}, {"id": "fda:K222988", "company": "Ht Medical D.B.A. Xenix Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222988: neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222988", "people": [{"name": "Ryan Phillips", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222988%22"}, {"id": "fda:K232021", "company": "Philips Healthcare (Suzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232021: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232021", "people": [{"name": "Li Sherry", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232021%22"}, {"id": "fda:K232334", "company": "El.En S.P.A.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232334: DEKA SIMON", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232334", "people": [{"name": "Paolo Peruzzi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232334%22"}, {"id": "fda:K230805", "company": "TriMed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-09-01", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230805: TriMed Clavicle Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230805", "people": [{"name": "David Medoff", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230805%22"}, {"id": "denovo:DEN230007", "company": "Xenex Disinfection Services, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-09-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230007 granted: LightStrike+ (MXSUV1-SL and MXSUV1-FT)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230007"}, {"id": "nih:5R44MH112216-03", "company": "Fox Learning Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": 539986, "summary": "NIH award 5R44MH112216-03: Development and Randomized Clinical Trial of an App-based Intervention to Reduce Postpartum Depression in High-Risk Women ($539,986)", "source_url": "https://reporter.nih.gov/project-details/10706452", "people": [{"name": "DEBRA L FOX", "role": "Principal Investigator"}, {"name": "ELLEN L POLESHUCK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA265626-02", "company": "Molecular Theranostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44CA265626-02: Commercialization of an MRI contrast agent for differential diagnosis of prostate cancer ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10704488", "people": [{"name": "SONGQI GAO", "role": "Principal Investigator"}, {"name": "Michael F Tweedle", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH124562-04", "company": "Experiad, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": 840082, "summary": "NIH award 5R44MH124562-04: Goalspace: A Platform for Parent-Assisted Behavioral Interventions ($840,082)", "source_url": "https://reporter.nih.gov/project-details/10674912", "people": [{"name": "REX M JAKOBOVITS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R42HD104325-03", "company": "Recupero Robotics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": 707667, "summary": "NIH award 5R42HD104325-03: Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES) ($707,667)", "source_url": "https://reporter.nih.gov/project-details/10709654", "people": [{"name": "MICHELLE J. JOHNSON", "role": "Principal Investigator"}, {"name": "Alwyn P. Johnson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AG084411-01", "company": "Rush River Research Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": 375704, "summary": "NIH award 1R43AG084411-01: Innovative Chair to Prevent Pressure Injuries in Persons Living with Alzheimer's Disease and Related Dementias ($375,704)", "source_url": "https://reporter.nih.gov/project-details/10760048", "people": [{"name": "Julie Lundstrom", "role": "Principal Investigator"}, {"name": "JUSTINE SUZETTE SEFCIK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK137730-01", "company": "Gel4med, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": 1119996, "summary": "NIH award 1R44DK137730-01: Antimicrobial dermal matrices to promote infection free wound closure in DTU-DFUs. ($1,119,996)", "source_url": "https://reporter.nih.gov/project-details/10766085", "people": [{"name": "Manav Mehta", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43DK135084-01S1", "company": "Integrated Medical Sensors", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": 100000, "summary": "NIH award 3R43DK135084-01S1: A Smart Semiconductor based Integrated Continuous Diabetes Monitoring Platform ($100,000)", "source_url": "https://reporter.nih.gov/project-details/10900360", "people": [{"name": "Muhammad Mujeeb-U-Rahman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA250861-03", "company": "Quantitative Imaging Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": 818247, "summary": "NIH award 5R44CA250861-03: Ultra-high content analyses of circulating and solid tumor cells: A diagnostic reference system for disease burden ($818,247)", "source_url": "https://reporter.nih.gov/project-details/10704738", "people": [{"name": "Michel Nederlof", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44EB030874-03", "company": "Optosurgical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": 966023, "summary": "NIH award 5R44EB030874-03: hANDY-i(TM): A non-invasive, dual-sensor handheld imager for intraoperative preservation of parathyroid glands ($966,023)", "source_url": "https://reporter.nih.gov/project-details/10706615", "people": [{"name": "Richard Jaepyeong Cha", "role": "Principal Investigator"}, {"name": "Eugene Oh", "role": "Principal Investigator"}, {"name": "Kaitlyn Frazier Strickland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "fda:K231323", "company": "Aspero Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231323: Ancora-SB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231323", "people": [{"name": "Mark Rentschler", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231323%22"}, {"id": "fda:K232353", "company": "Shanxi Hongjin Plastic Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232353: Powder Free Nitrile Examination Gloves (Black)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232353", "people": [{"name": "Wu Zhigang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232353%22"}, {"id": "fda:K223597", "company": "23AndMe, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223597: 23andMe\u00ae Personal Genome Service\u00ae (PGS\u00ae) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223597", "people": [{"name": "Marianna Frendo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223597%22"}, {"id": "fda:K230578", "company": "Wrp Asia Pacific Sdn. Bhd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230578: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230578", "people": [{"name": "Saravanan Ramasamy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230578%22"}, {"id": "fda:K232287", "company": "Ray Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232287: RAYSCAN a-Expert3D", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232287", "people": [{"name": "Sooji Huh", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232287%22"}, {"id": "fda:K213271", "company": "Health Value Creation B.V., Trading AS Corporis Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213271: MedicloseTM System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213271", "people": [{"name": "Kim Sondeijker", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213271%22"}, {"id": "fda:K231978", "company": "Vivachek Biotech (Hangzhou) Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231978: BioSieve\u0099 Marijuana Test Panel 50; BioSieve\u0099 Marijuana Test Strip 50; BioSieve\u0099 Dx Marijuana Test Strip 20; BioSieve\u0099 Dx Marijuana Test Strip 50; BioSieve\u0099 Dx Marijuana Test Panel 20; BioSieve\u0099 Dx Marijuana Test Panel 50", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231978", "people": [{"name": "Jessica Chen", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231978%22"}, {"id": "fda:K223533", "company": "Ki Mobility, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223533: Little Wave Arc; Little Wave Flip", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223533", "people": [{"name": "Mark Murphy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223533%22"}, {"id": "fda:K230488", "company": "Walz Elektronik GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230488: EL27-Compact; Sterile EHL-Probes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230488", "people": [{"name": "Bernd Vollmer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230488%22"}, {"id": "fda:K231433", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231433: The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231433", "people": [{"name": "Cynthia Knapp", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231433%22"}, {"id": "fda:K223527", "company": "Ki Mobility, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223527: Little Wave Clik, Rogue XP, Little Wave XP, Spark", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223527", "people": [{"name": "Mark Murphy", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223527%22"}, {"id": "fda:K222563", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222563: BD Kiestra IdentifA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222563", "people": [{"name": "Laura Stewart", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222563%22"}, {"id": "fda:K231626", "company": "Skydance Vascular, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231626: OSPREY Closed IV Catheter System (OspreyV2)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231626", "people": [{"name": "Scott Pease", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231626%22"}, {"id": "fda:K221959", "company": "Neurofield, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221959: Q21", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221959", "people": [{"name": "Nicholas J. Dogris", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221959%22"}, {"id": "fda:K231616", "company": "Zeus Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231616: ZEUS IFA(TM) nDNA Test System, ZEUS dIFine", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231616", "people": [{"name": "Mark Kopnitsky", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231616%22"}, {"id": "fda:K231611", "company": "Surgalign Spine Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-31", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231611: HOLO Portal\u0099 Surgical Guidance System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231611", "people": [{"name": "Jeremy Markovich", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231611%22"}, {"id": "sbir:DOD:W51701-23-C-0271", "company": "Nanohmics Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-08-31", "observed": "2026-09-18", "amount_usd": 1899999, "summary": "DOD SBIR Phase II award $1,899,999: Wearable Technologies for Physiological Monitoring", "source_url": "https://www.sbir.gov/awards?search=A2-9791"}, {"id": "nih:5R44HD105552-03", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 620864, "summary": "NIH award 5R44HD105552-03: Additive Manufacturing of Patient-Specific Masks and Nasal Prongs to Improve Pediatric Ventilation Outcomes and Reduce Pressure Sores ($620,864)", "source_url": "https://reporter.nih.gov/project-details/10571860", "people": [{"name": "Roger Brooks Bagwell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA265758-03", "company": "Omniscient Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 918003, "summary": "NIH award 5R44CA265758-03: Sedationless Multi-View High-Resolution Endoscopy ($918,003)", "source_url": "https://reporter.nih.gov/project-details/10669811", "people": [{"name": "Bhaskar Banerjee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44DA058952-01", "company": "Mmj Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 159110, "summary": "NIH award 1R44DA058952-01: Creation and Validation of the Dose-Opioid-Source Evaluation tool (DOSE) - a Robust Opioid Use Clinical Outcome Assessment for Qualification as an FDA Medical Device Development Tool (MDDT) ($159,110)", "source_url": "https://reporter.nih.gov/project-details/10739706", "people": [{"name": "Amy Lynn Baxter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44GM135957-03S1", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 267144, "summary": "NIH award 3R44GM135957-03S1: Ultra-Sensitive Vapor Phase Hydrogen Peroxide Sensor for Decontaminating Pharmaceutical Manufacturing Facilities (2nd Admin Supplement Request) ($267,144)", "source_url": "https://reporter.nih.gov/project-details/10885691", "people": [{"name": "Brian E Brumfield", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43PS005274-01", "company": "Varigen Biosciences Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 252073, "summary": "NIH award 1R43PS005274-01: Rapid molecular diagnostic assay for detection of Hepatitis C virus at point of care ($252,073)", "source_url": "https://reporter.nih.gov/project-details/10544416", "people": [{"name": "Yogesh Chander", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK136652-01", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 284517, "summary": "NIH award 1R43DK136652-01: Point-of-Care Assay for Type 1 Diabetes Diagnosis and Prognostication ($284,517)", "source_url": "https://reporter.nih.gov/project-details/10721535", "people": [{"name": "Eric Ervin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH133495-01A1", "company": "Tanzen Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 486552, "summary": "NIH award 1R43MH133495-01A1: RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Legs Syndrome in Pediatric Patients with Attention Deficit/Hyperactivity Disorder ($486,552)", "source_url": "https://reporter.nih.gov/project-details/10760442", "people": [{"name": "CODY GREGORY FELTCH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EY035206-01", "company": "Visionquest Biomedical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 274088, "summary": "NIH award 1R43EY035206-01: Automated system to improve compliance to diabetic retinopathy screening ($274,088)", "source_url": "https://reporter.nih.gov/project-details/10697609", "people": [{"name": "Vinayak S Joshi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CK000698-01", "company": "Attogene", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 248848, "summary": "NIH award 1R43CK000698-01: PA22176, SBIR, Phase I, Lateral Flow Assay to Detect Malaria ($248,848)", "source_url": "https://reporter.nih.gov/project-details/10697156", "people": [{"name": "JOSEPH FRANCIS KREBS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL162169-02", "company": "Shape Medical Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 844522, "summary": "NIH award 5R44HL162169-02: Assessing the Utility of Submaximal Cardiopulmonary Exercise Testing in Diagnosis and Treatment Management of Pulmonary Arterial Hypertension ($844,522)", "source_url": "https://reporter.nih.gov/project-details/10692802", "people": [{"name": "Dean Judson MacCarter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43NS132644-01A1", "company": "Quasar, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 499996, "summary": "NIH award 1R43NS132644-01A1: A Dry Electrode for Universal Accessibility to EEG ($499,996)", "source_url": "https://reporter.nih.gov/project-details/10761609", "people": [{"name": "Neil J McDonald", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL140662-08", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 863466, "summary": "NIH award 5R44HL140662-08: Improving Anticoagulation Monitoring in Pediatric Patients: Use of a Microfluidic Platform to Test Low Volume Blood Samples Obtained by Heel-Stick Collection ($863,466)", "source_url": "https://reporter.nih.gov/project-details/10597031", "people": [{"name": "VAMSEE K. PAMULA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 8, "new_award": false}, {"id": "nih:1R44GM151918-01", "company": "Qatch Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": 951162, "summary": "NIH award 1R44GM151918-01: High-throughput injectability screening of high concentration protein formulations by microfluidic quartz resonators ($951,162)", "source_url": "https://reporter.nih.gov/project-details/10760592", "people": [{"name": "Zehra Parlak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "fda:K223303", "company": "Axon Spine Medical System", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223303: Spinery\u0099 RF Ablation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223303", "people": [{"name": "Salvatore Accardo", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223303%22"}, {"id": "fda:K231580", "company": "Medtronic Xomed, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231580: NIM\u0099 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231580", "people": [{"name": "Alexandra Oliver", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231580%22"}, {"id": "fda:K231123", "company": "Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231123: Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231123", "people": [{"name": "Michael Stuart", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231123%22"}, {"id": "fda:K232295", "company": "Syntheon, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232295: LAA Exclusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232295", "people": [{"name": "Toygar Unal", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232295%22"}, {"id": "fda:K231093", "company": "Stryker Endoscopy", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231093: AlphaVent Suture Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231093", "people": [{"name": "Katie Farraro", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231093%22"}, {"id": "fda:K231024", "company": "Procept Biorobotics, Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231024: AquaBeam Robotic System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231024", "people": [{"name": "Sara Muddell", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231024%22"}, {"id": "fda:K230155", "company": "Mick Radio-Nuclear Instruments, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230155: Mick Valencia Applicator Set", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230155", "people": [{"name": "James Hurlman", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230155%22"}, {"id": "fda:K231656", "company": "Brainomix Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231656: Brainomix 360 e-MRI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231656", "people": [{"name": "Zsolt Szrnka", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231656%22"}, {"id": "fda:K231276", "company": "Smartcardia SA", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231276: SmartCardia 7L Platform", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231276", "people": [{"name": "Srinivasan Murali", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231276%22"}, {"id": "fda:K232343", "company": "Arrow International, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232343: AC3\u0099 Series IABP", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232343", "people": [{"name": "Sheila Payzant", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232343%22"}, {"id": "fda:K231156", "company": "Alcresta Therapeutics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231156: Enzyme Packed Cartridge - RELiZORB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231156", "people": [{"name": "Matthew King", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231156%22"}, {"id": "fda:K231961", "company": "Shenzhen Sino-K Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231961: NIBPCuff", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231961", "people": [{"name": "Lao Chengxin", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231961%22"}, {"id": "fda:K213418", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213418: MONTAGE Settable, Resorbable Hemostatic Bone Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213418", "people": [{"name": "Howard Schrayer", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213418%22"}, {"id": "fda:K230013", "company": "Silk'N Beauty , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230013: Silk'n Titan Allways", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230013", "people": [{"name": "Amit Goren", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230013%22"}, {"id": "fda:K230355", "company": "Canon Medical Systems Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230355: Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230355", "people": [{"name": "Janine F Reyes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230355%22"}, {"id": "fda:K230603", "company": "Teleflex Medical", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230603: Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230603", "people": [{"name": "Kristen Bisanz", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230603%22"}, {"id": "fda:K231289", "company": "Wellysis Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231289: S-Patch Ex Wearable ECG Patch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231289", "people": [{"name": "DoGyun Im", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231289%22"}, {"id": "fda:K231246", "company": "Merit Medical Systems, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231246: Ventrax\u0099 Delivery System (VTR851)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231246", "people": [{"name": "Jenny Soderquist", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231246%22"}, {"id": "fda:K231988", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231988: Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2\u00b5g/ml", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231988", "people": [{"name": "Joel Mathew", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231988%22"}, {"id": "fda:K223468", "company": "Novastep", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223468: Nexis\u00ae compressive screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223468", "people": [{"name": "Gilles Audic", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223468%22"}, {"id": "fda:K223130", "company": "Covidien", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223130: Shiley\u0099 Pediatric Oral/Nasal Endotracheal Tube with TaperGuard\u0099 Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223130", "people": [{"name": "Anila Tarte", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223130%22"}, {"id": "fda:K232324", "company": "Medartis, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232324: StealthFix Intraosseous Fixation System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232324", "people": [{"name": "Chelsea Kozior", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232324%22"}, {"id": "fda:K223367", "company": "Ochsner Clinic Foundation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-30", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223367: Ochsner Connected Inhaler Sensor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223367", "people": [{"name": "Hakm Murad", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223367%22"}, {"id": "nih:5R44CA240021-03", "company": "Giner, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 997685, "summary": "NIH award 5R44CA240021-03: Rapid, Multiplexed Biosensor for Non-Invasive Detection of Gene Mutations and Personalization of Therapy in Non-Small Cell Lung Cancer ($997,685)", "source_url": "https://reporter.nih.gov/project-details/10480889", "people": [{"name": "Avni A Argun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R44MH122115-04S1", "company": "Spectragenetics", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 307673, "summary": "NIH award 3R44MH122115-04S1: Highly Multiplexed Cell-Based GPCR Assay. ($307,673)", "source_url": "https://reporter.nih.gov/project-details/10877457", "people": [{"name": "G. Reid Asbury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43HD113477-01", "company": "Indelible Learning, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 302424, "summary": "NIH award 1R43HD113477-01: Interactive hand hygiene training for special education pre-vocational students ($302,424)", "source_url": "https://reporter.nih.gov/project-details/10761562", "people": [{"name": "Jasminka Criley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44MH133502-01S1", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 106332, "summary": "NIH award 3R44MH133502-01S1: Integrated software platform to enhance school mental health assessment and data-driven student services ($106,332)", "source_url": "https://reporter.nih.gov/project-details/10874882", "people": [{"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}, {"name": "SHARON H Hoover", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44EY032825-02", "company": "F Square Medical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 905945, "summary": "NIH award 2R44EY032825-02: Development of the First-ever Safe and Effective Anterior Chamber Paracentesis Instrument to Treat and Diagnose Ocular Diseases ($905,945)", "source_url": "https://reporter.nih.gov/project-details/10697928", "people": [{"name": "samer farah", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44GM137648-02", "company": "Fluent Biosciences Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 1146224, "summary": "NIH award 2R44GM137648-02: Commercialization of methods and reagents for high-throughput single cell analysis ($1,146,224)", "source_url": "https://reporter.nih.gov/project-details/10699477", "people": [{"name": "Kristina Fontanez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NS108850-04", "company": "Backyard Brains, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 934311, "summary": "NIH award 5R44NS108850-04: Introducing Neuroscience and Neurocomputation Concepts to High School Students using Brain-based Neurorobots ($934,311)", "source_url": "https://reporter.nih.gov/project-details/10695869", "people": [{"name": "Gregory John Gage", "role": "Principal Investigator"}, {"name": "Christopher Aidan Harris", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R41AR082170-02", "company": "G5 Biological Innovations L.l.c.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 95883, "summary": "NIH award 5R41AR082170-02: Intraoperative Kit for AuNP-Tissue Grafts ($95,883)", "source_url": "https://reporter.nih.gov/project-details/10707519", "people": [{"name": "David Grant", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA281547-01A1", "company": "Vizlitics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 406500, "summary": "NIH award 1R43CA281547-01A1: VIPCare: Virtual Predictive Care workflow with integrated surveillance for optimal care protocol selection and management in at-risk prostate cancer patients ($406,500)", "source_url": "https://reporter.nih.gov/project-details/10758350", "people": [{"name": "Sharon Hensley Alford", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL170918-01", "company": "Cyion Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 343203, "summary": "NIH award 1R43HL170918-01: An in vitro electrophysiology system for high-throughput measurement of cardiomyocyte action potential ($343,203)", "source_url": "https://reporter.nih.gov/project-details/10759677", "people": [{"name": "XIN JIANG", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EY035198-01", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 331131, "summary": "NIH award 1R43EY035198-01: Evaluation of photoreceptors health and function in diabetic retinopathy patients using a high-resolution retinal imaging device with controlled light stimulus ($331,131)", "source_url": "https://reporter.nih.gov/project-details/10696696", "people": [{"name": "Mircea Mujat", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK136703-01", "company": "Integrated Medical Sensors", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": 350000, "summary": "NIH award 1R43DK136703-01: A Miniaturized and Integrated Continuous Metabolic Monitoring Platform ($350,000)", "source_url": "https://reporter.nih.gov/project-details/10721798", "people": [{"name": "Muhammad Mujeeb-U-Rahman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K232313", "company": "Ethicon Endo Surgery, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232313: LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232313", "people": [{"name": "Lakrisha Tinner", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232313%22"}, {"id": "fda:K230765", "company": "Nuvasive Specialized Orthopedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230765: Precice Ankle Salvage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230765", "people": [{"name": "Miriam Cervantes", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230765%22"}, {"id": "fda:K232226", "company": "FH Industrie", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232226: ARROW Off-Centred Humeral Insert", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232226", "people": [{"name": "Naoual Rahimi", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232226%22"}, {"id": "fda:K221361", "company": "Bodimetrics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K221361: circul\u0099 pro Ring", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221361", "people": [{"name": "Mark Goettling", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K221361%22"}, {"id": "fda:K231407", "company": "Premium Medical Technology, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-29", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231407: StarFin", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231407", "people": [{"name": "Kuowei Chang", "role": "510(k) submission contact"}], "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231407%22"}, {"id": "nih:5R44MH125700-03", "company": "Paradromics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": 234718, "summary": "NIH award 5R44MH125700-03: Development and evaluation of novel high-density intracortical microelectrode arrays for clinical applications ($234,718)", "source_url": "https://reporter.nih.gov/project-details/10698164", "people": [{"name": "Matthew R Angle", "role": "Principal Investigator"}, {"name": "SYDNEY S CASH", "role": "Principal Investigator"}, {"name": "Shaoyu Qiao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43CA285041-01", "company": "Binary Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": 398040, "summary": "NIH award 1R43CA285041-01: Monitoring Immunotherapy Response via Gene Silencing Landscapes in Cell-Free DNA ($398,040)", "source_url": "https://reporter.nih.gov/project-details/10760450", "people": [{"name": "Michael T Barrett", "role": "Principal Investigator"}, {"name": "Abhijit Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD105579-03", "company": "Neurolutions, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": 794998, "summary": "NIH award 5R44HD105579-03: A Fully Remote Telehealth Brain Computer Interface And Assessment System For Motor Rehabilitation Of Chronic Stroke ($794,998)", "source_url": "https://reporter.nih.gov/project-details/10690004", "people": [{"name": "Robert Coker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44AG050366-04", "company": "Parabon Nanolabs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": 917300, "summary": "NIH award 2R44AG050366-04: Novel whole-genome analysis methods for Alzheimer's risk prediction ($917,300)", "source_url": "https://reporter.nih.gov/project-details/10698985", "people": [{"name": "Ellen McRae Greytak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:3R44NS127667-02S1", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": 97500, "summary": "NIH award 3R44NS127667-02S1: Exploring the Parameter Space of High Frequency Magnetic Perturbation in Manipulating Neural Excitability and Plasticity. ($97,500)", "source_url": "https://reporter.nih.gov/project-details/10841060", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM145183-03", "company": "Microsensor Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": 726410, "summary": "NIH award 5R44GM145183-03: SBIR Fast Track: Development of a High-throughput Magnetic Cytometer for Single Cell Sorting ($726,410)", "source_url": "https://reporter.nih.gov/project-details/10703514", "people": [{"name": "Peng Paul Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA165314-07", "company": "Imcare Biotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": 1289036, "summary": "NIH award 5R44CA165314-07: A novel diagnostic Kit for Hepatocellular Carcinoma ($1,289,036)", "source_url": "https://reporter.nih.gov/project-details/10670881", "people": [{"name": "Xuanyong Lu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "nih:1R43HL166039-01A1", "company": "Rush River Research Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": 299254, "summary": "NIH award 1R43HL166039-01A1: Auto-Titrating Oral Appliance for Sleep Disordered Breathing ($299,254)", "source_url": "https://reporter.nih.gov/project-details/10697976", "people": [{"name": "Julie Lundstrom", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44MH111450-05S1", "company": "Psyc Tech, Ltd", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": 298116, "summary": "NIH award 3R44MH111450-05S1: Finalizing and Testing an Online Therapist Training and Assistance Program to Facilitate Implementation of Comprehensive Behavioral Intervention for Tic Disorders (CBIT-Trainer) ($298,116)", "source_url": "https://reporter.nih.gov/project-details/10890569", "people": [{"name": "Michael B Himle", "role": "Principal Investigator"}, {"name": "Suzanne Mouton-Odum", "role": "Principal Investigator"}, {"name": "Douglas W Woods", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:4R44DA056251-02", "company": "Opio Connect, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": 1548618, "summary": "NIH award 4R44DA056251-02: Booth\u2122 by Opio\u2122: Developing technology to expand the reach of opioid treatment programs into rural and underserved areas. ($1,548,618)", "source_url": "https://reporter.nih.gov/project-details/10819268", "people": [{"name": "Amber Norbeck", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K231623", "company": "Skeletal Dynamics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231623: Distal Elbow Plating System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231623", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231623%22"}, {"id": "fda:K231676", "company": "Carl Zeiss Meditec, AG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231676: CALLISTO eye", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231676", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231676%22"}, {"id": "fda:K222525", "company": "Roundworks Technologies Private Limited", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222525: Alveoair Digital Spirometer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222525", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222525%22"}, {"id": "fda:K231537", "company": "Sofwave Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231537: SofWave System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231537", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231537%22"}, {"id": "fda:K232387", "company": "Treace Medical Concepts", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232387: Treace Medical Concepts (TMC) Compression Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232387", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232387%22"}, {"id": "fda:K223639", "company": "Techsomed", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223639: VisAble.IO", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223639", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223639%22"}, {"id": "fda:K230159", "company": "Soundbite Medical Solutions, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230159: SoundBite\u00ae Crossing System XS Peripheral", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230159", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230159%22"}, {"id": "fda:K231435", "company": "Kimberly-Clark Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231435: KIMTECH\u0099 Polaris\u0099 Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231435", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231435%22"}, {"id": "fda:K231422", "company": "Limaca Medical, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231422: Precision GI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231422", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231422%22"}, {"id": "fda:K230221", "company": "Versant Medical Physics and Radiation Safety", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-28", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230221: QDOSE\u00ae Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230221", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230221%22"}, {"id": "breakthrough:K231422", "company": "Limaca Medical, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-08-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K231422: PRECISION GI", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W51701-23-C-0268", "company": "Neurable Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-08-28", "observed": "2026-09-18", "amount_usd": 1888226, "summary": "DOD SBIR Phase II award $1,888,226: Decoding Cognitive Fatigue: Leveraging EEG for Enhanced Soldier Performance and Biopotential Applications.", "source_url": "https://www.sbir.gov/awards?search=A2-9814"}, {"id": "nih:5R44MH131510-02", "company": "Experiad, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": 687313, "summary": "NIH award 5R44MH131510-02: Acuity - A Clinical Decision Support System for Applied Behavior Analysis ($687,313)", "source_url": "https://reporter.nih.gov/project-details/10681393", "people": [{"name": "REX M JAKOBOVITS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG084374-01", "company": "Minnesota Healthsolutions Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": 343030, "summary": "NIH award 1R43AG084374-01: A novel driving coach app for older adults with cognitive impairment ($343,030)", "source_url": "https://reporter.nih.gov/project-details/10759329", "people": [{"name": "Pouya Johnathon Ehsani", "role": "Principal Investigator"}, {"name": "Kevin M. Kramer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44ES024041-06", "company": "Access Sensor Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": 913856, "summary": "NIH award 5R44ES024041-06: Validation of the UPAS+: A filter-based air sampler coupled with a suite of real-time sensors ($913,856)", "source_url": "https://reporter.nih.gov/project-details/10690663", "people": [{"name": "Daniel D Miller-Lionberg", "role": "Principal Investigator"}, {"name": "Jessica Tryner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:4R44HD111134-02", "company": "Autoivf, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": 1069950, "summary": "NIH award 4R44HD111134-02: OvaSafe: A microfluidic device enabling automated oocyte vitrification ($1,069,950)", "source_url": "https://reporter.nih.gov/project-details/10892324", "people": [{"name": "Ismail Emre Ozkumur", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K230165", "company": "Coloplast", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230165: Luja Coud\u00e9 (20118 Male CH8 - small packaging (Pocket size)), Luja Coud\u00e9 (20111 Male CH10 - small packaging (Pocket size)), Luja Coud\u00e9 (20112 Male CH12 - small packaging (Pocket size)), Luja Coud\u00e9 (20114 Male CH14 - small packaging (Pocket size)), Luja Coud\u00e9 (20101 Male CH10 - large packaging), Luja Coud\u00e9 (20102 Male CH12 - large packaging), Luja Coud\u00e9 (20104 Male CH14 - large packaging), Luja Coud\u00e9 (20106 Male CH16 - large packaging)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230165", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230165%22"}, {"id": "fda:K230566", "company": "Joytech Healthcare Co. , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230566: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230566", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230566%22"}, {"id": "fda:K222972", "company": "Bioprotect, Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222972: BioProtect Balloon Implant\u0099 System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222972", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222972%22"}, {"id": "fda:K213670", "company": "Becton, Dickinson and Company", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K213670: BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213670", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K213670%22"}, {"id": "fda:K230364", "company": "Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230364: VitalFlow\u0099 Console", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230364", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230364%22"}, {"id": "fda:K231903", "company": "Orthocon, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231903: Montage-QS Settable, Resorbable Bone Putty", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231903", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231903%22"}, {"id": "fda:K230409", "company": "Shenzhen Jamr Technology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230409: Wrist Type Blood Pressure Monitor (W05,W1101L)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230409", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230409%22"}, {"id": "fda:K223898", "company": "Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223898: VitalFlowTM Centrifugal Pump", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223898", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223898%22"}, {"id": "fda:K223727", "company": "Wontech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223727: Lavieen", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223727", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223727%22"}, {"id": "fda:K231994", "company": "Thermo Fisher Scientific", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231994: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231994", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231994%22"}, {"id": "fda:K230014", "company": "Tonica Elektronik A/S", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230014: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230014", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230014%22"}, {"id": "fda:K230094", "company": "Responsive Arthroscopy, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230094: Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230094", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230094%22"}, {"id": "fda:K222786", "company": "Q'Apel Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222786: 072 Aspiration System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222786", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222786%22"}, {"id": "fda:K223600", "company": "Wuhan Zonsen Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223600: Sterilization Wrap", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223600", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223600%22"}, {"id": "fda:K231183", "company": "Shandong Haidike Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231183: Non absorbable Surgical Polyester Suture", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231183", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231183%22"}, {"id": "fda:K231872", "company": "Kirwan Surgical Products, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231872: Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231872", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231872%22"}, {"id": "fda:K231255", "company": "Novo Nordisk, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231255: NovoFine\u00ae Plus", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231255", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231255%22"}, {"id": "fda:K230928", "company": "Vein 360, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230928: Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230928", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230928%22"}, {"id": "fda:K232214", "company": "Sight Sciences, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232214: OMNI Surgical System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232214", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232214%22"}, {"id": "fda:K223807", "company": "Shenzhen Sino-K Medical Technology Co.,Ltd", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223807: Reusable Temperature Probe, Disposable Temperature Probe", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223807", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223807%22"}, {"id": "fda:K223180", "company": "Airamed GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-25", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223180: AIRAscore", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223180", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223180%22"}, {"id": "nih:3R44DE031461-02S1", "company": "Pediametrix Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": 44553, "summary": "NIH award 3R44DE031461-02S1: Mobile Three-Dimensional Screening for Cranial Malformations ($44,553)", "source_url": "https://reporter.nih.gov/project-details/10888913", "people": [{"name": "Fereshteh Aalamifar", "role": "Principal Investigator"}, {"name": "Reza Seifabadi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HD112285-01A1", "company": "Limber Prosthetics & Orthotics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": 247429, "summary": "NIH award 1R43HD112285-01A1: LIMBER UniLeg: A digital and additive manufacturing approach for accessible prosthetic care. ($247,429)", "source_url": "https://reporter.nih.gov/project-details/10761671", "people": [{"name": "Herbert Joseph Barrack", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG076248-02", "company": "Theranova, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": 653381, "summary": "NIH award 5R44AG076248-02: A novel enteral feeding system for the earlier and safer delivery of enteral nutrition through continuous monitoring of tip location ($653,381)", "source_url": "https://reporter.nih.gov/project-details/10689817", "people": [{"name": "Daniel Rogers Burnett", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44GM143977-02", "company": "Edvotek, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": 966210, "summary": "NIH award 2R44GM143977-02: The EdvoReader: Developing a Quantitative PCR and Colorimetry Instrument for Laboratory Skills Training ($966,210)", "source_url": "https://reporter.nih.gov/project-details/10760647", "people": [{"name": "Brian Ell", "role": "Principal Investigator"}, {"name": "DANIELLE SNOWFLACK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44LM013859-02", "company": "Lifeboard Medical", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": 622894, "summary": "NIH award 5R44LM013859-02: Leveraging Health Information Technology to Improve Trauma Resuscitation ($622,894)", "source_url": "https://reporter.nih.gov/project-details/10693384", "people": [{"name": "Michael H. Metzler", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K231680", "company": "L&K BIOMED Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231680: AccelFix Lumbar Expandable Cage System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231680", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231680%22"}, {"id": "fda:K231604", "company": "Cochlear Americas", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231604: Instrument Case", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231604", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231604%22"}, {"id": "fda:K222103", "company": "Shandong Yinghng Medical Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222103: Nitrile Patient Examination Gloves, Powder Free, Pink Color", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222103", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222103%22"}, {"id": "fda:K220085", "company": "Kronus, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220085: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220085", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220085%22"}, {"id": "fda:K232215", "company": "Hemosonics, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232215: Quantra Hemostasis Analyzer", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232215", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232215%22"}, {"id": "fda:K232291", "company": "Livanova Deutschland, GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232291: Essenz HLM, Essenz ILBM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232291", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232291%22"}, {"id": "fda:K223607", "company": "Icu Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223607: Plum Duo\u0099 Infusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223607", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223607%22"}, {"id": "fda:K231599", "company": "Stryker Leibinger GmbH & Co KG", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231599: Stryker MP, Mandible, HMMF and MMF AXS Screws", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231599", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231599%22"}, {"id": "fda:K231557", "company": "Izenimplant Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231557: ZENEX FreeMilling & CCM Cast Abutment", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231557", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231557%22"}, {"id": "fda:K231944", "company": "Tenon Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231944: CATAMARAN SI Joint Fusion System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231944", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231944%22"}, {"id": "fda:K220145", "company": "Monaghan Medical Corporation", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220145: Monaghan medical filtered mouthpiece kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220145", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220145%22"}, {"id": "fda:K232218", "company": "Medyssey USA, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232218: Zenius\u0099 Spinal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232218", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232218%22"}, {"id": "fda:K230976", "company": "Arthrex, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230976: Arthrex Radiopaque FiberTape Cerclage sutures", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230976", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230976%22"}, {"id": "fda:K231274", "company": "Natural Cycles Nordic AB", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231274: Natural Cycles", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231274", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231274%22"}, {"id": "fda:K231506", "company": "Current Health , Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231506: Current Health System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231506", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231506%22"}, {"id": "fda:K223150", "company": "A Plus Biotechnology Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223150: APS Metal Plate & Screw System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223150", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223150%22"}, {"id": "fda:K223606", "company": "Icu Medical, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223606: LifeShield\u0099 Infusion Safety Software Suite", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223606", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223606%22"}, {"id": "fda:K212766", "company": "Advamedica, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-24", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K212766: Maxiocel Chitosan Wound Dressing", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212766", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K212766%22"}, {"id": "nih:5R42DE030040-03", "company": "Virtually Better, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 419346, "summary": "NIH award 5R42DE030040-03: Disseminable Evidence-Based Treatment for the Dental Office: Virtual Exposure Tools for Dental Fear - neVR Fear the Dentist ($419,346)", "source_url": "https://reporter.nih.gov/project-details/10691890", "people": [{"name": "Margo Adams Larsen", "role": "Principal Investigator"}, {"name": "Richard Eliot Heyman", "role": "Principal Investigator"}, {"name": "AMY Michele Smith SLEP", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44HL169158-01", "company": "Perosphere Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 1068783, "summary": "NIH award 1R44HL169158-01: Novel Broad-Spectrum Point-of-Care Coagulometer ($1,068,783)", "source_url": "https://reporter.nih.gov/project-details/10707617", "people": [{"name": "Sasha H Bakhru", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43CK000697-01A1", "company": "Aptalogic, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 264271, "summary": "NIH award 1R43CK000697-01A1: PA21259, SBIR, Phase I, Aptamer-upconverting nanocrystal conjugate lateral flow assay for immediate Ebola virus detection ($264,271)", "source_url": "https://reporter.nih.gov/project-details/10547116", "people": [{"name": "Soma Banerjee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH124567-04", "company": "Turing Medical Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 1775407, "summary": "NIH award 5R44MH124567-04: Motion-robust brain MRI for infants ($1,775,407)", "source_url": "https://reporter.nih.gov/project-details/10684950", "people": [{"name": "MAXWELL BERTOLERO", "role": "Principal Investigator"}, {"name": "Damien A Fair", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44GH002369-02", "company": "Vectech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 1962860, "summary": "NIH award 2R44GH002369-02: Automated lab identification and sorting (Rapid-IDX) for mosquito surveillance ($1,962,860)", "source_url": "https://reporter.nih.gov/project-details/10823063", "people": [{"name": "Jewell Amanda Brey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CK000699-01", "company": "Varigen Biosciences Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 252235, "summary": "NIH award 1R43CK000699-01: PA-21-259, SBIR, Phase I, Rapid molecular diagnostic assay for detection of Candida auris at point of care ($252,235)", "source_url": "https://reporter.nih.gov/project-details/10544885", "people": [{"name": "Yogesh Chander", "role": "Principal Investigator"}, {"name": "Jeniel E Nett", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM136046-02", "company": "Proteinaceous, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 955646, "summary": "NIH award 2R44GM136046-02: Data-Driven Software to Automate Top-Down Mass Spectrometry of Large Molecules ($955,646)", "source_url": "https://reporter.nih.gov/project-details/10761429", "people": [{"name": "Kenneth Durbin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43MH135772-01", "company": "Numentus Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 300691, "summary": "NIH award 1R43MH135772-01: High-speed hyperspectral imaging for highly multiplexed immunofluorescence imaging ($300,691)", "source_url": "https://reporter.nih.gov/project-details/10699518", "people": [{"name": "GREGORY W FARIS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG084365-01", "company": "Plans4care Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 500000, "summary": "NIH award 1R44AG084365-01: Plans4Care: Personalized Dementia Care On-Demand ($500,000)", "source_url": "https://reporter.nih.gov/project-details/10758864", "people": [{"name": "Eric Jutkowitz", "role": "Principal Investigator"}, {"name": "Sokha Koeuth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS127667-02", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 1123254, "summary": "NIH award 5R44NS127667-02: Exploring the Parameter Space of High Frequency Magnetic Perturbation in Manipulating Neural Excitability and Plasticity. ($1,123,254)", "source_url": "https://reporter.nih.gov/project-details/10684222", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44AG079734-02", "company": "Einsenca Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 1154734, "summary": "NIH award 4R44AG079734-02: PET Imaging of Damaging Neuroinflammation in Alzheimer's Disease ($1,154,734)", "source_url": "https://reporter.nih.gov/project-details/10894989", "people": [{"name": "Andrew Christian Larson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NS127696-02", "company": "Cnd Life Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 952525, "summary": "NIH award 5R44NS127696-02: Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies ($952,525)", "source_url": "https://reporter.nih.gov/project-details/10703452", "people": [{"name": "Todd Levine", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44HL162443-02", "company": "Atomo, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 841730, "summary": "NIH award 4R44HL162443-02: Finding undiagnosed ATTR-CM patients using AI technology in clinical settings ($841,730)", "source_url": "https://reporter.nih.gov/project-details/10898234", "people": [{"name": "Kelly D Myers", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA246941-03", "company": "Earlydiagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 997285, "summary": "NIH award 5R44CA246941-03: MethylScan for Early Detection of Liver and Lung Cancer ($997,285)", "source_url": "https://reporter.nih.gov/project-details/10705298", "people": [{"name": "Steven-Huy B Han", "role": "Principal Investigator"}, {"name": "ANNA S.F. LOK", "role": "Principal Investigator"}, {"name": "Xiaohui Ni", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R43MH129065-02", "company": "Doxy.me, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 418884, "summary": "NIH award 5R43MH129065-02: Developing a virtual reality clinic to enhance telemental health. ($418,884)", "source_url": "https://reporter.nih.gov/project-details/10696144", "people": [{"name": "Brian E. Bunnell", "role": "Principal Investigator"}, {"name": "Triton Ong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:2R44GM140660-02", "company": "Bioaesthetics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 874179, "summary": "NIH award 2R44GM140660-02: PHMB-Impregnated Acellular Biologic Grafts for Treatment of Third-Degree Burns ($874,179)", "source_url": "https://reporter.nih.gov/project-details/10761354", "people": [{"name": "Nicholas Pashos", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44HL154960-02", "company": "Bridgesource Medical Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": 1013092, "summary": "NIH award 2R44HL154960-02: Novel Device to Optimize Aerosol Drug Delivery for Pulmonary Hypertension Treatment ($1,013,092)", "source_url": "https://reporter.nih.gov/project-details/10698474", "people": [{"name": "John E Porterfield", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "fda:K231517", "company": "Ortho Clinical Diagnostics", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231517: VITROS Immunodiagnostic Products CEA Reagent Pack", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231517", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231517%22"}, {"id": "fda:K230812", "company": "Withings", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230812: Withings Scan Monitor 2.0", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230812", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230812%22"}, {"id": "fda:K222946", "company": "Oneday Biotech Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K222946: Oneday Mini Implant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222946", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K222946%22"}, {"id": "fda:K230610", "company": "Dongguan Shin YI Healthcare Products Factory", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230610: Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230610", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230610%22"}, {"id": "fda:K232243", "company": "Ttbio Corp.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232243: EVO 700 series high speed handpiece", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232243", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232243%22"}, {"id": "fda:K223590", "company": "Beckman Coulter, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223590: Access Folate Assay", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223590", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223590%22"}, {"id": "fda:K230079", "company": "Ansell Healthcare Products, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-23", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230079: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230079", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230079%22"}, {"id": "nih:5R44AG052196-06", "company": "Spr Therapeutics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": 902624, "summary": "NIH award 5R44AG052196-06: Electrical stimulation to reduce pain and improve function after knee replacement ($902,624)", "source_url": "https://reporter.nih.gov/project-details/10692752", "people": [{"name": "Joseph Wilder Boggs", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R44HD102235-03", "company": "Theranova, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": 608576, "summary": "NIH award 5R44HD102235-03: A Photo-based Menstrual Blood Loss Metric ($608,576)", "source_url": "https://reporter.nih.gov/project-details/10693342", "people": [{"name": "Daniel Rogers Burnett", "role": "Principal Investigator"}, {"name": "Vanessa Jacoby", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HD105575-02", "company": "Claria Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": 141917, "summary": "NIH award 5R44HD105575-02: A Safe, Fast, and Cost-Effective System for Tissue Removal in Laparoscopic Hysterectomy and Other Minimally Invasive Surgery ($141,917)", "source_url": "https://reporter.nih.gov/project-details/10693810", "people": [{"name": "Daniel Francis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44EB030973-03", "company": "Bridgesource Medical Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": 958929, "summary": "NIH award 5R44EB030973-03: Post Cardiac Surgery Hemodynamics Diagnostic Device ($958,929)", "source_url": "https://reporter.nih.gov/project-details/10707900", "people": [{"name": "Anil Kottam", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43OH012533-01A1", "company": "Speech Technology/applied Research Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": 295671, "summary": "NIH award 1R43OH012533-01A1: Scrubbing Complex Sound Sources for Factory Situational Awareness ($295,671)", "source_url": "https://reporter.nih.gov/project-details/10761362", "people": [{"name": "Karen L Payton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "fda:K220938", "company": "Aura Wellness, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K220938: Nova HD+", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220938", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K220938%22"}, {"id": "fda:K231510", "company": "Xiantao Zhibo Non-Woven Products Co., Ltd.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231510: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231510", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231510%22"}, {"id": "fda:K223574", "company": "Philips Medizin Systeme Boeblingen GmbH", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K223574: IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223574", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K223574%22"}, {"id": "fda:K231811", "company": "Zavation Medical Products, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231811: Zavation Connector System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231811", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231811%22"}, {"id": "fda:DEN220052", "company": "Brachyfoam, Inc. D/B/A Advaray", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) DEN220052: BrachyGel Vaginal Hydrogel Packing System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN220052"}, {"id": "fda:K230899", "company": "Qure.Ai Technologies", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K230899: qXR-PTX-PE", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230899", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K230899%22"}, {"id": "fda:K231205", "company": "Gurunanda, LLC", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231205: GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231205", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231205%22"}, {"id": "fda:K231503", "company": "DePuy Orthopaedics, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231503: CUPTIMIZE\u0099 Advanced", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231503", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231503%22"}, {"id": "fda:K232190", "company": "Medtronic Vascular", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K232190: 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232190", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K232190%22"}, {"id": "fda:K231496", "company": "Paragon 28, Inc.", "kind": "fda_clearance", "kind_label": "FDA 510(k) clearance", "date": "2023-08-22", "observed": "2026-08-21", "amount_usd": null, "summary": "FDA 510(k) K231496: TITAN 3-D Wedge System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231496", "source_url_api": "https://api.fda.gov/device/510k.json?search=k_number:%22K231496%22"}, {"id": "denovo:DEN220052", "company": "Brachyfoam, Inc. D/B/A Advaray", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-08-22", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220052 granted: BrachyGel Vaginal Hydrogel Packing Syste", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220052"}, {"id": "nih:1R44AI179440-01", "company": "Orlance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-21", "observed": "2026-08-21", "amount_usd": 996500, "summary": "NIH award 1R44AI179440-01: Clinic-Ready MACH-1 Gene Gun for delivery of a universal influenza DNA vaccine ($996,500)", "source_url": "https://reporter.nih.gov/project-details/10761364", "people": [{"name": "Kenneth C Bagley", "role": "Principal Investigator"}, {"name": "Deborah H. Fuller", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK125243-02", "company": "Adva-tec, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-21", "observed": "2026-08-21", "amount_usd": 879019, "summary": "NIH award 5R44DK125243-02: Clinical evaluation of a compliant, degradable ureteral stent to reduce patient pain and improve tolerability ($879,019)", "source_url": "https://reporter.nih.gov/project-details/10241270", "people": [{"name": "Jennifer Cartledge", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44HL169065-01", "company": "Bloomer Health Tech Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-21", "observed": "2026-08-21", "amount_usd": 998904, "summary": "NIH award 1R44HL169065-01: Bloomer Augmented Garment Platform-Barrier Removal for women in cArdiac rehab (BRA) ($998,904)", "source_url": "https://reporter.nih.gov/project-details/10695666", "people": [{"name": "Alicia Chong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG074840-02", "company": "Myolex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-21", "observed": "2026-08-21", "amount_usd": 813035, "summary": "NIH award 5R44AG074840-02: Accurate and rapid assessment of sarcopenia in older adults through electrical impedance myography ($813,035)", "source_url": "https://reporter.nih.gov/project-details/10668482", "people": [{"name": "William David Arnold", "role": "Principal Investigator"}, {"name": "Brian C Clark", "role": "Principal Investigator"}, {"name": "David P. Dickinson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH111450-05", "company": "Psyc Tech, Ltd", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-21", "observed": "2026-08-21", "amount_usd": 883393, "summary": "NIH award 5R44MH111450-05: Finalizing and Testing an Online Therapist Training and Assistance Program to Facilitate Implementation of Comprehensive Behavioral Intervention for Tic Disorders (CBIT-Trainer) ($883,393)", "source_url": "https://reporter.nih.gov/project-details/10679070", "people": [{"name": "Michael B Himle", "role": "Principal Investigator"}, {"name": "Suzanne Mouton-Odum", "role": "Principal Investigator"}, {"name": "Douglas W Woods", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R42MD014947-03", "company": "Klein Buendel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-21", "observed": "2026-08-21", "amount_usd": 692438, "summary": "NIH award 5R42MD014947-03: Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers) ($692,438)", "source_url": "https://reporter.nih.gov/project-details/10691385", "people": [{"name": "Robert Lee Newton", "role": "Principal Investigator"}, {"name": "Kayla Nuss", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R43HG012724-02", "company": "Goeppert, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-21", "observed": "2026-08-21", "amount_usd": 163281, "summary": "NIH award 5R43HG012724-02: METHYL-SENTRY: Proposed feasibility study of a nanopore diagnostic tool with rapid automated measurement of cell free DNA methylation state for clinical cancer evaluation ($163,281)", "source_url": "https://reporter.nih.gov/project-details/10708833", "people": [{"name": "David John Niedzwiecki", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:3R44MH119842-03S1", "company": "Cytocybernetics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-21", "observed": "2026-08-21", "amount_usd": 378610, "summary": "NIH award 3R44MH119842-03S1: Advanced Dynamic Clamp for Neuroscience ($378,610)", "source_url": "https://reporter.nih.gov/project-details/10868186", "people": [{"name": "Mark W Nowak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MD016829-02", "company": "Benten Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-19", "observed": "2026-08-21", "amount_usd": 906240, "summary": "NIH award 5R44MD016829-02: Knowledge and Usage of Lactation using Education and Advice from Support Network (KULEA-NET) ($906,240)", "source_url": "https://reporter.nih.gov/project-details/10710040", "people": [{"name": "W. DOUGLAS EVANS", "role": "Principal Investigator"}, {"name": "Tony Xuyen Ma", "role": "Principal Investigator"}, {"name": "Loral Patchen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43GM151899-01", "company": "Gmj Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-18", "observed": "2026-08-21", "amount_usd": 358862, "summary": "NIH award 1R43GM151899-01: Sodium Dodecyl Sulfate Removal Interface to Enable Characterization of Fragment Impurities in Monoclonal Antibodies by Capillary Electrophoresis Sodium Dodecyl Sulfate Coupled to Mass Spectrometry ($358,862)", "source_url": "https://reporter.nih.gov/project-details/10759354", "people": [{"name": "Oluwatosin Dada", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DD001311-01", "company": "Oregon Res Behavioral Intervention Strat", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-18", "observed": "2026-08-21", "amount_usd": 295738, "summary": "NIH award 1R43DD001311-01: Optimizing Health and Well-Being of Diverse Mothers with IDD and Their Infants During the Perinatal Period: A Virtual Advocate Tool for Data-Driven Supports ($295,738)", "source_url": "https://reporter.nih.gov/project-details/10760051", "people": [{"name": "Kathleen M Baggett", "role": "Principal Investigator"}, {"name": "EDWARD GUSTAV FEIL", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM151926-01", "company": "Double Helix Optics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-18", "observed": "2026-08-21", "amount_usd": 387211, "summary": "NIH award 1R43GM151926-01: High-resolution extended-depth phase-engineered objectives to accelerate spatial 'omics R&D through computational optics ($387,211)", "source_url": "https://reporter.nih.gov/project-details/10761173", "people": [{"name": "Scott Gaumer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI177170-01", "company": "Analytical Diagnostic Solutions, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-18", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43AI177170-01: ADA2 Diagnostic Platform: Point-of-care test for determination of patient enzyme levels for diagnosis of the rare disease Deaminase2 Deficiency (DADA2) ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10698520", "people": [{"name": "Robert Harper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI179304-01", "company": "Jan Biotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-18", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43AI179304-01: Pediatric Latent HIV Reservoir Characterization and Quantification Assay ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10761022", "people": [{"name": "Janet L Huie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG045011-05", "company": "Function Promoting Therapies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-18", "observed": "2026-08-21", "amount_usd": 948808, "summary": "NIH award 5R44AG045011-05: Phase IIB: Development of TruT Algorithm for Commercialization in Androgen Disorders ($948,808)", "source_url": "https://reporter.nih.gov/project-details/10707198", "people": [{"name": "Ravi Jasuja", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44MH119870-04", "company": "Pinnacle Technology, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-18", "observed": "2026-08-21", "amount_usd": 907224, "summary": "NIH award 5R44MH119870-04: Commercialization of Enzyme Modified Carbon-Fiber Electrodes Paired with Voltammetry for Simultaneous Real-Time Monitoring of Electroactive and Non-Electroactive Species at Discrete Brain Locations ($907,224)", "source_url": "https://reporter.nih.gov/project-details/10704151", "people": [{"name": "DAVID A JOHNSON", "role": "Principal Investigator"}, {"name": "LESLIE A SOMBERS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "denovo:DEN230019", "company": "Boston Scientific Corporation", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-08-18", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230019 granted: AXIOS Stent and Electrocautery-Enhanced", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230019"}, {"id": "nih:1R44AI179310-01", "company": "Scanogen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-17", "observed": "2026-08-21", "amount_usd": 999966, "summary": "NIH award 1R44AI179310-01: Highly Multiplexed Single Molecule Tethering ($999,966)", "source_url": "https://reporter.nih.gov/project-details/10760792", "people": [{"name": "Alfredo Andres Celedon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH135814-01", "company": "Spike Neuro LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-17", "observed": "2026-08-21", "amount_usd": 567282, "summary": "NIH award 1R43MH135814-01: Addressing the wireless power problem: A low-power hybrid radio for neuroscience experiments ($567,282)", "source_url": "https://reporter.nih.gov/project-details/10697023", "people": [{"name": "Rebecca Jeanne Gerth", "role": "Principal Investigator"}, {"name": "James Morizio", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AI174405-01A1", "company": "Henley Ion, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-17", "observed": "2026-08-21", "amount_usd": 940026, "summary": "NIH award 1R44AI174405-01A1: A micronized electrostatic precipitator for next-generation respiratory protection against pathogenic aerosols ($940,026)", "source_url": "https://reporter.nih.gov/project-details/10695348", "people": [{"name": "Julian HENLEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R43NS132529-02", "company": "Neurocomp Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-17", "observed": "2026-08-21", "amount_usd": 253697, "summary": "NIH award 5R43NS132529-02: Cerebral Palsy Risk Identification System ($253,697)", "source_url": "https://reporter.nih.gov/project-details/10709554", "people": [{"name": "JAMES P O'HALLORAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI150263-04", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-16", "observed": "2026-08-21", "amount_usd": 983642, "summary": "NIH award 5R44AI150263-04: A modular platform for infectious disease surveillance at point-of-need. ($983,642)", "source_url": "https://reporter.nih.gov/project-details/10697143", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44DK131770-03", "company": "Epicypher, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-16", "observed": "2026-08-21", "amount_usd": 1002068, "summary": "NIH award 5R44DK131770-03: Development of a high-throughput epigenomic mapping platform to molecularly phenotype Crohn's disease ($1,002,068)", "source_url": "https://reporter.nih.gov/project-details/10683287", "people": [{"name": "Andrea Lynn Johnstone", "role": "Principal Investigator"}, {"name": "SHEHZAD Z. SHEIKH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "denovo:DEN220073", "company": "Bluewind Medical , Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-08-16", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220073 granted: Revi System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220073"}, {"id": "nih:1R43MD018954-01", "company": "Isimcha, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-15", "observed": "2026-08-21", "amount_usd": 416944, "summary": "NIH award 1R43MD018954-01: ISimcha Technology Platform for Recruiting a Diverse Population of Older Adults into Clinical Trials ($416,944)", "source_url": "https://reporter.nih.gov/project-details/10761602", "people": [{"name": "Jamerson Brenda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL169137-01A1", "company": "Urban Design 4 Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-15", "observed": "2026-08-21", "amount_usd": 275660, "summary": "NIH award 1R43HL169137-01A1: PED-PHAM: An Automated and Scalable Spatial Tool That Predicts and Monetizes Health Impacts of the Built, Natural, and Social Environment ($275,660)", "source_url": "https://reporter.nih.gov/project-details/10761396", "people": [{"name": "James Chapman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM150378-01", "company": "Rewire Neuroscience, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-15", "observed": "2026-08-21", "amount_usd": 275756, "summary": "NIH award 1R43GM150378-01: Customizable Artificial Intelligence for the Biomedical Masses: Development of a User-Friendly Automated Machine Learning Platform for Biology Image Analysis. ($275,756)", "source_url": "https://reporter.nih.gov/project-details/10699828", "people": [{"name": "John H Harkness", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL169077-01A1", "company": "Boundless Science, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-15", "observed": "2026-08-21", "amount_usd": 298871, "summary": "NIH award 1R43HL169077-01A1: Extra-Corporeal Oxygenator with Minimal Blood Surface Contact ($298,871)", "source_url": "https://reporter.nih.gov/project-details/10760184", "people": [{"name": "Andrew Jones", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HD097017-02A1", "company": "Couplet Care, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-15", "observed": "2026-08-21", "amount_usd": 1341487, "summary": "NIH award 2R44HD097017-02A1: Development of the Couplet Care Bassinet to support safe implementation of skin-to-skin contact and rooming-in on postnatal units ($1,341,487)", "source_url": "https://reporter.nih.gov/project-details/10761313", "people": [{"name": "Stacie McEntyre", "role": "Principal Investigator"}, {"name": "Cecilia Tomori", "role": "Principal Investigator"}, {"name": "Kristin Patricia Tully", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "breakthrough:K231094", "company": "Annalise-ai Pty, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-08-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K231094: ANNALISE ENTERPRISE CTB TRIAGE-OH", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R44HD112264-01A1", "company": "Inherent Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-14", "observed": "2026-08-21", "amount_usd": 269682, "summary": "NIH award 1R44HD112264-01A1: Novel Epigenetic Test for the Treatment and Improvement of Longitudinal Health-Outcomes for Men with Severe Infertility ($269,682)", "source_url": "https://reporter.nih.gov/project-details/10760354", "people": [{"name": "Kristin R Brogaard", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG084351-01", "company": "Revel Pharmaceuticals Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-14", "observed": "2026-08-21", "amount_usd": 277623, "summary": "NIH award 1R43AG084351-01: Development of enzymatic tools for rapid measurement of Advanced Glycation End Product-protein adducts ($277,623)", "source_url": "https://reporter.nih.gov/project-details/10757215", "people": [{"name": "Aaron Cravens", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG079718-02", "company": "Augnition Labs LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-14", "observed": "2026-08-21", "amount_usd": 960670, "summary": "NIH award 5R44AG079718-02: Augmem: A Novel Digital Cognitive Assessment for the Early Detection of Alzheimer's Disease ($960,670)", "source_url": "https://reporter.nih.gov/project-details/10688227", "people": [{"name": "Adele Gilpin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44HL147667-02A1", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-14", "observed": "2026-08-21", "amount_usd": 939577, "summary": "NIH award 2R44HL147667-02A1: Respiratory Oxygen Adherence Monitor for COPD Patients ($939,577)", "source_url": "https://reporter.nih.gov/project-details/10698796", "people": [{"name": "Eileen T. Krepkovich", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42GM136084-03", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-14", "observed": "2026-08-21", "amount_usd": 987019, "summary": "NIH award 5R42GM136084-03: Enhanced MDx: a computational model to optimize pre-analytical pathogen isolation from whole blood ($987,019)", "source_url": "https://reporter.nih.gov/project-details/10650836", "people": [{"name": "Cass T Miller", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41AG084421-01", "company": "Neucyte, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-14", "observed": "2026-08-21", "amount_usd": 500000, "summary": "NIH award 1R41AG084421-01: Miniaturized AD/ADRD Microphysiological Systems Platform for High-throughput Screening ($500,000)", "source_url": "https://reporter.nih.gov/project-details/10761587", "people": [{"name": "Wayne W Poon", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42MH124566-03", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-11", "observed": "2026-08-21", "amount_usd": 995608, "summary": "NIH award 5R42MH124566-03: NeuroExM ($995,608)", "source_url": "https://reporter.nih.gov/project-details/10686269", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL170868-01", "company": "Vena Vitals, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-11", "observed": "2026-08-21", "amount_usd": 295924, "summary": "NIH award 1R43HL170868-01: Wearable alert system for detecting postoperative hypotension ($295,924)", "source_url": "https://reporter.nih.gov/project-details/10760370", "people": [{"name": "Joshua Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL166051-01A1", "company": "Coram Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-11", "observed": "2026-08-21", "amount_usd": 259290, "summary": "NIH award 1R43HL166051-01A1: Non Magnetic MRI Conditional External Defibrillator with Reduced Skeletal Muscle Contraction ($259,290)", "source_url": "https://reporter.nih.gov/project-details/10698845", "people": [{"name": "ALBERT Clark LARDO", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44HL167428-01S1", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-11", "observed": "2026-08-21", "amount_usd": 122700, "summary": "NIH award 3R44HL167428-01S1: Minimally Invasive High Intensity Therapeutic Ultrasound for the Treatment of Obstructive Hypertrophic Cardiomyopathy ($122,700)", "source_url": "https://reporter.nih.gov/project-details/10851470", "people": [{"name": "Howard Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI179438-01", "company": "Ige Immuno Diagnostic Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-11", "observed": "2026-08-21", "amount_usd": 294948, "summary": "NIH award 1R43AI179438-01: Universal Rapid test for HIV Diagnosis ($294,948)", "source_url": "https://reporter.nih.gov/project-details/10761415", "people": [{"name": "Maria-Jose Miguez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AA030953-01A1", "company": "Thrive Digital Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-11", "observed": "2026-08-21", "amount_usd": 275301, "summary": "NIH award 1R44AA030953-01A1: DEVELOPMENT OF A NOVEL PEER RECOVERY SUPPORTER TRAINING PLATFORM TO DISSEMINATE EVIDENCE-BASED TRAINING AT SCALE ($275,301)", "source_url": "https://reporter.nih.gov/project-details/10764597", "people": [{"name": "Christopher Neil Pesce", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD110316-01A1", "company": "Little Room Innovations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-10", "observed": "2026-08-21", "amount_usd": 275197, "summary": "NIH award 1R43HD110316-01A1: Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot ($275,197)", "source_url": "https://reporter.nih.gov/project-details/10758936", "people": [{"name": "Harrison Logan Bartlett", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD112265-01A1", "company": "Novocuff Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-10", "observed": "2026-08-21", "amount_usd": 295605, "summary": "NIH award 1R43HD112265-01A1: Development and testing of the Novocuff device to prevent infant morbidities and mortalities caused by preterm birth. ($295,605)", "source_url": "https://reporter.nih.gov/project-details/10761418", "people": [{"name": "Donald Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG072990-03", "company": "See Yourself Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-09", "observed": "2026-08-21", "amount_usd": 999391, "summary": "NIH award 5R44AG072990-03: The HOPE App: An Immersive Telehealth Solution for Older Adults with Diabetes ($999,391)", "source_url": "https://reporter.nih.gov/project-details/10703505", "people": [{"name": "Maxwell Lee Drascher", "role": "Principal Investigator"}, {"name": "Suzanne Mitchell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AR079300-02", "company": "Osteocentric Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-09", "observed": "2026-08-21", "amount_usd": 210522, "summary": "NIH award 5R44AR079300-02: Optimization of a Novel Thread Geometry for Various Orthopedic Surgery Applications ($210,522)", "source_url": "https://reporter.nih.gov/project-details/10491290", "people": [{"name": "Andrew Ray Fauth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL166048-02", "company": "Pericor, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-09", "observed": "2026-08-21", "amount_usd": 850378, "summary": "NIH award 5R44HL166048-02: PeriPath: A Single Incision Delivery Tool for Epicardial Pacing and Defibrillation: Phase 2 ($850,378)", "source_url": "https://reporter.nih.gov/project-details/10694084", "people": [{"name": "CHARLES I BERUL", "role": "Principal Investigator"}, {"name": "Justin Opfermann", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DK135139-02", "company": "Intrinsic Lifesciences, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-09", "observed": "2026-08-21", "amount_usd": 788664, "summary": "NIH award 5R44DK135139-02: Novel Point-of-Care Device for Urinary Hepcidin to Detect Iron Deficiency in Children and Adolescents ($788,664)", "source_url": "https://reporter.nih.gov/project-details/10709598", "people": [{"name": "Vaughn E Ostland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG060857-06", "company": "Blue Iris Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-08", "observed": "2026-08-21", "amount_usd": 1229712, "summary": "NIH award 5R44AG060857-06: A light exposure tracker designed to improve the circadian entrainment for Alzheimer Disease patients ($1,229,712)", "source_url": "https://reporter.nih.gov/project-details/10707191", "people": [{"name": "Erik Page", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "breakthrough:K230551", "company": "Boston Scientific Corporation", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-08-08", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K230551: VISUAL-ICE CRYOABLATION SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43MD018551-01", "company": "Adhera Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-07", "observed": "2026-08-21", "amount_usd": 286246, "summary": "NIH award 1R43MD018551-01: Adaptation of a Digital Health Intervention for Chronic Condition Related fatigue to the Latino population ($286,246)", "source_url": "https://reporter.nih.gov/project-details/10697435", "people": [{"name": "Luis Fernandez Luque", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41GM150320-01", "company": "Advanced Gene Transfer Company, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-05", "observed": "2026-08-21", "amount_usd": 275045, "summary": "NIH award 1R41GM150320-01: Enhanced CRISPR gene editing in pluripotent stem cells using carbon nanotube arrays ($275,045)", "source_url": "https://reporter.nih.gov/project-details/10698269", "people": [{"name": "IAN M DICKERSON", "role": "Principal Investigator"}, {"name": "Michael George Schrlau", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42AG058336-03", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-04", "observed": "2026-08-21", "amount_usd": 721081, "summary": "NIH award 5R42AG058336-03: Care Assistant for Family Caregivers of Persons with Dementia During Out of the Home Activities ($721,081)", "source_url": "https://reporter.nih.gov/project-details/10709467", "people": [{"name": "Shane M. Anderson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41GM151910-01", "company": "Blotting Innovations, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-04", "observed": "2026-08-21", "amount_usd": 297664, "summary": "NIH award 1R41GM151910-01: Gelbrane: Combined Gel and Membrane for Robust Western Blotting ($297,664)", "source_url": "https://reporter.nih.gov/project-details/10759072", "people": [{"name": "Marc R. Birtwistle", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH131442-01A1", "company": "Spreading Activation Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-04", "observed": "2026-08-21", "amount_usd": 458782, "summary": "NIH award 1R43MH131442-01A1: Suicide, depression, and anxiety screening using an automated virtual assistant ($458,782)", "source_url": "https://reporter.nih.gov/project-details/10695410", "people": [{"name": "Joshua Cohen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44AG076093-02", "company": "Proactive Memory Services, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-04", "observed": "2026-08-21", "amount_usd": 1279718, "summary": "NIH award 4R44AG076093-02: CUSTOMIZABLE TRAINING SOFTWARE FOR PROFESSIONAL ALZHEIMER DIRECT CARE PROVIDERS ($1,279,718)", "source_url": "https://reporter.nih.gov/project-details/10894960", "people": [{"name": "NORMAN LOUIS FOSTER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44MH135525-01A1", "company": "Radiation Monitoring Devices, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-04", "observed": "2026-08-21", "amount_usd": 275188, "summary": "NIH award 1R44MH135525-01A1: Ultra-dense ceramic scintillator for BrainPET scanner ($275,188)", "source_url": "https://reporter.nih.gov/project-details/10761208", "people": [{"name": "JAROSLAW GLODO", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43GM148082-01S1", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-04", "observed": "2026-08-21", "amount_usd": 35810, "summary": "NIH award 3R43GM148082-01S1: Smart sensor for guiding safe delivery of anesthetic and pain drugs through epidurals ($35,810)", "source_url": "https://reporter.nih.gov/project-details/10883933", "people": [{"name": "NICUSOR IFTIMIA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44NR019963-03", "company": "Cove Technology Consulting LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-04", "observed": "2026-08-21", "amount_usd": 868295, "summary": "NIH award 4R44NR019963-03: A closed-loop gravity infusion control device ($868,295)", "source_url": "https://reporter.nih.gov/project-details/10886215", "people": [{"name": "Chie Kawahara", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AI172551-02", "company": "Aldatu Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-04", "observed": "2026-08-21", "amount_usd": 931246, "summary": "NIH award 5R44AI172551-02: PANDAA for universal, pan-lineage molecular detection of filoviruses to enable rapid epidemic response. ($931,246)", "source_url": "https://reporter.nih.gov/project-details/10672434", "people": [{"name": "Iain James MacLeod", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK136654-01", "company": "Procyon Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-03", "observed": "2026-08-21", "amount_usd": 299968, "summary": "NIH award 1R43DK136654-01: Accelerated absorption of insulin via a subcutaneously implanted, vascularized micro-chamber ($299,968)", "source_url": "https://reporter.nih.gov/project-details/10721366", "people": [{"name": "Robert C Johnson", "role": "Principal Investigator"}, {"name": "KLEARCHOS K PAPAS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL154932-03", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-03", "observed": "2026-08-21", "amount_usd": 940209, "summary": "NIH award 5R44HL154932-03: Portable Noninvasive Positive Airway Device for COPD Patient Therapy ($940,209)", "source_url": "https://reporter.nih.gov/project-details/10675430", "people": [{"name": "Robert J Knuesel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "denovo:DEN230003", "company": "Viz. Ai, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-08-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230003 granted: Viz HCM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230003"}, {"id": "nih:5R42HD107747-03", "company": "Ifit Prosthetics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-02", "observed": "2026-08-21", "amount_usd": 883271, "summary": "NIH award 5R42HD107747-03: Adjustable prosthetic sockets for children and adolescents with lower limb loss to accommodate growth ($883,271)", "source_url": "https://reporter.nih.gov/project-details/10689904", "people": [{"name": "TIMOTHY R DILLINGHAM", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AA029868-03", "company": "Evidence-based Practice Institute, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-02", "observed": "2026-08-21", "amount_usd": 767097, "summary": "NIH award 5R44AA029868-03: Treating Drivers of Suicide in Primary Care using Jaspr Health ($767,097)", "source_url": "https://reporter.nih.gov/project-details/10689325", "people": [{"name": "Linda A Dimeff", "role": "Principal Investigator"}, {"name": "David Alan Jobes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44MH132234-02", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-02", "observed": "2026-08-21", "amount_usd": 999844, "summary": "NIH award 4R44MH132234-02: System for Volumetric 2-photon Imaging of Neuroactivity Using Light Beads Microscopy ($999,844)", "source_url": "https://reporter.nih.gov/project-details/10755027", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NS127692-02", "company": "Spikegadgets, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-02", "observed": "2026-08-21", "amount_usd": 652837, "summary": "NIH award 5R44NS127692-02: Commercialization of integrated electrode-electronics system for large scale, long-lasting electrophysiology ($652,837)", "source_url": "https://reporter.nih.gov/project-details/10651898", "people": [{"name": "Loren M Frank", "role": "Principal Investigator"}, {"name": "Mattias Peter Karlsson", "role": "Principal Investigator"}, {"name": "Chong Xie", "role": "Principal Investigator"}, {"name": "Jan Zimmermann", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DA051289-03", "company": "Emitech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-02", "observed": "2026-08-21", "amount_usd": 761201, "summary": "NIH award 5R44DA051289-03: Wearable sensor for opioids detection based on electrochemical sensor arrayintegrated with Bluetooth device ($761,201)", "source_url": "https://reporter.nih.gov/project-details/10684853", "people": [{"name": "Igor A Levitsky", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL166003-02", "company": "Prolocor Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-02", "observed": "2026-08-21", "amount_usd": 687938, "summary": "NIH award 5R44HL166003-02: Validation of Platelet Expression of Fc\u0263RIIa as a Precision Tool ($687,938)", "source_url": "https://reporter.nih.gov/project-details/10682562", "people": [{"name": "Jeanne Ohrnberger", "role": "Principal Investigator"}, {"name": "David J Schneider", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA268466-03", "company": "Doseoptics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-01", "observed": "2026-08-21", "amount_usd": 999998, "summary": "NIH award 5R44CA268466-03: Ultra-fast imaging for the safe delivery of electron FLASH radiation therapy ($999,998)", "source_url": "https://reporter.nih.gov/project-details/10708158", "people": [{"name": "Petr Bruza", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL147745-03", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-01", "observed": "2026-08-21", "amount_usd": 982630, "summary": "NIH award 5R44HL147745-03: An Improved Robotic Electrophysiology Platform for Arrhythmia Ablation ($982,630)", "source_url": "https://reporter.nih.gov/project-details/10704224", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "Mitch N Faddis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH129278-03", "company": "Advanced MRI Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-01", "observed": "2026-08-21", "amount_usd": 1350964, "summary": "NIH award 5R44MH129278-03: Highly Efficient MRI Pulse Sequences for High Resolution Physiological and Functional Brain Imaging ($1,350,964)", "source_url": "https://reporter.nih.gov/project-details/10684334", "people": [{"name": "Alexander Beckett", "role": "Principal Investigator"}, {"name": "David Alan Feinberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43MH135817-01", "company": "Neurotargeting Systems", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-01", "observed": "2026-08-21", "amount_usd": 383553, "summary": "NIH award 1R43MH135817-01: A novel system and procedure for non-surgical placement of EEG electrodes in mice ($383,553)", "source_url": "https://reporter.nih.gov/project-details/10694319", "people": [{"name": "Ludmila Gerashchenko", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AI152654-03", "company": "Miravista Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-01", "observed": "2026-08-21", "amount_usd": 999212, "summary": "NIH award 2R44AI152654-03: Development of Coccidioides Cytokine Release Assay ($999,212)", "source_url": "https://reporter.nih.gov/project-details/10760131", "people": [{"name": "Eric Holbrook", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HG013476-01", "company": "Jbs Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-01", "observed": "2026-08-21", "amount_usd": 406500, "summary": "NIH award 1R43HG013476-01: Development of a Urine Genetic Test for NonMuscle Invasive Bladder Cancer ($406,500)", "source_url": "https://reporter.nih.gov/project-details/10759106", "people": [{"name": "Selena Lin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42CA232867-03", "company": "Morgan And Mendel Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-08-01", "observed": "2026-08-21", "amount_usd": 1031474, "summary": "NIH award 5R42CA232867-03: Robust Predictor of Colon Cancer Risk ($1,031,474)", "source_url": "https://reporter.nih.gov/project-details/10684777", "people": [{"name": "Harry Ostrer", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "sbir:DOD:W911NF23P0032", "company": "Inhance Digital Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-08-01", "observed": "2026-09-18", "amount_usd": 197834, "summary": "DOD SBIR Phase I award $197,834: Mixed Reality For Female Soldier Tactical Combat Casualty Care (MRFS-TCCC)", "source_url": "https://www.sbir.gov/awards?search=A234-009-0991"}, {"id": "nih:5R44CA272029-02", "company": "Adeptrix Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-31", "observed": "2026-08-21", "amount_usd": 436856, "summary": "NIH award 5R44CA272029-02: HistoneScan\u2122: a multiplex immunoassay for histone epigenetic profiling ($436,856)", "source_url": "https://reporter.nih.gov/project-details/10654855", "people": [{"name": "Vladislav Bergo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AI177129-01", "company": "Scribe Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-31", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43AI177129-01: High throughput antibody discovery against cell membrane bound target proteins using innovative MOD technology for direct screening in single-cell assays ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10698891", "people": [{"name": "Russell H Cole", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA059474-01", "company": "Pirouette Pharma Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-31", "observed": "2026-08-21", "amount_usd": 326500, "summary": "NIH award 1R43DA059474-01: A Rugged, Reliable, Portable, Safe, and Simple Naloxone HCl Auto-Injector for Life-Saving Treatment of Opioid Overdose ($326,500)", "source_url": "https://reporter.nih.gov/project-details/10764158", "people": [{"name": "Conor R Cullinane", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH135947-01", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-31", "observed": "2026-08-21", "amount_usd": 275722, "summary": "NIH award 1R43MH135947-01: The SE-Learn Online Professional Development Platform for Enhanced Social Emotional Learning with Students ($275,722)", "source_url": "https://reporter.nih.gov/project-details/10601591", "people": [{"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44NR020341-02", "company": "Peacefully, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-31", "observed": "2026-08-21", "amount_usd": 1070852, "summary": "NIH award 4R44NR020341-02: A comprehensive web-based program to help advanced cancer patients plan for end of life ($1,070,852)", "source_url": "https://reporter.nih.gov/project-details/10889373", "people": [{"name": "Jennifer Good", "role": "Principal Investigator"}, {"name": "Megan Johnson Shen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44ES034312-02", "company": "Million Marker Wellness Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-31", "observed": "2026-08-21", "amount_usd": 1028322, "summary": "NIH award 2R44ES034312-02: A Personalized Digital Intervention Program to Reduce Exposure to Endocrine Disrupting Chemicals among a Child-Bearing Age Cohort ($1,028,322)", "source_url": "https://reporter.nih.gov/project-details/10699889", "people": [{"name": "Jenna Hua", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43ES035653-01", "company": "Bioprinting Laboratories, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-31", "observed": "2026-08-21", "amount_usd": 284638, "summary": "NIH award 1R43ES035653-01: Gene-edited liver organoids for predictive hepatotoxicity ($284,638)", "source_url": "https://reporter.nih.gov/project-details/10758179", "people": [{"name": "Pranav Joshi", "role": "Principal Investigator"}, {"name": "MOO-YEAL LEE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DA052941-03", "company": "Arborsense, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-31", "observed": "2026-08-21", "amount_usd": 869683, "summary": "NIH award 5R44DA052941-03: Rapid and non-invasive device for drug detection through sweat ($869,683)", "source_url": "https://reporter.nih.gov/project-details/10665052", "people": [{"name": "Girish Kulkarni", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44CA285039-01", "company": "Exvade Bioscience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-31", "observed": "2026-08-21", "amount_usd": 399217, "summary": "NIH award 1R44CA285039-01: Tumor Monorail Device for Serial Glioblastoma Biopsy ($399,217)", "source_url": "https://reporter.nih.gov/project-details/10760627", "people": [{"name": "Sean Meehan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44EY034409-02", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-31", "observed": "2026-08-21", "amount_usd": 841839, "summary": "NIH award 5R44EY034409-02: Ultra-high speed AO-OCT clinical system to image ganglion cells and microglia ($841,839)", "source_url": "https://reporter.nih.gov/project-details/10705315", "people": [{"name": "Mircea Mujat", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "sbir:DOD:W911NF23P0036", "company": "Simx, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-07-31", "observed": "2026-09-18", "amount_usd": 199567, "summary": "DOD SBIR Phase I award $199,567: Bridging the Gap in Female Casualty Care: Modular Extended Reality Medical Simulation Training using Mixed Reality and High Fidelity Manikins", "source_url": "https://www.sbir.gov/awards?search=A234-009-0972"}, {"id": "sbir:DOD:W911NF23P0037", "company": "Vcom3d Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-07-31", "observed": "2026-09-18", "amount_usd": 199773, "summary": "DOD SBIR Phase I award $199,773: Mixed Reality Trainer for Female Combat Casualty Care (MRT-FC3)", "source_url": "https://www.sbir.gov/awards?search=A234-009-0977"}, {"id": "nih:3R44AG074128-03S1", "company": "Whiplash Technology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-28", "observed": "2026-08-21", "amount_usd": 99876, "summary": "NIH award 3R44AG074128-03S1: Design, Development, and Validation of an AI-enabled Legal Planning and Financial Management Training Solution for ADRD Caregivers ($99,876)", "source_url": "https://reporter.nih.gov/project-details/10770055", "people": [{"name": "Christian Elliott", "role": "Principal Investigator"}, {"name": "Nicole E Werner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AI176913-01", "company": "Rational Vaccines, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-28", "observed": "2026-08-21", "amount_usd": 291480, "summary": "NIH award 1R43AI176913-01: Development of a Highly Specific and Sensitive HSV-1 and HSV-2 Diagnostic Test ($291,480)", "source_url": "https://reporter.nih.gov/project-details/10694271", "people": [{"name": "Edward Gershburg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL149598-03", "company": "Cellfe Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-28", "observed": "2026-08-21", "amount_usd": 843224, "summary": "NIH award 5R44HL149598-03: Efficient and scalable microfluidic gene delivery to hematopoietic stem cells to treat blood diseases ($843,224)", "source_url": "https://reporter.nih.gov/project-details/10656158", "people": [{"name": "Sewoon Han", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44DK136396-01A1", "company": "X-therma Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-28", "observed": "2026-08-21", "amount_usd": 971228, "summary": "NIH award 1R44DK136396-01A1: Greatly Extended Subzero Ischemic Storage of Renal Allografts Using Novel Bio-inspired Next Generation Cryoprotectants ($971,228)", "source_url": "https://reporter.nih.gov/project-details/10761617", "people": [{"name": "Gerald Brandacher", "role": "Principal Investigator"}, {"name": "Mark A Kline", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH132180-01", "company": "Habitaware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-28", "observed": "2026-08-21", "amount_usd": 420178, "summary": "NIH award 1R43MH132180-01: Technology Assisted Treatment for Binge Eating Behavior ($420,178)", "source_url": "https://reporter.nih.gov/project-details/10603975", "people": [{"name": "Sameer Kumar", "role": "Principal Investigator"}, {"name": "CAROL B. PETERSON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG074135-03", "company": "Moai Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-28", "observed": "2026-08-21", "amount_usd": 993312, "summary": "NIH award 5R44AG074135-03: Covering Care: Long-term care planning and education tool for AD/ADRD caregivers ($993,312)", "source_url": "https://reporter.nih.gov/project-details/10684333", "people": [{"name": "Olu Olofinboba", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44GM148128-02", "company": "Nanocellect Biomedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-27", "observed": "2026-08-21", "amount_usd": 872956, "summary": "NIH award 5R44GM148128-02: AI-Aided Tool for Day Zero Selection of High Performing Cells for Biopharma Cell Line Development ($872,956)", "source_url": "https://reporter.nih.gov/project-details/10672364", "people": [{"name": "Sung Hwan Cho", "role": "Principal Investigator"}, {"name": "Yu-Hwa Lo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG074128-03", "company": "Whiplash Technology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-27", "observed": "2026-08-21", "amount_usd": 845729, "summary": "NIH award 5R44AG074128-03: Design, Development, and Validation of an AI-enabled Legal Planning and Financial Management Training Solution for ADRD Caregivers ($845,729)", "source_url": "https://reporter.nih.gov/project-details/10703504", "people": [{"name": "Christian Elliott", "role": "Principal Investigator"}, {"name": "Nicole E Werner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AI179366-01", "company": "Allergy Amulet, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-27", "observed": "2026-08-21", "amount_usd": 157669, "summary": "NIH award 1R43AI179366-01: A rapid, low-cost, point-of-consumption detection device for gluten in food. ($157,669)", "source_url": "https://reporter.nih.gov/project-details/10761510", "people": [{"name": "Stephen Frayne", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG079760-02", "company": "Miro Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-27", "observed": "2026-08-21", "amount_usd": 980904, "summary": "NIH award 5R44AG079760-02: The Proactive Screening and diagnosis of mild cognitive impairment and depression in patients aged 65 and over: An Implementation Study ($980,904)", "source_url": "https://reporter.nih.gov/project-details/10706563", "people": [{"name": "Shenly Glenn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AI170123-01A1", "company": "Lynntech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-27", "observed": "2026-08-21", "amount_usd": 290196, "summary": "NIH award 1R43AI170123-01A1: An Isothermal Method to Amplify RNA from Bloodborne Viruses ($290,196)", "source_url": "https://reporter.nih.gov/project-details/10760602", "people": [{"name": "Karl V Gorzelnik", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44HD088332-04S1", "company": "Media Rez, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-27", "observed": "2026-08-21", "amount_usd": 100000, "summary": "NIH award 3R44HD088332-04S1: Supplement for an intervention to increase HIV Testing Uptake among Adolescents and Young Adults ($100,000)", "source_url": "https://reporter.nih.gov/project-details/10881477", "people": [{"name": "Amanda Derryck Castel", "role": "Principal Investigator"}, {"name": "Daniel J Greenberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43MH134669-01", "company": "Pinnacle Technology, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-27", "observed": "2026-08-21", "amount_usd": 289837, "summary": "NIH award 1R43MH134669-01: Functionalized Multi-Modal Tetrode Arrays for Real-Time, Site-Specific Neurochemical Monitoring ($289,837)", "source_url": "https://reporter.nih.gov/project-details/10759908", "people": [{"name": "DAVID A JOHNSON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG080843-02", "company": "Silverbills Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-27", "observed": "2026-08-21", "amount_usd": 1080149, "summary": "NIH award 5R44AG080843-02: SilverBills: A Legal, Technical and Financial Tool for Aging LGBTQ+ Individuals with Impaired Cognition. ($1,080,149)", "source_url": "https://reporter.nih.gov/project-details/10710196", "people": [{"name": "Eric Chess", "role": "Principal Investigator"}, {"name": "Marci Lobel-Esrig", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA257522-03", "company": "Multifunctional Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-26", "observed": "2026-08-21", "amount_usd": 692035, "summary": "NIH award 5R44CA257522-03: Dual-Tracer PET Tumor Imaging ($692,035)", "source_url": "https://reporter.nih.gov/project-details/10690000", "people": [{"name": "Dan J Kadrmas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AI165129-02", "company": "Ambergen, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-26", "observed": "2026-08-21", "amount_usd": 978625, "summary": "NIH award 5R44AI165129-02: New Technology for High-Resolution Antibody Profiling for SARS-CoV-2 ($978,625)", "source_url": "https://reporter.nih.gov/project-details/10686794", "people": [{"name": "Mark Lim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44DK135256-01A1", "company": "Cerulean Scientific Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-26", "observed": "2026-08-21", "amount_usd": 801880, "summary": "NIH award 1R44DK135256-01A1: Slippery Omniphobic Coating for Hemodialysis Catheter to Resist Fibrin Sheathing and Infection and Improve Patient Outcomes ($801,880)", "source_url": "https://reporter.nih.gov/project-details/10759575", "people": [{"name": "Todd McFarland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL164199-02", "company": "Cpr Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-26", "observed": "2026-08-21", "amount_usd": 1084010, "summary": "NIH award 5R44HL164199-02: A Multimodal Integrated System For Improved Cardiopulmonary Resuscitation ($1,084,010)", "source_url": "https://reporter.nih.gov/project-details/10705185", "people": [{"name": "HENRY R HALPERIN", "role": "Principal Investigator"}, {"name": "Norman A Paradis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AI172708-01A1", "company": "Burst Diagnostics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-25", "observed": "2026-08-21", "amount_usd": 279557, "summary": "NIH award 1R43AI172708-01A1: Strep-CaDI: A fast, accurate, and sensitive point-of-care test for Group A Streptococcus ($279,557)", "source_url": "https://reporter.nih.gov/project-details/10699852", "people": [{"name": "Zachary David Call", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM130201-04", "company": "Doty Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-25", "observed": "2026-08-21", "amount_usd": 641402, "summary": "NIH award 5R44GM130201-04: A Reliable Switched Angle Spinning (SAS) Probe with Gradients (PFG) for Proteins in Solid-State NMR ($641,402)", "source_url": "https://reporter.nih.gov/project-details/10667507", "people": [{"name": "Francis DAVID Doty", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43OD034167-01", "company": "Bay Genomics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-25", "observed": "2026-08-21", "amount_usd": 255006, "summary": "NIH award 1R43OD034167-01: A portable quantitative polymerase chain reaction platform (qPCR) for rapid detection of pathogens impacting model organisms in animal facilities ($255,006)", "source_url": "https://reporter.nih.gov/project-details/10604150", "people": [{"name": "Scott Franklin Geller", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG060861-03", "company": "Adm Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-25", "observed": "2026-08-21", "amount_usd": 913471, "summary": "NIH award 5R44AG060861-03: Multi-modal machine learning detection and tracking of traumatic brain injury neurodegeneration and its differentiation from Alzheimer's disease ($913,471)", "source_url": "https://reporter.nih.gov/project-details/10709652", "people": [{"name": "ANA S LUKIC", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HD102245-03", "company": "Mc3, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-25", "observed": "2026-08-21", "amount_usd": 771711, "summary": "NIH award 5R44HD102245-03: Pediatric ECMO Oxygenator with Integrated Monitoring ($771,711)", "source_url": "https://reporter.nih.gov/project-details/10462756", "people": [{"name": "Scott I Merz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43CA272030-01A1", "company": "Trace Biosciences Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-24", "observed": "2026-08-21", "amount_usd": 386211, "summary": "NIH award 1R43CA272030-01A1: Two-Color Near-Infrared Fluorescence Guided Surgery Tools Enabling Simultaneous Cancer Margin and Nerve Visualization during Head and Neck Squamous Cell Carcinoma Resection ($386,211)", "source_url": "https://reporter.nih.gov/project-details/10603689", "people": [{"name": "Connor William Barth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI179331-01", "company": "Cactus Bio, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-24", "observed": "2026-08-21", "amount_usd": 243118, "summary": "NIH award 1R43AI179331-01: A Point-of-Care Test for Rapid Diagnosis of Valley Fever ($243,118)", "source_url": "https://reporter.nih.gov/project-details/10759985", "people": [{"name": "Francisca Grill", "role": "Principal Investigator"}, {"name": "Thomas E Grys", "role": "Principal Investigator"}, {"name": "DOUGLAS F. LAKE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH132196-02", "company": "Ambergen, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-24", "observed": "2026-08-21", "amount_usd": 910446, "summary": "NIH award 5R44MH132196-02: A Highly Multiplexed, Multiomic 3D Mouse Brain Map Using MALDI-IHC ($910,446)", "source_url": "https://reporter.nih.gov/project-details/10705203", "people": [{"name": "Mark Lim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44DK137702-01", "company": "Sfc Fluidics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-24", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 1R44DK137702-01: Advanced Development of Gemini-DHAP ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10760050", "people": [{"name": "Forrest Payne", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM134849-03", "company": "Immuto Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-21", "observed": "2026-08-21", "amount_usd": 842961, "summary": "NIH award 5R44GM134849-03: Plasma-Generated Hydroxyl Radicals for Analysis of Three-Dimensional Structures in Protein Therapeutics ($842,961)", "source_url": "https://reporter.nih.gov/project-details/10673055", "people": [{"name": "Faraz Choudhury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH113520-05", "company": "Health Rhythms, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-21", "observed": "2026-08-21", "amount_usd": 990519, "summary": "NIH award 5R44MH113520-05: Automating and Obtaining FDA Approval for a Digital Intervention for Depression ($990,519)", "source_url": "https://reporter.nih.gov/project-details/10451555", "people": [{"name": "Ellen Frank", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "sbir:DOD:FA8649-23-P-1069", "company": "Signos Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-07-21", "observed": "2026-09-18", "amount_usd": 1247557, "summary": "DOD SBIR Phase II award $1,247,557: Physiological Enhanced Readiness and Fitness Optimization Monitor and Artificial Intelligence (PERFORM-AI)", "source_url": "https://www.sbir.gov/awards?search=F2D-8774"}, {"id": "nih:1R43CA278168-01A1", "company": "Neotherma Oncology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-20", "observed": "2026-08-21", "amount_usd": 399999, "summary": "NIH award 1R43CA278168-01A1: Integration of non-invasive deep tissue microwave thermometry in the VectRx hyperthermia device in a transgenic liver tumor pig model ($399,999)", "source_url": "https://reporter.nih.gov/project-details/10697183", "people": [{"name": "Pierre N Floriano", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA278579-02", "company": "Cryocrate, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-20", "observed": "2026-08-21", "amount_usd": 864173, "summary": "NIH award 5R44CA278579-02: Innovation of Biobanking for Cellular Adoptive Immunotherapies Based on a First-in-Class Biocompatible Cryopreservation Technology for T and NK Cells and Their CAR-Engineered Products ($864,173)", "source_url": "https://reporter.nih.gov/project-details/10705271", "people": [{"name": "Xu Han", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R42HD104325-02S1", "company": "Recupero Robotics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-20", "observed": "2026-08-21", "amount_usd": 18756, "summary": "NIH award 3R42HD104325-02S1: CT imaging-based prediction and stratification of motor and cognitive behavior after stroke for targeted game-based robot therapy: Diversity Supplement ($18,756)", "source_url": "https://reporter.nih.gov/project-details/10765218", "people": [{"name": "MICHELLE J. JOHNSON", "role": "Principal Investigator"}, {"name": "Alwyn P. Johnson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "sbir:DOD:HT9425-23-C-0057", "company": "Sharp Vision Software LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-07-20", "observed": "2026-09-18", "amount_usd": 1299603, "summary": "DOD SBIR Phase II award $1,299,603: Augmented Reality Training Tools with Realistic Animations and Voice Navigation on Tablet and AR Headset for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2S-0041"}, {"id": "nih:5R44MH121664-03", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-19", "observed": "2026-08-21", "amount_usd": 917382, "summary": "NIH award 5R44MH121664-03: Home-Based Parent-Child Intervention to Enhance Executive Function ($917,382)", "source_url": "https://reporter.nih.gov/project-details/10673947", "people": [{"name": "Shane M. Anderson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44MD015947-02", "company": "Oregon Res Behavioral Intervention Strat", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-19", "observed": "2026-08-21", "amount_usd": 1029677, "summary": "NIH award 2R44MD015947-02: SIBTime: Media-enhanced Technology for Promoting the Behavioral Health and Family Relationships of Typically Developing Young Siblings ($1,029,677)", "source_url": "https://reporter.nih.gov/project-details/10699837", "people": [{"name": "CAROL W METZLER", "role": "Principal Investigator"}, {"name": "Jessie Marquez", "role": "Principal Investigator"}, {"name": "PATRICIA F VADASY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44MH135529-01A1", "company": "Blackrock Microsystems", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-19", "observed": "2026-08-21", "amount_usd": 496413, "summary": "NIH award 1R44MH135529-01A1: High density chronic optogenetic interface for primate brains ($496,413)", "source_url": "https://reporter.nih.gov/project-details/10706899", "people": [{"name": "Alessandra Angelucci", "role": "Principal Investigator"}, {"name": "Steven M Blair", "role": "Principal Investigator"}, {"name": "Keith Mathieson", "role": "Principal Investigator"}, {"name": "Sandeep Negi", "role": "Principal Investigator"}, {"name": "Loren Rieth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG082621-01", "company": "Evon Medics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-19", "observed": "2026-08-21", "amount_usd": 448887, "summary": "NIH award 1R44AG082621-01: Development and Evaluation of Portable Compendium of Psychophysical and Physiological Tests for Alzheimer's Disease and Related Dementias (ADRD) ($448,887)", "source_url": "https://reporter.nih.gov/project-details/10699349", "people": [{"name": "Charles Chiedu Nwaokobia", "role": "Principal Investigator"}, {"name": "Evaristus A Nwulia", "role": "Principal Investigator"}, {"name": "Vamsi Reddy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220047", "company": "Galen Robotics", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-07-19", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220047 granted: Galen ES Cooperative Surgical Assistant", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220047"}, {"id": "sbir:DOD:FA8649-23-P-1118", "company": "Simx, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-07-19", "observed": "2026-09-18", "amount_usd": 1249948, "summary": "DOD SBIR Phase II award $1,249,948: CASEVAC Medical Simulation Training for Combat Casualty Care using Virtual Reality", "source_url": "https://www.sbir.gov/awards?search=FX224-OCSO1-0644"}, {"id": "nih:5R44MH118154-04", "company": "Fieldline, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-18", "observed": "2026-08-21", "amount_usd": 314559, "summary": "NIH award 5R44MH118154-04: A wearable high-density MEG system with uOPMs ($314,559)", "source_url": "https://reporter.nih.gov/project-details/10675755", "people": [{"name": "Orang Alem", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43AI179363-01", "company": "Partillion Bioscience Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-18", "observed": "2026-08-21", "amount_usd": 275489, "summary": "NIH award 1R43AI179363-01: Multiplexed analysis of secreted proteins from single-cells using high dynamic range nanovials ($275,489)", "source_url": "https://reporter.nih.gov/project-details/10761557", "people": [{"name": "Joseph de Rutte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA257178-03", "company": "Integrated Sensors, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-18", "observed": "2026-08-21", "amount_usd": 688527, "summary": "NIH award 5R44CA257178-03: Ultrafast and Precise External Beam Monitor for FLASH and Other Advanced Radiation Therapy Modalities ($688,527)", "source_url": "https://reporter.nih.gov/project-details/10667648", "people": [{"name": "Peter S Friedman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44EB031656-03", "company": "Radiation Monitoring Devices, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-18", "observed": "2026-08-21", "amount_usd": 629470, "summary": "NIH award 5R44EB031656-03: Tl-Halide Scintillators for TOF-PET ($629,470)", "source_url": "https://reporter.nih.gov/project-details/10674007", "people": [{"name": "JAROSLAW GLODO", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MD014923-04", "company": "Joyuus, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-18", "observed": "2026-08-21", "amount_usd": 865506, "summary": "NIH award 5R44MD014923-04: Joyuus: A Web-based Tool for Postpartum Care Self-care to Address the Complex Needs of Underserved Women ($865,506)", "source_url": "https://reporter.nih.gov/project-details/10707103", "people": [{"name": "Lisa Marceau", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44CA285136-01", "company": "Bd Holding, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-18", "observed": "2026-08-21", "amount_usd": 885606, "summary": "NIH award 1R44CA285136-01: An Improved Epigenetic Algorithm for Guiding Low Dose CT Lung Cancer Screening ($885,606)", "source_url": "https://reporter.nih.gov/project-details/10761599", "people": [{"name": "Kelsey Dawes", "role": "Principal Investigator"}, {"name": "Robert A Philibert", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK136390-01", "company": "Affinergy, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-17", "observed": "2026-08-21", "amount_usd": 613787, "summary": "NIH award 1R44DK136390-01: A novel peptide assay for hepcidin clinical monitoring ($613,787)", "source_url": "https://reporter.nih.gov/project-details/10698746", "people": [{"name": "Martyn Darby", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA254649-03", "company": "Alaunus Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-17", "observed": "2026-08-21", "amount_usd": 696026, "summary": "NIH award 5R44CA254649-03: Development of a multi-analyte diagnostic assay to improve the risk stratification of indeterminate thyroid nodules ($696,026)", "source_url": "https://reporter.nih.gov/project-details/10684875", "people": [{"name": "GISELLE M KNUDSEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL168988-01A1", "company": "Otis Dental, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-17", "observed": "2026-08-21", "amount_usd": 299753, "summary": "NIH award 1R43HL168988-01A1: Otis Brux-Sensor Night Guard - a novel wireless custom night guard system with pressure sensors to quantitatively measure bite compression forces and alleviate sleep bruxism ($299,753)", "source_url": "https://reporter.nih.gov/project-details/10684494", "people": [{"name": "Richard Beranek", "role": "Principal Investigator"}, {"name": "Andrew Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS132623-01", "company": "Opsin Biotherapeutics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-17", "observed": "2026-08-21", "amount_usd": 327864, "summary": "NIH award 1R43NS132623-01: Optogenetic Pain Modulator for non-opioid chronic pain management ($327,864)", "source_url": "https://reporter.nih.gov/project-details/10701510", "people": [{"name": "Darryl J Narcisse", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44ES035556-01", "company": "Nortis, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-17", "observed": "2026-08-21", "amount_usd": 275453, "summary": "NIH award 1R44ES035556-01: A liver-on-chip platform to evaluate panels of clinically relevant gene variants for screening of xenobiotic compounds ($275,453)", "source_url": "https://reporter.nih.gov/project-details/10738215", "people": [{"name": "Thomas Neumann", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL170947-01", "company": "Giner, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-15", "observed": "2026-08-21", "amount_usd": 282224, "summary": "NIH award 1R43HL170947-01: Population monitoring of stress markers in underserved communities ($282,224)", "source_url": "https://reporter.nih.gov/project-details/10766447", "people": [{"name": "Avni A Argun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HG011608-03", "company": "Armonica Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-14", "observed": "2026-08-21", "amount_usd": 908760, "summary": "NIH award 5R44HG011608-03: Single molecule DNA/RNA sequencing technology based on a parallel Raman scattering readout in a coupled nanochannel/nanopore system ($908,760)", "source_url": "https://reporter.nih.gov/project-details/10682588", "people": [{"name": "Steven Brueck", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HD111096-01", "company": "Smart Human Dynamics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-14", "observed": "2026-08-21", "amount_usd": 251622, "summary": "NIH award 1R43HD111096-01: Wearable Device and Digital Health Platform to Optimize Sleep During Pregnancy ($251,622)", "source_url": "https://reporter.nih.gov/project-details/10602171", "people": [{"name": "Steve R Dugan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH132130-03", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-14", "observed": "2026-08-21", "amount_usd": 950372, "summary": "NIH award 5R44MH132130-03: Point-of-care HIV viral load system using RPA and MXR ($950,372)", "source_url": "https://reporter.nih.gov/project-details/10665089", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44EY030829-03", "company": "Aeon Imaging, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-14", "observed": "2026-08-21", "amount_usd": 727239, "summary": "NIH award 5R44EY030829-03: Visual acuity and functional measurements in the aging eye ($727,239)", "source_url": "https://reporter.nih.gov/project-details/10617800", "people": [{"name": "ANN E ELSNER", "role": "Principal Investigator"}, {"name": "Thomas J. Gast", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AI174420-01A1", "company": "Pataigin, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-14", "observed": "2026-08-21", "amount_usd": 275712, "summary": "NIH award 1R43AI174420-01A1: Rapid Microbial ID Direct From Specimen ($275,712)", "source_url": "https://reporter.nih.gov/project-details/10699890", "people": [{"name": "ERIK J NILSSON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN230012", "company": "Ruthless, LLC Dba Ruthless Spine", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-07-14", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN230012 granted: Ruthless Spine RJB", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230012"}, {"id": "nih:5R43AI172561-02", "company": "Astradx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-13", "observed": "2026-08-21", "amount_usd": 293647, "summary": "NIH award 5R43AI172561-02: AstraDx: Sub-Hour AST Via Computational Image Processing ($293,647)", "source_url": "https://reporter.nih.gov/project-details/10670875", "people": [{"name": "Jonathan Florez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:3R44CA265446-02S1", "company": "Envisagenics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-12", "observed": "2026-08-21", "amount_usd": 77000, "summary": "NIH award 3R44CA265446-02S1: Comprehensive validation and commercial readiness of SpliceIO, a software platform for neoantigen discovery using RNA-seq data ($77,000)", "source_url": "https://reporter.nih.gov/project-details/10838973", "people": [{"name": "MARTIN AKERMAN", "role": "Principal Investigator"}, {"name": "GAYATRI ARUN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43NS132653-01", "company": "Scion Neurostim, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-12", "observed": "2026-08-21", "amount_usd": 666640, "summary": "NIH award 1R43NS132653-01: Simple, Home-use, neurostimulAtion tReatment for Parkinson's disease dEmeNtia (SHARPEN) ($666,640)", "source_url": "https://reporter.nih.gov/project-details/10697178", "people": [{"name": "Kristen Kathleen Foster", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HD113494-01", "company": "Biomotum, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-12", "observed": "2026-08-21", "amount_usd": 274282, "summary": "NIH award 1R41HD113494-01: An adjustable stiffness orthosis to maintain muscle engagement and push-off power in cerebral palsy. ($274,282)", "source_url": "https://reporter.nih.gov/project-details/10759670", "people": [{"name": "Zachary Forest Lerner", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "sbir:DOD:HT9425-23-P-0056", "company": "Advanced Respiratory Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-07-12", "observed": "2026-09-18", "amount_usd": 249658, "summary": "DOD SBIR Phase I award $249,658: The Coaxial Femoral Cannula (CFC) for Far Forward Extracoporeal Life Support Initiation, Prolonged Field Care, and Transport", "source_url": "https://www.sbir.gov/awards?search=H231-003-0072"}, {"id": "nih:4R44HG012288-02", "company": "Geneial LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-11", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 4R44HG012288-02: Privacy-Preserving Connectivity for Rare-Disease Patients ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10834324", "people": [{"name": "Adam Wesley Hansen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42MH128101-03", "company": "Lyssn.io, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-10", "observed": "2026-08-21", "amount_usd": 609951, "summary": "NIH award 5R42MH128101-03: Enhancing the quality of CBT in community mental health through AI-generated fidelity feedback ($609,951)", "source_url": "https://reporter.nih.gov/project-details/10674481", "people": [{"name": "David Charles Atkins", "role": "Principal Investigator"}, {"name": "Torrey A. Creed", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG074779-02", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-10", "observed": "2026-08-21", "amount_usd": 1207722, "summary": "NIH award 5R44AG074779-02: An Informatics Platform for Objectively Quantifying Electric Power Wheelchair Usage for those with Alzheimer's Disease, Alzheimer's Disease Related Dementias, and Cognitive Impairments ($1,207,722)", "source_url": "https://reporter.nih.gov/project-details/10457478", "people": [{"name": "Adam Becker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AI177239-01", "company": "Nightingale Labs Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-10", "observed": "2026-08-21", "amount_usd": 298102, "summary": "NIH award 1R43AI177239-01: Feasibility of early detection of infection and sepsis in the home ($298,102)", "source_url": "https://reporter.nih.gov/project-details/10706940", "people": [{"name": "Raymond C Chan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44MH126819-03S1", "company": "Evidence-based Practice Institute, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-10", "observed": "2026-08-21", "amount_usd": 189710, "summary": "NIH award 3R44MH126819-03S1: iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide Diversity Supplement ($189,710)", "source_url": "https://reporter.nih.gov/project-details/10815920", "people": [{"name": "Linda A Dimeff", "role": "Principal Investigator"}, {"name": "Cindy M. Schaeffer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "sbir:DOE:DE-SC0024006", "company": "Zymeron Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-07-10", "observed": "2026-09-18", "amount_usd": 200000, "summary": "DOE SBIR Phase I award $200,000: Advanced portable low temperature plasma device for chronic wound disinfection and healing", "source_url": "https://www.sbir.gov/awards?search=0000272533"}, {"id": "nih:4R44MH131514-02", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-08", "observed": "2026-08-21", "amount_usd": 1204215, "summary": "NIH award 4R44MH131514-02: Development of an Acoustic Implant Protection System to Improve Performance and Longevity of Neural Interfaces ($1,204,215)", "source_url": "https://reporter.nih.gov/project-details/10763996", "people": [{"name": "Maureen L. Mulvihill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44CA210770-04A1", "company": "Civatech Oncology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-08", "observed": "2026-08-21", "amount_usd": 1864846, "summary": "NIH award 2R44CA210770-04A1: Commercializing CivaSheet for Pancreatic Cancer Patients ($1,864,846)", "source_url": "https://reporter.nih.gov/project-details/10684454", "people": [{"name": "Kristy Perez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44OD023029-03", "company": "Photosound Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-07", "observed": "2026-08-21", "amount_usd": 926753, "summary": "NIH award 5R44OD023029-03: Integrated photoacoustic and fluorescence imaging system for anatomical, functional, and molecular characterization of murine models ($926,753)", "source_url": "https://reporter.nih.gov/project-details/10680593", "people": [{"name": "Hans-Peter Franz Brecht", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL147734-03", "company": "Retham Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-07", "observed": "2026-08-21", "amount_usd": 1220267, "summary": "NIH award 5R44HL147734-03: An in vitro diagnostic assay for the early and accurate detection of platelet-activating antibodies associated with Heparin-induced Thrombocytopenia ($1,220,267)", "source_url": "https://reporter.nih.gov/project-details/10653274", "people": [{"name": "Curtis Jones", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R42AI177108-01", "company": "Clairyon, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-07", "observed": "2026-08-21", "amount_usd": 257723, "summary": "NIH award 1R42AI177108-01: AIVIS: Next Generation Vigilant Information Seeking Artificial Intelligence-based Clinical Decision Support for Sepsis ($257,723)", "source_url": "https://reporter.nih.gov/project-details/10699457", "people": [{"name": "Christopher Josef", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R41AI162477-02", "company": "Microbiochip Diagnostics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-07", "observed": "2026-08-21", "amount_usd": 131387, "summary": "NIH award 5R41AI162477-02: Point-of-care microdevices for simultaneous detection of multiple pertussis-like respiratory diseases from Bordetella species ($131,387)", "source_url": "https://reporter.nih.gov/project-details/10685950", "people": [{"name": "Xiujun Li", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "denovo:DEN220058", "company": "Better Therapeutics", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-07-07", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220058 granted: BT-", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220058"}, {"id": "nih:1R41DC020869-01A1", "company": "Ripple, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-06", "observed": "2026-08-21", "amount_usd": 382366, "summary": "NIH award 1R41DC020869-01A1: Closed-loop laryngeal pacing for voice restoration ($382,366)", "source_url": "https://reporter.nih.gov/project-details/10761204", "people": [{"name": "James T. Heaton", "role": "Principal Investigator"}, {"name": "Scott Hiatt", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD018245-01", "company": "Saavsus, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-06", "observed": "2026-08-21", "amount_usd": 259552, "summary": "NIH award 1R43MD018245-01: Development, feasibility, and acceptability of Aim to Play, a user-friendly digital application for teacher skills training and physical education activities for K-2 elementary students ($259,552)", "source_url": "https://reporter.nih.gov/project-details/10598343", "people": [{"name": "Deborah Johnson-Shelton", "role": "Principal Investigator"}, {"name": "Jeanette Ricci", "role": "Principal Investigator"}, {"name": "Erika Westling", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43ES035657-01", "company": "Scitovation, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-06", "observed": "2026-08-21", "amount_usd": 269977, "summary": "NIH award 1R43ES035657-01: Triage of Developmental and Reproductive Toxicants using an In vitro to In Vivo Extrapolation (IVIVE)-Toxicokinetic Computational modeling Application ($269,977)", "source_url": "https://reporter.nih.gov/project-details/10757140", "people": [{"name": "Marjory Moreau", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI150060-04", "company": "Biopeptides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-05", "observed": "2026-08-21", "amount_usd": 971240, "summary": "NIH award 5R44AI150060-04: A peptide-based point-of-care vertical flow assay for the rapid diagnosis of Lyme disease ($971,240)", "source_url": "https://reporter.nih.gov/project-details/10653862", "people": [{"name": "Paul Michael Arnaboldi", "role": "Principal Investigator"}, {"name": "Dino Di Carlo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44GM152984-01A1", "company": "Massmatrix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-05", "observed": "2026-08-21", "amount_usd": 860633, "summary": "NIH award 1R44GM152984-01A1: Accelerating Gene Therapy and Editing with Advanced MS-Based Data Analysis for Nonstandard and Hybrid Nucleotide Sequences ($860,633)", "source_url": "https://reporter.nih.gov/project-details/10699241", "people": [{"name": "George Hall Johnson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA285182-01", "company": "Waved Medical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-05", "observed": "2026-08-21", "amount_usd": 405950, "summary": "NIH award 1R41CA285182-01: Image-based risk assessment to identify women at high-risk for breast cancer ($405,950)", "source_url": "https://reporter.nih.gov/project-details/10759110", "people": [{"name": "Andre Khalil", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI174576-01", "company": "Numentus Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-03", "observed": "2026-08-21", "amount_usd": 298794, "summary": "NIH award 1R43AI174576-01: Bacteria and pathogen characterizations using outer membrane vesicles ($298,794)", "source_url": "https://reporter.nih.gov/project-details/10602343", "people": [{"name": "GREGORY W FARIS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA285170-01", "company": "Pathware Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-03", "observed": "2026-08-21", "amount_usd": 399994, "summary": "NIH award 1R43CA285170-01: Leveraging Label-Free Digital Imaging to Enable Rapid On-Site Evaluation (ROSE) During Thyroid Biopsy Procedures ($399,994)", "source_url": "https://reporter.nih.gov/project-details/10756316", "people": [{"name": "Troy Holsing", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R41MH126795-02", "company": "Academic Web Pages, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-03", "observed": "2026-08-21", "amount_usd": 81697, "summary": "NIH award 5R41MH126795-02: MentorHub: A Supportive Accountability Tool for MHapps ($81,697)", "source_url": "https://reporter.nih.gov/project-details/10606497", "people": [{"name": "Nancy McNamara", "role": "Principal Investigator"}, {"name": "Jean Rhodes", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:6R44MH122052-04", "company": "Quiver Bioscience Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-07-01", "observed": "2026-08-21", "amount_usd": 793383, "summary": "NIH award 6R44MH122052-04: Functional drug fingerprinting with all-optical electrophysiology ($793,383)", "source_url": "https://reporter.nih.gov/project-details/10668476", "people": [{"name": "Benjamin Nathaniel Harwood", "role": "Principal Investigator"}, {"name": "Steven John Ryan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R42ES033912-03", "company": "Neurosetta LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-30", "observed": "2026-08-21", "amount_usd": 645624, "summary": "NIH award 5R42ES033912-03: Development and Evaluation of Rosette Array Technology for HumanNeurodevelopmental Toxicity Screening ($645,624)", "source_url": "https://reporter.nih.gov/project-details/10672992", "people": [{"name": "Randolph Scott Ashton", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL167475-01", "company": "Quantiport, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-30", "observed": "2026-08-21", "amount_usd": 231308, "summary": "NIH award 1R43HL167475-01: Development of a rapid, scalable, and deployable point-of-care blood volume diagnostic for monitoring postpartum and trauma-related hemorrhage ($231,308)", "source_url": "https://reporter.nih.gov/project-details/10603819", "people": [{"name": "LAWRENCE J BUSSE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44DA055407-02", "company": "Neuroptics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-30", "observed": "2026-08-21", "amount_usd": 1271838, "summary": "NIH award 4R44DA055407-02: Development and Commercialization of a pupillometer to predict postoperative opioid-induced respiratory depression in children ($1,271,838)", "source_url": "https://reporter.nih.gov/project-details/10838773", "people": [{"name": "Jeffrey Wade Oliver", "role": "Principal Investigator"}, {"name": "Claudio Privitera", "role": "Principal Investigator"}, {"name": "Senthilkumar Sadhasivam", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA281615-01", "company": "Kintara Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-29", "observed": "2026-08-21", "amount_usd": 1254180, "summary": "NIH award 1R44CA281615-01: An Open-Labeled, Single Arm Phase 2 Efficacy and Safety Study of REM-001 Photodynamic Therapy (PDT) for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) ($1,254,180)", "source_url": "https://reporter.nih.gov/project-details/10699535", "people": [{"name": "Dennis Brown", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DC017625-03", "company": "Aural Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-29", "observed": "2026-08-21", "amount_usd": 712471, "summary": "NIH award 5R44DC017625-03: Automated objective outcome measures for clinical use in dysarthria ($712,471)", "source_url": "https://reporter.nih.gov/project-details/10640837", "people": [{"name": "Sherman Charles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44CA285064-01", "company": "Magnetic Insight, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-29", "observed": "2026-08-21", "amount_usd": 1011684, "summary": "NIH award 1R44CA285064-01: Development of a prototype clinical theranostic platform combining Magnetic Particle Imaging (MPI) and Magnetic Fluid Hyperthermia (MFH) for the treatment of brain tumors ($1,011,684)", "source_url": "https://reporter.nih.gov/project-details/10761630", "people": [{"name": "Patrick Goodwill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R42AG071290-02", "company": "Synchrohealth LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-29", "observed": "2026-08-21", "amount_usd": 919218, "summary": "NIH award 2R42AG071290-02: BandPass: A Remote Monitoring System for Sarcopenia and Functional Decline ($919,218)", "source_url": "https://reporter.nih.gov/project-details/10697080", "people": [{"name": "Ryan Joseph Halter", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "denovo:DEN200052", "company": "Renalytix Ai, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-06-29", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200052 granted: KidneyIntelX.dkd", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200052"}, {"id": "breakthrough:DEN200052", "company": "Renalytix AI, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-06-29", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN200052: KIDNEYINTELX.DKD", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P150035/S003", "company": "Abbott Medical", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-06-29", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P150035/S003: AVEIR DR LEADLESS SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R41NS132732-01", "company": "Aneuvas Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-28", "observed": "2026-08-21", "amount_usd": 300527, "summary": "NIH award 1R41NS132732-01: Developing a new aspiration catheter solution for the treatment of large and medium vessel occlusions ($300,527)", "source_url": "https://reporter.nih.gov/project-details/10699636", "people": [{"name": "Timothy Andrew Becker", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HG012409-02", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-28", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44HG012409-02: Nanoscale Tools for Inosine Sequencing ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10651806", "people": [{"name": "Eric Ervin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42DK119048-03", "company": "Hemex Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-28", "observed": "2026-08-21", "amount_usd": 865222, "summary": "NIH award 5R42DK119048-03: Portable, affordable, quantitative microchip electrophoresis for hemoglobin A1C testing ($865,222)", "source_url": "https://reporter.nih.gov/project-details/10656550", "people": [{"name": "PETER GALEN", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DC020406-02", "company": "Nadi LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-28", "observed": "2026-08-21", "amount_usd": 840813, "summary": "NIH award 5R44DC020406-02: An Open-source Speech Processing Platform (OSP) for Research on Hearing Loss and Related Disorders ($840,813)", "source_url": "https://reporter.nih.gov/project-details/10629372", "people": [{"name": "Harinath Garudadri", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44AG058312-04", "company": "Osteodx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-27", "observed": "2026-08-21", "amount_usd": 1160485, "summary": "NIH award 2R44AG058312-04: Development of Cortical Bone Mechanics Technology for Enhancing the Diagnosis of Osteoporosis ($1,160,485)", "source_url": "https://reporter.nih.gov/project-details/10697217", "people": [{"name": "Brian C Clark", "role": "Principal Investigator"}, {"name": "Andrew Dick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44DK127659-03", "company": "Mimetas US, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-27", "observed": "2026-08-21", "amount_usd": 993146, "summary": "NIH award 5R44DK127659-03: Development of the NephroPlate: A high-throughput kidney-on-a-chip platform for identifying chronic kidney disease therapies ($993,146)", "source_url": "https://reporter.nih.gov/project-details/10686105", "people": [{"name": "Morgan Halman", "role": "Principal Investigator"}, {"name": "Laura Perin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42DC019877-02", "company": "Modality.ai , Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-26", "observed": "2026-08-21", "amount_usd": 998469, "summary": "NIH award 4R42DC019877-02: A digital tool for monitoring speech decline in ALS ($998,469)", "source_url": "https://reporter.nih.gov/project-details/10838866", "people": [{"name": "JORDAN R GREEN", "role": "Principal Investigator"}, {"name": "Vikram Ramanarayanan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL149480-03", "company": "Flobio, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-26", "observed": "2026-08-21", "amount_usd": 413054, "summary": "NIH award 5R44HL149480-03: A rapid microfluidic diagnostic assay for the measurement of Direct Oral Anticoagulants from patient whole blood ($413,054)", "source_url": "https://reporter.nih.gov/project-details/10615908", "people": [{"name": "Adam Cuker", "role": "Principal Investigator"}, {"name": "Mark Kunkel", "role": "Principal Investigator"}, {"name": "Jason M Rossi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42DA053075-03", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-26", "observed": "2026-08-21", "amount_usd": 981839, "summary": "NIH award 5R42DA053075-03: Developing novel technologies to monitor nociception and opioid administration during surgery and general anesthesia in order to minimize post-operative opioid requirements ($981,839)", "source_url": "https://reporter.nih.gov/project-details/10654060", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42HG011219-03", "company": "Datirium, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-23", "observed": "2026-08-21", "amount_usd": 779624, "summary": "NIH award 5R42HG011219-03: SciDAP: Scientific Data Analysis Platform ($779,624)", "source_url": "https://reporter.nih.gov/project-details/10622562", "people": [{"name": "Artem Barski", "role": "Principal Investigator"}, {"name": "Andrey Kartashov", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL154912-03", "company": "Inomagen Therapeutics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-23", "observed": "2026-08-21", "amount_usd": 1749913, "summary": "NIH award 5R44HL154912-03: A New and Disruptive Gene Based Therapy for Atrial Fibrillation ($1,749,913)", "source_url": "https://reporter.nih.gov/project-details/10563221", "people": [{"name": "Robert Charles Moen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R44DA049300-03S1", "company": "Prapela, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-22", "observed": "2026-08-21", "amount_usd": 137437, "summary": "NIH award 3R44DA049300-03S1: Prapela\u2122 SVS: A cost-effective stochastic vibrotactile stimulation device toimprove the clinical course of infants with neonatal abstinence syndrome. ($137,437)", "source_url": "https://reporter.nih.gov/project-details/10837421", "people": [{"name": "John Phillip Konsin", "role": "Principal Investigator"}, {"name": "Rachana Singh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA203038-05", "company": "Veriskin, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-21", "observed": "2026-08-21", "amount_usd": 757314, "summary": "NIH award 5R44CA203038-05: Pivotal Clinical Study of the TruScore Device for Non-Invasive Skin Cancer Diagnostics ($757,314)", "source_url": "https://reporter.nih.gov/project-details/10665700", "people": [{"name": "MIRIANAS CHACHISVILIS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:4R44AR080503-02", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-21", "observed": "2026-08-21", "amount_usd": 884903, "summary": "NIH award 4R44AR080503-02: Simulation and Education Tool for Physical Examinations of Orthopedic Pathologies ($884,903)", "source_url": "https://reporter.nih.gov/project-details/10728097", "people": [{"name": "John Paul Condon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL167492-01", "company": "Vibrato Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-21", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43HL167492-01: Acoustic-anatomic modeling and development of a patient-specific wearable therapeutic ultrasound device for peripheral arterial disease ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10603253", "people": [{"name": "Juliana Elstad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA278090-01A1", "company": "Dropletpharm Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-21", "observed": "2026-08-21", "amount_usd": 275766, "summary": "NIH award 1R43CA278090-01A1: Microchip electrophoresis as basis for fully integrated, fully automated, low-cost radiopharmaceutical QC platform ($275,766)", "source_url": "https://reporter.nih.gov/project-details/10697506", "people": [{"name": "Jason Jones", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DA053078-02", "company": "Real Prevention, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-20", "observed": "2026-08-21", "amount_usd": 858761, "summary": "NIH award 2R44DA053078-02: Developing and testing the Opioid Rapid Response System ($858,761)", "source_url": "https://reporter.nih.gov/project-details/10696992", "people": [{"name": "Hye Jeong Choi", "role": "Principal Investigator"}, {"name": "Michael Hecht", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44NS132605-01", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-19", "observed": "2026-08-21", "amount_usd": 1523833, "summary": "NIH award 1R44NS132605-01: Low-Dose Magneto-Thrombolysis to Expand Stroke Care ($1,523,833)", "source_url": "https://reporter.nih.gov/project-details/10693650", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "COLIN Pieter DERDEYN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220048", "company": "Invictus Medical, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-06-16", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220048 granted: Neoasis", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220048"}, {"id": "breakthrough:BP220799", "company": "Avita Medical Americas, LLC.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-06-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth BP220799: RECELL AUTOLOGOUS CELL HARVESTING DEVICE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R41NS132614-01", "company": "Automated Imaging Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-15", "observed": "2026-08-21", "amount_usd": 272736, "summary": "NIH award 1R41NS132614-01: Assessment of Deep Learning Classification Methods for Parkinsonism ($272,736)", "source_url": "https://reporter.nih.gov/project-details/10695418", "people": [{"name": "Angelos Barmpoutis", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44MH128076-02", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-15", "observed": "2026-08-21", "amount_usd": 872983, "summary": "NIH award 2R44MH128076-02: Next generation axonal quantification and classification using AI ($872,983)", "source_url": "https://reporter.nih.gov/project-details/10698843", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA240019-03", "company": "Calla Health Foundation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-15", "observed": "2026-08-21", "amount_usd": 995987, "summary": "NIH award 5R44CA240019-03: Innovations in cervical cancer diagnosis for low resource settings using advanced optical imaging and machine learning diagnostic algorithms. ($995,987)", "source_url": "https://reporter.nih.gov/project-details/10654870", "people": [{"name": "MARLEE KRIEGER", "role": "Principal Investigator"}, {"name": "Nirmala Ramanujam", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "breakthrough:P220002", "company": "Premia Spine, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-06-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P220002: TOPS SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43DA057773-01A1", "company": "Neurotype Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-14", "observed": "2026-08-21", "amount_usd": 326672, "summary": "NIH award 1R43DA057773-01A1: Closed-loop attention bias modification brain training for opioid use disorder ($326,672)", "source_url": "https://reporter.nih.gov/project-details/10699099", "people": [{"name": "Scott Burwell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG078121-03", "company": "Adaptelligence, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-14", "observed": "2026-08-21", "amount_usd": 1178468, "summary": "NIH award 5R44AG078121-03: Automated Health Assessment through Mobile Sensing and Machine Learning of Daily Activities ($1,178,468)", "source_url": "https://reporter.nih.gov/project-details/10683062", "people": [{"name": "Diane Joyce Cook", "role": "Principal Investigator"}, {"name": "Lawrence Holder", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AI174456-01", "company": "Nami Diagnostics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-14", "observed": "2026-08-21", "amount_usd": 224079, "summary": "NIH award 1R43AI174456-01: Development of A Novel Nanoparticle Biosensor for Rapid, Point-of-Care Sepsis Diagnosis and Risk Assessment ($224,079)", "source_url": "https://reporter.nih.gov/project-details/10602155", "people": [{"name": "Ke Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM144009-03", "company": "Wellsim Biomedical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-13", "observed": "2026-08-21", "amount_usd": 749163, "summary": "NIH award 5R44GM144009-03: A Label-free Extracellular-vesicle Automated Purification System (LEAP System) ($749,163)", "source_url": "https://reporter.nih.gov/project-details/10647831", "people": [{"name": "Yuchao Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44DA055396-02", "company": "Dynamicare Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-12", "observed": "2026-08-21", "amount_usd": 819079, "summary": "NIH award 4R44DA055396-02: Incentivized Collaborative Care to Desseminate Contingency Management ($819,079)", "source_url": "https://reporter.nih.gov/project-details/10765107", "people": [{"name": "Anthony DeFulio", "role": "Principal Investigator"}, {"name": "David R Gastfriend", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AA030948-01", "company": "Managed Health Connections, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-12", "observed": "2026-08-21", "amount_usd": 1398716, "summary": "NIH award 1R44AA030948-01: Advanced Contingency Management System for Reduction of Alcohol Use. ($1,398,716)", "source_url": "https://reporter.nih.gov/project-details/10699864", "people": [{"name": "Ron Kimberly Johnson", "role": "Principal Investigator"}, {"name": "Michael G McDonell", "role": "Principal Investigator"}, {"name": "Sterling M McPherson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK108397-05", "company": "Lipella Pharmaceuticals, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-12", "observed": "2026-08-21", "amount_usd": 680049, "summary": "NIH award 5R44DK108397-05: Phenotyping Interstitial Cystitis/Bladder Pain Syndrome by ICE-MRI Based Bladder Permeability Assay ($680,049)", "source_url": "https://reporter.nih.gov/project-details/10705263", "people": [{"name": "JONATHAN H KAUFMAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44AG082605-01", "company": "Together Senior Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-09", "observed": "2026-08-21", "amount_usd": 1535530, "summary": "NIH award 1R44AG082605-01: A Novel Algorithm to Identify People with Undiagnosed Alzheimer's Disease and Related Dementias ($1,535,530)", "source_url": "https://reporter.nih.gov/project-details/10696912", "people": [{"name": "Deborah E. Barnes", "role": "Principal Investigator"}, {"name": "Cynthia Louise Benjamin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AI167330-02", "company": "Scanogen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-09", "observed": "2026-08-21", "amount_usd": 999995, "summary": "NIH award 4R44AI167330-02: Culture and amplification-free bacterial sepsis diagnosis ($999,995)", "source_url": "https://reporter.nih.gov/project-details/10805776", "people": [{"name": "Alfredo Andres Celedon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL147787-03", "company": "Sigt, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-09", "observed": "2026-08-21", "amount_usd": 1055598, "summary": "NIH award 5R44HL147787-03: High Frequency Dielectric Sensing Cardiac Radio Frequency Ablation Monitoring and Lesion Assessment System ($1,055,598)", "source_url": "https://reporter.nih.gov/project-details/10609534", "people": [{"name": "Parag Karmarkar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DK127631-03", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-09", "observed": "2026-08-21", "amount_usd": 378331, "summary": "NIH award 5R44DK127631-03: Kidney Support in Pediatric Patients Using an Ultrafiltration Device ($378,331)", "source_url": "https://reporter.nih.gov/project-details/10620178", "people": [{"name": "Robert J Knuesel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41AG082600-01", "company": "Signal Solutions, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-09", "observed": "2026-08-21", "amount_usd": 180612, "summary": "NIH award 1R41AG082600-01: Noninvasive sleep enhancement and behavior monitoring technologies for Alzheimer's model mice ($180,612)", "source_url": "https://reporter.nih.gov/project-details/10698532", "people": [{"name": "BRUCE Frederick O'HARA", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44HL162151-02", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-09", "observed": "2026-08-21", "amount_usd": 830640, "summary": "NIH award 4R44HL162151-02: A Low Blood Volume Platform for Recurrent Anticoagulation and Kidney Monitoring during Continuous Renal Replacement Therapy in Critically Ill Children ($830,640)", "source_url": "https://reporter.nih.gov/project-details/10820748", "people": [{"name": "VAMSEE K. PAMULA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "denovo:DEN220078", "company": "Futura Medical Developments Limited", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-06-09", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220078 granted: Eroxon", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220078"}, {"id": "nih:1R44CA278140-01A1", "company": "Phase Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-08", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 1R44CA278140-01A1: AI-based AML risk stratification using next generation cytogenomics ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10699150", "people": [{"name": "Stephen Matthew Eacker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA058470-01", "company": "Autonomous Healthcare, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-08", "observed": "2026-08-21", "amount_usd": 325001, "summary": "NIH award 1R43DA058470-01: Noncontact Remote Monitoring for the Detection of Opioid-Induced Respiratory Depression ($325,001)", "source_url": "https://reporter.nih.gov/project-details/10684530", "people": [{"name": "Behnood Gholami", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43DA056259-01S1", "company": "Sonara Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-08", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43DA056259-01S1: Remotely Observed Methadone Evaluation (ROME) ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10774067", "people": [{"name": "Steffani R Bailey", "role": "Principal Investigator"}, {"name": "Michael Giles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DC016247-07", "company": "Batandcat, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-07", "observed": "2026-08-21", "amount_usd": 1282699, "summary": "NIH award 5R44DC016247-07: Portable Hearing Laboratory - CRP ($1,282,699)", "source_url": "https://reporter.nih.gov/project-details/10641678", "people": [{"name": "Caslav Vojislav Pavlovic", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "breakthrough:BP170122/S502", "company": "Avita Medical Americas, LLC", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-06-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth BP170122/S502: RECELL AUTOLOGOUS CELL HARVESTING DEVICE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P220021", "company": "Endologix, LLC.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-06-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P220021: DETOUR SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R42AG080886-01S1", "company": "Tritonx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-06", "observed": "2026-08-21", "amount_usd": 54600, "summary": "NIH award 3R42AG080886-01S1: Clinical effectiveness of a wearable hydration device ($54,600)", "source_url": "https://reporter.nih.gov/project-details/10773374", "people": [{"name": "Eamon Johnson", "role": "Principal Investigator"}, {"name": "Joseph Piktel", "role": "Principal Investigator"}, {"name": "MARY Joan ROACH", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM131501-03", "company": "Nirvana Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-06", "observed": "2026-08-21", "amount_usd": 816870, "summary": "NIH award 5R44GM131501-03: Fluorescent nanofoldamers for multiplex flow cytometry ($816,870)", "source_url": "https://reporter.nih.gov/project-details/10624461", "people": [{"name": "Christopher J MacNevin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44HD109106-01A1", "company": "Barrett Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-06", "observed": "2026-08-21", "amount_usd": 1049104, "summary": "NIH award 1R44HD109106-01A1: SmartAssist\u2122: Adaptive robotic assistance to maximize patient engagement with the Barrett Upper-Extremity Robotic Trainer (Burt) ($1,049,104)", "source_url": "https://reporter.nih.gov/project-details/10699140", "people": [{"name": "Randie Black-Schaffer", "role": "Principal Investigator"}, {"name": "Craig McDonald", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220028", "company": "Cue Health, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-06-06", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220028 granted: Cue COVID-19 Molecular Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220028"}, {"id": "nih:5R44CA277890-02", "company": "Vergent Bioscience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-05", "observed": "2026-08-21", "amount_usd": 874253, "summary": "NIH award 5R44CA277890-02: Improving lung cancer surgery with an intraoperative, tumor-targeted, activatable fluorescent imaging agent ($874,253)", "source_url": "https://reporter.nih.gov/project-details/10701056", "people": [{"name": "Eric Scott Bensen", "role": "Principal Investigator"}, {"name": "Sunil Singhal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44EY032424-02A1", "company": "Lynthera Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-05", "observed": "2026-08-21", "amount_usd": 795000, "summary": "NIH award 2R44EY032424-02A1: Sustained delivery technology for Cyclosporine A in the treatment of autoimmune response ($795,000)", "source_url": "https://reporter.nih.gov/project-details/10698850", "people": [{"name": "Roman Domszy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43OD034532-01A1", "company": "Aquillius Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-05", "observed": "2026-08-21", "amount_usd": 395558, "summary": "NIH award 1R43OD034532-01A1: Development of a Respiratory Sensor for Animal Model Research ($395,558)", "source_url": "https://reporter.nih.gov/project-details/10697651", "people": [{"name": "MyPhuong T Le", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK133084-02", "company": "Ideal Medical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-02", "observed": "2026-08-21", "amount_usd": 931064, "summary": "NIH award 5R44DK133084-02: Demonstration of the Feasibility of Closed Loop Control of Blood Glucose in the Intensive Care Unit Setting Using a Novel Artificial Intelligence Based Glucose Control System ($931,064)", "source_url": "https://reporter.nih.gov/project-details/10631190", "people": [{"name": "Leon DeJournett", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43CA261417-01S1", "company": "Wild Dog Physics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-02", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43CA261417-01S1: Enabling remote medical physics services for medical accelerator quality assurance through a novel, table-top imaging device ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10773360", "people": [{"name": "Janelle Arlene Molloy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220041", "company": "Tristel Solutions Limited", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-06-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220041 granted: Tristel Duo ULT", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220041"}, {"id": "nih:1R41CA281543-01", "company": "Hilight Surgical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-01", "observed": "2026-08-21", "amount_usd": 239040, "summary": "NIH award 1R41CA281543-01: Fluorescence lifetime imaging device for 5-ALA-guided neurosurgery ($239,040)", "source_url": "https://reporter.nih.gov/project-details/10698741", "people": [{"name": "Julien Bec", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL169010-01", "company": "Bold Type LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-01", "observed": "2026-08-21", "amount_usd": 299721, "summary": "NIH award 1R43HL169010-01: A multi-sensor catheter for diagnosing obstructive sleep apnea ($299,721)", "source_url": "https://reporter.nih.gov/project-details/10696658", "people": [{"name": "Jose Luis Bohorquez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH126819-03", "company": "Evidence-based Practice Institute, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-01", "observed": "2026-08-21", "amount_usd": 626381, "summary": "NIH award 5R44MH126819-03: iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide ($626,381)", "source_url": "https://reporter.nih.gov/project-details/10625446", "people": [{"name": "Linda A Dimeff", "role": "Principal Investigator"}, {"name": "Cindy M. Schaeffer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AI179269-01", "company": "Red Genomics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-01", "observed": "2026-08-21", "amount_usd": 295294, "summary": "NIH award 1R43AI179269-01: Target Insertion Amplification and Sequence (TIAS): A novel targeted sequencing technology that performs rapid target enrichment and next generation sequencing sample preparation simultaneously ($295,294)", "source_url": "https://reporter.nih.gov/project-details/10758909", "people": [{"name": "Phillip Neal Gray", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG079709-01A1", "company": "Isoformix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-01", "observed": "2026-08-21", "amount_usd": 384767, "summary": "NIH award 1R43AG079709-01A1: Clusterin glycosylation as diagnostic and prognostic biomarker for Alzheimer's disease ($384,767)", "source_url": "https://reporter.nih.gov/project-details/10699168", "people": [{"name": "DOBRIN NEDELKOV", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK136450-01", "company": "Halomine, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-06-01", "observed": "2026-08-21", "amount_usd": 325001, "summary": "NIH award 1R43DK136450-01: Non-coating anti-microbial, anti-host protein deposition, anti-inflammatory urinary catheter ($325,001)", "source_url": "https://reporter.nih.gov/project-details/10697567", "people": [{"name": "Marc D. Hein", "role": "Principal Investigator"}, {"name": "Ekrem Ozkan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL169134-01", "company": "Medluidics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-31", "observed": "2026-08-21", "amount_usd": 233541, "summary": "NIH award 1R43HL169134-01: PAH-on-a-chip: a novel disease-on-a-device model for studying the pathobiology of and screening drugs for pulmonary arterial hypertension ($233,541)", "source_url": "https://reporter.nih.gov/project-details/10695605", "people": [{"name": "Fakhrul Ahsan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44TR004557-01", "company": "Curi Bio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-31", "observed": "2026-08-21", "amount_usd": 324648, "summary": "NIH award 1R44TR004557-01: A cross-species preclinical platform to enhance the translation of new medicines ($324,648)", "source_url": "https://reporter.nih.gov/project-details/10699196", "people": [{"name": "Nicholas Andrew Geisse", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44DE032564-01", "company": "Revbio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-31", "observed": "2026-08-21", "amount_usd": 1265448, "summary": "NIH award 1R44DE032564-01: Development of a Novel Bone Adhesive Scaffold to Accelerate Bone Regeneration and Improve Ridge Height Maintenance for the Treatment of Patients with Residual Ridge Resorption ($1,265,448)", "source_url": "https://reporter.nih.gov/project-details/10603678", "people": [{"name": "Rahul Jadia", "role": "Principal Investigator"}, {"name": "George Kay", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:6R44NR019963-02", "company": "Cove Technology Consulting LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-31", "observed": "2026-08-21", "amount_usd": 34595, "summary": "NIH award 6R44NR019963-02: A closed-loop gravity infusion control device ($34,595)", "source_url": "https://reporter.nih.gov/project-details/10833418", "people": [{"name": "Chie Kawahara", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42NS110165-03", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-31", "observed": "2026-08-21", "amount_usd": 738079, "summary": "NIH award 5R42NS110165-03: 3D Printed Multifunctional Brain Windows for Simultaneous Optical Imaging and Electrophysiology ($738,079)", "source_url": "https://reporter.nih.gov/project-details/10632060", "people": [{"name": "Suhasa B Kodandaramaiah", "role": "Principal Investigator"}, {"name": "Michael McAlpine", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42MH123215-04", "company": "Lyssn.io, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-31", "observed": "2026-08-21", "amount_usd": 698475, "summary": "NIH award 5R42MH123215-04: CBTpro: Scaling up CBT for psychosis using simulated patients and spoken language technologies ($698,475)", "source_url": "https://reporter.nih.gov/project-details/10618955", "people": [{"name": "Sarah Lynn Kopelovich", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43AR082738-01", "company": "Ascan L. L. C.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-30", "observed": "2026-08-21", "amount_usd": 276073, "summary": "NIH award 1R43AR082738-01: Tissue Oxygen Scanning for Acute Compartment Syndrome (ACS) Diagnosis ($276,073)", "source_url": "https://reporter.nih.gov/project-details/10697253", "people": [{"name": "Shai Ashkenazi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM142430-01A1", "company": "Backyard Brains, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-30", "observed": "2026-08-21", "amount_usd": 324631, "summary": "NIH award 1R43GM142430-01A1: A biologically-inspired, interactive digital device to introduce K12 students to computational neuroscience ($324,631)", "source_url": "https://reporter.nih.gov/project-details/10706026", "people": [{"name": "Gregory John Gage", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AI155367-02", "company": "Godx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-30", "observed": "2026-08-21", "amount_usd": 1050000, "summary": "NIH award 2R44AI155367-02: Rapid, Handheld, Point-of-Care Stool Sample-prep Device for the Extraction and Detection of Nucleic Acid from Diarrheal Pathogens ($1,050,000)", "source_url": "https://reporter.nih.gov/project-details/10611784", "people": [{"name": "Chang Hee Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HD112277-01", "company": "Bold Type LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-29", "observed": "2026-08-21", "amount_usd": 384959, "summary": "NIH award 1R43HD112277-01: A device to treat high-tone pelvic floor dysfunction in women ($384,959)", "source_url": "https://reporter.nih.gov/project-details/10697072", "people": [{"name": "Jose Luis Bohorquez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD110306-01A1", "company": "Mother's Milk Is Best, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-29", "observed": "2026-08-21", "amount_usd": 1032045, "summary": "NIH award 1R44HD110306-01A1: Point of Care maternal milk concentration device to optimize neonatal growth with targeted nutrition support ($1,032,045)", "source_url": "https://reporter.nih.gov/project-details/10697455", "people": [{"name": "Elizabeth Randall Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41EY034411-01A1", "company": "Xr Navigation Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-26", "observed": "2026-08-21", "amount_usd": 275766, "summary": "NIH award 1R41EY034411-01A1: Audiom: Developing an Indoor Non-Visual Mapping System ($275,766)", "source_url": "https://reporter.nih.gov/project-details/10695772", "people": [{"name": "Brandon Biggs", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG082591-01", "company": "Brain Thrive Technology LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-26", "observed": "2026-08-21", "amount_usd": 498094, "summary": "NIH award 1R41AG082591-01: Developing of a computer-based multimodal mind and body approach for mild cognitive decline ($498,094)", "source_url": "https://reporter.nih.gov/project-details/10699442", "people": [{"name": "JIAN KONG", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44AG074727-03S1", "company": "Together Senior Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-25", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44AG074727-03S1: BRAIN HEALTH TOGETHER: A LIVE-STREAMING GROUP-BASED DIGITAL PROGRAM ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10747235", "people": [{"name": "Deborah E. Barnes", "role": "Principal Investigator"}, {"name": "Cynthia Louise Benjamin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41CA272043-01A1", "company": "Briopryme Biologics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-25", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R41CA272043-01A1: A decellularized porcine placenta matrix hydrogel for management of radiation-induced proctitis ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10599727", "people": [{"name": "Jian Jian Li", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA057759-01", "company": "Volver Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-24", "observed": "2026-08-21", "amount_usd": 275743, "summary": "NIH award 1R43DA057759-01: Rumbo: An Integrated Mobile and Web-Based Application to Overcome Barriers to Receive Substance Use Disorder (SUD) Treatment and Improve Outcomes for Spanish-Speaking, Hispanic and Latinx Individuals ($275,743)", "source_url": "https://reporter.nih.gov/project-details/10601173", "people": [{"name": "William P Campbell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM130227-03", "company": "Eliaz Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-24", "observed": "2026-08-21", "amount_usd": 990810, "summary": "NIH award 5R44GM130227-03: Depleting Circulating Galectin-3 with Therapeutic Apheresis: A NovelTreatment for Sepsis/AKI ($990,810)", "source_url": "https://reporter.nih.gov/project-details/10636905", "people": [{"name": "Isaac Eliaz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43CA275629-01A1", "company": "Captis Diagnostics", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-24", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R43CA275629-01A1: Non-invasive detection of tumor NTRK gene fusions via rapid, efficient and low-cost extracellular vesicle isolation method ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10707684", "people": [{"name": "Hongzhang He", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI153011-03", "company": "Orlance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-23", "observed": "2026-08-21", "amount_usd": 998889, "summary": "NIH award 5R44AI153011-03: Universal Influenza A/B Vaccine ($998,889)", "source_url": "https://reporter.nih.gov/project-details/10617390", "people": [{"name": "Kenneth C Bagley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41EB033717-01A1", "company": "Calimetrix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-23", "observed": "2026-08-21", "amount_usd": 282252, "summary": "NIH award 1R41EB033717-01A1: Advanced Quantitative Magnetic Resonance Imaging Phantoms for Nonalcoholic Fatty Liver Disease ($282,252)", "source_url": "https://reporter.nih.gov/project-details/10698927", "people": [{"name": "Jean H. Brittain", "role": "Principal Investigator"}, {"name": "Scott B. Reeder", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EY034800-01A1", "company": "Opticent, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-23", "observed": "2026-08-21", "amount_usd": 253012, "summary": "NIH award 1R43EY034800-01A1: Extraordinary Dispersion Engineering In Enabling Ultrafast Swept Source visiblelight Optical Coherence Tomography ($253,012)", "source_url": "https://reporter.nih.gov/project-details/10698705", "people": [{"name": "Roman Kuranov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI172703-02", "company": "Phase Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-23", "observed": "2026-08-21", "amount_usd": 995873, "summary": "NIH award 5R44AI172703-02: Therapeutic phage host-range prediction using proximity-guided metagenomics and artificial intelligence ($995,873)", "source_url": "https://reporter.nih.gov/project-details/10629378", "people": [{"name": "Ivan Liachko", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA281570-01", "company": "Hypermelt, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-23", "observed": "2026-08-21", "amount_usd": 275721, "summary": "NIH award 1R43CA281570-01: Simple and Accessible Microfluidic Platform for Single Molecule Sequence Profiling of Tumor-derived DNA within Liquid Biopsies ($275,721)", "source_url": "https://reporter.nih.gov/project-details/10699214", "people": [{"name": "Christine O'Keefe", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "breakthrough:K223504", "company": "Ceribell, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-05-23", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K223504: CERIBELL STATUS EPILEPTICUS MONITOR", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R42DA049448-03S1", "company": "Q2i, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-22", "observed": "2026-08-21", "amount_usd": 114174, "summary": "NIH award 3R42DA049448-03S1: Reward-based technology to improve opioid use disorder treatment initiation after an ED visit ($114,174)", "source_url": "https://reporter.nih.gov/project-details/10794875", "people": [{"name": "Edwin D Boudreaux", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44AG076256-02", "company": "Maphabit, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-22", "observed": "2026-08-21", "amount_usd": 1263950, "summary": "NIH award 4R44AG076256-02: An assistive-technology based Caregiver Training Program (CTP) to enhance caregiver effectiveness, well-being, and quality of life, which will improve overall care for individuals living with AD/ADRD. ($1,263,950)", "source_url": "https://reporter.nih.gov/project-details/10834789", "people": [{"name": "Matthew Golden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44EB029804-03", "company": "Quel Imaging LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-22", "observed": "2026-08-21", "amount_usd": 973991, "summary": "NIH award 5R44EB029804-03: Phase II: Fluorescence guided surgery standardization tools ($973,991)", "source_url": "https://reporter.nih.gov/project-details/10664034", "people": [{"name": "Ethan Phillip Marshall LaRochelle", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R42HL152921-02A1", "company": "Inovodel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-22", "observed": "2026-08-21", "amount_usd": 1467953, "summary": "NIH award 2R42HL152921-02A1: Chemical-based Nitric Oxide Gas-generating Drug Device for the Treatment of Pulmonary Hypertension ($1,467,953)", "source_url": "https://reporter.nih.gov/project-details/10611768", "people": [{"name": "Gary Lessing", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44AI109891-06", "company": "Dxdiscovery, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-19", "observed": "2026-08-21", "amount_usd": 1009408, "summary": "NIH award 2R44AI109891-06: Point-of-care lateral flow immunoassay for diagnosis of pertussis ($1,009,408)", "source_url": "https://reporter.nih.gov/project-details/10693572", "people": [{"name": "Amanda Burnham-Marusich", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R43HL169094-01", "company": "Cardio-theranostics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-19", "observed": "2026-08-21", "amount_usd": 390028, "summary": "NIH award 1R43HL169094-01: Formulation and pharmacokinetics of subcutaneous administration of deferiprone for prevention of chronic heart failure following hemorrhagic myocardial infarction. ($390,028)", "source_url": "https://reporter.nih.gov/project-details/10700370", "people": [{"name": "Robert E Finney", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM131560-03", "company": "Epicypher, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-19", "observed": "2026-08-21", "amount_usd": 1024490, "summary": "NIH award 5R44GM131560-03: Quantification of combinatorial epigenetic modifications using defined nucleosome standards ($1,024,490)", "source_url": "https://reporter.nih.gov/project-details/10630256", "people": [{"name": "Andrea Lynn Johnstone", "role": "Principal Investigator"}, {"name": "Michael-Christopher Keogh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA265446-02", "company": "Envisagenics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-18", "observed": "2026-08-21", "amount_usd": 980257, "summary": "NIH award 5R44CA265446-02: Comprehensive validation and commercial readiness of SpliceIO, a software platform for neoantigen discovery using RNA-seq data ($980,257)", "source_url": "https://reporter.nih.gov/project-details/10647773", "people": [{"name": "MARTIN AKERMAN", "role": "Principal Investigator"}, {"name": "GAYATRI ARUN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG080889-02", "company": "Adeptrix Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-18", "observed": "2026-08-21", "amount_usd": 1433652, "summary": "NIH award 5R44AG080889-02: Multiplexed immunoassay for building patient-specific molecular profiles of CSF amyloid beta and TAU ($1,433,652)", "source_url": "https://reporter.nih.gov/project-details/10707200", "people": [{"name": "Vladislav Bergo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG050326-04", "company": "Advanced Brain Monitoring, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-18", "observed": "2026-08-21", "amount_usd": 978121, "summary": "NIH award 5R44AG050326-04: Multi-site longitudinal Integrated Neurocognitive and Sleep-Behavior Profiler for the Endophenotypic Classification of Dementia Subtypes (INSPECDS) ($978,121)", "source_url": "https://reporter.nih.gov/project-details/10707195", "people": [{"name": "Chris Berka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "denovo:DEN220027", "company": "Brahms GmbH, Part of Thermo Fisher Scien", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-05-18", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220027 granted: B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S sFlt-1/ PlGF KRYPTOR Test Sy", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220027"}, {"id": "breakthrough:DEN220027", "company": "Brahms Gmbh, Part Of Thermo Fisher Scientific", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-05-18", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220027: B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S SFLT-1/ PLGF KRYPTOR TEST SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44DK127580-03", "company": "Crm Medical Devices, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-17", "observed": "2026-08-21", "amount_usd": 775342, "summary": "NIH award 5R44DK127580-03: Validation of a Neurogenic Bladder Management Solution to Promote Independence and Reduce Long-Term Morbidity for Patients Unable to Perform Intermittent Catheterization ($775,342)", "source_url": "https://reporter.nih.gov/project-details/10691472", "people": [{"name": "Christopher Elliott", "role": "Principal Investigator"}, {"name": "Christian S Eversull", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44AI157022-02", "company": "Cell Microsystems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-17", "observed": "2026-08-21", "amount_usd": 838127, "summary": "NIH award 2R44AI157022-02: Rapid identification and selection of functional antigen-specific monoclonalantibodies by FcGR-enabled screening on CellRaft Arrays in the CellRaft AIRSystem ($838,127)", "source_url": "https://reporter.nih.gov/project-details/10698784", "people": [{"name": "Jessica Hartman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44HD090811-04A1", "company": "Infinite Biomedical Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-17", "observed": "2026-08-21", "amount_usd": 873316, "summary": "NIH award 2R44HD090811-04A1: Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses ($873,316)", "source_url": "https://reporter.nih.gov/project-details/10603007", "people": [{"name": "Rahul Reddy Kaliki", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R41AT011996-01A1", "company": "Hypnoscientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-16", "observed": "2026-08-21", "amount_usd": 324568, "summary": "NIH award 1R41AT011996-01A1: Digital clinical hypnosis for chronic pain management ($324,568)", "source_url": "https://reporter.nih.gov/project-details/10696872", "people": [{"name": "Mark P Jensen", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG082574-01", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-15", "observed": "2026-08-21", "amount_usd": 309746, "summary": "NIH award 1R43AG082574-01: A novel instrument for continuous blood pressure monitoring ($309,746)", "source_url": "https://reporter.nih.gov/project-details/10696510", "people": [{"name": "Brian R Clark", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EY026466-05", "company": "Opticent, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-15", "observed": "2026-08-21", "amount_usd": 779313, "summary": "NIH award 5R44EY026466-05: Visible-light optical coherence tomography for clinical glaucoma management ($779,313)", "source_url": "https://reporter.nih.gov/project-details/10630252", "people": [{"name": "Roman Kuranov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "hde:H210002", "company": "Globus Medical, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2023-05-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H210002: REFLECT\u2122 Scoliosis Correction System", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "nih:3R42DA049655-04S1", "company": "Vox Biomedical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-12", "observed": "2026-08-21", "amount_usd": 99967, "summary": "NIH award 3R42DA049655-04S1: Exhaled breath drug detection using differential mobility spectrometry ($99,967)", "source_url": "https://reporter.nih.gov/project-details/10771661", "people": [{"name": "Jacob Golde", "role": "Principal Investigator"}, {"name": "SCOTT E LUKAS", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44AI149903-03", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-12", "observed": "2026-08-21", "amount_usd": 999008, "summary": "NIH award 2R44AI149903-03: Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients ($999,008)", "source_url": "https://reporter.nih.gov/project-details/10699435", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R43MH130298-01S1", "company": "Guiding Technologies Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-12", "observed": "2026-08-21", "amount_usd": 6500, "summary": "NIH award 3R43MH130298-01S1: Smart Technology to Empower Collaborative Partnerships Among Behavior Practitioners and Caregivers to Deliver Quality ABA ($6,500)", "source_url": "https://reporter.nih.gov/project-details/10837190", "people": [{"name": "John Teofil Nosek", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD107729-01A1", "company": "Meditrace LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-11", "observed": "2026-08-21", "amount_usd": 260434, "summary": "NIH award 1R44HD107729-01A1: Fast-Track Multimodal monitoring for neonatal neurocritical care ($260,434)", "source_url": "https://reporter.nih.gov/project-details/10601201", "people": [{"name": "Tony Christopher Carnes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44HD097809-04A1", "company": "Reia, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-11", "observed": "2026-08-21", "amount_usd": 994718, "summary": "NIH award 2R44HD097809-04A1: Non-surgical treatment option for pelvic organ prolapse ($994,718)", "source_url": "https://reporter.nih.gov/project-details/10695369", "people": [{"name": "Paul Hanissian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AG074778-03", "company": "Kinto", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-10", "observed": "2026-08-21", "amount_usd": 1133385, "summary": "NIH award 5R44AG074778-03: Development of a technology-enabled care coaching service for families caring for AD/ADRD & a 300-family study to assess the service's impact on CG financial knowledge, efficacy, strain & action. ($1,133,385)", "source_url": "https://reporter.nih.gov/project-details/10681361", "people": [{"name": "Joseph Chung", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44ES031881-02A1", "company": "Lebrun Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-09", "observed": "2026-08-21", "amount_usd": 878010, "summary": "NIH award 2R44ES031881-02A1: IVD EIT a Nonanimal Kit and Service for the Detection of Ocular Irritants: Phase II ($878,010)", "source_url": "https://reporter.nih.gov/project-details/10699287", "people": [{"name": "Stewart Lebrun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "denovo:DEN220083", "company": "Swing Therapeutics, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-05-09", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220083 granted: Stanza", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220083"}, {"id": "breakthrough:DEN220083", "company": "Swing Therapeutics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-05-09", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220083: STANZA", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44DK130702-03", "company": "Nephropathology Associates", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-08", "observed": "2026-08-21", "amount_usd": 930814, "summary": "NIH award 5R44DK130702-03: Development of a Precision Medicine-based Diagnostic Tool for Membranous Nephropathy ($930,814)", "source_url": "https://reporter.nih.gov/project-details/10703484", "people": [{"name": "Christopher P Larsen", "role": "Principal Investigator"}, {"name": "Aaron Joseph Storey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44AG073141-02", "company": "Allied Innovative Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-05", "observed": "2026-08-21", "amount_usd": 977713, "summary": "NIH award 2R44AG073141-02: Highly sensitive immunoassay for determination of biomarkers for neurodegenerative diseases ($977,713)", "source_url": "https://reporter.nih.gov/project-details/10698757", "people": [{"name": "Simon Bystryak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R42HL167342-01A1", "company": "Sensydia Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-05", "observed": "2026-08-21", "amount_usd": 605537, "summary": "NIH award 1R42HL167342-01A1: A non-invasive, automated platform for hemodynamic assessment of patients at risk of heart failure or pulmonary hypertension ($605,537)", "source_url": "https://reporter.nih.gov/project-details/10699067", "people": [{"name": "Anthony Arnold", "role": "Principal Investigator"}, {"name": "Aman Mahajan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "denovo:DEN210038", "company": "Ortho-Clinical Diagnostics, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-05-05", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210038 granted: VITROS Immunodiagnostic Products Anti-SA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210038"}, {"id": "denovo:DEN210040", "company": "Ortho-Clinical Diagnostics, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-05-05", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210040 granted: VITROS Immunodiagnostic Products Anti-SA", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210040"}, {"id": "nih:1R41DC021128-01", "company": "Haystack Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-03", "observed": "2026-08-21", "amount_usd": 350033, "summary": "NIH award 1R41DC021128-01: Endoscopy-assisted intracochlear access via ultrasharp-microneedles ($350,033)", "source_url": "https://reporter.nih.gov/project-details/10699330", "people": [{"name": "Aykut Aksit", "role": "Principal Investigator"}, {"name": "Anil K Lalwani", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44AA029868-02S1", "company": "Evidence-based Practice Institute, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-03", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44AA029868-02S1: Treating Drivers of Suicide in Primary Care using Jaspr Health TABA Supplement ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10805635", "people": [{"name": "Linda A Dimeff", "role": "Principal Investigator"}, {"name": "David Alan Jobes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44DK131700-02S1", "company": "Bright Uro, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-03", "observed": "2026-08-21", "amount_usd": 54047, "summary": "NIH award 3R44DK131700-02S1: Clinical Feasibility of Wireless Catheter-Free Urodynamics for Extended, Comprehensive Urological Evaluation in the Home Setting ($54,047)", "source_url": "https://reporter.nih.gov/project-details/10762486", "people": [{"name": "Derek Herrera", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44DC020684-01A1", "company": "Thrive Neuromedical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-03", "observed": "2026-08-21", "amount_usd": 1191469, "summary": "NIH award 1R44DC020684-01A1: Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants ($1,191,469)", "source_url": "https://reporter.nih.gov/project-details/10697501", "people": [{"name": "Dean R Koch", "role": "Principal Investigator"}, {"name": "Nathalie Maitre", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "sbir:DOD:FA8649-23-P-0600", "company": "Dxlab Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-05-03", "observed": "2026-09-18", "amount_usd": 74399, "summary": "DOD SBIR Phase I award $74,399: FDA-authorized, point-of care diagnostic platform for rapid and sensitive detection of harmful pathogens.", "source_url": "https://www.sbir.gov/awards?search=FX235-CSO1-0197"}, {"id": "nih:5R44CA273961-02", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-02", "observed": "2026-08-21", "amount_usd": 890056, "summary": "NIH award 5R44CA273961-02: Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures ($890,056)", "source_url": "https://reporter.nih.gov/project-details/10625956", "people": [{"name": "NICUSOR IFTIMIA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "breakthrough:P210032/S007", "company": "W. L. Gore & Associates, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-05-02", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P210032/S007: GORE TAG THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:FA8649-23-P-0731", "company": "Autonomus Medical Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-05-02", "observed": "2026-09-18", "amount_usd": 74134, "summary": "DOD SBIR Phase I award $74,134: In support of prolonged field care, enabling rapid treatment of noncompressible hemorrhage by a non-specialist in austere environments using the artificial intelligence guided ultrasound intervention device (AI-GUIDE)", "source_url": "https://www.sbir.gov/awards?search=FX235-CSO1-1320"}, {"id": "nih:1R44MH133517-01", "company": "Lyssn.io, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-01", "observed": "2026-08-21", "amount_usd": 275373, "summary": "NIH award 1R44MH133517-01: Voice-based AI to scale evaluation of crisis counseling in 988 rollout ($275,373)", "source_url": "https://reporter.nih.gov/project-details/10699048", "people": [{"name": "David Charles Atkins", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH133502-01", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-01", "observed": "2026-08-21", "amount_usd": 837340, "summary": "NIH award 1R44MH133502-01: Integrated software platform to enhance school mental health assessment and data-driven student services ($837,340)", "source_url": "https://reporter.nih.gov/project-details/10696497", "people": [{"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}, {"name": "SHARON H Hoover", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R42HL162214-02", "company": "Biochip Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-01", "observed": "2026-08-21", "amount_usd": 865376, "summary": "NIH award 4R42HL162214-02: Microfluidic Technology for Concurrent Assessment of Red Blood Cell Adhesion and Deformability ($865,376)", "source_url": "https://reporter.nih.gov/project-details/10811328", "people": [{"name": "Chiara Federici", "role": "Principal Investigator"}, {"name": "Umut A. Gurkan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG074818-02", "company": "I-function, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-01", "observed": "2026-08-21", "amount_usd": 1062816, "summary": "NIH award 5R44AG074818-02: Development of a Remotely Deliverable Cognitive Assessment Sensitive to Early Stage Mild Cognitive Impairment. ($1,062,816)", "source_url": "https://reporter.nih.gov/project-details/10623313", "people": [{"name": "Peter Kallestrup", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43ES035348-01", "company": "Bubbleology Research International, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-01", "observed": "2026-08-21", "amount_usd": 204881, "summary": "NIH award 1R43ES035348-01: GCS-CEAS: a novel tool for exposure assessment during disaster response ($204,881)", "source_url": "https://reporter.nih.gov/project-details/10699942", "people": [{"name": "Ira Leifer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD105529-03", "company": "Autoivf, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-05-01", "observed": "2026-08-21", "amount_usd": 815410, "summary": "NIH award 5R44HD105529-03: OvaReady: An automated microfluidic oocyte retrieval and denudation device expanding access to IVF ($815,410)", "source_url": "https://reporter.nih.gov/project-details/10613599", "people": [{"name": "Ismail Emre Ozkumur", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "sbir:DOD:FA8649-23-P-0744", "company": "Gelsana Therapeutics Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-05-01", "observed": "2026-09-18", "amount_usd": 74950, "summary": "DOD SBIR Phase I award $74,950: End-User Exploration of Novel Zwitterionic Hydrogels for Improved Burn, Blast, and Chronic Wound Healing", "source_url": "https://www.sbir.gov/awards?search=FX235-CSO1-1384"}, {"id": "nih:1R44HL167428-01", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-30", "observed": "2026-08-21", "amount_usd": 784548, "summary": "NIH award 1R44HL167428-01: Minimally Invasive High Intensity Therapeutic Ultrasound for the Treatment of Obstructive Hypertrophic Cardiomyopathy ($784,548)", "source_url": "https://reporter.nih.gov/project-details/10603460", "people": [{"name": "Howard Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AI177245-01", "company": "Zeteo Tech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-28", "observed": "2026-08-21", "amount_usd": 967498, "summary": "NIH award 1R44AI177245-01: Noninvasive Diagnostic Markers of Lower Respiratory Tract Infection in Mechanically Ventilated Patients ($967,498)", "source_url": "https://reporter.nih.gov/project-details/10697471", "people": [{"name": "Dapeng Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44GM149106-01A1", "company": "Cellchorus Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-28", "observed": "2026-08-21", "amount_usd": 324340, "summary": "NIH award 1R44GM149106-01A1: Dynamic single-cell analysis instrument to evaluate immune cell function ($324,340)", "source_url": "https://reporter.nih.gov/project-details/10699036", "people": [{"name": "Laurence J.N. Cooper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI170389-02", "company": "Cryocrate, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-28", "observed": "2026-08-21", "amount_usd": 736276, "summary": "NIH award 5R44AI170389-02: Innovation of Skin Banking and Transplantation Based on a First-in-Class Biocompatible Cryopreservation Technology ($736,276)", "source_url": "https://reporter.nih.gov/project-details/10618957", "people": [{"name": "Xu Han", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AI174499-01A1", "company": "Truly Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-28", "observed": "2026-08-21", "amount_usd": 272625, "summary": "NIH award 1R43AI174499-01A1: Enabling standardized point-of-care tuberculosis diagnostics via rapid osmotic concentration ($272,625)", "source_url": "https://reporter.nih.gov/project-details/10697134", "people": [{"name": "James Lai", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB034611-01", "company": "Elements Endoscopy Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-28", "observed": "2026-08-21", "amount_usd": 299803, "summary": "NIH award 1R43EB034611-01: Development of a Modular Flexible Semi-Disposable Endoscope Platform ($299,803)", "source_url": "https://reporter.nih.gov/project-details/10694511", "people": [{"name": "Dwight Meglan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL167502-01A1", "company": "Neoolife, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-27", "observed": "2026-08-21", "amount_usd": 553838, "summary": "NIH award 1R41HL167502-01A1: Development of a Biomimetic Stentless Pulmonary Heart Valve for the Treatment of Pediatric Congenital Heart Disease ($553,838)", "source_url": "https://reporter.nih.gov/project-details/10696291", "people": [{"name": "Garrett N Coyan", "role": "Principal Investigator"}, {"name": "Antonio D'Amore", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD109075-01A1", "company": "Advanced Tactile Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-27", "observed": "2026-08-21", "amount_usd": 299942, "summary": "NIH award 1R43HD109075-01A1: Stress strain imaging for detection and characterization of endometriosis, adenomyosis and uterine fibroids ($299,942)", "source_url": "https://reporter.nih.gov/project-details/10695456", "people": [{"name": "Vladimir Egorov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AI162425-02", "company": "Vectech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-27", "observed": "2026-08-21", "amount_usd": 950392, "summary": "NIH award 2R44AI162425-02: High accuracy automated tick classification using computer vision ($950,392)", "source_url": "https://reporter.nih.gov/project-details/10699845", "people": [{"name": "Autumn Goodwin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R42HG012288-01S1", "company": "Geneial LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-27", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R42HG012288-01S1: Privacy-Preserving Connectivity for Rare-Disease Patients ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10774186", "people": [{"name": "Adam Wesley Hansen", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI174562-01", "company": "Amplifidx Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-26", "observed": "2026-08-21", "amount_usd": 286775, "summary": "NIH award 1R43AI174562-01: STI NG Plus, a Swab to Answer Molecular Panel Test for Point of Care Diagnosis and Treatment Recommendation ($286,775)", "source_url": "https://reporter.nih.gov/project-details/10603834", "people": [{"name": "Shoulian Dong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA235915-02", "company": "Surgivance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-25", "observed": "2026-08-21", "amount_usd": 1020044, "summary": "NIH award 2R44CA235915-02: Advanced Surgical Pathology Device ($1,020,044)", "source_url": "https://reporter.nih.gov/project-details/10698697", "people": [{"name": "Daniel Summer Gareau", "role": "Principal Investigator"}, {"name": "Jason Ezra Hawkes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM137671-03", "company": "Ligo Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-24", "observed": "2026-08-21", "amount_usd": 854290, "summary": "NIH award 5R44GM137671-03: Reliable model building for cryo-EM ($854,290)", "source_url": "https://reporter.nih.gov/project-details/10612108", "people": [{"name": "Raquel Bromberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43GM149051-01A1", "company": "Vox Biomedical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-24", "observed": "2026-08-21", "amount_usd": 275741, "summary": "NIH award 1R43GM149051-01A1: Machine Learning Based Differential Mobility Spectrometry Library Development ($275,741)", "source_url": "https://reporter.nih.gov/project-details/10696533", "people": [{"name": "Jacob Golde", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43OD034043-01A1", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-21", "observed": "2026-08-21", "amount_usd": 274441, "summary": "NIH award 1R43OD034043-01A1: An automated system for post-surgical health and environmental monitoring with real-time alerts for laboratory rodents using scalable hardware and deep learning ($274,441)", "source_url": "https://reporter.nih.gov/project-details/10694734", "people": [{"name": "Paul Gibson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL160257-02", "company": "Applied Physics Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-21", "observed": "2026-08-21", "amount_usd": 838807, "summary": "NIH award 5R44HL160257-02: A scalable superconducting dual-shielded fetal magnetocardiography system ($838,807)", "source_url": "https://reporter.nih.gov/project-details/10615914", "people": [{"name": "William Goodman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HG013069-01", "company": "Alida Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-21", "observed": "2026-08-21", "amount_usd": 347653, "summary": "NIH award 1R43HG013069-01: Engineered RNA Modification Recognition ($347,653)", "source_url": "https://reporter.nih.gov/project-details/10697237", "people": [{"name": "Zachary Miles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI157776-03", "company": "Accel Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-20", "observed": "2026-08-21", "amount_usd": 97316, "summary": "NIH award 5R44AI157776-03: A COVID-19 Point of Care Serological Assay for Rapid Quantification of Antibody Titer. ($97,316)", "source_url": "https://reporter.nih.gov/project-details/10574627", "people": [{"name": "Alberto Gandini", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R43AG076169-01S1", "company": "Claritytek, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-20", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43AG076169-01S1: Virtual Reality Cognitive Therapy for Alzheimer's Disease ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10768289", "people": [{"name": "Razi Masood", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220082", "company": "Gaylord Solutions, LLC", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-04-20", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220082 granted: Breast Implant Removal Device (BIRD)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220082"}, {"id": "nih:1R41DA056276-01", "company": "Altrumed LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-19", "observed": "2026-08-21", "amount_usd": 319930, "summary": "NIH award 1R41DA056276-01: The DOVE Device to Prevent Opioid Overdose Deaths: An Armband That Senses Overdose and Automatically Injects Naloxone ($319,930)", "source_url": "https://reporter.nih.gov/project-details/10485568", "people": [{"name": "Jacob Brenner", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DA057122-01", "company": "Evidence-based Practice Institute, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-19", "observed": "2026-08-21", "amount_usd": 319737, "summary": "NIH award 1R44DA057122-01: iKinnect Mobile Technology to Reduce Teen Substance Misuse and Health Disparities ($319,737)", "source_url": "https://reporter.nih.gov/project-details/10545162", "people": [{"name": "Linda A Dimeff", "role": "Principal Investigator"}, {"name": "Cindy M. Schaeffer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM130262-03", "company": "Proteinaceous, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-19", "observed": "2026-08-21", "amount_usd": 796742, "summary": "NIH award 5R44GM130262-03: A comprehensive solution for native top down mass spectrometry data analyses across structural biology and biopharma ($796,742)", "source_url": "https://reporter.nih.gov/project-details/10621751", "people": [{"name": "Kenneth Durbin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R41AR082170-01S1", "company": "G5 Biological Innovations L.l.c.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-17", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R41AR082170-01S1: Intraoperative Kit for AuNP-Tissue Grafts ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10773571", "people": [{"name": "David Grant", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43AR080507-01A1S1", "company": "Apex Orthopaedic Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-17", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43AR080507-01A1S1: R-FIX (Rib-FIXation System) for Severe Progressive Spinal Deformity: I-Corps Supplement ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10772940", "people": [{"name": "Richard H. Gross", "role": "Principal Investigator"}, {"name": "Hai Yao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43AR080486-01A1S1", "company": "Biomed Consulting, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-17", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43AR080486-01A1S1: Development of a Standardized, Reliable and Easy-to-Use Clinical Instrument to Measure First Ray Mobility and Position of the Medial Forefoot to Assist with Clinical Decisions and Treatments ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10772958", "people": [{"name": "Howard J. Hillstrom", "role": "Principal Investigator"}, {"name": "Rajshree Hillstrom", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DA051257-03", "company": "Ayuda Medical", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-17", "observed": "2026-08-21", "amount_usd": 964000, "summary": "NIH award 5R44DA051257-03: A Naloxone Parachute: Novel Wearable Dual-Sensor Regional Oximeter to Detect Opioid-Induced Hypoxia and Enable Emergent Naloxone Rescue ($964,000)", "source_url": "https://reporter.nih.gov/project-details/10612485", "people": [{"name": "Desislava Zlatanova Hite", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "denovo:DEN220059", "company": "Noctrix Health, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-04-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220059 granted: NTX100 Tonic Motor Activation (NTX100 To", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220059"}, {"id": "breakthrough:DEN220059", "company": "Noctrix Health, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-04-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220059: NTX100 TONIC MOTOR ACTIVATION (NTX100 TOMAC) SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:2R44AI157123-02", "company": "Aerosol Dynamics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-14", "observed": "2026-08-21", "amount_usd": 580279, "summary": "NIH award 2R44AI157123-02: Biocascade inlet ($580,279)", "source_url": "https://reporter.nih.gov/project-details/10695846", "people": [{"name": "Arantzazu Eiguren Fernandez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM146477-02", "company": "Applied Nanostructures, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-12", "observed": "2026-08-21", "amount_usd": 805173, "summary": "NIH award 5R44GM146477-02: A micromachining fluidic cantilever for single cell advanced patch clamping and cellular characterization using atomic force microscopy ($805,173)", "source_url": "https://reporter.nih.gov/project-details/10615901", "people": [{"name": "Ami Chand", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AI172709-01A1", "company": "Tango Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-12", "observed": "2026-08-21", "amount_usd": 275606, "summary": "NIH award 1R43AI172709-01A1: Generating fast-on rate reagents for lateral flow assays to detect HCV ($275,606)", "source_url": "https://reporter.nih.gov/project-details/10697630", "people": [{"name": "BRIAN KENNETH KAY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA261516-02", "company": "Sonalasense Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-12", "observed": "2026-08-21", "amount_usd": 1061045, "summary": "NIH award 5R44CA261516-02: Evaluation of the safety and efficacy of non-invasive sonodynamic therapy for diffuse intrinsic pontine glioma ($1,061,045)", "source_url": "https://reporter.nih.gov/project-details/10610340", "people": [{"name": "Stuart Marcus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DK112468-04", "company": "Cg Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-11", "observed": "2026-08-21", "amount_usd": 499992, "summary": "NIH award 5R44DK112468-04: Automated System for High Yield Pancreatic Islet Isolation ($499,992)", "source_url": "https://reporter.nih.gov/project-details/10601118", "people": [{"name": "Lotien Richard Huang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:3R44AG072990-02S1", "company": "See Yourself Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-11", "observed": "2026-08-21", "amount_usd": 100366, "summary": "NIH award 3R44AG072990-02S1: The HOPE App Diversity Supplement: An Immersive Telehealth Solution for Older Adults with Diabetes ($100,366)", "source_url": "https://reporter.nih.gov/project-details/10748978", "people": [{"name": "Suzanne Mitchell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA243764-03", "company": "Acoustic Range Estimates, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-11", "observed": "2026-08-21", "amount_usd": 377958, "summary": "NIH award 5R44CA243764-03: Thermoacoustic Range Verification During Delivery of a Clinical Plan by a Synchrocyclotron: transition from research prototype to turnkey clinical device ($377,958)", "source_url": "https://reporter.nih.gov/project-details/10600975", "people": [{"name": "SARAH Kathryn PATCH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG073096-03", "company": "Neuroem Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-10", "observed": "2026-08-21", "amount_usd": 984357, "summary": "NIH award 5R44AG073096-03: Disaggregation of Toxic Protein Oligomers in Brain with ElectromagneticTreatment ($984,357)", "source_url": "https://reporter.nih.gov/project-details/10377571", "people": [{"name": "Edward Culver Goodwin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG076072-02", "company": "Cnd Life Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-10", "observed": "2026-08-21", "amount_usd": 1168467, "summary": "NIH award 5R44AG076072-02: A Diagnostic Test for Dementia with Lewy Bodies ($1,168,467)", "source_url": "https://reporter.nih.gov/project-details/10589126", "people": [{"name": "Todd Levine", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK135084-01", "company": "Integrated Medical Sensors", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-10", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43DK135084-01: A Smart Semiconductor based Integrated Continuous Diabetes Monitoring Platform ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10589708", "people": [{"name": "Muhammad Mujeeb-U-Rahman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220033", "company": "Moximed, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-04-10", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220033 granted: MISHA Knee System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220033"}, {"id": "breakthrough:DEN220033", "company": "Moximed, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-04-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220033: MISHA KNEE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43AI177180-01", "company": "Electronucleics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-07", "observed": "2026-08-21", "amount_usd": 275731, "summary": "NIH award 1R43AI177180-01: Rapid point-of-care detection of Trichomonas Vaginalis ($275,731)", "source_url": "https://reporter.nih.gov/project-details/10699836", "people": [{"name": "Sam Bae", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN210055", "company": "Candesant Biomedical, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-04-07", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210055 granted: The N-SWEAT Patch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210055"}, {"id": "nih:1R44HL169045-01", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-06", "observed": "2026-08-21", "amount_usd": 299999, "summary": "NIH award 1R44HL169045-01: A Near-Patient, Low Blood Volume Platform for Rapid Comprehensive Evaluation of Coagulation in Trauma Patients ($299,999)", "source_url": "https://reporter.nih.gov/project-details/10697216", "people": [{"name": "VAMSEE K. PAMULA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44AG074128-02S1", "company": "Whiplash Technology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-05", "observed": "2026-08-21", "amount_usd": 49650, "summary": "NIH award 3R44AG074128-02S1: Design, Development, and Validation of an AI-enabled Legal Planning and Financial Management Training Solution for ADRD Caregivers ($49,650)", "source_url": "https://reporter.nih.gov/project-details/10771050", "people": [{"name": "Christian Elliott", "role": "Principal Investigator"}, {"name": "Nicole E Werner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42GM143986-03", "company": "Biosensing Instrument, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-05", "observed": "2026-08-21", "amount_usd": 832386, "summary": "NIH award 5R42GM143986-03: Critical angle reflection imaging for label-free quantification of molecular interactions ($832,386)", "source_url": "https://reporter.nih.gov/project-details/10596659", "people": [{"name": "Nguyen Ly", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "sbir:DOD:W51701-23-C-0089", "company": "Maxentric Technologies LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-04-05", "observed": "2026-09-18", "amount_usd": 149841, "summary": "DOD SBIR Phase I award $149,841: Wearable Technologies for Physiological Monitoring Open Topic", "source_url": "https://www.sbir.gov/awards?search=A224-025-0686"}, {"id": "sbir:DOD:W51701-23-C-0091", "company": "Nanohmics Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-04-05", "observed": "2026-09-18", "amount_usd": 149999, "summary": "DOD SBIR Phase I award $149,999: Wearable Technologies for Physiological Monitoring VitalScopeTM - Ingestible Capsule for Vital Signs Monitoring", "source_url": "https://www.sbir.gov/awards?search=A224-025-0639"}, {"id": "nih:5R44GM145168-02", "company": "Phi Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-03", "observed": "2026-08-21", "amount_usd": 649893, "summary": "NIH award 5R44GM145168-02: Label-free cell viability assays using Phase Imaging with Computational Specificity ($649,893)", "source_url": "https://reporter.nih.gov/project-details/10620330", "people": [{"name": "CATALIN CHIRITESCU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "sbir:DOD:W51701-23-C-0090", "company": "Design Interactive, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-04-03", "observed": "2026-09-18", "amount_usd": 149994, "summary": "DOD SBIR Phase I award $149,994: Wearable Technology Ecosystem for Physiological Monitoring and Actionable Insights", "source_url": "https://www.sbir.gov/awards?search=A224-025-0624"}, {"id": "sbir:DOD:W51701-23-C-0114", "company": "Aptima Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-04-03", "observed": "2026-09-18", "amount_usd": 149992, "summary": "DOD SBIR Phase I award $149,992: PRISM: Physiological Ruggedized Integrated Sensor-based Monitoring", "source_url": "https://www.sbir.gov/awards?search=A234-004-0409"}, {"id": "nih:1R44HL167296-01", "company": "Aventusoft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-04-01", "observed": "2026-08-21", "amount_usd": 399999, "summary": "NIH award 1R44HL167296-01: A mobile health framework for left ventricular end diastolic pressure diagnostics and monitoring. ($399,999)", "source_url": "https://reporter.nih.gov/project-details/10601929", "people": [{"name": "Kaustubh Kale", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R42AI157552-03", "company": "Microbial Imaging, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-31", "observed": "2026-08-21", "amount_usd": 609132, "summary": "NIH award 5R42AI157552-03: Imaging Bacterial Infections in Vivo: First in Man Studies ($609,132)", "source_url": "https://reporter.nih.gov/project-details/10611527", "people": [{"name": "Mark Myron Goodman", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AG074888-01A1", "company": "Stexole LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-31", "observed": "2026-08-21", "amount_usd": 259600, "summary": "NIH award 1R43AG074888-01A1: Tele-Sox: A Tele-Medicine solution based on wearables and gamification to prevent Venous thromboembolism in Oncology Geriatric Patients ($259,600)", "source_url": "https://reporter.nih.gov/project-details/10547300", "people": [{"name": "Rosha Joshi", "role": "Principal Investigator"}, {"name": "Bijan Najafi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL167401-01", "company": "Mitralprint Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-31", "observed": "2026-08-21", "amount_usd": 299577, "summary": "NIH award 1R41HL167401-01: Development of a novel sensor for the real-time measurement of mitral coaptation force ($299,577)", "source_url": "https://reporter.nih.gov/project-details/10601890", "people": [{"name": "Daniel Grinberg", "role": "Principal Investigator"}, {"name": "Anthony Medigo", "role": "Principal Investigator"}, {"name": "Benjamin Isaac Rapoport", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN200011", "company": "Masimo Corporation", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-03-31", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200011 granted: Masimo SafetyNet", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200011"}, {"id": "breakthrough:DEN200011", "company": "Masimo Corporation", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-03-31", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN200011: MASIMO SAFETYNET OPIOID SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44AI157672-03", "company": "First Light Diagnostics , Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-30", "observed": "2026-08-21", "amount_usd": 991573, "summary": "NIH award 5R44AI157672-03: Rapid antimicrobial susceptibility testing directly from urine specimens ($991,573)", "source_url": "https://reporter.nih.gov/project-details/10598047", "people": [{"name": "Lawrence Burg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44AI136172-03A1", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-30", "observed": "2026-08-21", "amount_usd": 1020000, "summary": "NIH award 2R44AI136172-03A1: Point-of-care diagnostic test for T. cruzi (Chagas) infection ($1,020,000)", "source_url": "https://reporter.nih.gov/project-details/10603665", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "denovo:DEN210039", "company": "Happiest Baby, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-03-30", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210039 granted: SNOO Smart Sleeper", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210039"}, {"id": "sbir:DOD:W5170123C0087", "company": "Neurable Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-03-30", "observed": "2026-09-18", "amount_usd": 149915, "summary": "DOD SBIR Phase I award $149,915: An Easily Integratable Wearable Real-Time Cognition & Physiological Monitoring Device for Human Performance Optimization", "source_url": "https://www.sbir.gov/awards?search=A224-025-0682"}, {"id": "nih:5R41MH129004-02", "company": "Advanced Medical Electronics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-29", "observed": "2026-08-21", "amount_usd": 442217, "summary": "NIH award 5R41MH129004-02: Improving Patient Care Through Objective Monitoring of At-Home Repetitive Ritual Behaviors in Obsessive-Compulsive Disorder ($442,217)", "source_url": "https://reporter.nih.gov/project-details/10600055", "people": [{"name": "Anu Asnaani", "role": "Principal Investigator"}, {"name": "Nalaka S Gooneratne", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG071416-03", "company": "Retain Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-29", "observed": "2026-08-21", "amount_usd": 784098, "summary": "NIH award 5R44AG071416-03: RETAIN: A digital therapeutic for Alzheimer's risk reduction ($784,098)", "source_url": "https://reporter.nih.gov/project-details/10596190", "people": [{"name": "Mark McInnis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44TR003832-03", "company": "Accuhealth Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-29", "observed": "2026-08-21", "amount_usd": 999936, "summary": "NIH award 5R44TR003832-03: Health 360x Clinical Research Platform for Scalable Access to Clinical Trials ($999,936)", "source_url": "https://reporter.nih.gov/project-details/10624966", "people": [{"name": "Chamberlain Obialo", "role": "Principal Investigator"}, {"name": "Elizabeth O. Ofili", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "denovo:DEN220030", "company": "Bioretec, Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-03-29", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220030 granted: RemeOs\u2122 Screw LAG Solid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220030"}, {"id": "breakthrough:DEN220030", "company": "Bioretec, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-03-29", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220030: REMEOS SCREW LAG SOLID", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W5170123C0084", "company": "Mantel Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-03-29", "observed": "2026-09-18", "amount_usd": 149829, "summary": "DOD SBIR Phase I award $149,829: Transpalatal EEG for Human Performance Monitoring and Optimization", "source_url": "https://www.sbir.gov/awards?search=A224-025-0659"}, {"id": "nih:1R41HL164298-01A1", "company": "Clearvoya LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-28", "observed": "2026-08-21", "amount_usd": 256879, "summary": "NIH award 1R41HL164298-01A1: Motion-Resistant Background Subtraction Angiography with Deep Learning: Real-Time, Edge Hardware Implementation and Product Development ($256,879)", "source_url": "https://reporter.nih.gov/project-details/10602275", "people": [{"name": "Sameer A Ansari", "role": "Principal Investigator"}, {"name": "DONALD Robinson CANTRELL", "role": "Principal Investigator"}, {"name": "Leon Cho", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42HL160384-03", "company": "Biochip Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-28", "observed": "2026-08-21", "amount_usd": 842828, "summary": "NIH award 5R42HL160384-03: Endothelialized microfluidic assays for emerging therapies in sickle cell disease ($842,828)", "source_url": "https://reporter.nih.gov/project-details/10602474", "people": [{"name": "Chiara Federici", "role": "Principal Investigator"}, {"name": "Umut A. Gurkan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43CA277895-01A1", "company": "Current Surgical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-28", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R43CA277895-01A1: In vivo feasibility of a smart needle ablation treatment for liver cancer ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10699190", "people": [{"name": "Alireza Mashal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43AG076092-01S1", "company": "Tanzen Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-27", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43AG076092-01S1: RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Legs Syndrome in Patients with Alzheimer's Disease ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10741903", "people": [{"name": "Justin Brooks", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41DA056334-01A1", "company": "Spacerx LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-27", "observed": "2026-08-21", "amount_usd": 318605, "summary": "NIH award 1R41DA056334-01A1: Using in-vivo Real-time Biosensor to Evaluate Prodrugs Designed to Prolong Therapeutic Effects for Smoking Cessation. ($318,605)", "source_url": "https://reporter.nih.gov/project-details/10546293", "people": [{"name": "John Nicholas Betley", "role": "Principal Investigator"}, {"name": "Peter H Lee", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI174487-01A1", "company": "Kephera Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-27", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43AI174487-01A1: Development of an ELISA for serosurveillance of human hookworm ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10697222", "people": [{"name": "Andrew E. Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42CA268156-02", "company": "Opsiclear LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-27", "observed": "2026-08-21", "amount_usd": 191481, "summary": "NIH award 5R42CA268156-02: 3D optical histopathology for head and neck intraoperative consultation. ($191,481)", "source_url": "https://reporter.nih.gov/project-details/10578781", "people": [{"name": "YEHE LIU", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA281474-01", "company": "Isabl Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-27", "observed": "2026-08-21", "amount_usd": 1041487, "summary": "NIH award 1R44CA281474-01: Isabl GxT: A clinically actionable whole genome and transcriptome precision medicine platform ($1,041,487)", "source_url": "https://reporter.nih.gov/project-details/10697472", "people": [{"name": "Juan Santiago Medina", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK136439-01", "company": "Hydrocision Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-24", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43DK136439-01: Development of a Dedicated Fluidjet Technology for Single-session Debridement of Necrotizing Pancreatitis ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10699626", "people": [{"name": "Paul Kowalski", "role": "Principal Investigator"}, {"name": "Mark Lewis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI172578-01A1", "company": "Salus Discovery, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-24", "observed": "2026-08-21", "amount_usd": 275526, "summary": "NIH award 1R43AI172578-01A1: Enhancing detection and mobile monitoring of schistosomiasis with urine-based analyte pre-concentration technology ($275,526)", "source_url": "https://reporter.nih.gov/project-details/10697011", "people": [{"name": "Cody Carrell", "role": "Principal Investigator"}, {"name": "Brianna Mullins", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DC018437-03", "company": "Altec, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-23", "observed": "2026-08-21", "amount_usd": 584894, "summary": "NIH award 5R44DC018437-03: Adaptive & Individualized AAC ($584,894)", "source_url": "https://reporter.nih.gov/project-details/10600065", "people": [{"name": "Gianluca De Luca", "role": "Principal Investigator"}, {"name": "Jennifer Vojtech", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG071430-03", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-23", "observed": "2026-08-21", "amount_usd": 418143, "summary": "NIH award 5R44AG071430-03: Interactive Training Tool Providing Technique Feedback for COPD Medication Delivery ($418,143)", "source_url": "https://reporter.nih.gov/project-details/10579858", "people": [{"name": "Patrick A Lichter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AI177051-01", "company": "Acatechol, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-22", "observed": "2026-08-21", "amount_usd": 273485, "summary": "NIH award 1R43AI177051-01: Hybrid repellant-antimicrobial gemini coatings for prevention of catheter-associated bloodstream infections ($273,485)", "source_url": "https://reporter.nih.gov/project-details/10697071", "people": [{"name": "Kollbe Ahn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA275508-01A1", "company": "Sonalasense Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-21", "observed": "2026-08-21", "amount_usd": 694814, "summary": "NIH award 1R44CA275508-01A1: Sonodynamic therapy using MRI-guided focused ultrasound in combination with 5-aminolevulinic acid to treat recurrent glioblastoma multiforme ($694,814)", "source_url": "https://reporter.nih.gov/project-details/10699858", "people": [{"name": "Stuart Marcus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AI174618-01A1", "company": "Dplexbio Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-17", "observed": "2026-08-21", "amount_usd": 494340, "summary": "NIH award 1R44AI174618-01A1: Emulsion digital PCR ($494,340)", "source_url": "https://reporter.nih.gov/project-details/10699081", "people": [{"name": "Peter B Allen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43HL164136-01A1S2", "company": "Karios Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-17", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43HL164136-01A1S2: I-Corps: A Sprayable Tissue-Binding Hydrogel to Prevent Postsurgical Cardiac Adhesions ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10741261", "people": [{"name": "Gregory Grover", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL168994-01", "company": "Bairitone Health Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-17", "observed": "2026-08-21", "amount_usd": 299850, "summary": "NIH award 1R43HL168994-01: SOMNAR: A platform to localize airway obstruction in sleep apnea ($299,850)", "source_url": "https://reporter.nih.gov/project-details/10690879", "people": [{"name": "Onur Kilic", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AI174495-01A1", "company": "Big Eye Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-16", "observed": "2026-08-21", "amount_usd": 921480, "summary": "NIH award 1R44AI174495-01A1: SUPPORTING WHO ONCHOCERCIASIS ELIMINATION PROGRAMS: PROGRESSING A HIGHLY SENSITIVE AND ULTRA-SPECIFIC RAPID DIAGNOSTIC TEST TO COMMERCIALIZATION READINESS ($921,480)", "source_url": "https://reporter.nih.gov/project-details/10697164", "people": [{"name": "Marco Antonio Biamonte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43HL160238-01A1S2", "company": "Mddriven LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-16", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43HL160238-01A1S2: A HANDS-FREE LUNG AND CARDIOVASCULAR ASSESSMENT DEVICE (LCAD) FOR THE REMOTE CARE OF PATIENTS WITH CHRONIC CARDIOPULMONARY CONDITIONS ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10741296", "people": [{"name": "Wilman Rene Ortega", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44ES031458-03", "company": "Aerosol Dynamics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-15", "observed": "2026-08-21", "amount_usd": 612102, "summary": "NIH award 5R44ES031458-03: A PULSED CONDENSATION PARTICLE COUNTER FOR COST EFFECTIVE MONITORING OF ULTRAFINE AIRBORNE PARTICLES ($612,102)", "source_url": "https://reporter.nih.gov/project-details/10599312", "people": [{"name": "Susanne Vera Hering", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43GM150354-01", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-15", "observed": "2026-08-21", "amount_usd": 286171, "summary": "NIH award 1R43GM150354-01: Metabolic cytometry for in-line process analysis ($286,171)", "source_url": "https://reporter.nih.gov/project-details/10698665", "people": [{"name": "Jesung Park", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R41CA272122-02", "company": "Soft Imaging, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-14", "observed": "2026-08-21", "amount_usd": 194231, "summary": "NIH award 5R41CA272122-02: 3D Image Analysis Software for Breast Reconstruction Surgical Planning, Outcome Assessment & Clinical Consultation ($194,231)", "source_url": "https://reporter.nih.gov/project-details/10589908", "people": [{"name": "Fatima Aziz Merchant", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:4R44DE031461-02", "company": "Pediametrix Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-13", "observed": "2026-08-21", "amount_usd": 821085, "summary": "NIH award 4R44DE031461-02: Mobile Three-Dimensional Screening for Cranial Malformations ($821,085)", "source_url": "https://reporter.nih.gov/project-details/10795791", "people": [{"name": "Fereshteh Aalamifar", "role": "Principal Investigator"}, {"name": "Reza Seifabadi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43CA278604-01S1", "company": "Pathware Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-13", "observed": "2026-08-21", "amount_usd": 95567, "summary": "NIH award 3R43CA278604-01S1: Harnessing Coded Ptychography to Deliver AI-powered Evaluation of Unstained Lung Biopsies at the Point-Of-Care ($95,567)", "source_url": "https://reporter.nih.gov/project-details/10740674", "people": [{"name": "Torsten Lyon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42CA275665-01A1", "company": "Digital Health Navigation Solutions, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-13", "observed": "2026-08-21", "amount_usd": 397979, "summary": "NIH award 1R42CA275665-01A1: A cloud-based digital health navigation program for colorectal cancer screening ($397,979)", "source_url": "https://reporter.nih.gov/project-details/10697474", "people": [{"name": "David P Miller", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI172667-01A1", "company": "Mstm, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-10", "observed": "2026-08-21", "amount_usd": 159060, "summary": "NIH award 1R43AI172667-01A1: Development of multimode vacuum ionization for use in medical diagnostics ($159,060)", "source_url": "https://reporter.nih.gov/project-details/10697560", "people": [{"name": "Charles N McEwen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DC019586-03", "company": "Restorear Devices, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-09", "observed": "2026-08-21", "amount_usd": 338296, "summary": "NIH award 5R44DC019586-03: Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation ($338,296)", "source_url": "https://reporter.nih.gov/project-details/10593170", "people": [{"name": "Curtis Scott King", "role": "Principal Investigator"}, {"name": "Suhrud M. Rajguru", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "denovo:DEN220039", "company": "Quidel Corporation", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-03-08", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220039 granted: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220039"}, {"id": "nih:1R43MH132156-01", "company": "Outcome Referrals Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-07", "observed": "2026-08-21", "amount_usd": 274787, "summary": "NIH award 1R43MH132156-01: Consumer-Therapist-Connector: Increasing Access to Quality Behavioral Healthcare ($274,787)", "source_url": "https://reporter.nih.gov/project-details/10601368", "people": [{"name": "David R. Kraus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI174349-01", "company": "Jbs Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-07", "observed": "2026-08-21", "amount_usd": 306500, "summary": "NIH award 1R43AI174349-01: Development of a PCR assay for quantitative detection of HBV cccDNA ($306,500)", "source_url": "https://reporter.nih.gov/project-details/10602051", "people": [{"name": "Selena Lin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN210033", "company": "Neuromod Devices Limited", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-03-06", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210033 granted: Lenire Tinnitus Treatment Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210033"}, {"id": "nih:3R43GM144973-01S1", "company": "Cytosorbents, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-03", "observed": "2026-08-21", "amount_usd": 6500, "summary": "NIH award 3R43GM144973-01S1: Novel Extracorporeal Therapy for the Reversal of Septic Shock and Restoring Hemodynamic Stability ($6,500)", "source_url": "https://reporter.nih.gov/project-details/10744682", "people": [{"name": "Phillip Chan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HG012532-02", "company": "Curio Bioscience Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-02", "observed": "2026-08-21", "amount_usd": 699239, "summary": "NIH award 5R44HG012532-02: A reagent kit for spatial transcriptomic analysis ($699,239)", "source_url": "https://reporter.nih.gov/project-details/10592373", "people": [{"name": "Christina Fan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44GM143996-02", "company": "Infotech Soft, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-02", "observed": "2026-08-21", "amount_usd": 714276, "summary": "NIH award 4R44GM143996-02: Deep-CDS: Deep Learning Semantic Data Lake for Clinical Decision Support ($714,276)", "source_url": "https://reporter.nih.gov/project-details/10747223", "people": [{"name": "Mansur R. Kabuka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42MD014943-03", "company": "Klein Buendel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-02", "observed": "2026-08-21", "amount_usd": 706564, "summary": "NIH award 5R42MD014943-03: Translating an In-Person Brief, Bystander Bullying Intervention (STAC) to a Technology-Based - Phase II ($706,564)", "source_url": "https://reporter.nih.gov/project-details/10629311", "people": [{"name": "Aida Midgett", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "breakthrough:K221696", "company": "Rewalk Robotics, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-03-02", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K221696: REWALK P6.0", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K223602", "company": "Abbott Laboratories", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-03-02", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K223602: TBI", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44DA051105-03", "company": "Giner, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-01", "observed": "2026-08-21", "amount_usd": 893058, "summary": "NIH award 5R44DA051105-03: Rapid Assessment of Illicit Drugs in Wastewater ($893,058)", "source_url": "https://reporter.nih.gov/project-details/10576367", "people": [{"name": "Avni A Argun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL167347-01", "company": "Magpad, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-01", "observed": "2026-08-21", "amount_usd": 308401, "summary": "NIH award 1R43HL167347-01: MagPAD: Magnetic Puncture, Access, and Delivery of Large Bore Devices to the Heart Via the Venous System ($308,401)", "source_url": "https://reporter.nih.gov/project-details/10600737", "people": [{"name": "Mark Doherty", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA281581-01", "company": "Invenio Imaging Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-01", "observed": "2026-08-21", "amount_usd": 945279, "summary": "NIH award 1R44CA281581-01: A multicenter study in bronchoscopy combining Stimulated Raman Histology with Artificial intelligence for rapid lung cancer detection - The ON-SITE study ($945,279)", "source_url": "https://reporter.nih.gov/project-details/10698382", "people": [{"name": "Allen Cole Burks", "role": "Principal Investigator"}, {"name": "Christian Freudiger", "role": "Principal Investigator"}, {"name": "Bryan Christopher Husta", "role": "Principal Investigator"}, {"name": "David Edward Ost", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44HL140669-04A1", "company": "Volumetrix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-03-01", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 2R44HL140669-04A1: Non-Invasive Venous Waveform Analysis (NIVA) in patients with Heart Failure (HF) ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10580638", "people": [{"name": "Kyle Mitchell Hocking", "role": "Principal Investigator"}, {"name": "JOANN LINDENFELD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44CA268305-02", "company": "Fischer Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-28", "observed": "2026-08-21", "amount_usd": 979261, "summary": "NIH award 5R44CA268305-02: MammoCAT Advanced Full Field Digital Mammography System ($979,261)", "source_url": "https://reporter.nih.gov/project-details/10580860", "people": [{"name": "Shabbir Bakir Bambot", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM145185-02", "company": "Fluent Biosciences Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-28", "observed": "2026-08-21", "amount_usd": 775245, "summary": "NIH award 5R44GM145185-02: New tools for highly accessible single cell RNA sequencing ($775,245)", "source_url": "https://reporter.nih.gov/project-details/10579927", "people": [{"name": "Kristina Fontanez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL142440-03", "company": "Alleviant Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-28", "observed": "2026-08-21", "amount_usd": 1017154, "summary": "NIH award 5R44HL142440-03: Transcatheter Device for Congestive Heart Failure Treatment Through Left Atrial Decompression ($1,017,154)", "source_url": "https://reporter.nih.gov/project-details/10584517", "people": [{"name": "Thomas Diffley Pate", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R43HD110346-01S1", "company": "Ovaryit, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-27", "observed": "2026-08-21", "amount_usd": 54035, "summary": "NIH award 3R43HD110346-01S1: Workshop for implementing support tools to promote safety in the prescribing of oral contraceptives ($54,035)", "source_url": "https://reporter.nih.gov/project-details/10742446", "people": [{"name": "Devin Bustin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH132191-01", "company": "Northwest Prevention Science Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-27", "observed": "2026-08-21", "amount_usd": 251907, "summary": "NIH award 1R43MH132191-01: A Digital Health Technology to Prevent Family Violence and Improve Child Mental Health ($251,907)", "source_url": "https://reporter.nih.gov/project-details/10604116", "people": [{"name": "Christopher Hazen", "role": "Principal Investigator"}, {"name": "ELIZABETH A STORMSHAK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220063", "company": "Caption Health, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-02-24", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220063 granted: Caption Interpretation Automated Ejectio", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220063"}, {"id": "denovo:DEN220065", "company": "Enterasense , Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-02-24", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220065 granted: Pill Sense System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220065"}, {"id": "nih:5R44MH122115-04", "company": "Spectragenetics", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-23", "observed": "2026-08-21", "amount_usd": 661142, "summary": "NIH award 5R44MH122115-04: Highly Multiplexed Cell-Based GPCR Assay. ($661,142)", "source_url": "https://reporter.nih.gov/project-details/10581706", "people": [{"name": "G. Reid Asbury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:3R43HL164239-01S1", "company": "Innovative Biotherapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-17", "observed": "2026-08-21", "amount_usd": 6500, "summary": "NIH award 3R43HL164239-01S1: SCD-PICC Therapy for Respiratory Insufficiency associated with COVID-19 in non-ICU settings ($6,500)", "source_url": "https://reporter.nih.gov/project-details/10744488", "people": [{"name": "Christopher Pino", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN210022", "company": "Medasense Biometrics , Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-02-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210022 granted: PMD-", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210022"}, {"id": "nih:1R43GM148111-01", "company": "Doty Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-15", "observed": "2026-08-21", "amount_usd": 299649, "summary": "NIH award 1R43GM148111-01: Ultra-low-temperature (6 K) static NMR-DNP for metalloproteins, proteins in cells, and materials ($299,649)", "source_url": "https://reporter.nih.gov/project-details/10546201", "people": [{"name": "Francis DAVID Doty", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM149072-01", "company": "Bennubio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-15", "observed": "2026-08-21", "amount_usd": 275175, "summary": "NIH award 1R43GM149072-01: Simultaneous analysis of cell-borne and soluble biomarkers by high throughput acoustic flow cytometry ($275,175)", "source_url": "https://reporter.nih.gov/project-details/10602869", "people": [{"name": "John Peter O'Rourke", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK131766-01A1", "company": "Fistula Solution Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-15", "observed": "2026-08-21", "amount_usd": 773063, "summary": "NIH award 1R44DK131766-01A1: Novel Post-surgical Incision Management Device to Prevent Ostomy Complications ($773,063)", "source_url": "https://reporter.nih.gov/project-details/10590062", "people": [{"name": "Andrew T Obst", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44DA049631-03S1", "company": "Mmj Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-14", "observed": "2026-08-21", "amount_usd": 89400, "summary": "NIH award 3R44DA049631-03S1: Addressing Opioid Use Disorder with an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute and Chronic Low Back Pain. ($89,400)", "source_url": "https://reporter.nih.gov/project-details/10193957", "people": [{"name": "Amy Lynn Baxter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44MH128484-02", "company": "Ksana Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-13", "observed": "2026-08-21", "amount_usd": 843799, "summary": "NIH award 4R44MH128484-02: Development and testing of a digitally assisted risk reduction platform for youth at high risk for suicide ($843,799)", "source_url": "https://reporter.nih.gov/project-details/10728554", "people": [{"name": "NICHOLAS B ALLEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44DK120242-02A1", "company": "Silicon Kidney, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-13", "observed": "2026-08-21", "amount_usd": 1019979, "summary": "NIH award 2R44DK120242-02A1: A silicon nanopore membrane blood filter enabling anticoagulant free continuous renal replacement therapy for acute kidney injury ($1,019,979)", "source_url": "https://reporter.nih.gov/project-details/10546997", "people": [{"name": "Charles Blaha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG080852-01", "company": "Sano Healthcare Consultants, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-13", "observed": "2026-08-21", "amount_usd": 298544, "summary": "NIH award 1R43AG080852-01: Reducing the Risk and Economic burden of Recurrent stroke by improving medication adherence using a Novel SMART Pill CONTAINER, Cap, and Health Literacy Technologies ($298,544)", "source_url": "https://reporter.nih.gov/project-details/10601743", "people": [{"name": "Edwin Kendrick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL167435-01", "company": "Cellia Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-13", "observed": "2026-08-21", "amount_usd": 275985, "summary": "NIH award 1R43HL167435-01: Microfluidic Cartridge for Point-of-Care Hematology Analysis ($275,985)", "source_url": "https://reporter.nih.gov/project-details/10603090", "people": [{"name": "Kelly Mabry", "role": "Principal Investigator"}, {"name": "Francisco E Robles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44EY029906-02", "company": "Lightoptech Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-10", "observed": "2026-08-21", "amount_usd": 717714, "summary": "NIH award 2R44EY029906-02: In vivo high-definition 3D corneal imaging ($717,714)", "source_url": "https://reporter.nih.gov/project-details/10602663", "people": [{"name": "Cristina Canavesi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HG012850-01", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-10", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R43HG012850-01: Sequencing the Mono-Methylated Derivatives of Cytidine ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10581093", "people": [{"name": "Eric Ervin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44ES034314-01", "company": "Giner, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-08", "observed": "2026-08-21", "amount_usd": 845085, "summary": "NIH award 1R44ES034314-01: Field Instrument for Assessment of Arsenic Exposure ($845,085)", "source_url": "https://reporter.nih.gov/project-details/10484041", "people": [{"name": "Avni A Argun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "sbir:DOD:FA8649-23-P-0516", "company": "Simx, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2023-02-07", "observed": "2026-09-18", "amount_usd": 1249900, "summary": "DOD SBIR Phase II award $1,249,900: Virtual Reality-based Prolonged Casualty Care Training for Multi-Capable Airmen", "source_url": "https://www.sbir.gov/awards?search=F2D-7563"}, {"id": "nih:5R41AI167224-02", "company": "Computer Technology Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-06", "observed": "2026-08-21", "amount_usd": 298130, "summary": "NIH award 5R41AI167224-02: Biomarker-enhanced Artificial Intelligence-Based Pediatric Sepsis Screening Tool Towards Early Recognition and Personalized Therapeutics ($298,130)", "source_url": "https://reporter.nih.gov/project-details/10579339", "people": [{"name": "Ioannis Koutroulis", "role": "Principal Investigator"}, {"name": "Carmelo Velez", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43DE032549-01", "company": "Cellectgen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-03", "observed": "2026-08-21", "amount_usd": 320606, "summary": "NIH award 1R43DE032549-01: DEVELOPMENT OF A SALIVARY ASSAY FOR MEASURING PERIODONTAL DISEASE ACTIVITY ($320,606)", "source_url": "https://reporter.nih.gov/project-details/10600906", "people": [{"name": "Robert Gellibolian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44MH129023-02", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-03", "observed": "2026-08-21", "amount_usd": 998922, "summary": "NIH award 4R44MH129023-02: Microscope system for large scale optical imaging of neuronal activity using kilohertz frame rates ($998,922)", "source_url": "https://reporter.nih.gov/project-details/10541683", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43HL164136-01A1S1", "company": "Karios Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-03", "observed": "2026-08-21", "amount_usd": 6500, "summary": "NIH award 3R43HL164136-01A1S1: A Sprayable Tissue-Binding Hydrogel to Prevent Postsurgical Cardiac Adhesions ($6,500)", "source_url": "https://reporter.nih.gov/project-details/10759613", "people": [{"name": "Gregory Grover", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:7R44MD014923-03", "company": "Joyuus, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-03", "observed": "2026-08-21", "amount_usd": 864828, "summary": "NIH award 7R44MD014923-03: Joyuus: A Web-based Tool for Postpartum Care Self-care to Address the Complex Needs of Underserved Women ($864,828)", "source_url": "https://reporter.nih.gov/project-details/10728456", "people": [{"name": "Lisa Marceau", "role": "Principal Investigator"}, {"name": "Kristine Merz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AG080853-01", "company": "Kinima, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-03", "observed": "2026-08-21", "amount_usd": 259964, "summary": "NIH award 1R43AG080853-01: Augmented Reality Personalized Motion Tracking Assessment and Improvement Technology for Fall Prevention for the Spanish Speaking Hispanic/Latino Population in a Community Setting Using Mobile Phone ($259,964)", "source_url": "https://reporter.nih.gov/project-details/10601526", "people": [{"name": "Renee Migdal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220044", "company": "InBios International, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-02-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220044 granted: Active Anthrax DetectTM Plus Rapid Test", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220044"}, {"id": "nih:3R41HL160317-01A1S1", "company": "Zbeats, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-02", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R41HL160317-01A1S1: Feasibility testing of a novel AI-enabled, cloud-based ECG diagnostic solution to enable fast and affordable diagnosis in long-term continuous ambulatory ECG monitoring ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10742360", "people": [{"name": "Bin Fang", "role": "Principal Investigator"}, {"name": "Puja Parikh", "role": "Principal Investigator"}, {"name": "Elinor R. Schoenfeld", "role": "Principal Investigator"}, {"name": "Gan-Xin Yan", "role": "Principal Investigator"}, {"name": "Peng Zhang", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43MH126793-02", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-01", "observed": "2026-08-21", "amount_usd": 164922, "summary": "NIH award 5R43MH126793-02: A Mobile Text Approach to Measurement and Feedback for Wraparound Care Coordination ($164,922)", "source_url": "https://reporter.nih.gov/project-details/10570236", "people": [{"name": "ERIC J. BRUNS", "role": "Principal Investigator"}, {"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL152825-03", "company": "Minnesota Healthsolutions Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-01", "observed": "2026-08-21", "amount_usd": 935869, "summary": "NIH award 5R44HL152825-03: Clinical Decision Support for Assessing Pulmonary Embolism using Machine Learning ($935,869)", "source_url": "https://reporter.nih.gov/project-details/10576273", "people": [{"name": "Kevin M. Kramer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44GM149063-01", "company": "Ferrologix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-02-01", "observed": "2026-08-21", "amount_usd": 921412, "summary": "NIH award 1R44GM149063-01: Functionally Closed Purification and Elution of Untouched Cells using Cleavable Magnetic Beads with Digital Magnetic Sorting ($921,412)", "source_url": "https://reporter.nih.gov/project-details/10603997", "people": [{"name": "Coleman Murray", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220014", "company": "Reflexion Medical, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2023-02-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220014 granted: RefleXion Medical Radiotherapy System (R", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220014"}, {"id": "breakthrough:DEN220014", "company": "Reflexion Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2023-02-01", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220014: REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43AG080844-01", "company": "Aptus Biosciences LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-31", "observed": "2026-08-21", "amount_usd": 445554, "summary": "NIH award 1R43AG080844-01: Diagnostic aptamer reagents to develop multi-analyte blood test for pre-clinical, mild and moderate Alzheimer's disease ($445,554)", "source_url": "https://reporter.nih.gov/project-details/10597840", "people": [{"name": "BHARAT GAWANDE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM139467-03", "company": "E-msion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-31", "observed": "2026-08-21", "amount_usd": null, "summary": "NIH award 5R44GM139467-03: An adaptive compute solution for characterizing macromolecular complexes by mass spectrometry with electron-based fragmentation ($1)", "source_url": "https://reporter.nih.gov/project-details/10581698", "people": [{"name": "Adrian Guthals", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44MH125238-03", "company": "Istovisr", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-31", "observed": "2026-08-21", "amount_usd": 798921, "summary": "NIH award 2R44MH125238-03: Scaling Volumetric Imaging, Analysis and Science Communication Using Immersive Virtual Reality ($798,921)", "source_url": "https://reporter.nih.gov/project-details/10604786", "people": [{"name": "Gianfranco Doretto", "role": "Principal Investigator"}, {"name": "Michael David Morehead", "role": "Principal Investigator"}, {"name": "GEORGE A SPIROU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AI167334-02", "company": "Arc Bio, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-30", "observed": "2026-08-21", "amount_usd": 931074, "summary": "NIH award 5R44AI167334-02: Development and validation of a sample-to-answer metagenomics workflow for comprehensive pathogen detection in central nervous system infections ($931,074)", "source_url": "https://reporter.nih.gov/project-details/10560552", "people": [{"name": "Stephane Gourguechon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH119842-03", "company": "Cytocybernetics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-30", "observed": "2026-08-21", "amount_usd": 858855, "summary": "NIH award 5R44MH119842-03: Advanced Dynamic Clamp for Neuroscience ($858,855)", "source_url": "https://reporter.nih.gov/project-details/10577885", "people": [{"name": "Mark W Nowak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44EY033565-02", "company": "Injectsense, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-27", "observed": "2026-08-21", "amount_usd": 624000, "summary": "NIH award 5R44EY033565-02: iOP-Connect System for Long-Term Continuous Monitoring of Glaucoma Therapy by means of an Implantable Autonomous Intraocular Pressure Sensor ($624,000)", "source_url": "https://reporter.nih.gov/project-details/10556408", "people": [{"name": "Kevin Douglas BERG", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R41DA057798-01S1", "company": "Hava Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-27", "observed": "2026-08-21", "amount_usd": 54670, "summary": "NIH award 3R41DA057798-01S1: Hale: A Mobile-Connected Medical Vaporizer that Alleviates Nicotine Dependence ($54,670)", "source_url": "https://reporter.nih.gov/project-details/10740808", "people": [{"name": "Joshua Israel", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44DA056277-01S1", "company": "Rescue Biomedical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-27", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R44DA056277-01S1: ICORPS: User-centric development of closed-loop therapy for opioid overdose ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10742328", "people": [{"name": "Hyowon Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44MH131514-01S1", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-27", "observed": "2026-08-21", "amount_usd": 54991, "summary": "NIH award 3R44MH131514-01S1: ICORPs Support for Development of an Acoustic Implant Protection System to Improve Performance and Longevity of Neural Interfaces ($54,991)", "source_url": "https://reporter.nih.gov/project-details/10739498", "people": [{"name": "Maureen L. Mulvihill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44HL145950-03S2", "company": "City Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-26", "observed": "2026-08-21", "amount_usd": 41924, "summary": "NIH award 3R44HL145950-03S2: Leadless Pacemaker Betavoltaic Power Source ($41,924)", "source_url": "https://reporter.nih.gov/project-details/10741896", "people": [{"name": "Peter Cabauy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AG080940-01", "company": "Spark Neuro Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-26", "observed": "2026-08-21", "amount_usd": 1314973, "summary": "NIH award 1R44AG080940-01: Developing a novel EEG-based index for evaluating amyloid and tau burden in Alzheimer's Disease ($1,314,973)", "source_url": "https://reporter.nih.gov/project-details/10602059", "people": [{"name": "Che Lucero", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44HL145950-03S1", "company": "City Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-25", "observed": "2026-08-21", "amount_usd": 34163, "summary": "NIH award 3R44HL145950-03S1: Leadless Pacemaker Betavoltaic Power Source ($34,163)", "source_url": "https://reporter.nih.gov/project-details/10741913", "people": [{"name": "Peter Cabauy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HD103159-03", "company": "Nextgenjane, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-25", "observed": "2026-08-21", "amount_usd": 401530, "summary": "NIH award 5R44HD103159-03: Developing a non-invasive, definitive diagnostic for endometriosis using biomarkers in menstrual effluence ($401,530)", "source_url": "https://reporter.nih.gov/project-details/10569047", "people": [{"name": "Stephen Gire", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AG081111-01", "company": "Outlier Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-25", "observed": "2026-08-21", "amount_usd": 504505, "summary": "NIH award 1R43AG081111-01: A Gesture-Powered Software Platform of Neurologic Music Therapy Games and Puzzles: To Stimulate Neuroplasticity and Prolong Functional Independence in Individuals Diagnosed with Alzheimer's Disease ($504,505)", "source_url": "https://reporter.nih.gov/project-details/10611831", "people": [{"name": "Peter Gray", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM145195-02", "company": "Omicscraft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-25", "observed": "2026-08-21", "amount_usd": 997931, "summary": "NIH award 5R44GM145195-02: MetaboQuest: A Suite of Tools for Metabolite Annotation ($997,931)", "source_url": "https://reporter.nih.gov/project-details/10570907", "people": [{"name": "Dawit Mengistu", "role": "Principal Investigator"}, {"name": "Habtom W Ressom", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM135957-03", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-24", "observed": "2026-08-21", "amount_usd": 799247, "summary": "NIH award 5R44GM135957-03: Ultra-sensitive Vapor Phase Hydrogen Peroxide Sensor for Decontaminating Pharmaceutical Manufacturing Facilities ($799,247)", "source_url": "https://reporter.nih.gov/project-details/10557857", "people": [{"name": "Brian E Brumfield", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42MH125688-02", "company": "Miresource, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-20", "observed": "2026-08-21", "amount_usd": 499858, "summary": "NIH award 4R42MH125688-02: Automated Mental Health Referral System ($499,858)", "source_url": "https://reporter.nih.gov/project-details/10685663", "people": [{"name": "Arno Klein", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH114773-04", "company": "Habitaware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-20", "observed": "2026-08-21", "amount_usd": 878966, "summary": "NIH award 5R44MH114773-04: Technology Assisted Treatment for Trichotillomania ($878,966)", "source_url": "https://reporter.nih.gov/project-details/10559586", "people": [{"name": "Christopher A. Flessner", "role": "Principal Investigator"}, {"name": "Sameer Kumar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44AG047722-07", "company": "Posit Science Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-20", "observed": "2026-08-21", "amount_usd": 924904, "summary": "NIH award 2R44AG047722-07: Phase IIB Plasticity-based Adaptive Cognitive Remediation for Alzheimers Disease ($924,904)", "source_url": "https://reporter.nih.gov/project-details/10603717", "people": [{"name": "Hyun Kyu Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "nih:4R44DA050214-02", "company": "Chess Mobile Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-20", "observed": "2026-08-21", "amount_usd": 778865, "summary": "NIH award 4R44DA050214-02: An innovative platform and smartphone app to deliver tailored interventions and facilitate completed referrals related to substance use. ($778,865)", "source_url": "https://reporter.nih.gov/project-details/10713171", "people": [{"name": "Lisa Ellen Graves", "role": "Principal Investigator"}, {"name": "Hans Morefield", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM139438-03", "company": "Qatch Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-19", "observed": "2026-08-21", "amount_usd": 901343, "summary": "NIH award 5R44GM139438-03: Developing prototype injectability and developability testing system based on microfluidic quartz resonators ($901,343)", "source_url": "https://reporter.nih.gov/project-details/10569024", "people": [{"name": "Zehra Parlak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AI155075-03", "company": "Jan Biotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-18", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI155075-03: Sequence-based RNA Fluorescence Assay to Measure Latent HIV Reservoirs ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10561679", "people": [{"name": "Janet L Huie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41HD109072-01", "company": "Auscultech Dx, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-18", "observed": "2026-08-21", "amount_usd": 256322, "summary": "NIH award 1R41HD109072-01: Development of a portable beat-to-beat fetal ECG system ($256,322)", "source_url": "https://reporter.nih.gov/project-details/10483922", "people": [{"name": "Anita Krishnan", "role": "Principal Investigator"}, {"name": "Raj Shekhar", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43MD017188-01S1", "company": "Castner Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-17", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43MD017188-01S1: Precision Assessment Algorithm for Reducing Disaster-related Respiratory Health Disparities ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10764033", "people": [{"name": "Jessica Castner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG081006-01", "company": "Melax Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-17", "observed": "2026-08-21", "amount_usd": 1121445, "summary": "NIH award 1R44AG081006-01: Clinical Decision Support System for Early Detection of Cognitive Decline Using Electronic Health Records and Deep Learning ($1,121,445)", "source_url": "https://reporter.nih.gov/project-details/10603902", "people": [{"name": "Jingcheng Du", "role": "Principal Investigator"}, {"name": "Frank J Manion", "role": "Principal Investigator"}, {"name": "Li Zhou", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43TR004327-01", "company": "Desicorp, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-16", "observed": "2026-08-21", "amount_usd": 281873, "summary": "NIH award 1R43TR004327-01: Developing a High-Flow Acoustofluidic Loading Platform for Research Cell Stabilization in the Anhydrous State ($281,873)", "source_url": "https://reporter.nih.gov/project-details/10603701", "people": [{"name": "Brett R Janis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44NS120591-02", "company": "Brain Electrophysiology Laboratory Company, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-11", "observed": "2026-08-21", "amount_usd": 575380, "summary": "NIH award 4R44NS120591-02: Sourcerer IC: A Web-Based Integrative Multi-Modal Workflow for Epilepsy Surgical Planning ($575,380)", "source_url": "https://reporter.nih.gov/project-details/10710319", "people": [{"name": "PHAN LUU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44HL146012-03S2", "company": "Convergent Engineering, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-09", "observed": "2026-08-21", "amount_usd": 52478, "summary": "NIH award 3R44HL146012-03S2: RT Assistant - handheld patient safety tool for mechanical ventilation ($52,478)", "source_url": "https://reporter.nih.gov/project-details/10755397", "people": [{"name": "Neil R. Euliano", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44GM139468-02", "company": "Doty Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-05", "observed": "2026-08-21", "amount_usd": 860734, "summary": "NIH award 2R44GM139468-02: A Novel Waveguide to Enable MAS-DNP-NMR in Standard-bore High-field Magnets ($860,734)", "source_url": "https://reporter.nih.gov/project-details/10602643", "people": [{"name": "Francis DAVID Doty", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI142886-03", "company": "Cleu Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-03", "observed": "2026-08-21", "amount_usd": 470755, "summary": "NIH award 5R44AI142886-03: RAPID ELECTROCHEMICAL BIOSENSOR FOR POINT-OF-CARE DIAGNOSIS OF JOINT INFECTION ($470,755)", "source_url": "https://reporter.nih.gov/project-details/10570823", "people": [{"name": "Andrew Neil Fleischman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44NS130769-01", "company": "Drinksavvy, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2023-01-02", "observed": "2026-08-21", "amount_usd": 840440, "summary": "NIH award 1R44NS130769-01: Development of a Colorimetric Sensor for Detection of Cerebrospinal Fluid Leaks ($840,440)", "source_url": "https://reporter.nih.gov/project-details/10602859", "people": [{"name": "Min Hu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44HL146012-03S1", "company": "Convergent Engineering, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-24", "observed": "2026-08-21", "amount_usd": 73140, "summary": "NIH award 3R44HL146012-03S1: RT Assistant - handheld patient safety tool for mechanical ventilation ($73,140)", "source_url": "https://reporter.nih.gov/project-details/10748727", "people": [{"name": "Neil R. Euliano", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:6R43CK000679-01M002", "company": "Nanohmics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-23", "observed": "2026-08-21", "amount_usd": 218000, "summary": "NIH award 6R43CK000679-01M002: Lateral Flow-Electrochemiluminescent (LF-ECL) Test Strips and Portable Reader for Ultrasensitive Foodborne Pathogen Detection ($218,000)", "source_url": "https://reporter.nih.gov/project-details/10757758", "people": [{"name": "John Bruno", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220017", "company": "Nanovi A/S", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-12-23", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220017 granted: BioXmark", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220017"}, {"id": "breakthrough:K222774", "company": "Si-bone, Inc", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-12-22", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K222774: IFUSE BEDROCK GRANITE IMPLANT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R44AG074840-01A1S1", "company": "Myolex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-21", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44AG074840-01A1S1: Accurate and rapid assessment of sarcopenia in older adults through electrical impedance myography - Development of Regulatory Plans Supplement ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10700526", "people": [{"name": "William David Arnold", "role": "Principal Investigator"}, {"name": "Brian C Clark", "role": "Principal Investigator"}, {"name": "Elmer C Lupton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220012", "company": "Tornier S.A.S.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-12-16", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220012 granted: Tornier Pyrocarbon Humeral Head", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220012"}, {"id": "nih:1R41TR004320-01", "company": "Penderia Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-15", "observed": "2026-08-21", "amount_usd": 256223, "summary": "NIH award 1R41TR004320-01: Novel Pigment Sensing Pulse Oximeter Technology for Mitigating Racial Bias in Oxygen Saturation Measurements ($256,223)", "source_url": "https://reporter.nih.gov/project-details/10599746", "people": [{"name": "Michael McGeehan", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK134864-01", "company": "Wave 80 Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-13", "observed": "2026-08-21", "amount_usd": 299930, "summary": "NIH award 1R43DK134864-01: Multi-Platform Homogeneous Multiplexed Autoantibody Assay Based on Liquid Micropiston-Enhanced Time-Resolved Forster Resonance Energy Transfer ($299,930)", "source_url": "https://reporter.nih.gov/project-details/10576777", "people": [{"name": "Amy Droitcour", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG062069-04A1", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-13", "observed": "2026-08-21", "amount_usd": 885288, "summary": "NIH award 2R44AG062069-04A1: Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy (KneeBRIGHT) ($885,288)", "source_url": "https://reporter.nih.gov/project-details/10603260", "people": [{"name": "Eileen T. Krepkovich", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44HL152912-03", "company": "Cognita Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-09", "observed": "2026-08-21", "amount_usd": 772672, "summary": "NIH award 5R44HL152912-03: SonoHeal: Smart Resonating Closed-loop Airway Clearance Technology ($772,672)", "source_url": "https://reporter.nih.gov/project-details/10532248", "people": [{"name": "Rajoshi Biswas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R43HL160238-01A1S1", "company": "Mddriven LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-08", "observed": "2026-08-21", "amount_usd": 6500, "summary": "NIH award 3R43HL160238-01A1S1: A HANDS-FREE LUNG AND CARDIOVASCULAR ASSESSMENT DEVICE (LCAD) FOR THE REMOTE CARE OF PATIENTS WITH CHRONIC CARDIOPULMONARY CONDITIONS ($6,500)", "source_url": "https://reporter.nih.gov/project-details/10746641", "people": [{"name": "Wilman Rene Ortega", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "breakthrough:K221842", "company": "Roche Diagonostics", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-12-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K221842: ELECSYS B-AMYLOID (1-42) CSF II, ELECSYS PHOSPHO-TAU (181P) CSF", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43AI174666-01", "company": "N8 Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-02", "observed": "2026-08-21", "amount_usd": 258455, "summary": "NIH award 1R43AI174666-01: Ceragenin-coated pedicle screws to tackle surgical-site infections. ($258,455)", "source_url": "https://reporter.nih.gov/project-details/10602633", "people": [{"name": "Glenn Brunner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43ES034322-01A1", "company": "Dl Adv-tech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-02", "observed": "2026-08-21", "amount_usd": 258999, "summary": "NIH award 1R43ES034322-01A1: Multiplexed biosensor for personal wildfire exposure assessment ($258,999)", "source_url": "https://reporter.nih.gov/project-details/10601152", "people": [{"name": "Dan (Annie) Du", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44HL149561-03S1", "company": "Aventusoft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-02", "observed": "2026-08-21", "amount_usd": 74836, "summary": "NIH award 3R44HL149561-03S1: Administrative Supplement to Promote Diversity in Research and Development Small Businesses-SBIR (EF) ($74,836)", "source_url": "https://reporter.nih.gov/project-details/10670792", "people": [{"name": "Kaustubh Kale", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42MD015915-03", "company": "Fetal Life, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-12-01", "observed": "2026-08-21", "amount_usd": 629140, "summary": "NIH award 5R42MD015915-03: Portable Affordable Innovative and Smart Device-Coupled Electronic Fetal Monitoring System to Improve Rural Access to Obstetrics Services and Improve Outcomes in Rural Communities ($629,140)", "source_url": "https://reporter.nih.gov/project-details/10570927", "people": [{"name": "Sundeep Dronawat", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42GM144999-02", "company": "Cohere-med, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-11-30", "observed": "2026-08-21", "amount_usd": 912755, "summary": "NIH award 4R42GM144999-02: Solving Sepsis: Early Identification and Prompt Management Using Machine Learning ($912,755)", "source_url": "https://reporter.nih.gov/project-details/10623375", "people": [{"name": "Manesh R Patel", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44AG076067-02", "company": "Life Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-11-23", "observed": "2026-08-21", "amount_usd": 1233110, "summary": "NIH award 4R44AG076067-02: Optimization of an at-home continuous multi-domain monitoring and assessment system to improve Alzheimer's and related disorders clinical trials ($1,233,110)", "source_url": "https://reporter.nih.gov/project-details/10725397", "people": [{"name": "Lawrence J Frye", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "breakthrough:K222463", "company": "Ultromics Limited", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-11-23", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K222463: ECHOGO HEART FAILURE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44DK129097-03", "company": "3dt Holdings, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-11-22", "observed": "2026-08-21", "amount_usd": 854130, "summary": "NIH award 5R44DK129097-03: Biomechatronics Device for Diagnosis/Therapy of Anorectal Disorders ($854,130)", "source_url": "https://reporter.nih.gov/project-details/10551849", "people": [{"name": "William Combs", "role": "Principal Investigator"}, {"name": "Hans Gregersen", "role": "Principal Investigator"}, {"name": "GHASSAN S KASSAB", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "breakthrough:K222237", "company": "Cala Health, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-11-22", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K222237: CALA KIQ", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K222009", "company": "Carlsmed, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-11-22", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K222009: APREVO ANTERIOR LUMBAR INTERBODY FUSION DEVICE WITH INTERFIXATION", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R44HL151094-03S2", "company": "Curi Bio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-11-15", "observed": "2026-08-21", "amount_usd": 169156, "summary": "NIH award 3R44HL151094-03S2: Predictive assessment of acute and chronic cardiotoxicity using combinatorially matured hPSC-CMs ($169,156)", "source_url": "https://reporter.nih.gov/project-details/10711373", "people": [{"name": "Nicholas Andrew Geisse", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R43AI167169-02", "company": "Jbs Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-11-14", "observed": "2026-08-21", "amount_usd": 298793, "summary": "NIH award 5R43AI167169-02: Novel assay to detect integrated HBV DNA in urine of chronic hepatitis B patients ($298,793)", "source_url": "https://reporter.nih.gov/project-details/10539333", "people": [{"name": "Selena Lin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "denovo:DEN200044", "company": "Perkinelmer, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-11-09", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200044 granted: Eonis SCID-SMA Kit", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200044"}, {"id": "sbir:DOD:FA8649-23-P-0212", "company": "Simx, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-11-01", "observed": "2026-09-18", "amount_usd": 74972, "summary": "DOD SBIR Phase I award $74,972: CASEVAC Medical Simulation Training for Combat Casualty Care using Virtual Reality", "source_url": "https://www.sbir.gov/awards?search=FX224-OCSO1-0644"}, {"id": "breakthrough:K221218", "company": "Argentum Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-10-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K221218: SILVERLON WOUND CONTACT, BURN CONTACT DRESSINGS", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "denovo:DEN220024", "company": "Intelligent Ultrasound Limited", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-10-18", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220024 granted: ScanNav Anatomy Peripheral Nerve Block", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220024"}, {"id": "denovo:DEN210027", "company": "Braincool AB", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-10-14", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210027 granted: The Cooral System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210027"}, {"id": "breakthrough:DEN210027", "company": "Braincool Ab", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-10-14", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN210027: THE COORAL SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "denovo:DEN200067", "company": "Siemens Healthcare Diagnostics Products", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-09-29", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200067 granted: INNOVANCE VWF Ac", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200067"}, {"id": "nih:1R43FD007584-01", "company": "Triple Ring Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-27", "observed": "2026-08-21", "amount_usd": 198918, "summary": "NIH award 1R43FD007584-01: Virtual dose mapping for radiation sterilization ($198,918)", "source_url": "https://reporter.nih.gov/project-details/10541758", "people": [{"name": "TOBIAS FUNK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44FD006891-02A1", "company": "Venarum Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-26", "observed": "2026-08-21", "amount_usd": 831482, "summary": "NIH award 2R44FD006891-02A1: K9-ICT: A Novel Urethral Valve Treatment for Canine Urinary Incontinence ($831,482)", "source_url": "https://reporter.nih.gov/project-details/10484548", "people": [{"name": "Janet Galtes", "role": "Principal Investigator"}, {"name": "Taylor Kirk", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43MD017545-01", "company": "Medentum Innovations Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-26", "observed": "2026-08-21", "amount_usd": 259453, "summary": "NIH award 1R43MD017545-01: Building a Digital Respiratory Disease Framework for COPD management in Central Appalachia ($259,453)", "source_url": "https://reporter.nih.gov/project-details/10480681", "people": [{"name": "STARLA KISER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG078073-01A1", "company": "Early Alzheimer's Diagnostics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-26", "observed": "2026-08-21", "amount_usd": 306974, "summary": "NIH award 1R41AG078073-01A1: Screening for Alzheimer's Disease Based on Raman Spectroscopy of Blood ($306,974)", "source_url": "https://reporter.nih.gov/project-details/10547295", "people": [{"name": "IGOR K LEDNEV", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD018300-01", "company": "Dance4healing, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-26", "observed": "2026-08-21", "amount_usd": 259611, "summary": "NIH award 1R43MD018300-01: Dance4Healing: a feasibility study to reduce health disparity and increase engagement of an intergenerational telehealth program for minority diabetes patients and their care partners. ($259,611)", "source_url": "https://reporter.nih.gov/project-details/10604415", "people": [{"name": "Amy chunmei Li", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG080843-01", "company": "Silverbills Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-26", "observed": "2026-08-21", "amount_usd": 1405894, "summary": "NIH award 1R44AG080843-01: SilverBills: A Legal, Technical and Financial Tool for Aging LGBTQ+ Individuals with Impaired Cognition. ($1,405,894)", "source_url": "https://reporter.nih.gov/project-details/10600935", "people": [{"name": "Eric Chess", "role": "Principal Investigator"}, {"name": "Marci Lobel-Esrig", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44FD006910-02", "company": "Nanohmics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-26", "observed": "2026-08-21", "amount_usd": 585293, "summary": "NIH award 2R44FD006910-02: Polarization Metasurface Detection Device for Food Safety ($585,293)", "source_url": "https://reporter.nih.gov/project-details/10603716", "people": [{"name": "Mark E. Lucente", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43MD018240-01", "company": "Orthocare Innovations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-25", "observed": "2026-08-21", "amount_usd": 258768, "summary": "NIH award 1R43MD018240-01: Miasano: Mobile Health App for Improved Evidence-Based Rehabilitation Outcomes and Multi-Lingual Clinical Interactions ($258,768)", "source_url": "https://reporter.nih.gov/project-details/10601742", "people": [{"name": "David A Boone", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD018244-01", "company": "Environment And Health Group, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-25", "observed": "2026-08-21", "amount_usd": 328562, "summary": "NIH award 1R43MD018244-01: Integrated Clinic and Patient Technology-Enabled Program to Reduce the Risks of Cardiometabolic Disease Among Latinas with Prior Pregnancy Complications ($328,562)", "source_url": "https://reporter.nih.gov/project-details/10601518", "people": [{"name": "Dharma E CORTES", "role": "Principal Investigator"}, {"name": "Ellen W Seely", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MD016829-01A1", "company": "Benten Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-25", "observed": "2026-08-21", "amount_usd": 915801, "summary": "NIH award 1R44MD016829-01A1: Knowledge and Usage of Lactation using Education and Advice from Support Network (KULEA-NET) ($915,801)", "source_url": "https://reporter.nih.gov/project-details/10484245", "people": [{"name": "W. DOUGLAS EVANS", "role": "Principal Investigator"}, {"name": "Tony Xuyen Ma", "role": "Principal Investigator"}, {"name": "Loral Patchen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS127710-01A1", "company": "Modendo Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-24", "observed": "2026-08-21", "amount_usd": 450000, "summary": "NIH award 1R43NS127710-01A1: Multi-probe minimally invasive endomicroscope ($450,000)", "source_url": "https://reporter.nih.gov/project-details/10604023", "people": [{"name": "Antonio Miguel Caravaca Aguirre", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HL144214-02", "company": "Inspired Therapeutics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-24", "observed": "2026-08-21", "amount_usd": 1002565, "summary": "NIH award 2R44HL144214-02: Development of the Inspired Therapeutics NeoMate Mechanical Circulatory Support System for Neonates and Infants ($1,002,565)", "source_url": "https://reporter.nih.gov/project-details/10547304", "people": [{"name": "Kurt A Dasse", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R42AG080886-01", "company": "Tritonx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-24", "observed": "2026-08-21", "amount_usd": 259939, "summary": "NIH award 1R42AG080886-01: Clinical effectiveness of a wearable hydration device ($259,939)", "source_url": "https://reporter.nih.gov/project-details/10603046", "people": [{"name": "Eamon Johnson", "role": "Principal Investigator"}, {"name": "Joseph Piktel", "role": "Principal Investigator"}, {"name": "MARY Joan ROACH", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD018239-01", "company": "Rush River Research Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-24", "observed": "2026-08-21", "amount_usd": 299587, "summary": "NIH award 1R43MD018239-01: Modernized Culturally Sensitive Family Medical History Tool ($299,587)", "source_url": "https://reporter.nih.gov/project-details/10601751", "people": [{"name": "Julie Lundstrom", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R42AG058336-02A1", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-23", "observed": "2026-08-21", "amount_usd": 731897, "summary": "NIH award 2R42AG058336-02A1: Care Assistant for Family Caregivers of Persons with Dementia During Out of the Home Activities ($731,897)", "source_url": "https://reporter.nih.gov/project-details/10481764", "people": [{"name": "Shane M. Anderson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41AG080977-01", "company": "Headwaters Innovation, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-23", "observed": "2026-08-21", "amount_usd": 265844, "summary": "NIH award 1R41AG080977-01: Early detection and monitoring of Alzheimers Disease and Related Dementias using non-semantic linguistic and acoustic features of speech derived from hearing aids ($265,844)", "source_url": "https://reporter.nih.gov/project-details/10600233", "people": [{"name": "Brian John Bischoff", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG060861-02", "company": "Adm Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-23", "observed": "2026-08-21", "amount_usd": 1044935, "summary": "NIH award 2R44AG060861-02: Multi-modal machine learning detection and tracking of traumatic brain injury neurodegeneration and its differentiation from Alzheimer's disease ($1,044,935)", "source_url": "https://reporter.nih.gov/project-details/10604087", "people": [{"name": "ANA S LUKIC", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43MD018236-01", "company": "Benten Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-23", "observed": "2026-08-21", "amount_usd": 398457, "summary": "NIH award 1R43MD018236-01: MommaConnect, a mobile health platform (mHealth) based on our evidence-based Mother-Baby Connections (MBC) perinatal mental health program ($398,457)", "source_url": "https://reporter.nih.gov/project-details/10601772", "people": [{"name": "June Andrews Horowitz", "role": "Principal Investigator"}, {"name": "Tony Xuyen Ma", "role": "Principal Investigator"}, {"name": "Barbara Posmontier", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HG012298-01A1", "company": "Goeppert, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-23", "observed": "2026-08-21", "amount_usd": 141406, "summary": "NIH award 1R43HG012298-01A1: Multilayer Device for Sequencing DNA Through a Solid-State Nanopore ($141,406)", "source_url": "https://reporter.nih.gov/project-details/10483455", "people": [{"name": "David John Niedzwiecki", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS132529-01", "company": "Neurocomp Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-23", "observed": "2026-08-21", "amount_usd": 243096, "summary": "NIH award 1R43NS132529-01: Cerebral Palsy Risk Identification System ($243,096)", "source_url": "https://reporter.nih.gov/project-details/10545159", "people": [{"name": "JAMES P O'HALLORAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD018326-01", "company": "Moai Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-23", "observed": "2026-08-21", "amount_usd": 275632, "summary": "NIH award 1R43MD018326-01: Minority and Underserved Youth Learning about Concussions through Virtual Environments ($275,632)", "source_url": "https://reporter.nih.gov/project-details/10595833", "people": [{"name": "Olu Olofinboba", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK135139-01", "company": "Intrinsic Lifesciences, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-23", "observed": "2026-08-21", "amount_usd": 960522, "summary": "NIH award 1R44DK135139-01: Novel Point-of-Care Device for Urinary Hepcidin to Detect Iron Deficiency in Children and Adolescents ($960,522)", "source_url": "https://reporter.nih.gov/project-details/10597914", "people": [{"name": "Vaughn E Ostland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R42AG078721-01", "company": "Gateway Biotechnology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-23", "observed": "2026-08-21", "amount_usd": 555803, "summary": "NIH award 1R42AG078721-01: Developing a clinical diagnostic tool for age-related cochlear synaptopathy. ($555,803)", "source_url": "https://reporter.nih.gov/project-details/10515554", "people": [{"name": "Joseph Pinkl", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41AR082266-01", "company": "Sintx Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 275747, "summary": "NIH award 1R41AR082266-01: Development and Pre-Clinical Testing of Antimicrobial PEKK/Silicon Nitride Trauma Plates with Carbon Fiber Reinforcement ($275,747)", "source_url": "https://reporter.nih.gov/project-details/10600180", "people": [{"name": "Ryan Bock", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS117294-03", "company": "Noctrix Health, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 1064334, "summary": "NIH award 5R44NS117294-03: Treatment of Restless Legs Syndrome through non-invasive peripheral nerve stimulation ($1,064,334)", "source_url": "https://reporter.nih.gov/project-details/10407653", "people": [{"name": "Jonathan David Charlesworth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HG012724-01", "company": "Goeppert, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 130000, "summary": "NIH award 1R43HG012724-01: METHYL-SENTRY: Proposed feasibility study of a nanopore diagnostic tool with rapid automated measurement of cell free DNA methylation state for clinical cancer evaluation ($130,000)", "source_url": "https://reporter.nih.gov/project-details/10547114", "people": [{"name": "Brian DiPaolo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NR020775-01", "company": "Probari, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 359010, "summary": "NIH award 1R43NR020775-01: Coeus: An information tool to support safe admission to the nursing home ($359,010)", "source_url": "https://reporter.nih.gov/project-details/10545678", "people": [{"name": "Russell Evans", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR081735-01", "company": "Asante Bio LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 247705, "summary": "NIH award 1R43AR081735-01: Knotless Soft Tissue Augments for Improving Arthroscopic Rotator Cuff Repair Biomechanics ($247,705)", "source_url": "https://reporter.nih.gov/project-details/10546104", "people": [{"name": "Michael Paul Francis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB033239-01", "company": "Neurolux, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 259612, "summary": "NIH award 1R43EB033239-01: Wireless Implantable Mechano-Acoustic Recording Device ($259,612)", "source_url": "https://reporter.nih.gov/project-details/10484423", "people": [{"name": "Cameron Good", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41DA057798-01", "company": "Hava Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 278283, "summary": "NIH award 1R41DA057798-01: Hale: A Mobile-Connected Medical Vaporizer that Alleviates Nicotine Dependence ($278,283)", "source_url": "https://reporter.nih.gov/project-details/10601467", "people": [{"name": "Joshua Israel", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR082160-01", "company": "Algometrx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 272392, "summary": "NIH award 1R43AR082160-01: Development of a novel technology for the determination of a physiologic phenotype in patients with Systemic Lupus Erythematosus ($272,392)", "source_url": "https://reporter.nih.gov/project-details/10597545", "people": [{"name": "Julia Cole Finkel", "role": "Principal Investigator"}, {"name": "Kevin Jackson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42HD104325-02", "company": "Recupero Robotics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 718313, "summary": "NIH award 4R42HD104325-02: Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES) ($718,313)", "source_url": "https://reporter.nih.gov/project-details/10675319", "people": [{"name": "MICHELLE J. JOHNSON", "role": "Principal Investigator"}, {"name": "Alwyn P. Johnson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL162148-01", "company": "Boundless Science, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 299996, "summary": "NIH award 1R43HL162148-01: Aerosol Ventilation to Reduce Ventilator Induced Lung Injury ($299,996)", "source_url": "https://reporter.nih.gov/project-details/10383334", "people": [{"name": "Andrew Jones", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK133012-01A1", "company": "Tybr Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 269911, "summary": "NIH award 1R43DK133012-01A1: Improving the safety and effectiveness of adhesion prevention following colorectal procedures with high risk of cancer or infection ($269,911)", "source_url": "https://reporter.nih.gov/project-details/10603903", "people": [{"name": "Timothy Joseph Keane", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HD111289-01", "company": "Elite Athlete Products Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 344843, "summary": "NIH award 1R41HD111289-01: NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait ($344,843)", "source_url": "https://reporter.nih.gov/project-details/10611686", "people": [{"name": "CHANDRAMOULI KRISHNAN", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DK117813-06", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 1047462, "summary": "NIH award 2R44DK117813-06: Active Disposable Cap for Endoscope Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps ($1,047,462)", "source_url": "https://reporter.nih.gov/project-details/10611153", "people": [{"name": "Maureen L. Mulvihill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R43EB033718-01", "company": "Solid Material Solutions, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-22", "observed": "2026-08-21", "amount_usd": 359464, "summary": "NIH award 1R43EB033718-01: Superconducting scanner magnet for much lower cost, compact proton therapy systems ($359,464)", "source_url": "https://reporter.nih.gov/project-details/10546708", "people": [{"name": "Alexander Otto", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41GM148112-01", "company": "Blotting Innovations, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 288767, "summary": "NIH award 1R41GM148112-01: Accessible and Robust High-Throughput Western Blotting for Small Sample Sizes ($288,767)", "source_url": "https://reporter.nih.gov/project-details/10545990", "people": [{"name": "Marc R. Birtwistle", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA268466-02", "company": "Doseoptics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 1000002, "summary": "NIH award 2R44CA268466-02: Ultra-fast imaging for the safe delivery of electron FLASH radiation therapy ($1,000,002)", "source_url": "https://reporter.nih.gov/project-details/10603353", "people": [{"name": "Petr Bruza", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL164155-01", "company": "Health In Color, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 254991, "summary": "NIH award 1R43HL164155-01: Managing Adolescent Asthma Virtually (MAAV) ($254,991)", "source_url": "https://reporter.nih.gov/project-details/10481220", "people": [{"name": "Laverne Morrow Carter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG080878-01", "company": "Wellsim Biomedical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 291692, "summary": "NIH award 1R43AG080878-01: EXODOTS for diagnostic evaluation and monitoring of Alzheimer's disease ($291,692)", "source_url": "https://reporter.nih.gov/project-details/10600890", "people": [{"name": "Yuchao Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44NS130864-01", "company": "Neurodex Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 449999, "summary": "NIH award 1R44NS130864-01: Development of a Blood-based Test for Identifying Synucleinopathy in Patients with Dementia ($449,999)", "source_url": "https://reporter.nih.gov/project-details/10602294", "people": [{"name": "Erez Eitan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL164222-01A1", "company": "Linshom Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 360833, "summary": "NIH award 1R44HL164222-01A1: Advanced Prediction of Emerging Respiratory Decline with the Linshom Continuous Predictive Respiratory Sensor (CPRS) ($360,833)", "source_url": "https://reporter.nih.gov/project-details/10546880", "people": [{"name": "Ronen Feldman", "role": "Principal Investigator"}, {"name": "Richard D. Urman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44EB030973-02", "company": "Bridgesource Medical Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 740251, "summary": "NIH award 4R44EB030973-02: Post Cardiac Surgery Hemodynamics Diagnostic Device ($740,251)", "source_url": "https://reporter.nih.gov/project-details/10453483", "people": [{"name": "Anil Kottam", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44DA056277-01", "company": "Rescue Biomedical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 319995, "summary": "NIH award 1R44DA056277-01: User-centric development of closed-loop therapy for opioid overdose ($319,995)", "source_url": "https://reporter.nih.gov/project-details/10485478", "people": [{"name": "Vy Le", "role": "Principal Investigator"}, {"name": "Hyowon Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44DA056316-01A1", "company": "Axcend, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 258624, "summary": "NIH award 1R44DA056316-01A1: Compact Liquid Chromatography for Routine Screening in Drug Treatment Centers ($258,624)", "source_url": "https://reporter.nih.gov/project-details/10599765", "people": [{"name": "MILTON L. LEE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG076186-01", "company": "Benten Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 456161, "summary": "NIH award 1R43AG076186-01: eREACH - Expanding Research and Recruitment by Adults through Community Health workers that automating screenings and referrals plus improving communication and health information delivery ($456,161)", "source_url": "https://reporter.nih.gov/project-details/10384548", "people": [{"name": "Tony Xuyen Ma", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HD111106-01", "company": "Venova Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 300067, "summary": "NIH award 1R41HD111106-01: Development of a novel, non-hormonal female contraceptive device ($300,067)", "source_url": "https://reporter.nih.gov/project-details/10602355", "people": [{"name": "Emily Man", "role": "Principal Investigator"}, {"name": "Katharine O'Connell White", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL162443-01A1", "company": "Atomo, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 251792, "summary": "NIH award 1R44HL162443-01A1: Finding undiagnosed ATTR-CM patients using AI technology in clinical settings ($251,792)", "source_url": "https://reporter.nih.gov/project-details/10481909", "people": [{"name": "Kelly D Myers", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD111134-01", "company": "Autoivf, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-21", "observed": "2026-08-21", "amount_usd": 287875, "summary": "NIH award 1R44HD111134-01: OvaSafe: A microfluidic device enabling automated oocyte vitrification ($287,875)", "source_url": "https://reporter.nih.gov/project-details/10602590", "people": [{"name": "Ismail Emre Ozkumur", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG080889-01", "company": "Adeptrix Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 1040019, "summary": "NIH award 1R44AG080889-01: Multiplexed immunoassay for building patient-specific molecular profiles of CSF amyloid beta and TAU ($1,040,019)", "source_url": "https://reporter.nih.gov/project-details/10602768", "people": [{"name": "Tamil Selvan Anthonymuthu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG050326-03A1", "company": "Advanced Brain Monitoring, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 999922, "summary": "NIH award 2R44AG050326-03A1: Multi-site longitudinal Integrated Neurocognitive and Sleep-Behavior Profiler for the Endophenotypic Classification of Dementia Subtypes (INSPECDS) ($999,922)", "source_url": "https://reporter.nih.gov/project-details/10603714", "people": [{"name": "Chris Berka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HD106824-01A1", "company": "Lactation Lab Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 299671, "summary": "NIH award 1R43HD106824-01A1: Development of a point of care test-strip kit to quantify breastmilk nutrient profile ($299,671)", "source_url": "https://reporter.nih.gov/project-details/10481739", "people": [{"name": "Stephanie Lynne Canale", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG080849-01", "company": "Whiplash Technology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 499814, "summary": "NIH award 1R43AG080849-01: Alzheimer's Family Connection: A Novel Online Community and Personalized Resource Connection for Rural ADRD Caregivers ($499,814)", "source_url": "https://reporter.nih.gov/project-details/10602087", "people": [{"name": "Christian Elliott", "role": "Principal Investigator"}, {"name": "Nicole E Werner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AR082170-01", "company": "G5 Biological Innovations L.l.c.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 178101, "summary": "NIH award 1R41AR082170-01: Intraoperative Kit for AuNP-Tissue Grafts ($178,101)", "source_url": "https://reporter.nih.gov/project-details/10598225", "people": [{"name": "David Grant", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG079777-01", "company": "Bmseed, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 449997, "summary": "NIH award 1R44AG079777-01: A physiologically relevant pre-clinical drug screening platform for Alzheimer's Disease and Traumatic Brain Injury with integrated stretchable microelectrodes ($449,997)", "source_url": "https://reporter.nih.gov/project-details/10482284", "people": [{"name": "Oliver Graudejus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG045011-04", "company": "Function Promoting Therapies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 1008781, "summary": "NIH award 2R44AG045011-04: Phase IIB: Development of TruT Algorithm for Commercialization in Androgen Disorders ($1,008,781)", "source_url": "https://reporter.nih.gov/project-details/10603887", "people": [{"name": "Ravi Jasuja", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44GM146574-01", "company": "Aleo Bme, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 895594, "summary": "NIH award 1R44GM146574-01: SBIR Direct Phase II: Nature Inspired Biphasic Glue for Dura Repair ($895,594)", "source_url": "https://reporter.nih.gov/project-details/10489915", "people": [{"name": "Chao Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG076169-01", "company": "Claritytek, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 445324, "summary": "NIH award 1R43AG076169-01: Virtual Reality Cognitive Therapy for Alzheimer's Disease ($445,324)", "source_url": "https://reporter.nih.gov/project-details/10385270", "people": [{"name": "Razi Masood", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR080477-01A1", "company": "Orthopedic Wellness Laboratories, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 259219, "summary": "NIH award 1R43AR080477-01A1: Cervical Muscle Diagnostic and Conditioning System for Injury Rehabilitation and Prevention ($259,219)", "source_url": "https://reporter.nih.gov/project-details/10480354", "people": [{"name": "James McInnes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HD110310-01A1", "company": "Compact Medical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 299973, "summary": "NIH award 1R41HD110310-01A1: The Butterfly BVM, a Novel Resuscitator to Prevent Hyperventilation in Pediatric Resuscitation ($299,973)", "source_url": "https://reporter.nih.gov/project-details/10603659", "people": [{"name": "Jonathan Merrell", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG060857-05", "company": "Blue Iris Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 1248510, "summary": "NIH award 2R44AG060857-05: A light exposure tracker designed to improve the circadian entrainment for Alzheimer Disease patients ($1,248,510)", "source_url": "https://reporter.nih.gov/project-details/10604198", "people": [{"name": "Erik Page", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44NS115460-03", "company": "Thermaquil, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-20", "observed": "2026-08-21", "amount_usd": 677548, "summary": "NIH award 5R44NS115460-03: Drug Free Nerve Block Device for the Relief of Pain and Symptoms in Migraines and other Headaches ($677,548)", "source_url": "https://reporter.nih.gov/project-details/10493404", "people": [{"name": "Stephen Popielarski", "role": "Principal Investigator"}, {"name": "Hsiangkuo Yuan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL158362-01A1", "company": "Agitated Solutions, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 305538, "summary": "NIH award 1R43HL158362-01A1: Intravenous delivery of oxygen microbubbles for the treatment of hypoxia and ARDS ($305,538)", "source_url": "https://reporter.nih.gov/project-details/10384013", "people": [{"name": "Benjamin Arcand", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR081736-01", "company": "Conquerab Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 258953, "summary": "NIH award 1R43AR081736-01: DISPOSABLE DEVICE FOR RAPID POINT-OF-CARE DETECTION AND COMPARISON OF ANTIBODY RESPONSES AGAINST THERAPEUTIC PROTEINS IN RHEUMATOID ARTHRITIS PATIENTS ($258,953)", "source_url": "https://reporter.nih.gov/project-details/10545283", "people": [{"name": "Maria D. F. S. Barbosa", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44NS129521-01", "company": "Turing Medical Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 499832, "summary": "NIH award 1R44NS129521-01: Behavioral feedback and rewards for improving functional brain mapping in presurgical pediatric patients ($499,832)", "source_url": "https://reporter.nih.gov/project-details/10546990", "people": [{"name": "Ken Bruener", "role": "Principal Investigator"}, {"name": "Damien A Fair", "role": "Principal Investigator"}, {"name": "Jarod Roland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41NS125874-01", "company": "Carina Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 339999, "summary": "NIH award 1R41NS125874-01: Improved Diagnosis of Shunt Malfunction with Automatic Quantification of Ventricular Space ($339,999)", "source_url": "https://reporter.nih.gov/project-details/10384590", "people": [{"name": "Xue Feng", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44MH112216-02", "company": "Fox Learning Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 870193, "summary": "NIH award 2R44MH112216-02: Development and Randomized Clinical Trial of an App-based Intervention to Reduce Postpartum Depression in High-Risk Women ($870,193)", "source_url": "https://reporter.nih.gov/project-details/10480615", "people": [{"name": "DEBRA L FOX", "role": "Principal Investigator"}, {"name": "ELLEN L POLESHUCK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41DK135161-01", "company": "Newventureiq, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 279951, "summary": "NIH award 1R41DK135161-01: A Deep Learning Model to Quantify Arteriosclerosis in Donor Kidney Biopsies ($279,951)", "source_url": "https://reporter.nih.gov/project-details/10601825", "people": [{"name": "Joseph P Gaut", "role": "Principal Investigator"}, {"name": "Victoria G Swamidass", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG079760-01", "company": "Miro Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 1491441, "summary": "NIH award 1R44AG079760-01: The Proactive Screening and diagnosis of mild cognitive impairment and depression in patients aged 65 and over: An Implementation Study ($1,491,441)", "source_url": "https://reporter.nih.gov/project-details/10551816", "people": [{"name": "Shenly Glenn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44NR019963-01A1", "company": "Shift Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 216597, "summary": "NIH award 1R44NR019963-01A1: A closed-loop gravity infusion control device ($216,597)", "source_url": "https://reporter.nih.gov/project-details/10384629", "people": [{"name": "Chie Kawahara", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AT011593-02", "company": "2morrow, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 1181602, "summary": "NIH award 4R44AT011593-02: HEAL - Development and implementation of a provider prescribed, behavioral digital therapeutic designed to support, educate, screen and remotely monitor patients with chronic pain ($1,181,602)", "source_url": "https://reporter.nih.gov/project-details/10532462", "people": [{"name": "Jo Masterson", "role": "Principal Investigator"}, {"name": "Deanna Waters", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AA030702-01", "company": "Ria Technology Management Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 267065, "summary": "NIH award 1R44AA030702-01: A Telehealth Intervention to Increase Screening and Treatment for Alcohol Use Disorder ($267,065)", "source_url": "https://reporter.nih.gov/project-details/10604054", "people": [{"name": "JOHN E. MENDELSON", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44MD014923-02", "company": "Orange Square Design, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": null, "summary": "NIH award 2R44MD014923-02: Joyuus: A Web-based Tool for Postpartum Care Self-care to Address the Complex Needs of Underserved Women ($1)", "source_url": "https://reporter.nih.gov/project-details/10544362", "people": [{"name": "Lisa D Marceau", "role": "Principal Investigator"}, {"name": "Kristine Merz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44NS125745-01A1", "company": "Evon Medics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 499999, "summary": "NIH award 1R44NS125745-01A1: Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P) ($499,999)", "source_url": "https://reporter.nih.gov/project-details/10547925", "people": [{"name": "Charles Chiedu Nwaokobia", "role": "Principal Investigator"}, {"name": "Evaristus A Nwulia", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44EB030874-02", "company": "Optosurgical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-19", "observed": "2026-08-21", "amount_usd": 749839, "summary": "NIH award 2R44EB030874-02: hANDY-i(TM): A non-invasive, dual-sensor handheld imager for intraoperative preservation of parathyroid glands ($749,839)", "source_url": "https://reporter.nih.gov/project-details/10545988", "people": [{"name": "Richard Jaepyeong Cha", "role": "Principal Investigator"}, {"name": "Eugene Oh", "role": "Principal Investigator"}, {"name": "Jonathon O Russell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44DE032290-01", "company": "Radiation Monitoring Devices, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-16", "observed": "2026-08-21", "amount_usd": 259550, "summary": "NIH award 1R44DE032290-01: Semiconductor detector for low-dose, high-resolution dental DR imaging ($259,550)", "source_url": "https://reporter.nih.gov/project-details/10544863", "people": [{"name": "JAMES F CHRISTIAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44GM148138-01", "company": "Auragent Bioscience, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-16", "observed": "2026-08-21", "amount_usd": 943531, "summary": "NIH award 1R44GM148138-01: High performance and widely accessible secretomics assay platform ($943,531)", "source_url": "https://reporter.nih.gov/project-details/10547532", "people": [{"name": "Scott L Crick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA275587-01", "company": "Gradient Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-16", "observed": "2026-08-21", "amount_usd": 259549, "summary": "NIH award 1R41CA275587-01: Feasibility of a Multi-Phase Algorithmic Non-Thermal Ablation Technology for the Treatment of Inoperable Tumors ($259,549)", "source_url": "https://reporter.nih.gov/project-details/10547371", "people": [{"name": "Jordan Fong", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA272107-01", "company": "Atlasxomics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-16", "observed": "2026-08-21", "amount_usd": 251087, "summary": "NIH award 1R43CA272107-01: Spatially Resolved, Multi-Omics Analyses of Immune Infiltrates in GBM Microenvironment ($251,087)", "source_url": "https://reporter.nih.gov/project-details/10483889", "people": [{"name": "Jennifer Mary Garbarino", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR080507-01A1", "company": "Apex Orthopaedic Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-16", "observed": "2026-08-21", "amount_usd": 299886, "summary": "NIH award 1R43AR080507-01A1: R-FIX (Rib-FIXation System) for Severe Progressive Spinal Deformity ($299,886)", "source_url": "https://reporter.nih.gov/project-details/10482559", "people": [{"name": "Richard H. Gross", "role": "Principal Investigator"}, {"name": "Hai Yao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR080486-01A1", "company": "Biomed Consulting, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-16", "observed": "2026-08-21", "amount_usd": 259613, "summary": "NIH award 1R43AR080486-01A1: Development of a Standardized, Reliable and Easy-to-Use Clinical Instrument to Measure First Ray Mobility and Position of the Medial Forefoot to Assist with Clinical Decisions and Treatments ($259,613)", "source_url": "https://reporter.nih.gov/project-details/10483379", "people": [{"name": "Howard J. Hillstrom", "role": "Principal Investigator"}, {"name": "Rajshree Hillstrom", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DE031194-01A1", "company": "Praevium Research, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-16", "observed": "2026-08-21", "amount_usd": 275001, "summary": "NIH award 1R44DE031194-01A1: Next generation MEMS-VCSEL technology for ultra-low-cost dental and periodontal swept source optical coherence tomography imaging ($275,001)", "source_url": "https://reporter.nih.gov/project-details/10481677", "people": [{"name": "Vijaysekhar Jayaraman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220025", "company": "Phagenesis Limited", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-09-16", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220025 granted: Phagenyx System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220025"}, {"id": "breakthrough:DEN220025", "company": "Phagenesis Limited", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-09-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN220025: PHAGENYX SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43HL164195-01A1", "company": "Maxwell Biomedical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 299449, "summary": "NIH award 1R43HL164195-01A1: Spatial Resynchronization Therapy for AFib ($299,449)", "source_url": "https://reporter.nih.gov/project-details/10546248", "people": [{"name": "Graydon Ernest Beatty", "role": "Principal Investigator"}, {"name": "Benjamin Coppola", "role": "Principal Investigator"}, {"name": "Randy Werneth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM148126-01", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 279013, "summary": "NIH award 1R43GM148126-01: Improving extraction success of FFPE samples with automated and reliable microfluidic sample preparation ($279,013)", "source_url": "https://reporter.nih.gov/project-details/10547272", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG079732-01", "company": "Imaginostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 915931, "summary": "NIH award 1R43AG079732-01: Validation of a Novel Magnetic Resonance Imaging (MRI) Technology for both Diagnostic Screening and Quantification of Brain Vascular Physiology in Alzheimer's-Disease-Related Dementias ($915,931)", "source_url": "https://reporter.nih.gov/project-details/10547491", "people": [{"name": "Codi Amir Gharagouzloo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA278579-01", "company": "Cryocrate, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 898913, "summary": "NIH award 1R44CA278579-01: Innovation of Biobanking for Cellular Adoptive Immunotherapies Based on a First-in-Class Biocompatible Cryopreservation Technology for T and NK Cells and Their CAR-Engineered Products ($898,913)", "source_url": "https://reporter.nih.gov/project-details/10611789", "people": [{"name": "Xu Han", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL166053-01", "company": "Mirtech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 309942, "summary": "NIH award 1R41HL166053-01: Shim System for Removing ICD Artifacts from Patient Cardiac MR Images ($309,942)", "source_url": "https://reporter.nih.gov/project-details/10546727", "people": [{"name": "Yue Chen", "role": "Principal Investigator"}, {"name": "Mirko I. Hrovat", "role": "Principal Investigator"}, {"name": "ehud Jeruham schmidt", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DK108397-04", "company": "Lipella Pharmaceuticals, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 673049, "summary": "NIH award 2R44DK108397-04: Phenotyping Interstitial Cystitis/Bladder Pain Syndrome by ICE-MRI Based Bladder Permeability Assay ($673,049)", "source_url": "https://reporter.nih.gov/project-details/10545115", "people": [{"name": "JONATHAN H KAUFMAN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R41AR079357-01A1", "company": "Elizur Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 259612, "summary": "NIH award 1R41AR079357-01A1: CuffLink: Remotely Monitored Rotator Cuff Repair Rehabilitation at Home ($259,612)", "source_url": "https://reporter.nih.gov/project-details/10546661", "people": [{"name": "Kevin M Bell", "role": "Principal Investigator"}, {"name": "Jennifer Lambiase", "role": "Principal Investigator"}, {"name": "Michael McClincy", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR082237-01", "company": "Evoke Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 274865, "summary": "NIH award 1R43AR082237-01: Spinal Fusion Implant with Embedded Biomechanically Powered Sensor ($274,865)", "source_url": "https://reporter.nih.gov/project-details/10603735", "people": [{"name": "Leighton LaPierre", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB029880-01A1", "company": "Acoustiic Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 399617, "summary": "NIH award 1R43EB029880-01A1: 3D Shear-wave Imaging Transducer for Liver Cancer Screening ($399,617)", "source_url": "https://reporter.nih.gov/project-details/10484871", "people": [{"name": "Holly Susan Lay", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH132196-01", "company": "Ambergen, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 1084108, "summary": "NIH award 1R44MH132196-01: A Highly Multiplexed, Multiomic 3D Mouse Brain Map Using MALDI-IHC ($1,084,108)", "source_url": "https://reporter.nih.gov/project-details/10603396", "people": [{"name": "Mark Lim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44EY034409-01", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 875633, "summary": "NIH award 1R44EY034409-01: Ultra-high speed AO-OCT clinical system to image ganglion cells and microglia ($875,633)", "source_url": "https://reporter.nih.gov/project-details/10547181", "people": [{"name": "Mircea Mujat", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA246941-02A1", "company": "Earlydiagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 997285, "summary": "NIH award 2R44CA246941-02A1: MethylScan for Early Detection of Liver and Lung Cancer ($997,285)", "source_url": "https://reporter.nih.gov/project-details/10603422", "people": [{"name": "Steven-Huy B Han", "role": "Principal Investigator"}, {"name": "ANNA S.F. LOK", "role": "Principal Investigator"}, {"name": "Xiaohui Ni", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44HL164199-01A1", "company": "Cpr Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-15", "observed": "2026-08-21", "amount_usd": 597368, "summary": "NIH award 1R44HL164199-01A1: A Multimodal Integrated System For Improved Cardiopulmonary Resuscitation ($597,368)", "source_url": "https://reporter.nih.gov/project-details/10546620", "people": [{"name": "HENRY R HALPERIN", "role": "Principal Investigator"}, {"name": "Norman A Paradis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI172459-01", "company": "Big Eye Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-14", "observed": "2026-08-21", "amount_usd": 258171, "summary": "NIH award 1R43AI172459-01: First-in-class, highly sensitive and specific rapid diagnostic test to detect Paragonimus infections ($258,171)", "source_url": "https://reporter.nih.gov/project-details/10545410", "people": [{"name": "Marco Antonio Biamonte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA268275-01A1", "company": "Clear Session, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-14", "observed": "2026-08-21", "amount_usd": 387235, "summary": "NIH award 1R43CA268275-01A1: Latinas CaPACES: Connecting and Promoting Active Cancer Engagement Successfully using a Culturally-Tailored Digital Tool to Reduce Delays in Breast Cancer Diagnostic Follow-up Testing and Treatment ($387,235)", "source_url": "https://reporter.nih.gov/project-details/10475355", "people": [{"name": "Maria De Jesus", "role": "Principal Investigator"}, {"name": "Carl Haacke", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA265626-01A1", "company": "Molecular Theranostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-14", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 1R44CA265626-01A1: Commercialization of an MRI contrast agent for differential diagnosis of prostate cancer ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10481722", "people": [{"name": "Yajuan Li", "role": "Principal Investigator"}, {"name": "Michael F Tweedle", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH128999-01A1", "company": "Panluminate Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-14", "observed": "2026-08-21", "amount_usd": 248545, "summary": "NIH award 1R43MH128999-01A1: Development of a sample preparation protocol for brain ultrastructural analysis, immunolabeling, and neuronal tracing by light microscopy ($248,545)", "source_url": "https://reporter.nih.gov/project-details/10483978", "people": [{"name": "Ons M'Saad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44CA250861-02", "company": "Quantitative Imaging Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-14", "observed": "2026-08-21", "amount_usd": 871668, "summary": "NIH award 4R44CA250861-02: Ultra-high content analyses of circulating and solid tumor cells: A diagnostic reference system for disease burden ($871,668)", "source_url": "https://reporter.nih.gov/project-details/10687285", "people": [{"name": "Michel Nederlof", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44HL147745-02A1", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-13", "observed": "2026-08-21", "amount_usd": 1103426, "summary": "NIH award 2R44HL147745-02A1: An Improved Robotic Electrophysiology Platform for Arrhythmia Ablation ($1,103,426)", "source_url": "https://reporter.nih.gov/project-details/10481922", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "Mitch N Faddis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL158286-02", "company": "Bleep, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-13", "observed": "2026-08-21", "amount_usd": 842197, "summary": "NIH award 5R44HL158286-02: DreamPort-Eclipse: Compact, ultra-low contact, custom fit CPAP human interface solution for obstructive sleep apnea ($842,197)", "source_url": "https://reporter.nih.gov/project-details/10492657", "people": [{"name": "Stuart Heatherington", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44MH119870-03", "company": "Pinnacle Technology, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-13", "observed": "2026-08-21", "amount_usd": 907224, "summary": "NIH award 2R44MH119870-03: Commercialization of Enzyme Modified Carbon-Fiber Electrodes Paired with Voltammetry for Simultaneous Real-Time Monitoring of Electroactive and Non-Electroactive Species at Discrete Brain Locations ($907,224)", "source_url": "https://reporter.nih.gov/project-details/10603193", "people": [{"name": "DAVID A JOHNSON", "role": "Principal Investigator"}, {"name": "LESLIE A SOMBERS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41NS129418-01", "company": "Tulip Make Me Move Desk, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 256580, "summary": "NIH award 1R41NS129418-01: Development of a Multifunctional Rehabilitation Standing and Stepping Device for Persons with Parkinson's Disease ($256,580)", "source_url": "https://reporter.nih.gov/project-details/10546077", "people": [{"name": "Nicolaas Bohnen", "role": "Principal Investigator"}, {"name": "JAMES K RICHARDSON", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK133005-01A1", "company": "N8 Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 299155, "summary": "NIH award 1R43DK133005-01A1: Ceragenin-based antimicrobial coating to tackle hemodialysis catheter-related infections. ($299,155)", "source_url": "https://reporter.nih.gov/project-details/10602612", "people": [{"name": "Glenn Brunner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG073011-01A1", "company": "Etectrx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 496388, "summary": "NIH award 1R43AG073011-01A1: Ensuring medication ingestion without altering existing medication regimen ($496,388)", "source_url": "https://reporter.nih.gov/project-details/10384824", "people": [{"name": "Tony Christopher Carnes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44MH123253-03S1", "company": "Petcoil, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 98508, "summary": "NIH award 3R44MH123253-03S1: A Portable PET Insert System for Simultaneous TOF-PET and MR Brain Imaging ($98,508)", "source_url": "https://reporter.nih.gov/project-details/10583593", "people": [{"name": "Chenming Chang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43CA278186-01", "company": "Ananya Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 396587, "summary": "NIH award 1R43CA278186-01: Portable, low-cost cryotherapy system that does not require consumable cryogen gas for the treatment of cervical precancerous lesions ($396,587)", "source_url": "https://reporter.nih.gov/project-details/10602226", "people": [{"name": "Wei-Hsiang Chang", "role": "Principal Investigator"}, {"name": "Anubhuti Parvatiyar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44AG074128-02", "company": "Whiplash Technology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 903624, "summary": "NIH award 4R44AG074128-02: Design, Development, and Validation of an AI-enabled Legal Planning and Financial Management Training Solution for ADRD Caregivers ($903,624)", "source_url": "https://reporter.nih.gov/project-details/10691571", "people": [{"name": "Christian Elliott", "role": "Principal Investigator"}, {"name": "Nicole E Werner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG076190-01A1", "company": "Vibrato Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R44AG076190-01A1: Non-invasive therapeutic ultrasound device for treatment of peripheral arterial disease in elderly population ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10478420", "people": [{"name": "Juliana Elstad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41HL160317-01A1", "company": "Zbeats, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 259613, "summary": "NIH award 1R41HL160317-01A1: Feasibility testing of a novel AI-enabled, cloud-based ECG diagnostic solution to enable fast and affordable diagnosis in long-term continuous ambulatory ECG monitoring ($259,613)", "source_url": "https://reporter.nih.gov/project-details/10545691", "people": [{"name": "Bin Fang", "role": "Principal Investigator"}, {"name": "Puja Parikh", "role": "Principal Investigator"}, {"name": "Elinor R. Schoenfeld", "role": "Principal Investigator"}, {"name": "Peng Zhang", "role": "Principal Investigator"}, {"name": "Bin Zhao", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DK130702-02", "company": "Nephropathology Associates", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 1018450, "summary": "NIH award 2R44DK130702-02: Development of a Precision Medicine-based Diagnostic Tool for Membranous Nephropathy ($1,018,450)", "source_url": "https://reporter.nih.gov/project-details/10602134", "people": [{"name": "Christopher P Larsen", "role": "Principal Investigator"}, {"name": "Aaron Joseph Storey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44NS127696-01", "company": "Cnd Life Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 1092613, "summary": "NIH award 1R44NS127696-01: Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies ($1,092,613)", "source_url": "https://reporter.nih.gov/project-details/10481117", "people": [{"name": "Todd Levine", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44GM145183-02", "company": "Microsensor Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 999681, "summary": "NIH award 4R44GM145183-02: SBIR Fast Track: Development of a High-throughput Magnetic Cytometer for Single Cell Sorting ($999,681)", "source_url": "https://reporter.nih.gov/project-details/10599601", "people": [{"name": "Peng Paul Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41AG078039-01A1", "company": "Spark Neuro Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 299786, "summary": "NIH award 1R41AG078039-01A1: Improving an EEG-based neurodiagnostic software platform to detect Alzheimer's Disease in MCI patients ($299,786)", "source_url": "https://reporter.nih.gov/project-details/10546255", "people": [{"name": "Richard J. Caselli", "role": "Principal Investigator"}, {"name": "Che Lucero", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL162179-01A1", "company": "Advancedcpr Solutions LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 394832, "summary": "NIH award 1R43HL162179-01A1: Head Up CPR System with Integrated and Optimized Mechanical Active Compression Decompression for Improving Survival after Cardiac Arrest ($394,832)", "source_url": "https://reporter.nih.gov/project-details/10482631", "people": [{"name": "Keith Lurie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42ES034684-01", "company": "Spectree Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 259573, "summary": "NIH award 1R42ES034684-01: Multispectral Sensor for Chemical Composition Analysis of Ultrafine Aerosols in Air Quality Assessment ($259,573)", "source_url": "https://reporter.nih.gov/project-details/10546675", "people": [{"name": "ALEXANDER V MAMISHEV", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R42NS103704-04", "company": "Cerulean Scientific Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 497377, "summary": "NIH award 5R42NS103704-04: Omniphobic Cerebral Shunt to Eliminate Clogging and Dysfunction ($497,377)", "source_url": "https://reporter.nih.gov/project-details/10490443", "people": [{"name": "Carolyn A Harris", "role": "Principal Investigator"}, {"name": "James Patterson McAllister", "role": "Principal Investigator"}, {"name": "Todd McFarland", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44AG072990-02", "company": "See Yourself Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-12", "observed": "2026-08-21", "amount_usd": 997968, "summary": "NIH award 2R44AG072990-02: The HOPE App: An Immersive Telehealth Solution for Older Adults with Diabetes ($997,968)", "source_url": "https://reporter.nih.gov/project-details/10482490", "people": [{"name": "Suzanne Mitchell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL164136-01A1", "company": "Karios Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-09", "observed": "2026-08-21", "amount_usd": 998222, "summary": "NIH award 1R43HL164136-01A1: A Sprayable Tissue-Binding Hydrogel to Prevent Postsurgical Cardiac Adhesions ($998,222)", "source_url": "https://reporter.nih.gov/project-details/10546558", "people": [{"name": "Gregory Grover", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42NS125895-01A1", "company": "Wincs International, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-09", "observed": "2026-08-21", "amount_usd": 429757, "summary": "NIH award 1R42NS125895-01A1: An Integrated Neurochemical/Electrophysiological Recording and Neuromodulation System for Basic and Clinical Research ($429,757)", "source_url": "https://reporter.nih.gov/project-details/10477708", "people": [{"name": "Kevin Elliott Bennet", "role": "Principal Investigator"}, {"name": "Kendall Lee", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH114725-05", "company": "Adaptive Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-09", "observed": "2026-08-21", "amount_usd": 1323561, "summary": "NIH award 5R44MH114725-05: Integrating a suite of mental health apps for depression in a healthcare setting. ($1,323,561)", "source_url": "https://reporter.nih.gov/project-details/10261574", "people": [{"name": "Carolyn MacIver", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R43HL164149-01", "company": "Skinaxis, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-09", "observed": "2026-08-21", "amount_usd": 259602, "summary": "NIH award 1R43HL164149-01: Effect of flow lamination device on aerosolized drug delivery characteristics ($259,602)", "source_url": "https://reporter.nih.gov/project-details/10480263", "people": [{"name": "Arevik Mosoian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R41MH124581-02S1", "company": "Iris Ob Health Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-09", "observed": "2026-08-21", "amount_usd": 137274, "summary": "NIH award 3R41MH124581-02S1: Bioethical Considerations for Building, Evaluating, and Implementing Artificial Intelligence in Perinatal Mood and Anxiety Disorders ($137,274)", "source_url": "https://reporter.nih.gov/project-details/10593284", "people": [{"name": "Michael B. Laskoff", "role": "Principal Investigator"}, {"name": "Jyotishman Pathak", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "hde:H210004", "company": "Vesalio", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2022-09-09", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H210004: NeVa VS", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "nih:1R44CA277890-01", "company": "Vergent Bioscience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-08", "observed": "2026-08-21", "amount_usd": 1124282, "summary": "NIH award 1R44CA277890-01: Improving lung cancer surgery with an intraoperative, tumor-targeted, activatable fluorescent imaging agent ($1,124,282)", "source_url": "https://reporter.nih.gov/project-details/10600351", "people": [{"name": "Eric Scott Bensen", "role": "Principal Investigator"}, {"name": "Sunil Singhal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM148105-01", "company": "Ligo Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-08", "observed": "2026-08-21", "amount_usd": 249999, "summary": "NIH award 1R43GM148105-01: Dynamical Diffraction Analysis for 3D Electron Crystallography ($249,999)", "source_url": "https://reporter.nih.gov/project-details/10546970", "people": [{"name": "Raquel Bromberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AR079963-01A1", "company": "Agitated Solutions Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-08", "observed": "2026-08-21", "amount_usd": 281978, "summary": "NIH award 1R43AR079963-01A1: Novel contrast agent tool for musculoskeletal injection procedures ($281,978)", "source_url": "https://reporter.nih.gov/project-details/10483672", "people": [{"name": "Morgan Elizabeth Evans", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK129075-02", "company": "Perikinetics Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-08", "observed": "2026-08-21", "amount_usd": 1048080, "summary": "NIH award 5R44DK129075-02: An Intraperitoneal Insulin Delivery System for Management of Type 1 Diabetes ($1,048,080)", "source_url": "https://reporter.nih.gov/project-details/10584462", "people": [{"name": "Daniel Rogers Burnett", "role": "Principal Investigator"}, {"name": "Christopher Hanson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44NR020275-02", "company": "Neoneur LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-08", "observed": "2026-08-21", "amount_usd": 946364, "summary": "NIH award 4R44NR020275-02: Improving high-risk infant care: from Hospital to Home with Neoneur Telehealth ($946,364)", "source_url": "https://reporter.nih.gov/project-details/10672732", "people": [{"name": "Caroline Hoedemaker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA268452-01A1", "company": "Rush River Research Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-08", "observed": "2026-08-21", "amount_usd": 298663, "summary": "NIH award 1R43CA268452-01A1: Novel Ultrasound Based Viscoelasticity Imaging Tool to Reduce Invasive Breast Lesion Biopsy Rate ($298,663)", "source_url": "https://reporter.nih.gov/project-details/10603447", "people": [{"name": "Julie Lundstrom", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA278604-01", "company": "Pathware Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-08", "observed": "2026-08-21", "amount_usd": 399583, "summary": "NIH award 1R43CA278604-01: Harnessing Coded Ptychography to Deliver AI-powered Evaluation of Unstained Lung Biopsies at the Point-Of-Care ($399,583)", "source_url": "https://reporter.nih.gov/project-details/10602206", "people": [{"name": "Torsten Lyon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL164224-01A1", "company": "Ontogen Medtech LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-08", "observed": "2026-08-21", "amount_usd": 258793, "summary": "NIH award 1R43HL164224-01A1: A Novel Catheter for Thrombolytic Drug Infusion Therapy to treat Pulmonary Embolism ($258,793)", "source_url": "https://reporter.nih.gov/project-details/10547235", "people": [{"name": "Tyler Panian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA277934-01", "company": "Scribe Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-07", "observed": "2026-08-21", "amount_usd": 349997, "summary": "NIH award 1R43CA277934-01: Microenvironment on Demand (MOD): A platform for single-cell cytotoxicity assays ($349,997)", "source_url": "https://reporter.nih.gov/project-details/10601155", "people": [{"name": "Russell H Cole", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH130305-01A1", "company": "Dimagi, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-07", "observed": "2026-08-21", "amount_usd": 259467, "summary": "NIH award 1R43MH130305-01A1: A novel digital platform for measurement-based peer supervision of non-specialist providers conducting brief psychological interventions ($259,467)", "source_url": "https://reporter.nih.gov/project-details/10545922", "people": [{"name": "Y. Xian Ho", "role": "Principal Investigator"}, {"name": "Neal Lesh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG058339-02A1", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-07", "observed": "2026-08-21", "amount_usd": 1281557, "summary": "NIH award 2R44AG058339-02A1: Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals with Alzheimer Disease ($1,281,557)", "source_url": "https://reporter.nih.gov/project-details/10547408", "people": [{"name": "John Kablan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44GM143996-01A1", "company": "Infotech Soft, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-07", "observed": "2026-08-21", "amount_usd": 253463, "summary": "NIH award 1R44GM143996-01A1: Deep-CDS: Deep Learning Semantic Data Lake for Clinical Decision Support ($253,463)", "source_url": "https://reporter.nih.gov/project-details/10546333", "people": [{"name": "Mansur R. Kabuka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG078071-01A1", "company": "Kinima, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-07", "observed": "2026-08-21", "amount_usd": 273020, "summary": "NIH award 1R43AG078071-01A1: Augmented Reality Personalized Motion Tracking Assessment and Improvement Technology for Fall Prevention in a Community Setting Using Mobile Phone ($273,020)", "source_url": "https://reporter.nih.gov/project-details/10551594", "people": [{"name": "Renee Migdal", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH125700-02", "company": "Paradromics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-06", "observed": "2026-08-21", "amount_usd": 1433024, "summary": "NIH award 5R44MH125700-02: Development and evaluation of novel high-density intracortical microelectrode arrays for clinical applications ($1,433,024)", "source_url": "https://reporter.nih.gov/project-details/10483140", "people": [{"name": "Matthew R Angle", "role": "Principal Investigator"}, {"name": "SYDNEY S CASH", "role": "Principal Investigator"}, {"name": "Shaoyu Qiao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44AI150060-03S1", "company": "Biopeptides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-06", "observed": "2026-08-21", "amount_usd": 65384, "summary": "NIH award 3R44AI150060-03S1: A peptide-based point-of-care vertical flow assay for the rapid diagnosis of Lyme disease ($65,384)", "source_url": "https://reporter.nih.gov/project-details/10668819", "people": [{"name": "Paul Michael Arnaboldi", "role": "Principal Investigator"}, {"name": "Dino Di Carlo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R44AG071034-02S2", "company": "Active Life Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-05", "observed": "2026-08-21", "amount_usd": 299649, "summary": "NIH award 3R44AG071034-02S2: A New Device to measure Whole and Tissue Level Bone Strength. ($299,649)", "source_url": "https://reporter.nih.gov/project-details/10613794", "people": [{"name": "Peter Burks", "role": "Principal Investigator"}, {"name": "Simon Yue-Cheong Tang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44MH132234-01", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-05", "observed": "2026-08-21", "amount_usd": 449982, "summary": "NIH award 1R44MH132234-01: System for Volumetric 2-photon Imaging of Neuroactivity Using Light Beads Microscopy ($449,982)", "source_url": "https://reporter.nih.gov/project-details/10603310", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD110346-01", "company": "Ovaryit, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-05", "observed": "2026-08-21", "amount_usd": 214719, "summary": "NIH award 1R43HD110346-01: Implementation of support tools to promote safety in the prescribing of oral contraceptives ($214,719)", "source_url": "https://reporter.nih.gov/project-details/10547335", "people": [{"name": "Mary Kucek", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH131514-01", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-05", "observed": "2026-08-21", "amount_usd": 500248, "summary": "NIH award 1R44MH131514-01: Development of an Acoustic Implant Protection System to Improve Performance and Longevity of Neural Interfaces ($500,248)", "source_url": "https://reporter.nih.gov/project-details/10552838", "people": [{"name": "Maureen L. Mulvihill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AI150263-03", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-04", "observed": "2026-08-21", "amount_usd": 998995, "summary": "NIH award 4R44AI150263-03: A modular platform for infectious disease surveillance at point-of-need. ($998,995)", "source_url": "https://reporter.nih.gov/project-details/10633681", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44NS108850-03A1", "company": "Backyard Brains, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-02", "observed": "2026-08-21", "amount_usd": 928237, "summary": "NIH award 2R44NS108850-03A1: Introducing Neuroscience and Neurocomputation Concepts to High School Students using Brain-based Neurorobots ($928,237)", "source_url": "https://reporter.nih.gov/project-details/10385012", "people": [{"name": "Gregory John Gage", "role": "Principal Investigator"}, {"name": "Christopher Aidan Harris", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41EB033758-01", "company": "Brimrose Technology Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-02", "observed": "2026-08-21", "amount_usd": 344468, "summary": "NIH award 1R41EB033758-01: Continuous Photoacoustic Monitoring of Neonatal Stroke in Intensive Care Unit ($344,468)", "source_url": "https://reporter.nih.gov/project-details/10548689", "people": [{"name": "Emad M Boctor", "role": "Principal Investigator"}, {"name": "Feng Jin", "role": "Principal Investigator"}, {"name": "Jeeun Kang", "role": "Principal Investigator"}, {"name": "ChenChia Wang", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42AG063655-02", "company": "L. Krenk, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-02", "observed": "2026-08-21", "amount_usd": 499470, "summary": "NIH award 4R42AG063655-02: Algorithm to Identify Patients at Risk of Medication-Related Hospitalization ($499,470)", "source_url": "https://reporter.nih.gov/project-details/10668571", "people": [{"name": "Francis T Chan", "role": "Principal Investigator"}, {"name": "Leslie Krenk", "role": "Principal Investigator"}, {"name": "Karen Lisa Pellegrin", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AR081720-01", "company": "Nephropathology Associates", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-02", "observed": "2026-08-21", "amount_usd": 259379, "summary": "NIH award 1R43AR081720-01: Development of specific peptide reagents for serologic monitoring of Exostosin autoantibodies in membranous lupus nephritis ($259,379)", "source_url": "https://reporter.nih.gov/project-details/10545924", "people": [{"name": "Christopher P Larsen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AR080617-02", "company": "Rivanna Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-02", "observed": "2026-08-21", "amount_usd": 853559, "summary": "NIH award 5R44AR080617-02: Automated three-dimensional spinal navigation system for chronic pain therapy ($853,559)", "source_url": "https://reporter.nih.gov/project-details/10490879", "people": [{"name": "Frank William Mauldin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44DA056251-01", "company": "Opio Connect, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-02", "observed": "2026-08-21", "amount_usd": 156220, "summary": "NIH award 1R44DA056251-01: Booth\u2122 by Opio\u2122: Developing technology to expand the reach of opioid treatment programs into rural and underserved areas. ($156,220)", "source_url": "https://reporter.nih.gov/project-details/10481923", "people": [{"name": "Amber Norbeck", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH129065-01", "company": "Doxy.me, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-02", "observed": "2026-08-21", "amount_usd": 442246, "summary": "NIH award 1R43MH129065-01: Developing a virtual reality clinic to enhance telemental health. ($442,246)", "source_url": "https://reporter.nih.gov/project-details/10385276", "people": [{"name": "Brian E. Bunnell", "role": "Principal Investigator"}, {"name": "Triton Ong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44HD104973-02", "company": "Total Child Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-01", "observed": "2026-08-21", "amount_usd": 854134, "summary": "NIH award 4R44HD104973-02: Validation of the online Toddler Autism and Development Adaptive Screener (TADAS) at 18 months ($854,134)", "source_url": "https://reporter.nih.gov/project-details/10662589", "people": [{"name": "Barbara Jo Howard", "role": "Principal Investigator"}, {"name": "Raymond STURNER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AR079941-01A1", "company": "Dencoda LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-01", "observed": "2026-08-21", "amount_usd": 256586, "summary": "NIH award 1R43AR079941-01A1: Development of DNA-linked Matrix Metallo Protease activity probes in Osteoarthritis research ($256,586)", "source_url": "https://reporter.nih.gov/project-details/10479317", "people": [{"name": "Dongwook Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD108823-01", "company": "Mucommune, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-09-01", "observed": "2026-08-21", "amount_usd": 259499, "summary": "NIH award 1R43HD108823-01: User-based identification of preferred design features for MM008, a non-hormonal contraceptive vaginal ring ($259,499)", "source_url": "https://reporter.nih.gov/project-details/10459077", "people": [{"name": "Keiichiro Kushiro", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "breakthrough:K220177", "company": "Magnus Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-09-01", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K220177: MAGNUS NEUROMODULATION SYSTEM (MNS) WITH SAINT TECHNOLOGY, MODEL NUMBER 1001K", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43HL161759-01A1", "company": "Biotricity Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-31", "observed": "2026-08-21", "amount_usd": 240053, "summary": "NIH award 1R43HL161759-01A1: AI-enabled Stroke Prediction in Patients with Chronic Kidney Disease ($240,053)", "source_url": "https://reporter.nih.gov/project-details/10481070", "people": [{"name": "Waqaas Al-Siddiq", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL160268-01A1", "company": "Physcade, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-31", "observed": "2026-08-21", "amount_usd": 257154, "summary": "NIH award 1R43HL160268-01A1: Non-Invasive Machine Learned Device to Personalize Arrhythmia Therapy ($257,154)", "source_url": "https://reporter.nih.gov/project-details/10468565", "people": [{"name": "Suhaas Anbazhakan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EH001371-01", "company": "Creare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-31", "observed": "2026-08-21", "amount_usd": 258622, "summary": "NIH award 1R43EH001371-01: Web-based Platform for Improved Healthcare Resiliency to Extreme Weather Events ($258,622)", "source_url": "https://reporter.nih.gov/project-details/10489864", "people": [{"name": "JERRY BIESZCZAD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA224460-05", "company": "Focal Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-31", "observed": "2026-08-21", "amount_usd": 2000000, "summary": "NIH award 5R44CA224460-05: Implantable iontophoresis chemotherapy delivery device for direct infusion ofgemcitabine into pancreatic adenocarcinoma: Device development and First-in-Human clinical trial ($2,000,000)", "source_url": "https://reporter.nih.gov/project-details/10458734", "people": [{"name": "William Andrew Daunch", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44HD105575-01A1", "company": "Claria Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-31", "observed": "2026-08-21", "amount_usd": 1569462, "summary": "NIH award 1R44HD105575-01A1: A Safe, Fast, and Cost-Effective System for Tissue Removal in Laparoscopic Hysterectomy and Other Minimally Invasive Surgery ($1,569,462)", "source_url": "https://reporter.nih.gov/project-details/10383794", "people": [{"name": "Daniel Francis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK129164-02", "company": "Spinex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-31", "observed": "2026-08-21", "amount_usd": 924935, "summary": "NIH award 5R44DK129164-02: Transformation of Dormant Spinal Networks to Mitigate Symptoms of Neurogenic Bladder ($924,935)", "source_url": "https://reporter.nih.gov/project-details/10469494", "people": [{"name": "Parag Gad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44HL151094-03S1", "company": "Curi Bio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-31", "observed": "2026-08-21", "amount_usd": 242088, "summary": "NIH award 3R44HL151094-03S1: Predictive assessment of acute and chronic cardiotoxicity using combinatorially matured hPSC-CMs ($242,088)", "source_url": "https://reporter.nih.gov/project-details/10679410", "people": [{"name": "Nicholas Andrew Geisse", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R42DE030829-01S1", "company": "Innotech Precision Medicine, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-31", "observed": "2026-08-21", "amount_usd": 500000, "summary": "NIH award 3R42DE030829-01S1: A multimodal platform for Oral screening of COVID-19 ($500,000)", "source_url": "https://reporter.nih.gov/project-details/10665346", "people": [{"name": "ROYA KHOSRAVI-FAR", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL166048-01", "company": "Pericor, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-31", "observed": "2026-08-21", "amount_usd": 914055, "summary": "NIH award 1R44HL166048-01: PeriPath: A Single Incision Delivery Tool for Epicardial Pacing and Defibrillation: Phase 2 ($914,055)", "source_url": "https://reporter.nih.gov/project-details/10547070", "people": [{"name": "CHARLES I BERUL", "role": "Principal Investigator"}, {"name": "Justin Opfermann", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD102235-02", "company": "Theranova, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-30", "observed": "2026-08-21", "amount_usd": 721899, "summary": "NIH award 5R44HD102235-02: A Photo-based Menstrual Blood Loss Metric ($721,899)", "source_url": "https://reporter.nih.gov/project-details/10493090", "people": [{"name": "Daniel Rogers Burnett", "role": "Principal Investigator"}, {"name": "Vanessa Jacoby", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL151094-03", "company": "Curi Bio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-30", "observed": "2026-08-21", "amount_usd": 750000, "summary": "NIH award 5R44HL151094-03: Predictive assessment of acute and chronic cardiotoxicity using combinatorially matured hPSC-CMs ($750,000)", "source_url": "https://reporter.nih.gov/project-details/10480067", "people": [{"name": "Nicholas Andrew Geisse", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R42HG012288-01", "company": "Geneial LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-30", "observed": "2026-08-21", "amount_usd": 349997, "summary": "NIH award 1R42HG012288-01: Privacy-Preserving Connectivity for Rare-Disease Patients ($349,997)", "source_url": "https://reporter.nih.gov/project-details/10378819", "people": [{"name": "Adam Wesley Hansen", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HG010446-03", "company": "Genomenon, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-30", "observed": "2026-08-21", "amount_usd": 855024, "summary": "NIH award 5R44HG010446-03: Micropublications for Automating Genome Sequence Variant Interpretation from Medical Literature ($855,024)", "source_url": "https://reporter.nih.gov/project-details/10491767", "people": [{"name": "Mark Julin Kiel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL158375-02", "company": "Advanced Cooling Therapy, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-30", "observed": "2026-08-21", "amount_usd": 1700000, "summary": "NIH award 5R44HL158375-02: Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation ($1,700,000)", "source_url": "https://reporter.nih.gov/project-details/10480805", "people": [{"name": "DAVID J CALLANS", "role": "Principal Investigator"}, {"name": "Erik Benjamin Kulstad", "role": "Principal Investigator"}, {"name": "Cory Michael Tschabrunn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44LM013859-01", "company": "Lifeboard Medical", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-30", "observed": "2026-08-21", "amount_usd": 651784, "summary": "NIH award 1R44LM013859-01: Leveraging Health Information Technology to Improve Trauma Resuscitation ($651,784)", "source_url": "https://reporter.nih.gov/project-details/10330650", "people": [{"name": "Michael H. Metzler", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD084151-06", "company": "Miyazaki Enterprises, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-30", "observed": "2026-08-21", "amount_usd": 981109, "summary": "NIH award 5R44HD084151-06: Effect of Validated Skills Simulation with the Miya Model on Operating Room Performance of Vaginal Hysterectomy ($981,109)", "source_url": "https://reporter.nih.gov/project-details/10486044", "people": [{"name": "Bruce D Anderson", "role": "Principal Investigator"}, {"name": "Chi Chiung Grace Chen", "role": "Principal Investigator"}, {"name": "Howard Curlin", "role": "Principal Investigator"}, {"name": "Leslie Kammire", "role": "Principal Investigator"}, {"name": "Veronica Lerner", "role": "Principal Investigator"}, {"name": "Ernest Lockrow", "role": "Principal Investigator"}, {"name": "Nichole Mahnert", "role": "Principal Investigator"}, {"name": "Catherine Ann Matthews", "role": "Principal Investigator"}, {"name": "Douglas W. Miyazaki", "role": "Principal Investigator"}, {"name": "Jamal Mourad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R41GM142406-01A1", "company": "Aimloxy LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-30", "observed": "2026-08-21", "amount_usd": 256571, "summary": "NIH award 1R41GM142406-01A1: Reduction of Pigmentation Dependent Errors using Spectroscopic Pulse Oximetery ($256,571)", "source_url": "https://reporter.nih.gov/project-details/10385103", "people": [{"name": "Vikas Khurana", "role": "Principal Investigator"}, {"name": "Chetan A Patil", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EY028081-04", "company": "Eyenuk, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-29", "observed": "2026-08-21", "amount_usd": 250000, "summary": "NIH award 5R44EY028081-04: Fully-Automated Lesion Characterization in Ultrawide-Field Retinal Images ($250,000)", "source_url": "https://reporter.nih.gov/project-details/10477385", "people": [{"name": "Sandeep Bhat", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AG052196-05", "company": "Spr Therapeutics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-29", "observed": "2026-08-21", "amount_usd": 1139554, "summary": "NIH award 5R44AG052196-05: Electrical stimulation to reduce pain and improve function after knee replacement ($1,139,554)", "source_url": "https://reporter.nih.gov/project-details/10492713", "people": [{"name": "Joseph Wilder Boggs", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R43GM144973-01", "company": "Cytosorbents, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-29", "observed": "2026-08-21", "amount_usd": 281835, "summary": "NIH award 1R43GM144973-01: Novel Extracorporeal Therapy for the Reversal of Septic Shock and Restoring Hemodynamic Stability ($281,835)", "source_url": "https://reporter.nih.gov/project-details/10374283", "people": [{"name": "Phillip Chan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R41AG076098-01S1", "company": "Wellsim Biomedical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-29", "observed": "2026-08-21", "amount_usd": 110405, "summary": "NIH award 3R41AG076098-01S1: EXODUS-enabled High-throughput Multi-omics Profiling of Extracellular Vesicles for Diagnosis of Preclinical Alzheimer's Disease ($110,405)", "source_url": "https://reporter.nih.gov/project-details/10604194", "people": [{"name": "Yuchao Chen", "role": "Principal Investigator"}, {"name": "Xianjun Dong", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DA055161-01", "company": "Rissana, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-29", "observed": "2026-08-21", "amount_usd": 253447, "summary": "NIH award 1R44DA055161-01: A digital intervention to decrease self-stigma among pregnant and postpartum women with opioid use disorder ($253,447)", "source_url": "https://reporter.nih.gov/project-details/10360365", "people": [{"name": "Patricia A Cavazos-Rehg", "role": "Principal Investigator"}, {"name": "Micah Goodman", "role": "Principal Investigator"}, {"name": "Alex Taylor Ramsey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44EY033254-02", "company": "Cryocrate, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-29", "observed": "2026-08-21", "amount_usd": 726985, "summary": "NIH award 5R44EY033254-02: Late-stage Preclinical Development and cGMP Production of a First-in-Class Cornea Cryopreservation Kit Based on FDA Feedback ($726,985)", "source_url": "https://reporter.nih.gov/project-details/10476603", "people": [{"name": "Xu Han", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44MH124574-03", "company": "Neuromotion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-29", "observed": "2026-08-21", "amount_usd": 716811, "summary": "NIH award 5R44MH124574-03: A Mightier healthcare system: Introducing a game-based pediatric mental health intervention into payor-sponsored care to evaluate financial and clinical outcomes ($716,811)", "source_url": "https://reporter.nih.gov/project-details/10489727", "people": [{"name": "Jason Kahn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41HD109131-01", "company": "Precision Neuroscopics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-29", "observed": "2026-08-21", "amount_usd": 127763, "summary": "NIH award 1R41HD109131-01: New Electrodes for Enabling Inclusive EEG Monitoring in Black Populations ($127,763)", "source_url": "https://reporter.nih.gov/project-details/10484809", "people": [{"name": "Jasmine Kwasa", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG079734-01", "company": "Einsenca Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-29", "observed": "2026-08-21", "amount_usd": 497602, "summary": "NIH award 1R44AG079734-01: PET Imaging of Damaging Neuroinflammation in Alzheimer's Disease ($497,602)", "source_url": "https://reporter.nih.gov/project-details/10547472", "people": [{"name": "Andrew Christian Larson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL162169-01A1", "company": "Shape Medical Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-29", "observed": "2026-08-21", "amount_usd": 1223664, "summary": "NIH award 1R44HL162169-01A1: Assessing the Utility of Submaximal Cardiopulmonary Exercise Testing in Diagnosis and Treatment Management of Pulmonary Arterial Hypertension ($1,223,664)", "source_url": "https://reporter.nih.gov/project-details/10482044", "people": [{"name": "Dean Judson MacCarter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44MD017174-02", "company": "Benten Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-27", "observed": "2026-08-21", "amount_usd": 825014, "summary": "NIH award 4R44MD017174-02: Multi-modal Intervention for Lactation Care (MILC) will be a mHealth platform to increase ($825,014)", "source_url": "https://reporter.nih.gov/project-details/10500048", "people": [{"name": "Tony Xuyen Ma", "role": "Principal Investigator"}, {"name": "Yukiko Washio", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R42DE030040-02", "company": "Virtually Better, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-26", "observed": "2026-08-21", "amount_usd": 808724, "summary": "NIH award 4R42DE030040-02: Disseminable Evidence-Based Treatment for the Dental Office: Virtual Exposure Tools for Dental Fear - neVR Fear the Dentist ($808,724)", "source_url": "https://reporter.nih.gov/project-details/10596379", "people": [{"name": "Margo Adams Larsen", "role": "Principal Investigator"}, {"name": "Richard Eliot Heyman", "role": "Principal Investigator"}, {"name": "AMY Michele Smith SLEP", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44DK127580-02", "company": "Crm Medical Devices, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-26", "observed": "2026-08-21", "amount_usd": 768122, "summary": "NIH award 2R44DK127580-02: Validation of a Neurogenic Bladder Management Solution to Promote Independence and Reduce Long-Term Morbidity for Patients Unable to Perform Intermittent Catheterization ($768,122)", "source_url": "https://reporter.nih.gov/project-details/10548666", "people": [{"name": "Christopher Elliott", "role": "Principal Investigator"}, {"name": "Christian S Eversull", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG043191-06", "company": "Blue Marble Rehab, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-26", "observed": "2026-08-21", "amount_usd": 978861, "summary": "NIH award 5R44AG043191-06: Health in Motion- A Pragmatic Clinical Trial ($978,861)", "source_url": "https://reporter.nih.gov/project-details/10432097", "people": [{"name": "Sheryl Flynn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R42AG059475-03", "company": "Advanced Smart Systems/evaluation Techno", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-26", "observed": "2026-08-21", "amount_usd": 968372, "summary": "NIH award 5R42AG059475-03: Mitigating Injurious Falls in Older Adults Through Non-Injurious Fall and Gait Analysis From Floor Vibrations ($968,372)", "source_url": "https://reporter.nih.gov/project-details/10495263", "people": [{"name": "Stacy Lynne Fritz", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG058277-03", "company": "Photozig, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-26", "observed": "2026-08-21", "amount_usd": 989297, "summary": "NIH award 5R44AG058277-03: Mindfulness-based Cognitive Coping Mobile App Intervention for caregivers of individuals with Alzheimer's Disease ($989,297)", "source_url": "https://reporter.nih.gov/project-details/10468322", "people": [{"name": "BRUNO KAJIYAMA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44GM139504-03", "company": "Lase Innovation Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-26", "observed": "2026-08-21", "amount_usd": 755367, "summary": "NIH award 5R44GM139504-03: Cyclic Flow Cytometry for Ultra-High Marker Single-Cell Analysis ($755,367)", "source_url": "https://reporter.nih.gov/project-details/10485275", "people": [{"name": "Sheldon J.J. Kwok", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41HL158414-01A1", "company": "Refined Imaging, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-26", "observed": "2026-08-21", "amount_usd": 322996, "summary": "NIH award 1R41HL158414-01A1: Implementation and validation of a lung x-ray interferometry imaging system, with applications to COPD, COVID-19 and other lung diseases ($322,996)", "source_url": "https://reporter.nih.gov/project-details/10384525", "people": [{"name": "KENNETH L MATTHEWS", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN210052", "company": "Vibrant, Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-08-26", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210052 granted: Vibrant System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210052"}, {"id": "sbir:DOD:W81XWH19C0012", "company": "Lynntech Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-08-26", "observed": "2026-09-18", "amount_usd": 1538952, "summary": "DOD SBIR Phase II award $1,538,952: Point of Care Test for Disease Severity and Risk Stratification", "source_url": "https://www.sbir.gov/awards?search=H2-0383"}, {"id": "nih:5R44GM134789-03", "company": "Rewire Neuroscience, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-25", "observed": "2026-08-21", "amount_usd": 776318, "summary": "NIH award 5R44GM134789-03: Development of an adaptive machine learning platform for automated analysis of biomarkers in biomedical images ($776,318)", "source_url": "https://reporter.nih.gov/project-details/10483118", "people": [{"name": "John H Harkness", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R41CA261420-02", "company": "Navigation Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-25", "observed": "2026-08-21", "amount_usd": 75973, "summary": "NIH award 5R41CA261420-02: Bronchoscopic lung navigation system for accurately excising lung nodules ($75,973)", "source_url": "https://reporter.nih.gov/project-details/10479993", "people": [{"name": "Jayender Jagadeesan", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44HD104539-02", "company": "Zsx Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-25", "observed": "2026-08-21", "amount_usd": 753040, "summary": "NIH award 5R44HD104539-02: Zip-stitch for Laparoscopic Hysterectomy - Clinical Validation ($753,040)", "source_url": "https://reporter.nih.gov/project-details/10491771", "people": [{"name": "Dan C Mazzucco", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA261318-02", "company": "Veravanti, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-25", "observed": "2026-08-21", "amount_usd": 1002190, "summary": "NIH award 5R44CA261318-02: Endoscope development for the clinical use of near infrared fluorescence molecular probes in the GI tract ($1,002,190)", "source_url": "https://reporter.nih.gov/project-details/10493360", "people": [{"name": "Gerald McMorrow", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44ES024041-05", "company": "Access Sensor Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-25", "observed": "2026-08-21", "amount_usd": 961499, "summary": "NIH award 5R44ES024041-05: Validation of the UPAS+: A filter-based air sampler coupled with a suite of real-time sensors ($961,499)", "source_url": "https://reporter.nih.gov/project-details/10491221", "people": [{"name": "Daniel D Miller-Lionberg", "role": "Principal Investigator"}, {"name": "Jessica Tryner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:4R42MD014947-02", "company": "Klein Buendel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-25", "observed": "2026-08-21", "amount_usd": 859118, "summary": "NIH award 4R42MD014947-02: Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers) ($859,118)", "source_url": "https://reporter.nih.gov/project-details/10500045", "people": [{"name": "Robert Lee Newton", "role": "Principal Investigator"}, {"name": "Kayla Nuss", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "sbir:DOD:W81XWH-22-P-0130", "company": "Quantum Applied Science & Research Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-08-25", "observed": "2026-09-18", "amount_usd": 249998, "summary": "DOD SBIR Phase I award $249,998: Dry Electrode Flight helmet Integrated Eeg System (DEFIES)", "source_url": "https://www.sbir.gov/awards?search=H222-001-0018"}, {"id": "sbir:DOD:W81XWH-22-P-0128", "company": "Triton Systems, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-08-25", "observed": "2026-09-18", "amount_usd": 249933, "summary": "DOD SBIR Phase I award $249,933: Developing a Hardened Portable EEG System", "source_url": "https://www.sbir.gov/awards?search=H222-001-0013"}, {"id": "nih:4R44HD105579-02", "company": "Neurolutions, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-24", "observed": "2026-08-21", "amount_usd": 863240, "summary": "NIH award 4R44HD105579-02: A Fully Remote Telehealth Brain Computer Interface And Assessment System For Motor Rehabilitation Of Chronic Stroke ($863,240)", "source_url": "https://reporter.nih.gov/project-details/10653373", "people": [{"name": "Kern Bhugra", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG076248-01A1", "company": "Theranova, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-24", "observed": "2026-08-21", "amount_usd": 1004449, "summary": "NIH award 1R44AG076248-01A1: A novel enteral feeding system for the earlier and safer delivery of enteral nutrition through continuous monitoring of tip location ($1,004,449)", "source_url": "https://reporter.nih.gov/project-details/10485011", "people": [{"name": "Daniel Rogers Burnett", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R42HD107747-02", "company": "Ifit Prosthetics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-24", "observed": "2026-08-21", "amount_usd": 880549, "summary": "NIH award 4R42HD107747-02: Adjustable prosthetic sockets for children and adolescents with lower limb loss to accommodate growth ($880,549)", "source_url": "https://reporter.nih.gov/project-details/10658207", "people": [{"name": "TIMOTHY R DILLINGHAM", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43EB033725-01", "company": "Health Discovery Labs LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-24", "observed": "2026-08-21", "amount_usd": 259481, "summary": "NIH award 1R43EB033725-01: Closed Loop Electrical Muscle Stimulation System (CL-EMS) with improved safety for ICU environment to mitigate ICU Acquired Weakness ($259,481)", "source_url": "https://reporter.nih.gov/project-details/10545702", "people": [{"name": "Oussama Hassan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA257522-02A1", "company": "Multifunctional Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-24", "observed": "2026-08-21", "amount_usd": 697643, "summary": "NIH award 2R44CA257522-02A1: Dual-Tracer PET Tumor Imaging ($697,643)", "source_url": "https://reporter.nih.gov/project-details/10546374", "people": [{"name": "Dan J Kadrmas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44NS127725-01", "company": "Open Ephys, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-24", "observed": "2026-08-21", "amount_usd": 707156, "summary": "NIH award 1R44NS127725-01: ONIX: A Neural Acquisition System for Unencumbered, Closed-Loop Recordings in Small, Freely Moving Animals ($707,156)", "source_url": "https://reporter.nih.gov/project-details/10482182", "people": [{"name": "Jonathan Newman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI157716-03", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-24", "observed": "2026-08-21", "amount_usd": 253737, "summary": "NIH award 5R44AI157716-03: Rapid Differential Diagnosis of COVID-19 and Common Respiratory Infections ($253,737)", "source_url": "https://reporter.nih.gov/project-details/10491251", "people": [{"name": "VAMSEE K. PAMULA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG074727-03", "company": "Together Senior Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-23", "observed": "2026-08-21", "amount_usd": 979126, "summary": "NIH award 5R44AG074727-03: BRAIN HEALTH TOGETHER: A LIVE-STREAMING GROUP-BASED DIGITAL PROGRAM ($979,126)", "source_url": "https://reporter.nih.gov/project-details/10493302", "people": [{"name": "Deborah E. Barnes", "role": "Principal Investigator"}, {"name": "Cynthia Louise Benjamin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44AA029868-02", "company": "Evidence-based Practice Institute, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-23", "observed": "2026-08-21", "amount_usd": 1017589, "summary": "NIH award 4R44AA029868-02: Treating Drivers of Suicide in Primary Care using Jaspr Health ($1,017,589)", "source_url": "https://reporter.nih.gov/project-details/10659264", "people": [{"name": "Linda A Dimeff", "role": "Principal Investigator"}, {"name": "David Alan Jobes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DA047150-03", "company": "Square2 Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-23", "observed": "2026-08-21", "amount_usd": 682626, "summary": "NIH award 5R44DA047150-03: Socializing a Science-based Digital Therapeutic for Substance Use Disorders ($682,626)", "source_url": "https://reporter.nih.gov/project-details/10476597", "people": [{"name": "Michael John Grabinski", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44NS120798-02", "company": "Rivanna Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-23", "observed": "2026-08-21", "amount_usd": 830602, "summary": "NIH award 5R44NS120798-02: Real-time three-dimensional spinal navigation system for bedside lumbar puncture placement ($830,602)", "source_url": "https://reporter.nih.gov/project-details/10483220", "people": [{"name": "Frank William Mauldin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "sbir:DOD:W81XWH-22-C-0095", "company": "Tda Research, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-08-23", "observed": "2026-09-18", "amount_usd": 1100000, "summary": "DOD SBIR Phase II award $1,100,000: Stackable Portable Oxygen Generator for Deployed Army Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2-0707"}, {"id": "nih:1R43HL162270-01", "company": "Polymerix LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-22", "observed": "2026-08-21", "amount_usd": 165600, "summary": "NIH award 1R43HL162270-01: A universal ambient air-oxygen blender to treat respiratory distress in newborns ($165,600)", "source_url": "https://reporter.nih.gov/project-details/10384958", "people": [{"name": "Bruce Lawrence Carvalho", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43AG076091-02S1", "company": "Virtici, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-22", "observed": "2026-08-21", "amount_usd": 73171, "summary": "NIH award 3R43AG076091-02S1: A Novel Multiparameter Blood Test for Early Detection of Alzheimer's Disease ($73,171)", "source_url": "https://reporter.nih.gov/project-details/10683848", "people": [{"name": "Neil A Fanger", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG079718-01", "company": "Augnition Labs LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-22", "observed": "2026-08-21", "amount_usd": 1004853, "summary": "NIH award 1R44AG079718-01: Augmem: A Novel Digital Cognitive Assessment for the Early Detection of Alzheimer's Disease ($1,004,853)", "source_url": "https://reporter.nih.gov/project-details/10545457", "people": [{"name": "Adele Gilpin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43OH012495-01", "company": "Piezobiomembrane, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-22", "observed": "2026-08-21", "amount_usd": 276415, "summary": "NIH award 1R43OH012495-01: Moisture-resistant, sterilizable and reusable N-95 like piezoelectric facemask filtering membrane with long-term biodegradability ($276,415)", "source_url": "https://reporter.nih.gov/project-details/10547176", "people": [{"name": "Linh Le", "role": "Principal Investigator"}, {"name": "Thanh Nguyen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL139184-03", "company": "Advancedcpr Solutions LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-22", "observed": "2026-08-21", "amount_usd": 928395, "summary": "NIH award 5R44HL139184-03: Phase II, Head Up Cardiopulmonary Resuscitation Device ($928,395)", "source_url": "https://reporter.nih.gov/project-details/10485256", "people": [{"name": "Keith Lurie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DC018757-03", "company": "Blackrock Microsystems", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-22", "observed": "2026-08-21", "amount_usd": 728152, "summary": "NIH award 5R44DC018757-03: Development of an AMF Orion/Blackrock HD-USEA based 60/128 channel implantable wireless simulator system for human auditory nerve implants ($728,152)", "source_url": "https://reporter.nih.gov/project-details/10470963", "people": [{"name": "Robert Jay Greenberg", "role": "Principal Investigator"}, {"name": "Sandeep Negi", "role": "Principal Investigator"}, {"name": "Florian Solzbacher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43CA265482-01A1", "company": "Precision Microwave, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-22", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R43CA265482-01A1: MWA verification system for improved confidence in treatment outcomes ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10481747", "people": [{"name": "Austin Pfannenstiel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD104328-03", "company": "Biomotum, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-20", "observed": "2026-08-21", "amount_usd": 772373, "summary": "NIH award 5R44HD104328-03: Development of a robotic ankle assist device to improve mobility in individuals with movement disorders. ($772,373)", "source_url": "https://reporter.nih.gov/project-details/10472074", "people": [{"name": "RAYMOND Clifton BROWNING", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42HL147728-02", "company": "Sonavi Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-20", "observed": "2026-08-21", "amount_usd": 1148290, "summary": "NIH award 4R42HL147728-02: Feelix @ Home: Testing and optimization of a smart stethoscope for home use to monitor changes in lung status of individuals with chronic conditions ($1,148,290)", "source_url": "https://reporter.nih.gov/project-details/10274773", "people": [{"name": "Ilene Joy Busch-Vishniac", "role": "Principal Investigator"}, {"name": "Mounya Elhilali", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HD097805-03", "company": "Advanced Tactile Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-20", "observed": "2026-08-21", "amount_usd": 839775, "summary": "NIH award 5R44HD097805-03: Tactile and ultrasound imaging fusion for functional assessment of the female pelvic floor ($839,775)", "source_url": "https://reporter.nih.gov/project-details/10491959", "people": [{"name": "Vladimir Egorov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43CK000679-01", "company": "Nanohmics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-19", "observed": "2026-08-21", "amount_usd": 225000, "summary": "NIH award 1R43CK000679-01: Lateral Flow-Electrochemiluminescent (LF-ECL) Test Strips and Portable Reader for Ultrasensitive Foodborne Pathogen Detection ($225,000)", "source_url": "https://reporter.nih.gov/project-details/10483325", "people": [{"name": "John Bruno", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43OH012425-01A1", "company": "Hava, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-19", "observed": "2026-08-21", "amount_usd": 259484, "summary": "NIH award 1R43OH012425-01A1: Rapid Production of Metal Organic Framework - Fabrics for Air Filtration ($259,484)", "source_url": "https://reporter.nih.gov/project-details/10546842", "people": [{"name": "Nick Cienski", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM125412-03", "company": "Ionic Pharmaceuticals", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-19", "observed": "2026-08-21", "amount_usd": 866742, "summary": "NIH award 5R44GM125412-03: Production of a dissolvable hydrogel-based wound dressing for second degree burns ($866,742)", "source_url": "https://reporter.nih.gov/project-details/10489409", "people": [{"name": "Aaron Henry Colby", "role": "Principal Investigator"}, {"name": "Benjamin Goldman Cooper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R43AG076091-02", "company": "Virtici, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-19", "observed": "2026-08-21", "amount_usd": 291961, "summary": "NIH award 5R43AG076091-02: A Novel Multiparameter Blood Test for Early Detection of Alzheimer's Disease ($291,961)", "source_url": "https://reporter.nih.gov/project-details/10491891", "people": [{"name": "Neil A Fanger", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:3R44AG065081-04S1", "company": "Maphabit, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-19", "observed": "2026-08-21", "amount_usd": 81990, "summary": "NIH award 3R44AG065081-04S1: Using gamification, predictive analytics, artificial intelligence, and Alexa Voice to optimize user experience for individuals living with AD/ADRD and their caregivers ($81,990)", "source_url": "https://reporter.nih.gov/project-details/10683426", "people": [{"name": "Matthew Golden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43CA272045-01A1", "company": "Tymora Analytical Operations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-19", "observed": "2026-08-21", "amount_usd": 290000, "summary": "NIH award 1R43CA272045-01A1: Development of lavage EV protein biomarkers for minimally-invasive detection of endometrial cancer ($290,000)", "source_url": "https://reporter.nih.gov/project-details/10540917", "people": [{"name": "Anton Iliuk", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AI165129-01A1", "company": "Ambergen, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-19", "observed": "2026-08-21", "amount_usd": 978625, "summary": "NIH award 1R44AI165129-01A1: New Technology for High-Resolution Antibody Profiling for SARS-CoV-2 ($978,625)", "source_url": "https://reporter.nih.gov/project-details/10481680", "people": [{"name": "Mark Lim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DE027574-03", "company": "Kitware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-19", "observed": "2026-08-21", "amount_usd": 844321, "summary": "NIH award 5R44DE027574-03: Automated Dental Fracture Detection using High Resolution CBCT and Advanced Image Analysis ($844,321)", "source_url": "https://reporter.nih.gov/project-details/10491799", "people": [{"name": "Beatriz Paniagua", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44DK127659-02", "company": "Mimetas US, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-18", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 2R44DK127659-02: Development of the NephroPlate: A high-throughput kidney-on-a-chip platform for identifying chronic kidney disease therapies ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10547358", "people": [{"name": "Kristin M Bircsak", "role": "Principal Investigator"}, {"name": "Laura Perin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA268678-01A1", "company": "Collinge And Associates", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-18", "observed": "2026-08-21", "amount_usd": 399085, "summary": "NIH award 1R43CA268678-01A1: mHealth app for caregiver instruction in manual therapy for chemotherapy-induced peripheral neuropathy ($399,085)", "source_url": "https://reporter.nih.gov/project-details/10482557", "people": [{"name": "WILLIAM B. COLLINGE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL152835-03", "company": "Vantis Vascular Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-18", "observed": "2026-08-21", "amount_usd": 1030698, "summary": "NIH award 5R44HL152835-03: Catheter for Complex Percutaneous Coronary Intervention ($1,030,698)", "source_url": "https://reporter.nih.gov/project-details/10468974", "people": [{"name": "Tim Alexander Fischell", "role": "Principal Investigator"}, {"name": "Frank S Saltiel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA239830-03", "company": "Sonovol, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-18", "observed": "2026-08-21", "amount_usd": 762081, "summary": "NIH award 5R44CA239830-03: A turnkey research platform to accelerate clinical translation of targeted immune-modulation enhanced therapies ($762,081)", "source_url": "https://reporter.nih.gov/project-details/10458077", "people": [{"name": "Tomasz Joseph Czernuszewicz", "role": "Principal Investigator"}, {"name": "Ryan Gessner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R42MH124566-02", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-18", "observed": "2026-08-21", "amount_usd": 994964, "summary": "NIH award 4R42MH124566-02: NeuroExM ($994,964)", "source_url": "https://reporter.nih.gov/project-details/10495622", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DE024919-06", "company": "Nanomag, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-18", "observed": "2026-08-21", "amount_usd": 297851, "summary": "NIH award 5R44DE024919-06: Commercialization Readiness Program (CRP) for Bioabsorbable Magnesium (Mg) Implants for Craniomaxillofacial Surgical Systems ($297,851)", "source_url": "https://reporter.nih.gov/project-details/10479015", "people": [{"name": "Stephen LeBeau", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R44CA239829-03", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-18", "observed": "2026-08-21", "amount_usd": 784016, "summary": "NIH award 5R44CA239829-03: Novel Minimally Invasive Endobronchial Approach for Lung Cancer Ablation ($784,016)", "source_url": "https://reporter.nih.gov/project-details/10495201", "people": [{"name": "Howard Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41AI162477-01A1", "company": "Microbiochip Diagnostics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-18", "observed": "2026-08-21", "amount_usd": 259565, "summary": "NIH award 1R41AI162477-01A1: Point-of-care microdevices for simultaneous detection of multiple pertussis-like respiratory diseases from Bordetella species ($259,565)", "source_url": "https://reporter.nih.gov/project-details/10385262", "people": [{"name": "Xiujun Li", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AR070071-03", "company": "If, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-18", "observed": "2026-08-21", "amount_usd": 711290, "summary": "NIH award 5R44AR070071-03: Development of a Photoacoustic Quantitative Ultrasound (PAQUS) device for clinical use ($711,290)", "source_url": "https://reporter.nih.gov/project-details/10495370", "people": [{"name": "Richard Franklin Morris", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH125687-02", "company": "Direct Electron, Lp", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-17", "observed": "2026-08-21", "amount_usd": 751669, "summary": "NIH award 5R44MH125687-02: An energy discriminating direct detector for multi-color SEM ($751,669)", "source_url": "https://reporter.nih.gov/project-details/10474559", "people": [{"name": "Benjamin Eugene Bammes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AR079336-02", "company": "Myolex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-17", "observed": "2026-08-21", "amount_usd": 979965, "summary": "NIH award 5R44AR079336-02: Early identification and prevention of acute compartment syndrome using a novel electrical impedance-based muscle-monitoring device ($979,965)", "source_url": "https://reporter.nih.gov/project-details/10490448", "people": [{"name": "David P. Dickinson", "role": "Principal Investigator"}, {"name": "Seward B. Rutkove", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43MD017555-01", "company": "Advanced Medical Electronics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-17", "observed": "2026-08-21", "amount_usd": 259439, "summary": "NIH award 1R43MD017555-01: Home-Based Placement of Feeding Tubes with a Mobile Assistant for Underserved Population ($259,439)", "source_url": "https://reporter.nih.gov/project-details/10480639", "people": [{"name": "GARY D HAVEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS108869-04", "company": "Axonova Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-17", "observed": "2026-08-21", "amount_usd": 900965, "summary": "NIH award 5R44NS108869-04: Generation of Tissue Engineered Nerve Grafts from GalSafe Porcine Neurons ($900,965)", "source_url": "https://reporter.nih.gov/project-details/10473788", "people": [{"name": "Kritika Katiyar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43CA272118-01", "company": "Kino Discovery, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-16", "observed": "2026-08-21", "amount_usd": 311322, "summary": "NIH award 1R43CA272118-01: Microfluidic system for complete and automated dissociation of tumor tissue into single cells ($311,322)", "source_url": "https://reporter.nih.gov/project-details/10485032", "people": [{"name": "Francis Duhay", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EB031741-02", "company": "Endotheia, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-16", "observed": "2026-08-21", "amount_usd": 663251, "summary": "NIH award 5R44EB031741-02: Dexterity Enhancement for Flexible Endoscopic Interventional Tools ($663,251)", "source_url": "https://reporter.nih.gov/project-details/10471880", "people": [{"name": "Joshua B Gafford", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA275524-01", "company": "Algometrx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-16", "observed": "2026-08-21", "amount_usd": 396711, "summary": "NIH award 1R43CA275524-01: Use of a novel physiologic measure for the assessment and monitoring of vincristine induced peripheral neuropathy (VIPN) in children and adolescents. ($396,711)", "source_url": "https://reporter.nih.gov/project-details/10547068", "people": [{"name": "Julia Cole Finkel", "role": "Principal Investigator"}, {"name": "Kevin Jackson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA254649-02", "company": "Alaunus Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-16", "observed": "2026-08-21", "amount_usd": 871193, "summary": "NIH award 2R44CA254649-02: Development of a multi-analyte diagnostic assay to improve the risk stratification of indeterminate thyroid nodules ($871,193)", "source_url": "https://reporter.nih.gov/project-details/10545522", "people": [{"name": "GISELLE M KNUDSEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44DA051289-02", "company": "Emitech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-16", "observed": "2026-08-21", "amount_usd": 775215, "summary": "NIH award 2R44DA051289-02: Wearable sensor for opioids detection based on electrochemical sensor arrayintegrated with Bluetooth device ($775,215)", "source_url": "https://reporter.nih.gov/project-details/10485805", "people": [{"name": "Igor A Levitsky", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R43MH128138-02", "company": "Emri Systems Llp", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-16", "observed": "2026-08-21", "amount_usd": 108266, "summary": "NIH award 5R43MH128138-02: Novel high-field MRI compatible subdural electrode and acquisition system for recording and stimulation in small animals ($108,266)", "source_url": "https://reporter.nih.gov/project-details/10487530", "people": [{"name": "Hernan Millan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:2R42CA232867-02A1", "company": "Morgan And Mendel Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-16", "observed": "2026-08-21", "amount_usd": 968518, "summary": "NIH award 2R42CA232867-02A1: Robust Predictor of Colon Cancer Risk ($968,518)", "source_url": "https://reporter.nih.gov/project-details/10544646", "people": [{"name": "Harry Ostrer", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL162327-01A1", "company": "Unify Medical", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-15", "observed": "2026-08-21", "amount_usd": 599863, "summary": "NIH award 1R43HL162327-01A1: Fluorescence Imaging Device with Edge Computing Capability for Intraoperative Vascular and Lymphatic Assessment ($599,863)", "source_url": "https://reporter.nih.gov/project-details/10547603", "people": [{"name": "Maziyar Askari Karchegani", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R42HG010855-03S1", "company": "Matchstick Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-15", "observed": "2026-08-21", "amount_usd": 155792, "summary": "NIH award 3R42HG010855-03S1: PIXUL-FFPE: High throughput platform for chromatin and DNA sample preparation from formalin fixed paraffin embedded (FFPE) tissue samples- supplement application. ($155,792)", "source_url": "https://reporter.nih.gov/project-details/10650670", "people": [{"name": "Karol Bomsztyk", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R44EY031198-02S1", "company": "Translational Imaging Innovations, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-15", "observed": "2026-08-21", "amount_usd": 212866, "summary": "NIH award 3R44EY031198-02S1: An Integrated Software Platform for Accelerating Image-Driven Ophthalmic Research and Driving New Insights and Endpoints to the Clinic ($212,866)", "source_url": "https://reporter.nih.gov/project-details/10631602", "people": [{"name": "Eric L. Buckland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NS113740-03", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-15", "observed": "2026-08-21", "amount_usd": 774621, "summary": "NIH award 5R44NS113740-03: An Instrument to Assess the Functional Impact of Chronic Pain ($774,621)", "source_url": "https://reporter.nih.gov/project-details/10479024", "people": [{"name": "Brian R Clark", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH129278-02", "company": "Advanced MRI Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-15", "observed": "2026-08-21", "amount_usd": 1589952, "summary": "NIH award 5R44MH129278-02: Highly Efficient MRI Pulse Sequences for High Resolution Physiological and Functional Brain Imaging ($1,589,952)", "source_url": "https://reporter.nih.gov/project-details/10491234", "people": [{"name": "Alexander Beckett", "role": "Principal Investigator"}, {"name": "David Alan Feinberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG077737-01", "company": "Hido Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-15", "observed": "2026-08-21", "amount_usd": 449609, "summary": "NIH award 1R43AG077737-01: Preventing Medication Mismanagement in People Living with Dementia through Automated Medication Dispensing with Facial Recognition and Video Observation ($449,609)", "source_url": "https://reporter.nih.gov/project-details/10461514", "people": [{"name": "Charles Gellman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH114944-05", "company": "Neurolux, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-15", "observed": "2026-08-21", "amount_usd": 991491, "summary": "NIH award 5R44MH114944-05: Advanced wireless optogenetics and photometry system for neuroscience research ($991,491)", "source_url": "https://reporter.nih.gov/project-details/10476574", "people": [{"name": "Roozbeh Ghaffari", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44NS127667-01", "company": "Magnetic Tides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-15", "observed": "2026-08-21", "amount_usd": 902565, "summary": "NIH award 1R44NS127667-01: Exploring the Parameter Space of High Frequency Magnetic Perturbation in Manipulating Neural Excitability and Plasticity. ($902,565)", "source_url": "https://reporter.nih.gov/project-details/10481976", "people": [{"name": "Ludovica Labruna", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AG074135-02", "company": "Moai Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-15", "observed": "2026-08-21", "amount_usd": 995980, "summary": "NIH award 4R44AG074135-02: Covering Care: Long-term care planning and education tool for AD/ADRD caregivers ($995,980)", "source_url": "https://reporter.nih.gov/project-details/10669855", "people": [{"name": "Olu Olofinboba", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA265301-03", "company": "Dimagi, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-14", "observed": "2026-08-21", "amount_usd": 736762, "summary": "NIH award 5R44CA265301-03: SurvivorCare: A digital health solution to support long-term cancer survivorship using patient navigation ($736,762)", "source_url": "https://reporter.nih.gov/project-details/10491778", "people": [{"name": "Y. Xian Ho", "role": "Principal Investigator"}, {"name": "Jonathan Lee Jackson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DD001299-01A1", "company": "Pgxl Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-12", "observed": "2026-08-21", "amount_usd": 309250, "summary": "NIH award 1R43DD001299-01A1: A sleep biomarker test for management of ADHD ($309,250)", "source_url": "https://reporter.nih.gov/project-details/10545222", "people": [{"name": "Christopher Thomas Burns", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HG012528-01", "company": "Wellsim Biomedical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-12", "observed": "2026-08-21", "amount_usd": 246812, "summary": "NIH award 1R43HG012528-01: Link phenotypic characteristics with gene expression profile of single cells at high throughput for drug discovery and cell therapy development ($246,812)", "source_url": "https://reporter.nih.gov/project-details/10482180", "people": [{"name": "Yuchao Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB033715-01", "company": "Akna Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-12", "observed": "2026-08-21", "amount_usd": 368190, "summary": "NIH award 1R43EB033715-01: Assay development for the assessment of pregnancy risks in early pregnancy ($368,190)", "source_url": "https://reporter.nih.gov/project-details/10547072", "people": [{"name": "Sascha Drewlo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG079741-01A1", "company": "Revbio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-12", "observed": "2026-08-21", "amount_usd": 375000, "summary": "NIH award 1R43AG079741-01A1: Improved Treatment of Vertebral Compression Fractures for Elderly Patients Using an Image-Guided, Percutaneous Delivery of a Novel Bone Adhesive ($375,000)", "source_url": "https://reporter.nih.gov/project-details/10547209", "people": [{"name": "Brian Hess", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:9R44AG078121-02", "company": "Adaptelligence, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-12", "observed": "2026-08-21", "amount_usd": 1178468, "summary": "NIH award 9R44AG078121-02: Automated Health Assessment through Mobile Sensing and Machine Learning of Daily Activities ($1,178,468)", "source_url": "https://reporter.nih.gov/project-details/10472075", "people": [{"name": "Diane Joyce Cook", "role": "Principal Investigator"}, {"name": "Lawrence Holder", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44DK131770-02", "company": "Epicypher, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-12", "observed": "2026-08-21", "amount_usd": 978127, "summary": "NIH award 4R44DK131770-02: Development of a high-throughput epigenomic mapping platform to molecularly phenotype Crohn's disease ($978,127)", "source_url": "https://reporter.nih.gov/project-details/10486369", "people": [{"name": "Andrea Lynn Johnstone", "role": "Principal Investigator"}, {"name": "SHEHZAD Z. SHEIKH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DK131644-02", "company": "Sonavex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-12", "observed": "2026-08-21", "amount_usd": 710000, "summary": "NIH award 5R44DK131644-02: Validation of a Bedside Automated 3D Ultrasound-based Arteriovenous Fistula Cannulation Guidance Solution to Improve AV Fistula Outcomes ($710,000)", "source_url": "https://reporter.nih.gov/project-details/10488261", "people": [{"name": "Xin Kang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43OH012421-01", "company": "Creare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-12", "observed": "2026-08-21", "amount_usd": 259354, "summary": "NIH award 1R43OH012421-01: Enhancement to Leak Free Non-Invasive Ventilation Mask for Infectious Patients ($259,354)", "source_url": "https://reporter.nih.gov/project-details/10484122", "people": [{"name": "Daniel Micka", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL164239-01", "company": "Innovative Biotherapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-12", "observed": "2026-08-21", "amount_usd": 325257, "summary": "NIH award 1R43HL164239-01: SCD-PICC Therapy for Respiratory Insufficiency associated with COVID-19 in non-ICU settings ($325,257)", "source_url": "https://reporter.nih.gov/project-details/10481579", "people": [{"name": "Christopher Pino", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HG011608-02", "company": "Armonica Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-11", "observed": "2026-08-21", "amount_usd": 943904, "summary": "NIH award 2R44HG011608-02: Single molecule DNA/RNA sequencing technology based on a parallel Raman scattering readout in a coupled nanochannel/nanopore system ($943,904)", "source_url": "https://reporter.nih.gov/project-details/10482189", "people": [{"name": "Steven Brueck", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AI170308-01A1", "company": "Peak Diagnostic Partners LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-11", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43AI170308-01A1: A comprehensive next generation sequencing diagnostic tool for lung infection among hospitalized patients ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10547598", "people": [{"name": "Tasha E. Fingerlin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG076093-01", "company": "Proactive Memory Services, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-11", "observed": "2026-08-21", "amount_usd": 456315, "summary": "NIH award 1R44AG076093-01: CUSTOMIZABLE TRAINING SOFTWARE FOR PROFESSIONAL ALZHEIMER DIRECT CARE PROVIDERS ($456,315)", "source_url": "https://reporter.nih.gov/project-details/10384143", "people": [{"name": "NORMAN LOUIS FOSTER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG065081-04", "company": "Maphabit, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-11", "observed": "2026-08-21", "amount_usd": 1256442, "summary": "NIH award 5R44AG065081-04: Using gamification, predictive analytics, artificial intelligence, and Alexa Voice to optimize user experience for individuals living with AD/ADRD and their caregivers ($1,256,442)", "source_url": "https://reporter.nih.gov/project-details/10468936", "people": [{"name": "Matthew Golden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R41AI167161-01A1", "company": "Ciencia, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-11", "observed": "2026-08-21", "amount_usd": 259613, "summary": "NIH award 1R41AI167161-01A1: Highly-sensitive, rapid and low cost plasmonic assay platform for Lyme disease diagnosis ($259,613)", "source_url": "https://reporter.nih.gov/project-details/10546574", "people": [{"name": "Nathaniel Charles Cady", "role": "Principal Investigator"}, {"name": "Ernest Fitch Guignon", "role": "Principal Investigator"}, {"name": "Klemen Strle", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44TR001704-04", "company": "Third Pole, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-11", "observed": "2026-08-21", "amount_usd": 792305, "summary": "NIH award 5R44TR001704-04: Portable electrical nitric oxide generator for treatment of pulmonary hypertension accompanying interstitial lung disease ($792,305)", "source_url": "https://reporter.nih.gov/project-details/10491114", "people": [{"name": "Greg Hall", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43GM148082-01", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-11", "observed": "2026-08-21", "amount_usd": 258541, "summary": "NIH award 1R43GM148082-01: Smart sensor for guiding safe delivery of anesthetic and pain drugs through epidurals ($258,541)", "source_url": "https://reporter.nih.gov/project-details/10545953", "people": [{"name": "NICUSOR IFTIMIA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44EY034410-01", "company": "Praevium Research, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-11", "observed": "2026-08-21", "amount_usd": 369999, "summary": "NIH award 1R44EY034410-01: Swept source retinal visible optical coherence tomography using broadly tunable frequency doubling of NIR MEMS-VCSELs ($369,999)", "source_url": "https://reporter.nih.gov/project-details/10546927", "people": [{"name": "Vijaysekhar Jayaraman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL166003-01", "company": "Prolocor Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-11", "observed": "2026-08-21", "amount_usd": 613937, "summary": "NIH award 1R44HL166003-01: Validation of Platelet Expression of Fc\u0263RIIa as a Precision Tool ($613,937)", "source_url": "https://reporter.nih.gov/project-details/10545286", "people": [{"name": "Jeanne Ohrnberger", "role": "Principal Investigator"}, {"name": "David J Schneider", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AG074778-02", "company": "Kinto", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-10", "observed": "2026-08-21", "amount_usd": 1218062, "summary": "NIH award 4R44AG074778-02: Development of a technology-enabled care coaching service for families caring for AD/ADRD & a 300-family study to assess the service's impact on CG financial knowledge, efficacy, strain & action. ($1,218,062)", "source_url": "https://reporter.nih.gov/project-details/10654937", "people": [{"name": "Joseph Chung", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HG011605-02", "company": "Honeycomb Biotechnologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-10", "observed": "2026-08-21", "amount_usd": 656166, "summary": "NIH award 5R44HG011605-02: Deployable, Single-use Device for Single Cell Genomics in Clinical Research ($656,166)", "source_url": "https://reporter.nih.gov/project-details/10457403", "people": [{"name": "Todd M Gierahn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44GM134756-03", "company": "Computchem LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-10", "observed": "2026-08-21", "amount_usd": 671205, "summary": "NIH award 5R44GM134756-03: Molecular Dynamics and Artificial Intelligence Based Tools to Innovate Covalent and Noncovalent Drug Design ($671,205)", "source_url": "https://reporter.nih.gov/project-details/10488747", "people": [{"name": "Julie Anne Harris", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44MH131510-01", "company": "Experiad, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-10", "observed": "2026-08-21", "amount_usd": 679957, "summary": "NIH award 1R44MH131510-01: Acuity - A Clinical Decision Support System for Applied Behavior Analysis ($679,957)", "source_url": "https://reporter.nih.gov/project-details/10552494", "people": [{"name": "REX M JAKOBOVITS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43GH002391-01A1", "company": "Optofluidic Bioassay LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-10", "observed": "2026-08-21", "amount_usd": 256131, "summary": "NIH award 1R43GH002391-01A1: Development of rapid, low-cost, and high throughput COVID-19 antibody assays ($256,131)", "source_url": "https://reporter.nih.gov/project-details/10482447", "people": [{"name": "Maung K Khaing Oo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DA051063-03", "company": "Medical Innovators Company, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-10", "observed": "2026-08-21", "amount_usd": 425535, "summary": "NIH award 5R44DA051063-03: A Software Product That Empowers Individuals Affected By Substance Use Disorders and Their Care Teams with Health and Social Resources ($425,535)", "source_url": "https://reporter.nih.gov/project-details/10491118", "people": [{"name": "Tom Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41DC020415-01", "company": "Redolynt, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-10", "observed": "2026-08-21", "amount_usd": 252118, "summary": "NIH award 1R41DC020415-01: Adaptive olfactory threshold testing in the clinical assessment of anosmia ($252,118)", "source_url": "https://reporter.nih.gov/project-details/10491037", "people": [{"name": "Steven D Munger", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DE031461-01A1", "company": "Pediametrix Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-09", "observed": "2026-08-21", "amount_usd": 252059, "summary": "NIH award 1R44DE031461-01A1: Mobile Three-Dimensional Screening for Cranial Malformations ($252,059)", "source_url": "https://reporter.nih.gov/project-details/10482547", "people": [{"name": "Fereshteh Aalamifar", "role": "Principal Investigator"}, {"name": "Reza Seifabadi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AA028463-03", "company": "Lyssn.io, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-09", "observed": "2026-08-21", "amount_usd": 814020, "summary": "NIH award 5R44AA028463-03: ClientBot: A conversational agent that supports skills practice and feedback for Motivational Interviewing for AUD ($814,020)", "source_url": "https://reporter.nih.gov/project-details/10476607", "people": [{"name": "David Charles Atkins", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43GH002369-01A1", "company": "Vectech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-09", "observed": "2026-08-21", "amount_usd": 275766, "summary": "NIH award 1R43GH002369-01A1: Automated lab identification and sorting (ALIDAS) for mosquito surveillance ($275,766)", "source_url": "https://reporter.nih.gov/project-details/10484761", "people": [{"name": "Jewell Amanda Brey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44OD023029-02A1", "company": "Photosound Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-09", "observed": "2026-08-21", "amount_usd": 997451, "summary": "NIH award 2R44OD023029-02A1: Integrated photoacoustic and fluorescence imaging system for anatomical, functional, and molecular characterization of murine models ($997,451)", "source_url": "https://reporter.nih.gov/project-details/10485114", "people": [{"name": "Sergey A Ermilov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA250877-03", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-09", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44CA250877-03: Rapid 3D Whole-Slide Digitization of Thick Cytopathology Slides with a Gigapixel Microscope ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10478298", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41DC020693-01", "company": "Synfonica, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-09", "observed": "2026-08-21", "amount_usd": 275752, "summary": "NIH award 1R41DC020693-01: Next-Generation Expressive Personalized Voices for Speech-Generating Devices ($275,752)", "source_url": "https://reporter.nih.gov/project-details/10547241", "people": [{"name": "H TIMOTHY Bunnell", "role": "Principal Investigator"}, {"name": "SUSAN R HERTZ", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GH002389-01A1", "company": "Jan Biotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-09", "observed": "2026-08-21", "amount_usd": 275766, "summary": "NIH award 1R43GH002389-01A1: Rapid COVID-19 Mutation Discrimination Test for Global SARS-CoV-2 Variant Surveillance ($275,766)", "source_url": "https://reporter.nih.gov/project-details/10483613", "people": [{"name": "Janet L Huie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG078718-01", "company": "5m Biomed, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-09", "observed": "2026-08-21", "amount_usd": 399840, "summary": "NIH award 1R43AG078718-01: Highly Sensitive and Robust Blood Test Platform for Screening and Early Detection of Alzheimer's Disease ($399,840)", "source_url": "https://reporter.nih.gov/project-details/10515572", "people": [{"name": "Yuancheng Li", "role": "Principal Investigator"}, {"name": "Hui Mao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41DE031485-01", "company": "Ms Technologies Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-09", "observed": "2026-08-21", "amount_usd": 299987, "summary": "NIH award 1R41DE031485-01: AIDen: An AI-empowered detection and diagnosis system for jaw lesions using CBCT ($299,987)", "source_url": "https://reporter.nih.gov/project-details/10383494", "people": [{"name": "Jing Li", "role": "Principal Investigator"}, {"name": "Fleming Y. M. Lure", "role": "Principal Investigator"}, {"name": "Frank Carsten Martin Setzer", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41HD109086-01A1", "company": "Stereology Resource Center, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-09", "observed": "2026-08-21", "amount_usd": 315169, "summary": "NIH award 1R41HD109086-01A1: An AI-based Multimodal Approach to Predict Pain in Postnatal Care Scenarios ($315,169)", "source_url": "https://reporter.nih.gov/project-details/10546650", "people": [{"name": "PETER Randolph MOUTON", "role": "Principal Investigator"}, {"name": "Yu Sun", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44ES024031-05", "company": "Ludlum Measurements, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-08", "observed": "2026-08-21", "amount_usd": 993506, "summary": "NIH award 5R44ES024031-05: AQEarth: Program Empowering Communities to Explore Map and Improve Air Quality ($993,506)", "source_url": "https://reporter.nih.gov/project-details/10474500", "people": [{"name": "John W Birks", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R41DC020133-01A1", "company": "Seeus95 Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-08", "observed": "2026-08-21", "amount_usd": 259505, "summary": "NIH award 1R41DC020133-01A1: Reusable, transparent, and reconfigurable N95-equivalent Respirator Masks: design, fabrication, and trials for enhanced adoption ($259,505)", "source_url": "https://reporter.nih.gov/project-details/10482253", "people": [{"name": "Zi Chen", "role": "Principal Investigator"}, {"name": "Alice Min Soo Chun", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH111450-04", "company": "Psyc Tech, Ltd", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-08", "observed": "2026-08-21", "amount_usd": 1059788, "summary": "NIH award 5R44MH111450-04: Finalizing and Testing an Online Therapist Training and Assistance Program to Facilitate Implementation of Comprehensive Behavioral Intervention for Tic Disorders (CBIT-Trainer) ($1,059,788)", "source_url": "https://reporter.nih.gov/project-details/10492719", "people": [{"name": "Michael B Himle", "role": "Principal Investigator"}, {"name": "Suzanne Mouton-Odum", "role": "Principal Investigator"}, {"name": "Douglas W Woods", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44CA268484-02", "company": "Boston Cell Standards Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-05", "observed": "2026-08-21", "amount_usd": 898163, "summary": "NIH award 5R44CA268484-02: National Immunohistochemistry Standardization Program - Establishment & Launch ($898,163)", "source_url": "https://reporter.nih.gov/project-details/10491921", "people": [{"name": "Steven A Bogen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44CA254560-02", "company": "Cooler Heads Care Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-05", "observed": "2026-08-21", "amount_usd": 1033003, "summary": "NIH award 2R44CA254560-02: Portable, Patient-Administered Scalp Cooling Cap to Reduce Provider Burden, Improve Patient Access, and Improve Patient Outcomes for Chemotherapy-Induced Alopecia ($1,033,003)", "source_url": "https://reporter.nih.gov/project-details/10480105", "people": [{"name": "Kate Dilligan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG076047-01A1", "company": "People Designs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-05", "observed": "2026-08-21", "amount_usd": 257978, "summary": "NIH award 1R43AG076047-01A1: Developing a PREPARE for Your Care delivery system to enhance adoption by healthcare organizations ($257,978)", "source_url": "https://reporter.nih.gov/project-details/10546110", "people": [{"name": "David Farrell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA056123-01", "company": "Hurdle Health Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-04", "observed": "2026-08-21", "amount_usd": 257730, "summary": "NIH award 1R43DA056123-01: Hurdle Health: Culturally Intentional Teletherapy to Address SUD and Co-Occurring Symptoms Amongst Black Men. ($257,730)", "source_url": "https://reporter.nih.gov/project-details/10469291", "people": [{"name": "Radawn Alcorn", "role": "Principal Investigator"}, {"name": "Norma Day-Vines", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HG012531-01", "company": "Sage Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-03", "observed": "2026-08-21", "amount_usd": 320862, "summary": "NIH award 1R43HG012531-01: High-throughput size-selection system for long-read sequencing library preparation ($320,862)", "source_url": "https://reporter.nih.gov/project-details/10480521", "people": [{"name": "TRUETT C BOLES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA056275-01", "company": "Beacon Tech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-03", "observed": "2026-08-21", "amount_usd": 252131, "summary": "NIH award 1R43DA056275-01: Digital Peer Support for Opioid Use Disorders: Scaling Chat Support Groups to meet Community Needs ($252,131)", "source_url": "https://reporter.nih.gov/project-details/10485580", "people": [{"name": "Satya Prateek Bommaraju", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI140813-03", "company": "Crosslife Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-03", "observed": "2026-08-21", "amount_usd": 999799, "summary": "NIH award 5R44AI140813-03: Rapid Point-of-Care RNA Diagnostic for Dengue Infection ($999,799)", "source_url": "https://reporter.nih.gov/project-details/10469689", "people": [{"name": "HyunDae Cho", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL107055-05", "company": "Cardialen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-03", "observed": "2026-08-21", "amount_usd": 999810, "summary": "NIH award 5R44HL107055-05: Implantable Unpinning Termination Therapy for Cardiac Arrhythmias ($999,810)", "source_url": "https://reporter.nih.gov/project-details/10441274", "people": [{"name": "Jeffrey Peters", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44MH118154-03", "company": "Fieldline, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-02", "observed": "2026-08-21", "amount_usd": 1048342, "summary": "NIH award 5R44MH118154-03: A wearable high-density MEG system with uOPMs ($1,048,342)", "source_url": "https://reporter.nih.gov/project-details/10442540", "people": [{"name": "Orang Alem", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43GM145205-01A1", "company": "Bioinvision, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-02", "observed": "2026-08-21", "amount_usd": 224207, "summary": "NIH award 1R43GM145205-01A1: Whole-Organism, Real-time Decision-enabled 3D Tissue Imaging and Recovery for Molecular Analysis ($224,207)", "source_url": "https://reporter.nih.gov/project-details/10546698", "people": [{"name": "SUSANN M BRADY-KALNAY", "role": "Principal Investigator"}, {"name": "Madhusudhana Gargesha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK131700-02", "company": "Bright Uro, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-02", "observed": "2026-08-21", "amount_usd": 997615, "summary": "NIH award 5R44DK131700-02: Clinical Feasibility of Wireless Catheter-Free Urodynamics for Extended, Comprehensive Urological Evaluation in the Home Setting ($997,615)", "source_url": "https://reporter.nih.gov/project-details/10492561", "people": [{"name": "Derek Herrera", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44HL154932-02", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-02", "observed": "2026-08-21", "amount_usd": 727378, "summary": "NIH award 4R44HL154932-02: Portable Noninvasive Positive Airway Device for COPD Patient Therapy ($727,378)", "source_url": "https://reporter.nih.gov/project-details/10274744", "people": [{"name": "Robert J Knuesel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43GM146498-01", "company": "Cascade Metrix, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-02", "observed": "2026-08-21", "amount_usd": 349917, "summary": "NIH award 1R43GM146498-01: A Multiplex Analyzer for Sepsis Management ($349,917)", "source_url": "https://reporter.nih.gov/project-details/10483277", "people": [{"name": "Kislaya Kunjan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM148106-01", "company": "Aincobio LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-01", "observed": "2026-08-21", "amount_usd": 357081, "summary": "NIH award 1R43GM148106-01: A scalable electrokinetic flow cytometer and cell sorter ($357,081)", "source_url": "https://reporter.nih.gov/project-details/10546934", "people": [{"name": "Lorenzo Damico", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44MH124562-03", "company": "Experiad, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-01", "observed": "2026-08-21", "amount_usd": 828488, "summary": "NIH award 4R44MH124562-03: Goalspace: A Platform for Parent-Assisted Behavioral Interventions ($828,488)", "source_url": "https://reporter.nih.gov/project-details/10495616", "people": [{"name": "REX M JAKOBOVITS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R41AG074835-01S1", "company": "Echowear LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-01", "observed": "2026-08-21", "amount_usd": 205229, "summary": "NIH award 3R41AG074835-01S1: Development of a Digital Cognitive Screening Test to detect Mild Cognitive Impairment and Dementia in Clinical Settings. ($205,229)", "source_url": "https://reporter.nih.gov/project-details/10579656", "people": [{"name": "Kunal Mankodiya", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM148130-01", "company": "Bioaesthetics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-01", "observed": "2026-08-21", "amount_usd": 258684, "summary": "NIH award 1R43GM148130-01: Infection Fighting Polymer Strengthened Biologic Grafts for Abdominal Wall Repair ($258,684)", "source_url": "https://reporter.nih.gov/project-details/10546671", "people": [{"name": "Nicholas Pashos", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44TR001324-04", "company": "Innovative Biotherapies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-08-01", "observed": "2026-08-21", "amount_usd": 553299, "summary": "NIH award 5R44TR001324-04: Fiber design and assessment for development of a novel biomimetic medical device ($553,299)", "source_url": "https://reporter.nih.gov/project-details/10458610", "people": [{"name": "Christopher Pino", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:4R42MH128101-02", "company": "Lyssn.io, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-30", "observed": "2026-08-21", "amount_usd": 810832, "summary": "NIH award 4R42MH128101-02: Enhancing the quality of CBT in community mental health through AI-generated fidelity feedback ($810,832)", "source_url": "https://reporter.nih.gov/project-details/10495612", "people": [{"name": "David Charles Atkins", "role": "Principal Investigator"}, {"name": "Torrey A. Creed", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44MH121664-02A1", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-29", "observed": "2026-08-21", "amount_usd": 811481, "summary": "NIH award 2R44MH121664-02A1: Home-Based Parent-Child Intervention to Enhance Executive Function ($811,481)", "source_url": "https://reporter.nih.gov/project-details/10546629", "people": [{"name": "Shane M. Anderson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43TR004056-01A1", "company": "Adrx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-29", "observed": "2026-08-21", "amount_usd": 270276, "summary": "NIH award 1R43TR004056-01A1: Development of a Blood-based Diagnostic for Early Detection of Transthyretin Amyloidosis ($270,276)", "source_url": "https://reporter.nih.gov/project-details/10547120", "people": [{"name": "Marcin Apostol", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI172505-01", "company": "Aincobio LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-29", "observed": "2026-08-21", "amount_usd": 302714, "summary": "NIH award 1R43AI172505-01: Rapid and automated detection of bloodborne pathogens for improved treatment and antimicrobial stewardship ($302,714)", "source_url": "https://reporter.nih.gov/project-details/10546973", "people": [{"name": "Lorenzo Damico", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HG012559-01", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-29", "observed": "2026-08-21", "amount_usd": 394141, "summary": "NIH award 1R43HG012559-01: Dual Reader Protein Sequencing ($394,141)", "source_url": "https://reporter.nih.gov/project-details/10498088", "people": [{"name": "Eric Ervin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44EB031656-02", "company": "Radiation Monitoring Devices, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-29", "observed": "2026-08-21", "amount_usd": 647202, "summary": "NIH award 4R44EB031656-02: Tl-Halide Scintillators for TOF-PET ($647,202)", "source_url": "https://reporter.nih.gov/project-details/10653275", "people": [{"name": "JAROSLAW GLODO", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R42ES033912-02", "company": "Neurosetta LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-28", "observed": "2026-08-21", "amount_usd": 838163, "summary": "NIH award 4R42ES033912-02: Development and Evaluation of Rosette Array Technology for HumanNeurodevelopmental Toxicity Screening ($838,163)", "source_url": "https://reporter.nih.gov/project-details/10637609", "people": [{"name": "Randolph Scott Ashton", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44GM134849-02", "company": "Immuto Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-28", "observed": "2026-08-21", "amount_usd": 1037792, "summary": "NIH award 2R44GM134849-02: Plasma-Generated Hydroxyl Radicals for Analysis of Three-Dimensional Structures in Protein Therapeutics ($1,037,792)", "source_url": "https://reporter.nih.gov/project-details/10547178", "people": [{"name": "Faraz Choudhury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL147771-03", "company": "Annoviant, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-28", "observed": "2026-08-21", "amount_usd": 1042014, "summary": "NIH award 5R44HL147771-03: Pulmonary valved conduit xenograft with regeneration potential ($1,042,014)", "source_url": "https://reporter.nih.gov/project-details/10491195", "people": [{"name": "Ajay Houde", "role": "Principal Investigator"}, {"name": "Naren R Vyavahare", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43TR004347-01A1", "company": "Nanohmics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-28", "observed": "2026-08-21", "amount_usd": 224999, "summary": "NIH award 1R43TR004347-01A1: Portable Optical Imager for Multiplexed Foodborne Pathogen Detection ($224,999)", "source_url": "https://reporter.nih.gov/project-details/10484520", "people": [{"name": "Zhongjian Hu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42HL145669-03", "company": "Kitware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-28", "observed": "2026-08-21", "amount_usd": 826115, "summary": "NIH award 5R42HL145669-03: Imaging biomarkers of severe respiratory infections in premature infants Phase II ($826,115)", "source_url": "https://reporter.nih.gov/project-details/10491039", "people": [{"name": "Andinet Asmamaw Enquobahrie", "role": "Principal Investigator"}, {"name": "Marius George Linguraru", "role": "Principal Investigator"}, {"name": "Gustavo Nino", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HD095779-03", "company": "Chosen Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-27", "observed": "2026-08-21", "amount_usd": 1056686, "summary": "NIH award 5R44HD095779-03: Noninvasive biomarkers for gastrointestinal disease in preterm infants ($1,056,686)", "source_url": "https://reporter.nih.gov/project-details/10493444", "people": [{"name": "Rebecca S Buckley", "role": "Principal Investigator"}, {"name": "Sunyoung Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44GM148128-01", "company": "Nanocellect Biomedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-27", "observed": "2026-08-21", "amount_usd": 891540, "summary": "NIH award 1R44GM148128-01: AI-Aided Tool for Day Zero Selection of High Performing Cells for Biopharma Cell Line Development ($891,540)", "source_url": "https://reporter.nih.gov/project-details/10546865", "people": [{"name": "Sung Hwan Cho", "role": "Principal Investigator"}, {"name": "Yu-Hwa Lo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43MH122028-02S1", "company": "Champaign Imaging, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-27", "observed": "2026-08-21", "amount_usd": 407385, "summary": "NIH award 3R43MH122028-02S1: Next Generation Pediatric Neuroimaging (NGPN) Feasibility ($407,385)", "source_url": "https://reporter.nih.gov/project-details/10599539", "people": [{"name": "Curtis Andrew Corum", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R41HD109038-01", "company": "Medical Predictive Science Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-27", "observed": "2026-08-21", "amount_usd": 261158, "summary": "NIH award 1R41HD109038-01: Clinical Decision Support System to Optimize Neonatal Nutrition and Growth ($261,158)", "source_url": "https://reporter.nih.gov/project-details/10478336", "people": [{"name": "William E King", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AI172551-01", "company": "Aldatu Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-27", "observed": "2026-08-21", "amount_usd": 964499, "summary": "NIH award 1R44AI172551-01: PANDAA for universal, pan-lineage molecular detection of filoviruses to enable rapid epidemic response. ($964,499)", "source_url": "https://reporter.nih.gov/project-details/10547447", "people": [{"name": "Iain James MacLeod", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL160238-01A1", "company": "Mddriven LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-27", "observed": "2026-08-21", "amount_usd": 299722, "summary": "NIH award 1R43HL160238-01A1: A HANDS-FREE LUNG AND CARDIOVASCULAR ASSESSMENT DEVICE (LCAD) FOR THE REMOTE CARE OF PATIENTS WITH CHRONIC CARDIOPULMONARY CONDITIONS ($299,722)", "source_url": "https://reporter.nih.gov/project-details/10480550", "people": [{"name": "Wilman Rene Ortega", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA165898-05", "company": "Xl Sci-tech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-27", "observed": "2026-08-21", "amount_usd": 1165716, "summary": "NIH award 5R44CA165898-05: PET Enabled Y-90 Microspheres for Radioembolization of Liver Tumors ($1,165,716)", "source_url": "https://reporter.nih.gov/project-details/10453651", "people": [{"name": "YONGREN Benjamin PENG", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "denovo:DEN210032", "company": "RQMIS, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-07-26", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210032 granted: AccuMeasure System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210032"}, {"id": "nih:1R43AI172561-01", "company": "Astradx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-25", "observed": "2026-08-21", "amount_usd": 299633, "summary": "NIH award 1R43AI172561-01: AstraDx: Sub-Hour AST Via Computational Image Processing ($299,633)", "source_url": "https://reporter.nih.gov/project-details/10547198", "people": [{"name": "Jonathan Florez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA165314-06", "company": "Imcare Biotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-25", "observed": "2026-08-21", "amount_usd": 1283792, "summary": "NIH award 5R44CA165314-06: A novel diagnostic Kit for Hepatocellular Carcinoma ($1,283,792)", "source_url": "https://reporter.nih.gov/project-details/10490412", "people": [{"name": "Xuanyong Lu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:3R42GM143986-02S1", "company": "Biosensing Instrument, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-25", "observed": "2026-08-21", "amount_usd": 283276, "summary": "NIH award 3R42GM143986-02S1: Critical angle reflection imaging for label-free quantification of molecular interactions ($283,276)", "source_url": "https://reporter.nih.gov/project-details/10641600", "people": [{"name": "Nguyen Ly", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI154380-03", "company": "Peak Diagnostic Partners LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-22", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI154380-03: Enabling comprehensive diagnosis of sub-acute infection in chronic respiratory disease via high sensitivity next generation sequencing ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10460284", "people": [{"name": "Roland Marcus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44CA265758-02", "company": "Omniscient Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-21", "observed": "2026-08-21", "amount_usd": 1031682, "summary": "NIH award 4R44CA265758-02: Sedationless Multi-View High-Resolution Endoscopy ($1,031,682)", "source_url": "https://reporter.nih.gov/project-details/10640358", "people": [{"name": "Bhaskar Banerjee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44PS005188-03", "company": "Instadiagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-21", "observed": "2026-08-21", "amount_usd": 464118, "summary": "NIH award 5R44PS005188-03: A Rapid Multiplexed Assay for the Diagnosis of Viral Hepatitis at the Point of Care ($464,118)", "source_url": "https://reporter.nih.gov/project-details/10488415", "people": [{"name": "Johann Desa", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DP006743-01", "company": "Saavsus, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-21", "observed": "2026-08-21", "amount_usd": 259475, "summary": "NIH award 1R43DP006743-01: Development, Feasibility, and Acceptability of Aim to Play, a User-Friendly Digital Application for Teacher Skills Training and Physical Education Activities for 3-5 Grade Elementary Students ($259,475)", "source_url": "https://reporter.nih.gov/project-details/10544679", "people": [{"name": "Deborah Johnson-Shelton", "role": "Principal Investigator"}, {"name": "Jeanette Ricci", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DC019894-02", "company": "Endotheia, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-19", "observed": "2026-08-21", "amount_usd": 661572, "summary": "NIH award 5R44DC019894-02: An Ultra-Thin Steerable Transnasal Endoscope to Replace Exploratory Middle Ear Surgeries ($661,572)", "source_url": "https://reporter.nih.gov/project-details/10469684", "people": [{"name": "Joshua B Gafford", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44MH122052-03", "company": "Q-state Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-19", "observed": "2026-08-21", "amount_usd": 1296058, "summary": "NIH award 2R44MH122052-03: Functional drug fingerprinting with all-optical electrophysiology ($1,296,058)", "source_url": "https://reporter.nih.gov/project-details/10547123", "people": [{"name": "Nathaniel Delaney-Busch", "role": "Principal Investigator"}, {"name": "Benjamin Nathaniel Harwood", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL162385-01", "company": "Valvention, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-19", "observed": "2026-08-21", "amount_usd": 349309, "summary": "NIH award 1R43HL162385-01: Leaflet sparing transcatheter aortic valve equipped with IVUS-guided delivery system. ($349,309)", "source_url": "https://reporter.nih.gov/project-details/10385414", "people": [{"name": "Ronald J Hosmer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG074840-01A1", "company": "Myolex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-19", "observed": "2026-08-21", "amount_usd": 889385, "summary": "NIH award 1R44AG074840-01A1: Accurate and rapid assessment of sarcopenia in older adults through electrical impedance myography ($889,385)", "source_url": "https://reporter.nih.gov/project-details/10484558", "people": [{"name": "William David Arnold", "role": "Principal Investigator"}, {"name": "Brian C Clark", "role": "Principal Investigator"}, {"name": "Elmer C Lupton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM146559-01", "company": "Cfd Research Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-18", "observed": "2026-08-21", "amount_usd": 342689, "summary": "NIH award 1R43GM146559-01: PredictSEP: A Predictive Diagnostic Assay for Sepsis ($342,689)", "source_url": "https://reporter.nih.gov/project-details/10484762", "people": [{"name": "Ketan H Bhatt", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AR079293-02", "company": "Apex Biomedical Company, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-18", "observed": "2026-08-21", "amount_usd": 607035, "summary": "NIH award 5R44AR079293-02: Improving Fracture Healing with Active Plating Technology ($607,035)", "source_url": "https://reporter.nih.gov/project-details/10492772", "people": [{"name": "MICHAEL BOTTLANG", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44MH118780-03S1", "company": "Adaptive Testing Technologies", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-18", "observed": "2026-08-21", "amount_usd": 85001, "summary": "NIH award 3R44MH118780-03S1: Computerized Adaptive Suicidal Risk Stratification and Prediction ($85,001)", "source_url": "https://reporter.nih.gov/project-details/10611259", "people": [{"name": "Edwin D Boudreaux", "role": "Principal Investigator"}, {"name": "Yehuda Cohen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44GM130201-03", "company": "Doty Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-18", "observed": "2026-08-21", "amount_usd": 668446, "summary": "NIH award 5R44GM130201-03: A Reliable Switched Angle Spinning (SAS) Probe with Gradients (PFG) for Proteins in Solid-State NMR ($668,446)", "source_url": "https://reporter.nih.gov/project-details/10456218", "people": [{"name": "Francis DAVID Doty", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA257178-02", "company": "Integrated Sensors, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-18", "observed": "2026-08-21", "amount_usd": 637201, "summary": "NIH award 5R44CA257178-02: Ultrafast and Precise External Beam Monitor for FLASH and Other Advanced Radiation Therapy Modalities ($637,201)", "source_url": "https://reporter.nih.gov/project-details/10489828", "people": [{"name": "Peter S Friedman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43NS125749-01", "company": "Cytocybernetics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-15", "observed": "2026-08-21", "amount_usd": 256581, "summary": "NIH award 1R43NS125749-01: Real Time NEURON Simulation for Experimental Applications ($256,581)", "source_url": "https://reporter.nih.gov/project-details/10384810", "people": [{"name": "Mark W Nowak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42LM013317-03", "company": "Phrase Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-15", "observed": "2026-08-21", "amount_usd": 857941, "summary": "NIH award 5R42LM013317-03: Multi-Institutional Implementation of Quality Decisions: a Clinical Decision Support Analytics Tool to Drive Outcomes ($857,941)", "source_url": "https://reporter.nih.gov/project-details/10469309", "people": [{"name": "Evan William Orenstein", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44CA203038-04", "company": "Veriskin, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-14", "observed": "2026-08-21", "amount_usd": 1499425, "summary": "NIH award 2R44CA203038-04: Pivotal Clinical Study of the TruScore Device for Non-Invasive Skin Cancer Diagnostics ($1,499,425)", "source_url": "https://reporter.nih.gov/project-details/10463434", "people": [{"name": "MIRIANAS CHACHISVILIS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44CA243762-03", "company": "Radiation Monitoring Devices, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-14", "observed": "2026-08-21", "amount_usd": 650448, "summary": "NIH award 5R44CA243762-03: Ultra-dense and Fast Ceramic Scintillator for PET ($650,448)", "source_url": "https://reporter.nih.gov/project-details/10459625", "people": [{"name": "JAROSLAW GLODO", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44LM013026-03", "company": "Artisight, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-14", "observed": "2026-08-21", "amount_usd": 822216, "summary": "NIH award 5R44LM013026-03: Whiteboard Coordinator: Intelligent Sensor Network and Machine Learning to Improve Operating Room Outcomes and Efficiency ($822,216)", "source_url": "https://reporter.nih.gov/project-details/10463847", "people": [{"name": "Andrew Gostine", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AR081748-01", "company": "Aravis Biotech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-13", "observed": "2026-08-21", "amount_usd": 299999, "summary": "NIH award 1R43AR081748-01: X-ray Visualized Implanted Sensor for Prosthetic Joint Infection (X-VIS-PJI) ($299,999)", "source_url": "https://reporter.nih.gov/project-details/10547368", "people": [{"name": "JEFFREY N ANKER", "role": "Principal Investigator"}, {"name": "Lindsey Sanders Calcutt", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:9R44MH132130-02A1", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-13", "observed": "2026-08-21", "amount_usd": 952622, "summary": "NIH award 9R44MH132130-02A1: Point-of-care HIV viral load system using RPA and MXR ($952,622)", "source_url": "https://reporter.nih.gov/project-details/10484628", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44DA052941-02", "company": "Arborsense, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-13", "observed": "2026-08-21", "amount_usd": 868719, "summary": "NIH award 2R44DA052941-02: Rapid and non-invasive device for drug detection through sweat ($868,719)", "source_url": "https://reporter.nih.gov/project-details/10544121", "people": [{"name": "Girish Kulkarni", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44EB029804-02", "company": "Quel Imaging LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-12", "observed": "2026-08-21", "amount_usd": 999083, "summary": "NIH award 2R44EB029804-02: Phase II: Fluorescence guided surgery standardization tools ($999,083)", "source_url": "https://reporter.nih.gov/project-details/10484198", "people": [{"name": "Ethan Phillip Marshall LaRochelle", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG074126-02", "company": "Silverbills Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-12", "observed": "2026-08-21", "amount_usd": 978137, "summary": "NIH award 5R44AG074126-02: SilverBills: A Financial and Legal Tech Tool for Caregivers ($978,137)", "source_url": "https://reporter.nih.gov/project-details/10480063", "people": [{"name": "Eric Chess", "role": "Principal Investigator"}, {"name": "Marci Lobel-Esrig", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "denovo:DEN210045", "company": "Apollo Endosurgery, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-07-12", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210045 granted: APOLLO ESG System, APOLLO ESG SX System,", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210045"}, {"id": "nih:3R43AG076063-01S1", "company": "Determined Health Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-11", "observed": "2026-08-21", "amount_usd": 316755, "summary": "NIH award 3R43AG076063-01S1: Digital Transformation to Reduce Social Isolation and Improve the Engagement, Care, and Support of Individuals Living with Alzheimer's Disease and Related Dementias: Diversity Supplement ($316,755)", "source_url": "https://reporter.nih.gov/project-details/10609787", "people": [{"name": "Scott Kaiser", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44AG071034-02S1", "company": "Active Life Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-08", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44AG071034-02S1: A New Device to measure Whole and Tissue Level Bone Strength. ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10656708", "people": [{"name": "Peter Burks", "role": "Principal Investigator"}, {"name": "Simon Yue-Cheong Tang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG056224-03", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-08", "observed": "2026-08-21", "amount_usd": 866317, "summary": "NIH award 5R44AG056224-03: A system to detect fall occurrence and location in hospital settings ($866,317)", "source_url": "https://reporter.nih.gov/project-details/10461967", "people": [{"name": "Brian R Clark", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42DA049655-04", "company": "Vox Biomedical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-08", "observed": "2026-08-21", "amount_usd": 480900, "summary": "NIH award 5R42DA049655-04: Exhaled breath drug detection using differential mobility spectrometry ($480,900)", "source_url": "https://reporter.nih.gov/project-details/10437033", "people": [{"name": "Jacob Golde", "role": "Principal Investigator"}, {"name": "SCOTT E LUKAS", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43AI167567-01A1", "company": "Heliowave Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-08", "observed": "2026-08-21", "amount_usd": 233475, "summary": "NIH award 1R43AI167567-01A1: HelioQUANT: A Platform for Fast, Label-Free, Automated Evaluation of Bioburden ($233,475)", "source_url": "https://reporter.nih.gov/project-details/10484843", "people": [{"name": "Adrian Ryan Guzman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44MD012782-03S1", "company": "Cog Analytics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-07", "observed": "2026-08-21", "amount_usd": 108922, "summary": "NIH award 3R44MD012782-03S1: Validation of the TAPS-Electronic Spanish Platform (TAPS-ESP): A Technology to Improve Access to Substance Use Screening and Reduce Behavioral Health Disparities in Hispanic Primary Care Patients ($108,922)", "source_url": "https://reporter.nih.gov/project-details/10653806", "people": [{"name": "Steven Bernard Carswell", "role": "Principal Investigator"}, {"name": "Katherine Sanchez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DC019318-01A1", "company": "Pionear Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-07", "observed": "2026-08-21", "amount_usd": 349501, "summary": "NIH award 1R43DC019318-01A1: Liquid-infused tympanostomy tubes with novel material design for efficient drug transport ($349,501)", "source_url": "https://reporter.nih.gov/project-details/10324862", "people": [{"name": "Ida Pavlichenko", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MD012782-03", "company": "Cog Analytics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-04", "observed": "2026-08-21", "amount_usd": 869935, "summary": "NIH award 5R44MD012782-03: Validation of the TAPS-Electronic Spanish Platform (TAPS-ESP): A Technology to Improve Access to Substance Use Screening and Reduce Behavioral Health Disparities in Hispanic Primary Care Patients ($869,935)", "source_url": "https://reporter.nih.gov/project-details/10490979", "people": [{"name": "Steven Bernard Carswell", "role": "Principal Investigator"}, {"name": "Katherine Sanchez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AR080503-01A1", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-01", "observed": "2026-08-21", "amount_usd": 264808, "summary": "NIH award 1R44AR080503-01A1: Simulation and Education Tool for Physical Examinations of Orthopedic Pathologies ($264,808)", "source_url": "https://reporter.nih.gov/project-details/10484180", "people": [{"name": "John Paul Condon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK108488-06", "company": "Innavasc Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-07-01", "observed": "2026-08-21", "amount_usd": 999998, "summary": "NIH award 5R44DK108488-06: A Bullet Proof vascular graft to prevent dialysis access cannulation injury ($999,998)", "source_url": "https://reporter.nih.gov/project-details/10461929", "people": [{"name": "Joseph Knight", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:3R44AG039965-06S1", "company": "Posit Science Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-30", "observed": "2026-08-21", "amount_usd": 201074, "summary": "NIH award 3R44AG039965-06S1: Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise (INHANCE) ($201,074)", "source_url": "https://reporter.nih.gov/project-details/10597850", "people": [{"name": "Mouna Attarha", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R44HD098938-04", "company": "Theranova, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-30", "observed": "2026-08-21", "amount_usd": 575818, "summary": "NIH award 5R44HD098938-04: A Novel Orogastric/Nasogastric Feeding Tube for Optimizing Nutritional Administration in the Neonatal Intensive Care Unit Population ($575,818)", "source_url": "https://reporter.nih.gov/project-details/10437792", "people": [{"name": "Daniel Rogers Burnett", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R42DK119048-02", "company": "Hemex Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-30", "observed": "2026-08-21", "amount_usd": 865376, "summary": "NIH award 2R42DK119048-02: Portable, affordable, quantitative microchip electrophoresis for hemoglobin A1C testing ($865,376)", "source_url": "https://reporter.nih.gov/project-details/10546889", "people": [{"name": "PETER GALEN", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44HL149598-02A1", "company": "Cellfe Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-30", "observed": "2026-08-21", "amount_usd": 837232, "summary": "NIH award 2R44HL149598-02A1: Efficient and scalable microfluidic gene delivery to hematopoietic stem cells to treat blood diseases ($837,232)", "source_url": "https://reporter.nih.gov/project-details/10385216", "people": [{"name": "Sewoon Han", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "breakthrough:K213913", "company": "Renovia, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-06-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K213913: LEVA PELVIC HEALTH SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44CK000578-02", "company": "Firebird Biomolecular Sciences, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-29", "observed": "2026-08-21", "amount_usd": 485197, "summary": "NIH award 5R44CK000578-02: PHS2019-02 Omnibus Solic of the NIH, CDC, and FDA for SBIR Apps No Clinical Trial (Parent SBIR R43/4 ($485,197)", "source_url": "https://reporter.nih.gov/project-details/10476977", "people": [{"name": "STEVEN A BENNER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "sbir:DOD:W911NF-22-P-0049", "company": "Photocide Protection Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-06-29", "observed": "2026-09-18", "amount_usd": 171836, "summary": "DOD STTR Phase I award $171,836: Antimicrobial Photodynamic Wound Dressings", "source_url": "https://www.sbir.gov/awards?search=A21C-T010-0338"}, {"id": "nih:1R44CA272029-01A1", "company": "Adeptrix Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-28", "observed": "2026-08-21", "amount_usd": 833042, "summary": "NIH award 1R44CA272029-01A1: HistoneScan\u2122: a multiplex immunoassay for histone epigenetic profiling ($833,042)", "source_url": "https://reporter.nih.gov/project-details/10545304", "people": [{"name": "Tamil Selvan Anthonymuthu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41AI167101-01", "company": "Pulmonescence Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-28", "observed": "2026-08-21", "amount_usd": 306500, "summary": "NIH award 1R41AI167101-01: Rapid Drug Susceptibility Test for Tuberculosis ($306,500)", "source_url": "https://reporter.nih.gov/project-details/10379831", "people": [{"name": "Jeffrey D. Cirillo", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EB028726-03", "company": "Double Helix Optics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-28", "observed": "2026-08-21", "amount_usd": 722136, "summary": "NIH award 5R44EB028726-03: Light Engineering Module for Fast High-Resolution Whole-Cell Imaging ($722,136)", "source_url": "https://reporter.nih.gov/project-details/10478167", "people": [{"name": "WARREN COLOMB", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R43DK130732-01A1S1", "company": "Sygnamap, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-28", "observed": "2026-08-21", "amount_usd": 6500, "summary": "NIH award 3R43DK130732-01A1S1: Precision Mass Spec Imaging Based Structure-Function Signatures of Diabetic Glomerulopathy ($6,500)", "source_url": "https://reporter.nih.gov/project-details/10596057", "people": [{"name": "Leila Hejazi", "role": "Principal Investigator"}, {"name": "Kumar Sharma", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG078012-01", "company": "Oscilloscape, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-28", "observed": "2026-08-21", "amount_usd": 449695, "summary": "NIH award 1R43AG078012-01: SynchronyGamma: A Music-Based Intervention for Alzheimer's and Mild Cognitive Impairment ($449,695)", "source_url": "https://reporter.nih.gov/project-details/10484478", "people": [{"name": "Edward W Large", "role": "Principal Investigator"}, {"name": "Psyche Loui", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI150060-03", "company": "Biopeptides, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-27", "observed": "2026-08-21", "amount_usd": 986480, "summary": "NIH award 5R44AI150060-03: A peptide-based point-of-care vertical flow assay for the rapid diagnosis of Lyme disease ($986,480)", "source_url": "https://reporter.nih.gov/project-details/10452660", "people": [{"name": "Paul Michael Arnaboldi", "role": "Principal Investigator"}, {"name": "Dino Di Carlo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44CA240019-02", "company": "Calla Health Foundation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-27", "observed": "2026-08-21", "amount_usd": 998014, "summary": "NIH award 4R44CA240019-02: Innovations in cervical cancer diagnosis for low resource settings using advanced optical imaging and machine learning diagnostic algorithms. ($998,014)", "source_url": "https://reporter.nih.gov/project-details/10618560", "people": [{"name": "MARLEE KRIEGER", "role": "Principal Investigator"}, {"name": "Nirmala Ramanujam", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R42DA053075-02", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-27", "observed": "2026-08-21", "amount_usd": 994837, "summary": "NIH award 4R42DA053075-02: Developing novel technologies to monitor nociception and opioid administration during surgery and general anesthesia in order to minimize post-operative opioid requirements ($994,837)", "source_url": "https://reporter.nih.gov/project-details/10595838", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HD097826-03", "company": "Orthocare Innovations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-24", "observed": "2026-08-21", "amount_usd": 872638, "summary": "NIH award 5R44HD097826-03: Assist-Knee: Energy Harvesting for Sit-to-Stand-to-Sit Transitions ($872,638)", "source_url": "https://reporter.nih.gov/project-details/10455669", "people": [{"name": "Adam Karekin Arabian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HD105512-02", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-24", "observed": "2026-08-21", "amount_usd": 882711, "summary": "NIH award 5R44HD105512-02: Terrain Imaging and Adaptive Control of Exoskeletons ($882,711)", "source_url": "https://reporter.nih.gov/project-details/10455578", "people": [{"name": "Adam Becker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44HL147734-02A1", "company": "Retham Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-24", "observed": "2026-08-21", "amount_usd": 479730, "summary": "NIH award 2R44HL147734-02A1: An in vitro diagnostic assay for the early and accurate detection of platelet-activating antibodies associated with Heparin-induced Thrombocytopenia ($479,730)", "source_url": "https://reporter.nih.gov/project-details/10479698", "people": [{"name": "Curtis Jones", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DK116436-03", "company": "Simergent, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-24", "observed": "2026-08-21", "amount_usd": 839649, "summary": "NIH award 5R44DK116436-03: Faraday, a Novel Automated Peritoneal Dialysis Device with Dialysate Customization ($839,649)", "source_url": "https://reporter.nih.gov/project-details/10441610", "people": [{"name": "Steve J Lindo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41EB032747-01A1", "company": "Yaya Scientific, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-23", "observed": "2026-08-21", "amount_usd": 328433, "summary": "NIH award 1R41EB032747-01A1: Label-free, Multimodality Diffuse Reflectance and Polarization-Based Proximity Probe for Iatrogenic Nerve Injury Prevention During Surgical Procedures ($328,433)", "source_url": "https://reporter.nih.gov/project-details/10491034", "people": [{"name": "Justin Baba", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44CA247639-02", "company": "Inherent Targeting, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-22", "observed": "2026-08-21", "amount_usd": 218995, "summary": "NIH award 4R44CA247639-02: Clinical Translation of Near Infrared Nerve-Specific Fluorophores for Nerve-sparing Prostatectomy ($218,995)", "source_url": "https://reporter.nih.gov/project-details/10633513", "people": [{"name": "Connor William Barth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43GM148147-01", "company": "Cytequest, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-22", "observed": "2026-08-21", "amount_usd": 275223, "summary": "NIH award 1R43GM148147-01: Adaptable and scalable electroporation for cellular therapy ($275,223)", "source_url": "https://reporter.nih.gov/project-details/10545845", "people": [{"name": "HAROLD G CRAIGHEAD", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HG012409-01", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-22", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 1R44HG012409-01: Nanoscale Tools for Inosine Sequencing ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10437956", "people": [{"name": "Eric Ervin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43CA246987-01A1S1", "company": "Averto Medical Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-22", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43CA246987-01A1S1: A Novel Device Alternative to Temporary Diverting Ostomies after Rectal Cancer Surgery ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10557387", "people": [{"name": "Kenton Dodyan Fong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH116751-04", "company": "Total Child Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-22", "observed": "2026-08-21", "amount_usd": 489483, "summary": "NIH award 5R44MH116751-04: Online system for identifying and addressing teen depression in primary care ($489,483)", "source_url": "https://reporter.nih.gov/project-details/10433890", "people": [{"name": "Barbara Jo Howard", "role": "Principal Investigator"}, {"name": "Raymond STURNER", "role": "Principal Investigator"}, {"name": "MARIANNE Zdeblick WAMBOLDT", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44NS127692-01", "company": "Spikegadgets, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-22", "observed": "2026-08-21", "amount_usd": 908369, "summary": "NIH award 1R44NS127692-01: Commercialization of integrated electrode-electronics system for large scale, long-lasting electrophysiology ($908,369)", "source_url": "https://reporter.nih.gov/project-details/10481712", "people": [{"name": "Loren M Frank", "role": "Principal Investigator"}, {"name": "Mattias Peter Karlsson", "role": "Principal Investigator"}, {"name": "Chong Xie", "role": "Principal Investigator"}, {"name": "Jan Zimmermann", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R41MH124581-02", "company": "Iris Ob Health Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-22", "observed": "2026-08-21", "amount_usd": 434262, "summary": "NIH award 5R41MH124581-02: Risk modeling and shared decision making for postpartum depression ($434,262)", "source_url": "https://reporter.nih.gov/project-details/10454932", "people": [{"name": "Michael B. Laskoff", "role": "Principal Investigator"}, {"name": "Jyotishman Pathak", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL145950-03", "company": "City Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-21", "observed": "2026-08-21", "amount_usd": 1050471, "summary": "NIH award 5R44HL145950-03: Leadless Pacemaker Betavoltaic Power Source ($1,050,471)", "source_url": "https://reporter.nih.gov/project-details/10429931", "people": [{"name": "Peter Cabauy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44OD024879-05", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-21", "observed": "2026-08-21", "amount_usd": 973119, "summary": "NIH award 5R44OD024879-05: Parallelized Imaging and Automated Analysis of Zebrafish Assays with a Gigapixel Microscope ($973,119)", "source_url": "https://reporter.nih.gov/project-details/10413246", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:2R42GM136084-02", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-21", "observed": "2026-08-21", "amount_usd": 999676, "summary": "NIH award 2R42GM136084-02: Enhanced MDx: a computational model to optimize pre-analytical pathogen isolation from whole blood ($999,676)", "source_url": "https://reporter.nih.gov/project-details/10484641", "people": [{"name": "Cass T Miller", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL146012-03", "company": "Convergent Engineering, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-20", "observed": "2026-08-21", "amount_usd": 650861, "summary": "NIH award 5R44HL146012-03: RT Assistant - handheld patient safety tool for mechanical ventilation ($650,861)", "source_url": "https://reporter.nih.gov/project-details/10427403", "people": [{"name": "Neil R. Euliano", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42HL134418-05", "company": "Polynova Cardiovascular, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-17", "observed": "2026-08-21", "amount_usd": 594265, "summary": "NIH award 5R42HL134418-05: A Novel Polymeric Valve for Transcatheter Aortic Valve Replacement ($594,265)", "source_url": "https://reporter.nih.gov/project-details/10464978", "people": [{"name": "DANNY BLUESTEIN", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:3R42CA265316-01S1", "company": "Filtro Medical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-17", "observed": "2026-08-21", "amount_usd": 199664, "summary": "NIH award 3R42CA265316-01S1: Endovascular ChemoFilter to Reduce Doxorubicin Toxicity during Intra-Arterial Chemotherapy ($199,664)", "source_url": "https://reporter.nih.gov/project-details/10588065", "people": [{"name": "Steven William Hetts", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44ES029001-03", "company": "Sciome, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-17", "observed": "2026-08-21", "amount_usd": 827804, "summary": "NIH award 5R44ES029001-03: Swift.ai: research and development of an integrated platform for machine-assisted research synthesis ($827,804)", "source_url": "https://reporter.nih.gov/project-details/10428382", "people": [{"name": "Brian Howard", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44DA055407-01", "company": "Neuroptics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-17", "observed": "2026-08-21", "amount_usd": 319082, "summary": "NIH award 1R44DA055407-01: Development and Commercialization of a pupillometer to predict postoperative opioid-induced respiratory depression in children ($319,082)", "source_url": "https://reporter.nih.gov/project-details/10390249", "people": [{"name": "Jeffrey Wade Oliver", "role": "Principal Investigator"}, {"name": "Claudio Privitera", "role": "Principal Investigator"}, {"name": "Senthilkumar Sadhasivam", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "denovo:DEN210004", "company": "Zuno Medical, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-06-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210004 granted: Zuno Smart Sterilization Container", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210004"}, {"id": "nih:1R44CA265446-01A1", "company": "Envisagenics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-16", "observed": "2026-08-21", "amount_usd": 1018170, "summary": "NIH award 1R44CA265446-01A1: Comprehensive validation and commercial readiness of SpliceIO, a software platform for neoantigen discovery using RNA-seq data ($1,018,170)", "source_url": "https://reporter.nih.gov/project-details/10482502", "people": [{"name": "MARTIN AKERMAN", "role": "Principal Investigator"}, {"name": "GAYATRI ARUN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM144009-02", "company": "Wellsim Biomedical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-16", "observed": "2026-08-21", "amount_usd": 749646, "summary": "NIH award 2R44GM144009-02: A Label-free Extracellular-vesicle Automated Purification System (LEAP System) ($749,646)", "source_url": "https://reporter.nih.gov/project-details/10546042", "people": [{"name": "Yuchao Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG062072-03", "company": "Parabon Nanolabs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-15", "observed": "2026-08-21", "amount_usd": 742644, "summary": "NIH award 5R44AG062072-03: Smartphone phenotype collection for diagnostic screening of mild cognitive impairment ($742,644)", "source_url": "https://reporter.nih.gov/project-details/10478979", "people": [{"name": "Steven L Armentrout", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44GM113556-07", "company": "Integral Molecular", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-15", "observed": "2026-08-21", "amount_usd": 204008, "summary": "NIH award 5R44GM113556-07: Next Generation Specificity Screening for Biotherapeutics using an Extracellular Proteome Array ($204,008)", "source_url": "https://reporter.nih.gov/project-details/10438827", "people": [{"name": "Benjamin J Doranz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "nih:1R41CA271962-01", "company": "Daynamica, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-15", "observed": "2026-08-21", "amount_usd": 399865, "summary": "NIH award 1R41CA271962-01: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients ($399,865)", "source_url": "https://reporter.nih.gov/project-details/10483109", "people": [{"name": "Yingling Fan", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH125483-01A1", "company": "Hido Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-15", "observed": "2026-08-21", "amount_usd": 234847, "summary": "NIH award 1R43MH125483-01A1: Automated Medication Platform with Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients with HIV/AIDS ($234,847)", "source_url": "https://reporter.nih.gov/project-details/10256239", "people": [{"name": "Charles Gellman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG077993-01", "company": "Hopeful Aging LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-13", "observed": "2026-08-21", "amount_usd": 259010, "summary": "NIH award 1R43AG077993-01: All About Me: An Intervention to Ease the Transition to Long-term Care, Build Community, and Improve Quality of Care for Persons with Dementia ($259,010)", "source_url": "https://reporter.nih.gov/project-details/10481163", "people": [{"name": "Gregg Gorzelle", "role": "Principal Investigator"}, {"name": "Michael John Skrajner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN220006", "company": "Covidien, LLC", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-06-13", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN220006 granted: ProdiGI", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220006"}, {"id": "sbir:DOD:W81XWH22C0049", "company": "Liberating Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-06-13", "observed": "2026-09-18", "amount_usd": 1099359, "summary": "DOD STTR Phase II award $1,099,359: Wireless Non-Invasive Advanced Control of Microprocessor Prostheses and Orthoses II", "source_url": "https://www.sbir.gov/awards?search=H2-0678"}, {"id": "nih:1R41CA261214-01A1", "company": "Argosmd, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-10", "observed": "2026-08-21", "amount_usd": 398209, "summary": "NIH award 1R41CA261214-01A1: High-speed, portable reflectance confocal microscope (pRCM) for imaging skin cancer ($398,209)", "source_url": "https://reporter.nih.gov/project-details/10381884", "people": [{"name": "Dongkyun Kang", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42HL150963-03", "company": "Caeli Vascular, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-09", "observed": "2026-08-21", "amount_usd": 969525, "summary": "NIH award 5R42HL150963-03: Isovolumetric Multimodal Venous Thrombectomy System ($969,525)", "source_url": "https://reporter.nih.gov/project-details/10458775", "people": [{"name": "Stacey Liekweg", "role": "Principal Investigator"}, {"name": "Mohamed A. Zayed", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DC016247-06", "company": "Batandcat, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-09", "observed": "2026-08-21", "amount_usd": 1240006, "summary": "NIH award 5R44DC016247-06: Portable Hearing Laboratory - CRP ($1,240,006)", "source_url": "https://reporter.nih.gov/project-details/10350681", "people": [{"name": "Caslav Vojislav Pavlovic", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R43DA056161-01", "company": "Telesage, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-08", "observed": "2026-08-21", "amount_usd": 256128, "summary": "NIH award 1R43DA056161-01: Development of a cloud-based, self-report SUD intake system enabling primary care clinicians to routinely complete, implement, document, and bill for biopsychosocial assessments for the underserved ($256,128)", "source_url": "https://reporter.nih.gov/project-details/10469898", "people": [{"name": "BENJAMIN B BRODEY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DC017625-02A1", "company": "Aural Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-08", "observed": "2026-08-21", "amount_usd": 734433, "summary": "NIH award 2R44DC017625-02A1: Automated objective outcome measures for clinical use in dysarthria ($734,433)", "source_url": "https://reporter.nih.gov/project-details/10323563", "people": [{"name": "Sherman Charles", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG058312-03", "company": "Osteodx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-08", "observed": "2026-08-21", "amount_usd": 832136, "summary": "NIH award 5R44AG058312-03: Development and validation of a novel non-invasive device for measuring the mechanical properties of cortical bone ($832,136)", "source_url": "https://reporter.nih.gov/project-details/10407076", "people": [{"name": "Brian C Clark", "role": "Principal Investigator"}, {"name": "Andrew Dick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "breakthrough:K213882", "company": "Earlitec Diagnostics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-06-08", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K213882: EARLIPOINT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:2R44GM130227-02A1", "company": "Eliaz Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-06", "observed": "2026-08-21", "amount_usd": 691161, "summary": "NIH award 2R44GM130227-02A1: Depleting Circulating Galectin-3 with Therapeutic Apheresis: A NovelTreatment for Sepsis/AKI ($691,161)", "source_url": "https://reporter.nih.gov/project-details/10483969", "people": [{"name": "Isaac Eliaz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA206801-06", "company": "Clarix Imaging Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-06", "observed": "2026-08-21", "amount_usd": 766569, "summary": "NIH award 5R44CA206801-06: Real-time volumetric specimen imager for 3D intra-operative lumpectomy margin assessment ($766,569)", "source_url": "https://reporter.nih.gov/project-details/10476998", "people": [{"name": "Xiao Han", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "sbir:DOD:HR001122C0125", "company": "Creare LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-06-06", "observed": "2026-09-18", "amount_usd": 1499308, "summary": "DOD SBIR Phase II award $1,499,308: Development of a Smart REBOA Catheter", "source_url": "https://www.sbir.gov/awards?search=D2-2646"}, {"id": "nih:3R44NS122604-02S1", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-03", "observed": "2026-08-21", "amount_usd": 34147, "summary": "NIH award 3R44NS122604-02S1: Flow Acceleration for Stroke Thrombolysis (FAST) System ($34,147)", "source_url": "https://reporter.nih.gov/project-details/10572098", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "Thomas M Hemmen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41CA268293-01", "company": "Pxalpha, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-03", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R41CA268293-01: The re-activatable Yb-169 radiation source: a therapeutic medical device to reduce the risk of brachytherapy and increase adoption ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10383611", "people": [{"name": "RYAN Thomas FLYNN", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG061985-05", "company": "Zetroz Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-03", "observed": "2026-08-21", "amount_usd": 1438616, "summary": "NIH award 5R44AG061985-05: Daily & Localized NSAID Sonophoresis for Symptomatic Treatment of Knee Osteoarthritis ($1,438,616)", "source_url": "https://reporter.nih.gov/project-details/10413228", "people": [{"name": "George Kenneth Lewis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:5R44MH112470-06", "company": "Caring Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-03", "observed": "2026-08-21", "amount_usd": 955916, "summary": "NIH award 5R44MH112470-06: Combining Autism Telehealth and Screening Technologies for Earlier Diagnostic Assessments ($955,916)", "source_url": "https://reporter.nih.gov/project-details/10424511", "people": [{"name": "Ronald Oberleitner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R44NS122604-02", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-02", "observed": "2026-08-21", "amount_usd": 1332702, "summary": "NIH award 5R44NS122604-02: Flow Acceleration for Stroke Thrombolysis (FAST) System ($1,332,702)", "source_url": "https://reporter.nih.gov/project-details/10451688", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "Thomas M Hemmen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL151032-03", "company": "Thrombolex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-06-01", "observed": "2026-08-21", "amount_usd": 978998, "summary": "NIH award 5R44HL151032-03: Novel Expandable Infusion Catheter for the Treatment of Acute Pulmonary Embolism ($978,998)", "source_url": "https://reporter.nih.gov/project-details/10402249", "people": [{"name": "Brian Garriock Firth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44ES030578-03", "company": "Medcognition, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-31", "observed": "2026-08-21", "amount_usd": 190752, "summary": "NIH award 5R44ES030578-03: Enabling Realistic HAZMAT Training Simulations with the PerSim\u00ae Augmented Reality Patient Simulator: Phase II ($190,752)", "source_url": "https://reporter.nih.gov/project-details/10405640", "people": [{"name": "Sohail Baig", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R43HL158306-01A1S1", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-31", "observed": "2026-08-21", "amount_usd": 8700, "summary": "NIH award 3R43HL158306-01A1S1: Magnetic Rotational Exploratory Platform for Coronary Lesions ($8,700)", "source_url": "https://reporter.nih.gov/project-details/10616021", "people": [{"name": "Richard Gordon Bach", "role": "Principal Investigator"}, {"name": "Francis Milton Creighton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK133084-01", "company": "Ideal Medical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-31", "observed": "2026-08-21", "amount_usd": 958212, "summary": "NIH award 1R44DK133084-01: Demonstration of the Feasibility of Closed Loop Control of Blood Glucose in the Intensive Care Unit Setting Using a Novel Artificial Intelligence Based Glucose Control System ($958,212)", "source_url": "https://reporter.nih.gov/project-details/10482483", "people": [{"name": "Leon DeJournett", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH113408-04", "company": "Wiser Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-31", "observed": "2026-08-21", "amount_usd": 517477, "summary": "NIH award 5R44MH113408-04: Evaluating the Comparative Validity and Reliability of SERAS: A Decision Support Tool for Assessing Near Term Risk of Suicide in Emergency Departments. ($517,477)", "source_url": "https://reporter.nih.gov/project-details/10426286", "people": [{"name": "Robert Russell Althoff", "role": "Principal Investigator"}, {"name": "WILLIAM CATS-BARIL", "role": "Principal Investigator"}, {"name": "JOHN E HELZER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:4R42NS110165-02", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-31", "observed": "2026-08-21", "amount_usd": 755288, "summary": "NIH award 4R42NS110165-02: 3D Printed Multifunctional Brain Windows for Simultaneous Optical Imaging and Electrophysiology ($755,288)", "source_url": "https://reporter.nih.gov/project-details/10535909", "people": [{"name": "Suhasa B Kodandaramaiah", "role": "Principal Investigator"}, {"name": "Michael McAlpine", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA268728-01A1", "company": "Fluid Synchrony, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-27", "observed": "2026-08-21", "amount_usd": 299998, "summary": "NIH award 1R44CA268728-01A1: An Implantable Micropump for Enhanced Metronomic Chemotherapy for Leptomeningeal Brain Cancer ($299,998)", "source_url": "https://reporter.nih.gov/project-details/10485049", "people": [{"name": "TUAN Q HOANG", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM131560-02", "company": "Epicypher, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-27", "observed": "2026-08-21", "amount_usd": 1024490, "summary": "NIH award 2R44GM131560-02: Quantification of combinatorial epigenetic modifications using defined nucleosome standards ($1,024,490)", "source_url": "https://reporter.nih.gov/project-details/10481109", "people": [{"name": "Andrea Lynn Johnstone", "role": "Principal Investigator"}, {"name": "Michael-Christopher Keogh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44EY026466-04", "company": "Opticent, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-27", "observed": "2026-08-21", "amount_usd": 705941, "summary": "NIH award 2R44EY026466-04: Visible-light optical coherence tomography for clinical glaucoma management ($705,941)", "source_url": "https://reporter.nih.gov/project-details/10484749", "people": [{"name": "Roman Kuranov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44DC020406-01", "company": "Nadi LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-26", "observed": "2026-08-21", "amount_usd": 1112006, "summary": "NIH award 1R44DC020406-01: An Open-source Speech Processing Platform (OSP) for Research on Hearing Loss and Related Disorders ($1,112,006)", "source_url": "https://reporter.nih.gov/project-details/10482312", "people": [{"name": "Harinath Garudadri", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AI172703-01", "company": "Phase Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-26", "observed": "2026-08-21", "amount_usd": 995873, "summary": "NIH award 1R44AI172703-01: Therapeutic phage host-range prediction using proximity-guided metagenomics and artificial intelligence ($995,873)", "source_url": "https://reporter.nih.gov/project-details/10547653", "people": [{"name": "Ivan Liachko", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R42MD014943-02A1", "company": "Klein Buendel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-26", "observed": "2026-08-21", "amount_usd": 962564, "summary": "NIH award 2R42MD014943-02A1: Translating an In-Person Brief, Bystander Bullying Intervention (STAC) to a Technology-Based - Phase II ($962,564)", "source_url": "https://reporter.nih.gov/project-details/10480239", "people": [{"name": "Aida Midgett", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "breakthrough:K220195", "company": "Si-bone, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-05-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K220195: IFUSE BEDROCK GRANITE IMPLANT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44DC017930-03", "company": "Creare, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-25", "observed": "2026-08-21", "amount_usd": 802494, "summary": "NIH award 5R44DC017930-03: Diagnostic Hearing Test System for Telehealth in Underserved Communities ($802,494)", "source_url": "https://reporter.nih.gov/project-details/10452703", "people": [{"name": "ODILE H CLAVIER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R42DC019877-01A1", "company": "Modality.ai , Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-25", "observed": "2026-08-21", "amount_usd": 332831, "summary": "NIH award 1R42DC019877-01A1: A digital tool for monitoring speech decline in ALS ($332,831)", "source_url": "https://reporter.nih.gov/project-details/10482581", "people": [{"name": "JORDAN R GREEN", "role": "Principal Investigator"}, {"name": "Vikram Ramanarayanan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R42AR074897-03", "company": "Design Concepts, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-24", "observed": "2026-08-21", "amount_usd": 806658, "summary": "NIH award 5R42AR074897-03: Wearable shear-wave tensiometry for tracking tendon load during dynamic movement ($806,658)", "source_url": "https://reporter.nih.gov/project-details/10252945", "people": [{"name": "Peter G Adamczyk", "role": "Principal Investigator"}, {"name": "DARRYL G THELEN", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "denovo:DEN200062", "company": "Angle Europe , Ltd.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-05-24", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200062 granted: Parsortix PC1 Device", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200062"}, {"id": "nih:5R44GM131530-03", "company": "Claremont Biosolutions, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-23", "observed": "2026-08-21", "amount_usd": 867721, "summary": "NIH award 5R44GM131530-03: Automated Ultra-Long DNA and RNA Extraction for Long-read Sequencing Applications ($867,721)", "source_url": "https://reporter.nih.gov/project-details/10386934", "people": [{"name": "MARK T BROWN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43EB030990-01A1", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-23", "observed": "2026-08-21", "amount_usd": 304329, "summary": "NIH award 1R43EB030990-01A1: MEMS-enhanced solid-phase isothermal amplification for rapid, multiplexed molecular diagnostics ($304,329)", "source_url": "https://reporter.nih.gov/project-details/10484147", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA273961-01", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-23", "observed": "2026-08-21", "amount_usd": 888733, "summary": "NIH award 1R44CA273961-01: Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures ($888,733)", "source_url": "https://reporter.nih.gov/project-details/10481578", "people": [{"name": "NICUSOR IFTIMIA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD092210-03", "company": "Preemie-pacer, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-23", "observed": "2026-08-21", "amount_usd": 644653, "summary": "NIH award 5R44HD092210-03: Mechanism to Promote Safe and Efficient Oral Feeding in Preterm Infants ($644,653)", "source_url": "https://reporter.nih.gov/project-details/10396540", "people": [{"name": "Amit Mohan Mathur", "role": "Principal Investigator"}, {"name": "Thomas Oleksy", "role": "Principal Investigator"}, {"name": "Roberta Pineda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44HL162151-01", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-23", "observed": "2026-08-21", "amount_usd": 266110, "summary": "NIH award 1R44HL162151-01: A Low Blood Volume Platform for Recurrent Anticoagulation and Kidney Monitoring during Continuous Renal Replacement Therapy in Critically Ill Children ($266,110)", "source_url": "https://reporter.nih.gov/project-details/10383224", "people": [{"name": "VAMSEE K. PAMULA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA268344-01", "company": "Astrin Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-23", "observed": "2026-08-21", "amount_usd": 399678, "summary": "NIH award 1R41CA268344-01: Development of a novel personalized medicine platform using apheretically isolated circulating tumor cells to assess drug responsiveness in prostate cancer ($399,678)", "source_url": "https://reporter.nih.gov/project-details/10384366", "people": [{"name": "Justin Michael Drake", "role": "Principal Investigator"}, {"name": "Jayant Parthasarathy", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DC019589-01", "company": "Altec, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-21", "observed": "2026-08-21", "amount_usd": 254556, "summary": "NIH award 1R43DC019589-01: SpeechSense: An Interactive Sensor Platform for Speech Therapy ($254,556)", "source_url": "https://reporter.nih.gov/project-details/10256832", "people": [{"name": "Gianluca De Luca", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL127543-06", "company": "Opticyte, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-20", "observed": "2026-08-21", "amount_usd": 910791, "summary": "NIH award 5R44HL127543-06: Noninvasive compact device to monitor myoglobin saturation in anemia and critical illness ($910,791)", "source_url": "https://reporter.nih.gov/project-details/10396991", "people": [{"name": "LORILEE S. L. ARAKAKI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R43AI167193-01", "company": "Day Zero Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-20", "observed": "2026-08-21", "amount_usd": 303932, "summary": "NIH award 1R43AI167193-01: Development of a Novel Whole Genome Sequencing-based Platform for Rapid Identification and Antimicrobial Profiling of Uropathogens ($303,932)", "source_url": "https://reporter.nih.gov/project-details/10382740", "people": [{"name": "Amanda Nicole Billings", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44MH126819-02", "company": "Evidence-based Practice Institute, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-20", "observed": "2026-08-21", "amount_usd": 1009310, "summary": "NIH award 4R44MH126819-02: iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide ($1,009,310)", "source_url": "https://reporter.nih.gov/project-details/10495619", "people": [{"name": "Linda A Dimeff", "role": "Principal Investigator"}, {"name": "Cindy M. Schaeffer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43EY033266-01A1", "company": "Chromologic, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-20", "observed": "2026-08-21", "amount_usd": 299930, "summary": "NIH award 1R43EY033266-01A1: Eye-Path Resubmission ($299,930)", "source_url": "https://reporter.nih.gov/project-details/10480705", "people": [{"name": "Espoir Kyubwa", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43AG071360-01A1S1", "company": "Brookside Research & Development Company", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-20", "observed": "2026-08-21", "amount_usd": 28091, "summary": "NIH award 3R43AG071360-01A1S1: Prototype Multimedia ADRD Falls Prevention System for Family Caregivers ($28,091)", "source_url": "https://reporter.nih.gov/project-details/10561549", "people": [{"name": "VICTORIA P PANZER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R43MD017137-02", "company": "Handl Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-19", "observed": "2026-08-21", "amount_usd": 237448, "summary": "NIH award 5R43MD017137-02: A mobile application to offer upfront healthcare prices and automated medical billing for socioeconomically disadvantaged Americans ($237,448)", "source_url": "https://reporter.nih.gov/project-details/10494210", "people": [{"name": "Ahmed Marmoush", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:4R44TR003832-02", "company": "Accuhealth Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-19", "observed": "2026-08-21", "amount_usd": 999936, "summary": "NIH award 4R44TR003832-02: Health 360x Clinical Research Platform for Scalable Access to Clinical Trials ($999,936)", "source_url": "https://reporter.nih.gov/project-details/10515803", "people": [{"name": "Chamberlain Obialo", "role": "Principal Investigator"}, {"name": "Elizabeth O. Ofili", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44EB027525-03", "company": "Barrett Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-18", "observed": "2026-08-21", "amount_usd": 817777, "summary": "NIH award 5R44EB027525-03: PostureCheck: A vision-based compensatory-posture-detection tool to enhance performance of the BURT\u00ae upper-extremity stroke-therapy device ($817,777)", "source_url": "https://reporter.nih.gov/project-details/10437603", "people": [{"name": "Paolo Bonato", "role": "Principal Investigator"}, {"name": "Alexandros Lioulemes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41AG078103-01", "company": "Klein Buendel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-18", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R41AG078103-01: Computer-based Learning to Enhance ADRD Care in Prison: Just Care for Dementia ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10483628", "people": [{"name": "Susan Jayne Loeb", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM131501-02A1", "company": "Nirvana Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-18", "observed": "2026-08-21", "amount_usd": 825109, "summary": "NIH award 2R44GM131501-02A1: Fluorescent nanofoldamers for multiplex flow cytometry ($825,109)", "source_url": "https://reporter.nih.gov/project-details/10484531", "people": [{"name": "Christopher J MacNevin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG078009-01", "company": "Potluck, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-18", "observed": "2026-08-21", "amount_usd": 449777, "summary": "NIH award 1R44AG078009-01: Enhancing Social Engagement through Online Gameplay for Older Adults with and without Mild Cognitive Impairment ($449,777)", "source_url": "https://reporter.nih.gov/project-details/10484643", "people": [{"name": "Maribeth Gandy Coleman", "role": "Principal Investigator"}, {"name": "Dillon Myers", "role": "Principal Investigator"}, {"name": "Kayci Vickers", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH130298-01", "company": "Guiding Technologies Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-18", "observed": "2026-08-21", "amount_usd": 297785, "summary": "NIH award 1R43MH130298-01: Smart Technology to Empower Collaborative Partnerships Among Behavior Practitioners and Caregivers to Deliver Quality ABA ($297,785)", "source_url": "https://reporter.nih.gov/project-details/10482136", "people": [{"name": "John Teofil Nosek", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN210046", "company": "Neurometrix, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-05-18", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210046 granted: Quell-FM", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210046"}, {"id": "breakthrough:DEN210046", "company": "Neurometrix, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-05-18", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN210046: QUELL-FM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R41CA254557-01A1S2", "company": "Pranascience Institute LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-17", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R41CA254557-01A1S2: PRANAYAMA BASED MOBILE APP FOR BREAST CANCER SURVIVORSHIP: I-CORPS SUPPLEMENT ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10558811", "people": [{"name": "SUNDARAVADIVEL BALASUBRAMANIAN", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG074818-01A1", "company": "I-function, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-17", "observed": "2026-08-21", "amount_usd": 1251954, "summary": "NIH award 1R44AG074818-01A1: Development of a Remotely Deliverable Cognitive Assessment Sensitive to Early Stage Mild Cognitive Impairment. ($1,251,954)", "source_url": "https://reporter.nih.gov/project-details/10482236", "people": [{"name": "Peter Kallestrup", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "denovo:DEN210044", "company": "Bonesupport AB", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-05-17", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210044 granted: CERAMENT G", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210044"}, {"id": "breakthrough:DEN210044", "company": "Bonesupport Ab", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-05-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN210044: CERAMENT G", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:2R42HG011219-02", "company": "Datirium, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-16", "observed": "2026-08-21", "amount_usd": 802500, "summary": "NIH award 2R42HG011219-02: SciDAP: Scientific Data Analysis Platform ($802,500)", "source_url": "https://reporter.nih.gov/project-details/10484046", "people": [{"name": "Artem Barski", "role": "Principal Investigator"}, {"name": "Andrey Kartashov", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42EY028820-03", "company": "Intelon Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-16", "observed": "2026-08-21", "amount_usd": 568479, "summary": "NIH award 5R42EY028820-03: Brillouin optical eye scanner prototypes for commercialization ($568,479)", "source_url": "https://reporter.nih.gov/project-details/10408829", "people": [{"name": "DIMITRI CHERNYAK", "role": "Principal Investigator"}, {"name": "Seok-Hyun Andy Yun", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R42GM144999-01", "company": "Cohere-med, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-16", "observed": "2026-08-21", "amount_usd": 275766, "summary": "NIH award 1R42GM144999-01: Solving Sepsis: Early Identification and Prompt Management Using Machine Learning ($275,766)", "source_url": "https://reporter.nih.gov/project-details/10384254", "people": [{"name": "Manesh R Patel", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44MD014077-04", "company": "Isa Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-13", "observed": "2026-08-21", "amount_usd": 279407, "summary": "NIH award 5R44MD014077-04: Reducing Health Disparities among African American Women: A Mobile Cognitive Behavioral Stress Management Intervention ($279,407)", "source_url": "https://reporter.nih.gov/project-details/10401477", "people": [{"name": "DOUGLAS W BILLINGS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R42DA049448-03", "company": "Q2i, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-13", "observed": "2026-08-21", "amount_usd": 902836, "summary": "NIH award 5R42DA049448-03: Reward-based technology to improve opioid use disorder treatment initiation after an ED visit ($902,836)", "source_url": "https://reporter.nih.gov/project-details/10414138", "people": [{"name": "Edwin D Boudreaux", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44GM130262-02", "company": "Proteinaceous, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-13", "observed": "2026-08-21", "amount_usd": 764178, "summary": "NIH award 2R44GM130262-02: A comprehensive solution for native top down mass spectrometry data analyses across structural biology and biopharma ($764,178)", "source_url": "https://reporter.nih.gov/project-details/10384677", "people": [{"name": "Kenneth Durbin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AG059524-03", "company": "Collagen Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-13", "observed": "2026-08-21", "amount_usd": 725517, "summary": "NIH award 5R44AG059524-03: Targeted Imaging of Fibrosis in the Left Atrium ($725,517)", "source_url": "https://reporter.nih.gov/project-details/10400168", "people": [{"name": "Valerie Humblet", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R41GM146329-01S1", "company": "AI Metrics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-13", "observed": "2026-08-21", "amount_usd": 6500, "summary": "NIH award 3R41GM146329-01S1: Pulmonary Surface Irregularity score: A Quantitative CT Biomarker for Idiopathic Pulmonary Fibrosis ($6,500)", "source_url": "https://reporter.nih.gov/project-details/10591666", "people": [{"name": "ROBERT B JACOBUS", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL160348-01A1", "company": "Boundless Science, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-13", "observed": "2026-08-21", "amount_usd": 299024, "summary": "NIH award 1R43HL160348-01A1: Aerosol Ventilation for Rapid Cooling of Transplant Donor Lungs ($299,024)", "source_url": "https://reporter.nih.gov/project-details/10481907", "people": [{"name": "Andrew Jones", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM139535-02", "company": "Biosensing Instrument, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-13", "observed": "2026-08-21", "amount_usd": 829265, "summary": "NIH award 5R44GM139535-02: Development of a charge-sensitive optical detection system for high-throughput study of small molecules ($829,265)", "source_url": "https://reporter.nih.gov/project-details/10407060", "people": [{"name": "Nguyen Ly", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "breakthrough:P210032", "company": "W. L. Gore & Associates, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-05-13", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P210032: GORE TAG THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R41MH126734-02", "company": "Adhere.ly, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-12", "observed": "2026-08-21", "amount_usd": 394769, "summary": "NIH award 5R41MH126734-02: Improving adherence to evidence-based practice using an innovative and easy-to-use health IT solution ($394,769)", "source_url": "https://reporter.nih.gov/project-details/10442582", "people": [{"name": "Brian E. Bunnell", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44DA049300-03", "company": "Prapela, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-12", "observed": "2026-08-21", "amount_usd": 1169404, "summary": "NIH award 5R44DA049300-03: Prapela\u2122 SVS: A cost-effective stochastic vibrotactile stimulation device toimprove the clinical course of infants with neonatal abstinence syndrome. ($1,169,404)", "source_url": "https://reporter.nih.gov/project-details/10408163", "people": [{"name": "John Phillip Konsin", "role": "Principal Investigator"}, {"name": "Rachana Singh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DK118994-04", "company": "Affinergy, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-11", "observed": "2026-08-21", "amount_usd": 682788, "summary": "NIH award 5R44DK118994-04: Rapid assay to monitor vancomycin levels at the point of care in hemodialysis patients ($682,788)", "source_url": "https://reporter.nih.gov/project-details/10398206", "people": [{"name": "Martyn Darby", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AI136118-04", "company": "L2 Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-11", "observed": "2026-08-21", "amount_usd": 692082, "summary": "NIH award 5R44AI136118-04: An antigen-detection assay to diagnose Babesia microti infection ($692,082)", "source_url": "https://reporter.nih.gov/project-details/10403621", "people": [{"name": "Michel Ledizet", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44GM145168-01A1", "company": "Phi Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-10", "observed": "2026-08-21", "amount_usd": 894309, "summary": "NIH award 1R44GM145168-01A1: Label-free cell viability assays using Phase Imaging with Computational Specificity ($894,309)", "source_url": "https://reporter.nih.gov/project-details/10484781", "people": [{"name": "CATALIN CHIRITESCU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK127631-02", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-10", "observed": "2026-08-21", "amount_usd": 763118, "summary": "NIH award 5R44DK127631-02: Kidney Support in Pediatric Patients Using an Ultrafiltration Device ($763,118)", "source_url": "https://reporter.nih.gov/project-details/10407077", "people": [{"name": "Robert J Knuesel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44HD101201-02", "company": "Salus Discovery, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-10", "observed": "2026-08-21", "amount_usd": 962850, "summary": "NIH award 4R44HD101201-02: Enhancing Pediatric Diagnosis of Tuberculosis with FLOW Technology ($962,850)", "source_url": "https://reporter.nih.gov/project-details/10548952", "people": [{"name": "Brianna Mullins", "role": "Principal Investigator"}, {"name": "Jay Wyatt Warrick", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44NS107142-03", "company": "Neurolux, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-09", "observed": "2026-08-21", "amount_usd": 721617, "summary": "NIH award 5R44NS107142-03: Low Cost, Fully Implantable Wireless Neural Recording Device ($721,617)", "source_url": "https://reporter.nih.gov/project-details/10407657", "people": [{"name": "Roozbeh Ghaffari", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R44MD012782-02S1", "company": "Cog Analytics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-08", "observed": "2026-08-21", "amount_usd": 36990, "summary": "NIH award 3R44MD012782-02S1: Validation of the TAPS-Electronic Spanish Platform (TAPS-ESP): A Technology to Improve Access to Substance Use Screening and Reduce Behavioral Health Disparities in Hispanic Primary Care Patients ($36,990)", "source_url": "https://reporter.nih.gov/project-details/10544208", "people": [{"name": "Steven Bernard Carswell", "role": "Principal Investigator"}, {"name": "Katherine Sanchez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41HL150951-01A1", "company": "Plateletdiagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-06", "observed": "2026-08-21", "amount_usd": 259586, "summary": "NIH award 1R41HL150951-01A1: Leveraging platelet signal transduction for personalized antiplatelet therapy ($259,586)", "source_url": "https://reporter.nih.gov/project-details/10480329", "people": [{"name": "David Barrios", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA261579-01A1", "company": "Xilis, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-06", "observed": "2026-08-21", "amount_usd": 398486, "summary": "NIH award 1R44CA261579-01A1: Micro-Organospheres Drug Screen to Lead Care (MODEL): a Precision Oncology Platform to Guide Breast Cancer Therapy ($398,486)", "source_url": "https://reporter.nih.gov/project-details/10383051", "people": [{"name": "Daniel Delubac", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS102302-04", "company": "Neogenesis Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-06", "observed": "2026-08-21", "amount_usd": 1099867, "summary": "NIH award 5R44NS102302-04: Development and qualification of Talon microIPG to treat Chronic Migraines ($1,099,867)", "source_url": "https://reporter.nih.gov/project-details/10421177", "people": [{"name": "Savannah Chorley", "role": "Principal Investigator"}, {"name": "Gary Dulak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44AI170389-01", "company": "Cryocrate, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-06", "observed": "2026-08-21", "amount_usd": 751525, "summary": "NIH award 1R44AI170389-01: Innovation of Skin Banking and Transplantation Based on a First-in-Class Biocompatible Cryopreservation Technology ($751,525)", "source_url": "https://reporter.nih.gov/project-details/10485309", "people": [{"name": "Xu Han", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R42MH123215-03", "company": "Lyssn.io, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-06", "observed": "2026-08-21", "amount_usd": 752133, "summary": "NIH award 4R42MH123215-03: CBTpro: Scaling up CBT for psychosis using simulated patients and spoken language technologies ($752,133)", "source_url": "https://reporter.nih.gov/project-details/10495605", "people": [{"name": "Sarah Lynn Kopelovich", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DK130756-01A1", "company": "Aleo Bme, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-06", "observed": "2026-08-21", "amount_usd": 249827, "summary": "NIH award 1R43DK130756-01A1: Multifunctional injectable agent for endoscopic mucosal resection ($249,827)", "source_url": "https://reporter.nih.gov/project-details/10481496", "people": [{"name": "Chao Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "sbir:DOD:W911NF-22-P-0018", "company": "Qledcures LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-05-06", "observed": "2026-09-18", "amount_usd": 172928, "summary": "DOD STTR Phase I award $172,928: Portable quantum dot electroluminescent (QDEL) light sources for point of care photodynamic treatment of deep wound MDR infections", "source_url": "https://www.sbir.gov/awards?search=A21C-T010-0018"}, {"id": "nih:1R44AG076256-01A1", "company": "Maphabit, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-05", "observed": "2026-08-21", "amount_usd": 449826, "summary": "NIH award 1R44AG076256-01A1: An assistive-technology based Caregiver Training Program (CTP) to enhance caregiver effectiveness, well-being, and quality of life, which will improve overall care for individuals living with AD/ADRD. ($449,826)", "source_url": "https://reporter.nih.gov/project-details/10484412", "people": [{"name": "Matthew Golden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43NR020289-01A1", "company": "Etectrx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-04", "observed": "2026-08-21", "amount_usd": 259270, "summary": "NIH award 1R43NR020289-01A1: ID-Cap System: Next generation ingestible sensors for medication adherence measurement ($259,270)", "source_url": "https://reporter.nih.gov/project-details/10475453", "people": [{"name": "Tony Christopher Carnes", "role": "Principal Investigator"}, {"name": "Peter R Chai", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44EY030829-02", "company": "Aeon Imaging, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-04", "observed": "2026-08-21", "amount_usd": 632430, "summary": "NIH award 2R44EY030829-02: Visual acuity and functional measurements in the aging eye ($632,430)", "source_url": "https://reporter.nih.gov/project-details/10478474", "people": [{"name": "ANN E ELSNER", "role": "Principal Investigator"}, {"name": "Thomas J. Gast", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "denovo:DEN200072", "company": "Fujirebio Diagnostics,Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-05-04", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200072 granted: Lumipulse G \u00df-Amyloid Ratio (1-42/1-40)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200072"}, {"id": "breakthrough:DEN200072", "company": "Fujirebio Diagnostics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-05-04", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN200072: LUMIPULSE G \u00df-AMYLOID RATIO (1-42/1-40)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R43DA055376-01", "company": "Oregon Res Behavioral Intervention Strat", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-03", "observed": "2026-08-21", "amount_usd": 256492, "summary": "NIH award 1R43DA055376-01: Click City: Marijuana - An Interactive, Scalable, High-Fidelity, Digital Prevention Program for Youth ($256,492)", "source_url": "https://reporter.nih.gov/project-details/10383049", "people": [{"name": "Judy A Andrews", "role": "Principal Investigator"}, {"name": "Erika Westling", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44AI153011-02", "company": "Orlance, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-03", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 4R44AI153011-02: Universal Influenza A/B Vaccine ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10539015", "people": [{"name": "Kenneth C Bagley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HD104323-03", "company": "Phase Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-05-03", "observed": "2026-08-21", "amount_usd": 837867, "summary": "NIH award 5R44HD104323-03: A next-generation method for cytogenomics using Hi-C proximity ligation sequencing ($837,867)", "source_url": "https://reporter.nih.gov/project-details/10397703", "people": [{"name": "Stephen Matthew Eacker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "denovo:DEN200063", "company": "Al.Chi.Mi.A. S.R.L", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-05-02", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200063 granted: Kerasave", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200063"}, {"id": "nih:3R44AG065081-03A1S1", "company": "Maphabit, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-30", "observed": "2026-08-21", "amount_usd": 20498, "summary": "NIH award 3R44AG065081-03A1S1: Using gamification, predictive analytics, artificial intelligence, and Alexa Voice to optimize user experience for individuals living with AD/ADRD and their caregivers ($20,498)", "source_url": "https://reporter.nih.gov/project-details/10590558", "people": [{"name": "Matthew Golden", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42AI143011-04", "company": "Moonlight Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-30", "observed": "2026-08-21", "amount_usd": 918854, "summary": "NIH award 5R42AI143011-04: Microneedle Based Targeted Allergen Specific Immunotherapy for Treatment of Peanut Allergies ($918,854)", "source_url": "https://reporter.nih.gov/project-details/10407661", "people": [{"name": "Samirkumar Patel", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44GM146477-01A1", "company": "Applied Nanostructures, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-29", "observed": "2026-08-21", "amount_usd": 680381, "summary": "NIH award 1R44GM146477-01A1: A micromachining fluidic cantilever for single cell advanced patch clamping and cellular characterization using atomic force microscopy ($680,381)", "source_url": "https://reporter.nih.gov/project-details/10478331", "people": [{"name": "Ami Chand", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43HG012526-01", "company": "Atlasxomics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-29", "observed": "2026-08-21", "amount_usd": 221977, "summary": "NIH award 1R43HG012526-01: Microfluidics Platform for Spatial Multi-Omics Analysis of Tissue at Single Cell Resolution ($221,977)", "source_url": "https://reporter.nih.gov/project-details/10483029", "people": [{"name": "Joseph Charles Gennaro", "role": "Principal Investigator"}, {"name": "Liya Wang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL160257-01A1", "company": "Applied Physics Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-29", "observed": "2026-08-21", "amount_usd": 888439, "summary": "NIH award 1R44HL160257-01A1: A scalable superconducting dual-shielded fetal magnetocardiography system ($888,439)", "source_url": "https://reporter.nih.gov/project-details/10480398", "people": [{"name": "William Goodman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL145953-04", "company": "Imbio, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-29", "observed": "2026-08-21", "amount_usd": 449666, "summary": "NIH award 5R44HL145953-04: Vascular Deformation Mapping (VDM) for Automated, 3D Assessment of Thoracic Aortic Aneurysm ($449,666)", "source_url": "https://reporter.nih.gov/project-details/10409547", "people": [{"name": "Nicholas Scott Burris", "role": "Principal Investigator"}, {"name": "CHARLES R HATT", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44HL149480-02A1", "company": "Flobio, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-29", "observed": "2026-08-21", "amount_usd": 1222556, "summary": "NIH award 2R44HL149480-02A1: A rapid microfluidic diagnostic assay for the measurement of Direct Oral Anticoagulants from patient whole blood ($1,222,556)", "source_url": "https://reporter.nih.gov/project-details/10482562", "people": [{"name": "Adam Cuker", "role": "Principal Investigator"}, {"name": "Mark Kunkel", "role": "Principal Investigator"}, {"name": "Jason M Rossi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "denovo:DEN200066", "company": "Biofire Diagnostics, LLC", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-04-29", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200066 granted: BioFire Joint Infection (JI) Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200066"}, {"id": "nih:5R44ES032393-03", "company": "Nortis, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-28", "observed": "2026-08-21", "amount_usd": 803596, "summary": "NIH award 5R44ES032393-03: Rat and Canine Microphysiological Systems of the Kidney Proximal Tubule for Chemical Toxicity Screening ($803,596)", "source_url": "https://reporter.nih.gov/project-details/10405579", "people": [{"name": "Thomas Neumann", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41TR004224-01", "company": "Mountainpass Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-27", "observed": "2026-08-21", "amount_usd": 324084, "summary": "NIH award 1R41TR004224-01: Development and Evaluation of an Integrated Biomarker Capture System for Use in Remote Trials ($324,084)", "source_url": "https://reporter.nih.gov/project-details/10479571", "people": [{"name": "Jennifer Renee Dahne", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "breakthrough:P180051/S001", "company": "Transmedics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-04-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P180051/S001: ORGAN CARE SYSTEM (OCS) HEART SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K220231", "company": "Ultrathera Technologies, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-04-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K220231: GYROSTIM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44DK123905-03", "company": "Innovative Design Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-26", "observed": "2026-08-21", "amount_usd": 776242, "summary": "NIH award 5R44DK123905-03: Development of a Bariatric Mannequin System to Enable Realistic Examination Simulations of Obese Patients ($776,242)", "source_url": "https://reporter.nih.gov/project-details/10401913", "people": [{"name": "John Paul Condon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R41AG073066-01S2", "company": "Iscreen 2 Prevent LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-25", "observed": "2026-08-21", "amount_usd": 26488, "summary": "NIH award 3R41AG073066-01S2: An AI-assisted screening platform within a multivariate framework for biomarkers of mild cognitive impairment due to Alzheimer's disease ($26,488)", "source_url": "https://reporter.nih.gov/project-details/10571773", "people": [{"name": "Delia Cabrera-DeBuc", "role": "Principal Investigator"}, {"name": "Carlos E. Mendoza-Santiesteban", "role": "Principal Investigator"}, {"name": "Alberto Rafael Ramos", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44HD105529-02", "company": "Autoivf, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-25", "observed": "2026-08-21", "amount_usd": 849973, "summary": "NIH award 4R44HD105529-02: OvaReady: An automated microfluidic oocyte retrieval and denudation device expanding access to IVF ($849,973)", "source_url": "https://reporter.nih.gov/project-details/10604758", "people": [{"name": "Ismail Emre Ozkumur", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HD107718-01", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-22", "observed": "2026-08-21", "amount_usd": 299790, "summary": "NIH award 1R43HD107718-01: Virtual Activities of Living for Occupational Rehabilitation ($299,790)", "source_url": "https://reporter.nih.gov/project-details/10382990", "people": [{"name": "Richard J. Adams", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R41CA257624-01A1S1", "company": "Microstructure Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-22", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R41CA257624-01A1S1: Non-invasive neurosurgical planning with Random Matrix Theory MRI ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10541655", "people": [{"name": "Grigoriy Lemberskiy", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD105511-01A1", "company": "Assist Equipment Development, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-22", "observed": "2026-08-21", "amount_usd": 225397, "summary": "NIH award 1R43HD105511-01A1: A Low-Cost, Practical Fitness Monitor of Socket-Suspension Systems for Lower Limb Amputees ($225,397)", "source_url": "https://reporter.nih.gov/project-details/10384774", "people": [{"name": "Ming Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DA051257-02", "company": "Ayuda Medical", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-21", "observed": "2026-08-21", "amount_usd": 911396, "summary": "NIH award 2R44DA051257-02: A Naloxone Parachute: Novel Wearable Dual-Sensor Regional Oximeter to Detect Opioid-Induced Hypoxia and Enable Emergent Naloxone Rescue ($911,396)", "source_url": "https://reporter.nih.gov/project-details/10485822", "people": [{"name": "Desislava Zlatanova Hite", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44GM137671-02", "company": "Ligo Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-20", "observed": "2026-08-21", "amount_usd": 865376, "summary": "NIH award 2R44GM137671-02: Reliable model building for cryo-EM ($865,376)", "source_url": "https://reporter.nih.gov/project-details/10484081", "people": [{"name": "Raquel Bromberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:7R43EB031763-02", "company": "Advanced Medical Device Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-20", "observed": "2026-08-21", "amount_usd": 216595, "summary": "NIH award 7R43EB031763-02: Inline RF Warmer Using RF Technology ($216,595)", "source_url": "https://reporter.nih.gov/project-details/10583098", "people": [{"name": "Ahmad Khanifar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R44AI167330-01A1", "company": "Scanogen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-19", "observed": "2026-08-21", "amount_usd": 298601, "summary": "NIH award 1R44AI167330-01A1: Culture and amplification-free bacterial sepsis diagnosis ($298,601)", "source_url": "https://reporter.nih.gov/project-details/10484211", "people": [{"name": "Alfredo Andres Celedon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R42AI157552-02", "company": "Microbial Imaging, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-19", "observed": "2026-08-21", "amount_usd": 677001, "summary": "NIH award 4R42AI157552-02: Imaging Bacterial Infections in Vivo: First in Man Studies ($677,001)", "source_url": "https://reporter.nih.gov/project-details/10543621", "people": [{"name": "Mark Myron Goodman", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "breakthrough:P210006", "company": "Vascutek, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-04-19", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P210006: THORAFLEX HYBRID", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44MH116827-05", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-18", "observed": "2026-08-21", "amount_usd": 1004903, "summary": "NIH award 5R44MH116827-05: ClearScope ($1,004,903)", "source_url": "https://reporter.nih.gov/project-details/10403446", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:3R43AI162425-01A1S1", "company": "Vectech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-18", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43AI162425-01A1S1: I-Corps: Optical design and the development of high accuracy automated tick classification using computer vision ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10561399", "people": [{"name": "Autumn Goodwin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43MH128076-01S1", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-15", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43MH128076-01S1: Next generation axonal quantification and classification using AI ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10609151", "people": [{"name": "Paul Angstman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AI170131-01", "company": "Big Eye Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-15", "observed": "2026-08-21", "amount_usd": 259562, "summary": "NIH award 1R44AI170131-01: Ultrasensitive, High-Specificity Rapid Test to Support the End-Game of the Global Program to Eliminate Lymphatic Filariasis ($259,562)", "source_url": "https://reporter.nih.gov/project-details/10480110", "people": [{"name": "Marco Antonio Biamonte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44MH118137-04S1", "company": "Spikegadgets, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-15", "observed": "2026-08-21", "amount_usd": 168200, "summary": "NIH award 3R44MH118137-04S1: A scalable system for high-throughput and longitudinal electrophysiology in rodent brain research ($168,200)", "source_url": "https://reporter.nih.gov/project-details/10565321", "people": [{"name": "Mattias Peter Karlsson", "role": "Principal Investigator"}, {"name": "Lan Luan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44CA261516-01A1", "company": "Sonalasense Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-15", "observed": "2026-08-21", "amount_usd": 938955, "summary": "NIH award 1R44CA261516-01A1: Evaluation of the safety and efficacy of non-invasive sonodynamic therapy for diffuse intrinsic pontine glioma ($938,955)", "source_url": "https://reporter.nih.gov/project-details/10382835", "people": [{"name": "Stuart Marcus", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG060881-03", "company": "Revbio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-14", "observed": "2026-08-21", "amount_usd": 624511, "summary": "NIH award 5R44AG060881-03: Improved Treatment of Distal Radius Fractures Using an Image-Guided, Percutaneous Delivery of a Novel Bone Adhesive ($624,511)", "source_url": "https://reporter.nih.gov/project-details/10380629", "people": [{"name": "Brian Hess", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44HL149561-03", "company": "Aventusoft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-14", "observed": "2026-08-21", "amount_usd": 1500000, "summary": "NIH award 5R44HL149561-03: A novel non-invasive device for screening and optimized management to improve heart failure outcomes in patients with diabetes mellitus ($1,500,000)", "source_url": "https://reporter.nih.gov/project-details/10397163", "people": [{"name": "Kaustubh Kale", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AI170418-01", "company": "Orthobond Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-14", "observed": "2026-08-21", "amount_usd": 146428, "summary": "NIH award 1R43AI170418-01: Development of an Antimicrobial Pedicle Screw System: Studies Designed to Mitigate the Risk of Bacterial Resistance ($146,428)", "source_url": "https://reporter.nih.gov/project-details/10482147", "people": [{"name": "Jordan Katz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43DA054845-01S1", "company": "Dandelion Science Corp", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-13", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43DA054845-01S1: A Digital Therapeutic for Pain Relief through AI-Guided Visual Stimulation ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10561374", "people": [{"name": "Adam Hanina", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HL147787-02A1", "company": "Sigt, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-13", "observed": "2026-08-21", "amount_usd": 598321, "summary": "NIH award 2R44HL147787-02A1: High Frequency Dielectric Sensing Cardiac Radio Frequency Ablation Monitoring and Lesion Assessment System ($598,321)", "source_url": "https://reporter.nih.gov/project-details/10483317", "people": [{"name": "Parag Karmarkar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43DA055401-01S1", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-13", "observed": "2026-08-21", "amount_usd": 54863, "summary": "NIH award 3R43DA055401-01S1: Coridea NIH I-Corps Program ($54,863)", "source_url": "https://reporter.nih.gov/project-details/10541722", "people": [{"name": "Howard Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41DK131651-01A1", "company": "Pediatric Medical Device Company LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-13", "observed": "2026-08-21", "amount_usd": 256579, "summary": "NIH award 1R41DK131651-01A1: The First Non-Surgical Anti-Stomal Prolapse Medical Device to Treat and Prevent Stomal Prolapse ($256,579)", "source_url": "https://reporter.nih.gov/project-details/10482616", "people": [{"name": "Folarin Erogbogbo", "role": "Principal Investigator"}, {"name": "HOANG NGUYEN", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI167263-01A1", "company": "Numentus Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-12", "observed": "2026-08-21", "amount_usd": 285597, "summary": "NIH award 1R43AI167263-01A1: Very rapid, low cost multiplexed test for SARS, Influenza A and Influenza B Resubmission ($285,597)", "source_url": "https://reporter.nih.gov/project-details/10490209", "people": [{"name": "GREGORY W FARIS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EB028728-03", "company": "Inkspace Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-12", "observed": "2026-08-21", "amount_usd": 818229, "summary": "NIH award 5R44EB028728-03: Flexible, lightweight coils for radiation-transparent multi-modality imaging ($818,229)", "source_url": "https://reporter.nih.gov/project-details/10418816", "people": [{"name": "Gillian Gentry Haemer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R43GM142413-01A1S1", "company": "Rebel Medicine Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-11", "observed": "2026-08-21", "amount_usd": 6500, "summary": "NIH award 3R43GM142413-01A1S1: Development of a novel sustained release local anesthetic wound dressing for partial-thickness dermal injuries ($6,500)", "source_url": "https://reporter.nih.gov/project-details/10557010", "people": [{"name": "Brett Davis", "role": "Principal Investigator"}, {"name": "JILL E SHEA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD088332-04", "company": "Media Rez, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-11", "observed": "2026-08-21", "amount_usd": 381880, "summary": "NIH award 5R44HD088332-04: An intervention to increase HIV Testing Uptake among Adolescents and Young Adults ($381,880)", "source_url": "https://reporter.nih.gov/project-details/10377481", "people": [{"name": "Amanda Derryck Castel", "role": "Principal Investigator"}, {"name": "Daniel J Greenberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:3R44HL142455-03S1", "company": "Tissue Testing Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-08", "observed": "2026-08-21", "amount_usd": 124317, "summary": "NIH award 3R44HL142455-03S1: Ice-free vitrification and nano warming technology for banking of cardiovascular structures. ($124,317)", "source_url": "https://reporter.nih.gov/project-details/10587348", "people": [{"name": "Kelvin G.M. Brockbank", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41MH126795-01A1", "company": "Academic Web Pages, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-08", "observed": "2026-08-21", "amount_usd": 185046, "summary": "NIH award 1R41MH126795-01A1: MentorHub: A Supportive Accountability Tool for MHapps ($185,046)", "source_url": "https://reporter.nih.gov/project-details/10384062", "people": [{"name": "Nancy McNamara", "role": "Principal Investigator"}, {"name": "Jean Rhodes", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH126836-01A1", "company": "Meru Health Medical, P.a.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-07", "observed": "2026-08-21", "amount_usd": 749689, "summary": "NIH award 1R44MH126836-01A1: HYBRID TYPE 1 EFFECTIVENESS-IMPLEMENTATION TRIAL FOR PRIMARY CARE DEPRESSION SCREENING AND REFERRAL TO A REMOTE DIGITAL MENTAL HEALTH CLINIC ($749,689)", "source_url": "https://reporter.nih.gov/project-details/10375031", "people": [{"name": "Nicholas Peiper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK127835-02", "company": "Urogenie LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-04", "observed": "2026-08-21", "amount_usd": 621825, "summary": "NIH award 5R44DK127835-02: Automated Digital Uroflowmetry For Office and Home Use ($621,825)", "source_url": "https://reporter.nih.gov/project-details/10380043", "people": [{"name": "Roman Fedorovsky", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43CA261381-01S1", "company": "Malcova LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-04", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43CA261381-01S1: PATIENT-SPECIFIC NARROW BEAM BREAST CT ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10540256", "people": [{"name": "Peymon Ghazi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK112468-03", "company": "Cg Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-04", "observed": "2026-08-21", "amount_usd": 740395, "summary": "NIH award 5R44DK112468-03: Automated System for High Yield Pancreatic Islet Isolation ($740,395)", "source_url": "https://reporter.nih.gov/project-details/10373120", "people": [{"name": "Lotien Richard Huang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44CA243764-02A1", "company": "Acoustic Range Estimates, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-04", "observed": "2026-08-21", "amount_usd": 1050635, "summary": "NIH award 2R44CA243764-02A1: Thermoacoustic Range Verification During Delivery of a Clinical Plan by a Synchrocyclotron: transition from research prototype to turnkey clinical device ($1,050,635)", "source_url": "https://reporter.nih.gov/project-details/10481746", "people": [{"name": "SARAH Kathryn PATCH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41MH129004-01", "company": "Advanced Medical Electronics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-01", "observed": "2026-08-21", "amount_usd": 449760, "summary": "NIH award 1R41MH129004-01: Improving Patient Care Through Objective Monitoring of At-Home Repetitive Ritual Behaviors in Obsessive-Compulsive Disorder ($449,760)", "source_url": "https://reporter.nih.gov/project-details/10384150", "people": [{"name": "Anu Asnaani", "role": "Principal Investigator"}, {"name": "Nalaka S Gooneratne", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL125484-06", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-04-01", "observed": "2026-08-21", "amount_usd": 995038, "summary": "NIH award 5R44HL125484-06: Digital Microfluidics - Minimizing Blood Volume for Pediatric Coagulation Screening ($995,038)", "source_url": "https://reporter.nih.gov/project-details/10376747", "people": [{"name": "VAMSEE K. PAMULA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R43HD108826-01", "company": "Inherent Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-31", "observed": "2026-08-21", "amount_usd": 255244, "summary": "NIH award 1R43HD108826-01: Clinical epigenetic diagnostic for spermatogenic failure and future health risks ($255,244)", "source_url": "https://reporter.nih.gov/project-details/10459080", "people": [{"name": "Kristin R Brogaard", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R41AG073066-01S1", "company": "Iscreen 2 Prevent LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-31", "observed": "2026-08-21", "amount_usd": 33187, "summary": "NIH award 3R41AG073066-01S1: An AI-assisted screening platform within a multivariate framework for biomarkers of mild cognitive impairment due to Alzheimer's disease ($33,187)", "source_url": "https://reporter.nih.gov/project-details/10552520", "people": [{"name": "Delia Cabrera-DeBuc", "role": "Principal Investigator"}, {"name": "Carlos E. Mendoza-Santiesteban", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43AG073040-01S1", "company": "Biopico", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-31", "observed": "2026-08-21", "amount_usd": 4663, "summary": "NIH award 3R43AG073040-01S1: A Humanized Organ Plate Paradigm for High Throughput Alzheimer's disease Therapeutics ($4,663)", "source_url": "https://reporter.nih.gov/project-details/10551783", "people": [{"name": "John Collins", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DC017097-04", "company": "Altec, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-31", "observed": "2026-08-21", "amount_usd": 580784, "summary": "NIH award 5R44DC017097-04: EMG Voice Restoration ($580,784)", "source_url": "https://reporter.nih.gov/project-details/10376786", "people": [{"name": "Gianluca De Luca", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:3R43AG076091-01S1", "company": "Virtici, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-31", "observed": "2026-08-21", "amount_usd": 30488, "summary": "NIH award 3R43AG076091-01S1: A Novel Multiparameter Blood Test for Early Detection of Alzheimer's Disease ($30,488)", "source_url": "https://reporter.nih.gov/project-details/10570790", "people": [{"name": "Neil A Fanger", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44ES031458-02A1", "company": "Aerosol Dynamics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-31", "observed": "2026-08-21", "amount_usd": 610651, "summary": "NIH award 2R44ES031458-02A1: A PULSED CONDENSATION PARTICLE COUNTER FOR COST EFFECTIVE MONITORING OF ULTRAFINE AIRBORNE PARTICLES ($610,651)", "source_url": "https://reporter.nih.gov/project-details/10484421", "people": [{"name": "Susanne Vera Hering", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44HL147825-03", "company": "Medfree, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-29", "observed": "2026-08-21", "amount_usd": 651889, "summary": "NIH award 5R44HL147825-03: Mitral Valve Repair System to Percutaneously Treat Moderate to Severe Regurgitation Using Alfieri Edge-to-Edge Technique ($651,889)", "source_url": "https://reporter.nih.gov/project-details/10374949", "people": [{"name": "Raghuveer Basude", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AI157672-02", "company": "First Light Diagnostics , Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-29", "observed": "2026-08-21", "amount_usd": 991573, "summary": "NIH award 5R44AI157672-02: Rapid antimicrobial susceptibility testing directly from urine specimens ($991,573)", "source_url": "https://reporter.nih.gov/project-details/10378165", "people": [{"name": "Lawrence Burg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "denovo:DEN200042", "company": "Brain Temp, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-03-29", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200042 granted: BrainTemp Neonate System (BTNeo System)", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200042"}, {"id": "breakthrough:P210034", "company": "Cartiheal, Ltd.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-03-29", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P210034: AGILI-C", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R43GM145015-01S1", "company": "Wellsim Biomedical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-28", "observed": "2026-08-21", "amount_usd": 6500, "summary": "NIH award 3R43GM145015-01S1: Multi-omics profiling of individual exosomes for their origin-tracing, biomarker discovery, and biological function characterization ($6,500)", "source_url": "https://reporter.nih.gov/project-details/10572470", "people": [{"name": "Yuchao Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "sbir:DOD:W81XWH20C0112", "company": "Kericure Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-03-28", "observed": "2026-09-18", "amount_usd": 549861, "summary": "DOD SBIR Phase II award $549,861: Deployable Wound Care Products to Decrease Preventable Death Outcomes by Mitigating Infection on Battlefield and through Long Term Care", "source_url": "https://www.sbir.gov/awards?search=H2D-0023"}, {"id": "nih:1R42HL162214-01", "company": "Biochip Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-25", "observed": "2026-08-21", "amount_usd": 259611, "summary": "NIH award 1R42HL162214-01: Microfluidic Technology for Concurrent Assessment of Red Blood Cell Adhesion and Deformability ($259,611)", "source_url": "https://reporter.nih.gov/project-details/10384175", "people": [{"name": "Chiara Federici", "role": "Principal Investigator"}, {"name": "Umut A. Gurkan", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44GM145183-01", "company": "Microsensor Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-25", "observed": "2026-08-21", "amount_usd": 259599, "summary": "NIH award 1R44GM145183-01: SBIR Fast Track: Development of a High-throughput Magnetic Cytometer for Single Cell Sorting ($259,599)", "source_url": "https://reporter.nih.gov/project-details/10385619", "people": [{"name": "Peng Paul Liu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK132989-01", "company": "Cerulean Scientific Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-25", "observed": "2026-08-21", "amount_usd": 299429, "summary": "NIH award 1R43DK132989-01: Tethered liquid perfluorocarbon coating for preventing urinary catheter colonization ($299,429)", "source_url": "https://reporter.nih.gov/project-details/10481166", "people": [{"name": "Todd McFarland", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS127733-01", "company": "Sentiomed, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-25", "observed": "2026-08-21", "amount_usd": 255781, "summary": "NIH award 1R43NS127733-01: Passive intracranial pressure sensor for hydrocephalus shunts and cranioplasty implants with ultrasound readout ($255,781)", "source_url": "https://reporter.nih.gov/project-details/10484847", "people": [{"name": "Corbin Zean Clawson", "role": "Principal Investigator"}, {"name": "Navid Farhoudi", "role": "Principal Investigator"}, {"name": "Thomas Orsini", "role": "Principal Investigator"}, {"name": "JOHN D ROLSTON", "role": "Principal Investigator"}, {"name": "Florian Solzbacher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL140662-07", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-25", "observed": "2026-08-21", "amount_usd": 878833, "summary": "NIH award 5R44HL140662-07: Improving Anticoagulation Monitoring in Pediatric Patients: Use of a Microfluidic Platform to Test Low Volume Blood Samples Obtained by Heel-Stick Collection ($878,833)", "source_url": "https://reporter.nih.gov/project-details/10400164", "people": [{"name": "VAMSEE K. PAMULA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 7, "new_award": false}, {"id": "sbir:DOD:W81XWH22P0021", "company": "CFD Research Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-03-25", "observed": "2026-09-18", "amount_usd": 249947, "summary": "DOD SBIR Phase I award $249,947: A Ruggedized Wearable and Sustained Therapeutic Delivery System", "source_url": "https://www.sbir.gov/awards?search=H213-009-0112"}, {"id": "nih:5R44OD030029-03", "company": "Bio Tillion, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-24", "observed": "2026-08-21", "amount_usd": 826168, "summary": "NIH award 5R44OD030029-03: System to Track Samples in Liquid Nitrogen Environment ($826,168)", "source_url": "https://reporter.nih.gov/project-details/10392514", "people": [{"name": "Hananel Davidowitz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43GM146508-01", "company": "Neuroindx Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-24", "observed": "2026-08-21", "amount_usd": 350000, "summary": "NIH award 1R43GM146508-01: High throughput single cell linear displacement adhesion assay ($350,000)", "source_url": "https://reporter.nih.gov/project-details/10483237", "people": [{"name": "Lili C Kudo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R42GM143986-02", "company": "Biosensing Instrument, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-24", "observed": "2026-08-21", "amount_usd": 825247, "summary": "NIH award 4R42GM143986-02: Critical angle reflection imaging for label-free quantification of molecular interactions ($825,247)", "source_url": "https://reporter.nih.gov/project-details/10573402", "people": [{"name": "Nguyen Ly", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44AG071416-02", "company": "Retain Health Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-23", "observed": "2026-08-21", "amount_usd": 1644444, "summary": "NIH award 4R44AG071416-02: RETAIN: A digital therapeutic for Alzheimer's risk reduction ($1,644,444)", "source_url": "https://reporter.nih.gov/project-details/10569134", "people": [{"name": "Mark McInnis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43NR019516-01S1", "company": "Qua, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-22", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43NR019516-01S1: I- Corps Supplement to The PPAL: The Bedside Commode as a Safe Self-Toilet Transfer Device for Aging Adults I-Corps Program, ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10561251", "people": [{"name": "Margaret Ellen Graham", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL162131-01", "company": "Minnesota Healthsolutions Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-21", "observed": "2026-08-21", "amount_usd": 299345, "summary": "NIH award 1R43HL162131-01: A Lifestyle Program for Comorbid Obstructive Sleep Apnea with Severy Obesity ($299,345)", "source_url": "https://reporter.nih.gov/project-details/10382179", "people": [{"name": "Roberto Pablo Benzo", "role": "Principal Investigator"}, {"name": "Matthew Knutson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK131680-01A1", "company": "Predict Health, LLC, The", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-16", "observed": "2026-08-21", "amount_usd": 280160, "summary": "NIH award 1R43DK131680-01A1: Rapid and Quantitative Point Of Care Stool Assays For The Diagnosis And Monitoring Of Inflammatory Bowel Disease ($280,160)", "source_url": "https://reporter.nih.gov/project-details/10479703", "people": [{"name": "KANNAN ALPADI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41DK131678-01A1", "company": "Coprata, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-16", "observed": "2026-08-21", "amount_usd": 349877, "summary": "NIH award 1R41DK131678-01A1: Smart Toilet with Artificial Intelligence for Remote Management of Inflammatory Bowel Disease ($349,877)", "source_url": "https://reporter.nih.gov/project-details/10482219", "people": [{"name": "Sonia Grego", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DC019586-02", "company": "Restorear Devices, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-16", "observed": "2026-08-21", "amount_usd": 767772, "summary": "NIH award 5R44DC019586-02: Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation ($767,772)", "source_url": "https://reporter.nih.gov/project-details/10362716", "people": [{"name": "Curtis Scott King", "role": "Principal Investigator"}, {"name": "Suhrud M. Rajguru", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44HG012532-01", "company": "Curio Bioscience Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-15", "observed": "2026-08-21", "amount_usd": 1299179, "summary": "NIH award 1R44HG012532-01: A reagent kit for spatial transcriptomic analysis ($1,299,179)", "source_url": "https://reporter.nih.gov/project-details/10480106", "people": [{"name": "Christina Fan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DC020084-01A1", "company": "Speech Technology/applied Research Corp.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-15", "observed": "2026-08-21", "amount_usd": 259566, "summary": "NIH award 1R43DC020084-01A1: Hear What I Want: an Acoustically Smart Personalized Common Room ($259,566)", "source_url": "https://reporter.nih.gov/project-details/10484661", "people": [{"name": "RICHARD S GOLDHOR", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43MH122035-01A1S2", "company": "Diagnostic Driving, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-15", "observed": "2026-08-21", "amount_usd": 73961, "summary": "NIH award 3R43MH122035-01A1S2: Initial validation of a novel pre-screening tool for HIV-associated CNS impairment: The Virtual Driving and CNS Assessment System (VDCA) ($73,961)", "source_url": "https://reporter.nih.gov/project-details/10474765", "people": [{"name": "Venkatesh Kandadai", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "sbir:DOD:FA8649-22-P-0693", "company": "Tournitek Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-03-10", "observed": "2026-09-18", "amount_usd": 749827, "summary": "DOD STTR Phase II award $749,827: TourniTek: Pre-Hospital Thermal Regulation For The Prolonged Field Care of Traumatic Injuries", "source_url": "https://www.sbir.gov/awards?search=FX21A-TCSO1-0045"}, {"id": "nih:5R41AR078720-02", "company": "Springbok, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-09", "observed": "2026-08-21", "amount_usd": 51409, "summary": "NIH award 5R41AR078720-02: Development of a commercially viable machine learning product to automatically detect rotator cuff muscle pathology ($51,409)", "source_url": "https://reporter.nih.gov/project-details/10495191", "people": [{"name": "Silvia Salinas Blemker", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:1R43DE031456-01", "company": "Sintx Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-09", "observed": "2026-08-21", "amount_usd": 299980, "summary": "NIH award 1R43DE031456-01: Development and Pre-Clinical Testing of PEKK/Silicon Nitride Composite Craniomaxillofacial Implants ($299,980)", "source_url": "https://reporter.nih.gov/project-details/10381823", "people": [{"name": "Ryan Bock", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG076072-01", "company": "Cnd Life Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-09", "observed": "2026-08-21", "amount_usd": 1239804, "summary": "NIH award 1R44AG076072-01: A Diagnostic Test for Dementia with Lewy Bodies ($1,239,804)", "source_url": "https://reporter.nih.gov/project-details/10382153", "people": [{"name": "Todd Levine", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R44HL142455-02S1", "company": "Tissue Testing Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-07", "observed": "2026-08-21", "amount_usd": 12392, "summary": "NIH award 3R44HL142455-02S1: Ice-free vitrification and nano warming technology for banking of cardiovascular structures. ($12,392)", "source_url": "https://reporter.nih.gov/project-details/10498995", "people": [{"name": "Kelvin G.M. Brockbank", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG076092-01", "company": "Tanzen Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-07", "observed": "2026-08-21", "amount_usd": 500709, "summary": "NIH award 1R43AG076092-01: RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Legs Syndrome in Patients with Alzheimer's Disease ($500,709)", "source_url": "https://reporter.nih.gov/project-details/10384159", "people": [{"name": "Justin Brooks", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44NR020341-01", "company": "Peacefully, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-07", "observed": "2026-08-21", "amount_usd": 256065, "summary": "NIH award 1R44NR020341-01: A comprehensive web-based program to help advanced cancer patients plan for end of life ($256,065)", "source_url": "https://reporter.nih.gov/project-details/10394748", "people": [{"name": "Jennifer Good", "role": "Principal Investigator"}, {"name": "Megan Johnson Shen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44EY030812-03", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-07", "observed": "2026-08-21", "amount_usd": 482523, "summary": "NIH award 5R44EY030812-03: Comprehensive imaging and quantification of blood flow for investigating ocular diseases without additional contrast agent ($482,523)", "source_url": "https://reporter.nih.gov/project-details/10349594", "people": [{"name": "Mircea Mujat", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42NR017124-03", "company": "Faceview Mask, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-04", "observed": "2026-08-21", "amount_usd": 385393, "summary": "NIH award 5R42NR017124-03: A Transparent Surgical Mask to Improve Patient/Caregiver Communication, Minimize Errors and Increase Patient Satisfaction ($385,393)", "source_url": "https://reporter.nih.gov/project-details/10390374", "people": [{"name": "Jeanne Hahne", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R41AG074788-01S1", "company": "Infrared Rx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-04", "observed": "2026-08-21", "amount_usd": 6937, "summary": "NIH award 3R41AG074788-01S1: Oxygen-Guided Therapy for Optimal Rehabilitation for Peripheral Artery Disease ($6,937)", "source_url": "https://reporter.nih.gov/project-details/10545825", "people": [{"name": "Kevin K. McCully", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HL142440-02A1", "company": "Alleviant Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-04", "observed": "2026-08-21", "amount_usd": 898558, "summary": "NIH award 2R44HL142440-02A1: Transcatheter Device for Congestive Heart Failure Treatment Through Left Atrial Decompression ($898,558)", "source_url": "https://reporter.nih.gov/project-details/10381360", "people": [{"name": "Thomas Diffley Pate", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DA056089-01", "company": "Nemalife Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-04", "observed": "2026-08-21", "amount_usd": 318373, "summary": "NIH award 1R43DA056089-01: AI-assisted behavioral profiling of an invertebrate model to identify new psychedelic therapeutics for stimulant use disorders ($318,373)", "source_url": "https://reporter.nih.gov/project-details/10467072", "people": [{"name": "Dhaval Subhas Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB031714-01", "company": "Airilabs LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-03", "observed": "2026-08-21", "amount_usd": 249045, "summary": "NIH award 1R43EB031714-01: Diffraction tomography for accurate digital pathology on a portable microscope ($249,045)", "source_url": "https://reporter.nih.gov/project-details/10257624", "people": [{"name": "Pratik Bokadia", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44EY025452-05", "company": "Plenoptika, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-03", "observed": "2026-08-21", "amount_usd": 717387, "summary": "NIH award 5R44EY025452-05: Commercialization of automated mobile device for accurate comprehensive refraction ($717,387)", "source_url": "https://reporter.nih.gov/project-details/10359070", "people": [{"name": "Gary Yiu-Kin Chu", "role": "Principal Investigator"}, {"name": "Shivang Rajendra Dave", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44NR020275-01", "company": "Neoneur LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-02", "observed": "2026-08-21", "amount_usd": 256579, "summary": "NIH award 1R44NR020275-01: Improving high-risk infant care: from Hospital to Home with Neoneur Telehealth ($256,579)", "source_url": "https://reporter.nih.gov/project-details/10383553", "people": [{"name": "Caroline Hoedemaker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI157650-02", "company": "Aldatu Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-02", "observed": "2026-08-21", "amount_usd": 829151, "summary": "NIH award 5R44AI157650-02: PANDAA for universal, pan-lineage molecular detection of Crimean-Congo Hemorrhagic Fever virus ($829,151)", "source_url": "https://reporter.nih.gov/project-details/10377392", "people": [{"name": "Iain James MacLeod", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44MH122115-03", "company": "Spectragenetics", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-01", "observed": "2026-08-21", "amount_usd": 711325, "summary": "NIH award 4R44MH122115-03: Highly Multiplexed Cell-Based GPCR Assay. ($711,325)", "source_url": "https://reporter.nih.gov/project-details/10495614", "people": [{"name": "G. Reid Asbury", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43NS127702-01", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-01", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R43NS127702-01: Comprehensive Botulinum Characterization via the Bilayer Nanowell Integrated Assay ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10480376", "people": [{"name": "Eric Ervin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM139467-02A1", "company": "E-msion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-03-01", "observed": "2026-08-21", "amount_usd": 865372, "summary": "NIH award 2R44GM139467-02A1: An adaptive compute solution for characterizing macromolecular complexes by mass spectrometry with electron-based fragmentation ($865,372)", "source_url": "https://reporter.nih.gov/project-details/10480227", "people": [{"name": "Adrian Guthals", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44AG071063-02S2", "company": "Ipaces, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-28", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44AG071063-02S2: Neuro-exergaming for the prevention and remediation of decline due to Alzheimer's disease and related dementias: A clinical trial of the interactive Physical and Cognitive Exercise System (iPACES v3) ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10533109", "people": [{"name": "PAUL J ARCIERO", "role": "Principal Investigator"}, {"name": "Cay Anderson-Hanley", "role": "Principal Investigator"}, {"name": "John P. Arciero", "role": "Principal Investigator"}, {"name": "Mina Dunnam", "role": "Principal Investigator"}, {"name": "David Arthur Merrill", "role": "Principal Investigator"}, {"name": "STELLA E PANOS", "role": "Principal Investigator"}, {"name": "Emilie Saulnier", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44CA268305-01A1", "company": "Fischer Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-28", "observed": "2026-08-21", "amount_usd": 1023397, "summary": "NIH award 1R44CA268305-01A1: MammoCAT Advanced Full Field Digital Mammography System ($1,023,397)", "source_url": "https://reporter.nih.gov/project-details/10481694", "people": [{"name": "Shabbir Bakir Bambot", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "sbir:DOD:W81XWH-22-C-0026", "company": "CFD Research Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-02-28", "observed": "2026-09-18", "amount_usd": 1099959, "summary": "DOD STTR Phase II award $1,099,959: Point-of-Care Nucleic Acid Assays", "source_url": "https://www.sbir.gov/awards?search=A2-9158"}, {"id": "nih:5R44GM140797-02", "company": "Direct Electron, Lp", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-25", "observed": "2026-08-21", "amount_usd": 639342, "summary": "NIH award 5R44GM140797-02: An Ultrafast Electron Counting Camera for 100 kV Cryo-EM ($639,342)", "source_url": "https://reporter.nih.gov/project-details/10335281", "people": [{"name": "Benjamin Eugene Bammes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44GM145185-01", "company": "Fluent Biosciences Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-25", "observed": "2026-08-21", "amount_usd": 903654, "summary": "NIH award 1R44GM145185-01: New tools for highly accessible single cell RNA sequencing ($903,654)", "source_url": "https://reporter.nih.gov/project-details/10394664", "people": [{"name": "Kristina Fontanez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI150203-03", "company": "Entvantage Dx", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-25", "observed": "2026-08-21", "amount_usd": 865293, "summary": "NIH award 5R44AI150203-03: Clinical Validation of Sinu-Test, A Multiplexed Device for Rapid Diagnosis of Acute Bacterial Sinusitis, to support CLIA Waiver ($865,293)", "source_url": "https://reporter.nih.gov/project-details/10363689", "people": [{"name": "Oriana E. Hawkins", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG071430-02", "company": "Koronis Biomedical Technologies Corporat", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-25", "observed": "2026-08-21", "amount_usd": 667212, "summary": "NIH award 5R44AG071430-02: Interactive Training Tool Providing Technique Feedback for COPD Medication Delivery ($667,212)", "source_url": "https://reporter.nih.gov/project-details/10358639", "people": [{"name": "Patrick A Lichter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41AI167224-01A1", "company": "Computer Technology Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-24", "observed": "2026-08-21", "amount_usd": 299093, "summary": "NIH award 1R41AI167224-01A1: Biomarker-enhanced Artificial Intelligence-Based Pediatric Sepsis Screening Tool Towards Early Recognition and Personalized Therapeutics ($299,093)", "source_url": "https://reporter.nih.gov/project-details/10482172", "people": [{"name": "Ioannis Koutroulis", "role": "Principal Investigator"}, {"name": "Carmelo Velez", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM143964-01A1", "company": "Isoformix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-24", "observed": "2026-08-21", "amount_usd": 256158, "summary": "NIH award 1R43GM143964-01A1: Immunoplate-MALDI MS platform and assays ($256,158)", "source_url": "https://reporter.nih.gov/project-details/10384628", "people": [{"name": "DOBRIN NEDELKOV", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42CA268156-01", "company": "Opsiclear LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-23", "observed": "2026-08-21", "amount_usd": 262959, "summary": "NIH award 1R42CA268156-01: 3D optical histopathology for head and neck intraoperative consultation. ($262,959)", "source_url": "https://reporter.nih.gov/project-details/10379553", "people": [{"name": "YEHE LIU", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "denovo:DEN210034", "company": "Global Protection Corp.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-02-23", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210034 granted: ONE Male Condom", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210034"}, {"id": "nih:2R44MH119842-02A1", "company": "Cytocybernetics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-22", "observed": "2026-08-21", "amount_usd": 860834, "summary": "NIH award 2R44MH119842-02A1: Advanced Dynamic Clamp for Neuroscience ($860,834)", "source_url": "https://reporter.nih.gov/project-details/10483575", "people": [{"name": "Mark W Nowak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "sbir:DOD:W911SR-22-P-0003", "company": "Kericure Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-02-22", "observed": "2026-09-18", "amount_usd": 167470, "summary": "DOD SBIR Phase I award $167,470: Ruggedized Spray on Antimicrobial Wound Dressing for Treatment of Multiple Sulfur Mustard-Induced Dermal Injuries in Theater to Mitigate Infection, Pain and Promote Healing", "source_url": "https://www.sbir.gov/awards?search=C212-005-0041"}, {"id": "nih:3R43GM144007-01S1", "company": "Indelible Learning, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-21", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43GM144007-01S1: Interactive Digital Media-based Learning for Hand Hygiene in School-Age Children ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10541754", "people": [{"name": "Jasminka Criley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R44AG056250-04S1", "company": "Proactive Life, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-18", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44AG056250-04S1: Business and regulatory development for Integrating sleep enhancement technology into clinical practice ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10428404", "people": [{"name": "Daniel Gartenberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44DA051105-02", "company": "Giner, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-17", "observed": "2026-08-21", "amount_usd": 849128, "summary": "NIH award 2R44DA051105-02: Rapid Assessment of Illicit Drugs in Wastewater ($849,128)", "source_url": "https://reporter.nih.gov/project-details/10397306", "people": [{"name": "Avni A Argun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41CA268268-01", "company": "Glycopath, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-17", "observed": "2026-08-21", "amount_usd": 428443, "summary": "NIH award 1R41CA268268-01: Development of the GlycoHCCTyper for the early detection of HCC ($428,443)", "source_url": "https://reporter.nih.gov/project-details/10382624", "people": [{"name": "Stephen Castellino", "role": "Principal Investigator"}, {"name": "Anand S. Mehta", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM145194-01", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-17", "observed": "2026-08-21", "amount_usd": 292788, "summary": "NIH award 1R43GM145194-01: System for unitary automation of library preparation ($292,788)", "source_url": "https://reporter.nih.gov/project-details/10395282", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HL152825-02", "company": "Minnesota Healthsolutions Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-17", "observed": "2026-08-21", "amount_usd": 1018633, "summary": "NIH award 2R44HL152825-02: Clinical Decision Support for Assessing Pulmonary Embolism using Machine Learning ($1,018,633)", "source_url": "https://reporter.nih.gov/project-details/10381875", "people": [{"name": "Kevin M. Kramer", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44NS122604-01S1", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-16", "observed": "2026-08-21", "amount_usd": 17074, "summary": "NIH award 3R44NS122604-01S1: Flow Acceleration for Stroke Thrombolysis (FAST) System ($17,074)", "source_url": "https://reporter.nih.gov/project-details/10464028", "people": [{"name": "Francis Milton Creighton", "role": "Principal Investigator"}, {"name": "Thomas M Hemmen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AI157776-02", "company": "Accel Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-16", "observed": "2026-08-21", "amount_usd": 963581, "summary": "NIH award 4R44AI157776-02: A COVID-19 Point of Care Serological Assay for Rapid Quantification of Antibody Titer. ($963,581)", "source_url": "https://reporter.nih.gov/project-details/10542478", "people": [{"name": "Alberto Gandini", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42AG066325-03", "company": "Pascall Systems, Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-16", "observed": "2026-08-21", "amount_usd": 1214935, "summary": "NIH award 5R42AG066325-03: Personalized anesthetic brain monitoring: Developing novel systems, sensors, and algorithms for aging, dementia, and Alzheimers disease patients ($1,214,935)", "source_url": "https://reporter.nih.gov/project-details/10360566", "people": [{"name": "Tuan Le Mau", "role": "Principal Investigator"}, {"name": "Patrick L. Purdon", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43CA257133-01A1", "company": "Precision Epigenomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-16", "observed": "2026-08-21", "amount_usd": 397831, "summary": "NIH award 1R43CA257133-01A1: Lung Cancer, DNA Methylation, and Liquid Biopsy ($397,831)", "source_url": "https://reporter.nih.gov/project-details/10257798", "people": [{"name": "Mark Anthony Nelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44HD105552-02", "company": "Actuated Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-14", "observed": "2026-08-21", "amount_usd": 1149988, "summary": "NIH award 4R44HD105552-02: Additive Manufacturing of Patient-Specific Masks and Nasal Prongs to Improve Pediatric Ventilation Outcomes and Reduce Pressure Sores ($1,149,988)", "source_url": "https://reporter.nih.gov/project-details/10547992", "people": [{"name": "Roger Brooks Bagwell", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL162109-01", "company": "Corvion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-11", "observed": "2026-08-21", "amount_usd": 428204, "summary": "NIH award 1R43HL162109-01: Development of a Minimally Invasive Partial Circulatory Support Device for Chronic Use ($428,204)", "source_url": "https://reporter.nih.gov/project-details/10378419", "people": [{"name": "Greg Aber", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42MH108219-04", "company": "Mountainpass Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-11", "observed": "2026-08-21", "amount_usd": 732620, "summary": "NIH award 5R42MH108219-04: Development and testing of a behavioral activation mobile therapy for elevated depressive symptoms ($732,620)", "source_url": "https://reporter.nih.gov/project-details/10341195", "people": [{"name": "Jennifer Renee Dahne", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:2R44AI142886-02A1", "company": "Cleu Diagnostics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-11", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 2R44AI142886-02A1: RAPID ELECTROCHEMICAL BIOSENSOR FOR POINT-OF-CARE DIAGNOSIS OF JOINT INFECTION ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10481724", "people": [{"name": "Andrew Neil Fleischman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44GM145195-01", "company": "Omicscraft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-11", "observed": "2026-08-21", "amount_usd": 997931, "summary": "NIH award 1R44GM145195-01: MetaboQuest: A Suite of Tools for Metabolite Annotation ($997,931)", "source_url": "https://reporter.nih.gov/project-details/10395223", "people": [{"name": "Dawit Mengistu", "role": "Principal Investigator"}, {"name": "Habtom W Ressom", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43HL156598-01S2", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-10", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43HL156598-01S2: Innovation Corps Administrative Supplement for Magnetic Bronchoscope for Improved Pulmonary Access ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10541319", "people": [{"name": "WALTER BLUME", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM145015-01", "company": "Wellsim Biomedical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-10", "observed": "2026-08-21", "amount_usd": 249974, "summary": "NIH award 1R43GM145015-01: Multi-omics profiling of individual exosomes for their origin-tracing, biomarker discovery, and biological function characterization ($249,974)", "source_url": "https://reporter.nih.gov/project-details/10384216", "people": [{"name": "Yuchao Chen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH126793-01A1", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-10", "observed": "2026-08-21", "amount_usd": 328220, "summary": "NIH award 1R43MH126793-01A1: A Mobile Text Approach to Measurement and Feedback for Wraparound Care Coordination ($328,220)", "source_url": "https://reporter.nih.gov/project-details/10383526", "people": [{"name": "ERIC J. BRUNS", "role": "Principal Investigator"}, {"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43HL160321-01S1", "company": "Ximio Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-10", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43HL160321-01S1: Development of a cloud-based network of smartwatch applications to improve cardiopulmonary resuscitation during cardiac arrest response. ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10541288", "people": [{"name": "Adam LaPrad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44DE030842-02", "company": "Mpod, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-10", "observed": "2026-08-21", "amount_usd": 490361, "summary": "NIH award 4R44DE030842-02: A scalable aptamer-based electrochemical biosensor for rapid detection of SARS-CoV-2 from saliva ($490,361)", "source_url": "https://reporter.nih.gov/project-details/10320990", "people": [{"name": "Jeffrey Ly", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43HL162240-01", "company": "Vcardio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-10", "observed": "2026-08-21", "amount_usd": 229693, "summary": "NIH award 1R43HL162240-01: Method for Rapid Non-Invasive Assessment of Coronary Stenosis ($229,693)", "source_url": "https://reporter.nih.gov/project-details/10384509", "people": [{"name": "Josh Nickols", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44HD103159-02", "company": "Nextgenjane, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-08", "observed": "2026-08-21", "amount_usd": 1108476, "summary": "NIH award 4R44HD103159-02: Developing a non-invasive, definitive diagnostic for endometriosis using biomarkers in menstrual effluence ($1,108,476)", "source_url": "https://reporter.nih.gov/project-details/10547989", "people": [{"name": "Stephen Gire", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44GM139438-02", "company": "Qatch Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-08", "observed": "2026-08-21", "amount_usd": 598658, "summary": "NIH award 2R44GM139438-02: Developing prototype injectability and developability testing system based on microfluidic quartz resonators ($598,658)", "source_url": "https://reporter.nih.gov/project-details/10384221", "people": [{"name": "Zehra Parlak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43EY032815-01A1", "company": "M2-cor, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-04", "observed": "2026-08-21", "amount_usd": 255671, "summary": "NIH award 1R43EY032815-01A1: Non-Linear Optical femtosecond laser device to alter corneal curvature and stiffness. ($255,671)", "source_url": "https://reporter.nih.gov/project-details/10392214", "people": [{"name": "Michael Karavitis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44HL154912-02", "company": "Inomagen Therapeutics, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-04", "observed": "2026-08-21", "amount_usd": 1636504, "summary": "NIH award 4R44HL154912-02: A New and Disruptive Gene Based Therapy for Atrial Fibrillation ($1,636,504)", "source_url": "https://reporter.nih.gov/project-details/10523697", "people": [{"name": "Robert Charles Moen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "sbir:DOD:FA8649-22-9-9001", "company": "Spark Neuro Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-02-04", "observed": "2026-09-18", "amount_usd": 2749999, "summary": "DOD STTR Phase II award $2,749,999: EEG-Based Traumatic and Subconcussive Brain Injury Detector", "source_url": "https://www.sbir.gov/awards?search=FX20C-TCSO1-0117"}, {"id": "nih:3R43DA053870-01S1", "company": "Aidar Health, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-03", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43DA053870-01S1: Technologies for OUD Prevention, Control and Supportive Care - Development of Patient/Caregiver mobile application and Provider Dashboard ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10541741", "people": [{"name": "SATHYA ELUMALAI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44AI155075-02", "company": "Jan Biotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-03", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 4R44AI155075-02: Sequence-based RNA Fluorescence Assay to Measure Latent HIV Reservoirs ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10514181", "people": [{"name": "Janet L Huie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44HL158397-02", "company": "Obsidio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-03", "observed": "2026-08-21", "amount_usd": 1247814, "summary": "NIH award 4R44HL158397-02: Development of an Innovative Material for Transcatheter Peripheral Embolization ($1,247,814)", "source_url": "https://reporter.nih.gov/project-details/10513904", "people": [{"name": "Ehsan Jabbarzadeh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R43DA053048-01S1", "company": "Vrx Medical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-03", "observed": "2026-08-21", "amount_usd": 52750, "summary": "NIH award 3R43DA053048-01S1: Using Augmented Reality illusion therapy to develop a non-opioid chronic pain digital treatment ($52,750)", "source_url": "https://reporter.nih.gov/project-details/10541646", "people": [{"name": "PAUL LAFFERTY", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R43DA053121-01A1S1", "company": "Pillsmart Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-03", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43DA053121-01A1S1: Facilitating supervised self-management of stimulant medications among adolescents: improving adherence, reducing stigma, and supporting caregivers ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10541769", "people": [{"name": "Artin Perse", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AI167334-01", "company": "Arc Bio, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-02", "observed": "2026-08-21", "amount_usd": 997735, "summary": "NIH award 1R44AI167334-01: Development and validation of a sample-to-answer metagenomics workflow for comprehensive pathogen detection in central nervous system infections ($997,735)", "source_url": "https://reporter.nih.gov/project-details/10384637", "people": [{"name": "Stephane Gourguechon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43DA052941-01S1", "company": "Arborsense, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-02", "observed": "2026-08-21", "amount_usd": 55000, "summary": "NIH award 3R43DA052941-01S1: Rapid and non-invasive device for drug detection through sweat ($55,000)", "source_url": "https://reporter.nih.gov/project-details/10540571", "people": [{"name": "Girish Kulkarni", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44MH114773-03", "company": "Habitaware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-02-01", "observed": "2026-08-21", "amount_usd": 879144, "summary": "NIH award 2R44MH114773-03: Technology Assisted Treatment for Trichotillomania ($879,144)", "source_url": "https://reporter.nih.gov/project-details/10385271", "people": [{"name": "Christopher A. Flessner", "role": "Principal Investigator"}, {"name": "Sameer Kumar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44GM133239-03", "company": "Protein Metrics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-31", "observed": "2026-08-21", "amount_usd": 795816, "summary": "NIH award 5R44GM133239-03: New Algorithms and Software for Mass Spectrometric Analysis of Intact Proteins and Complexes ($795,816)", "source_url": "https://reporter.nih.gov/project-details/10333416", "people": [{"name": "MARSHALL Wayne BERN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH123373-03", "company": "Alto Neuroscience, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-31", "observed": "2026-08-21", "amount_usd": 1016513, "summary": "NIH award 5R44MH123373-03: Validating of Machine Learning-Based EEG Treatment Biomarkers in Depression ($1,016,513)", "source_url": "https://reporter.nih.gov/project-details/10366060", "people": [{"name": "Amit Etkin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44GM135957-02", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-28", "observed": "2026-08-21", "amount_usd": 928483, "summary": "NIH award 2R44GM135957-02: Ultra-sensitive Vapor Phase Hydrogen Peroxide Sensor for Decontaminating Pharmaceutical Manufacturing Facilities ($928,483)", "source_url": "https://reporter.nih.gov/project-details/10383016", "people": [{"name": "Brian E Brumfield", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R42NR017124-02S1", "company": "Faceview Mask, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-28", "observed": "2026-08-21", "amount_usd": 56893, "summary": "NIH award 3R42NR017124-02S1: A Transparent Surgical Mask to Improve Patient/Caregiver Communication, Minimize Errors and Increase Patient Satisfaction ($56,893)", "source_url": "https://reporter.nih.gov/project-details/10549122", "people": [{"name": "Jeanne Hahne", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI162570-02", "company": "Phase Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-28", "observed": "2026-08-21", "amount_usd": 820379, "summary": "NIH award 5R44AI162570-02: A method for the culture-free discovery and host affiliation of novel viruses from metagenomic samples ($820,379)", "source_url": "https://reporter.nih.gov/project-details/10347377", "people": [{"name": "Ivan Liachko", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44GM133305-03S1", "company": "Gel4med, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-27", "observed": "2026-08-21", "amount_usd": 50000, "summary": "NIH award 3R44GM133305-03S1: TABA funding for the Fast Track project \"ANTIMICROBIAL DERMAL MATRICES TO PROMOTE INFECTION FREE WOUND CLOSURE IN CUTANEOUS WOUNDS_R44GM133305\" ($50,000)", "source_url": "https://reporter.nih.gov/project-details/10526336", "people": [{"name": "Manav Mehta", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "breakthrough:K203768", "company": "Insulet Corporation", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-01-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K203768: OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K203772", "company": "Insulet Corporation", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-01-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K203772: OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K203774", "company": "Insulet Corporation", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2022-01-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K203774: OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:3R44AG071063-02S1", "company": "Ipaces, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-26", "observed": "2026-08-21", "amount_usd": 25536, "summary": "NIH award 3R44AG071063-02S1: Diversifying research staff and participants: A Spanish language adaptation of the interactive Physical and Cognitive Exercise System (iPACES) ($25,536)", "source_url": "https://reporter.nih.gov/project-details/10533257", "people": [{"name": "Cay Anderson-Hanley", "role": "Principal Investigator"}, {"name": "Maria Victoria Erbella", "role": "Principal Investigator"}, {"name": "Emilie Saulnier", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44EY033565-01", "company": "Injectsense, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-26", "observed": "2026-08-21", "amount_usd": 993500, "summary": "NIH award 1R44EY033565-01: iOP-Connect System for Long-Term Continuous Monitoring of Glaucoma Therapy by means of an Implantable Autonomous Intraocular Pressure Sensor ($993,500)", "source_url": "https://reporter.nih.gov/project-details/10383459", "people": [{"name": "Kevin Douglas BERG", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R43AG073141-01S1", "company": "Allied Innovative Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-26", "observed": "2026-08-21", "amount_usd": 34270, "summary": "NIH award 3R43AG073141-01S1: Highly sensitive immunoassay for determination of biomarkers for neurodegenerative diseases ($34,270)", "source_url": "https://reporter.nih.gov/project-details/10513251", "people": [{"name": "Simon Bystryak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG076063-01", "company": "Determined Health Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-25", "observed": "2026-08-21", "amount_usd": 499952, "summary": "NIH award 1R43AG076063-01: Digital Transformation to Reduce Social Isolation and Improve the Engagement, Care, and Support of Individuals Living with Alzheimer's Disease and Related Dementias ($499,952)", "source_url": "https://reporter.nih.gov/project-details/10383590", "people": [{"name": "Scott Kaiser", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM137649-03", "company": "Axcend, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-24", "observed": "2026-08-21", "amount_usd": 717769, "summary": "NIH award 5R44GM137649-03: Portable Liquid Chromatography Platform for Diverse Pharmaceutical Applications ($717,769)", "source_url": "https://reporter.nih.gov/project-details/10348791", "people": [{"name": "MILTON L. LEE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R44HL129577-03S2", "company": "Polyvascular Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-21", "observed": "2026-08-21", "amount_usd": 120938, "summary": "NIH award 3R44HL129577-03S2: Development of a Polymeric Percutaneous Pulmonary Valve for Use in Young Children ($120,938)", "source_url": "https://reporter.nih.gov/project-details/10530809", "people": [{"name": "Will Clifton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "denovo:DEN200059", "company": "Preventiongenetics, LLC", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-01-21", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200059 granted: POMC/PCSK1/LEPR CDx Panel", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200059"}, {"id": "nih:3R44CA254844-03S1", "company": "Carina Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-20", "observed": "2026-08-21", "amount_usd": 49504, "summary": "NIH award 3R44CA254844-03S1: Automatic Organ Segmentation Tool for Radiation Treatment Planning of Cancers ($49,504)", "source_url": "https://reporter.nih.gov/project-details/10518374", "people": [{"name": "Xue Feng", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R44HL129577-03S1", "company": "Polyvascular Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-19", "observed": "2026-08-21", "amount_usd": 120938, "summary": "NIH award 3R44HL129577-03S1: Development of a Polymeric Percutaneous Pulmonary Valve for Use in Young Children ($120,938)", "source_url": "https://reporter.nih.gov/project-details/10530786", "people": [{"name": "Will Clifton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AG076067-01", "company": "Life Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-19", "observed": "2026-08-21", "amount_usd": 453828, "summary": "NIH award 1R44AG076067-01: Optimization of an at-home continuous multi-domain monitoring and assessment system to improve Alzheimer's and related disorders clinical trials ($453,828)", "source_url": "https://reporter.nih.gov/project-details/10383237", "people": [{"name": "Lawrence J Frye", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:3R42CA217383-03S1", "company": "Morgan And Mendel Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-19", "observed": "2026-08-21", "amount_usd": 160000, "summary": "NIH award 3R42CA217383-03S1: Robust Predictor of Breast Cancer Risk ($160,000)", "source_url": "https://reporter.nih.gov/project-details/10319323", "people": [{"name": "Harry Ostrer", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44DK129097-02", "company": "3dt Holdings, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-17", "observed": "2026-08-21", "amount_usd": 1070822, "summary": "NIH award 4R44DK129097-02: Biomechatronics Device for Diagnosis/Therapy of Anorectal Disorders ($1,070,822)", "source_url": "https://reporter.nih.gov/project-details/10404789", "people": [{"name": "William Combs", "role": "Principal Investigator"}, {"name": "Hans Gregersen", "role": "Principal Investigator"}, {"name": "GHASSAN S KASSAB", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44MH125636-02", "company": "Limbix Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-17", "observed": "2026-08-21", "amount_usd": 1720969, "summary": "NIH award 4R44MH125636-02: Limbix Spark: a CBT-based mobile intervention for adolescent depression ($1,720,969)", "source_url": "https://reporter.nih.gov/project-details/10451988", "people": [{"name": "SCOTT N COMPTON", "role": "Principal Investigator"}, {"name": "Jessica Lake", "role": "Principal Investigator"}, {"name": "Eric D Perakslis", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA257802-02", "company": "Arsenal Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-14", "observed": "2026-08-21", "amount_usd": 1117374, "summary": "NIH award 5R44CA257802-02: Flow Responsive Embolic Agent for the Complete Devascularization of Meningiomas ($1,117,374)", "source_url": "https://reporter.nih.gov/project-details/10405029", "people": [{"name": "QUYNH P PHAM", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R43MH125512-02", "company": "Lifecanvas Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-13", "observed": "2026-08-21", "amount_usd": 220618, "summary": "NIH award 5R43MH125512-02: AI-driven biomarker analysis of intact whole brains imaged at micron and sub-micron resolution ($220,618)", "source_url": "https://reporter.nih.gov/project-details/10330017", "people": [{"name": "Katherine Cora Ames", "role": "Principal Investigator"}, {"name": "Curtis Marx", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:5R44AI124871-04", "company": "Scanogen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-13", "observed": "2026-08-21", "amount_usd": 988666, "summary": "NIH award 5R44AI124871-04: Bloodstream infection detection directly on whole blood ($988,666)", "source_url": "https://reporter.nih.gov/project-details/10331311", "people": [{"name": "Alfredo Andres Celedon", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44HL129577-03", "company": "Polyvascular Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-13", "observed": "2026-08-21", "amount_usd": 989945, "summary": "NIH award 5R44HL129577-03: Development of a Polymeric Percutaneous Pulmonary Valve for Use in Young Children ($989,945)", "source_url": "https://reporter.nih.gov/project-details/10332734", "people": [{"name": "Will Clifton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41MD017162-01", "company": "Asp.md", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-13", "observed": "2026-08-21", "amount_usd": 255147, "summary": "NIH award 1R41MD017162-01: Empowering providers to improve care for disadvantaged patients: design and prototype testing of novel user interface for electronic health records ($255,147)", "source_url": "https://reporter.nih.gov/project-details/10401209", "people": [{"name": "CHRISTOPHER KREIS", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG071409-02", "company": "Trace-ability, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-12", "observed": "2026-08-21", "amount_usd": 1252101, "summary": "NIH award 5R44AG071409-02: Enabling nationwide AD PET imaging to support most efficient clinical trials by adoption of radically simplified and standardized quality control in commercial production of AD PET tracers. ($1,252,101)", "source_url": "https://reporter.nih.gov/project-details/10333415", "people": [{"name": "Paolo Benigni", "role": "Principal Investigator"}, {"name": "Arkadij Elizarov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43MH129045-01", "company": "Imaginostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-11", "observed": "2026-08-21", "amount_usd": 436556, "summary": "NIH award 1R43MH129045-01: Development of a Frontier Magnetic Resonance (MR) Imaging Technology As a Tool for Visualization and Quantified Vascular-Feature Measurement for Use in Brain and Behavioral Research on Small Animals ($436,556)", "source_url": "https://reporter.nih.gov/project-details/10384839", "people": [{"name": "Codi Amir Gharagouzloo", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS125892-01", "company": "Axonova Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-11", "observed": "2026-08-21", "amount_usd": 250421, "summary": "NIH award 1R43NS125892-01: Development of Tissue Engineered Neuromuscular Interfaces from GalSafe Neurons. ($250,421)", "source_url": "https://reporter.nih.gov/project-details/10385405", "people": [{"name": "Kritika Katiyar", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42HL144275-03", "company": "Nota Laboratories, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2022-01-07", "observed": "2026-08-21", "amount_usd": 865106, "summary": "NIH award 5R42HL144275-03: Low Cost Electrochemical Gas Phase Nitric Oxide Generator for Biomedical Applications ($865,106)", "source_url": "https://reporter.nih.gov/project-details/10328221", "people": [{"name": "Robert H. Bartlett", "role": "Principal Investigator"}, {"name": "Glenn Martin", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "denovo:DEN210015", "company": "Sunrise", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2022-01-07", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210015 granted: Sunrise Sleep Disorder Diagnostic Aid", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210015"}, {"id": "sbir:DOD:W81XWH18C0314", "company": "Motion Control, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2022-01-05", "observed": "2026-09-18", "amount_usd": 542359, "summary": "DOD STTR Phase II award $542,359: Biomimetic Slope Adaptive Foot-Ankle Prosthesis", "source_url": "https://www.sbir.gov/awards?search=H2-0299"}, {"id": "nih:1R44NS120591-01A1", "company": "Brain Electrophysiology Laboratory Company, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-12-31", "observed": "2026-08-21", "amount_usd": 262362, "summary": "NIH award 1R44NS120591-01A1: Sourcerer IC: A Web-Based Integrative Multi-Modal Workflow for Epilepsy Surgical Planning ($262,362)", "source_url": "https://reporter.nih.gov/project-details/10379723", "people": [{"name": "PHAN LUU", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R42ES033912-01", "company": "Neurosetta LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-12-30", "observed": "2026-08-21", "amount_usd": 199800, "summary": "NIH award 1R42ES033912-01: Development and Evaluation of Rosette Array Technology for HumanNeurodevelopmental Toxicity Screening ($199,800)", "source_url": "https://reporter.nih.gov/project-details/10385198", "people": [{"name": "Randolph Scott Ashton", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG071034-02", "company": "Active Life Scientific, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-12-30", "observed": "2026-08-21", "amount_usd": 778160, "summary": "NIH award 5R44AG071034-02: A New Device to measure Whole and Tissue Level Bone Strength. ($778,160)", "source_url": "https://reporter.nih.gov/project-details/10322736", "people": [{"name": "Peter Burks", "role": "Principal Investigator"}, {"name": "Simon Yue-Cheong Tang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DK131707-01", "company": "Vibrato Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-12-24", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43DK131707-01: Clinical study of a wearable therapeutic ultrasound sleeve for treatment of neuro-ischemic and ischemic diabetic foot ulcers ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10383532", "people": [{"name": "Juliana Elstad", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AG045947-05", "company": "Healthcare Technologies And Methods", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-12-22", "observed": "2026-08-21", "amount_usd": 1172256, "summary": "NIH award 5R44AG045947-05: An Innovative Person-Centered Hearing Aid Education and Aural Rehab System ($1,172,256)", "source_url": "https://reporter.nih.gov/project-details/10324597", "people": [{"name": "Alan Letzt", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "denovo:DEN210024", "company": "Spectranetics, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2021-12-21", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210024 granted: CavaClear Laser Sheath", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210024"}, {"id": "breakthrough:DEN210024", "company": "Spectranetics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-12-21", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN210024: CAVACLEAR LASER SHEATH", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W31P4Q-22-C-0010", "company": "Lalaith Astor Technical Consulting House, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-12-20", "observed": "2026-09-18", "amount_usd": 1493560, "summary": "DOD SBIR Phase II award $1,493,560: Medical Device Verification Using Model-Based Testing", "source_url": "https://www.sbir.gov/awards?search=D2D-0166"}, {"id": "breakthrough:K212616", "company": "Koios Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-12-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K212616: KOIOS DS", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44HL149550-03", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-12-10", "observed": "2026-08-21", "amount_usd": 988194, "summary": "NIH award 5R44HL149550-03: Endobronchial Supervalve for the Treatment of Emphysema ($988,194)", "source_url": "https://reporter.nih.gov/project-details/10307640", "people": [{"name": "Mark Gelfand", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AI167169-01", "company": "Jbs Science, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-12-10", "observed": "2026-08-21", "amount_usd": 305372, "summary": "NIH award 1R43AI167169-01: Novel assay to detect integrated HBV DNA in urine of chronic hepatitis B patients ($305,372)", "source_url": "https://reporter.nih.gov/project-details/10384247", "people": [{"name": "Selena Lin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "denovo:DEN200041", "company": "Medical Precision BV", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2021-12-10", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200041 granted: Comfort Marker 2.0.", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200041"}, {"id": "nih:3R43EB030947-01A1S1", "company": "Lifetime Omics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-12-09", "observed": "2026-08-21", "amount_usd": 30166, "summary": "NIH award 3R43EB030947-01A1S1: In Vivo Cluster AI Prediction (CLAIRE) of COVID-19 Disease Progression ($30,166)", "source_url": "https://reporter.nih.gov/project-details/10485139", "people": [{"name": "Patricia Buendia", "role": "Principal Investigator"}, {"name": "Jose Guillermo Castro", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH129023-01", "company": "Microbrightfield, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-12-08", "observed": "2026-08-21", "amount_usd": 995291, "summary": "NIH award 1R44MH129023-01: Microscope system for large scale optical imaging of neuronal activity using kilohertz frame rates ($995,291)", "source_url": "https://reporter.nih.gov/project-details/10384932", "people": [{"name": "JACOB R GLASER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "denovo:DEN200005", "company": "Klox Technlogies, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2021-12-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200005 granted: Klox Biophotonic LumiHeal System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200005"}, {"id": "nih:1R43DE031195-01A1", "company": "Ostiio LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-12-01", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43DE031195-01A1: A Smart, Fully Subcutaneous Distraction System to Improve Outcomes in Patients with Congenital or Acquired Craniofacial Differences ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10382148", "people": [{"name": "Jessica DesNoyer", "role": "Principal Investigator"}, {"name": "Ari M Wes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL158306-01A1", "company": "Unandup, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-11-30", "observed": "2026-08-21", "amount_usd": 456397, "summary": "NIH award 1R43HL158306-01A1: Magnetic Rotational Exploratory Platform for Coronary Lesions ($456,397)", "source_url": "https://reporter.nih.gov/project-details/10384033", "people": [{"name": "Richard Gordon Bach", "role": "Principal Investigator"}, {"name": "Francis Milton Creighton", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43ES033873-01", "company": "Quantitative Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-11-30", "observed": "2026-08-21", "amount_usd": 256580, "summary": "NIH award 1R43ES033873-01: An Online, Real-Time Microfluidic Biosensor for PFOA and PFOS ($256,580)", "source_url": "https://reporter.nih.gov/project-details/10383822", "people": [{"name": "Nicholas Csicsery", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44HL152912-02A1", "company": "Cognita Labs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-11-26", "observed": "2026-08-21", "amount_usd": 780162, "summary": "NIH award 2R44HL152912-02A1: SonoHeal: Smart Resonating Closed-loop Airway Clearance Technology ($780,162)", "source_url": "https://reporter.nih.gov/project-details/10385490", "people": [{"name": "Rajoshi Biswas", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "denovo:DEN210012", "company": "Virility Medical", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2021-11-23", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210012 granted: vPatch", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210012"}, {"id": "denovo:DEN210014", "company": "Appliedvr, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2021-11-16", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210014 granted: EaseVRx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210014"}, {"id": "breakthrough:DEN210014", "company": "Appliedvr, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-11-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN210014: EASEVRX", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "denovo:DEN210006", "company": "Alung Technologies, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2021-11-13", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210006 granted: Hemolung Respiratory Assist System", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210006"}, {"id": "denovo:DEN200040", "company": "DNA Genotek, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2021-11-03", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200040 granted: OMNIgene GUT Dx", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200040"}, {"id": "nih:5R44MH118752-04", "company": "Inscopix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-11-01", "observed": "2026-08-21", "amount_usd": 597973, "summary": "NIH award 5R44MH118752-04: Next generation in vivo miniature microscopes integrating dual-color imaging, 3D imaging, and optogenetic stimulation with a cloud-compatible data acquisition platform ($597,973)", "source_url": "https://reporter.nih.gov/project-details/10292908", "people": [{"name": "Kunal Ghosh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "sbir:DOD:W81XWH-22-C-0013", "company": "Critical Innovations LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-10-26", "observed": "2026-09-18", "amount_usd": 508664, "summary": "DOD SBIR Phase II award $508,664: Succor Combat Foam for Advanced Wound Care of Traumatized Tissue", "source_url": "https://www.sbir.gov/awards?search=A2-8980"}, {"id": "denovo:DEN210005", "company": "Luminopia, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2021-10-20", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN210005 granted: Luminopia One", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210005"}, {"id": "breakthrough:K202927", "company": "Syncthink, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-10-02", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K202927: EYE-SYNC", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "denovo:DEN190055", "company": "Iotamotion, Inc.", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2021-10-01", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN190055 granted: iotaSOFT Insertion System - Drive Unit,", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN190055"}, {"id": "nih:2R44AR070071-02A1", "company": "If, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-27", "observed": "2026-08-21", "amount_usd": 942730, "summary": "NIH award 2R44AR070071-02A1: Development of a Photoacoustic Quantitative Ultrasound (PAQUS) device for clinical use ($942,730)", "source_url": "https://reporter.nih.gov/project-details/10258569", "people": [{"name": "Richard Franklin Morris", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41AR078720-01A1", "company": "Springbok, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-25", "observed": "2026-08-21", "amount_usd": 208204, "summary": "NIH award 1R41AR078720-01A1: Development of a commercially viable machine learning product to automatically detect rotator cuff muscle pathology ($208,204)", "source_url": "https://reporter.nih.gov/project-details/10268004", "people": [{"name": "Silvia Salinas Blemker", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R41CA254557-01A1S1", "company": "Pranascience Institute LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-24", "observed": "2026-08-21", "amount_usd": 66588, "summary": "NIH award 3R41CA254557-01A1S1: Supplement - PRANAYAMA BASED GROUP VIDEO APP FOR CANCER SURVIVORSHIP. Phase I. Breast Cancer Pilot ($66,588)", "source_url": "https://reporter.nih.gov/project-details/10481777", "people": [{"name": "SUNDARAVADIVEL BALASUBRAMANIAN", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R42AG059475-02A1", "company": "Advanced Smart Systems/evaluation Techno", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-24", "observed": "2026-08-21", "amount_usd": 740205, "summary": "NIH award 2R42AG059475-02A1: Mitigating Injurious Falls in Older Adults Through Non-Injurious Fall and Gait Analysis From Floor Vibrations ($740,205)", "source_url": "https://reporter.nih.gov/project-details/10383468", "people": [{"name": "Stacy Lynne Fritz", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43EB031655-01A1", "company": "Subtle Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-24", "observed": "2026-08-21", "amount_usd": 132173, "summary": "NIH award 1R43EB031655-01A1: Real-time AI-enhanced Low Dose Fluoroscopy ($132,173)", "source_url": "https://reporter.nih.gov/project-details/10385142", "people": [{"name": "Enhao Gong", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA239829-02A1", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-24", "observed": "2026-08-21", "amount_usd": 783896, "summary": "NIH award 2R44CA239829-02A1: Novel Minimally Invasive Endobronchial Approach for Lung Cancer Ablation ($783,896)", "source_url": "https://reporter.nih.gov/project-details/10249490", "people": [{"name": "Howard Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44AG074727-02", "company": "Together Senior Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 1504982, "summary": "NIH award 2R44AG074727-02: BRAIN HEALTH TOGETHER: A LIVE-STREAMING GROUP-BASED DIGITAL PROGRAM ($1,504,982)", "source_url": "https://reporter.nih.gov/project-details/10324919", "people": [{"name": "Deborah E. Barnes", "role": "Principal Investigator"}, {"name": "Cynthia Louise Benjamin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44HD105579-01", "company": "Neurolutions, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 299891, "summary": "NIH award 1R44HD105579-01: A Fully Remote Telehealth Brain Computer Interface And Assessment System For Motor Rehabilitation Of Chronic Stroke ($299,891)", "source_url": "https://reporter.nih.gov/project-details/10255900", "people": [{"name": "Kern Bhugra", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD102235-01A1", "company": "Theranova, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 717254, "summary": "NIH award 1R44HD102235-01A1: A Photo-based Menstrual Blood Loss Metric ($717,254)", "source_url": "https://reporter.nih.gov/project-details/10134912", "people": [{"name": "Daniel Rogers Burnett", "role": "Principal Investigator"}, {"name": "Vanessa Jacoby", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41EB032284-01", "company": "Optosurgical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 256579, "summary": "NIH award 1R41EB032284-01: A Biliary Tract-Specific Fluorescence Image-guided Surgery ($256,579)", "source_url": "https://reporter.nih.gov/project-details/10323760", "people": [{"name": "Richard Jaepyeong Cha", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD107822-01", "company": "Hillmed Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 251964, "summary": "NIH award 1R44HD107822-01: An Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management ($251,964)", "source_url": "https://reporter.nih.gov/project-details/10386341", "people": [{"name": "Nicholas Dias", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA261401-01A1", "company": "Stratagen Bio, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 399740, "summary": "NIH award 1R43CA261401-01A1: Quantitative oxygen sensing to enable personalized oncology treatment planning ($399,740)", "source_url": "https://reporter.nih.gov/project-details/10325250", "people": [{"name": "Gregory Ekchian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HD106834-01", "company": "Charles River Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 259600, "summary": "NIH award 1R43HD106834-01: Rehabilitation Engagement at Home with a socially Assistive roBot for Pediatric Adherence (REHAB-PAL) ($259,600)", "source_url": "https://reporter.nih.gov/project-details/10325476", "people": [{"name": "Leonard Eusebi", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA052945-01A1", "company": "Neurobehavioral Research, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 269320, "summary": "NIH award 1R43DA052945-01A1: Network Synchrony Neurofeedback for Opioid Dependence ($269,320)", "source_url": "https://reporter.nih.gov/project-details/10382736", "people": [{"name": "George Fein", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42CA265316-01", "company": "Filtro Medical Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R42CA265316-01: Endovascular ChemoFilter to Reduce Doxorubicin Toxicity during Intra-Arterial Chemotherapy ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10321515", "people": [{"name": "Steven William Hetts", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41GM146329-01", "company": "AI Metrics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 299999, "summary": "NIH award 1R41GM146329-01: Pulmonary Surface Irregularity score: A Quantitative CT Biomarker for Idiopathic Pulmonary Fibrosis ($299,999)", "source_url": "https://reporter.nih.gov/project-details/10325404", "people": [{"name": "ROBERT B JACOBUS", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD017137-01", "company": "Handl Health LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 237448, "summary": "NIH award 1R43MD017137-01: A mobile application to offer upfront healthcare prices and automated medical billing for socioeconomically disadvantaged Americans ($237,448)", "source_url": "https://reporter.nih.gov/project-details/10384243", "people": [{"name": "Ahmed Marmoush", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA261318-01A1", "company": "Veravanti, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 993178, "summary": "NIH award 1R44CA261318-01A1: Endoscope development for the clinical use of near infrared fluorescence molecular probes in the GI tract ($993,178)", "source_url": "https://reporter.nih.gov/project-details/10325563", "people": [{"name": "Gerald McMorrow", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA265673-01", "company": "Cytoveris Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 399948, "summary": "NIH award 1R43CA265673-01: Artificial Intelligence Enabled Multi-Spectral Autofluorescence Imaging for Real-time Determination of Muscle in Bladder Tumor During Resection ($399,948)", "source_url": "https://reporter.nih.gov/project-details/10325131", "people": [{"name": "Rishikesh Pandey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB032676-01", "company": "Physical Sciences, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 263009, "summary": "NIH award 1R43EB032676-01: Smart Multi-grid Template for Focal Therapy of Prostate Cancer ($263,009)", "source_url": "https://reporter.nih.gov/project-details/10382006", "people": [{"name": "Jesung Park", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R41EB032275-01S1", "company": "Precision Sensing, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-23", "observed": "2026-08-21", "amount_usd": 13284, "summary": "NIH award 3R41EB032275-01S1: Ultra-high sensitivity, high spatial resolution single photon emission tomography using mechanical flux manipulation. ($13,284)", "source_url": "https://reporter.nih.gov/project-details/10488941", "people": [{"name": "Larry Pierce", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44AG052196-04A1", "company": "Spr Therapeutics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 954397, "summary": "NIH award 2R44AG052196-04A1: Electrical stimulation to reduce pain and improve function after knee replacement ($954,397)", "source_url": "https://reporter.nih.gov/project-details/10324450", "people": [{"name": "Joseph Wilder Boggs", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44AR079293-01", "company": "Apex Biomedical Company, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 455454, "summary": "NIH award 1R44AR079293-01: Improving Fracture Healing with Active Plating Technology ($455,454)", "source_url": "https://reporter.nih.gov/project-details/10249794", "people": [{"name": "MICHAEL BOTTLANG", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44HD095779-02", "company": "Chosen Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 991043, "summary": "NIH award 2R44HD095779-02: Noninvasive biomarkers for gastrointestinal disease in preterm infants ($991,043)", "source_url": "https://reporter.nih.gov/project-details/10327205", "people": [{"name": "Rebecca S Buckley", "role": "Principal Investigator"}, {"name": "Sunyoung Kim", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA257701-01A1", "company": "Symple Surgical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 399834, "summary": "NIH award 1R43CA257701-01A1: A Novel Radiometry\u2010Guided Ablation Catheter to Reliably Treat Barrett's Esophagus ($399,834)", "source_url": "https://reporter.nih.gov/project-details/10385615", "people": [{"name": "Sohail Desai", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG074740-01", "company": "Ability Interactive LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 499360, "summary": "NIH award 1R43AG074740-01: Interactive Software for Assessing Meaningful Cognitive Function ($499,360)", "source_url": "https://reporter.nih.gov/project-details/10323851", "people": [{"name": "John Eric Ferguson", "role": "Principal Investigator"}, {"name": "Adriana Hughes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL158286-01A1", "company": "Bleep, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 860622, "summary": "NIH award 1R44HL158286-01A1: DreamPort-Eclipse: Compact, ultra-low contact, custom fit CPAP human interface solution for obstructive sleep apnea ($860,622)", "source_url": "https://reporter.nih.gov/project-details/10323209", "people": [{"name": "Stuart Heatherington", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK131700-01", "company": "Bright Uro, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 999992, "summary": "NIH award 1R44DK131700-01: Clinical Feasibility of Wireless Catheter-Free Urodynamics for Extended, Comprehensive Urological Evaluation in the Home Setting ($999,992)", "source_url": "https://reporter.nih.gov/project-details/10384381", "people": [{"name": "Derek Herrera", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44AA030000-02", "company": "Dascena, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 1999554, "summary": "NIH award 2R44AA030000-02: Using Clinical Treatment Data in a Machine Learning Approach for Sepsis Detection ($1,999,554)", "source_url": "https://reporter.nih.gov/project-details/10258043", "people": [{"name": "Jana Hoffman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43EB031013-01", "company": "Levisonics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 225177, "summary": "NIH award 1R43EB031013-01: Drop-of-blood technology for home-use monitoring of anticoagulant therapy ($225,177)", "source_url": "https://reporter.nih.gov/project-details/10187996", "people": [{"name": "Nithya Kasireddy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA257624-01A1", "company": "Microstructure Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 399999, "summary": "NIH award 1R41CA257624-01A1: Non-invasive neurosurgical planning with Random Matrix Theory MRI ($399,999)", "source_url": "https://reporter.nih.gov/project-details/10258848", "people": [{"name": "Grigoriy Lemberskiy", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA055401-01", "company": "Coridea, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 223921, "summary": "NIH award 1R43DA055401-01: On Demand Electrostimulation ($223,921)", "source_url": "https://reporter.nih.gov/project-details/10390902", "people": [{"name": "Howard Levin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA261540-01", "company": "Benten Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 300618, "summary": "NIH award 1R43CA261540-01: OC-DETECT,A mHealth for CHWs can facilitate the task-shifting of intake, provide on-demand training, improve communication between CHWs and their supervisors, and support digital-enhanced referral ($300,618)", "source_url": "https://reporter.nih.gov/project-details/10258860", "people": [{"name": "Tony Xuyen Ma", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA055399-01", "company": "Attune Neurosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 319441, "summary": "NIH award 1R43DA055399-01: Transcranial ultrasound device for enhancing sleep in OUD ($319,441)", "source_url": "https://reporter.nih.gov/project-details/10390994", "people": [{"name": "Rajiv Mahadevan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG074788-01", "company": "Infrared Rx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 247303, "summary": "NIH award 1R41AG074788-01: Oxygen-Guided Therapy for Optimal Rehabilitation for Peripheral Artery Disease ($247,303)", "source_url": "https://reporter.nih.gov/project-details/10324798", "people": [{"name": "Kevin K. McCully", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44MH111450-03A1", "company": "Psyc Tech, Ltd", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 1202047, "summary": "NIH award 2R44MH111450-03A1: Finalizing and Testing an Online Therapist Training and Assistance Program to Facilitate Implementation of Comprehensive Behavioral Intervention for Tic Disorders (CBIT-Trainer) ($1,202,047)", "source_url": "https://reporter.nih.gov/project-details/10382479", "people": [{"name": "Michael B Himle", "role": "Principal Investigator"}, {"name": "Suzanne Mouton-Odum", "role": "Principal Investigator"}, {"name": "Douglas W Woods", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R42MD014947-01A1", "company": "Klein Buendel, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 316117, "summary": "NIH award 1R42MD014947-01A1: Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers) ($316,117)", "source_url": "https://reporter.nih.gov/project-details/10401222", "people": [{"name": "DAVID B BULLER", "role": "Principal Investigator"}, {"name": "Robert Lee Newton", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA256984-01A1", "company": "Therabionic Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 1059091, "summary": "NIH award 1R44CA256984-01A1: Randomized phase II study of TheraBionic in advanced hepatocellular carcinoma ($1,059,091)", "source_url": "https://reporter.nih.gov/project-details/10254967", "people": [{"name": "Valerie Pasche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44NS115460-02", "company": "Thermaquil, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-22", "observed": "2026-08-21", "amount_usd": 998122, "summary": "NIH award 2R44NS115460-02: Drug Free Nerve Block Device for the Relief of Pain and Symptoms in Migraines and other Headaches ($998,122)", "source_url": "https://reporter.nih.gov/project-details/10386456", "people": [{"name": "Stephen Popielarski", "role": "Principal Investigator"}, {"name": "Hsiangkuo Yuan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41DE030039-01A1", "company": "M2 Technologies LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 196573, "summary": "NIH award 1R41DE030039-01A1: A two-dimensional antiscatter grid for dental cone beam computed tomography ($196,573)", "source_url": "https://reporter.nih.gov/project-details/10258749", "people": [{"name": "Cem Altunbas", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA268484-01", "company": "Boston Cell Standards Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 1101356, "summary": "NIH award 1R44CA268484-01: National Immunohistochemistry Standardization Program - Establishment & Launch ($1,101,356)", "source_url": "https://reporter.nih.gov/project-details/10383397", "people": [{"name": "Steven A Bogen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD017188-01", "company": "Castner Incorporated", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 228344, "summary": "NIH award 1R43MD017188-01: Precision Assessment Algorithm for Reducing Disaster-related Respiratory Health Disparities ($228,344)", "source_url": "https://reporter.nih.gov/project-details/10401726", "people": [{"name": "Jessica Castner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG076098-01", "company": "Wellsim Biomedical Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 251359, "summary": "NIH award 1R41AG076098-01: EXODUS-enabled High-throughput Multi-omics Profiling of Extracellular Vesicles for Diagnosis of Preclinical Alzheimer's Disease ($251,359)", "source_url": "https://reporter.nih.gov/project-details/10383586", "people": [{"name": "Yuchao Chen", "role": "Principal Investigator"}, {"name": "Xianjun Dong", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM142413-01A1", "company": "Rebel Medicine Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 256551, "summary": "NIH award 1R43GM142413-01A1: Development of a novel sustained release local anesthetic wound dressing for partial-thickness dermal injuries ($256,551)", "source_url": "https://reporter.nih.gov/project-details/10325534", "people": [{"name": "Brett Davis", "role": "Principal Investigator"}, {"name": "JILL E SHEA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43FD006914-01A1", "company": "Trace-ability, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 168087, "summary": "NIH award 1R43FD006914-01A1: Rapid pre-release sterility test for PET Drugs. ($168,087)", "source_url": "https://reporter.nih.gov/project-details/10258453", "people": [{"name": "Arkadij Elizarov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG076091-01", "company": "Virtici, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 412462, "summary": "NIH award 1R43AG076091-01: A Novel Multiparameter Blood Test for Early Detection of Alzheimer's Disease ($412,462)", "source_url": "https://reporter.nih.gov/project-details/10384224", "people": [{"name": "Neil A Fanger", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43FD007313-01", "company": "Triple Ring Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 168087, "summary": "NIH award 1R43FD007313-01: An e-beam sterilization dose map simulation tool ($168,087)", "source_url": "https://reporter.nih.gov/project-details/10320621", "people": [{"name": "TOBIAS FUNK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA265301-02", "company": "Dimagi, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 764805, "summary": "NIH award 2R44CA265301-02: SurvivorCare: A digital health solution to support long-term cancer survivorship using patient navigation ($764,805)", "source_url": "https://reporter.nih.gov/project-details/10321516", "people": [{"name": "Y. Xian Ho", "role": "Principal Investigator"}, {"name": "Jonathan Lee Jackson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG067843-01A1", "company": "Gracefall, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 298873, "summary": "NIH award 1R43AG067843-01A1: Sensor Fusion System For Early And Accurate Fall Detection and Injury Protection ($298,873)", "source_url": "https://reporter.nih.gov/project-details/10256574", "people": [{"name": "Emily A Keshner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R42HD097831-02", "company": "Contech Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 1036191, "summary": "NIH award 2R42HD097831-02: SnapCap: a device to decontaminate central venous catheters (CVC) with 5 snaps ($1,036,191)", "source_url": "https://reporter.nih.gov/project-details/10383994", "people": [{"name": "John Nagi Kheir", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44HG010446-02", "company": "Genomenon, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 855024, "summary": "NIH award 2R44HG010446-02: Micropublications for Automating Genome Sequence Variant Interpretation from Medical Literature ($855,024)", "source_url": "https://reporter.nih.gov/project-details/10255401", "people": [{"name": "Mark Julin Kiel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43FD007315-01", "company": "Akonni Biosystems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 168087, "summary": "NIH award 1R43FD007315-01: Lateral flow array for undeclared food allergens ($168,087)", "source_url": "https://reporter.nih.gov/project-details/10320285", "people": [{"name": "Alexander Kukhtin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB032750-01", "company": "Archiemd, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 256577, "summary": "NIH award 1R43EB032750-01: Advanced haptics simulation platform for improved nurse skills ($256,577)", "source_url": "https://reporter.nih.gov/project-details/10383492", "people": [{"name": "ROBERT J LEVINE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA261376-01A1", "company": "Capsulomics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 399995, "summary": "NIH award 1R41CA261376-01A1: Diagnosis of Esophageal Squamous Cell Carcinoma in Low-Income Countries ($399,995)", "source_url": "https://reporter.nih.gov/project-details/10325590", "people": [{"name": "Daniel Gregory Lunz", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HD104539-01A1", "company": "Zsx Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 928014, "summary": "NIH award 1R44HD104539-01A1: Zip-stitch for Laparoscopic Hysterectomy - Clinical Validation ($928,014)", "source_url": "https://reporter.nih.gov/project-details/10253968", "people": [{"name": "Dan C Mazzucco", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R42DK078400-05", "company": "Tricol Biomedical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 853858, "summary": "NIH award 2R42DK078400-05: Chitosan Endoluminal Hemostatic Dressing ($853,858)", "source_url": "https://reporter.nih.gov/project-details/10256107", "people": [{"name": "Simon John McCarthy", "role": "Principal Investigator"}, {"name": "HUA XIE", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R43DA055394-01", "company": "Affect Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 309360, "summary": "NIH award 1R43DA055394-01: Demonstration of a Digital Care Program for Methamphetamine Use Disorder ($309,360)", "source_url": "https://reporter.nih.gov/project-details/10382485", "people": [{"name": "Kristin Muhlner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41CA265655-01", "company": "Oncotab, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 400000, "summary": "NIH award 1R41CA265655-01: An integrated strategy using a serum and imaging biomarker for the early detection of pancreatic cancer. ($400,000)", "source_url": "https://reporter.nih.gov/project-details/10325659", "people": [{"name": "Pinku Mukherjee", "role": "Principal Investigator"}, {"name": "Ru zhou", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS120394-01A1", "company": "Soterya, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 502561, "summary": "NIH award 1R43NS120394-01A1: A device to prevent Sudden Unexpected Death in Epilepsy (SUDEP) ($502,561)", "source_url": "https://reporter.nih.gov/project-details/10323597", "people": [{"name": "Jong Woo Lee", "role": "Principal Investigator"}, {"name": "Justin Ke Nguyen", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG072943-01", "company": "Prepped Health, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 299782, "summary": "NIH award 1R41AG072943-01: Remote Patient Monitoring of Family Caregivers of Patients with Alzheimer's Disease ($299,782)", "source_url": "https://reporter.nih.gov/project-details/10253642", "people": [{"name": "Jonathan Nicolla", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DE027574-02A1", "company": "Kitware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-21", "observed": "2026-08-21", "amount_usd": 855962, "summary": "NIH award 2R44DE027574-02A1: Automated Dental Fracture Detection using High Resolution CBCT and Advanced Image Analysis ($855,962)", "source_url": "https://reporter.nih.gov/project-details/10322271", "people": [{"name": "Beatriz Paniagua", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "denovo:DEN200080", "company": "Paige.Ai", "kind": "fda_denovo", "kind_label": "FDA De Novo grant", "date": "2021-09-21", "observed": "2026-09-15", "amount_usd": null, "summary": "FDA De Novo DEN200080 granted: Paige Prostate", "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200080"}, {"id": "breakthrough:DEN200080", "company": "Paige.ai", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-09-21", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN200080: PAIGE PROSTATE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:1R42HD107747-01", "company": "Ifit Prosthetics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 292648, "summary": "NIH award 1R42HD107747-01: Adjustable prosthetic sockets for children and adolescents with lower limb loss to accommodate growth ($292,648)", "source_url": "https://reporter.nih.gov/project-details/10382682", "people": [{"name": "TIMOTHY R DILLINGHAM", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44HD097805-02A1", "company": "Advanced Tactile Imaging, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 838781, "summary": "NIH award 2R44HD097805-02A1: Tactile and ultrasound imaging fusion for functional assessment of the female pelvic floor ($838,781)", "source_url": "https://reporter.nih.gov/project-details/10325038", "people": [{"name": "Vladimir Egorov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AR079300-01A1", "company": "Osteocentric Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 1104366, "summary": "NIH award 1R44AR079300-01A1: Optimization of a Novel Thread Geometry for Various Orthopedic Surgery Applications ($1,104,366)", "source_url": "https://reporter.nih.gov/project-details/10324164", "people": [{"name": "Andrew Ray Fauth", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH129278-01", "company": "Advanced MRI Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 1340229, "summary": "NIH award 1R44MH129278-01: Highly Efficient MRI Pulse Sequences for High Resolution Physiological and Functional Brain Imaging ($1,340,229)", "source_url": "https://reporter.nih.gov/project-details/10326081", "people": [{"name": "Alexander Beckett", "role": "Principal Investigator"}, {"name": "David Alan Feinberg", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44DA055396-01", "company": "Dynamicare Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 255071, "summary": "NIH award 1R44DA055396-01: Incentivized Collaborative Care to Desseminate Contingency Management ($255,071)", "source_url": "https://reporter.nih.gov/project-details/10391245", "people": [{"name": "Anthony DeFulio", "role": "Principal Investigator"}, {"name": "David R Gastfriend", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41GM144015-01", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 350000, "summary": "NIH award 1R41GM144015-01: The Nanopore-based Ion Selective Electrode Vial ($350,000)", "source_url": "https://reporter.nih.gov/project-details/10325420", "people": [{"name": "Sean German", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44TR001704-03A1", "company": "Third Pole, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 998712, "summary": "NIH award 2R44TR001704-03A1: Portable electrical nitric oxide generator for treatment of pulmonary hypertension accompanying interstitial lung disease ($998,712)", "source_url": "https://reporter.nih.gov/project-details/10322907", "people": [{"name": "Greg Hall", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:3R44HD097809-03S1", "company": "Reia, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 160845, "summary": "NIH award 3R44HD097809-03S1: Non-surgical treatment option for pelvic organ prolapse ($160,845)", "source_url": "https://reporter.nih.gov/project-details/10452463", "people": [{"name": "Paul Hanissian", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44DK129075-01A1", "company": "Perikinetics Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 993339, "summary": "NIH award 1R44DK129075-01A1: An Intraperitoneal Insulin Delivery System for Management of Type 1 Diabetes ($993,339)", "source_url": "https://reporter.nih.gov/project-details/10382879", "people": [{"name": "Daniel Rogers Burnett", "role": "Principal Investigator"}, {"name": "Christopher Hanson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44HL147771-02A1", "company": "Annoviant, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 817553, "summary": "NIH award 2R44HL147771-02A1: Pulmonary valved conduit xenograft with regeneration potential ($817,553)", "source_url": "https://reporter.nih.gov/project-details/10257850", "people": [{"name": "Ajay Houde", "role": "Principal Investigator"}, {"name": "Naren R Vyavahare", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44DA051063-02", "company": "Medical Innovators Company, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 425535, "summary": "NIH award 2R44DA051063-02: A Software Product That Empowers Individuals Affected By Substance Use Disorders and Their Care Teams with Health and Social Resources ($425,535)", "source_url": "https://reporter.nih.gov/project-details/10360396", "people": [{"name": "Tom Lee", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R42HL145669-02A1", "company": "Kitware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 852101, "summary": "NIH award 2R42HL145669-02A1: Imaging biomarkers of severe respiratory infections in premature infants Phase II ($852,101)", "source_url": "https://reporter.nih.gov/project-details/10137685", "people": [{"name": "Andinet Asmamaw Enquobahrie", "role": "Principal Investigator"}, {"name": "Marius George Linguraru", "role": "Principal Investigator"}, {"name": "Gustavo Nino", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44ES024041-04", "company": "Access Sensor Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 934114, "summary": "NIH award 2R44ES024041-04: Validation of the UPAS+: A filter-based air sampler coupled with a suite of real-time sensors ($934,114)", "source_url": "https://reporter.nih.gov/project-details/10312360", "people": [{"name": "Sheryl Magzamen", "role": "Principal Investigator"}, {"name": "Daniel D Miller-Lionberg", "role": "Principal Investigator"}, {"name": "Jessica Tryner", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R44HD105529-01A1", "company": "Autoivf, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 255426, "summary": "NIH award 1R44HD105529-01A1: OvaReady: An automated microfluidic oocyte retrieval and denudation device expanding access to IVF ($255,426)", "source_url": "https://reporter.nih.gov/project-details/10324678", "people": [{"name": "Ismail Emre Ozkumur", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:4R44AI157716-02", "company": "Baebies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-20", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 4R44AI157716-02: Rapid Differential Diagnosis of COVID-19 and Common Respiratory Infections ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10449549", "people": [{"name": "VAMSEE K. PAMULA", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44MD012782-02", "company": "Cog Analytics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-18", "observed": "2026-08-21", "amount_usd": 818132, "summary": "NIH award 2R44MD012782-02: Validation of the TAPS-Electronic Spanish Platform (TAPS-ESP): A Technology to Improve Access to Substance Use Screening and Reduce Behavioral Health Disparities in Hispanic Primary Care Patients ($818,132)", "source_url": "https://reporter.nih.gov/project-details/10384516", "people": [{"name": "Steven Bernard Carswell", "role": "Principal Investigator"}, {"name": "Katherine Sanchez", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44EB030955-01A1", "company": "Agilemd, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-18", "observed": "2026-08-21", "amount_usd": 1995966, "summary": "NIH award 1R44EB030955-01A1: Opening The Black Box: Enhancing Machine Learning Interpretability To Optimize Clinical Response To Sudden Deterioration In COVID-19 Patients ($1,995,966)", "source_url": "https://reporter.nih.gov/project-details/10259197", "people": [{"name": "Dana Peres Edelson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB032730-01", "company": "Nalu Scientific, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-18", "observed": "2026-08-21", "amount_usd": 262993, "summary": "NIH award 1R43EB032730-01: Design and Development of SyMPET: System on chip Modular readout for high-resolution TOF-PET ($262,993)", "source_url": "https://reporter.nih.gov/project-details/10385669", "people": [{"name": "Kevin Flood", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD017157-01", "company": "Applied Universal Dynamics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-18", "observed": "2026-08-21", "amount_usd": 260303, "summary": "NIH award 1R43MD017157-01: Detecting Medical Emergencies in Isolated Older Adults Living Alone in Rural Areas ($260,303)", "source_url": "https://reporter.nih.gov/project-details/10400417", "people": [{"name": "Paul Gibson", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB029884-01A1", "company": "Aventusoft, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-18", "observed": "2026-08-21", "amount_usd": 225000, "summary": "NIH award 1R43EB029884-01A1: Innovative, non-invasive, battery-less, disposable cardiac biosensor for hemodynamic monitoring ($225,000)", "source_url": "https://reporter.nih.gov/project-details/10188673", "people": [{"name": "Kaustubh Kale", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43EB032276-01", "company": "Softworthy LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-18", "observed": "2026-08-21", "amount_usd": 232115, "summary": "NIH award 1R43EB032276-01: A simulation-based technology for stochastic modeling, sensitivity analysis and design optimization, aimed at development of next-generation micro-fluidic devices for biomedical applications. ($232,115)", "source_url": "https://reporter.nih.gov/project-details/10323474", "people": [{"name": "GAURAV KEWLANI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44MD017174-01", "company": "Benten Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-18", "observed": "2026-08-21", "amount_usd": 313508, "summary": "NIH award 1R44MD017174-01: Multi-modal Intervention for Lactation Care (MILC) will be a mHealth platform to increase ($313,508)", "source_url": "https://reporter.nih.gov/project-details/10401171", "people": [{"name": "Tony Xuyen Ma", "role": "Principal Investigator"}, {"name": "Yukiko Washio", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41EB031739-01A1", "company": "Biopac Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-18", "observed": "2026-08-21", "amount_usd": 256015, "summary": "NIH award 1R41EB031739-01A1: A Smart Assistant for MRI Technologists ($256,015)", "source_url": "https://reporter.nih.gov/project-details/10385269", "people": [{"name": "Alan MACY", "role": "Principal Investigator"}, {"name": "SIMON K WARFIELD", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MD016363-01", "company": "Dascena, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-18", "observed": "2026-08-21", "amount_usd": 256585, "summary": "NIH award 1R43MD016363-01: Developing an Unbiased Machine Learning Tool for Prediction of Acute Coronary Syndrome ($256,585)", "source_url": "https://reporter.nih.gov/project-details/10258045", "people": [{"name": "Qingqing Mao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NR020292-01A1", "company": "Kamin Consulting, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-17", "observed": "2026-08-21", "amount_usd": 297877, "summary": "NIH award 1R43NR020292-01A1: Improving the accessibility and relevance of Medical Nutritional Therapy among people with Type 2 diabetes in the Latino community through a customizable, AI-powered application. ($297,877)", "source_url": "https://reporter.nih.gov/project-details/10258480", "people": [{"name": "Shireen Abdullah", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R42NS103704-03", "company": "Cerulean Scientific Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-17", "observed": "2026-08-21", "amount_usd": 1035612, "summary": "NIH award 5R42NS103704-03: Omniphobic cerebral shunt to eliminate clogging and dysfunction ($1,035,612)", "source_url": "https://reporter.nih.gov/project-details/10269033", "people": [{"name": "Saibal Bandyopadhyay", "role": "Principal Investigator"}, {"name": "Carolyn A Harris", "role": "Principal Investigator"}, {"name": "James Patterson McAllister", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL158345-01", "company": "X-cor Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-17", "observed": "2026-08-21", "amount_usd": 293121, "summary": "NIH award 1R43HL158345-01: Development of a CO2-bicarbonate combined membrane capture system for accessible treatment of acute respiratory failure. ($293,121)", "source_url": "https://reporter.nih.gov/project-details/10258029", "people": [{"name": "Brian Yale Chang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM142386-01A1", "company": "Proteinaceous, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-17", "observed": "2026-08-21", "amount_usd": 251961, "summary": "NIH award 1R43GM142386-01A1: A proteoform-centric informatics platform for targeted top-down characterization and quantitation ($251,961)", "source_url": "https://reporter.nih.gov/project-details/10325492", "people": [{"name": "Kenneth Durbin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R42HD104325-01A1", "company": "Recupero Robotics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-17", "observed": "2026-08-21", "amount_usd": 256603, "summary": "NIH award 1R42HD104325-01A1: Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES) ($256,603)", "source_url": "https://reporter.nih.gov/project-details/10256401", "people": [{"name": "MICHELLE J. JOHNSON", "role": "Principal Investigator"}, {"name": "Alwyn P. Johnson", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44CA165314-05A1", "company": "Imcare Biotech, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-17", "observed": "2026-08-21", "amount_usd": 1420847, "summary": "NIH award 2R44CA165314-05A1: A novel diagnostic Kit for Hepatocellular Carcinoma ($1,420,847)", "source_url": "https://reporter.nih.gov/project-details/10249530", "people": [{"name": "Xuanyong Lu", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44AR079336-01A1", "company": "Myolex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-17", "observed": "2026-08-21", "amount_usd": 697807, "summary": "NIH award 1R44AR079336-01A1: Early identification and prevention of acute compartment syndrome using a novel electrical impedance-based muscle-monitoring device ($697,807)", "source_url": "https://reporter.nih.gov/project-details/10325320", "people": [{"name": "Elmer C Lupton", "role": "Principal Investigator"}, {"name": "Seward B. Rutkove", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AR080617-01", "company": "Rivanna Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-17", "observed": "2026-08-21", "amount_usd": 877193, "summary": "NIH award 1R44AR080617-01: Automated three-dimensional spinal navigation system for chronic pain therapy ($877,193)", "source_url": "https://reporter.nih.gov/project-details/10384241", "people": [{"name": "Frank William Mauldin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA261446-01", "company": "5 Point App", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-16", "observed": "2026-08-21", "amount_usd": 397367, "summary": "NIH award 1R43CA261446-01: A New Multi-functional and Connected Mobile App Guiding Acupressure Use for Self-management and Monitoring of Cancer Related Fatigue and Sleep Disturbances ($397,367)", "source_url": "https://reporter.nih.gov/project-details/10255903", "people": [{"name": "SUSAN L BECK", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA268466-01", "company": "Doseoptics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-16", "observed": "2026-08-21", "amount_usd": 279543, "summary": "NIH award 1R43CA268466-01: Ultra-fast imaging for the safe delivery of electron FLASH radiation therapy ($279,543)", "source_url": "https://reporter.nih.gov/project-details/10384307", "people": [{"name": "Petr Bruza", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM144000-01", "company": "Partillion Bioscience Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-16", "observed": "2026-08-21", "amount_usd": 355051, "summary": "NIH award 1R43GM144000-01: High-throughput antibody discovery directly from B cells using nanovial technology ($355,051)", "source_url": "https://reporter.nih.gov/project-details/10324363", "people": [{"name": "Joseph de Rutte", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44CA257178-01A1", "company": "Integrated Sensors, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-16", "observed": "2026-08-21", "amount_usd": 561573, "summary": "NIH award 1R44CA257178-01A1: Ultrafast and Precise External Beam Monitor for FLASH and Other Advanced Radiation Therapy Modalities ($561,573)", "source_url": "https://reporter.nih.gov/project-details/10324507", "people": [{"name": "Peter S Friedman", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41GM145129-01", "company": "Odmr Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-16", "observed": "2026-08-21", "amount_usd": 259000, "summary": "NIH award 1R41GM145129-01: Diamond NMR spectrometer for microfluidic metabolite profiling ($259,000)", "source_url": "https://reporter.nih.gov/project-details/10385582", "people": [{"name": "Victor Marcel Acosta", "role": "Principal Investigator"}, {"name": "Andrejs Jarmola", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM133267-03", "company": "Euclid Beamlabs, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-16", "observed": "2026-08-21", "amount_usd": 764785, "summary": "NIH award 5R44GM133267-03: Laser-free Ultrafast Tunable Stroboscopic TEM imaging for Biomedical Applications ($764,785)", "source_url": "https://reporter.nih.gov/project-details/10242205", "people": [{"name": "Chunguang Jing", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH124574-02", "company": "Neuromotion, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-16", "observed": "2026-08-21", "amount_usd": 733178, "summary": "NIH award 5R44MH124574-02: A Mightier healthcare system: Introducing a game-based pediatric mental health intervention into payor-sponsored care to evaluate financial and clinical outcomes ($733,178)", "source_url": "https://reporter.nih.gov/project-details/10256051", "people": [{"name": "Jason Kahn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43DA055182-01", "company": "C4 Innovations, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-16", "observed": "2026-08-21", "amount_usd": 220098, "summary": "NIH award 1R43DA055182-01: Overcoming Stigma and Improving Outcomes for Substance Use Disorders Through Education, Engagement, and Empowerment ($220,098)", "source_url": "https://reporter.nih.gov/project-details/10360831", "people": [{"name": "ELLEN L EDENS", "role": "Principal Investigator"}, {"name": "Bethany Marcogliese", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41GM146313-01", "company": "Ubitrix International, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-15", "observed": "2026-08-21", "amount_usd": 256079, "summary": "NIH award 1R41GM146313-01: A Framework for mHealth App Security and Privacy Analysis ($256,079)", "source_url": "https://reporter.nih.gov/project-details/10325277", "people": [{"name": "Sheikh Iqbal Ahamed", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM125412-02", "company": "Ionic Pharmaceuticals", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-15", "observed": "2026-08-21", "amount_usd": 830300, "summary": "NIH award 2R44GM125412-02: Production of a dissolvable hydrogel-based wound dressing for second degree burns ($830,300)", "source_url": "https://reporter.nih.gov/project-details/10324951", "people": [{"name": "Aaron Henry Colby", "role": "Principal Investigator"}, {"name": "Benjamin Goldman Cooper", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:6R44CA203350-05", "company": "Exact Sciences Thrive LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-15", "observed": "2026-08-21", "amount_usd": 83802, "summary": "NIH award 6R44CA203350-05: Genetic Cytology for Ovarian and Endometrial Cancer Screening ($83,802)", "source_url": "https://reporter.nih.gov/project-details/10487642", "people": [{"name": "ISAAC A KINDE", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R41AG074835-01", "company": "Echowear LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-15", "observed": "2026-08-21", "amount_usd": 300234, "summary": "NIH award 1R41AG074835-01: Development of a Digital Cognitive Screening Test to detect Mild Cognitive Impairment and Dementia in Clinical Settings. ($300,234)", "source_url": "https://reporter.nih.gov/project-details/10323509", "people": [{"name": "Kunal Mankodiya", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41GM146268-01", "company": "Sintx Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-15", "observed": "2026-08-21", "amount_usd": 308301, "summary": "NIH award 1R41GM146268-01: 3D Printed Silicon Nitride Porous PEEK Composite Spinal Cages for Anti-Infection ($308,301)", "source_url": "https://reporter.nih.gov/project-details/10323105", "people": [{"name": "Bryan J. McEntire", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43NS122713-01", "company": "Imggyd LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-15", "observed": "2026-08-21", "amount_usd": 352944, "summary": "NIH award 1R43NS122713-01: AccuGyd: Accurate Guidance for MRI-Guided Minimally Invasive Neurosurgery ($352,944)", "source_url": "https://reporter.nih.gov/project-details/10258259", "people": [{"name": "TERRENCE R OAKES", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43LM013986-01", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-15", "observed": "2026-08-21", "amount_usd": 301487, "summary": "NIH award 1R43LM013986-01: Federated Automated Survey Tool (FAST) ($301,487)", "source_url": "https://reporter.nih.gov/project-details/10382821", "people": [{"name": "Alec J Bateman", "role": "Principal Investigator"}, {"name": "B EUGENE PARKER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43GM144007-01", "company": "Indelible Learning, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-14", "observed": "2026-08-21", "amount_usd": 256579, "summary": "NIH award 1R43GM144007-01: Interactive Digital Media-based Learning for Hand Hygiene in School-Age Children ($256,579)", "source_url": "https://reporter.nih.gov/project-details/10326072", "people": [{"name": "Jasminka Criley", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG074869-01", "company": "Numentus Technologies Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-14", "observed": "2026-08-21", "amount_usd": 299151, "summary": "NIH award 1R43AG074869-01: Single Exosome Technology for Alzheimer's Disease ($299,151)", "source_url": "https://reporter.nih.gov/project-details/10330840", "people": [{"name": "GREGORY W FARIS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41GM143959-01", "company": "Versametrics LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-14", "observed": "2026-08-21", "amount_usd": 249623, "summary": "NIH award 1R41GM143959-01: Enabling study of electrically transduced information from biomolecules with a low-cost, versatile measurement (Versametrics) system ($249,623)", "source_url": "https://reporter.nih.gov/project-details/10324989", "people": [{"name": "Aaron Franklin", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM134756-02A1", "company": "Computchem LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-14", "observed": "2026-08-21", "amount_usd": 702792, "summary": "NIH award 2R44GM134756-02A1: Molecular Dynamics and Artificial Intelligence Based Tools to Innovate Covalent and Noncovalent Drug Design ($702,792)", "source_url": "https://reporter.nih.gov/project-details/10323917", "people": [{"name": "Julie Anne Harris", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44HD104973-01A1", "company": "Total Child Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-14", "observed": "2026-08-21", "amount_usd": 250263, "summary": "NIH award 1R44HD104973-01A1: Validation of the online Toddler Autism and Development Adaptive Screener (TADAS) at 18 months ($250,263)", "source_url": "https://reporter.nih.gov/project-details/10153564", "people": [{"name": "Barbara Jo Howard", "role": "Principal Investigator"}, {"name": "Raymond STURNER", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI141264-04", "company": "Volatylix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-14", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 5R44AI141264-04: A Rapid Breath Test for Invasive Aspergillosis ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10215505", "people": [{"name": "Donald E Pogorzelski", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43DK131910-01", "company": "Giner, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-13", "observed": "2026-08-21", "amount_usd": 259602, "summary": "NIH award 1R43DK131910-01: At-home Testing of Blood Sodium for Management of Diabetes Insipidus ($259,602)", "source_url": "https://reporter.nih.gov/project-details/10395189", "people": [{"name": "Avni A Argun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43HL158335-01A1", "company": "Stemplant LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-13", "observed": "2026-08-21", "amount_usd": 298724, "summary": "NIH award 1R43HL158335-01A1: Development of a balloon angioplasty catheter capable of simultaneous endovascular delivery of liquid therapeutic agents into the vascular wall ($298,724)", "source_url": "https://reporter.nih.gov/project-details/10324960", "people": [{"name": "SPENCER A. BROWN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DA053870-01", "company": "Aidar Health, Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-13", "observed": "2026-08-21", "amount_usd": 221150, "summary": "NIH award 1R43DA053870-01: Technologies for OUD Prevention, Control and Supportive Care - Development of Patient/Caregiver mobile application and Provider Dashboard ($221,150)", "source_url": "https://reporter.nih.gov/project-details/10259108", "people": [{"name": "SATHYA ELUMALAI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK131644-01", "company": "Sonavex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-13", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 1R44DK131644-01: Validation of a Bedside Automated 3D Ultrasound-based Arteriovenous Fistula Cannulation Guidance Solution to Improve AV Fistula Outcomes ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10384715", "people": [{"name": "Xin Kang", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41GM140530-01A1", "company": "Syracuse Biolabs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-13", "observed": "2026-08-21", "amount_usd": 218846, "summary": "NIH award 1R41GM140530-01A1: A novel method for improved separation of metagenomic samples for preservation and identification. ($218,846)", "source_url": "https://reporter.nih.gov/project-details/10324639", "people": [{"name": "Michael Marciano", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM125485-04", "company": "Abterra Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-13", "observed": "2026-08-21", "amount_usd": 675037, "summary": "NIH award 5R44GM125485-04: Quorum: glycopeptide discovery via mass spectrometry and spectral networking ($675,037)", "source_url": "https://reporter.nih.gov/project-details/10256760", "people": [{"name": "Anand Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43IP001166-01", "company": "AI Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-10", "observed": "2026-08-21", "amount_usd": 243000, "summary": "NIH award 1R43IP001166-01: Development of Antigen-based Vertical Flow Assay for the Rapid Detection of SARS-CoV-2, Influenza A/B, and RSV ($243,000)", "source_url": "https://reporter.nih.gov/project-details/10258549", "people": [{"name": "Arunkumar Arumugam", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG074725-01", "company": "Edgewater Safety Systems LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-10", "observed": "2026-08-21", "amount_usd": 499969, "summary": "NIH award 1R43AG074725-01: Development of Memesto, a wearable repetitive message and music therapy device that senses and reduces agitation in persons with AD/ADRD. ($499,969)", "source_url": "https://reporter.nih.gov/project-details/10322846", "people": [{"name": "Jeffery Banker", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG074778-01", "company": "Kinto", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-10", "observed": "2026-08-21", "amount_usd": 437367, "summary": "NIH award 1R44AG074778-01: Development of a technology-enabled care coaching service for families caring for AD/ADRD & a 300-family study to assess the service's impact on CG financial knowledge, efficacy, strain & action. ($437,367)", "source_url": "https://reporter.nih.gov/project-details/10325119", "people": [{"name": "Joseph Chung", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R41NS122602-01", "company": "Conway Medical LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-10", "observed": "2026-08-21", "amount_usd": 490053, "summary": "NIH award 1R41NS122602-01: Enabling rapid and effective stroke thrombectomy procedures from a Transradial approach: Combining introducer sheath, guide catheter, and distal access catheter into a single device. ($490,053)", "source_url": "https://reporter.nih.gov/project-details/10254745", "people": [{"name": "DAVID F KALLMES", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43MH128138-01", "company": "Emri Systems Llp", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-10", "observed": "2026-08-21", "amount_usd": 118251, "summary": "NIH award 1R43MH128138-01: Novel high-field MRI compatible subdural electrode and acquisition system for recording and stimulation in small animals ($118,251)", "source_url": "https://reporter.nih.gov/project-details/10325694", "people": [{"name": "Hernan Millan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:6R44AG059520-03", "company": "Together Senior Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-09", "observed": "2026-08-21", "amount_usd": 1003374, "summary": "NIH award 6R44AG059520-03: EXTENDING INDEPENDENCE AND QUALITY OF LIFE FOR PEOPLE WITH ALZHEIMER'S DISEASE OR DEMENTIA THROUGH TELEHEALTH PROGRAM DELIVERY ($1,003,374)", "source_url": "https://reporter.nih.gov/project-details/10204865", "people": [{"name": "Deborah E. Barnes", "role": "Principal Investigator"}, {"name": "Cynthia Louise Benjamin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R44AA029868-01", "company": "Evidence-based Practice Institute, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-09", "observed": "2026-08-21", "amount_usd": 397990, "summary": "NIH award 1R44AA029868-01: Treating Drivers of Suicide in Primary Care using Jaspr Health ($397,990)", "source_url": "https://reporter.nih.gov/project-details/10383171", "people": [{"name": "Linda A Dimeff", "role": "Principal Investigator"}, {"name": "David Alan Jobes", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:7R44CA247137-02", "company": "Dl Analytics, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-09", "observed": "2026-08-21", "amount_usd": 297844, "summary": "NIH award 7R44CA247137-02: Validation of a lab-free low-cost screening test for prevention of cervical cancer: automated visual evaluation ($297,844)", "source_url": "https://reporter.nih.gov/project-details/10441826", "people": [{"name": "David Levitz", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:3R44CA228844-03S1", "company": "Ferrologix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-09", "observed": "2026-08-21", "amount_usd": 93906, "summary": "NIH award 3R44CA228844-03S1: Ferrologix Administrative Supplement for High Throughput & Quantitative Cell Purification for Immunotherapy Manufacture ($93,906)", "source_url": "https://reporter.nih.gov/project-details/10358888", "people": [{"name": "Coleman Murray", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:6R44GM125485-03", "company": "Abterra Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-09", "observed": "2026-08-21", "amount_usd": 550832, "summary": "NIH award 6R44GM125485-03: Quorum: glycopeptide discovery via mass spectrometry and spectral networking ($550,832)", "source_url": "https://reporter.nih.gov/project-details/10477666", "people": [{"name": "Anand Patel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41EB032275-01", "company": "Precision Sensing, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-09", "observed": "2026-08-21", "amount_usd": 251896, "summary": "NIH award 1R41EB032275-01: Ultra-high sensitivity, high spatial resolution single photon emission tomography using mechanical flux manipulation. ($251,896)", "source_url": "https://reporter.nih.gov/project-details/10323609", "people": [{"name": "Larry Pierce", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG074825-01", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-08", "observed": "2026-08-21", "amount_usd": 299954, "summary": "NIH award 1R43AG074825-01: A Novel Instrument to Address Freezing of Gait in Parkinson's Patients ($299,954)", "source_url": "https://reporter.nih.gov/project-details/10323757", "people": [{"name": "Brian R Clark", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG072982-01", "company": "Hello Robot Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-08", "observed": "2026-08-21", "amount_usd": 256064, "summary": "NIH award 1R43AG072982-01: Stretching their reach: Robotic support for domestic activities for older individuals with mobility limitations ($256,064)", "source_url": "https://reporter.nih.gov/project-details/10258084", "people": [{"name": "Aaron Edsinger", "role": "Principal Investigator"}, {"name": "WENDY A ROGERS", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK130732-01A1", "company": "Sygnamap, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-08", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43DK130732-01A1: Precision Mass Spec Imaging Based Structure-Function Signatures of Diabetic Glomerulopathy ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10384163", "people": [{"name": "Leila Hejazi", "role": "Principal Investigator"}, {"name": "Kumar Sharma", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44DK131770-01", "company": "Epicypher, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-08", "observed": "2026-08-21", "amount_usd": 301921, "summary": "NIH award 1R44DK131770-01: Development of a high-throughput epigenomic mapping platform to molecularly phenotype Crohn's disease ($301,921)", "source_url": "https://reporter.nih.gov/project-details/10384457", "people": [{"name": "Andrea Lynn Johnstone", "role": "Principal Investigator"}, {"name": "SHEHZAD Z. SHEIKH", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM139504-02", "company": "Lase Innovation Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-08", "observed": "2026-08-21", "amount_usd": 955253, "summary": "NIH award 2R44GM139504-02: Cyclic Flow Cytometry for Ultra-High Marker Single-Cell Analysis ($955,253)", "source_url": "https://reporter.nih.gov/project-details/10325053", "people": [{"name": "Sheldon J.J. Kwok", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43IP001163-01", "company": "Dl Adv-tech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-08", "observed": "2026-08-21", "amount_usd": 242132, "summary": "NIH award 1R43IP001163-01: Rapid SARS-CoV-2 Spike Protein Neutralizing Antibody Tests for Evaluating COVID Vaccine-Generated Immunity ($242,132)", "source_url": "https://reporter.nih.gov/project-details/10384304", "people": [{"name": "Suiqiong Li", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41GM140575-01", "company": "Biolum Sciences, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-08", "observed": "2026-08-21", "amount_usd": 251943, "summary": "NIH award 1R41GM140575-01: A Chemiluminescent Assay and Device for Monitoring Vascular Endogenous Nitric Oxide ($251,943)", "source_url": "https://reporter.nih.gov/project-details/10140149", "people": [{"name": "Alexander Ryan Lippert", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44GM133291-03", "company": "Cell X Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-08", "observed": "2026-08-21", "amount_usd": 500269, "summary": "NIH award 5R44GM133291-03: Automation and Performance-Based Selection to Improve the Reproducibility of MSCs ($500,269)", "source_url": "https://reporter.nih.gov/project-details/10252056", "people": [{"name": "Viviane Luangphakdy", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44HL139184-02A1", "company": "Advancedcpr Solutions LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-08", "observed": "2026-08-21", "amount_usd": 1069357, "summary": "NIH award 2R44HL139184-02A1: Phase II, Head Up Cardiopulmonary Resuscitation Device ($1,069,357)", "source_url": "https://reporter.nih.gov/project-details/10325222", "people": [{"name": "Keith Lurie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AA029646-01", "company": "Benten Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-08", "observed": "2026-08-21", "amount_usd": 332056, "summary": "NIH award 1R43AA029646-01: WE-CARE - an innovative platform of Women Engaged in Comprehensive Addiction and Recovery Environments for SubstanceUse Women ($332,056)", "source_url": "https://reporter.nih.gov/project-details/10323630", "people": [{"name": "Tony Xuyen Ma", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HD084151-05", "company": "Miyazaki Enterprises, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-08", "observed": "2026-08-21", "amount_usd": 998047, "summary": "NIH award 5R44HD084151-05: Effect of Validated Skills Simulation with the Miya Model on Operating Room Performance of Vaginal Hysterectomy ($998,047)", "source_url": "https://reporter.nih.gov/project-details/10267677", "people": [{"name": "Bruce D Anderson", "role": "Principal Investigator"}, {"name": "Chi Chiung Grace Chen", "role": "Principal Investigator"}, {"name": "Howard Curlin", "role": "Principal Investigator"}, {"name": "Leslie Kammire", "role": "Principal Investigator"}, {"name": "Edgar Leclaire", "role": "Principal Investigator"}, {"name": "Veronica Lerner", "role": "Principal Investigator"}, {"name": "Ernest Lockrow", "role": "Principal Investigator"}, {"name": "Nichole Mahnert", "role": "Principal Investigator"}, {"name": "Catherine Ann Matthews", "role": "Principal Investigator"}, {"name": "Douglas W. Miyazaki", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44MH125700-01A1", "company": "Paradromics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-07", "observed": "2026-08-21", "amount_usd": 1488420, "summary": "NIH award 1R44MH125700-01A1: Development and evaluation of novel high-density intracortical microelectrode arrays for clinical applications ($1,488,420)", "source_url": "https://reporter.nih.gov/project-details/10255795", "people": [{"name": "Matthew R Angle", "role": "Principal Investigator"}, {"name": "SYDNEY S CASH", "role": "Principal Investigator"}, {"name": "Shaoyu Qiao", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44GM134789-02A1", "company": "Rewire Neuroscience, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-07", "observed": "2026-08-21", "amount_usd": 948520, "summary": "NIH award 2R44GM134789-02A1: Development of an adaptive machine learning platform for automated analysis of biomarkers in biomedical images ($948,520)", "source_url": "https://reporter.nih.gov/project-details/10259501", "people": [{"name": "John H Harkness", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA261389-01A1", "company": "Microelastic Ultrasound Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-07", "observed": "2026-08-21", "amount_usd": 256514, "summary": "NIH award 1R43CA261389-01A1: Ultrasound-Based Device to Guide Treatment of Lymphedema Using Skin Elasticity as a Biomarker ($256,514)", "source_url": "https://reporter.nih.gov/project-details/10325213", "people": [{"name": "Peter Hollender", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44NS120798-01A1", "company": "Rivanna Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-07", "observed": "2026-08-21", "amount_usd": 1032828, "summary": "NIH award 1R44NS120798-01A1: Real-time three-dimensional spinal navigation system for bedside lumbar puncture placement ($1,032,828)", "source_url": "https://reporter.nih.gov/project-details/10252315", "people": [{"name": "Frank William Mauldin", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43DK130034-01", "company": "Minutia, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-06", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 1R43DK130034-01: Real-time intracellular monitoring of microRNAs in human stem cell-derived insulin producing organoids ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10296294", "people": [{"name": "Catherine Digovich", "role": "Principal Investigator"}, {"name": "Matthias Hebrok", "role": "Principal Investigator"}, {"name": "Sapna Puri", "role": "Principal Investigator"}, {"name": "Tuan Vo-Dinh", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HL154933-02", "company": "Biotex, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-04", "observed": "2026-08-21", "amount_usd": 1358290, "summary": "NIH award 5R44HL154933-02: Novel 3-D Printed Implant for Improved Hemodialysis Access ($1,358,290)", "source_url": "https://reporter.nih.gov/project-details/10222783", "people": [{"name": "Ashok Gowda", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:4R44CA240021-02", "company": "Giner, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-03", "observed": "2026-08-21", "amount_usd": 1002148, "summary": "NIH award 4R44CA240021-02: Rapid, Multiplexed Biosensor for Non-Invasive Detection of Gene Mutations and Personalization of Therapy in Non-Small Cell Lung Cancer ($1,002,148)", "source_url": "https://reporter.nih.gov/project-details/10471039", "people": [{"name": "Avni A Argun", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA257433-01A1", "company": "Nanoview Diagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-03", "observed": "2026-08-21", "amount_usd": 351922, "summary": "NIH award 1R43CA257433-01A1: Single Vesicle Phenotyping of Circulating Exosomes Carrying Immunomodulatory Markers for Therapy Selection and Monitoring. ($351,922)", "source_url": "https://reporter.nih.gov/project-details/10254689", "people": [{"name": "George Daaboul", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AG074834-01", "company": "Suramedical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-03", "observed": "2026-08-21", "amount_usd": 299977, "summary": "NIH award 1R43AG074834-01: Reducing time to heal chronic leg wounds through monitoring, engagement and intelligent intervention via WoundAlert system ($299,977)", "source_url": "https://reporter.nih.gov/project-details/10325512", "people": [{"name": "Jonathan M Engel", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44HL158375-01", "company": "Advanced Cooling Therapy, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-03", "observed": "2026-08-21", "amount_usd": 800000, "summary": "NIH award 1R44HL158375-01: Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation ($800,000)", "source_url": "https://reporter.nih.gov/project-details/10255387", "people": [{"name": "Erik Benjamin Kulstad", "role": "Principal Investigator"}, {"name": "Pasquale Santangeli", "role": "Principal Investigator"}, {"name": "Cory Michael Tschabrunn", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG074135-01", "company": "Moai Technologies, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-03", "observed": "2026-08-21", "amount_usd": 299812, "summary": "NIH award 1R44AG074135-01: Covering Care: Long-term care planning and education tool for AD/ADRD caregivers ($299,812)", "source_url": "https://reporter.nih.gov/project-details/10301286", "people": [{"name": "Olu Olofinboba", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R43CA254531-01A1", "company": "Glannaventa, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-02", "observed": "2026-08-21", "amount_usd": 399331, "summary": "NIH award 1R43CA254531-01A1: Outpatient Screening for Early-Stage High-Grade Serous Ovarian Cancer in Higher Risk Women ($399,331)", "source_url": "https://reporter.nih.gov/project-details/10325175", "people": [{"name": "John Black", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R41MH122201-02", "company": "Advanced Biomedical Informatics Group", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-02", "observed": "2026-08-21", "amount_usd": 451546, "summary": "NIH award 5R41MH122201-02: Generalizing and Standardizing fMRI Tools for Differentiating Mental Illnesses and Predicting Medication-Class Response in Patients ($451,546)", "source_url": "https://reporter.nih.gov/project-details/10264906", "people": [{"name": "Henry Jeremy Bockholt", "role": "Principal Investigator"}, {"name": "VINCE D CALHOUN", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 2, "new_award": false}, {"id": "nih:4R44HL151094-02", "company": "Curi Bio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-02", "observed": "2026-08-21", "amount_usd": 750000, "summary": "NIH award 4R44HL151094-02: Predictive assessment of acute and chronic cardiotoxicity using combinatorially matured hPSC-CMs ($750,000)", "source_url": "https://reporter.nih.gov/project-details/10274730", "people": [{"name": "Nicholas Andrew Geisse", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R41CA261420-01A1", "company": "Navigation Sciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-02", "observed": "2026-08-21", "amount_usd": 324002, "summary": "NIH award 1R41CA261420-01A1: Bronchoscopic lung navigation system for accurately excising lung nodules ($324,002)", "source_url": "https://reporter.nih.gov/project-details/10325793", "people": [{"name": "Jayender Jagadeesan", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R44AG074126-01", "company": "Silverbills Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-02", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 1R44AG074126-01: SilverBills: A Financial and Legal Tech Tool for Caregivers ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10302021", "people": [{"name": "Eric Chess", "role": "Principal Investigator"}, {"name": "Marci Lobel-Esrig", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA240022-03", "company": "Deephealth, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-02", "observed": "2026-08-21", "amount_usd": 927817, "summary": "NIH award 5R44CA240022-03: Towards Clinically Effective AI for Screening Mammography ($927,817)", "source_url": "https://reporter.nih.gov/project-details/10163142", "people": [{"name": "William Edward Lotter", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44DK113878-05", "company": "Stream Dx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-02", "observed": "2026-08-21", "amount_usd": 983074, "summary": "NIH award 5R44DK113878-05: Stream Dx: Point of Care Cellular Enabled IoT Communication Hub for Improved Diagnosis, Monitoring, and Post-Treatment Evaluation of LUTS ($983,074)", "source_url": "https://reporter.nih.gov/project-details/10224688", "people": [{"name": "James Hotaling", "role": "Principal Investigator"}, {"name": "Scott Bradford McClellan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:3R44GM134738-03S1", "company": "Glycan Therapeutics Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-02", "observed": "2026-08-21", "amount_usd": 272811, "summary": "NIH award 3R44GM134738-03S1: Diverse Heparan Sulfate Oligosaccharide Libraries For Understanding and Therapeutically Manipulating Glycosaminoglycans ($272,811)", "source_url": "https://reporter.nih.gov/project-details/10414669", "people": [{"name": "Vijayakanth Pagadala", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44NS084701-05", "company": "Creosalus, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-01", "observed": "2026-08-21", "amount_usd": 304861, "summary": "NIH award 5R44NS084701-05: Catheter for Large Volume Intraparenchymal Brain Therapies ($304,861)", "source_url": "https://reporter.nih.gov/project-details/10222787", "people": [{"name": "Vasiliy Abramov", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:2R44AG062072-02A1", "company": "Parabon Nanolabs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-01", "observed": "2026-08-21", "amount_usd": 1186625, "summary": "NIH award 2R44AG062072-02A1: Smartphone phenotype collection for diagnostic screening of mild cognitive impairment ($1,186,625)", "source_url": "https://reporter.nih.gov/project-details/10255750", "people": [{"name": "Steven L Armentrout", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DK105593-06", "company": "Cellf-bio Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-01", "observed": "2026-08-21", "amount_usd": 1393626, "summary": "NIH award 5R44DK105593-06: BioSphincter to Treat Fecal Incontinence. Phase 1/2 Clinical Trial. SBIR Phase IIB ($1,393,626)", "source_url": "https://reporter.nih.gov/project-details/10002239", "people": [{"name": "KHALIL N BITAR", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:1R43AG073141-01", "company": "Allied Innovative Systems, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-01", "observed": "2026-08-21", "amount_usd": 422885, "summary": "NIH award 1R43AG073141-01: Highly sensitive immunoassay for determination of biomarkers for neurodegenerative diseases ($422,885)", "source_url": "https://reporter.nih.gov/project-details/10255799", "people": [{"name": "Simon Bystryak", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44DK123910-03", "company": "Coaptech, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-01", "observed": "2026-08-21", "amount_usd": 774058, "summary": "NIH award 5R44DK123910-03: Percutaneous Ultrasound Gastrostomy: Clinical Evaluation of a Feeding Tube Placement Method in the Pediatric Population ($774,058)", "source_url": "https://reporter.nih.gov/project-details/10268249", "people": [{"name": "Howard Carolan", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44MH124567-02", "company": "Turing Medical Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-01", "observed": "2026-08-21", "amount_usd": 1822239, "summary": "NIH award 4R44MH124567-02: Motion-robust brain MRI for infants ($1,822,239)", "source_url": "https://reporter.nih.gov/project-details/10264551", "people": [{"name": "Todd William Deckard", "role": "Principal Investigator"}, {"name": "Nico Dosenbach", "role": "Principal Investigator"}, {"name": "Damien A Fair", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43MH128075-01", "company": "3-c Institute For Social Development", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-01", "observed": "2026-08-21", "amount_usd": 259291, "summary": "NIH award 1R43MH128075-01: Developing the Unified Protocol-Single Session Experience Platform for Adolescent Mental Health ($259,291)", "source_url": "https://reporter.nih.gov/project-details/10324965", "people": [{"name": "MELISSA E. DEROSIER", "role": "Principal Investigator"}, {"name": "JILL EHRENREICH-MAY", "role": "Principal Investigator"}, {"name": "Jessica Lee Schleider", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS110247-03", "company": "Minnetronix, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-09-01", "observed": "2026-08-21", "amount_usd": 395323, "summary": "NIH award 5R44NS110247-03: Automation of Extracorporeal Filtration of Subarachnoid Hemorrhage via Spinal Catheter ($395,323)", "source_url": "https://reporter.nih.gov/project-details/10252064", "people": [{"name": "Aaron Richard McCabe", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44NS113740-02", "company": "Barron Associates, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 725367, "summary": "NIH award 4R44NS113740-02: An Instrument to Assess the Functional Impact of Chronic Pain ($725,367)", "source_url": "https://reporter.nih.gov/project-details/10436545", "people": [{"name": "Brian R Clark", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:2R44EB028726-02", "company": "Double Helix Optics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 738430, "summary": "NIH award 2R44EB028726-02: Light Engineering Module for Fast High-Resolution Whole-Cell Imaging ($738,430)", "source_url": "https://reporter.nih.gov/project-details/10325024", "people": [{"name": "WARREN COLOMB", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43AG072981-01A1", "company": "Amissa, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 495787, "summary": "NIH award 1R43AG072981-01A1: A MULTIFACETED DIGITAL HEALTH PLATFORM TO ADVANCE ALZHEIMER'S DISEASE PATIENT MONITORING, SAFETY, CARE, AND RESEARCH. ($495,787)", "source_url": "https://reporter.nih.gov/project-details/10325493", "people": [{"name": "Jon Andrew Corkey", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AI155116-03", "company": "Hemex Health, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 827800, "summary": "NIH award 5R44AI155116-03: Rapid, Point of Care Diagnostic for Malaria, highly sensitive for P. vivax, with species differentiation ($827,800)", "source_url": "https://reporter.nih.gov/project-details/10231237", "people": [{"name": "PETER GALEN", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43DK130036-01", "company": "Diatech Diabetes, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 299989, "summary": "NIH award 1R43DK130036-01: Development of a personalized infusion failure detection algorithm combining tissue counter pressure and blood glucose data for closed-loop diabetes management ($299,989)", "source_url": "https://reporter.nih.gov/project-details/10296116", "people": [{"name": "John Clark Gray", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:4R44CA250877-02", "company": "Ramona Optics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 4R44CA250877-02: Rapid 3D Whole-Slide Digitization of Thick Cytopathology Slides with a Gigapixel Microscope ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10465303", "people": [{"name": "Mark Harfouche", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R43CA261312-01A1", "company": "Vizlitics Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 398721, "summary": "NIH award 1R43CA261312-01A1: OncoPath: Intelligent Clinical Pathway Decision Support Tool for Pre-Authorization Documentation in Non-Small Cell Lung Cancer Treatment ($398,721)", "source_url": "https://reporter.nih.gov/project-details/10325551", "people": [{"name": "Sharon Hensley Alford", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HG011433-02", "company": "Elegen Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 789906, "summary": "NIH award 5R44HG011433-02: Novel microfluidic platform for versatile, fast, low-cost DNA synthesis and assembly ($789,906)", "source_url": "https://reporter.nih.gov/project-details/10268210", "people": [{"name": "Matthew Hill", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44DE024919-05", "company": "Nanomag, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 580868, "summary": "NIH award 5R44DE024919-05: Commercialization Readiness Program (CRP) for Bioabsorbable Magnesium (Mg) Implants for Craniomaxillofacial Surgical Systems ($580,868)", "source_url": "https://reporter.nih.gov/project-details/10266126", "people": [{"name": "Stephen LeBeau", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R43HL158361-01", "company": "Advancedcpr Solutions LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 383376, "summary": "NIH award 1R43HL158361-01: Fully Automated Basic Life Services Resuscitation System to Improve Survival after Cardiac Arrest ($383,376)", "source_url": "https://reporter.nih.gov/project-details/10256435", "people": [{"name": "Keith Lurie", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA254692-02", "company": "Lynx Dx, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 995327, "summary": "NIH award 5R44CA254692-02: Urine Diagnostic Tool for the Detection of High-grade Prostate Cancer ($995,327)", "source_url": "https://reporter.nih.gov/project-details/10250527", "people": [{"name": "Yashar Sharifi Niknafs", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42CA217383-03", "company": "Morgan And Mendel Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-31", "observed": "2026-08-21", "amount_usd": 1008203, "summary": "NIH award 5R42CA217383-03: Robust Predictor of Breast Cancer Risk ($1,008,203)", "source_url": "https://reporter.nih.gov/project-details/10219183", "people": [{"name": "Harry Ostrer", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44EY028081-03", "company": "Eyenuk, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-30", "observed": "2026-08-21", "amount_usd": 747733, "summary": "NIH award 5R44EY028081-03: Fully-Automated Lesion Characterization in Ultrawide-Field Retinal Images ($747,733)", "source_url": "https://reporter.nih.gov/project-details/10247802", "people": [{"name": "Sandeep Bhat", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43IP001168-01A1", "company": "Immport Therapeutics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-30", "observed": "2026-08-21", "amount_usd": 243000, "summary": "NIH award 1R43IP001168-01A1: Identification of Serodiagnostic Epitopes for SARS-CoV-2, endemic HCoV?s and influenza virus ($243,000)", "source_url": "https://reporter.nih.gov/project-details/10259177", "people": [{"name": "DAVID CAMERINI", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41AG073024-01", "company": "Neuroscope Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-30", "observed": "2026-08-21", "amount_usd": 461031, "summary": "NIH award 1R41AG073024-01: Development of perivascular space mapping toolset as a diagnostic aid for Alzheimer's disease ($461,031)", "source_url": "https://reporter.nih.gov/project-details/10255954", "people": [{"name": "Jeiran Choupan", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:3R42DC015142-03S1", "company": "Prentke Romich Company", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-30", "observed": "2026-08-21", "amount_usd": 120352, "summary": "NIH award 3R42DC015142-03S1: Compatibility between Brain-Computer Interface and High-Efficiency Augmentative and Alternative Communication Systems ($120,352)", "source_url": "https://reporter.nih.gov/project-details/10474856", "people": [{"name": "Russell Thomas Cross", "role": "Principal Investigator"}, {"name": "KATYA J HILL", "role": "Principal Investigator"}, {"name": "JANE E HUGGINS", "role": "Principal Investigator"}], "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41HG012163-01", "company": "Electronic Biosciences, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-30", "observed": "2026-08-21", "amount_usd": 399999, "summary": "NIH award 1R41HG012163-01: Long-lived Platform Development for Exonuclease-Based Sequencing ($399,999)", "source_url": "https://reporter.nih.gov/project-details/10322603", "people": [{"name": "Eric Ervin", "role": "Principal Investigator"}], "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R43AI157508-01A1", "company": "Redbud Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-30", "observed": "2026-08-21", "amount_usd": 288729, "summary": "NIH award 1R43AI157508-01A1: Rapid point-of-care molecular test for HCV VL ($288,729)", "source_url": "https://reporter.nih.gov/project-details/10330833", "people": [{"name": "Jay Kenneth Fisher", "role": "Principal Investigator"}], "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44CA243827-03", "company": "In Vivo Analytics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-30", "observed": "2026-08-21", "amount_usd": 969173, "summary": "NIH award 5R44CA243827-03: Fluorescence tomography plugin unit for spatial monitoring of T cell migration ($969,173)", "source_url": "https://reporter.nih.gov/project-details/10264164", "people": [{"name": "Alexander D. Klose", "role": "Principal Investigator"}], "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "sbir:DOD:W81XWH21P0120", "company": "Lynntech Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-08-30", "observed": "2026-09-18", "amount_usd": 249999, "summary": "DOD SBIR Phase I award $249,999: Portable Oxygen Generator for Deployed Army Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H211-009-0082"}, {"id": "sbir:DOD:W81XWH21P0117", "company": "Tda Research, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-08-30", "observed": "2026-09-18", "amount_usd": 249997, "summary": "DOD SBIR Phase I award $249,997: Stackable Portable Oxygen Generator for Deployed Army Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H211-009-0191"}, {"id": "nih:3R44MH122066-03S1", "company": "Turing Medical Technologies Inc", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-28", "observed": "2026-08-21", "amount_usd": 300000, "summary": "NIH award 3R44MH122066-03S1: Visual biofeedback to reduce head motion during MRI scans ($300,000)", "source_url": "https://reporter.nih.gov/project-details/10442332", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:4R44AA028463-02", "company": "Lyssn.io, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-27", "observed": "2026-08-21", "amount_usd": 855238, "summary": "NIH award 4R44AA028463-02: ClientBot: A conversational agent that supports skills practice and feedback for Motivational Interviewing for AUD ($855,238)", "source_url": "https://reporter.nih.gov/project-details/10449463", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R42HG010855-03", "company": "Matchstick Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-27", "observed": "2026-08-21", "amount_usd": 984799, "summary": "NIH award 5R42HG010855-03: PIXUL-FFPE: High throughput platform for chromatin and DNA sample preparation from formalin fixed paraffin embedded (FFPE) tissue samples. ($984,799)", "source_url": "https://reporter.nih.gov/project-details/10259723", "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R41AG073066-01", "company": "Iscreen 2 Prevent LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-27", "observed": "2026-08-21", "amount_usd": 461215, "summary": "NIH award 1R41AG073066-01: An AI-assisted screening platform within a multivariate framework for biomarkers of mild cognitive impairment due to Alzheimer's disease ($461,215)", "source_url": "https://reporter.nih.gov/project-details/10252098", "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:1R41DK131650-01", "company": "Optosurgical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-27", "observed": "2026-08-21", "amount_usd": 256579, "summary": "NIH award 1R41DK131650-01: Dye-free, multimodal, quantitative imaging to assess bowel perfusion during laparoscopic colorectal resection ($256,579)", "source_url": "https://reporter.nih.gov/project-details/10383413", "award_phase": "STTR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:2R44DA047150-02", "company": "Square2 Systems, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-27", "observed": "2026-08-21", "amount_usd": 836571, "summary": "NIH award 2R44DA047150-02: Socializing a Science-based Digital Therapeutic for Substance Use Disorders ($836,571)", "source_url": "https://reporter.nih.gov/project-details/10323186", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:5R44CA206801-05", "company": "Clarix Imaging Corporation", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-27", "observed": "2026-08-21", "amount_usd": 1460136, "summary": "NIH award 5R44CA206801-05: Real-time volumetric specimen imager for 3D intra-operative lumpectomy margin assessment ($1,460,136)", "source_url": "https://reporter.nih.gov/project-details/10208795", "award_phase": "SBIR Phase II", "award_year": 5, "new_award": false}, {"id": "nih:1R44EY033254-01", "company": "Cryocrate, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-27", "observed": "2026-08-21", "amount_usd": 753985, "summary": "NIH award 1R44EY033254-01: Late-stage Preclinical Development and cGMP Production of a First-in-Class Cornea Cryopreservation Kit Based on FDA Feedback ($753,985)", "source_url": "https://reporter.nih.gov/project-details/10326323", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "breakthrough:DEN200064", "company": "Canary Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-08-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN200064: CANARY TIBIAL EXTENSION WITH CANARY HEALTH IMPLANTED REPORTING PROCESSOR (CHIRP) SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P210007", "company": "Microtransponder, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-08-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P210007: VIVISTIM PAIRED VNS SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "nih:5R44DA050162-03", "company": "Paasp US, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-26", "observed": "2026-08-21", "amount_usd": 725450, "summary": "NIH award 5R44DA050162-03: PAASPort: A web-based tool for nonclinical research quality assessment and risk of bias management to advance development of innovative medications ($725,450)", "source_url": "https://reporter.nih.gov/project-details/10217084", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43GM143999-01", "company": "Gradient Medical, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-26", "observed": "2026-08-21", "amount_usd": 251914, "summary": "NIH award 1R43GM143999-01: Feasibility of INSPIRE Technology to Enhance CRISPR Mediated Genome Editors In Vivo ($251,914)", "source_url": "https://reporter.nih.gov/project-details/10324621", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44MH114944-04", "company": "Neurolux, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-26", "observed": "2026-08-21", "amount_usd": 995447, "summary": "NIH award 5R44MH114944-04: Advanced wireless optogenetics and photometry system for neuroscience research ($995,447)", "source_url": "https://reporter.nih.gov/project-details/10240473", "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:1R43CA257792-01A1", "company": "One World Design And Manufacturing Group Ltd", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-26", "observed": "2026-08-21", "amount_usd": 397221, "summary": "NIH award 1R43CA257792-01A1: MammoVest\u2122 Simulator System and Curriculum for Initial and Continued Education in Mammography Positioning ($397,221)", "source_url": "https://reporter.nih.gov/project-details/10325751", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44AR074375-03", "company": "Kitware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-26", "observed": "2026-08-21", "amount_usd": 445896, "summary": "NIH award 5R44AR074375-03: Quantitative, Image-Based Osteoarthritis Biomarkers Software Resubmission ($445,896)", "source_url": "https://reporter.nih.gov/project-details/10250562", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44AG060781-03", "company": "Vecna Technologies, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-26", "observed": "2026-08-21", "amount_usd": 2225928, "summary": "NIH award 5R44AG060781-03: VGo-Assist, A Mobile Telepresence Robot to Engage Persons with Alzheimer's Disease and Related Dementias ($2,225,928)", "source_url": "https://reporter.nih.gov/project-details/10268190", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44MH118780-03", "company": "Adaptive Testing Technologies", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-25", "observed": "2026-08-21", "amount_usd": 746613, "summary": "NIH award 5R44MH118780-03: Computerized Adaptive Suicidal Risk Stratification and Prediction ($746,613)", "source_url": "https://reporter.nih.gov/project-details/10254382", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44EB028208-03", "company": "Capesym, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-25", "observed": "2026-08-21", "amount_usd": 732292, "summary": "NIH award 5R44EB028208-03: Low-Cost, Low-Dose Flat Panel X-ray Detectors with a Novel Semiconductor ($732,292)", "source_url": "https://reporter.nih.gov/project-details/10245281", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:2R44PS005188-02", "company": "Instadiagnostics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-25", "observed": "2026-08-21", "amount_usd": 572902, "summary": "NIH award 2R44PS005188-02: A Rapid Multiplexed Assay for the Diagnosis of Viral Hepatitis at the Point of Care ($572,902)", "source_url": "https://reporter.nih.gov/project-details/10005702", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "nih:1R44AG074128-01", "company": "Whiplash Technology, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-25", "observed": "2026-08-21", "amount_usd": 299462, "summary": "NIH award 1R44AG074128-01: Design, Development, and Validation of an AI-enabled Legal Planning and Financial Management Training Solution for ADRD Caregivers ($299,462)", "source_url": "https://reporter.nih.gov/project-details/10301832", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:1R44MH125687-01A1", "company": "Direct Electron, Lp", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-24", "observed": "2026-08-21", "amount_usd": 1104885, "summary": "NIH award 1R44MH125687-01A1: An energy discriminating direct detector for multi-color SEM ($1,104,885)", "source_url": "https://reporter.nih.gov/project-details/10325452", "award_phase": "SBIR Phase II", "award_year": 1, "new_award": true}, {"id": "nih:2R44ES024031-04", "company": "Ludlum Measurements, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-24", "observed": "2026-08-21", "amount_usd": 1000000, "summary": "NIH award 2R44ES024031-04: AQEarth: Program Empowering Communities to Explore Map and Improve Air Quality ($1,000,000)", "source_url": "https://reporter.nih.gov/project-details/10311244", "award_phase": "SBIR Phase II", "award_year": 4, "new_award": false}, {"id": "nih:5R44AR075481-03", "company": "Kitware, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-24", "observed": "2026-08-21", "amount_usd": 734040, "summary": "NIH award 5R44AR075481-03: Virtual Rotator Cuff Arthroscopic Skill Trainer ($734,040)", "source_url": "https://reporter.nih.gov/project-details/10248494", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42DK120253-03", "company": "Newventureiq, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-24", "observed": "2026-08-21", "amount_usd": 775114, "summary": "NIH award 5R42DK120253-03: A Deep Learning Model to Improve Pathologist Interpretation of Donor Kidney Biopsies ($775,114)", "source_url": "https://reporter.nih.gov/project-details/10266188", "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R42DA050398-03", "company": "Q2i, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-24", "observed": "2026-08-21", "amount_usd": 594298, "summary": "NIH award 5R42DA050398-03: Technology Improving Success of Medication-Assisted Treatment in Primary Care ($594,298)", "source_url": "https://reporter.nih.gov/project-details/10223257", "award_phase": "STTR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43AG074812-01", "company": "Toi Labs, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-23", "observed": "2026-08-21", "amount_usd": 299676, "summary": "NIH award 1R43AG074812-01: Use of a Novel Toilet Seat to Passively Collect Digital Biomarkers in Assisted Living Settings ($299,676)", "source_url": "https://reporter.nih.gov/project-details/10325655", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44HG010445-03", "company": "Coral Genomics, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-23", "observed": "2026-08-21", "amount_usd": 1205206, "summary": "NIH award 5R44HG010445-03: Multiplexing methods to reduce sequencing costs ($1,205,206)", "source_url": "https://reporter.nih.gov/project-details/10262952", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:1R43HL160318-01", "company": "Boundless Science, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-23", "observed": "2026-08-21", "amount_usd": 299928, "summary": "NIH award 1R43HL160318-01: Ultrasound Enhanced Extracorporeal Membrane Oxygenation ($299,928)", "source_url": "https://reporter.nih.gov/project-details/10323520", "award_phase": "SBIR Phase I", "award_year": 1, "new_award": true}, {"id": "nih:5R44NS108869-03", "company": "Axonova Medical, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-23", "observed": "2026-08-21", "amount_usd": 934090, "summary": "NIH award 5R44NS108869-03: Generation of Tissue Engineered Nerve Grafts from GalSafe Porcine Neurons ($934,090)", "source_url": "https://reporter.nih.gov/project-details/10268167", "award_phase": "SBIR Phase II", "award_year": 3, "new_award": false}, {"id": "nih:5R44CA239461-06", "company": "Cancer Targeted Technology, LLC", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-23", "observed": "2026-08-21", "amount_usd": 365867, "summary": "NIH award 5R44CA239461-06: Clinical Evaluation of an Innovative PSMA-targeted Radiotherapy, CTT1403, in Prostate Cancer ($365,867)", "source_url": "https://reporter.nih.gov/project-details/10188466", "award_phase": "SBIR Phase II", "award_year": 6, "new_award": false}, {"id": "nih:5R44HL154937-02", "company": "Cardialen, Inc.", "kind": "nih_award", "kind_label": "NIH award", "date": "2021-08-22", "observed": "2026-08-21", "amount_usd": 527030, "summary": "NIH award 5R44HL154937-02: Novel Therapy System for Atrial Fibrillation ($527,030)", "source_url": "https://reporter.nih.gov/project-details/10252060", "award_phase": "SBIR Phase II", "award_year": 2, "new_award": false}, {"id": "breakthrough:DEN190056", "company": "Siemens Healthcare Diagnostics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-08-20", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN190056: ADVIA CENTAUR ENHANCED LIVER FIBROSIS (ELF)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W81XWH21P0122", "company": "WetWare BioSystems LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-08-16", "observed": "2026-09-18", "amount_usd": 249976, "summary": "DOD SBIR Phase I award $249,976: IRONCROWN: A Novel Medical Device for the Prehospital Diagnosis and Treatment of Traumatic Brain Injury", "source_url": "https://www.sbir.gov/awards?search=H211-002-0086"}, {"id": "sbir:NASA:80NSSC21C0552", "company": "Nahlia Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-07-26", "observed": "2026-09-18", "amount_usd": 759968, "summary": "NASA SBIR Phase II award $759,968: Autonomous Medical Response Agent (AMRA) for Prolonged Field Care in Space", "source_url": "https://www.sbir.gov/awards?search=204929"}, {"id": "breakthrough:K210542", "company": "Carlsmed, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-06-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K210542: APREVO TRANSFORAMINAL IBF", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W81XWH-18-C-0310", "company": "Makel Engineering, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-06-30", "observed": "2026-09-18", "amount_usd": 1033203, "summary": "DOD STTR Phase II award $1,033,203: Inspire - In-Mask Sensors for Physiological Investigation of Respiratory Exhalation", "source_url": "https://www.sbir.gov/awards?search=H2-0283"}, {"id": "breakthrough:DEN200069", "company": "Cognoa, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-06-02", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN200069: COGNOA ASD DIAGNOSIS AID", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W81XWH-19-C-0023", "company": "Soar Technology, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-06-01", "observed": "2026-09-18", "amount_usd": 2050529, "summary": "DOD STTR Phase II award $2,050,529: Combat Casualty Automated Trainer (C-CHAT)", "source_url": "https://www.sbir.gov/awards?search=H2-0376"}, {"id": "sbir:DOD:W81XWH-21-C-0034", "company": "Painqx Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-05-17", "observed": "2026-09-18", "amount_usd": 1493151, "summary": "DOD SBIR Phase II award $1,493,151: Development of a Device Utilizing EEG for the Objective Quantification and Analysis of Chronic Pain", "source_url": "https://www.sbir.gov/awards?search=H2S-0013"}, {"id": "breakthrough:DEN200046", "company": "Neurolutions, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-04-23", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN200046: NEUROLUTIONS IPSIHAND UPPER EXTREMITY REHABILITATION SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:FA8649-21-P-1264", "company": "iAssay, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-04-19", "observed": "2026-09-18", "amount_usd": 49983, "summary": "DOD SBIR Phase I award $49,983: iAssay: Universal, Compact and Portable Point of Care Rest Reader and Platform", "source_url": "https://www.sbir.gov/awards?search=FX211-CSO1-0198"}, {"id": "sbir:DOD:HR001121C0136", "company": "Creare LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-04-15", "observed": "2026-09-18", "amount_usd": 224545, "summary": "DOD SBIR Phase I award $224,545: Development of a Smart REBOA Catheter", "source_url": "https://www.sbir.gov/awards?search=D20I-26-0350"}, {"id": "sbir:DOD:FA8649-21-P-1353", "company": "Tournitek Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-04-12", "observed": "2026-09-18", "amount_usd": 49590, "summary": "DOD STTR Phase I award $49,590: TourniTek: Pre-hospital thermal regulation for the prolonged field care of traumatic injuries", "source_url": "https://www.sbir.gov/awards?search=FX21A-TCSO1-0045"}, {"id": "sbir:DOD:W81XWH19C0016", "company": "Tier 1 Performance Solutions LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-04-05", "observed": "2026-09-18", "amount_usd": 1695661, "summary": "DOD STTR Phase II award $1,695,661: ECCCHO: Effective Combat Casualty Care Handoff Operations", "source_url": "https://www.sbir.gov/awards?search=H2-0379"}, {"id": "breakthrough:DEN200050", "company": "Helius Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-03-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN200050: PORTABLE NEUROMODULATION STIMULATOR (PONS)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P200046", "company": "Medtronic, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-03-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P200046: HARMONY TPV SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:FA8649-21-P-0907", "company": "Definitive Biotechnologies LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-03-09", "observed": "2026-09-18", "amount_usd": 749991, "summary": "DOD SBIR Phase II award $749,991: Disposable, multiplex molecular device for simultaneous Point-of-Care COVID-19 / influenza Diagnosis (CIDx)", "source_url": "https://www.sbir.gov/awards?search=F2D-1631"}, {"id": "hde:H200001", "company": "paragon 28, inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2021-02-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H200001: Patient Specific Talus Spacer", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "breakthrough:P200039", "company": "Shockwave Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-02-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P200039: SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:FA8649-21-P-0359", "company": "WetWare BioSystems LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-02-05", "observed": "2026-09-18", "amount_usd": 49996, "summary": "DOD SBIR Phase I award $49,996: IRONCROWN: A Novel Medical Device for the Rapid and Noninvasive Detection, Diagnosis, and Treatment of Blast-Related Traumatic Brain Injury", "source_url": "https://www.sbir.gov/awards?search=FX203-CSO1-0812"}, {"id": "sbir:DOD:W81XWH21C0006", "company": "Nakamir Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-01-15", "observed": "2026-09-18", "amount_usd": 1099352, "summary": "DOD SBIR Phase II award $1,099,352: Augmented Reality Surgical Visualization Tool for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2-0553"}, {"id": "sbir:DOD:HDTRA-121-C-0008", "company": "Genecapture, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-01-14", "observed": "2026-09-18", "amount_usd": 999752, "summary": "DOD SBIR Phase II award $999,752: Infectious Disease Diagnostics and Differentiation of Viral vs. Bacterial Infections for Point of Care Applications", "source_url": "https://www.sbir.gov/awards?search=C2-0567"}, {"id": "breakthrough:K201778", "company": "Abbott Laboratories", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2021-01-08", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K201778: I-STAT ALINITY SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W81XWH-21-P-0003", "company": "CFD Research Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2021-01-04", "observed": "2026-09-18", "amount_usd": 166488, "summary": "DOD STTR Phase I award $166,488: Point-of-care Nucleic Acid Assays", "source_url": "https://www.sbir.gov/awards?search=A20B-T022-0100"}, {"id": "breakthrough:K202034", "company": "Carlsmed, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2020-12-03", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K202034: APREVO INTERVERTEBRAL BODY FUSION DEVICE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "hde:H190001", "company": "HDL Therapeutics, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2020-12-01", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H190001: Plasma Delipidation System (PDS-2\u2122 Syste", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H190003", "company": "Profound Medical, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2020-11-27", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H190003: Sonalleve MR-HIFU", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "breakthrough:BP130076/S034", "company": "Cerus Corporation", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2020-11-24", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth BP130076/S034: INTERCEPT BLOOD SYSTEM FOR PLASMA", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W81XWH-21-C-0030", "company": "Luna Innovations Incorporated", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-11-16", "observed": "2026-09-18", "amount_usd": 649998, "summary": "DOD SBIR Phase II award $649,998: FAST-DENV\u2122: A Point-of-Care Dengue Serodiagnostic", "source_url": "https://www.sbir.gov/awards?search=A2-8563"}, {"id": "breakthrough:DEN200033", "company": "Nightware, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2020-11-06", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN200033: NIGHTWARE KIT", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P200006", "company": "Foundation Medicine, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2020-10-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P200006: FOUNDATIONONE LIQUID CDX", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W81XWH-21-P-0018", "company": "Critical Innovations LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-10-08", "observed": "2026-09-18", "amount_usd": 167500, "summary": "DOD SBIR Phase I award $167,500: Succor Combat Foam for Advanced Wound Care of Traumatized Tissue", "source_url": "https://www.sbir.gov/awards?search=A202-137-0027"}, {"id": "sbir:DOD:W81XWH-21-P-0040", "company": "Design Interactive, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-10-08", "observed": "2026-09-18", "amount_usd": 111498, "summary": "DOD SBIR Phase I award $111,498: Asclepius: AI perception system for combat casualty care documentation", "source_url": "https://www.sbir.gov/awards?search=A202-136-0142"}, {"id": "sbir:DOD:W81XWH20C0060", "company": "Triton Systems, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-09-14", "observed": "2026-09-18", "amount_usd": 1099290, "summary": "DOD SBIR Phase II award $1,099,290: Low Cost Point-of-Care Diagnostic Platform for Reliable Therapeutic Drug Monitoring", "source_url": "https://www.sbir.gov/awards?search=H2-0545"}, {"id": "sbir:DOD:W81XWH-20-C-0094", "company": "Luna Innovations Incorporated", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-09-08", "observed": "2026-09-18", "amount_usd": 1099995, "summary": "DOD SBIR Phase II award $1,099,995: Development of the MagAid for Simplified Pain Management During Prolonged Field Care Using Pulsed Magnetic Fields", "source_url": "https://www.sbir.gov/awards?search=H2-0589"}, {"id": "breakthrough:K202215", "company": "Roche Molecular Systems, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2020-09-02", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K202215: COBAS BKV", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P160017/S076", "company": "Medtronic Minimed, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2020-08-31", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P160017/S076: MINIMED 770G SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:NASA:80NSSC20C0530", "company": "Nahlia Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-08-29", "observed": "2026-09-18", "amount_usd": 124977, "summary": "NASA SBIR Phase I award $124,977: Autonomous Medical Response Agent (AMRA) for Prolonged Field Care in Space", "source_url": "https://www.sbir.gov/awards?search=204929"}, {"id": "breakthrough:P190032", "company": "Foundation Medicine, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2020-08-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P190032: FOUNDATIONONE LIQUID CDX", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:USDA:2020-06041", "company": "Omnivis Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-08-20", "observed": "2026-09-18", "amount_usd": 100000, "summary": "USDA SBIR Phase I award $100,000: COVID-19 Rapid Response: A Handheld Diagnostic Device for COVID-19 in Meat and Poultry Processing Facilities", "source_url": "https://www.sbir.gov/awards?search=2020-06041"}, {"id": "breakthrough:P200010", "company": "Guardant Health, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2020-08-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P200010: GUARDANT360 CDx", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:HDTRA1-20-C-0030", "company": "Paratus Diagnostics", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-08-06", "observed": "2026-09-18", "amount_usd": 1387564, "summary": "DOD SBIR Phase II award $1,387,564: High Sensitivity, Low Complexity, Multiplexed Diagnostic Devices", "source_url": "https://www.sbir.gov/awards?search=C2-0566"}, {"id": "breakthrough:DEN200015", "company": "Roche Molecular Systems, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2020-07-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN200015: COBAS EBV", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K201098", "company": "Ambu Innovation Gmbh", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2020-07-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K201098: AMBU DUODENO SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W81XWH-16-C-0176", "company": "Aptitude Medical Systems Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-07-06", "observed": "2026-09-18", "amount_usd": 3049750, "summary": "DOD SBIR Phase II award $3,049,750: Real-Time Small-Volume Blood Sampling and Analysis for Coagulopathy of Trauma Analytes", "source_url": "https://www.sbir.gov/awards?search=H2-0189"}, {"id": "sbir:DOD:FA8649-20-9-9119", "company": "Aceso Plasma LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-06-15", "observed": "2026-09-18", "amount_usd": 1500000, "summary": "DOD SBIR Phase II award $1,500,000: Aceso Plasma Generator- Accelerated Wound Healing and Disinfection", "source_url": "https://www.sbir.gov/awards?search=FX192-SO1-0584"}, {"id": "sbir:DOD:W81XWH-21-C-0007", "company": "Real-time Innovations, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-04-30", "observed": "2026-09-18", "amount_usd": 637240, "summary": "DOD SBIR Phase II award $637,240: Methodologies and Tools for Securing Medical Device Systems in Integrated Clinical Environments (ICE)", "source_url": "https://www.sbir.gov/awards?search=A2-8370"}, {"id": "sbir:DOD:W81XWH-17-C-0176", "company": "Vitame Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-04-01", "observed": "2026-09-18", "amount_usd": 1000000, "summary": "DOD SBIR Phase II award $1,000,000: Iron.Scan \u2013 a multiplexed point-of-care diagnostic system for diagnosing anemia and iron deficiency", "source_url": "https://www.sbir.gov/awards?search=H2-0239"}, {"id": "sbir:DOD:140D0420C0002", "company": "Circuit Therapeutics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-03-31", "observed": "2026-09-18", "amount_usd": 2248756, "summary": "DOD SBIR Phase II award $2,248,756: Wearable Light Delivery in Optogenetics Clinical Applications", "source_url": "https://www.sbir.gov/awards?search=140D0420C0002"}, {"id": "sbir:DOD:W81XWH-20-C-0071", "company": "Inbios International Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-03-12", "observed": "2026-09-18", "amount_usd": 961577, "summary": "DOD SBIR Phase II award $961,577: Diagnostic Device for Norovirus Gastroenteritis", "source_url": "https://www.sbir.gov/awards?search=A2-8137"}, {"id": "sbir:DOD:FA8649-20-P-0816", "company": "Diversified 3D Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-03-09", "observed": "2026-09-18", "amount_usd": 49846, "summary": "DOD SBIR Phase I award $49,846: Rapid 3D Printing of Patient-specific Orthopedic Devices from Exiom", "source_url": "https://www.sbir.gov/awards?search=FX201-CSO1-0483"}, {"id": "sbir:DOD:FA8649-20-P-0822", "company": "Nirsense, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-03-09", "observed": "2026-09-18", "amount_usd": 49997, "summary": "DOD SBIR Phase I award $49,997: Near InfraRed Spectroscopy Insight for General Hemodynamic Tracking (NIRSIGHT)", "source_url": "https://www.sbir.gov/awards?search=FX201-CSO1-0506"}, {"id": "sbir:DOD:FA8649-20-P-0813", "company": "FireHUD, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-03-09", "observed": "2026-09-18", "amount_usd": 49999, "summary": "DOD SBIR Phase I award $49,999: Wearable Monitor to Detect Physiological Degradation of Aircrew and Mission Partners During High Altitude Unpressurized Operations", "source_url": "https://www.sbir.gov/awards?search=FX201-CSO1-0319"}, {"id": "sbir:DOD:FA8649-20-P-0703", "company": "Elemeno Health, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-03-09", "observed": "2026-09-18", "amount_usd": 47790, "summary": "DOD SBIR Phase I award $47,790: Point-of-Care Microlearning, as a Service: Drive MHS Clinical and Nursing Practice Consistency, Reducing Errors and Improving Outcomes", "source_url": "https://www.sbir.gov/awards?search=FX201-CSO1-0761"}, {"id": "sbir:DOD:FA8649-20-P-0095", "company": "Aceso Plasma LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-02-11", "observed": "2026-09-18", "amount_usd": 49000, "summary": "DOD SBIR Phase I award $49,000: Aceso Plasma Generator- Accelerated Wound Healing and Disinfection Device", "source_url": "https://www.sbir.gov/awards?search=FX192-SO1-0584"}, {"id": "breakthrough:DEN190040", "company": "Bay Labs, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2020-02-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN190040: CAPTION GUIDANCE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:FA8649-20-P-0420", "company": "OmniScience LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2020-01-16", "observed": "2026-09-18", "amount_usd": 100000, "summary": "DOD STTR Phase II award $100,000: ARCHER: an AI Readiness and Control Helmet for EEG Recognition", "source_url": "https://www.sbir.gov/awards?search=F19B-001-0155"}, {"id": "breakthrough:K193202", "company": "Boston Scientific", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2019-12-13", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K193202: EXALT MODEL D, SINGLE-USE DUODENOSCOPE, EXALT CONTROLLER", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P190016", "company": "Tusker Medical", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2019-11-25", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P190016: TULA SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W81XWH-20-C-0025", "company": "Daxor Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-10-31", "observed": "2026-09-18", "amount_usd": 1098669, "summary": "DOD SBIR Phase II award $1,098,669: Direct Blood Volume Analyzer for Improvement of Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=A2-7920"}, {"id": "sbir:DOD:W81XWH-20-C-0034", "company": "Charles River Analytics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-10-31", "observed": "2026-09-18", "amount_usd": 999954, "summary": "DOD SBIR Phase II award $999,954: Automated Ruggedized Combat Casualty Care - Intervention (ARC3-I)", "source_url": "https://www.sbir.gov/awards?search=A2-7882"}, {"id": "sbir:DOD:W81XWH-20-P-0035", "company": "Zymeron Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-10-30", "observed": "2026-09-18", "amount_usd": 111495, "summary": "DOD SBIR Phase I award $111,495: Rapid Point of Care Diagnostic Tests to Determine Dengue Serostatus", "source_url": "https://www.sbir.gov/awards?search=A192-124-0314"}, {"id": "sbir:DOD:W81XWH-20-P-0032", "company": "Luna Innovations Incorporated", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-10-30", "observed": "2026-09-18", "amount_usd": 111499, "summary": "DOD SBIR Phase I award $111,499: FAST-DENV\u2122: A Point-of-Care Dengue Serodiagnostic", "source_url": "https://www.sbir.gov/awards?search=A192-124-0253"}, {"id": "breakthrough:DEN190025", "company": "Orasure Technologies", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2019-10-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN190025: ORAQUICK EBOLA RAPID ANTIGEN TEST", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W912CG-19-C-0004", "company": "Ripple LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-09-12", "observed": "2026-09-18", "amount_usd": 3000000, "summary": "DOD SBIR Phase II award $3,000,000: Athena: Fully implantable stimulation and recording platform", "source_url": "https://www.sbir.gov/awards?search=D2-2247"}, {"id": "hde:H170001", "company": "ApiFix, Ltd.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2019-08-23", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H170001: Minimally Invasive Deformity Correction", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "breakthrough:P180050", "company": "Cvrx, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2019-08-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P180050: BAROSTIM NEO SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "hde:H190005", "company": "Zimmer Biomet Spine, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2019-08-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H190005: The Tether\u2122 - Vertebral Body Tethering S", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:NASA:80NSSC19C0133", "company": "Actuated Medical, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-08-06", "observed": "2026-09-18", "amount_usd": 743150, "summary": "NASA SBIR Phase II award $743,150: Additive Manufacturing of PEEK and Fiber-Reinforced PEEK for NASA Applications and Custom Medical Devices", "source_url": "https://www.sbir.gov/awards?search=181165"}, {"id": "sbir:DOD:W81XWH19C0138", "company": "CFD Research Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-08-05", "observed": "2026-09-18", "amount_usd": 162445, "summary": "DOD STTR Phase I award $162,445: POC Blood Coagulopathy Monitor", "source_url": "https://www.sbir.gov/awards?search=H19A-001-0024"}, {"id": "sbir:DOD:FA8649-19-9-9021", "company": "Shift Labs, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-08-02", "observed": "2026-09-18", "amount_usd": 1495002, "summary": "DOD SBIR Phase II award $1,495,002: Development of a Wirelessly-Enabled Infusion Monitor for BATDOK-Integrated Lightweight Prolonged Field Care", "source_url": "https://www.sbir.gov/awards?search=F191-005-1894"}, {"id": "sbir:DOD:W81XWH19C0130", "company": "Innosense Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-07-24", "observed": "2026-09-18", "amount_usd": 162499, "summary": "DOD STTR Phase I award $162,499: Multi-Functional Nanotube-Based Sensor Array for Detecting Blood Coagulation Defects", "source_url": "https://www.sbir.gov/awards?search=H19A-001-0007"}, {"id": "sbir:DOD:W81XWH19C0112", "company": "Vivonics Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-07-08", "observed": "2026-09-18", "amount_usd": 162500, "summary": "DOD SBIR Phase I award $162,500: Simplified Pneumothorax Emergency Air Release Guided Using NIRS (SPEARGUN)", "source_url": "https://www.sbir.gov/awards?search=H191-007-0009"}, {"id": "sbir:DOD:W81XWH19C0132", "company": "Nakamir Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-07-08", "observed": "2026-09-18", "amount_usd": 161809, "summary": "DOD SBIR Phase I award $161,809: Augmented Reality Surgical Visualization Tool for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H191-001-0113"}, {"id": "sbir:DOD:W81XWH19C0147", "company": "Luna Innovations Incorporated", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-07-08", "observed": "2026-09-18", "amount_usd": 161960, "summary": "DOD SBIR Phase I award $161,960: Development of the MagAid for Simplified Pain Management During Prolonged Field Care using Magnetic Fields", "source_url": "https://www.sbir.gov/awards?search=H191-011-0120"}, {"id": "sbir:DOD:W81XWH-20-C-0010", "company": "Arete Associates", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-07-03", "observed": "2026-09-18", "amount_usd": 999973, "summary": "DOD SBIR Phase II award $999,973: Smart Patient Monitoring Algorithms for Ruggedized Autonomous Combat Casualty Care Capability", "source_url": "https://www.sbir.gov/awards?search=A2-7789"}, {"id": "sbir:DOD:W81XWH-20-C-0011", "company": "Cambridge Research & Development, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-07-03", "observed": "2026-09-18", "amount_usd": 1030551, "summary": "DOD SBIR Phase II award $1,030,551: Patient Transportable Tactical Combat Casualty Care Documentation Capability", "source_url": "https://www.sbir.gov/awards?search=A2-7812"}, {"id": "sbir:DOD:W81XWH-20-C-0001", "company": "Maxentric Technologies LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-07-03", "observed": "2026-09-18", "amount_usd": 1099976, "summary": "DOD SBIR Phase II award $1,099,976: Medical Sensors Powered by Human Generated Energy", "source_url": "https://www.sbir.gov/awards?search=A2-7735"}, {"id": "sbir:DOD:W81XWH19C0087", "company": "Sensimetrics Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-06-19", "observed": "2026-09-18", "amount_usd": 1068606, "summary": "DOD SBIR Phase II award $1,068,606: Compact Speaker Array for Clinical Testing of Ear-level Devices", "source_url": "https://www.sbir.gov/awards?search=H2-0444"}, {"id": "hde:H180002", "company": "novocure, gmbh", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2019-05-23", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H180002: Optune Lua", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH19C0078", "company": "Ftl Labs Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-05-13", "observed": "2026-09-18", "amount_usd": 1074883, "summary": "DOD SBIR Phase II award $1,074,883: Compact Speaker Array for Clinical Testing of Ear-level Devices", "source_url": "https://www.sbir.gov/awards?search=H2-0422"}, {"id": "sbir:DOD:W81XWH19C0084", "company": "Triton Systems, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-05-01", "observed": "2026-09-18", "amount_usd": 149807, "summary": "DOD SBIR Phase I award $149,807: Low Cost Point-of-Care Diagnostic Platform for Reliable Therapeutic Drug Monitoring", "source_url": "https://www.sbir.gov/awards?search=A183-145-0095"}, {"id": "breakthrough:P180036", "company": "Impulse Dynamics, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2019-03-21", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P180036: OPTIMIZER SMART SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:FA8751-19-P-A054", "company": "Shift Labs, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-03-06", "observed": "2026-09-18", "amount_usd": 49851, "summary": "DOD SBIR Phase I award $49,851: Infusion Monitoring for Lightweight Prolonged Field Care", "source_url": "https://www.sbir.gov/awards?search=F191-005-1894"}, {"id": "sbir:DOD:W81XWH19C0031", "company": "Liberating Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-02-11", "observed": "2026-09-18", "amount_usd": 999080, "summary": "DOD STTR Phase II award $999,080: No Power Bionic Lower Extremity Prostheses", "source_url": "https://www.sbir.gov/awards?search=H2-0308"}, {"id": "sbir:DOD:W911QY-19-P-0086", "company": "Lifeware Labs LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-02-06", "observed": "2026-09-18", "amount_usd": 148975, "summary": "DOD SBIR Phase I award $148,975: A Wearable Microneedle Array for Efficient Deployment of Medical Countermeasures", "source_url": "https://www.sbir.gov/awards?search=A183-143-0374"}, {"id": "sbir:DOD:W900KK-19-C-0021", "company": "Vcom3d Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-02-05", "observed": "2026-09-18", "amount_usd": 536443, "summary": "DOD SBIR Phase II award $536,443: Net-Enabled Trainer for Combat Casualty Care (NETC3)", "source_url": "https://www.sbir.gov/awards?search=A2-7603"}, {"id": "sbir:DOD:140D04-19-C-0041", "company": "Charles River Analytics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-02-01", "observed": "2026-09-18", "amount_usd": 75000, "summary": "DOD SBIR Phase I award $75,000: Smart Fabric Triage for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=F183-004-0480"}, {"id": "sbir:DOD:140D04-19-C-0045", "company": "Vivonics Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-01-31", "observed": "2026-09-18", "amount_usd": 74982, "summary": "DOD SBIR Phase I award $74,982: MEDITACC: Medical Evaluation, Diagnosis, and Information Transfer for Advanced Casualty Care", "source_url": "https://www.sbir.gov/awards?search=F183-004-1248"}, {"id": "sbir:DOD:140D04-19-C-0043", "company": "Legionarius LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-01-31", "observed": "2026-09-18", "amount_usd": 74840, "summary": "DOD SBIR Phase I award $74,840: Autonomous bio-sensor infused triage & treatment system integration into ATAK and BATDOK for instant casualty reporting and tracking", "source_url": "https://www.sbir.gov/awards?search=F183-004-0952"}, {"id": "sbir:DOD:140D04-19-C-0038", "company": "Adyptation LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-01-31", "observed": "2026-09-18", "amount_usd": 74969, "summary": "DOD SBIR Phase I award $74,969: Autonomous Biomedical Monitoring", "source_url": "https://www.sbir.gov/awards?search=F183-004-1411"}, {"id": "sbir:DOD:W81XWH-19-C-0029", "company": "Charles River Analytics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-01-14", "observed": "2026-09-18", "amount_usd": 149946, "summary": "DOD SBIR Phase I award $149,946: Autonomous Rugged Combat Casualty Care \u2013 Intervention (ARC3-I)", "source_url": "https://www.sbir.gov/awards?search=A181-064-0552"}, {"id": "sbir:DOD:W81XWH19C0015", "company": "Quantified Design Solutions, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2019-01-07", "observed": "2026-09-18", "amount_usd": 999702, "summary": "DOD SBIR Phase II award $999,702: Mobile Causality Display Toolkit for Tactical Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2-0396"}, {"id": "sbir:DOD:W81XWH-19-C-0030", "company": "Reliance Robotics Incorporated", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-12-24", "observed": "2026-09-18", "amount_usd": 99946, "summary": "DOD SBIR Phase I award $99,946: Intelligent Trauma Intervention Algorithms for a Ruggedized Autonomous Combat Casualty Care Capability", "source_url": "https://www.sbir.gov/awards?search=A181-064-1218"}, {"id": "sbir:DOD:W81XWH19C0036", "company": "Advanced Cooling Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-12-17", "observed": "2026-09-18", "amount_usd": 149998, "summary": "DOD SBIR Phase I award $149,998: Limb Cooling Device to Preserve Ischemic Extremity for Prolonged Field Care", "source_url": "https://www.sbir.gov/awards?search=H182-003-0034"}, {"id": "breakthrough:K173681", "company": "Pear Therapeutics", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2018-12-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K173681: RESET-O", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P180007", "company": "Spiration, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2018-12-03", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P180007: SPIRATION VALVE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W81XWH-19-C-0048", "company": "Daxor Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-10-15", "observed": "2026-09-18", "amount_usd": 145169, "summary": "DOD SBIR Phase I award $145,169: Direct Blood Volume Analyzer for Improvement of Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=A182-122-0331"}, {"id": "sbir:DOD:W81XWH-19-C-0043", "company": "Quantiport, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-10-15", "observed": "2026-09-18", "amount_usd": 98363, "summary": "DOD SBIR Phase I award $98,363: Development of a Rapid and Accurate Blood Volume Analyzer for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=A182-122-0210"}, {"id": "sbir:DOD:W81XWH18C0363", "company": "Archie Md Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-09-26", "observed": "2026-09-18", "amount_usd": 999298, "summary": "DOD SBIR Phase II award $999,298: Mobile Virtual Interactive Presence Capability for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2-0341"}, {"id": "sbir:DOD:W81XWH18C0084", "company": "Liberating Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-09-24", "observed": "2026-09-18", "amount_usd": 999820, "summary": "DOD SBIR Phase II award $999,820: Technologies to Train Myoelectric Prosthesis Users for Optimal Functional Outcomes", "source_url": "https://www.sbir.gov/awards?search=H2-0357"}, {"id": "sbir:DOD:W81XWH18C0111", "company": "Liberating Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-09-24", "observed": "2026-09-18", "amount_usd": 486576, "summary": "DOD STTR Phase II award $486,576: Wireless Non-Invasive Advanced Control of Microprocessor Prostheses and Orthoses", "source_url": "https://www.sbir.gov/awards?search=H2-0309"}, {"id": "breakthrough:BP170122", "company": "Avita Medical, LLC.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2018-09-20", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth BP170122: RECELL AUTOLOGOUS CELL HARVESTING DEVICE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "hde:H170004", "company": "biotronik ag", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2018-09-14", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H170004: PK Papyrus Covered Coronary Stent System", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-18-C-0132", "company": "Charles River Analytics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-09-13", "observed": "2026-09-18", "amount_usd": 99105, "summary": "DOD SBIR Phase I award $99,105: Autonomous Ruggedized Combat Casualty Care - Diagnostics (ARC3-D)", "source_url": "https://www.sbir.gov/awards?search=A181-063-0218"}, {"id": "sbir:DOD:W81XWH-18-C-0330", "company": "Charles River Analytics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-09-11", "observed": "2026-09-18", "amount_usd": 99994, "summary": "DOD SBIR Phase I award $99,994: Automated Ruggedized Combat Casualty Care-Monitor (ARC3-M)", "source_url": "https://www.sbir.gov/awards?search=A181-065-0303"}, {"id": "sbir:DOD:W81XWH18C0114", "company": "Spectral Md, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-08-27", "observed": "2026-09-18", "amount_usd": 974465, "summary": "DOD STTR Phase II award $974,465: Medical Device to Assess the Viability of Tissue Prior to Skin Grafting", "source_url": "https://www.sbir.gov/awards?search=H2-0337"}, {"id": "sbir:DOD:W81XWH18C0136", "company": "Starix Technology, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-08-27", "observed": "2026-09-18", "amount_usd": 832367, "summary": "DOD SBIR Phase II award $832,367: Secure UWB Toolkit for Enroute Combat Casualty Care Wireless Communication", "source_url": "https://www.sbir.gov/awards?search=H2-0347"}, {"id": "sbir:DOD:W81XWH18C0127", "company": "LR TECHNOLOGIES, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-08-27", "observed": "2026-09-18", "amount_usd": 999973, "summary": "DOD STTR Phase II award $999,973: Medical Electro-Textile Sensor Simulation", "source_url": "https://www.sbir.gov/awards?search=H2-0317"}, {"id": "sbir:DOD:W81XWH18C0362", "company": "Intelligent Automation, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-08-27", "observed": "2026-09-18", "amount_usd": 1000000, "summary": "DOD SBIR Phase II award $1,000,000: SWAC3: Secure Wireless Architecture for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2-0351"}, {"id": "sbir:DOD:W81XWH18C0090", "company": "Orthocare Innovations LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-08-27", "observed": "2026-09-18", "amount_usd": 999599, "summary": "DOD SBIR Phase II award $999,599: Prosthesis Smart Alignment Tool : ProSAT Phase 2", "source_url": "https://www.sbir.gov/awards?search=H2-0330"}, {"id": "sbir:NASA:80NSSC18P1982", "company": "Actuated Medical, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-07-27", "observed": "2026-09-18", "amount_usd": 124983, "summary": "NASA SBIR Phase I award $124,983: Additive Manufacturing of PEEK and Fiber-Reinforced PEEK for NASA Applications and Custom Medical Devices", "source_url": "https://www.sbir.gov/awards?search=181165"}, {"id": "breakthrough:P180002", "company": "Pulmonx Corporation", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2018-06-29", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P180002: ZEPHYR ENDOBRONCHIAL VALVE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:P160017/S031", "company": "Medtronic Minimed, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2018-06-21", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P160017/S031: MINIMED 670G SYSTEM", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W81XWH18C0340", "company": "Sensimetrics Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-06-11", "observed": "2026-09-18", "amount_usd": 149986, "summary": "DOD SBIR Phase I award $149,986: Compact Speaker Array for Clinical Testing of Ear-level Devices", "source_url": "https://www.sbir.gov/awards?search=H181-007-0023"}, {"id": "breakthrough:P170039", "company": "Clinical Research Consultants, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2018-05-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P170039: CUSTOMFLEX ARTIFICIAL IRIS", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W81XWH-18-C-0129", "company": "Maxentric Technologies LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-05-23", "observed": "2026-09-18", "amount_usd": 149868, "summary": "DOD SBIR Phase I award $149,868: Medical Sensors Powered by Human Generated Energy", "source_url": "https://www.sbir.gov/awards?search=A181-061-0881"}, {"id": "sbir:DOD:W81XWH-18-C-0135", "company": "Cambridge Research & Development, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-05-23", "observed": "2026-09-18", "amount_usd": 137082, "summary": "DOD SBIR Phase I award $137,082: Patient Transportable Tactical Combat Casualty Care Documentation Capability", "source_url": "https://www.sbir.gov/awards?search=A181-060-1061"}, {"id": "sbir:DOD:W81XWH-18-C-0356", "company": "Arete Associates", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-05-23", "observed": "2026-09-18", "amount_usd": 144832, "summary": "DOD SBIR Phase I award $144,832: Smart Patient Monitoring Algorithms for Ruggedized Autonomous Combat Casualty Care Capability", "source_url": "https://www.sbir.gov/awards?search=A181-065-0612"}, {"id": "sbir:DOD:W900KK-18-C-0028", "company": "Charles River Analytics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-04-30", "observed": "2026-09-18", "amount_usd": 499978, "summary": "DOD SBIR Phase II award $499,978: Medical Augmented Reality for Combat Casualty Care (MARC)", "source_url": "https://www.sbir.gov/awards?search=A2-6727"}, {"id": "sbir:DOD:W900KK-18-C-0029", "company": "Design Interactive, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-04-12", "observed": "2026-09-18", "amount_usd": 499960, "summary": "DOD SBIR Phase II award $499,960: Augmented/Mixed Reality for Force-on-Force Combat Casualty Care Training", "source_url": "https://www.sbir.gov/awards?search=A2-6906"}, {"id": "breakthrough:DEN180001", "company": "Idx, LLC", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2018-04-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN180001: IDX-DR", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W900KK-18-C-0027", "company": "Soar Technology, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-04-06", "observed": "2026-09-18", "amount_usd": 501312, "summary": "DOD SBIR Phase II award $501,312: Combat Casualty Care Augmented Reality Intelligent Training Systems (C3ARESYS)", "source_url": "https://www.sbir.gov/awards?search=A2-6710"}, {"id": "sbir:DOD:W81XWH-18-C-0008", "company": "Charles River Analytics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-03-28", "observed": "2026-09-18", "amount_usd": 999897, "summary": "DOD SBIR Phase II award $999,897: Ensemble Prediction for Intelligent Combat Casualty Care (EPIC3)", "source_url": "https://www.sbir.gov/awards?search=A2-6785"}, {"id": "hde:H170002", "company": "Kaneka Pharma America LLC.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2018-03-20", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H170002: LIPOSORBER LA-15 System", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:140D6318C0019", "company": "Profusa, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-03-07", "observed": "2026-09-18", "amount_usd": 6758936, "summary": "DOD SBIR Phase II award $6,758,936: Lactate Sensors for Continuous Physiological Monitoring", "source_url": "https://www.sbir.gov/awards?search=D2-1987"}, {"id": "breakthrough:K173352", "company": "Concentric Medical, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2018-02-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K173352: TREVO PRO VUE RETRIEVER AND TREVO XP PRO VUE RETRIEVER (TREVO RETRIEVER)", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:DEN170045", "company": "Banyan Biomarkers, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2018-02-14", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth DEN170045: BANYAN BTI", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "breakthrough:K172935", "company": "Empatica Srl", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2018-01-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth K172935: EMBRACE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:140D6318C0002", "company": "Probiusdx Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-01-26", "observed": "2026-09-18", "amount_usd": 1496937, "summary": "DOD SBIR Phase II award $1,496,937: Point-of-care Monitoring of the Host-Pathogen Interaction during Infection", "source_url": "https://www.sbir.gov/awards?search=D2-1961"}, {"id": "sbir:DOD:W81XWH-18-C-0064", "company": "Tiger Tech Solutions Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-01-08", "observed": "2026-09-18", "amount_usd": 149947, "summary": "DOD SBIR Phase I award $149,947: Medical Wearable for First Responder Assessment and Remote Monitoring", "source_url": "https://www.sbir.gov/awards?search=H172-010-0004"}, {"id": "sbir:DOD:140D6318C0027", "company": "Mbio Diagnostics Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2018-01-08", "observed": "2026-09-18", "amount_usd": 2761705, "summary": "DOD SBIR Phase II award $2,761,705: Point-of-care Monitoring of the Host-Pathogen Interaction during Infection", "source_url": "https://www.sbir.gov/awards?search=D2-1972"}, {"id": "sbir:DOD:W81XWH-18-C-0061", "company": "Gener8, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-12-26", "observed": "2026-09-18", "amount_usd": 149871, "summary": "DOD SBIR Phase I award $149,871: Point of Care Test for Disease Severity and Risk Stratification", "source_url": "https://www.sbir.gov/awards?search=H172-008-0192"}, {"id": "sbir:DOD:W81XWH-18-C-0060", "company": "Lynntech Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-12-26", "observed": "2026-09-18", "amount_usd": 149997, "summary": "DOD SBIR Phase I award $149,997: Point of care, microfluidic, multi-electrode and optical hybrid CBC", "source_url": "https://www.sbir.gov/awards?search=H172-008-0043"}, {"id": "sbir:DOD:140D6318C0026", "company": "Lynntech Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-12-19", "observed": "2026-09-18", "amount_usd": 1496846, "summary": "DOD SBIR Phase II award $1,496,846: Signal-amplified, Real-time Therapeutic Drug Monitoring Device", "source_url": "https://www.sbir.gov/awards?search=D2-1974"}, {"id": "sbir:DOD:W81XWH-18-C-0058", "company": "Perceptronics Solutions, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-12-18", "observed": "2026-09-18", "amount_usd": 150000, "summary": "DOD STTR Phase I award $150,000: Handoff Training for Combat Casualty Care (HTC3) Framework", "source_url": "https://www.sbir.gov/awards?search=H17B-001-0001"}, {"id": "sbir:DOD:W81XWH-18-C-0059", "company": "Soar Technology, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-12-18", "observed": "2026-09-18", "amount_usd": 149976, "summary": "DOD STTR Phase I award $149,976: Combat Casualty Handoff Automated Trainer (CCHAT)", "source_url": "https://www.sbir.gov/awards?search=H17B-001-0018"}, {"id": "breakthrough:P170019", "company": "Foundation Medicine, Inc.", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2017-11-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P170019: FOUNDATIONONE CDX", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:FA8650-18-C-6872", "company": "Archie Md Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-11-29", "observed": "2026-09-18", "amount_usd": 727313, "summary": "DOD SBIR Phase II award $727,313: Inexpensive Haptic Devices and 3D Medical Game for the Interosseous Infusion Procedure", "source_url": "https://www.sbir.gov/awards?search=F161-046-1978"}, {"id": "sbir:DOD:W81XWH-18-C-0005", "company": "Aptima Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-11-15", "observed": "2026-09-18", "amount_usd": 149995, "summary": "DOD SBIR Phase I award $149,995: TC3 Toolkit: Tactical Combat Casualty Care (TC3) Toolkit", "source_url": "https://www.sbir.gov/awards?search=H172-006-0053"}, {"id": "sbir:DOD:W81XWH-18-C-0027", "company": "Tier 1 Performance Solutions LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-11-15", "observed": "2026-09-18", "amount_usd": 149986, "summary": "DOD STTR Phase I award $149,986: ECCCHO: Effective Combat Casualty Care Handoff Operations", "source_url": "https://www.sbir.gov/awards?search=H17B-002-0058"}, {"id": "sbir:DOD:HDTRA1-18-C-0004", "company": "Paratus Diagnostics", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-11-06", "observed": "2026-09-18", "amount_usd": 995589, "summary": "DOD SBIR Phase II award $995,589: High Sensitivity, Low Complexity, Multiplexed Diagnostic Devices", "source_url": "https://www.sbir.gov/awards?search=C2-0459"}, {"id": "sbir:DOD:W81XWH-17-C-0177", "company": "CFD Research Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-09-28", "observed": "2026-09-18", "amount_usd": 999904, "summary": "DOD SBIR Phase II award $999,904: Portable Iron Screening System for Point-of-Care Iron Status Determination", "source_url": "https://www.sbir.gov/awards?search=H2-0256"}, {"id": "sbir:DOD:W81XWH-17-C-0188", "company": "Innosense Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-09-25", "observed": "2026-09-18", "amount_usd": 999999, "summary": "DOD SBIR Phase II award $999,999: Diagnostic Device for Detecting Biomarkers of Early Multiorgan Injury in Saliva", "source_url": "https://www.sbir.gov/awards?search=H2-0240"}, {"id": "sbir:DOD:W81XWH-17-C-0189", "company": "Nanocomposix, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-09-25", "observed": "2026-09-18", "amount_usd": 1000000, "summary": "DOD SBIR Phase II award $1,000,000: Diagnostic device for detecting biomarkers of early multiorgan injury in saliva", "source_url": "https://www.sbir.gov/awards?search=A2-6803"}, {"id": "sbir:DOD:W911NF-17-C-0058", "company": "Ripple LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-09-22", "observed": "2026-09-18", "amount_usd": 1495965, "summary": "DOD SBIR Phase II award $1,495,965: Final qualification testing for myoelectric implant to control prostheses", "source_url": "https://www.sbir.gov/awards?search=D2-1947"}, {"id": "sbir:DOD:W81XWH-17-C-0084", "company": "Liberating Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-09-18", "observed": "2026-09-18", "amount_usd": 149946, "summary": "DOD STTR Phase I award $149,946: No Power Bionic Lower Extremity Prostheses", "source_url": "https://www.sbir.gov/awards?search=H16C-007-0027"}, {"id": "sbir:DOD:W81XWH-17-C-0170", "company": "Spectral Md, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-09-15", "observed": "2026-09-18", "amount_usd": 149828, "summary": "DOD STTR Phase I award $149,828: Medical Device to Assess the Viability of Tissue Prior to Skin Grafting", "source_url": "https://www.sbir.gov/awards?search=H17A-006-0002"}, {"id": "sbir:DOD:W81XWH-16-C-0207", "company": "RemPhos Technologies LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-09-08", "observed": "2026-09-18", "amount_usd": 149132, "summary": "DOD SBIR Phase I award $149,132: Miniature, point-of-care device for establishing sterile connections in combat environments", "source_url": "https://www.sbir.gov/awards?search=A161-055-1177"}, {"id": "sbir:DOD:W81XWH-17-C-0131", "company": "Triton Systems, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-09-01", "observed": "2026-09-18", "amount_usd": 149925, "summary": "DOD STTR Phase I award $149,925: Wearable Medical Electro-textile System for the Warfighter", "source_url": "https://www.sbir.gov/awards?search=H17A-001-0005"}, {"id": "sbir:DOD:W81XWH-17-C-0133", "company": "LR TECHNOLOGIES, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-09-01", "observed": "2026-09-18", "amount_usd": 149931, "summary": "DOD STTR Phase I award $149,931: Medical Electro-Textile Sensor Simulation", "source_url": "https://www.sbir.gov/awards?search=H17A-001-0021"}, {"id": "sbir:DOD:W81XWH-17-C-0103", "company": "Orthocare Innovations LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-08-15", "observed": "2026-09-18", "amount_usd": 149225, "summary": "DOD SBIR Phase I award $149,225: Prosthesis Smart Alignment Tool - ProSAT", "source_url": "https://www.sbir.gov/awards?search=H171-008-0102"}, {"id": "sbir:DOD:W81XWH-17-C-0168", "company": "Springactive, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-08-01", "observed": "2026-09-18", "amount_usd": 150000, "summary": "DOD STTR Phase I award $150,000: Wireless IMU Sensing for Activity Control of Ankle Prosthesis", "source_url": "https://www.sbir.gov/awards?search=H17A-005-0031"}, {"id": "sbir:DOD:W81XWH-17-C-0167", "company": "Liberating Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-08-01", "observed": "2026-09-18", "amount_usd": 149855, "summary": "DOD STTR Phase I award $149,855: Wireless Non-Invasive Advanced Control of Microprocessor Prostheses and Orthoses", "source_url": "https://www.sbir.gov/awards?search=H17A-005-0018"}, {"id": "sbir:DOD:W81XWH-18-C-0003", "company": "RemPhos Technologies LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-07-14", "observed": "2026-09-18", "amount_usd": 999743, "summary": "DOD SBIR Phase II award $999,743: Miniature, point-of-care device for establishing sterile connections in combat environments", "source_url": "https://www.sbir.gov/awards?search=A2-6834"}, {"id": "sbir:DOD:W81XWH-17-C-0085", "company": "Springactive, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-07-14", "observed": "2026-09-18", "amount_usd": 150000, "summary": "DOD STTR Phase I award $150,000: Passive SPARKy-P Prostheses (Spring Ankle with Regenerative Kinetics)", "source_url": "https://www.sbir.gov/awards?search=H16C-007-0068"}, {"id": "sbir:DOD:W81XWH-17-C-0086", "company": "Motion Control, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-07-10", "observed": "2026-09-18", "amount_usd": 149998, "summary": "DOD STTR Phase I award $149,998: Biomimetic Slope Adaptive Foot-Ankle Prosthesis", "source_url": "https://www.sbir.gov/awards?search=H16C-007-0024"}, {"id": "hde:H160002", "company": "medos international sarl", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2017-06-19", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H160002: PulseRider Aneurysm Neck Reconstruction", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-17-C-0082", "company": "Hemosonics", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-06-01", "observed": "2026-09-18", "amount_usd": 499998, "summary": "DOD SBIR Phase II award $499,998: A Point-of-Care Device for Diagnosis of Platelet Injury in Trauma Patients", "source_url": "https://www.sbir.gov/awards?search=H2-0089a"}, {"id": "sbir:DOD:W81XWH-17-C-0049", "company": "Triton Systems, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-05-22", "observed": "2026-09-18", "amount_usd": 149934, "summary": "DOD STTR Phase I award $149,934: VOC sensor for Real-Time Physiological Status Monitoring", "source_url": "https://www.sbir.gov/awards?search=H16C-002-0014"}, {"id": "sbir:DOD:W81XWH-17-C-0056", "company": "Bayspec, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-05-15", "observed": "2026-09-18", "amount_usd": 149961, "summary": "DOD STTR Phase I award $149,961: Mask integrated Volatile Organic Compound (VOC) sensor for real-time warfighter physiological status monitoring in extreme and toxic environments", "source_url": "https://www.sbir.gov/awards?search=H16C-002-0062"}, {"id": "sbir:DOD:W81XWH-17-C-0052", "company": "Makel Engineering, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-05-15", "observed": "2026-09-18", "amount_usd": 144946, "summary": "DOD STTR Phase I award $144,946: In-Mask Sensors for Physiological Investigation of Respiratory Exhalation - INSPIRE", "source_url": "https://www.sbir.gov/awards?search=H16C-002-0036"}, {"id": "hde:H150003", "company": "Wilson-Cook Medical Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2017-05-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H150003: Flourish Pediatric Esophageal Atresia An", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:D17PC00071", "company": "Inflammatix, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2017-01-18", "observed": "2026-09-18", "amount_usd": 999923, "summary": "DOD SBIR Phase II award $999,923: Point-of-care Monitoring of the Host-Pathogen Interaction during Infection", "source_url": "https://www.sbir.gov/awards?search=D2-1680"}, {"id": "hde:H070005", "company": "abbott medical", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2017-01-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H070005: THE AMPLATZER POST INFARCT MUSCULAR VSD", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:D17PC00032", "company": "Mbio Diagnostics Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-11-18", "observed": "2026-09-18", "amount_usd": 149503, "summary": "DOD SBIR Phase I award $149,503: Point of Care Host-Pathogen Monitoring System", "source_url": "https://www.sbir.gov/awards?search=D162-002-0188"}, {"id": "sbir:DOD:D17PC00024", "company": "Probiusdx Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-11-01", "observed": "2026-09-18", "amount_usd": 147130, "summary": "DOD SBIR Phase I award $147,130: Point-of-Care technologies to monitor and characterize host-pathogen interactions during acute severe infection", "source_url": "https://www.sbir.gov/awards?search=D162-002-0280"}, {"id": "sbir:DOD:D17PC00021", "company": "Lynntech Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-10-20", "observed": "2026-09-18", "amount_usd": 149791, "summary": "DOD SBIR Phase I award $149,791: Signal-amplified, Real-time Therapeutic Drug Monitoring Device", "source_url": "https://www.sbir.gov/awards?search=D162-001-0110"}, {"id": "sbir:DOD:W81XWH-16-C-0189", "company": "Neya Systems, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-09-30", "observed": "2026-09-18", "amount_usd": 999789, "summary": "DOD SBIR Phase II award $999,789: Mobile Virtual Interactive Presence Capability for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2-0172"}, {"id": "sbir:DOD:W81XWH-16-C-0175", "company": "Real-time Innovations, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-09-29", "observed": "2026-09-18", "amount_usd": 999974, "summary": "DOD SBIR Phase II award $999,974: Methodologies and Tools for Securing Medical Device Systems in Integrated Clinical Environments (ICE)", "source_url": "https://www.sbir.gov/awards?search=H2-0169"}, {"id": "sbir:DOD:W81XWH-16-C-0159", "company": "Nanocomposix, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-09-26", "observed": "2026-09-18", "amount_usd": 150000, "summary": "DOD SBIR Phase I award $150,000: Diagnostic device for detecting biomarkers of early multiorgan injury in saliva", "source_url": "https://www.sbir.gov/awards?search=H161-006-0130"}, {"id": "sbir:DOD:W81XWH-16-C-0177", "company": "Archie Md Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-09-26", "observed": "2026-09-18", "amount_usd": 999920, "summary": "DOD SBIR Phase II award $999,920: Mobile Virtual Interactive Presence Capability for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H2-0186"}, {"id": "sbir:DOD:HDTRA1-16-C-0051", "company": "Genecapture, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-09-20", "observed": "2026-09-18", "amount_usd": 150524, "summary": "DOD STTR Phase I award $150,524: Infectious Disease Diagnostics and Differentiation of Viral vs. Bacterial Infections for Point of Care Applications", "source_url": "https://www.sbir.gov/awards?search=C15C-001-0007"}, {"id": "sbir:DOD:W81XWH-16-C-0083", "company": "CFD Research Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-09-15", "observed": "2026-09-18", "amount_usd": 149981, "summary": "DOD SBIR Phase I award $149,981: Portable Iron Screening System for Point-of-Care Iron Status Determination", "source_url": "https://www.sbir.gov/awards?search=H161-005-0059"}, {"id": "sbir:DOD:FA8650-16-C-2717", "company": "Control Vision, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-09-14", "observed": "2026-09-18", "amount_usd": 749985, "summary": "DOD STTR Phase II award $749,985: Snapshot Imaging Laser Displacement Sensor for Hypersonic Diagnostic Testing", "source_url": "https://www.sbir.gov/awards?search=F15A-T38-0295"}, {"id": "sbir:DOD:W81XWH-16-C-0105", "company": "Charles River Analytics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-09-07", "observed": "2026-09-18", "amount_usd": 149970, "summary": "DOD SBIR Phase I award $149,970: Ensemble Prediction for Intelligent Combat Casualty Care (EPIC3)", "source_url": "https://www.sbir.gov/awards?search=A161-054-0437"}, {"id": "sbir:DOD:HDTRA1-16-P-0048", "company": "Paratus Diagnostics", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-08-29", "observed": "2026-09-18", "amount_usd": 149394, "summary": "DOD SBIR Phase I award $149,394: High Sensitivity, Low Complexity, Multiplexed Diagnostic Devices", "source_url": "https://www.sbir.gov/awards?search=C152-005-0107"}, {"id": "sbir:DOD:FA8650-16-M-6742", "company": "Archie Md Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-08-10", "observed": "2026-09-18", "amount_usd": 149969, "summary": "DOD SBIR Phase I award $149,969: Inexpensive Haptic Devices and 3D Medical Game for the Interosseous Infusion Procedure", "source_url": "https://www.sbir.gov/awards?search=F161-046-1978"}, {"id": "sbir:DOD:FA8650-16-M-6741", "company": "Simquest International, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-08-08", "observed": "2026-09-18", "amount_usd": 149922, "summary": "DOD SBIR Phase I award $149,922: Inexpensive Haptic Devices and 3D Medical Game for the Interosseous Infusion Procedure", "source_url": "https://www.sbir.gov/awards?search=F161-046-0700"}, {"id": "breakthrough:P150038", "company": "Insightec", "kind": "fda_breakthrough_auth", "kind_label": "FDA Breakthrough marketing authorization", "date": "2016-07-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA Breakthrough marketing auth P150038: EXABLATE", "source_url": "https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program"}, {"id": "sbir:DOD:W900KK-16-C-0040", "company": "Design Interactive, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-07-06", "observed": "2026-09-18", "amount_usd": 99999, "summary": "DOD SBIR Phase I award $99,999: Augmented/Mixed Reality for Force-on-Force Combat Casualty Care Training", "source_url": "https://www.sbir.gov/awards?search=A161-076-0599"}, {"id": "sbir:DOD:N00014-16-C-3046", "company": "Enterprise Sciences, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-06-28", "observed": "2026-09-18", "amount_usd": 1478802, "summary": "DOD SBIR Phase II award $1,478,802: Miniature, Portable, Device to Detect and Monitor Coagulopathy", "source_url": "https://www.sbir.gov/awards?search=N10A-043-0347a"}, {"id": "sbir:DOD:D16PC00097", "company": "Ada Technologies LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-06-03", "observed": "2026-09-18", "amount_usd": 1499933, "summary": "DOD SBIR Phase II award $1,499,933: Socket Diagnostic Tool Innovation for Upper Extremity Prostheses", "source_url": "https://www.sbir.gov/awards?search=D2-1565"}, {"id": "sbir:DOD:W81XWH-16-C-0034", "company": "Starix Technology, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-03-01", "observed": "2026-09-18", "amount_usd": 999170, "summary": "DOD SBIR Phase II award $999,170: Secure UWB Toolkit for Enroute Combat Casualty Care Wireless Communication", "source_url": "https://www.sbir.gov/awards?search=A2-5935"}, {"id": "sbir:DOD:W81XWH-16-C-0004", "company": "Lynntech Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-02-11", "observed": "2026-09-18", "amount_usd": 150000, "summary": "DOD SBIR Phase I award $150,000: Fully Integrated Light Therapy-Based Wound Dressings for Wound Healing Applications", "source_url": "https://www.sbir.gov/awards?search=H15B-002-0137"}, {"id": "sbir:DOD:W81XWH-16-C-0005", "company": "Polaronyx Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-01-18", "observed": "2026-09-18", "amount_usd": 149758, "summary": "DOD STTR Phase I award $149,758: Smart Femtosecond Fiber Laser Wound Healing System", "source_url": "https://www.sbir.gov/awards?search=H15B-002-0123"}, {"id": "sbir:DOD:W81XWH-16-C-0018", "company": "Intelligent Automation, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2016-01-11", "observed": "2026-09-18", "amount_usd": 1000000, "summary": "DOD SBIR Phase II award $1,000,000: SWAC3: Secure Wireless Architecture for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=A2-5994"}, {"id": "hde:H130006", "company": "Torax Medical, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2015-12-18", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H130006: FENIX CONTINENCE RESTORATION SYSTEM", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H140005", "company": "arup labaratories", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2015-12-18", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H140005: PDGFRB FISH ASSAY", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H140006", "company": "arup labaratories", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2015-12-18", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H140006: KIT D816V ASSAY", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-16-C-0097", "company": "Inbios International Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-11-13", "observed": "2026-09-18", "amount_usd": 891868, "summary": "DOD SBIR Phase II award $891,868: Diagnostic Device for Norovirus Gastroenteritis", "source_url": "https://www.sbir.gov/awards?search=A2-6136"}, {"id": "sbir:DOD:W81XWH-15-C-0201", "company": "Techulon, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-09-30", "observed": "2026-09-18", "amount_usd": 149996, "summary": "DOD SBIR Phase I award $149,996: Improving Wound Healing by Combating Multi-Drug Resistant Pathogens Using Small Molecule Antimicrobials", "source_url": "https://www.sbir.gov/awards?search=H151-007-0160"}, {"id": "sbir:DOD:W81XWH-15-C-0196", "company": "Real-time Innovations, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-09-30", "observed": "2026-09-18", "amount_usd": 149993, "summary": "DOD SBIR Phase I award $149,993: Methodologies and Tools for Securing Medical Device Systems in Integrated Clinical Environments (ICE)", "source_url": "https://www.sbir.gov/awards?search=H151-004-0137"}, {"id": "sbir:DOD:W81XWH-15-C-0200", "company": "Design Interactive, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-09-30", "observed": "2026-09-18", "amount_usd": 149931, "summary": "DOD SBIR Phase I award $149,931: Discrete Event Simulation and Optimization Approach for Balancing Usability and Security for Medical Devices in an Integrated Clinical Environment", "source_url": "https://www.sbir.gov/awards?search=H151-005-0129"}, {"id": "sbir:DOD:W81XWH-15-C-0135", "company": "How Many Engineers Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-09-30", "observed": "2026-09-18", "amount_usd": 149953, "summary": "DOD SBIR Phase I award $149,953: Methodologies and Tools for Securing Medical Device Systems in Integrated Clinical Environments (ICE)", "source_url": "https://www.sbir.gov/awards?search=H151-004-0186"}, {"id": "sbir:DOD:W81XWH-15-C-0022", "company": "Liberating Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-09-25", "observed": "2026-09-18", "amount_usd": 999657, "summary": "DOD SBIR Phase II award $999,657: Technologies to Train Myoelectric Prosthesis Users for Optimal Functional Outcomes", "source_url": "https://www.sbir.gov/awards?search=H2-0102"}, {"id": "sbir:DOD:W81XWH-15-C-0165", "company": "Aptitude Medical Systems Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-09-22", "observed": "2026-09-18", "amount_usd": 150000, "summary": "DOD SBIR Phase I award $150,000: Universal Microfluidic Device Platform to Enable Real-Time Continuous Measurement of Biomarkers of Coagulopathy Directly in Trauma Victims", "source_url": "https://www.sbir.gov/awards?search=H151-012-0092"}, {"id": "sbir:DOD:W81XWH-14-C-0146", "company": "Luna Innovations Incorporated", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-09-21", "observed": "2026-09-18", "amount_usd": 986106, "summary": "DOD SBIR Phase II award $986,106: A NANOeSPRi-based IVD Assay for Multiple Organ Injury", "source_url": "https://www.sbir.gov/awards?search=H2-0106"}, {"id": "sbir:DOD:W81XWH-15-C-0160", "company": "Neya Systems, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-09-18", "observed": "2026-09-18", "amount_usd": 149772, "summary": "DOD SBIR Phase I award $149,772: Mobile Virtual Interactive Presence Capability for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=H151-002-0138"}, {"id": "sbir:DOD:W81XWH-15-C-0159", "company": "Archie Md Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-09-18", "observed": "2026-09-18", "amount_usd": 149967, "summary": "DOD SBIR Phase I award $149,967: An anatomy-enabled, augmented reality, point-of-care, telemedicine application", "source_url": "https://www.sbir.gov/awards?search=H151-002-0227"}, {"id": "sbir:DOD:W81XWH-14-C-0154", "company": "Design Interactive, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-08-31", "observed": "2026-09-18", "amount_usd": 1499978, "summary": "DOD SBIR Phase II award $1,499,978: ADAPT-MP: Auto-Diagnostic Adaptive Precision Trainer for Myoelectric Prosthesis users", "source_url": "https://www.sbir.gov/awards?search=H2-0104"}, {"id": "sbir:DOD:W911NF-15-C-0069", "company": "Triangle BioSystems, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-08-26", "observed": "2026-09-18", "amount_usd": 1499972, "summary": "DOD SBIR Phase II award $1,499,972: EXTENSIBLE, WIRELESS, AND IMPLANTABLE NEURAL-INTERFACE MICROSYSTEMS", "source_url": "https://www.sbir.gov/awards?search=D2-1439"}, {"id": "sbir:DOD:FA8650-15-C-6614", "company": "Hemosonics", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-08-07", "observed": "2026-09-18", "amount_usd": 999727, "summary": "DOD SBIR Phase II award $999,727: A Point-of-Care Device for Diagnosis of Platelet Injury in Trauma Patients", "source_url": "https://www.sbir.gov/awards?search=H2-0089"}, {"id": "sbir:DOD:W81XWH-15-C-0040", "company": "Perfuzia Medical", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-07-31", "observed": "2026-09-18", "amount_usd": 149373, "summary": "DOD STTR Phase I award $149,373: Development of novel wound dressing technology combining advanced hydrogel and perfusion enhancement technologies.", "source_url": "https://www.sbir.gov/awards?search=A14A-016-0166"}, {"id": "hde:H080004", "company": "Integrum AB", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2015-07-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H080004: OPRA", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:N00014-15-P-1141", "company": "Quantum Applied Science & Research Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-07-06", "observed": "2026-09-18", "amount_usd": 149991, "summary": "DOD SBIR Phase I award $149,991: Diver Biometric Device using Novel Physiological Sensors", "source_url": "https://www.sbir.gov/awards?search=N151-078-0955"}, {"id": "sbir:DOD:FA8650-15-M-2624", "company": "Control Vision, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-06-30", "observed": "2026-09-18", "amount_usd": 150000, "summary": "DOD STTR Phase I award $150,000: Snapshot Imaging Laser Displacement Sensor for Hypervelocity Diagnostic Testing", "source_url": "https://www.sbir.gov/awards?search=F15A-T38-0295"}, {"id": "sbir:DOD:D15PC00145", "company": "Ftl Labs Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-06-29", "observed": "2026-09-18", "amount_usd": 149996, "summary": "DOD SBIR Phase I award $149,996: Prosthesis Socket Diagnostic Tool", "source_url": "https://www.sbir.gov/awards?search=D151-001-0077"}, {"id": "sbir:DOD:W81XWH-14-C-0019", "company": "Tissue Genesis, Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-06-13", "observed": "2026-09-18", "amount_usd": 997498, "summary": "DOD SBIR Phase II award $997,498: Handheld Adipose Stem Cell Processor for Point of Care Application", "source_url": "https://www.sbir.gov/awards?search=A2-5808"}, {"id": "sbir:DOD:D15PC00143", "company": "Texas Research Institute , Austin, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-06-10", "observed": "2026-09-18", "amount_usd": 149936, "summary": "DOD SBIR Phase I award $149,936: Socket Diagnostic Tool Innovation for Upper Extremity Prostheses", "source_url": "https://www.sbir.gov/awards?search=D151-001-0102"}, {"id": "sbir:DOD:FA8650-15-C-6612", "company": "Lynntech Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-04-24", "observed": "2026-09-18", "amount_usd": 996831, "summary": "DOD SBIR Phase II award $996,831: A Novel, Point-of-Care, Multi-Analysis Platelet Function Diagnostic System", "source_url": "https://www.sbir.gov/awards?search=H2-0078"}, {"id": "sbir:NASA:NNX15CC03C", "company": "Umpqua Research Company", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-04-22", "observed": "2026-09-18", "amount_usd": 734557, "summary": "NASA SBIR Phase II award $734,557: Advanced Capabilities Medical Suction Device", "source_url": "https://www.sbir.gov/awards?search=124303"}, {"id": "sbir:DOD:W31P4Q-15-C-0088", "company": "CFD Research Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-03-27", "observed": "2026-09-18", "amount_usd": 124949, "summary": "DOD SBIR Phase I award $124,949: IMPLANTABLE ENZYMATIC FUEL CELL TO POWER NEXT GENERATION NEUROTECHNOLOGY", "source_url": "https://www.sbir.gov/awards?search=D143-001-0027"}, {"id": "sbir:DOD:FA8650-15-C-6613", "company": "Lynntech Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-03-13", "observed": "2026-09-18", "amount_usd": 998485, "summary": "DOD SBIR Phase II award $998,485: Antimicrobial Protective Silicone and Carbon Based Wound Dressings", "source_url": "https://www.sbir.gov/awards?search=H2-0088"}, {"id": "hde:H130001", "company": "Kaneka Pharma America, LLC", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2015-03-05", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H130001: KANEKA LIXELLE BETA 2-MICROGLOBULIN APHE", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W911NF-15-C-0025", "company": "Cognionics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-02-11", "observed": "2026-09-18", "amount_usd": 499966, "summary": "DOD SBIR Phase II award $499,966: BrainFlight: Dry EEG Flight Testing and PIO Data Collection", "source_url": "https://www.sbir.gov/awards?search=D2-1418"}, {"id": "sbir:DOD:N00014-15-C-0046", "company": "Mimosa Acoustics Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-02-09", "observed": "2026-09-18", "amount_usd": 239125, "summary": "DOD SBIR Phase II award $239,125: Novel Methods to Monitor Health Status and Clinical Laboratory Data: Portable Acquisition, Assessment, and Reporting", "source_url": "https://www.sbir.gov/awards?search=O2-1118a"}, {"id": "hde:H140001", "company": "ABIOMED, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2015-01-23", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H140001: IMPELLA RP SYSTEM", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-15-C-0039", "company": "Zetroz Systems LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2015-01-01", "observed": "2026-09-18", "amount_usd": 149997, "summary": "DOD STTR Phase I award $149,997: Hydrogel-based Long-duration ultrasound wound dressing to enhance cellular regeneration and rapid wound closure", "source_url": "https://www.sbir.gov/awards?search=A14A-016-0081"}, {"id": "hde:H130007", "company": "CVRx, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2014-12-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H130007: BAROSTIM NEO LEGACY IMPLANTABLE PULSE GE", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-15-C-0030", "company": "Liberating Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-11-20", "observed": "2026-09-18", "amount_usd": 149991, "summary": "DOD SBIR Phase I award $149,991: Technologies to Train Myoelectric Prosthesis Users for Optimal Functional Outcomes", "source_url": "https://www.sbir.gov/awards?search=H141-011-0020"}, {"id": "sbir:DOD:W31P4Q-15-C-0027", "company": "Transient Electronics Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-11-18", "observed": "2026-09-18", "amount_usd": 1486590, "summary": "DOD SBIR Phase II award $1,486,590: An Implantable Transient Electronic Nerve Stimulation Device Based on Transient Electronics", "source_url": "https://www.sbir.gov/awards?search=D2-1299"}, {"id": "sbir:DOD:W81XWH-15-C-0007", "company": "Firebird Biomolecular Sciences LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-11-14", "observed": "2026-09-18", "amount_usd": 100000, "summary": "DOD SBIR Phase I award $100,000: Diagnostic Device for Norovirus Gastroenteritis", "source_url": "https://www.sbir.gov/awards?search=A141-049-0858"}, {"id": "sbir:DOD:W81XWH-15-C-0008", "company": "Inbios International Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-11-10", "observed": "2026-09-18", "amount_usd": 149075, "summary": "DOD SBIR Phase I award $149,075: Diagnostic Device for Norovirus Gastroenteritis", "source_url": "https://www.sbir.gov/awards?search=A141-049-0982"}, {"id": "sbir:DOD:W81XWH-14-C-0082", "company": "Sicore Technologies Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-09-30", "observed": "2026-09-18", "amount_usd": 100000, "summary": "DOD SBIR Phase I award $100,000: SWAC3: Secure Wireless Architecture for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=A141-051-0872"}, {"id": "sbir:DOD:W81XWH-14-C-0162", "company": "Starix Technology, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-09-29", "observed": "2026-09-18", "amount_usd": 99933, "summary": "DOD SBIR Phase I award $99,933: Secure UWB Toolkit for Enroute Combat Casualty Care Wireless Communication", "source_url": "https://www.sbir.gov/awards?search=A141-051-0332"}, {"id": "sbir:DOD:W81XWH-14-C-0160", "company": "TrellisWare Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-09-29", "observed": "2026-09-18", "amount_usd": 99968, "summary": "DOD SBIR Phase I award $99,968: Secure Wireless Communications for Enroute Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=A141-051-0012"}, {"id": "sbir:DOD:W81XWH-14-C-1399", "company": "Coapt LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-09-29", "observed": "2026-09-18", "amount_usd": 148328, "summary": "DOD SBIR Phase I award $148,328: Technologies to Train Myoelectric Prosthesis Users for Optimal Functional Outcomes", "source_url": "https://www.sbir.gov/awards?search=H141-011-0079"}, {"id": "sbir:DOD:W911NF-14-P-0045", "company": "Triangle BioSystems, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-09-22", "observed": "2026-09-18", "amount_usd": 149617, "summary": "DOD SBIR Phase I award $149,617: EXTENSIBLE, WIRELESS, AND IMPLANTABLE NEURAL-INTERFACE MICROSYSTEMS", "source_url": "https://www.sbir.gov/awards?search=D142-006-0094"}, {"id": "hde:H130004", "company": "Plexision Inc", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2014-08-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H130004: PLEXIMMUNE ASSAY", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H120003", "company": "xvivo perfusion", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2014-08-12", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H120003: XPS WITH STEEN SOLUTION PERFUSATE", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H130005", "company": "MicroVention, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2014-07-25", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H130005: LVIS INTRALUMINAL SUPPORT DEVICE", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:FA8650-14-M-6521", "company": "Hemosonics", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-04-17", "observed": "2026-09-18", "amount_usd": 149968, "summary": "DOD SBIR Phase I award $149,968: A Point-of-Care Device for Diagnosis of Platelet Injury in Trauma Patients", "source_url": "https://www.sbir.gov/awards?search=H132-013-0211"}, {"id": "sbir:DOD:FA8650-14-M-6522", "company": "Lynntech Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-04-16", "observed": "2026-09-18", "amount_usd": 149999, "summary": "DOD SBIR Phase I award $149,999: Antimicrobial Protective Silicone and Carbon Based Wound Dressings", "source_url": "https://www.sbir.gov/awards?search=H132-014-0067"}, {"id": "sbir:DOD:HR0011-14-9-0004", "company": "Cognionics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-04-04", "observed": "2026-09-18", "amount_usd": 999995, "summary": "DOD SBIR Phase II award $999,995: A Practical Real-World EEG Neuroimaging Platform", "source_url": "https://www.sbir.gov/awards?search=D2-1297"}, {"id": "sbir:DOD:FA8650-14-M-6520", "company": "Lynntech Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2014-01-27", "observed": "2026-09-18", "amount_usd": 149999, "summary": "DOD SBIR Phase I award $149,999: A Novel, Point-of-Care, Multi-Analysis Platelet Function Diagnostic System", "source_url": "https://www.sbir.gov/awards?search=H132-013-0062"}, {"id": "sbir:DOD:HQ0147-14-C-8305", "company": "American Energy Technologies Co", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2013-11-08", "observed": "2026-09-18", "amount_usd": 96165, "summary": "DOD SBIR Phase I award $96,165: 20-year Lithium Primary battery for Missile-Implantable Corrosion Monitoring Systems and as Primary Power Sources for mini-UAVs", "source_url": "https://www.sbir.gov/awards?search=L122-002-0003"}, {"id": "hde:H120005", "company": "Kaneka Pharma America LLC", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2013-10-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H120005: LIPOSORBER LA-15 SYSTEM", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:ED:H133S130064", "company": "Advanced Medical Electronics Corp", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2013-10-01", "observed": "2026-09-18", "amount_usd": 574954, "summary": "ED SBIR Phase II award $574,954: Enhancing Conversation Intelligibility for Hearing Aid Users in Noisy Environments", "source_url": "https://www.sbir.gov/awards?search=H133S130064"}, {"id": "sbir:DOD:H92222-13-P-0056", "company": "Utopiacompression,corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2013-07-22", "observed": "2026-09-18", "amount_usd": 149975, "summary": "DOD SBIR Phase I award $149,975: C-Care: An automated combat casualty diagnostic and monitoring system", "source_url": "https://www.sbir.gov/awards?search=S131-003-0022"}, {"id": "sbir:DOD:H92222-13-P-0055", "company": "DocBox Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2013-07-15", "observed": "2026-09-18", "amount_usd": 146094, "summary": "DOD SBIR Phase I award $146,094: Remote Electronic Medical Devices using the Integrated Clinical Environment (REMDICE)", "source_url": "https://www.sbir.gov/awards?search=S131-003-0054"}, {"id": "sbir:DOD:W81XWH-12-C-0004", "company": "Keranetics, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2013-06-21", "observed": "2026-09-18", "amount_usd": 751604, "summary": "DOD SBIR Phase II award $751,604: Flowable keratin biomaterials for improving infection control and wound healing, Phase 2.", "source_url": "https://www.sbir.gov/awards?search=A2-5197"}, {"id": "sbir:NASA:NNX13CC77P", "company": "Umpqua Research Company", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2013-05-23", "observed": "2026-09-18", "amount_usd": 125000, "summary": "NASA SBIR Phase I award $125,000: Advanced Capabilities Medical Suction Device", "source_url": "https://www.sbir.gov/awards?search=124303"}, {"id": "sbir:DOD:W81XWH-12-C-0056", "company": "Quantum Applied Science & Research Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2013-05-21", "observed": "2026-09-18", "amount_usd": 999933, "summary": "DOD SBIR Phase II award $999,933: An Auditory Evoked Response-Based Objective Tinnitus (AER-BOT) Diagnostic Device: Phase II", "source_url": "https://www.sbir.gov/awards?search=O2-1327"}, {"id": "sbir:DOD:W31P4Q-13-C-0155", "company": "Creare LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2013-05-09", "observed": "2026-09-18", "amount_usd": 99724, "summary": "DOD SBIR Phase I award $99,724: High-Quality, Low-Cost, Multi-Channel EEG System for Non-Traditional Users", "source_url": "https://www.sbir.gov/awards?search=D131-002-0040"}, {"id": "sbir:DOD:W31P4Q-13-C-0159", "company": "Transient Electronics Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2013-05-08", "observed": "2026-09-18", "amount_usd": 99940, "summary": "DOD SBIR Phase I award $99,940: Materials for an Implantable Transient Electronic Nerve Stimulation Device", "source_url": "https://www.sbir.gov/awards?search=D131-005-0070"}, {"id": "sbir:DOD:W31P4Q-13-C-0158", "company": "Design Interactive, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2013-05-06", "observed": "2026-09-18", "amount_usd": 99796, "summary": "DOD SBIR Phase I award $99,796: PETE Portable EEG Tool for Education", "source_url": "https://www.sbir.gov/awards?search=D131-002-0076"}, {"id": "hde:H110002", "company": "cortigent, inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2013-02-13", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H110002: ARGUS II RETINAL PROSTHESIS SYSTEM", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W911QX-12-C-0177", "company": "Creare LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2012-09-28", "observed": "2026-09-18", "amount_usd": 368522, "summary": "DOD SBIR Phase II award $368,522: Neurological Head Simulator for In-the-Field EEG Recordings", "source_url": "https://www.sbir.gov/awards?search=A2-4753"}, {"id": "sbir:DOD:W81XWH-11-C-0108", "company": "Modulated Imaging Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2012-09-24", "observed": "2026-09-18", "amount_usd": 1000000, "summary": "DOD SBIR Phase II award $1,000,000: Non-Radiological Imaging Devices for Combat Casualty Care Associated with Burn", "source_url": "https://www.sbir.gov/awards?search=O2-1285"}, {"id": "sbir:ED:H133S120017", "company": "Advanced Medical Electronics Corp", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2012-07-12", "observed": "2026-09-18", "amount_usd": 75000, "summary": "ED SBIR Phase I award $75,000: Enhancing Conversation Intelligibility for Hearing Aid Users in Noisy Environments", "source_url": "https://www.sbir.gov/awards?search=H133S120017"}, {"id": "sbir:DOD:W31P4Q-12-C-0192", "company": "Radiation Monitoring Devices, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2012-07-11", "observed": "2026-09-18", "amount_usd": 99997, "summary": "DOD STTR Phase I award $99,997: Non-invasive Continuous Hemodynamic Monitor", "source_url": "https://www.sbir.gov/awards?search=D12A-003-0032"}, {"id": "sbir:DOD:N00024-12-P-4036", "company": "Yardney Technical Products, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2012-02-23", "observed": "2026-09-18", "amount_usd": 79432, "summary": "DOD SBIR Phase I award $79,432: Battery Management, Monitoring and Diagnostic Device for Navy Energy Storage Modules", "source_url": "https://www.sbir.gov/awards?search=N113-177-0109"}, {"id": "sbir:NASA:NNX12CG02P", "company": "CFD Research Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2012-02-23", "observed": "2026-09-18", "amount_usd": 124923, "summary": "NASA STTR Phase I award $124,923: An Electrochemical, Point-of-Care Detector for Reagent-free, In-situ Diagnostics of Pathogens", "source_url": "https://www.sbir.gov/awards?search=110060"}, {"id": "sbir:DOD:N00024-12-P-4035", "company": "Tiax LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2012-02-17", "observed": "2026-09-18", "amount_usd": 79967, "summary": "DOD SBIR Phase I award $79,967: Battery Management, Monitoring and Diagnostic Device for Navy Energy Storage Modules", "source_url": "https://www.sbir.gov/awards?search=N113-177-0087"}, {"id": "sbir:DOD:N00024-12-P-4034", "company": "Williamsrdm, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2012-02-15", "observed": "2026-09-18", "amount_usd": 80000, "summary": "DOD SBIR Phase I award $80,000: Battery Management, Monitoring and Diagnostic Device for Navy Energy Storage Modules", "source_url": "https://www.sbir.gov/awards?search=N113-177-0039"}, {"id": "sbir:DOD:HR0011-12-9-0005", "company": "Spot On Sciences, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2012-02-02", "observed": "2026-09-18", "amount_usd": 991759, "summary": "DOD SBIR Phase II award $991,759: Sampling and Reagent Technologies for Point of Care Diagnostics", "source_url": "https://www.sbir.gov/awards?search=11SB1-0032"}, {"id": "hde:H100004", "company": "Berlin Heart, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2011-12-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H100004: EXCOR PEDIATRIC VENTRICULAR ASSIST DEVIC", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-12-C-0033", "company": "Rochal Industries, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-12-08", "observed": "2026-09-18", "amount_usd": 99880, "summary": "DOD SBIR Phase I award $99,880: Development of Flowable Biomaterials that Promote Wound Healing with Infection Control and Prevention", "source_url": "https://www.sbir.gov/awards?search=A112-108-0079"}, {"id": "sbir:DOD:N00014-12-M-0104", "company": "Electrical Geodesics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-12-05", "observed": "2026-09-18", "amount_usd": 149836, "summary": "DOD SBIR Phase I award $149,836: Ultra Low Field MRI / MEG dense array Scanner for Combat Casualty Care", "source_url": "https://www.sbir.gov/awards?search=O112-H18-3145"}, {"id": "hde:H090002", "company": "pyrexar medical, inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2011-11-18", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H090002: BSD-2000 HYPERTHERMIA SYSTEM", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-11-C-0480", "company": "Agave Biosystems Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-10-03", "observed": "2026-09-18", "amount_usd": 99999, "summary": "DOD STTR Phase I award $99,999: Specific Epigenetic Molecules Involved in Wound Healing and Repair", "source_url": "https://www.sbir.gov/awards?search=A11A-030-0459"}, {"id": "hde:H100006", "company": "synapse biomedical", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2011-09-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H100006: NEURX DIAPHRAGM PACING SYSTEM (DPS)", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:N00014-11-C-0456", "company": "Mimosa Acoustics Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-09-09", "observed": "2026-09-18", "amount_usd": 499894, "summary": "DOD SBIR Phase II award $499,894: Novel Methods to Monitor Health Status and Clinical Laboratory Data: Portable Acquisition, Assessment, and Reporting", "source_url": "https://www.sbir.gov/awards?search=O2-1118"}, {"id": "sbir:DOD:W81XWH-11-C-0007", "company": "Hstar Technologies", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-08-29", "observed": "2026-09-18", "amount_usd": 749940, "summary": "DOD STTR Phase II award $749,940: A Near Autonomous Combat Casualty Extraction Robotic System", "source_url": "https://www.sbir.gov/awards?search=A2-4631"}, {"id": "sbir:DOD:W81XWH-11-C-0104", "company": "Farus, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-08-23", "observed": "2026-09-18", "amount_usd": 150000, "summary": "DOD SBIR Phase I award $150,000: Non-Radiological Imaging Devices for Combat Casualty Care Associated with Burn", "source_url": "https://www.sbir.gov/awards?search=O111-H03-3014"}, {"id": "sbir:DOD:W81XWH-11-C-0107", "company": "SED Technology LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-08-10", "observed": "2026-09-18", "amount_usd": 149999, "summary": "DOD SBIR Phase I award $149,999: Non-Radiological Imaging Devices for Combat Casualty Care Associated with Burn", "source_url": "https://www.sbir.gov/awards?search=O111-H03-3012"}, {"id": "sbir:DOD:N68335-11-C-0385", "company": "Etegent Technologies, Ltd.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-08-09", "observed": "2026-09-18", "amount_usd": 749948, "summary": "DOD SBIR Phase II award $749,948: Low Cost, Dual Purpose Engine Control and Diagnostic Sensors", "source_url": "https://www.sbir.gov/awards?search=N101-013-1688"}, {"id": "sbir:DOD:N00014-11-C-0469", "company": "Enterprise Sciences, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-07-14", "observed": "2026-09-18", "amount_usd": 1499956, "summary": "DOD STTR Phase II award $1,499,956: Miniature, Portable Device to Detect and Monitor Coagulopathy", "source_url": "https://www.sbir.gov/awards?search=N10A-043-0347"}, {"id": "sbir:DOD:W81XWH-11-C-0106", "company": "Oceanit Laboratories Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-07-11", "observed": "2026-09-18", "amount_usd": 150000, "summary": "DOD SBIR Phase I award $150,000: Non-Radiological Imaging Devices for Combat Casualty Care Associated with Burn", "source_url": "https://www.sbir.gov/awards?search=O111-H03-3053"}, {"id": "sbir:NASA:NNX11CA48C", "company": "Ridgetop Group Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-06-01", "observed": "2026-09-18", "amount_usd": 599965, "summary": "NASA SBIR Phase II award $599,965: Embedded Data Acquisition Tools for Rotorcraft Diagnostic Sensors", "source_url": "https://www.sbir.gov/awards?search=094060"}, {"id": "sbir:DHS:D11PC20143", "company": "Progeny Systems, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-05-15", "observed": "2026-09-18", "amount_usd": 99795, "summary": "DHS SBIR Phase I award $99,795: Mitigation of Contact Lenses, Eye Surgery, Pupil Dilation, and Other Challenges in Iris Recognition", "source_url": "https://www.sbir.gov/awards?search=1111048"}, {"id": "sbir:DOD:W81XWH-10-C-0038", "company": "Agave Biosystems Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-04-30", "observed": "2026-09-18", "amount_usd": 780000, "summary": "DOD SBIR Phase II award $780,000: A Point-of-Care Field Assay for Dengue Viruses", "source_url": "https://www.sbir.gov/awards?search=A2-4447"}, {"id": "sbir:DOD:W31P4Q-11-C-0234", "company": "Spot On Sciences, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-04-26", "observed": "2026-09-18", "amount_usd": 148538, "summary": "DOD SBIR Phase I award $148,538: Sampling and Reagent Technologies for Point of Care Diagnostics", "source_url": "https://www.sbir.gov/awards?search=11SB1-0032"}, {"id": "sbir:DOD:W31P4Q-11-C-0219", "company": "Infoscitex Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-04-25", "observed": "2026-09-18", "amount_usd": 99937, "summary": "DOD SBIR Phase I award $99,937: Improved Collection, Specificity, and Longterm Reagent Storage for Point of Care Diagnostics", "source_url": "https://www.sbir.gov/awards?search=11SB1-0015"}, {"id": "sbir:DOD:W31P4Q-11-C-0223", "company": "Ifyber LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-04-20", "observed": "2026-09-18", "amount_usd": 100000, "summary": "DOD SBIR Phase I award $100,000: Lab-on-a-Bubble: A powerful, low-cost, point-of-care diagnostic platform technology", "source_url": "https://www.sbir.gov/awards?search=11SB1-0014"}, {"id": "hde:H100002", "company": "neurovasx", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2011-04-01", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H100002: CPAX ANEURYSM TREATMENT SYSTEM", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H080005", "company": "Elana, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2011-03-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H080005: ELANA ARTERIOTOMY SYSTEM", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:NASA:NNX11CD52P", "company": "Mesoscribe Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-02-18", "observed": "2026-09-18", "amount_usd": 100000, "summary": "NASA SBIR Phase I award $100,000: In Situ Diagnostic Sensors for Thermal Protection Systems", "source_url": "https://www.sbir.gov/awards?search=105845"}, {"id": "sbir:DOD:W911QX-11-C-0038", "company": "Creare LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2011-01-24", "observed": "2026-09-18", "amount_usd": 69754, "summary": "DOD SBIR Phase I award $69,754: Neurological Head Simulator for In-the-Field EEG Recordings", "source_url": "https://www.sbir.gov/awards?search=A102-066-1412"}, {"id": "sbir:DOD:W911QX-11-C-0025", "company": "CFD Research Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-12-13", "observed": "2026-09-18", "amount_usd": 69992, "summary": "DOD SBIR Phase I award $69,992: A Physical and Virtual Head Phantom for Evaluating Human Performance using EEG Equipment", "source_url": "https://www.sbir.gov/awards?search=A102-066-1483"}, {"id": "sbir:DOD:N00014-11-M-0361", "company": "Nanomason Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-10-18", "observed": "2026-09-18", "amount_usd": 69173, "summary": "DOD STTR Phase I award $69,173: Miniature, Portable, Device to Detect and Monitor Coagulopathy", "source_url": "https://www.sbir.gov/awards?search=N10A-043-0816"}, {"id": "sbir:DOD:W81XWH-10-C-0017", "company": "Inbios International Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-10-01", "observed": "2026-09-18", "amount_usd": 729896, "summary": "DOD SBIR Phase II award $729,896: Developing a Point-of-Care Diagnostic Assay for Leptospirosis", "source_url": "https://www.sbir.gov/awards?search=A092-105-0170"}, {"id": "sbir:DOD:W81XWH-10-C-0001", "company": "Chromologic LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-08-30", "observed": "2026-09-18", "amount_usd": 729846, "summary": "DOD SBIR Phase II award $729,846: Surgical Debridement Assist Device", "source_url": "https://www.sbir.gov/awards?search=A092-103-1998"}, {"id": "sbir:DOD:N00014-10-C-0240", "company": "Empirical Technologies Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-07-13", "observed": "2026-09-18", "amount_usd": 1215414, "summary": "DOD SBIR Phase II award $1,215,414: New Methods to Monitor Health Status and Clinical Laboratory Data", "source_url": "https://www.sbir.gov/awards?search=O2-0949"}, {"id": "sbir:DOD:N00014-10-M-0362", "company": "Enterprise Sciences, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-06-28", "observed": "2026-09-18", "amount_usd": 99996, "summary": "DOD STTR Phase I award $99,996: Miniature, Portable, Device to Detect and Monitor Coagulopathy", "source_url": "https://www.sbir.gov/awards?search=N10A-043-0347"}, {"id": "sbir:DOD:N00014-10-M-0360", "company": "Hemosonics", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-06-28", "observed": "2026-09-18", "amount_usd": 69992, "summary": "DOD STTR Phase I award $69,992: Miniature, Portable, Device to Detect and Monitor Coagulopathy", "source_url": "https://www.sbir.gov/awards?search=N10A-043-0364"}, {"id": "sbir:DOD:W81XWH-10-C-0229", "company": "Calbiotech, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-05-10", "observed": "2026-09-18", "amount_usd": 99959, "summary": "DOD SBIR Phase I award $99,959: Develop Field-usable Diagnostic Devices for the Specific Detection of Leishmania Major and L. Infantum in Sand Flies", "source_url": "https://www.sbir.gov/awards?search=O093-H21-3146"}, {"id": "sbir:DOD:W91ZLK-10-C-0004", "company": "Quantum Applied Science & Research Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-05-07", "observed": "2026-09-18", "amount_usd": 718649, "summary": "DOD SBIR Phase II award $718,649: Sensor Artifact and Noise Reduction Algorithms for Cognitive and Physiological Status Monitoring", "source_url": "https://www.sbir.gov/awards?search=A2-3872"}, {"id": "sbir:DOD:N00014-10-M-0233", "company": "Mimosa Acoustics Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-05-05", "observed": "2026-09-18", "amount_usd": 99460, "summary": "DOD SBIR Phase I award $99,460: Novel Methods to Monitor Health Status and Clinical Laboratory Data", "source_url": "https://www.sbir.gov/awards?search=O093-H26-3048"}, {"id": "sbir:DOD:N00014-10-M-0235", "company": "Li Creative Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-05-04", "observed": "2026-09-18", "amount_usd": 99965, "summary": "DOD SBIR Phase I award $99,965: Novel Methods to Monitor Health Status and Clinical Laboratory Data", "source_url": "https://www.sbir.gov/awards?search=O093-H26-3143"}, {"id": "sbir:DOD:N68335-10-C-0351", "company": "Etegent Technologies, Ltd.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-04-28", "observed": "2026-09-18", "amount_usd": 149866, "summary": "DOD SBIR Phase I award $149,866: Low Cost, Dual Purpose Engine Control and Diagnostic Sensors", "source_url": "https://www.sbir.gov/awards?search=N101-013-1688"}, {"id": "sbir:DOD:W81XWH-09-C-0036", "company": "Agave Biosystems Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-04-16", "observed": "2026-09-18", "amount_usd": 730000, "summary": "DOD SBIR Phase II award $730,000: Point-of-Care Diagnostic for Acute Q Fever using LAMP", "source_url": "https://www.sbir.gov/awards?search=A2-4000"}, {"id": "sbir:DOD:W81XWH-10-C-0168", "company": "Vector Test Systems", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-04-01", "observed": "2026-09-18", "amount_usd": 99984, "summary": "DOD SBIR Phase I award $99,984: Develop Field-usable Diagnostic Devices for the Specific Detection of Leishmania Major and L. Infantum in Sand Flies", "source_url": "https://www.sbir.gov/awards?search=O093-H21-3192"}, {"id": "sbir:DOD:W81XWH-10-C-0058", "company": "Physical Optics Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-04-01", "observed": "2026-09-18", "amount_usd": 99989, "summary": "DOD SBIR Phase I award $99,989: Screening of Cerebral Autoregulation and Neuroelectric Signals Through Hemodynamic Impedance Measurement and Electrocephalography", "source_url": "https://www.sbir.gov/awards?search=O093-H06-3009"}, {"id": "sbir:DOD:W81XWH-10-C-0180", "company": "Phoenix Biosystem, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-04-01", "observed": "2026-09-18", "amount_usd": 99368, "summary": "DOD SBIR Phase I award $99,368: Develop Field-usable Diagnostic Devices for the Specific Detection of Leishmania Major and L. Infantum in Sand Flies", "source_url": "https://www.sbir.gov/awards?search=O093-H21-3029"}, {"id": "sbir:DOD:W81XWH-09-C-0066", "company": "Vector Test Systems", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-03-19", "observed": "2026-09-18", "amount_usd": 729993, "summary": "DOD SBIR Phase II award $729,993: Development of a Point-of-care Assay for the Detection of Rift Valley Fever (RVF) Virus, a Militarily Important Pathogen of the CENTCOM and AFRICOM Ar", "source_url": "https://www.sbir.gov/awards?search=A2-4023"}, {"id": "sbir:DOD:W81XWH-10-C-0050", "company": "Quantum Applied Science & Research Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-02-15", "observed": "2026-09-18", "amount_usd": 69992, "summary": "DOD SBIR Phase I award $69,992: Integrated EEG+fNIRS Measurement System for In-field Collection of mTBI Data", "source_url": "https://www.sbir.gov/awards?search=A093-157-0565"}, {"id": "hde:H080002", "company": "Medtronic, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2010-01-25", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H080002: MELODY TRANSCATHETER PULMONARY VALVE AND", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-09-C-0041", "company": "TransMembrane Biosciences", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2010-01-16", "observed": "2026-09-18", "amount_usd": 729998, "summary": "DOD SBIR Phase II award $729,998: A Point-of-Care Assay for the Detection of Q fever", "source_url": "https://www.sbir.gov/awards?search=A2-4016"}, {"id": "sbir:DOD:W81XWH-09-C-0062", "company": "Mymic, L.l.c.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-12-15", "observed": "2026-09-18", "amount_usd": 1182240, "summary": "DOD SBIR Phase II award $1,182,240: Sim-Game based Training System for Scene and Patient Management Following Blast Injury from Explosives Including Improvised Explosive Device (IED)", "source_url": "https://www.sbir.gov/awards?search=O083-H12-3010"}, {"id": "sbir:DOD:W81XWH-09-C-0060", "company": "Simquest International, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-11-23", "observed": "2026-09-18", "amount_usd": 749841, "summary": "DOD SBIR Phase II award $749,841: Sim-Game based Training System for Scene and Patient Management Following Blast Injury from Explosives Including Improvised Explosive Device (IED)", "source_url": "https://www.sbir.gov/awards?search=O083-H12-3011"}, {"id": "sbir:DOD:W81XWH-09-C-0038", "company": "Inbios International Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-11-17", "observed": "2026-09-18", "amount_usd": 729256, "summary": "DOD SBIR Phase II award $729,256: Development of a Point-of-care Assay for the Detection of Sand Fly Fever Virus (SFFV), a Militarily Important Pathogen of the CENTCOM, EUCOM and AFRIC", "source_url": "https://www.sbir.gov/awards?search=A083-182-0191"}, {"id": "sbir:DOD:W81XWH-09-C-0006", "company": "I.S.S (USA), Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-09-10", "observed": "2026-09-18", "amount_usd": 779722, "summary": "DOD SBIR Phase II award $779,722: Compact quantitative near infrared device for combat casualty care", "source_url": "https://www.sbir.gov/awards?search=A2-3833"}, {"id": "sbir:DOD:N00014-09-M-0360", "company": "Ifyber LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-06-29", "observed": "2026-09-18", "amount_usd": 69999, "summary": "DOD STTR Phase I award $69,999: Nanoparticle-based Wound Care for Antibiotic Resistant Pathogens", "source_url": "https://www.sbir.gov/awards?search=N09A-033-0638"}, {"id": "sbir:DOD:N00014-09-M-0146", "company": "Empirical Technologies Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-03-31", "observed": "2026-09-18", "amount_usd": 100000, "summary": "DOD SBIR Phase I award $100,000: New Methods to Monitor Health Status and Clinical Laboratory Data", "source_url": "https://www.sbir.gov/awards?search=O082-H01-3103"}, {"id": "sbir:DOD:W81XWH-09-C-0030", "company": "Inbios International Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-02-26", "observed": "2026-09-18", "amount_usd": 69918, "summary": "DOD SBIR Phase I award $69,918: Development of a Point-of-care Assay for the Detection of Rift Valley Fever Virus, a Militarily Important Pathogen of the CENTCOM and AFRICOM Area of", "source_url": "https://www.sbir.gov/awards?search=A083-180-0114"}, {"id": "sbir:DHS:NBCHC090020", "company": "Utopiacompression,corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-02-12", "observed": "2026-09-18", "amount_usd": 824938, "summary": "DHS SBIR Phase II award $824,938: Responder Wireless Physiological Monitoring Device", "source_url": "https://www.sbir.gov/awards?search=711236"}, {"id": "sbir:DOD:W81XWH-09-C-0045", "company": "Renee Stout, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-02-12", "observed": "2026-09-18", "amount_usd": 99995, "summary": "DOD SBIR Phase I award $99,995: Sim-Game based Training System for Scene and Patient Management Following Blast Injury from Explosives Including Improvised Explosive Device (IED)", "source_url": "https://www.sbir.gov/awards?search=O083-H12-3036"}, {"id": "hde:H050003", "company": "medtronic inc.,neurological division.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2009-02-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H050003: MEDTRONIC (ACTIVA)DEEP BRAIN STIMULATION", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-09-C-0044", "company": "JXT Applications, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-02-02", "observed": "2026-09-18", "amount_usd": 99999, "summary": "DOD SBIR Phase I award $99,999: Sim-Game based Training System for Scene and Patient Management Following Blast Injury from Explosives Including Improvised Explosive Device (IED)", "source_url": "https://www.sbir.gov/awards?search=O083-H12-3024"}, {"id": "sbir:DOD:W81XWH-09-C-0067", "company": "TransMembrane Biosciences", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-01-27", "observed": "2026-09-18", "amount_usd": 70000, "summary": "DOD SBIR Phase I award $70,000: Development of a Point-of-care Assay for the Detection of Crimean-Congo Haemorrhagic Fever (CCHF) Virus, a Militarily Important Pathogen of the CENTCO", "source_url": "https://www.sbir.gov/awards?search=A083-181-0377"}, {"id": "sbir:DOD:W81XWH-09-C-0065", "company": "Inbios International Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-01-23", "observed": "2026-09-18", "amount_usd": 69456, "summary": "DOD SBIR Phase I award $69,456: A Point-of-Care Assay for the Detection of Coxiella Burnetii (Q fever) Infection in Soldiers Deployed to Iraq", "source_url": "https://www.sbir.gov/awards?search=A083-178-0430"}, {"id": "sbir:DOD:W81XWH-09-C-0034", "company": "Vector Test Systems", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-01-20", "observed": "2026-09-18", "amount_usd": 69993, "summary": "DOD SBIR Phase I award $69,993: Development of a Point-of-care Assay for the Detection of Sand Fly Fever Virus (SFFV), a Militarily Important Pathogen of the CENTCOM, EUCOM and AFRIC", "source_url": "https://www.sbir.gov/awards?search=A083-182-0221"}, {"id": "sbir:DOD:N00014-09-M-0102", "company": "Linea Research Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2009-01-08", "observed": "2026-09-18", "amount_usd": 100000, "summary": "DOD SBIR Phase I award $100,000: Multi-Parameter Physiological Monitor", "source_url": "https://www.sbir.gov/awards?search=O082-H01-3035"}, {"id": "sbir:DOD:W81XWH-08-C-0014", "company": "Eigent Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2008-11-17", "observed": "2026-09-18", "amount_usd": 1379950, "summary": "DOD SBIR Phase II award $1,379,950: Automated Identification Technology System (AIT) to Identify, Track and Monitor the Condition of Medical Supply Items from Point of Origin to End User", "source_url": "https://www.sbir.gov/awards?search=A2-3252"}, {"id": "hde:H060002", "company": "gyrus acmi, inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2008-10-24", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H060002: IBV VALVE SYSTEM", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H040004", "company": "medtronic sofamor danek, inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2008-10-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H040004: INFUSE/MASTERGRAFT CERAMIC OR INFUSE HDE", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-08-C-0006", "company": "Inbios International Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2008-10-09", "observed": "2026-09-18", "amount_usd": 1209590, "summary": "DOD SBIR Phase II award $1,209,590: A Point-of-Care Assay for the Detection of Spotted-fever group and Typhus group Rickettsia.", "source_url": "https://www.sbir.gov/awards?search=A072-153-0025"}, {"id": "hde:H070004", "company": "abbott", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2008-10-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H070004: CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTE", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W91ZLK-08-C-0018", "company": "Quantum Applied Science & Research Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2008-09-27", "observed": "2026-09-18", "amount_usd": 119941, "summary": "DOD SBIR Phase I award $119,941: Sensor Artifact and Noise Reduction Algorithms for Cognitive and Physiological Status Monitoring", "source_url": "https://www.sbir.gov/awards?search=A081-004-0084"}, {"id": "sbir:DOD:W81XWH-07-C-0103", "company": "Elintrix", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2008-07-08", "observed": "2026-09-18", "amount_usd": 749771, "summary": "DOD STTR Phase II award $749,771: Multi-Analyte, Wearable Chemical Nanosensor for Warfighter Physiological Status Monitor (WPSM)", "source_url": "https://www.sbir.gov/awards?search=A074-035-0440"}, {"id": "sbir:DOD:W81XWH-07-C-0104", "company": "Perl Research LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2008-07-01", "observed": "2026-09-18", "amount_usd": 750000, "summary": "DOD STTR Phase II award $750,000: Standoff Remote Triage Sensor Array for Robotic Casualty Extraction Systems", "source_url": "https://www.sbir.gov/awards?search=A074-040-0439"}, {"id": "hde:H070003", "company": "synapse biomedical", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2008-06-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H070003: NEURX RA/4 DEVICE", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:N00014-08-M-0226", "company": "Physical Optics Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2008-05-12", "observed": "2026-09-18", "amount_usd": 69989, "summary": "DOD SBIR Phase I award $69,989: Fused Optical Railgun Diagnostic Sensor", "source_url": "https://www.sbir.gov/awards?search=N081-066-0160"}, {"id": "sbir:DOD:W81XWH-07-C-0063", "company": "Stratatech Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2008-05-05", "observed": "2026-09-18", "amount_usd": 749790, "summary": "DOD SBIR Phase II award $749,790: Development of a Field-Ready Antimicrobial Wound Dressing for the Treatment of Vesicant Burns", "source_url": "https://www.sbir.gov/awards?search=C071-113-0151"}, {"id": "sbir:DOD:FA8650-08-C-6808", "company": "Progeny Systems, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2008-01-24", "observed": "2026-09-18", "amount_usd": 749670, "summary": "DOD SBIR Phase II award $749,670: Smart Hemodynamic Monitoring System for Critical Care Air Transport Team (CCATT)", "source_url": "https://www.sbir.gov/awards?search=O052-H15-3047"}, {"id": "sbir:DOD:FA8650-08-C-6809", "company": "Active Signal Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2007-12-19", "observed": "2026-09-18", "amount_usd": 749956, "summary": "DOD SBIR Phase II award $749,956: Smart Hemodynamic Monitoring System for Critical Care Air Transport Team (CCATT)", "source_url": "https://www.sbir.gov/awards?search=O052-H15-3013"}, {"id": "sbir:DOD:W81XWH-07-C-0030", "company": "Inbios International Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2007-10-31", "observed": "2026-09-18", "amount_usd": 725080, "summary": "DOD SBIR Phase II award $725,080: A Multiplexed Point-of-Care Assay for the Detection of Enteric Pathogens that Cause Severe Diarrhea in Deployed Soldiers", "source_url": "https://www.sbir.gov/awards?search=A062-158-0254"}, {"id": "hde:H990002", "company": "genzyme corp.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2007-10-25", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H990002: EPICEL (CULTURED EPIDERMAL AUTOGRAFTS)", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-06-C-0392", "company": "Simbex LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2007-09-11", "observed": "2026-09-18", "amount_usd": 749749, "summary": "DOD STTR Phase II award $749,749: A powered foot and ankle prosthesis for improved maneuverability and reduced metabolic cost", "source_url": "https://www.sbir.gov/awards?search=A064-031-0215"}, {"id": "sbir:DOD:N00014-07-C-0366", "company": "Tessonics Corp.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2007-07-30", "observed": "2026-09-18", "amount_usd": 744851, "summary": "DOD SBIR Phase II award $744,851: Portable Pulmonary Injury Diagnostic Device", "source_url": "https://www.sbir.gov/awards?search=O052-H12-3187"}, {"id": "hde:H060001", "company": "medos international sarl", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2007-05-08", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H060001: ENTERPRISE VASCULAR RECONSTRUCTIVE DEVIC", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H060003", "company": "ev3, inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2007-04-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H060003: ONYX ANEURYSM SYSTEM, ONYX HD-500 MODEL", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H060004", "company": "Fujirebio Diagnostics, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2007-01-24", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H060004: MESOMARK", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-06-C-0004", "company": "Vector Test Systems", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-12-11", "observed": "2026-09-18", "amount_usd": 749957, "summary": "DOD SBIR Phase II award $749,957: Development of a multiplexed point-of-care assay for the detection of infectious agents causing fever in deployed soldiers.", "source_url": "https://www.sbir.gov/awards?search=O052-H07-3210"}, {"id": "sbir:DOD:W81XWH-06-C-0080", "company": "Li Creative Technologies Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-12-05", "observed": "2026-09-18", "amount_usd": 999973, "summary": "DOD SBIR Phase II award $999,973: Mechanisms for Hands-Free Point of Care Data Entry in Combat Environments", "source_url": "https://www.sbir.gov/awards?search=O052-H10-3063"}, {"id": "sbir:DOD:W81XWH-06-C-0016", "company": "Cleveland Medical Devices, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-09-28", "observed": "2026-09-18", "amount_usd": 1879480, "summary": "DOD SBIR Phase II award $1,879,480: Ambulatory, Miniaturized, Automatic EEG Seizure Detector", "source_url": "https://www.sbir.gov/awards?search=A052-162-2339"}, {"id": "sbir:DOD:W81XWH-06-C-0024", "company": "Quick-Med Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-09-18", "observed": "2026-09-18", "amount_usd": 730000, "summary": "DOD SBIR Phase II award $730,000: Chemical Casualty Care: Wound Dressings Designed to Speed Wound Closure Following Debridement of Cutaneous Vesicant Injuries", "source_url": "https://www.sbir.gov/awards?search=A052-131-1765"}, {"id": "hde:H040006", "company": "Abiomed, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2006-09-05", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H040006: ABIOCOR IMPLANTABLE REPLACEMENT HEART", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:W81XWH-05-C-0164", "company": "Universal Stabilization Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-09-01", "observed": "2026-09-18", "amount_usd": 749606, "summary": "DOD STTR Phase II award $749,606: Preservation Of Platelets For Hemostatic And Wound Healing Bandages", "source_url": "https://www.sbir.gov/awards?search=A054-027-0345"}, {"id": "sbir:DOD:W81XWH-06-C-0384", "company": "Aerodyne Research Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-08-15", "observed": "2026-09-18", "amount_usd": 99944, "summary": "DOD STTR Phase I award $99,944: Miniature Generator Power for Advanced Prostheses", "source_url": "https://www.sbir.gov/awards?search=A064-031-0151"}, {"id": "sbir:DOD:W81XWH-06-C-0021", "company": "Ripple LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-08-14", "observed": "2026-09-18", "amount_usd": 729865, "summary": "DOD SBIR Phase II award $729,865: Field Deployable Electroencephalogram (EEG) for Assessing Nonconvulsive Seizures", "source_url": "https://www.sbir.gov/awards?search=A052-162-3902"}, {"id": "sbir:DOD:W81XWH-05-C-0098", "company": "Vector Test Systems", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-04-24", "observed": "2026-09-18", "amount_usd": 719304, "summary": "DOD SBIR Phase II award $719,304: Development of a field-usable diagnostic device for the detection of Leishmania parasites in Sand flies.", "source_url": "https://www.sbir.gov/awards?search=O043-H08-3019"}, {"id": "hde:H040005", "company": "Karl Storz Endoscopy-America, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2006-03-31", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H040005: FETOSCOPY INSTRUMENT SET", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:N00014-05-C-0388", "company": "Infoscitex Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-03-09", "observed": "2026-09-18", "amount_usd": 487668, "summary": "DOD STTR Phase II award $487,668: Casualty Patient Warming Device", "source_url": "https://www.sbir.gov/awards?search=N045-021-0166"}, {"id": "sbir:DOD:W81XWH-06-C-0095", "company": "Inbios International Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-01-30", "observed": "2026-09-18", "amount_usd": 99964, "summary": "DOD SBIR Phase I award $99,964: Development of a multiplexed point-of-care assay for the detection of infectious agents causing fever in deployed soldiers.", "source_url": "https://www.sbir.gov/awards?search=O052-H07-3010"}, {"id": "sbir:DOD:W81XWH-06-C-0092", "company": "Panbio, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-01-27", "observed": "2026-09-18", "amount_usd": 99936, "summary": "DOD SBIR Phase I award $99,936: Multiplex point-of-care assay to diagnose infectious diseases", "source_url": "https://www.sbir.gov/awards?search=O052-H07-3119"}, {"id": "sbir:DOD:W81XWH-05-C-0068", "company": "Electrical Geodesics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-01-20", "observed": "2026-09-18", "amount_usd": 749406, "summary": "DOD SBIR Phase II award $749,406: Simultaneous EEG Acquisition and Portable Near Infrared Spectroscopy for Recognition of Traumatic Brain Injury Severity and Outcome Assessments in Far", "source_url": "https://www.sbir.gov/awards?search=A2-2261"}, {"id": "sbir:DOD:W81XWH-06-C-0083", "company": "Digilore, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-01-19", "observed": "2026-09-18", "amount_usd": 99940, "summary": "DOD SBIR Phase I award $99,940: Mechanisms for Hands-Free Point of Care Data Entry in Combat Environments", "source_url": "https://www.sbir.gov/awards?search=O052-H10-3039"}, {"id": "sbir:DOD:W81XWH-06-C-0082", "company": "Handheld Speech LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-01-10", "observed": "2026-09-18", "amount_usd": 99840, "summary": "DOD SBIR Phase I award $99,840: Mechanisms for Hands-Free Point of Care Data Entry in Combat Environments", "source_url": "https://www.sbir.gov/awards?search=O052-H10-3037"}, {"id": "sbir:DOD:N00014-06-M-0033", "company": "Stethographics, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-01-04", "observed": "2026-09-18", "amount_usd": 97191, "summary": "DOD SBIR Phase I award $97,191: Portable Pulmonary Injury Diagnostic Device", "source_url": "https://www.sbir.gov/awards?search=O052-H12-3022"}, {"id": "sbir:DOD:N00014-06-M-0034", "company": "Tessonics Corp.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-01-04", "observed": "2026-09-18", "amount_usd": 94600, "summary": "DOD SBIR Phase I award $94,600: Portable Pulmonary Injury Diagnostic Device", "source_url": "https://www.sbir.gov/awards?search=O052-H12-3187"}, {"id": "sbir:DOD:N00014-06-M-0032", "company": "Active Signal Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2006-01-04", "observed": "2026-09-18", "amount_usd": 99593, "summary": "DOD SBIR Phase I award $99,593: Portable Pulmonary Injury Diagnostic Device", "source_url": "https://www.sbir.gov/awards?search=O052-H12-3014"}, {"id": "sbir:DOD:W81XWH-05-C-0057", "company": "Adlyfe, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-12-07", "observed": "2026-09-18", "amount_usd": 750000, "summary": "DOD SBIR Phase II award $750,000: Development of a hemostatic wound dressing incorporating lyophilized platelets", "source_url": "https://www.sbir.gov/awards?search=O2-0347"}, {"id": "sbir:DOD:FA8650-06-M-6601", "company": "Progeny Systems, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-12-01", "observed": "2026-09-18", "amount_usd": 99686, "summary": "DOD SBIR Phase I award $99,686: Smart Hemodynamic Monitoring System for Critical Care Air Transport Team (CCATT)", "source_url": "https://www.sbir.gov/awards?search=O052-H15-3047"}, {"id": "sbir:DOD:FA8650-06-M-6602", "company": "Active Signal Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-11-14", "observed": "2026-09-18", "amount_usd": 99839, "summary": "DOD SBIR Phase I award $99,839: Smart Hemodynamic Monitoring System for Critical Care Air Transport Team (CCATT)", "source_url": "https://www.sbir.gov/awards?search=O052-H15-3013"}, {"id": "sbir:DOD:W81XWH-06-C-0026", "company": "Access Pharmaceuticals, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-11-14", "observed": "2026-09-18", "amount_usd": 69988, "summary": "DOD SBIR Phase I award $69,988: Chemical Casualty Care: Hydrogel Nanoparticle Aggregates as Wound Dressings Following Debridement of Cutaneuous Vesicant Injuries", "source_url": "https://www.sbir.gov/awards?search=A052-131-1312"}, {"id": "sbir:DOD:W81XWH-06-C-0023", "company": "Lynntech Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-11-14", "observed": "2026-09-18", "amount_usd": 70000, "summary": "DOD SBIR Phase I award $70,000: Multifunctional Dressings for Improved Wound Healing", "source_url": "https://www.sbir.gov/awards?search=A052-131-1705"}, {"id": "sbir:DOD:FA8650-06-M-6603", "company": "Defense Research Technologies, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-11-11", "observed": "2026-09-18", "amount_usd": 99631, "summary": "DOD SBIR Phase I award $99,631: Smart Hemodynamic Monitoring System for Critical Care Air Transport Team (CCATT)", "source_url": "https://www.sbir.gov/awards?search=O052-H15-3108"}, {"id": "sbir:DOD:N00014-05-C-0235", "company": "Sapien Systems", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-08-23", "observed": "2026-09-18", "amount_usd": 749710, "summary": "DOD SBIR Phase II award $749,710: Electronic Combat Casualty Care Training (ECCCT)", "source_url": "https://www.sbir.gov/awards?search=O032-3041"}, {"id": "hde:H050001", "company": "stryker corp.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2005-08-03", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H050001: WINGSPAN STENT SYSTEM WITH GATEWAY PTA B", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:N68335-05-C-0296", "company": "Innovative Technology Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-05-12", "observed": "2026-09-18", "amount_usd": 1079720, "summary": "DOD SBIR Phase II award $1,079,720: Kinetic Metallization - A Repair Process for Ion Vapor Deposition (IVD) Aluminum", "source_url": "https://www.sbir.gov/awards?search=N041-023-0035"}, {"id": "hde:H030005", "company": "zoll circulation", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2005-03-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H030005: COAXIA NEUROFLO CATHETER", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:N00014-05-M-0101", "company": "Srico Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-03-10", "observed": "2026-09-18", "amount_usd": 99989, "summary": "DOD SBIR Phase I award $99,989: Neuro-physiological Optical Sensor Suite for Gravity-Induced Loss of Consciousness Monitoring and Intervention", "source_url": "https://www.sbir.gov/awards?search=O043-H10-3076"}, {"id": "sbir:DOD:W81XWH-05-C-0081", "company": "Technest, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-01-14", "observed": "2026-09-18", "amount_usd": 99999, "summary": "DOD SBIR Phase I award $99,999: Simultaneous EEG Acquisition and Portable Near Infrared Spectroscopy for Recognition of Traumatic Brain Injury Severity and Outcome Assessments in Far", "source_url": "https://www.sbir.gov/awards?search=O043-H11-3072"}, {"id": "sbir:DOD:W81XWH-05-C-0093", "company": "Innovative Technical Solutions, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-01-13", "observed": "2026-09-18", "amount_usd": 99979, "summary": "DOD SBIR Phase I award $99,979: Assessing Post-Blast Pulmonary Function using NIRS", "source_url": "https://www.sbir.gov/awards?search=O043-H14-3112"}, {"id": "sbir:DOD:W81XWH-05-C-0069", "company": "Infrascan Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2005-01-10", "observed": "2026-09-18", "amount_usd": 100000, "summary": "DOD SBIR Phase I award $100,000: Simultaneous EEG Acquisition and Portable Near Infrared Spectroscopy for Recognition of Traumatic Brain Injury Severity and Outcome Assessments in Far", "source_url": "https://www.sbir.gov/awards?search=O043-H11-3032"}, {"id": "sbir:DOD:W911NF-05-C-0017", "company": "Agave Biosystems Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2004-12-07", "observed": "2026-09-18", "amount_usd": 70000, "summary": "DOD SBIR Phase I award $70,000: ECIS Wound Healing High-Throughput Assay", "source_url": "https://www.sbir.gov/awards?search=A043-071-1724"}, {"id": "hde:H040002", "company": "Addition Technology", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2004-07-26", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H040002: INTACS PRESCRIPTION INSERTS FOR KERATOCO", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:N00014-04-M-0273", "company": "Arizant Healthcare, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2004-07-01", "observed": "2026-09-18", "amount_usd": 70000, "summary": "DOD STTR Phase I award $70,000: Patient Warming Device for Casualty Care", "source_url": "https://www.sbir.gov/awards?search=N045-021-0053"}, {"id": "sbir:DOD:N00014-04-M-0279", "company": "Foster-miller, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2004-07-01", "observed": "2026-09-18", "amount_usd": 69954, "summary": "DOD STTR Phase I award $69,954: Casualty Patient Warning Device", "source_url": "https://www.sbir.gov/awards?search=N045-021-0166"}, {"id": "sbir:DOD:N00014-04-M-0280", "company": "Thermogear, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2004-07-01", "observed": "2026-09-18", "amount_usd": 99855, "summary": "DOD STTR Phase I award $99,855: Patient Warming Device for Casualty Care", "source_url": "https://www.sbir.gov/awards?search=N045-021-0033"}, {"id": "sbir:DOD:W81XWH-04-C-0117", "company": "Foster-miller, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2004-06-16", "observed": "2026-09-18", "amount_usd": 99986, "summary": "DOD STTR Phase I award $99,986: Improved Performance, Stable Artificial Oxygen Carrier for Battlefield Casualty Care", "source_url": "https://www.sbir.gov/awards?search=A045-024-0154"}, {"id": "sbir:DOD:N00014-04-M-0244", "company": "Cybernet Systems Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2004-06-15", "observed": "2026-09-18", "amount_usd": 99909, "summary": "DOD SBIR Phase I award $99,909: NIRS for Deep Brain Tissue Oxygenation Measurement", "source_url": "https://www.sbir.gov/awards?search=O041-DH4-3057"}, {"id": "sbir:DOD:N00421-04-P-0624", "company": "Ats-mer, LLC", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2004-06-08", "observed": "2026-09-18", "amount_usd": 70000, "summary": "DOD SBIR Phase I award $70,000: Plasma Processing for Repair of Ion Vapor Deposited (IVD) Aluminum Coating", "source_url": "https://www.sbir.gov/awards?search=N041-023-1588"}, {"id": "sbir:DOD:N00421-04-P-0625", "company": "Nanomat, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2004-04-15", "observed": "2026-09-18", "amount_usd": 70000, "summary": "DOD SBIR Phase I award $70,000: Method for Repairing Damaged Ion Vapor Deposition (IVD) Aluminum Coatings", "source_url": "https://www.sbir.gov/awards?search=N041-023-1417"}, {"id": "hde:H020008", "company": "olympus biotech corporation", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2004-04-07", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H020008: OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUS", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:DOD:N00421-04-P-0623", "company": "Innovative Technology Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2004-04-05", "observed": "2026-09-18", "amount_usd": 99962, "summary": "DOD SBIR Phase I award $99,962: Kinetic Metallization - A Repair Process for Ion Vapor Deposition (IVD) Aluminum", "source_url": "https://www.sbir.gov/awards?search=N041-023-0035"}, {"id": "hde:H030003", "company": "reliantheart, inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2004-02-25", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H030003: DEBAKEY VAD CHILD VENTRICULAR ASSIST DEV", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H030004", "company": "Menssana Research Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2004-02-24", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H030004: HEARTSBREATH", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "sbir:NASA:NNM04AA68C", "company": "Quantum Devices Inc", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2004-01-16", "observed": "2026-09-18", "amount_usd": 69992, "summary": "NASA SBIR Phase I award $69,992: Accelerated Wound Healing Device Using Light Emitting Diodes (LEDs) Biostimulation to Support Long Term Human Exploration of Space", "source_url": "https://www.sbir.gov/awards?search=035643"}, {"id": "sbir:DOD:W911QY-04-C-0026", "company": "Luna Innovations Incorporated", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2003-12-12", "observed": "2026-09-18", "amount_usd": 69936, "summary": "DOD SBIR Phase I award $69,936: Antimicrobial and Hemostatic Wound Dressings", "source_url": "https://www.sbir.gov/awards?search=A032-0989"}, {"id": "sbir:DOD:W31P4Q-04-C-R051", "company": "Ascension Technology Corporation", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2003-12-11", "observed": "2026-09-18", "amount_usd": 993882, "summary": "DOD SBIR Phase II award $993,882: Metal-Tolerant MicroTracking Device for 3D Localization in Robotic Medical Procedures", "source_url": "https://www.sbir.gov/awards?search=02SB2-0479"}, {"id": "sbir:DOD:W31P4Q-04-C-R015", "company": "Md Biotech, Inc.", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2003-12-10", "observed": "2026-09-18", "amount_usd": 558362, "summary": "DOD SBIR Phase II award $558,362: Novel Concepts for Soldier-Centric Technology in Non-Traditional Combat Casualty Care: Ocular Scanning Instrumentation", "source_url": "https://www.sbir.gov/awards?search=02SB1-0317"}, {"id": "sbir:NASA:NNC04CA11C", "company": "Los Gatos Research", "kind": "sbir_award", "kind_label": "SBIR/STTR award", "date": "2003-12-01", "observed": "2026-09-18", "amount_usd": 599963, "summary": "NASA SBIR Phase II award $599,963: Novel Medical Diagnostic Instrument Based on Real-time Breath Analysis", "source_url": "https://www.sbir.gov/awards?search=023869"}, {"id": "hde:H020003", "company": "Medtronic, Inc", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2003-11-21", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H020003: CONTEGRA PULMONARY VALVED CONDUIT", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H020007", "company": "medtronic neuromodulation", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2003-04-15", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H020007: MEDTRONIC ACTIVA DEEP BRAIN STIMULATION", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H020002", "company": "stryker neurovascular", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2002-09-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H020002: NEUROFORM MICRODELIVERY STENT", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H010004", "company": "abbott vascular-cardiac therapies", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2002-08-09", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H010004: NEUROLINK SYSTEM", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H010005", "company": "smith & nephew, inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2002-03-22", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H010005: ASCENSION PIP", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H010002", "company": "olympus biotech corporation", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2001-10-17", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H010002: OP-1 IMPLANT", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H010001", "company": "encore medical l/p. d/b/a djo surgical", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2001-08-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H010001: METACARPAL PHALANGEAL JOINT IMPLANT", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H990013", "company": "ortec intl., inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2001-02-21", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H990013: COMPOSITE CULTURED SKIN", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H000001", "company": "abbott vascular devices", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2001-01-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H000001: JOMED JOSTENT CORONARY STENT GRAFT", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H990012", "company": "Cardiovascular Diagnostics, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2000-05-11", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H990012: TAS ECT TEST", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H990014", "company": "enterra medical, inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "2000-03-31", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H990014: GASTRIC ELECTRICAL STIMULATION (GES) SYS", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H980006", "company": "boston scientific corporation", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "1999-12-10", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H980006: MDS NORDION THERASPHERE YTTRIUM-90 GLASS", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H980007", "company": "Shelhigh, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "1999-09-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H980007: SHELHIGH NO-REACT PORCINE PULMONIC VALVE", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H990003", "company": "American Medical Systems, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "1999-09-20", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H990003: ARTIFICIAL BOWEL SPHINCTER PROSTHESIS", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H980008", "company": "mdci medical device consultants, inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "1999-02-19", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H980008: NEUROCONTROL VOCARE BLADDER SYSTEM", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H980005", "company": "mdci", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "1998-12-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H980005: NEUROCONTROL CORPORATION VOCARE BLADDER", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H980002", "company": "encore medical l/p. d/b/a djo surgical", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "1998-09-28", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H980002: PROXIMAL INTERPHALANGEAL (PIP) FINGER JO", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H970005", "company": "Possis Medical, Inc.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "1998-04-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H970005: PERMA-FLOW CORONARY GRAFT MODEL 2C10", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H970004", "company": "fresenius medical care", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "1998-04-06", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H970004: IMMUNOSORBA PROTEIN A COLUMN AND IMMUNOS", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H970003", "company": "william e. kaplan, m.d.", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "1997-12-16", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H970003: URO-STIM THERAPEUTIC STIMULATION UNIT", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H970001", "company": "Rocket Medical PLC", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "1997-09-30", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H970001: KCH FETAL BLADDER DRAINAGE CATHETER", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}, {"id": "hde:H960001", "company": "cook incorporated", "kind": "fda_hde", "kind_label": "FDA HDE approval", "date": "1997-02-14", "observed": "2026-09-18", "amount_usd": null, "summary": "FDA HDE approval H960001: HARRISON FETAL BLADDER STENT SET", "source_url": "https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions"}]}